PRESIDENTIAL COMMISSION ON THE HUMAN IMMUNODEFICIENCY VIRUS EPIDEMIC RESPONSE TO THE PANDEMIC BY THE UNITED STATES This Hearing was held at THE PAN AMERICAN HEALTH ORGANIZATION AUDITORIUM WASHINGTON, D.C. Tuesday, April 19, 1988 COMMISSIONERS PRESENT: ADMIRAL JAMES D. WATKINS, CHAIRMAN THERESA L. CRENSHAW, M.D. RICHARD M. Devos KRISTINE M. GEBBIE, R.N., M.N. BURTON JAMES LEE, III, M.D. FRANK LILLY, Ph.D. BENY J. PRIMM, M.D. CORY SerVAAS, M.D. WILLIAM WALSH, M.D. POLLY L. GAULT, EXECUTIVE DIRECTOR COMMISSIONERS NOT PRESENT: JOHN J. CREEDON JOHN CARDINAL O'CONNOR PENNY PULLEN I-N-D-E-X PAGE PANEL ONE INTERNATIONAL RESEARCH AND HUMAN SERVICES Robert Windom, M.D., Assistant Secretary for 165 Health, Department of Health & Human Services Karl A. Western, M.D., D.T.P.H., Assistant Director 173 International Research, National Institute of Allergy and Infectious Diseases, NIH. William Blattner, M.D., Chief 177 Viral Epidemiology Section, Environmental Epidemiology Branch National Cancer Institute William Heyward, M.D., M.P.H., Chief 179 International Activities AIDS Program Centers for Disease Control Atlanta, Georgia. Department of Defense Colonel William Bancroft, M.D., Director 181 Division of Communicable Diseases and Immunology Walter Reed Army Institute of Research Colonel Donald S. Burke, M.D., Chief 183 Department of Virus Diseases Walter Reed Army Institute of Research PANEL TWO RECIPIENTS OF BILATERAL RESEARCH AND OPERATIONAL AWARDS Allan Rosenfield, M.D., Dean 205 School of Public Health Columbia University W. Henry Mosley, M.D., M.P.H., Director 208 Institute for International Programs School of Hygiene and Public Health Johns Hopkins University Phyllis J. Kanki, D.V.M., D.Sc., Department of 211 Cancer Biology, Harvard School of Public Health Boston, Massachusetts. PANEL THREE BILATERAL ASSISTANCE PROGRAMS: PEACE CORPS David Scotton, Chief of Staff 226 Peace Corps I-N-D-E-X-{ continued) PAGE PANEL THREE (continued) Teresa Van Der Vlugt, M.D., Chief Medical Officer 226 Peace Corps Richard Wall, Peace Corps' AIDS Coordinator 230 PANEL FOUR BILATERAL ASSISTANCE PROGRAMS: AGENCY FOR INTERNATIONAL DEVELOPMENT Alan Woods, Administrator 237 Bradshaw Langmaid, Deputy Assistant Administrator 244 Bureau of Science and Technology Jeffrey Harris, M.D., AIDS Coordinator 246 Barbara Boyle Torrey, M.S., Chief 250 Center for International Research Bureau of Census Kenneth Bart, M.D., Director 252 Office of Health PANEL FIVE THE PRIVATE SECTOR PRIVATE VOLUNTARY ORGANIZATIONS Lewellys F. Barker, M.D., Chief Medical Officer 277 American Red Cross, President, International Society of Blood Transfusion Michael H. Alderman M.D., Chairman of the U.S. 280 Board, African Medical and Research Foundation (AMREF); Chairman, Departments of Epidemiology and Social Medicine, Albert Einstein College of Medicine and Montefiore Hospital David O. Nyamwaua,Ph.D., Director 283 Health Behavior and Education and Child Survival Coordinator, AMREF, Nairobi, Kenya Rufino L. Macagba, M.D., M.P.H., Director 284 International Health Programs, World Vision Relief and Development, Inc. George G. Ngatiri, M.D., M.P.H., Coordinator 286 Africa Region Health Programs, World Vision International RESPONSE TO THE PANDEMIC BY THE UNITED STATES 9:02 a.m. EXECUTIVE DIRECTOR GAULT: Good morning. Ladies and gentlemen, distinguished guests, members of the President's Commission, my name is Polly Gault. I am the designated federal official here and in that capacity it's my pleasure to declare this meeting open. Mr. Chairman? CHAIRMAN WATKINS: Good morning. I'm sorry that my road schedule did not allow me to be here for yesterday's productive hearing when the Commission examined the dynamics of the HIV epidemic in various regions of the world. The Commission looked at the epidemics manifestation in other nations as witnesses from these nations described their response. In addition, we began to look at the multilateral cooperation through the World Health Organization, the World Bank and the United Nations Development Program critical to meeting the challenges that will face the international community since AIDS is a global epidemic knowing no boundaries, borders, races or nationalities. As the Commission seeks recommendations on U.S. policy for the President, we must not fail to address our role in the world community. Today we'll continue our hearings with the response of the United States through our governmental and nongovernmental agencies. We will look at collaborative international research as well as our bilateral and multilateral international research. It is our sincere hope that by bringing together the experts to review the international issues at our hearing, we can participate in fostering international cooperation and collaboration in fighting this pandemic I'd like to express publicly my thanks to my colleague, Dr. Bill Walsh, for his dedication to organizing these excellent hearings and I'm happy to turn over and continue the hearing under his leadership at this time. Dr. Walsh. CHAIRMAN WALSH: Thank you very much, Mr. Chairman. I think that Admiral Watkins has adequately summarized the goings on of yesterday. I know that speaking for the Commission, we were very gratified and stimulated by what we learned and by the discussions that took place. And I know that they, as will the hearings today and tomorrow, contribute a great deal to the input that is so necessary for a proper and adequate report to the President. 164 International Research and Surveillance Programs CHAIRMAN WALSH: This morning the first section is on the international research and surveillance programs of the United States and our opening speaker is Dr. Robert Windom, the Assistant Secretary for Health at the Department of Health and Human Services who bears a great burden of responsibility in the fight against AIDS. In addition to all of ‘the duties that the Secretary's office carries, and I think of all the assistant secretaries this office carries the greatest burdens of responsibility. He also chairs the Interagency Task Force which was pulled together to coordinate the efforts against this dread disease. So without further ado, Dr. Windom, would you please give us the benefit of your thinking? DR. WINDOM: Thank you, Dr. Walsh and Mr. Chairman and members of the Commission. Thank you for the opportunity to be with you here this morning to discuss our Department's role in international research and surveillance programs. As you are aware, President Reagan has identified AIDS as this Administration's number one health priority. As the Assistant Secretary for Health one of my foremost duties is the oversight of AIDS related activities within the PHS, the Public Health Service. Many of these are international in scope since AIDS is a disease that transcends geographical and political boundaries. This was clearly emphasized at the recent World Summit of Health Ministries in London, which I attended with over 130 countries reporting AIDS cases to the World Health Organization. Therefore, we have every reason to approach this as a global problem. Today, I want to tell you about our efforts in the international arena. International collaboration has always been an integral part of the Public Health Service programs. One of the most fruitful examples of such interactions was the identification of the Human Immunodeficiency Virus, the HIV, as the etiological agent for AIDS by scientists at the National Institutes of Health here in the United States and the Pasteur Institute in France within two years after the recognition of AIDS as a new clinical condition was noted. Since that time, there have been numerous collaborative studies and exchanges of information between PHS researchers and their international counterparts. Such collaborative exchanges of information have been useful in the development of epidemiological studies, diagnostic tests, drug evaluation and vaccine development programs. In general, many of our international activities do not have separate appropriated funds, but instead are the results of 165 informal relationships developed from the need to share information. Most are funded from existing agency budgets through grants and fellowships rather than with specific allocations. There are, however, many projects being supported by the various agencies from their own funds for international collaborative studies. The PHS works very closely with the World Health Organization (WHO) and the Pan American Health Organization (PAHO). Many of the WHO and PAHO AIDS projects, such as the National Institutes of Health's collaborative effort with PAHO to study AIDS in the Caribbean are funded by our PHS. In addition, several PHS agencies have been designated by WHO as collaborating centers for AIDS and HIV, and in the future these agencies will be participating in studies providing scientific advice and, providing or exchanging research reagents with WHO and WHO-sponsored investigators. As early as 1984, PHS started one of the largest cooperative efforts, Projet SIDA, which is a French acronym for AIDS. This is a joint effort by NIH, the CDC, the Institute of Tropical Medicine, Antwerp, Belgium, and the Zairian Ministry of Health to study AIDS in Zaire. Data from this project clearly demonstrated the heterosexual transmission aspects of the virus. Recently the government of Zaire with CDC, NIH, the Armed Forces Institute of Pathology, and the Belgian Institution of Tropical Medicine undertook a major study in Kinshasa, Zaire to promote further understanding of the epidemiology of AIDS in Africa. Similar studies as well as less formalized collaboration are under way in other African countries. In another arena, Department scientists are continually participating in internal AIDS related meetings and symposia. Many, including myself, will be participants in the upcoming 4th International Conference on AIDS which will be held in Stockholm in June. Presentations and work groups with an international composition will cover nine areas of importance to the AIDS epidemic including: the pathogenesis and immunology, anti-viral therapy, problems in the development world, prevention, clinical management, psycho-social aspects, and health care and society. Most recently, the AIDS coordinator in my office has initiated plans for using computers to communicate electronically between our PHS and our international counterparts to further enhance the rapid exchange of information. He personally meets with his non-U.S. government counterparts and coordinators ona regular basis. A very special subset of international collaboration is represented by the AIDS specific training of many foreign 166 scientists at our own agency's laboratories. This program started at the very beginning of the epidemic and has significantly increased since then. As you can see, the range of problems being addressed by the international community is, indeed, broad. I would like now to discuss some of the specific efforts which are under way at several agencies within the PHS. Let's look at the NIH. The NIH and all of its institutes are involved in numerous international collaborative efforts, some of which will be discussed in greater detail by Dr. Western and Dr. Blattner who are here today. However, I would like to briefly just mention a few of these projects. Cooperation between NIH and the Pasteur Institute not only led to identification of the HIV as a cause of AIDS, but also to the subsequent development of tests in order to measure antibodies to the AIDS virus. This has contributed enormously to our ability to help ensure the safety of the blood supply and to enable us to track the spread of the disease. One of NIH's major international efforts is through the John E. Fogarty International Center for Advanced Study in the Health Sciences which was established in 1968 to provide a focus and organizational mechanism for NIH activities in international biomedical research. Among the general purposes of the Fogarty Center are: 1: To further international cooperation and collaboration in life science research programs, conferences and seminars. 2: To facilitate the assembly of scientists for discussion, study, and research relating to the development of health sciences internationally. 3: To provide postdoctoral fellowships for research training in the United States and abroad and promote exchanges of senior scientists between the United States and other countries. Let me tell you about two of the Fogarty Center's FY 1987 efforts on AIDS. First, the organization of the Third International Conference on AIDS, which was attended by more than 7,000 persons from the international community last year. Second, the development of guidelines for awarding fiscal year '88 AIDS research fellowships for individual scientists and institutional grants for collaborative research in AIDS. Just recently, the Fogarty Center invited applications from U.S. institutions with interest in developing international 167 training programs in epidemiology related to AIDS for foreign health scientists, clinicians, and allied health workers. I will not elaborate further on the collaborative research efforts sponsored by the Fogarty Institute since Dr. Western will describe some of these in his testimony. Now to the National Cancer Institute. Clinical trials of anti-AIDS therapeutics by the NCI and international scientists led to the approval of AZT as the first drug of proven efficacy to be used against AIDS. The epidemiology program of the NCI uses the research contract mechanism to support bilateral research studies such as those in the Caribbean Basin where NCI is helping to define epidemiological issues. African studies by NCI grantees have led to the discovery of the HIV-2 class of viruses in West Africa. Now NIAID. In June of 1987 the National Institute of Allergy and Infectious Disease and PAHO began a five year research contract entitled "Studies of Human Immunodeficiency Virus and Related Retrovirus Infection in Latin America and the Caribbean." This institute has also launched a program for international collaboration on AIDS research, which is open to U.S. research institutions and is designed to encourage multidisciplinary collaborative research with foreign institutions. At least 70 percent of the research must take place outside the United States and the research areas are broad and flexible. ADAMHA. Within another agency, the Alcohol, Drug Abuse and Mental Health Administration, the National Institute on Drug Abuse, NIDA, entered into an interagency agreement with the Mexican Minister of Health in order to initiate a surveillance and prevention program to help stem the spread of AIDS among IV drug abusers along the U.S./Mexican border. NIDA also sponsors a computerized filing system of ongoing research studies which is international in nature. The National Institutes of Mental Health, NIMH, through the Centers for AIDS Prevention Studies, CAPS, has initiated the Rwanda Project. They are studying risk behavior and information, attitudes and belief about AIDS, in a cohort of seronegative females with either HIV seropositive or HIV seronegative partners. These women will later be tested for changes in their antibody status and monitored for the subsequent development of AIDS. It will be valuable to have this information about cultures different from our own. As discussed by Dr. Young yesterday, the Food and Drug Administration will be collaborating with WHO to further advance the knowledge base of diagnostic tests and the safety of blood- 168 derived products. In addition, the FDA does permit the export of unapproved products for investigational use. This provides another avenue for the advancement of knowledge and the development of potentially useful data on new products. cDc. As a source of expert technical knowledge in disease prevention and control, CDC has provided assistance in the development of AIDS strategy plans for many countries including Colombia, Haiti, Panama, Rwanda and the Sudan. CDC also assisted PAHO by investigating the HIV prevalence in plasma from paid donors in Mexico. In collaboration with WHO, CDC helped in planning national programs to assess high-risk sexual behavior in various populations. In other major programs, CDC provides training on AIDS surveillance and in the serodiagnosis of HIV infections. These programs have involved such countries as Australia, Canada, France, the United Kingdom, Brazil, Mexico, and Egypt. We have Dr. Heyward here with us today to further elaborate on CDC's activities. As a final example, in a PHS interagency effort, CDC, FDA, and NIH are collaborating to develop HIV vaccine efficacy studies in Africa which will complement the PHS national efforts here. Finally, I would like to discuss an interdepartmental working group, the Federal Coordinating Committee, FCC, which I established in 1986 as a way to update other federal departments and agencies on our PHS AIDS activities. The FCC also serves as a forum for these groups to discuss international implications of key policy and operational issues. Currently represented on the FCC are seven departments, these are Agriculture, Defense, Education, Justice, Labor, State, HUD and also six agencies, ACTION, A.I.D., EPA, OPM, USIA and the Voice of America. Over the past year and a half, the FCC has become a major conduit for information exchange both within the United States government and also with other nations. Because of its expanded role in both international and work place issues, I would like to increase the FCC membership and I've invited all federal departments and agencies to participate. With regard to international coordination, A.I.D. has recently asked through our FCC for an enhanced collaboration with the Public Health Service. A.I.D. is responsible for directing the economic assistance activities of the United States with the developing world and recently received a mandate by Congress to coordinate efforts with other federal agencies regarding AIDS issues and to ensure that domestic AIDS efforts that are relevant, be shared with developing countries. It also required A.I.D. to share with U.S. entities its knowledge of international activities. To establish this information flow, A.I.D. will use the FCC as a forum to gather specific AIDS data 169 from FCC components involved in international efforts such as DOD and HHS. A.I.D. will then share information emanating from the Fcc with the international community. Currently, budget information and brief project reports regarding international AIDS activities are being prepared for A.I.D. by the FCC member agencies and departments. Let me conclude by saying that the Public Health Service is committed to doing all that we can in the international arena to contain the further pandemic spread of HIV and the resulting devastating disease which has already so seriously effected many regions of the globe. We will continue to use our energies and our resources by sharing information and collaborating with the world community of scientists in order to achieve this end. No greater priority exists. Thank you, Dr. Walsh, Mr. Chairman, members of the Commission. I'll be happy to answer any questions I can. CHAIRMAN WALSH: Dr. Windom, are you going to have to go back to the department or will you stay while these other gentlemen -- DR. WINDOM: I'm going to have to leave, sir, but I will be here for any questions that you have. CHAIRMAN WALSH: No. The point being that if you were going to stay, we'd delay the questions. But if you're going to have to leave, I'll give the panel the opportunity to ask you questions now. DR. WINDOM: I'd like to do that. CHAIRMAN WALSH: Since he didn't get a chance to ask a question all day yesterday since he wasn't here, we'll start with our Chairman. CHAIRMAN WATKINS: One of the things I'd like to know is what is the U.S. responsibility to funding both to the World Health Organization in its international efforts on AIDS discussed yesterday as well as to Pan American Health or any other international organization? Is there an agreement that we would make a certain contribution and to what extent have we met that responsibility so that I have some feel for where we stand in carrying out our international responsibilities to be a major participant in the international effort? DR. WINDOM: Yes, Admiral. The United States, is a major contributor to WHO. In fact, the requirement of our budget amount is about half of their total budget. However, several years ago Congress acted to cut back funding for the total year and programs that we were involved with, that also included our contribution at that time to WHO. So consequently, we were in 170 arrears for a number of years and still are. However, we're making amends to that now by adding more. In fact, that deficit now is much less. I can't give you exact figures, but I think we're in the $30 million range, whereas we were up to $120 million or more in deficit. So we're meeting that obligation as best we can, but the reason for being behind is because of the unilateral across the board cut in funding by the United States. And then to PAHO, PAHO is one of the six regions of the WHO and, receives its budget from WHO as one of its six components. And then we do, on occasion, make certain grants to PAHO directly. Those dollars and figures and amounts I can get for you, but I don't have the exact figures right now. CHAIRMAN WATKINS: I'd like to have that and also I'd like to know if there is any sort of special mechanism on the issue of AIDS or is it thrown into the total pot and allocated, in routine fashion? DR. WINDOM: WHO did make a specific request for AIDS funding beyond its regular request for the general budget. And we have funded them for an AIDS grant and I don't know that exact amount right now, but we can get that for you, too. But AIDS has been a separate request which we have funded along with eur continuing funding for a major budget. CHAIRMAN WATKINS: Maybe Dr. Walsh could expand on this, but I'd like to know if you would send me a letter giving me the funding profile of any agreements that we have made in prior years, the degree to which we have kept those commitments. Then specifically how that has reflected on our participation in the international AIDS effort. DR. WINDOM: Yes, sir. CHAIRMAN WALSH: All right. Ms. Gebbie. MRS. GEBBIE: One of the areas we covered a little bit yesterday was the occasional feelings of countries, developing countries particularly, of programs being shoved down their throats, things that they might not otherwise do as a condition of getting money. We also heard at least some things about the disconnectedness of various projects done by a university which happened to have a contact in a country, so it's gone in and done it. What perspective do you have on the processes now in place to try and eliminate that discontinuity and also to respect the individual differences or variances of the countries that might be recipients of our efforts? L171 DR. WINDOM: We certainly are concerned about that discordancy because it doesn't lead to the best results, really and, of course, we work in collaboration closely with WHO and with our coordinated work within the federal government so that each department, each agency that does deal with international programs can work in a fashion that will be most effective and not duplicative. And we talk to a country first before going into it to see if they are receptive, to see what they have ongoing and what we can do to work with their minister of health and their health officials. And that's often through the channels of WHO. We feel very strongly that must continue, but we also realize that at the early stages where we are with this disease, and knowing the world's concern about it, there will be those who may go forth a little bit sooner and may start ina country and may find out it's not going to be effective then, that will be resented. So we must work toward that goal so that the efforts are the most efficient, and the most economical provided with the reacceptance and welcoming of those countries. CHAIRMAN WALSH: Theresa? Frank, how about you? Cory? I really appreciated your summary of the coordinated activities. It will be helpful to us and we will appreciate the information the Admiral requested. I think we have a general knowledge of it, but we really don't have the specific knowledge and I was under the impression, until this week that we were well along in resolving the whole thing and then some things have happened. And I'd like your viewpoint on what we can do to remedy what got things off track a little bit on the payments to WHO. DR. WINDOM: Well, the reason it got off track originally was by the direction of Congress -- CHAIRMAN WALSH: But I think that recently the Administration has taken steps to rectify that. DR. WINDOM: That's right. CHAIRMAN WALSH: And, as you well know, now, it got off track again and we were hoping that would be resolved before we all went to Geneva. And anything you can do to help that, we'd be grateful for. . DR. WINDOM: It is embarrassing to go there under those circumstances, not to have the support. But then you have to recognize our own internal situation, too. CHAIRMAN WALSH: Well, thank you very much, Bob. 172 DR. WINDOM: Fine. Thank you. CHAIRMAN WALSH: All right. Will the next panel please come to the table? I would say that this next panel will overwhelm the Commiscion with all sorts of intelligence. The members of the panel are all outstanding in their own fields and we will begin with Dr. Karl Western, the Assistant Director for International Research at the National Institute of Allergy and Infectious Diseases in Bethesda and Dr. Western wanted to get started right away. DR. WESTERN: Mr. Chairman, members of the Commission, I am here today to provide an overview of international efforts in AIDS research supported by the National Institutes of Health. The NIH is the agency of the domestic U.S. Public Health Service responsible for basic and clinical biomedical research and research training. The authority of the NIH to conduct international research is the International Health Research Act of 1960. This act authorizes the NIH to "advance the status of the health sciences in the United States and thereby the health of the American people through cooperative endeavors with other countries in health research, research planning, and research training." The NIH is a decentralized agency. It consists of 15 institutes or centers which carry out research and five divisions which provide research support. In fiscal year 1987 the total NIH appropriation was $6.18 billion, of which $261 million or 4.7 percent, was specifically for AIDS research. AIDS research is expected to increase, to $468 million this current fiscal year and $588 million in fiscal year 1989. NIH research is carried out intramurally by NIH scientists in our own laboratories or extramurally through competitive research award to academic institutions. Intramural research accounts for only 15 percent of the total NIH budget. The remaining 85 percent is distributed through investigator initiated research grants, NIH research contracts to conduct applied research, and cooperative agreements which are developed by outside investigators but provide for significant NIH staff participation in their management. With the exception of the Fogarty International Center, the NIH does not have an international research account. All foreign awards and international collaboration are funded out of each Institute's domestic research budget. NIH international AIDS research funding is summarized for the six components of NIH which reported international AIDS research in a recent survey. Overall, in fiscal year 1987, international AIDS research constituted $6.5 million of the $261 million (2.4 percent) of the total NIH AIDS research budget. 173 This percentage is expected to be approximately 4.5 percent with correspondingly increased amounts for international research in fiscal year 1988 and 1989. NIH conducts international exchange and collaboration in five different ways. The first and most immediate is direct collaboration with NIH intramural laboratories and scientists. The second is through competitive extramural awards to foreign investigators. Non-U.S. scientists are eligible to apply for NIH grant awards and receive the same scientific peer review as domestic applicants. In order to be funded, foreign grant applications must both be scientifically approved by the initial review group and be in the top 50 percent of approved grants in that trimester. Foreign institutions are eligible to participate in NIH cooperative agreements. Federal contract law, however, specifies that contracts must be awarded to a U.S. contractor unless there are no qualified U.S. responders or the workscope can only be carried out by a foreign contractor. The third NIH approach to international collaboration is through domestic research awards with a foreign component. This frequently occurs spontaneously in the regular investigator- initiated grant process. From time to time, individual institutes may develop a special emphasis award program to promote international research collaboration. NIAID's new International Collaboration in AIDS Research (ICAR) Program, to which Dr. Windom has already referred, is the most recent example of promoting international research through domestic U.S. institutions. Fourthly, while NIH prefers to foster international collaboration through scientist-to-scientist channels, we do utilize bilateral agreements between the U.S. and foreign governments in biomedical research or science and technology, when these formal channels are mutually advantageous and expedite scientific cooperation. Fifth, but certainly not least, NIH works in close collaboration with multilateral agencies, particularly the World Health Organization and the WHO Global Program on AIDS. The first slide, summarizes NIH international AIDS research activities which are concentrated in epidemiology, particularly in the national history and risk assessment of AIDS; virology; pathogenesis including the evaluation of co-factors in other countries and cultures; treatment particularly the development and evaluation of anti-viral agents and immunomodulators; and vaccine development. NIH currently supports AIDS related research in 35 countries shown in the second slide. These projects and 174 activities are summarized individually in Annex One in my written deposition, which the Commission members already have. The National Institute of Allergy and Infectious Diseases is engaged in collaboration in AIDS with 17 of these countries at the present time. The major NIAID projects are summarized in the next two slides. As a result of the observation in 1982 that AIDS was occurring in Haitian men with no obvious risk factors, NIAID and the Pan American Health Organization brought together Haitian and U.S. investigators both in Washington and Port-au-Prince to exchange information. This has resulted in an NIAID grant to Cornell University to study the epidemiology of AIDS in Haiti. Last year, NIAID initiated a research contract with PAHO and the PAHO/WHO Caribbean Epidemiology Center in Port of Spain to study the natural history and epidemiology of AIDS in the 21 participating Caribbean governments. The NIAID-PAHO contract also provides for similar studies throughout Latin America. Shortly after initiation of these AIDS studies in the Caribbean, AIDS was observed to be occurring equally in heterosexual Central African men and women seeking medical attention in Europe. Projet SIDA, to which Dr. Windom has also referred, is a multidisciplinary study initiated in 1984 by the NIAID intermural program, the Centers for Disease Control, the Institute of Tropical Medicine at Antwerp and the Zairian Ministry of Health. Projet SIDA, which is based in Kinshasa, has clearly documented heterosexual transmission of AIDS from men to women and women to men. Efforts continue to elucidate risk factors for transmission, the natural history of HIV-1 infection and the immunopathogenesis of AIDS in the African setting. NIAID has also recently initiated a research award to the University of California in San Francisco for the study of heterosexual HIV=-1 and AIDS in Rwanda. To promote further international scientific collaboration in combatting AIDS, NIAID will soon announce the first program project grant awards in the International Collaboration in AIDS Research Program. The ICAR Program will link U.S. institution to foreign counterparts in Latin America and Africa. At least 70 percent of the research must be conducted outside the USA in a truly collaborative fashion. Perinatal and pediatric HIV infections, heterosexual transmission, geographical variation in HIV isolates, correlation of HIV variation with infection and expression of disease, and the role of co-factors in susceptibility to HIV infection and the development of AIDS will be of special emphasis to the ICAR progran. 175 During the past year, AIDS research has been added to existing bilateral biomedical research agreements with France, the Federal Republic of Germany and Japan. This afternoon, for example, an NIAID intermural staff scientist is leaving for Bonn to participate in the scientific review of AIDS research proposals submitted to the West German Federal Research Ministry. In July, an AIDS panel will be added to the U.S. Japan Cooperative Medical Sciences Program. Less formal collaboration has also developed in AIDS research with Canada, Sweden and the United Kingdon. These bilateral agreements with other industrialized countries differ from the collaborative research previously described in developing countries in their emphasis on basic AIDS research, the development of drugs and vaccines, and clinical trials. Japan represents a special situation because of its considerable pharmaceutical infrastructure and capability to develop drugs and biologicals, but so few AIDS cases and HIV infected individuals are in the Japanese population that it may be difficult or impossible for the Japanese to conduct Phase II and Phase III studies in their own populations. By contract, European institutions are expected to develop protocols comparable to those conducted in the USA and participate in multi-center trials of drugs and vaccines. Since Dr. Blattner of the National Cancer Institute will testify next, I will not go into any detail concerning the international AIDS activities of his institute. At present the National Institute of Child Health and Human Development funds research grants to the University of Washington to investigate the effect of HIV infection on maternal and child health in Kenya and to the University of California/San Francisco to study the perinatal transmission of HIV in Rwanda. Planned activities in fiscal years 1988 and 1989 include the role, if any, of breast feeding on HIV transmission in Africa and the screening of newborns for HIV infection in Spain, where intravenous drug abuse is a major risk factor. This year the Fogarty International Center has received funding and will initiate: (1) an international postdoctoral research program in AIDS and (2) international training grants in the epidemiology of AIDS. These awards will be made to US institutions to conduct international research training in the USA and overseas. The Fogarty International Center is also prepared to fund international AIDS activities in domestic research grants received by other NIH institutes and the ICAR program on a case by case basis. I should mention that the NIH has recently been designated a WHO collaborating center for AIDS research. Dr. Anthony S. Fauci, Director of NIAID and the NIH AIDS Coordinator 176 is the principal scientific contact. At NIH we appreciate this honor and look forward to even closer collaboration with WHO to apply research advances rapidly to the prevention and control of the AIDS pandemic. A final point is that many NIH domestic research awards do have an international component. For example, later this month an NIAID funded AIDS Research Repository will become operational. This five year, $8 million research support center will be available to all scientists in the world and will be one of three WHO reference centers. Thank you very much for your attention. I will be pleased to answer any questions at the conclusion of the panel. CHAIRMAN WALSH: Thank you, Dr. Western. Our next presenter is Dr. William Blattner, Chief of Viral Epidemiology at the Division of Environmental Epidemiology, National Cancer Institute in Bethesda. DR. BLATTNER: Mr. Chairman, members of the Commission, I appreciate the opportunity to share with you the NCI program of international AIDS research collaboration. In my oral presentation I would like to highlight by example some of the approaches that are detailed in my written testimony. In the history of the co-discovery of the AIDS agents, HIV, I have worked closely with Dr. Robert C. Gallo and seen and experienced the benefits of the kind of international scientific interchange that lead to new insights and progress which are a direct spinoff of direct person-to-person interaction. Of the meetings that I have attended with Dr. Gallo and our colleagues from France, perhaps two of the most important were those sponsored jointly by NCI and the Association for Cancer Research, the major French cancer research foundation. These international meetings provided avenues for sharing of data informally during the early days surrounding the first detection of HIV and the subsequent proof that a retrovirus caused AIDS. This tradition continues with the annual laboratory meetings organized by Dr. Gallo which bring together scientists from all over the world for informal presentations and many discussions, an approach that compliments the larger international meetings such as that to be held in Stockholm this June. The advantage of these small or informal meetings is that they serve to spawn the kind of direct substantive research collaboration that will be required to integrate the multidisciplines necessary for advances in therapy, vaccines and fundamental understanding of the natural history of disease. My own international epidemiologic research has centered on studies of HIV in the Caribbean basin and Africa. Since there are many excellent researchers and research groups 177 working in these areas, my own focus has been on identifying what I think are important gaps in our knowledge or new leads that need to be pursued. Our epidemiology research team consists of ten professionals who have a variety of commitments to projects in the U.S. and abroad. Therefore, we try to focus our energies on issues of broad significance, but in a targeted way. In particular, we have a long range interest in the issue of immunodeficiency in cancer and the insights to be gained from this epidemic which will benefit those at risk for AIDS and cancer. Thus, it is of interest in our studies of HIV among gay men in Trinidad that one developed a type of leukemia probably linked to his co-infection with human T-cell lymphotropic virus Type 1 (HTLV1). In addition, persons infected with both viruses seem to develop AIDS at a more rapid rate than those singly infected with HIV. This raises questions about the possible interaction of human retroviruses of relevance to drug abusers in the U.S. as well as among populations in Africa and elsewhere where coinfection with more than one retrovirsus could result in adverse interactions. We are pursuing this issue among larger numbers of coinfected individuals from the homosexual and heterosexual community in Trinidad. As part of this follow-up we were surprised that three percent of persons attending a clinic for sexually transmitted diseases in Trinidad were seropositive for HIV and we are now pursuing an analytic study to learn about the efficiency and cofactors for transmission. This study has the advantage that unlike studies of heterosexual transmission in the US, parenteral drug abuse is not a significant source of HIV infection in Trinidad and unlike some areas of Africa, because of an advanced health care system. In Trinidad needles are not reused in the medical setting. Some of our early epidemiologic studies in Africa focused on HIV infection in various populations. These studies provided some of the first quantitative estimates of the magnitude of HIV infection in some urban populations. More recently our focus has shifted to studies of HIV cancer relationships, especially in areas where over 60 percent of all cancers are linked to viruses. In one study we are tracking the new introduction of HIV into a remote area of Central Africa where Burkitt lymphoma has been an ongoing focus for over 20 years. This study not only promises to provide new information on the risk factors for spread of HIV to non-urban areas of Africa, but also provides the opportunity to track prospectively changes in the incidence of Burkitt lymphoma in the study area. 178 On a broader scale, NCI is developing a project in conjunction with the International Agency for Research on Cancer (IARC) to augment cancer registration activities to include HIV surveillance to look for changes in clinical patterns and incidence of certain cancer types with a possible link to immunodeficiency. In turn, biologic materials from such cases may prove valuable to basic cancer researchers in the study of mechanism of carcinogenesis. In summary, the emphasis of NCI international activities has been on the development of person-to-person collaborations focused on answering specific questions to the benefit of our understanding of the AIDS epidemic. I'll be glad to answer questions. Thank you. CHAIRMAN WALSH: Thank you very much, Doctor. Next we have Dr. William Heyward, Chief of International Activities, AIDS Program, CDC in Atlanta. DR. HEYWARD: Mr. Chairman and members of the Presidential Commission, I'm pleased to be here today to discuss cDc's international activities in AIDS from 1984 to 1987 and our proposed activities for fiscal year 1988. Since it was first reported in 1981, AIDS has been recognized worldwide with severe health and economic consequences. The detrimental effect of AIDS has been global, but its impact on some developing countries has been the most dramatic. The need for a global effort to combat AIDS is urgent. The 1986-87 World Health Assembly charged WHO to provide leadership in the global struggle against AIDS. WHO has quickly assumed this role as the lead organization to coordinate the international prevention and control of HIV infection and AIDS. At WHO's request, CDC detailed Dr. Jonathan Mann to WHO to serve as Director of the Global Program on AIDS. The AIDS program, Center for Infectious Disease of CDC, has also been designated by WHO as a WHO Collaborating Center for AIDS. In FY 1987, CDC AIDS Program staff at the request of WHO, made 15 short-term consultations to WHO headquarters in Geneva and additional consultations to regional offices to provide technical assistance to the Global Program on AIDS. In addition, CDC has responded to requests for assistance from 23 countries. To further provide assistance and a focal point for coordination of epidemiology and research in international AIDS, cDc has developed an International Activities office in the Center for Infectious Diseases. cbc is presently involved in a major AIDS project in Kinshasa, Zaire called Projet SIDA, which had led to a greater understanding of the epidemiology of HIV infection and AIDS in Central Africa. Projet SIDA, which began in 1984, is an 179 international collaborative effort between the Government of Zaire, CDC, the National Institute of Allergy and Infectious Diseases of the NIH, the Armed Forces Institute of Pathology and the Belgium Institute of Tropical Medicine. The project employs approximately 90 persons, including 85 Zairian nationals, and has an annual budget of $1.6 million. CDC provides a senior medical epidemiologist to Zaire to serve as the project director. Studies conducted by the project in Kinshasa show that heterosexual transmission of HIV accounts for 80 percent or more of the AIDS cases, blood transfusion and reuse of needles accounts for 5 to 15 percent, and mother to child transmission accounts for about 5 percent. CDC collaborated with Projet SIDA to examine the genetic relatedness of HIV from different geographic locations. Genetic analysis of virus isolates from Zaire, together with analysis of other HIV isolates from the U.S. and from elsewhere, provides important epidemiologic data as well as valuable information for vaccine development. A protocol for evaluating the safety and efficacy of immunizations in HIV-infected and uninfected children was initiated by Projet SIDA in September of 1987. The findings have worldwide significance since inadequate immune response to vaccine antigens in these children could affect the control of other immunizable infectious diseases. Other CDC international AIDS activities supported in FY 1987 included: 1: Assistance in developing and reviewing national AIDS plans for Colombia, Haiti, Panama, Rwanda and Sudan. 2: Technical assistance and consultation in laboratory testing capability in Rwanda. 3: Assistance to the Pan American Health Organization to investigate the prevalence of HIV infection in paid plasma donors in Mexico. 4: Assistance to WHO in developing a protocol and data collection instrument to measure high-risk sexual behaviors in various populations. 5: Training in AIDS surveillance for Australia, Canada, France and the United Kingdon. 6: Conducting courses in the serodiagnosis of HIV infection in Brazil, Mexico and Egypt. Our fiscal year 1988 objectives include: 1: Continued support to and through Projet SIDA. 180 2: Epidemiologic and laboratory studies of HIV-2 in Ivory Coast and Burkina Faso to determine the prevalence of HIV-2 infection and incidence of AIDS-like illness associated with this infection. Using Projet SIDA as the model, a research and prevention project for HIV-1 and HIV-2 will be established in Abidjan, Ivory Coast in May of 1988. A project director has been selected and limited funding has been identified to initiate the project. 3: Training courses on the serodiagnosis of HIV infection will be conducted in Brazil and Pakistan. 4: And continued consultative and technical assistance will be provided to WHO, A.I.D. and other international institutions for an estimated 10 to 15 countries. In closing, I would like to quote from Dr. Halfden Mahler's, Director General of WHO, presentation at an informal briefing on AIDS to the 42nd Session of the United Nations General Assembly on October 20, 1987. "The scientific work to master AIDS, like the disease itself, is now firmly and irrevocably international. In AIDS, there's really no longer any such thing as purely local or even purely national research. Looking to the future, we must also work to ensure that the fruits of international research, drugs for treatment and vaccine, will be available to the entire world." Thank you very much. CHAIRMAN WALSH: Thank you very much, Dr. Heyward. CHAIRMAN WALSH: Next we have from the Department of Defense Colonel William Bancroft who is Director of the Division of Communicable Disease and Immunology at Walter Reed Army Institute of Research. COLONEL BANCROFT: Admiral Watkins, Dr Walsh and members of the Commission, it's a pleasure to be here today. I am going to give you an overview of the DOD research program on HIV and this will be followed by more specific comments about the international aspect of our program by Colonel Burke. The authority for.our programs dates back to 1982 when Congress mandated that the Army be the lead agency for all infectious disease research for the military. Since 1985 we have been mandated by Congress to develop a research program for HIV. We receive our guidance from the Assistant Secretary of Defense for Health Affairs on conduct of this program. Tasking for the DOD HIV research program has come to the U.S. Army Medical Research and Development Command and then passed on to the Walter Reed Army Institute of Research as the 181 lead laboratory. Within the institute, we have expertise in virology, preventive medicine, and clinical treatment of infectious diseases. This has formed the core on which we've developed a research program. This is supplemented by extramural contracts. We play a unique role in the national effort on HIV because of our population, which includes nationwide representatives who travel all over the world, and are predominantly heterosexual. Since the institution of random drug screening, there is a declining instance of drug abuse. In addition to that, we have unique policies for the screening of all, civilian applicants for military service, the active duty force, reservists and National Guard. As a result, we identify more asymptomatic cases of HIV than any other large organization. We feel that this presents a unique opportunity for studying the early aspects of HIV infections. The research is directed in five areas, similar to that of other traditional infectious disease research. Improved diagnosis, natural history, the epidemiology, treatment and, if possible, vaccine development and evaluation. I'm not going to go into great detail about these things, but they all are directed towards the early stages of infection and try to meet the requirements of the Department of Defense and in addition, contribute useful information to the national effort to HIV research. We divide the work, intramural research is done within our own laboratories. This is primarily directed to improved diagnosis, the epidemiology of HIV and interpretation of risk factors in military populations. Clinical studies are done at the Walter Reed Army Medical Center for continuing work on natural history studies and treatment. But all of this work is supplemented by our extramural research contract program, which addresses all five areas of research. Today we have an emphasis on the international aspects of this research. For the DoD, most of this work is carried out through interaction with other services, through inter-service agreements. In particular the U.S. Navy, and extramural contractors who have access to samples from populations in other countries. So all of our work is highly coordinated with the inter-service agreements. It's coordinated with other federal agencies and it is very dependent upon our extramural contract progran. We have a problem with the budget. In 1986 ina supplemental appropriation for the Defense budget, we were 182 granted $33.6 million for HIV research. This was designated money; it could not be used for any other purpose. As you will see in Table One of the prepared statement I submitted to you, by 1989 that money has declined steadily to $8.8 million which is expected. We feel that this reduced level of funding is detrimental to a sustained complete program and that one of the areas which will probably suffer with the declining budget will be our extramural contract program. In conclusion, I'd just like to say that the Army needs a strong research program in retroviruses and particularly HIV to back up the high quality testing program we have underway and to provide valid data on which to base sound policy decisions. The Army plays a unique role in the national effort because we determine the prevalence and the incidence of HIV infections in young adults in this country. In addition, we identify large numbers of early infections in people who could enter into treatment protocols during the early stages of infection. We play a role in the international arena also in seroepidemiology studies which will be described. The HIV research program has strengthened the interaction and the research level between the other services, with other federal agencies and the extramural contract program with civilian agencies. To maintain a complete research program we will need sustained funding at least $20 million a year. Thank you. CHAIRMAN WALSH: Our next speaker is familiar to us. We've had him before us before, Colonel Donald Burke, chief of the Department of Virus Diseases at Walter Reed. COLONEL BURKE: Thank you, Dr. Walsh. Now that my boss has presented the broad brush picture of the HIV research program of the DOD, I will fill in some of the blanks for you. Specifically, I'll talk about the Department of Defense overseas programs. The DOD has a long standing commitment to medical research on diseases that are indigenous in foreign countries. The U.S. Army maintains medical research laboratories in Kenya, Thailand and Malaysia and the U.S. Navy maintains laboratories in Peru, Egypt, Indonesia and the Philippines. And the Uniformed Services University of the Health Sciences has ongoing cooperative studies in Pakistan and in the Zambia. Often the medical military research laboratory is used as a home base for studies conducted in neighboring countries as well. Research projects are approved through formal agreements with the host governments and are conducted with the close cooperation of the local national physicians and scientists. 183 Research work focuses on disease hazards that might be encountered by US military personnel operating in foreign theaters of combat. There is a long history of US military leadership in scientific research on tropical diseases such as malaria, hepatitis, mosquito-borne viruses, and diarrheal diseases. Results of the research efforts are of direct benefit to the cooperating host government as well as to the US military. During the past two years this network of US military medical research laboratories has been utilized to define the epidemiology of retroviruses in South America, in Asia, and in Africa. In addition to the research work conducted by military medical scientists, the Army has also awarded contracts to some civilian groups for research on retroviruses. I have provided a table which shows the ongoing major HIV studies from the Department of Defense. I'11 go through them briefly. There is a contract with Dr. Black at Yale for studies in the Amazon. The Navy Laboratory in Egypt does HIV-1 epidemiology studies and is a WHO reference center there. You heard from three of our research laboratories yesterday and today. That is Mike Kilpatrick spoke about the studies in Asia that the Navy has conducted, Dr. Perine from the U.S. UHS spoke about the Zambian studies yesterday and today Dr. Kanki from Harvard, a contractor, will talk about some of the studies in West Africa. Collectively we have obligated and disbursed only $5.9 million for international HIV research and we think that it's been money well spent thus far. Funding for the military overseas retrovirus research program has been closely collaborated with the National Institutes of Health. Thank you. CHAIRMAN WALSH: Thank you very much, Colonel Burke. Before I start the questioning just a brief comment.- I must say that yesterday I had the impression that there was far less international cooperation and collaboration going on than is apparent from what you all have testified today, which only brings us further to the point of whether there is adequate communication going on along with the collaboration. Because certainly some of the people yesterday highlighted the fact that they were not aware of an awful lot of this. And to me it was most informative and I think I'm delighted to find that we are exchanging knowledge and that we are in constant contact. And I commend you for sharing your research with other countries. What I'm going to do now is I think we'll start. I think we'll start on our left now with Dr. Lee. DR. LEE: Dr. Blattner, one of my pet concerns is a dilution of the money that's going into cancer research filtering 184 out into AIDS research, not that it's bad because the immunodefects that we're finding are so vital to the cancer problem. But I had Mary Ann Roper send me a little summary of her concept of how much money and personnel has slipped out of the NCI into the AIDS effort. And I wonder if you could supply something from your branch to me? Do you understand what I want actually? Is it possible to dissect that type of thing out, budgetarily and for personnel? DR. BLATTNER: I will try to supply that information to you. In my view, our AIDS research program has a great deal of relevance to the cancer issue and I've tried to make some of those points in my testimony. In addition, as I go to the seminars that Dr. DeVita organizes on a regular basis to keep abreast of the research activities of the Institute, much of the research has broad relevance to cancer. For example, in the therapeutics area new anti HIV drugs that are being targeted to specific genes of the AIDS virus, involve new pharmacologic approaches at the molecular level that are totally new and will have direct relevance to anti cancer therapies. As we get down to the fundamental understanding of the genes that are involved in cancer, these new agents which are called antisense compound will be designed then to block the effect of a particular cancer gene. This kind of fundamental work in AIDS is going to have broad spinoffs that will come back to benefit cancer as well. Thus, although we have made a major shift in terms of my own program, for example, into the area of retroviruses, we do spend a good bit of time looking at the related retroviruses, the ones that are more related to the leukemia and lymphomas, for example, HTLV-1. But we also keep our eye on the ball in terms of some of the opportunities such as the ones I mentioned looking at the immunodeficiency aspect of cancer and the etiologic insights that will come from that. In response to your request I will certainly supply information about which personnel have shifted from cancer to AIDS research and also information about which of these personnel slots come from NCI positions and which come from AIDS slots. DR. LEE: It may be that work is so relevant that you can't split it out. That's fine. DR. BLATTNER: Sure. DR. LEE: It's just in talking to Dr. Devita he seemed to be particularly concerned about this point. DR. BLATTNER: Certainly. DR. LEE: And if I could get some kind of handle on it, it might eventually be reflected in our recommendations. 185 DR. BLATTNER: Okay. I'll be glad to do that. DR. LEE: Thank you. CHAIRMAN WALSH: Are you finished? All right, Dr. Primm. DR. PRIMM: I would like to ask the panel what vehicle are you using to disseminate the results of your research to not necessarily people in academia, but people who are on the firing line dealing with the HIV infection? It becomes increasingly important for persons like myself who are working in the natural laboratories, and communities around the nation to have access to some of the results of your research, information that would help us tremendously. For example, you talked this morning about HIV-1 and HTLV-1 concomitant infections in people maybe hastening the onset of full blown opportunistic infection or AIDS itself. Information like that filters down to us very slowly. What are you using and what do you see could be done to facilitate that if it's not already being done and I'm just not aware of it? DR. HEYWARD: At the CDC we respond through various mechanisms. One is, of course, through the formal international conferences such as the upcoming conference which will be held in Stockholm. In many other AIDS conferences as well. More informally, through the consultations at WHO in which WHO brings together experts in certain fields of which we may have a particular researcher or expert present sharing this information to others. This is a very good vehicle I think that WHO provides. Another is at CDC we have a publication called Morbidity and Mortality Weekly Report, the MMWR, which comes out every week with new information. A good example of that was in the recently reported case of HIV-2 in New Jersey. This provides us a mechanism of quickly and over a wide area disseminating new information. The demands on information dissemination are exhausting and we have to balance this demand also with the fact that when our investigators are out of their laboratories and out of their field situations, the projects don't move often times. We could have people on the road all the time, but we have to keep projects going as well. But we do everything we can to disseminate the information as quickly as possible. DR. PRIMM: I understand that. But, you know, we have international conferences once a year and the other conferences that are held throughout the year are generally for specialists and that information doesn't filter out. 186 I'm also concerned with the information, by the Defense Department, Colonel Bancroft and Colonel Burke, which could help us particularly in communities where I serve in New York in a city area where sero prevalence rates among recruits seems to be held close to the vest. This would give policy makers a whole lot of insight into where to target information and education and prevention efforts. We know that minorities are certainly disproportionately effected by both infection and full blown AIDS, but my point is that your information could allow us to target certain areas. And we don't get information until a year or two later. That's the kind of thing I'm talking about. Dr. Blattner, what you discussed earlier today, I am aware of this information. But my colleagues aren't and it's not in the MMWR, as you have indicated, Dr. Heyward. I get the MMWR. And I'm privy to most information. But the information that he put out today about his findings in Trinidad and Jamaica are not currently, as I know of, in science or any of the major journals. This information is important to us. DR. BLATTNER: I'11 just make a comment that it is my own approach as a scientist to publish in the peer reviewed literature. The information concerning the Trinidad data was published in JAMA last May and in Lancet concerning the AIDS incidence in December. I think that the ability to take information which is complex and to disseminate it into a broader community is very important. You make a very good point that we could spend all of our time trying to keep up with all of the new information that gets published here and there. I'm not sure what the best mechanism for promoting the timely and comprehensive dissemination of this sort of information is in an ongoing way. But there might be innovative approaches that the Commission could encourage to improve information sharing. Perhaps the kinds of data resources that the National Library of Medicine (NLM), has responsibility for developing could be targeted to the broad community of scientists and physicians that you mention. NLM currently gets the information out in an abstract form that is easy to read and quick to read. Maybe approaches that we haven't used in the past could be used to disseminate the information more widely. COLONEL BANCROFT: The Department of Defense has made information on the screening program available to the general public through the Centers for Disease Control. And in particular the information of our total HIV program, has been probably as well distributed as any. The research results are still in the early stages, but if the information is not getting to the people who can benefit from it, then that should be a recommendation of the Commission that there be better distribution. 187 DR. PRIMM: Colonel Bancroft, I would agree that your recruit information has been very helpful to the people out in the field. But on your active duty information, it was a year or a year and a half before it was available. I never saw it anywhere and it certainly wasn't in the MMWR on your active duty personnel. And particularly information concerning your officers and minority enlisted personnel, which I thought were absolutely startling and revealing and particularly when we're talking about 4.7 out of every 1,000 black active duty military persons in the Army, being positive for the virus. And if they were no longer married, 6.6 out of every 1,000. And if they were black officers, five out of every 1,000. That is shocking. And I think that information ought to be out there and would help to alert the black community in this nation about the problem. These people are the cream of the crop, that are in the military services and particularly Army officers. Now those statistics, to me, are startling and they ought to be out there somewhere to convince the black community and get them out of the state of denial that they have been in, for a long period of time that would help, in a sense, to begin to get them to practice some prevention and the education efforts that have changed the whole situation in the homosexual/bisexual community. That's what I'm talking about specifically. COLONEL BANCROFT: Dr. Primm, I agree with your desire for the information. One of the reasons why the information has not been forthcoming as fast as the recruit information was the delay in completing the first screening of the whole active force. And there is an interest in analyzing the complete screening process rather than just part of it. Colonel Burke will comment. COLONEL BURKE: I think you've identified what is a genuine and serious problem, not only in the United States but on an international level. That is, any agency or country that does develop good information about the prevalence of HIV within that group or within that country is reluctant to disseminate the information because it's perceived that they are uniquely infected or they are uniquely involved and that somehow that carries with it some aspersions on the character of that group or the character of that country. This is a common problem not only within the United States, but in many of our international cooperative agreements we understand that we will not release information without the full agreement of the host government with whom we work. And we have to respect those if we want to maintain good relationships around the world, which we do. In the past, the Department of Defense has released data on applicants and some information on people on active duty 188 and has seen subsequently headlines appearing in the media saying that the military has a big problem with HIV, as if it were disproportionately associated with the military. I don't think that's the case at all. It's just that the military has the most aggressive program for identifying the persons who are infected and collecting the information. So I don't know what the right answer to that is, how you get around that problem. I think you've identified, a serious problem in our ability to deal with the epidemic, that is the reluctance to bring the information out as quickly as possible. If you or any other agency, let's say the city of New York request directly from the Department of Defense information about county by county prevalence rates among applicants, that would be forthcoming. I know that that's the case. And I encourage any agency to do that. We want for you to use this information. I think it's very valuable. CHAIRMAN WALSH: Dr. ServVaas. DR. SerVAAS: Following up on Dr. Primm's question, we've all been concerned about teenagers and I'm addressing Colonel Bancroft and Colonel Burke -- you test 17 to 19 year old military recruits and could tell us something of the prevalence. And I'd like to know about how many tests have been done? How many 17 to 19 year olds have you tested and what information could you give us about the prevalence in that group in this country and maybe even compared to the countries you test overseas? COLONEL BURKE: On data specifically from the United States and not in the international arena, we've tested a little more than a half a million teenagers. Prevalences vary from one in 20,000 in the north central states in the United States to as frequently as one in 200 in many of the urban epicenters of HIV in the United States, particularly the New York, the Baltimore/Washington area, some Houston and Austin. Some of the areas where there's a fair amount of HIV. Equivalence of perhaps several teenage children per high school in those infected epicenters. That isn't very different than what you find in a number of countries in Africa, other parts of the world where teenagers are infected, where male and female prevalences are the same. And I think it just is a reflection that in that group that the epidemic is moving a little bit away from the original traditional U.S. risk factors and into more of the groups that we don't normally associate with risk of infection, that is teenagers in American cities. The same would be true in teenagers in African cities today. 189 DR. SerVAAS: Can you separate out the women applicants or the teenage girls from the -- COLONEL BURKE: Again, in the United States and among teenagers the prevalence of infection among both males and females is essentially one to one among teenagers. That is, the rates among infected HIV infected teen females is about a 1.4 to one ratio male to female. DR. SerVAAS: Do you use a laboratory like Damon Laboratories -- I believe you use in this country, do you fly the serum back here to be tested or is it done over there? COLONEL BURKE: One of the things that we try to do in any of our studies overseas is to have as much of the testing and as much of the laboratory work done in the host country as possible. We feel that that's one of the ways of establishing a technology transfer to the collaborating host governments. So we do most of the screening work and as much of the confirmatory test work as possible in the host country and then we'll take specimens, selected specimens to confirm the accuracy eof that work. But by and large, no, we do not bring the specimens back to the United States. We encourage testing locally and in fact most of the laboratories that I listed do, in fact, serve as the national and/or regional laboratories for those host governments. CHAIRMAN WALSH: Mr. DeVos. MR. DevOS: I'll pass. Thank you. CHAIRMAN WALSH: Frank, do you have any questions? DR. LILLY: I'd like to ask about training programs. Dr. Blattner, you had in your presentation here a brief paragraph about training. I'd like to hear some more about that. What kinds of training are we doing for other countries, personnel, who desperately need to have the development of health care workers and researchers? How does that intersect with the training that we're doing of our personnel? DR. BLATTNER: Well, I think that there may be others on the panel that will have additional comments to make, so I'll speak from the perspective that my testimony comes from. The type of training that NCI is involved in is two fold. One involves the fact that there are a number of foreign nationals who come to NCI which is part of the tradition of training that we have had for many years at NCI. These are primarily people coming to wok in laboratories and occasionally coming to our own unit, for example, for training in epidemiology. In our overseas work we try to develop training opportunities through our 190 presence on site so that we transfer some of the laboratory or epidemiologic approaches that we are employing to insure the future capability on site. DR. LILLY: So these are the programs that you've had Classically and to which there has always been a certain flow of foreign nationals participating in those training programs? DR. BLATTNER: Yes. DR. LILLY: And there's nothing specific for foreign nationals? DR. BLATTNER: For AIDS, right. Yes. Not that I'm aware of, at least in NCI. It's been integrated into an ongoing program. It may be very well we should do better by increasing the availability of these programs with an AIDS focus. DR. LILLY: Well, I just want to know what exists, in fact, that's what my question's about right now. DR. WESTERN: In the international arena the appropriation of '88 monies to the Fogarty International Center, will be approximately $4.5 billion this year. Their two special programs will be support for US institutions to participate in research training on AIDS both for foreign nationals and to a limited extent the US scientists overseas. While new monies earmarked for AIDS research are being appropriated for NIH, the enhanced effort for research training on AIDS is very modest. There is, a budgetary distinction between new monies for AIDS versus the allocation of additional training slots. The latter has not yet happened. DR. LILLY: That's something that's worried me a great deal, the training that isn't being done. DR. WESTERN: The NIH and the CDC, are using our current level of training slots to include AIDS. We do not have any increase in slots or funds for AIDS training. DR. LILLY: Please hang on to the microphone a moment. I want to ask the others if they have any comments on this problem of training of personnel. But I wanted to ask you for just a one or two sentence summary of what is the funding of the Fogarty International Center? Where does it come from roughly? DR. WESTERN: It is part of the regular NIH budget process. DR. LILLY: Entirely? I mean, that's the entire source? 191 DR. WESTERN: Yes. With respect to the Fogarty International Center's activity on AIDS, this is all regular NIH budget funds. It's a new appropriation earmarked for AIDS. The Fogarty International Center does not have a mission to support research per se. They are one of the divisions at NIH which support research and they are also the only component of NIH which is explicitly international. DR. LILLY: I've always been mainly familiar with it as an international -- organization which fostered international communication and exchange, that's the way it's mostly come across to me in the past. I'd also like to ask, not just is there enough in training going on, which I don't think there is, but how much more do we need and how much money would it cost to do the amount of training that we really need to have done? DR. WESTERN: For those who have followed the NIH political and budget processes you'll realize that there has been a long debate over whether NIH as a domestic research agency should be involved in training at all. That debate has gone back and forth. The current policy is that we shall support research training. The percentage of NIH monies devoted to training overall has been extremely modest. A modest increase in both funding and training slots earmarked for AIDS training, would be money well spent and welcomed by Federal funding agencies. DR. LILLY: Did anyone else on the panel have comments on this area? DR. HEYWARD: I think this is one of the most important issues in developing our prevention and control programs for AIDS. CDC has training in two different areas, one is in the laboratory and the other is in epidemiology. In the laboratory CDC is providing laboratory proficiency testing for human immunodeficiency virus for 79 different international laboratories. This is essentially sending out panels of known positives and negatives in order for the laboratory in an international site to conduct their own quality control. This assists them a great deal in letting them know that they're on the mark with their laboratory testing. Another is in conducting these regional training courses. Many times it's a train the trainer type of session which provides a broader type of transfer of training to the individual countries. 192 In epidemiology there are several different mechanisms. One is each year there is an Epidemic Intelligence Service international track course that's given in July of each year at CDC. And we're finding many of these people are now national AIDS coordinators and in this sense it's providing a good deal of epidemiological expertise to these people. Also the EIS class itself usually has a couple of international persons involved. There are many other domestic courses that are given on surveillance and counseling and things like this that are intended for domestic purposes but, in fact, some people from other countries do attend those. DR. LILLY: Are you able, in fact, to find a demand for this training? I mean are there a lot more applicants than you can handle? DR. HEYWARD: Our effort is a drop in the bucket. There should be a much greater emphasis, I think, on providing training in AIDS. I think one of the things that might be considered would be an international AIDS training center in the US for epidemiology and laboratory training. Such a training center would greatly increase our capacity to respond to international requests for assistance and would also facilitate foreign countries capacity to conduct studies and institute prevention and control programs. DR. LILLY: So you're proposing a specific center. Has this been costed out? Do you have any idea, what the magnitude of this effort would be if it were to be created? DR. HEYWARD: No. DR. LILLY: Colonel Bancroft and Burke? COLONEL BANCROFT: The U.S. Army Medical Research and Development Command does conduct training programs, not necessarily for AIDS but for all infectious disease which are devoted toward post graduate training for basic science research through National Research Council Fellowships, training of physicians through infectious disease fellowships, and training of academic staff people through interagency personnel agreements. This has been going on for a number of years. In addition to that, we train Army physicians and civilian physicians, too, to attend our tropical medicine courses and other meetings which deal with this sort of thing. The current resources that we have do not permit us to expand our training, particularly in AIDS at the moment. 193 DR. LILLY: To what extent, does it need to be expanded to satisfy demand and need? COLONEL BANCROFT: We are probably meeting our demand right now with the resources that we have, mainly because the quality assurance program for laboratory testing is centered at Walter Reed Army Institute of Research under Colonel Burke. If the testing were to be distributed more widely, then we would probably have to institute some sort of training to transfer the quality assurance program to the laboratories. DR. WESTERN: With respect to the NIH, the objective of the Fogarty International Center international training awards is primarily to address this issue of international training in AIDS. By way of clarification, the NIH intermural laboratories rarely do training for the sake of training. They will train, non-US scientists, as part of the collaborative research effort. The strategy that the NIH has taken with the Fogarty International Training Center is not to start from scratch and build and equip and staff an international training center, but to build upon the capacity of the U.S. academic community. The FIC will be making several of these awards which should result in five AIDS training centers. The applications in general have been very, good. And they will include not just basic sciences such as immunology but also epidemiology and other applied science areas. DR. LILLY: Thank you. Do you have another comment, Dr. Blattner? DR. BLATTNER: I would just like to reinforce the concept that we're looking at an epidemic that is going to be here for a long time. Many of the young people that we train today to staff the clinics and the hospitals and the ministries of health are really an important focus for the ability of the world community to deal with their current and future epidemic. DR. LILLY: Thank you. CHAIRMAN WALSH: Dr. Crenshaw? DR. CRENSHAW: It seems to me that the Department of Defense is particularly vulnerable to the AIDS epidemic. A few things come to my mind and I'd like you to elaborate on other areas that I may not even have thought of. But first of all, there's been pressure to get rid of our bases overseas, like in the Philippine due to the HIV among the prostitutes surrounding the military and in Costa Rico one of our ships, I believe, was refused entry due to the issue of AIDS. We anticipate in the future, that there's going to be a critical 194 loss of manpower, and what "critical" means I don't really know, in terms of available fighting men in the prime of life that could impact over the course of time if we don't prevent this disease. And it seems to me that the defense budget is very threatened by the demands for AIDS research and AIDS treatment. Many people in the United States view it as a ready reserve bank account rather than a military defense fund, and so that seems to be one of the most available borrowing sources where pressure can be brought to bear. And there's been evidence periodically that it's been an opportunity for disinformation campaigns from other countries particularly -- Russia. These are just a few thoughts off the top of my head in terms of the additional problems that you end up having to contend with, you solve one and another crops up. On top of that I've heard that in our State Department with our embassies that there are many countries that are no longer desirable for our people to go to because they're concerned about the blood supply and various other issues. And other countries that are reluctant to have us still there representing them. So scratching the surface if you could comment a little bit about this and perhaps add to it any other complications or problems that you see and comment in addition on how the balance of power internationally could potentially be affected by this epidemic? Colonel Bancroft? COLONEL BANCROFT: Well, I think that the Commission is aware that there is a policy in the Department of Defense that anyone who is found to be seropositive for HIV antibody cannot be deployed overseas. That is to protect that individual from exposure to infections that they would not encounter in this country and also to prevent political ramifications of being accused of exporting a potentially lethal infection. In addition to that comment, I am not going to prognosticate what the implications are on the balance of power that HIV may contribute. I don't think anybody can predict that at this point, but it could be impressive. DR. CRENSHAW: It could be impressive? COLONEL BANCROFT: It could be. DR. CRENSHAW: So it's a reasonable question to entertain? COLONEL BANCROFT: Oh, I think so, but I'm not the one to try to answer that. 195 DR. CRENSHAW: Okay. Go ahead. COLONEL BURKE: Anyone who works full time in the HIV business and particularly in the international arena is well aware of the potential serious political ramifications for a large number of countries where there are high prevalences of infection in -- particularly in the upper classes, the intelligentsia, the rulers, of countries. All we need is to have a significant mortality in a number of now stable countries, and we will not have stable countries in the future. I think that's very simple. No one can predict exactly where that will occur or when it will occur, but I think given the information we have now that's a very legitimate question that you raise. What can we do to address HIV to promote political stability in those countries where there is a lot of HIV? And I think that's a very legitimate arena of effort for US health agencies, US diplomatic agencies, US defense agencies. DR. CRENSHAW: Is there anything that we can do other than what we're doing in the general course of our work to give you better assistance or support in these areas? Are you basically doing everything that's within your power given the limitations of time and resources? COLONEL BURKE: We're bringing, I think, a somewhat narrow perspective to the problem, and that is I work on HIV full time but I don't worry about other political and social concerns in the same countries. Conversely, the people who are long term planners, the people who are in charge of net assessment of our political risks in foreign countries perhaps aren't focused enough on this single problem. So one of the things I would suggest that the Commission could recommend to the President that this should be an issue that should be addressed systematically both in State and Department of Defense. It already has started, but I think that it needs an intensive and very careful thought as to what the future of the epidemic will be in terms of the military and political implications for stability. DR. CRENSHAW: Thank you. This is a very civilian question that you're about to get, and that is are there any aspects of data collection, your own research or knowledge of other international research or information that you get internationally about the HIV epidemic or AIDS that is classified and that you can't share with us? And if so, why? COLONEL BANCROFT: Our work is not classified. The release of information regarding the screening, of the active duty force is controlled by the Department of Defense. It is not our privilege alone to release that information directly to the public. But the research we do is open research. It is not 196 classified and we expect that eventually it will become published in the peer review press. DR. CRENSHAW: If you were to learn about some large extent of infection in another country, would there be any reason that if you had that knowledge, that couldn't immediately become public knowledge or is the political situation so sensitive that there are considerable restraints on our getting the full picture? COLONEL BANCROFT: Political considerations regarding HIV are still a reality and might influence the release of information -- DR. CRENSHAW: With that in mind, I'll ask a question that I hope you can answer. I've heard two different interpretations of the extent of HIV infection in the Soviet Union. One theory briefly goes that because there's such a repressive government that it's basically limited and nonexistent and not expected to spread. And another theory that goes through checking the incidence of Kaposi's Sarcoma which they report, there appears to be a lot of it and perhaps through their deployment of troops to Cuba that the population in Russia is more extensively involved than we're led to believe. Do you have any clarification to share on that picture? COLONEL BANCROFT: No. We have no information about Russia. I have nothing to contribute on that. DR. CRENSHAW: It seems that one of the additional tragedies of this epidemic is that if countries that are more repressive end up as a spinoff of that doing a much better job controlling the spread of AIDS and if countries that deal with it differently in the democratic countries have such a major problem, that creates a skew that doesn't seem right either and there must be a better alternative than those two extremes. So if you have any thoughts on that, I'd be open to them. But I think that's one of the issues that we deliberate with and struggle with because there seems to be no easy answers. CHAIRMAN WALSH: There are no further comments? Questions? DR. CRENSHAW: That's it. CHAIRMAN WALSH: All right, we'll go to you Dr. Gebbie. MRS. GEBBIE: The central focus for me is what are the things that we as a Commission can and should say in this area of international research supported by United States agencies that would be helpful in moving it forward? A good deal of what you said was simply that it's going forward and this is how we're 197 doing it, and it was kind of a nice show and tell but it didn't lead me to any difficult policy questions. Two have emerged. The one is the training of individuals from other countries who can contribute overall to the research, increasing the number of slots. And there was a request made to stabilize the funding base at an appropriate level so we weren't looking at seesaws or having it taper off too soon. But I would appreciate hearing from anyone other specifics of policy level issues that, were they to be addressed by this Commission, would be helpful to you in getting on with what you need to do in that international research arena. DR. BLATTNER: I think that one of the great limiting factors for us has to do with bureaucratic ceilings on foreign travel. Right now we're looking at the fact that in my program we're not going to be able to do anymore foreign travel other than go to the Stockholm meeting. Every year we run out of money for foreign travel and this limits our ability to conduct our foreign research program. I'm not sure where these ceilings come from and who is responsible for them. But the fact that there are major opportunities and issues that can only be addressed in the international setting and the fact that, to my knowledge, there's not been a significant adjustment for the international AIDS issue, it's business as usual in terms of availability of foreign travel funds which are set by ceiling on a budgetary basis every year by agency and then allocated within agencies. And certainly within my division and within my institute we've had generous support of this, but it's a chronic problem that maybe would require some reassessment of the bureaucratic process that limits us in our ability to interact with our overseas colleagues on the regular basis that we need to. Currently we have to plan each trip recognizing that we're going to have only one opportunity to make that visit. DR. WESTERN: At the request of the Commission, NIH did develop and put forward three "limiting factors". The first is the ceiling on international travel for Federal scientists. If you get a grant from NIH, it's permitted, to put in money for international travel to do the research and also to attend the critical scientific meetings like the International AIDS Conference, even if they are held overseas. Federal scientists, however, whether they work for NIH, CDC, FDA, USAID or DoD have strict ceilings for international travel. No distinction is made between international travel to conduct research or attend meetings. This ceiling in not related to how much money we have for AIDS. It is a separate policy issue. No distinction is made between going to Stockholm in June and going to Rwanda in July for a research study. In other 198 words, Federal agencies, therefore have strict limits on staff we can send to a scientific forum to report these research results. The ceiling also inhibits Federal scientists going outside the U.S.A. to pursue AIDS research questions. A more complex, problem with limited international travel is that NIH makes awards to US groups to conduct international research on AIDS. Someone -- a Health Science Administrator and a grants or contract officer has to supervise that project. As Federal scientists, they cannot make site visits to see how the studies are going. In a sensitive and aifficult area like AIDS, that's going to be a critical factor. The second limiting factor which I really will not dwell on unless there are specific questions is that of limited staff. The increase in AIDS funding, per se, has not been accompanied by any significant increase in scientific staff positions either to do the AIDS research intramurally, manage the NIH type scientific review, or administer the awards once they're made. Furthermore, Federal agencies are pursuing AIDS research interests in countries where ten years ago nobody would have predicted that NIH staff scientists or US universities would be conducting high priority multidisciplinary research activities. We don't really have the right mix of NIH staff scientists and research administrators to supervise or conduct these types of activities in the geographic areas where they must be done. The third limiting factor could is training. Very few of our academic institutions, have the critical mass of multidisciplinary trained investigators to do the sorts of international AIDS studies that need to be done. The problem is that we've got lots of people with domestic AIDS experience, but very little international contacts or experience. We also have people that have the international experience but don't have credentials in the AIDS investigation area. As AIDS research overseas involves tropical medicine, epidemiology, virology, sexually transmitted diseases, anthropology, and social science, there are very few faculties that can field the multidisciplinary team required for AIDS studies in Africa or in Latin America. MRS. GEBBIE: I think there's some more answers to that one. DR. HEYWARD: I support Dr. Western's and Dr. Blattner's comments. In addition, I'd like to make some specific recommendations. One is that greater support should be made available for us to provide technical and consultative assistance to other international organizations, WHO, A.I.D. and other organizations in response to requests from developing countries. 199 MRS. GEBBIE: May I stop and ask? Is your limiting factor there FTE, funding, both, something else? DR. HEYWARD: That's right. To do more, with our present resources it's basically robbing Peter to pay Paul. We're using people who have domestic AIDS responsibilities, providing their expertise to WHO and these other organizations. Whether the consultation is one week or one month, and in many cases, it's a year or more, it takes that person basically away from their domestic AIDS responsibilities for that length of time, and usually more. So we simply need more people and funds to assist WHO and AID in their efforts. I think Projet SIDA is an excellent example of a truly international collaborative effort and we need more of these collaborative research prevention projects which could be established in international sites. Projet SIDA should be expanded and new sites should be developed in different geographic areas to conduct these studies which are relevant not only in those geographic areas, but for here in the US. Another one I think that we must prepare for is HIV-2. It's known that it's endemic in West Africa. It's reported -- a few cases in Europe and now we've reported recently a case ina person in New Jersey who was from West Africa. We need to learn about this as soon as possible before we're dealing with an epidemic ourselves. And it's urgent for us to support investigations to learn more about HIV-2 as quickly as possible so that we can develop prevention and control strategies. I think the last recommendation I would have would be that more prevention and control projects in international sites should be conducted. We do a lot of epidemiologic and laboratory research, but we need to do more in the way of demonstration projects in prevention. And these are very difficult. It's obvious that they're not easy to do or they, I think, would have already been done. But we do need to place greater emphasis on that. CHAIRMAN WALSH: Oh, you have more? COLONEL BANCROFT: I'd just like to look at this same question from a different aspect. AIDS certainly is a serious threat, but there are other diseases which also need to continue to have research support, other infectious diseases. From the standpoint of the Department of Defense, we have research programs on malaria, arthropod-borne viral diseases such as Dengue, hepatitis and diarrheal diseases and wound infections. Congress has alleviated our problem here a bit by saying that the money which comes to us for AIDS research must 200 only be used for that and the rest of the infectious disease research is funded separately. I think that has been a great asset to our program in sustaining the work in other infectious diseases which are also important. CHAIRMAN WALSH: Mr. Chairman. CHAIRMAN WATKINS: Colonel Bancroft, let me focus on another issue. I've asked this once before and I was not at all satisfied with the answer. For many years we've had large research development budgets for defense. I have never heard that the potential for technological spinoff from those R&D programs is aggressively looked at in terms of the potential for taking advantage of that R&D in other fields. General Abramson's group, for example, presented to the Commission for the record that one of the spinoffs of their work was development of virtually impenetrable yet pliable material for use for protective gloves in lieu of latex. Essentially you couldn't cut it, you couldn't penetrate it and yet it was workable with the hands. It seems to me that within the military with the tremendous budgets, going into research and development a large portion of which is basic research, that there's potential for an active review of what's available for infectious diseases not necessarily focused on AIDS. This example of research from the Strategic Defense Initiative provides a model within Defense that might indicate that there's much more to be gained from technological spinoff from research development applicable to focusing on infectious disease and the problems that we're facing in an adequate funding for basic research. With those existing mechanisms within Defense you have the ideal embryo of, an international effort where shared research and development in other technological fields that can focus on such things as infectious disease could be searched out and more aggressively pursued so as part of the deliberations each year in Defense there might be somebody standing up and saying, "Look, this is not only good for here for weaponry purposes, but look at what the spinoff has been in basic research in the medical area." And begin to put some more emphasis on it. I've not seen that emphasis in any of the hearings I've been to and if it's done, it's done within the service surgeon generals and not at the higher level, at the Secretary of Defense level, for example. I'd like you to comment if there's any merit there and if we should maybe exchange some more views on this and hook me up with the right officials in Defense to push this a little harder because I don't think it's all that well organized. 201 COLONEL BANCROFT: I think some of these comments might be directed to Dr. Mazzuchi who will be presenting tomorrow representing the Assistant Secretary for Defense for Health Affairs. It has been my experience that the work that has been done on HIV, both the research and the screening program, has opened up better communication within the Department of Defense medical department than I have ever seen before. I think that there is good communication at the levels of the Surgeon Generals, and this has been promoted by the Assistant Secretary of Defense for Health Affairs. As far as research outside the medical community is concerned, I don't think that has changed. I have not seen any increase in the communication between the non-medical research and the Department of Defense and the medical research. CHAIRMAN WATKINS: From my experience there's been a tremendous amount that has evolved from the technical military side to the non-technical medical side almost by happenstance. The question is can it be organized better? Why can't we do that within the Department of Defense and work harder at seeing if we can make a contribution not only nationally but internationally? COLONEL BANCROFT: Sir, I cannot give you an answer on that, but I suspect that there are people in the Department of Defense who do not see a need for the exchange of the information. CHAIRMAN WATKINS: Do you see a need personally? COLONEL BANCROFT: I think that the example you gave is an indication that there is a benefit to greater exchange of information. Yes, sir. CHAIRMAN WATKINS: Colonel Burke, do you have any views? COLONEL BURKE: Again, I'll tend to look at it from my own perspective working in HIV research and ask are there things, are there products, are there ideas coming out of the Department of Defense that could be applicable to the work that I'm doing? We're interested in disease prevention, diagnoses of disease. And yes, occasionally we do get correspondence from other agencies that suggest alternative ways for diagnosing very small concentrations of certain antigens in fluids or alternative methods for trying to destroy immune cells. But that's the exception rather than the rule. I think that you're probably right. There probably are some methodologies out there probably more in the physics side that could be brought to bear on the medical side and we don't systematically exploit those very well. 202 CHAIRMAN WATKINS: Okay. Thank you. CHAIRMAN WALSH: Cory, you want to ask one more question? DR. SerVAAS: Is there time? CHAIRMAN WALSH: No, but go ahead and ask it if it's going to be as short as you said. DR. SerVAAS: It's just very short and it's Colonel Burke or Colonel Bancroft. In your written testimony you mentioned that you need to differentiate vaccine recipients from infected individuals and you mentioned seronegative virus positive blood donors and the need for an assay. Have you had any accidents with vaccinating military personnel who were virus positive but false negatives that you didn't know? COLONEL BANCROFT: You're alluding to the area of improved diagnoses research? DR. SerVAAS: Right. COLONEL BANCROFT: In this area we are, first of all, trying to replace the western blot as a confirmatory test and Colonel Burke has got good experience with an alternative ELISA test which looks promising there. The second had to do with trying to identify the viremic HIV infected individual who is not yet seropositive. This is important to blood banking, of course. And then the third is when a vaccine becomes available for use in people, we have to be able to differentiate the person who received the vaccine from those who are truly infected. That may be more difficult than it would seem on the surface, but it's premature to speculate very much on that right now. What was the rest of your question? I'm sorry. DR. SerVAAS: I guess my question is in the military you shouldn't vaccinate someone whose positive? COLONEL BANCROFT: We have a policy now of screening all applicants for military service, of course. And if they're positive now, they won't be entered into the military service so they won't receive the routine vaccinations. There was one instance in which a HIV infected individual received smallpox vaccine and developed disseminated vaccinia. This was a single instance before the routine screening of civilian applicants was instituted. It has been published. DR. SerVAAS: Thank you. Is there a delay in getting your material published in the peer reviewed journals? How long do you have to wait to get information like on the teenage 203 prevalence? How long does it usually take for you to get it published in professional journals? COLONEL BURKE: Most of the major medical journals have established policies now that they will try to accelerate publication of HIV and AIDS related articles. I think the median time for review of an article is probably in the order of two months or thereabouts from the time of submission and then perhaps another four months after that before publication. So usually from the time that the paper is actually submitted to the journal to the time that it appears, even for an accelerated course for most journals, would be on the order of six months. DR. SerVAAS: Thank you. CHAIRMAN WALSH: Okay. And before closing, I want to thank you all. I have just one question primarily for Dr. Heyward. I have the impression that while CDC has been fairly generously budgeted for at least the immediate future due to, the AIDS problem, that you have staff limitations on slots which have prevented you from responding positively to requests for assistance from WHO and other nations. Is that true? DR. HEYWARD: We do have limitations in our ability to respond, that's true. CHAIRMAN WALSH: Would it be helpful to create more slots and what kind of action does that take and from where must it be taken? DR. HEYWARD: I'm not sure I'm the best one to ask that question to. The determination, I think, of number of FTEs allowed at CDC or provided to CDC are made on a much higher level than where I sit. But within the AIDS Program, we have for FY '89 allocated five additional positions for international AIDS. The budget likewise is increasing. But again, this is in some ways coming from expertise that is developed out of domestic AIDS. CHAIRMAN WALSH: Do you think that's a sufficient, number of new slots? DR. HEYWARD: I think we're doing a lot. I think we need to do a lot more. CHAIRMAN WALSH: Okay. Thank you very much. Again, we've been very gratified by the stimulation that all of these panels have given us in the last day and a half. And you met every expectation for us. Thank you very much. The next panel can approach the table but we're going to have a one or two minute delay while the audio expert checks these microphones. 204 (Whereupon, a recess.) CHAIRMAN WALSH: Thank you for your patience in waiting for our technicians. We are ready now to listen to some of our recipients of bilateral research and operational awards. We feel it's important for us to know how the system works and whether it's working and what is the success of what you're doing. The first presentation will come from Dr. Allan Rosenfield, the Dean of the School of Public Health for Columbia University in New York City. Welcome. Please begin. DR. ROSENFIELD: Thank you very much and good morning. I appreciate the opportunity to testify. As the Dean of a school of public health in the U.S. urban area with one of the highest HIV seropositive prevalence rates in the world and at the same time director of a center involved in a large program of service and applied research in subsaharan Africa I'm particularly pleased to have this opportunity to speak on some of the key issues facing subsaharan African countries with comments on the relationships between our work on the AIDS epidemic in New York City and in Africa. As this distinguished Commission knows full well, New York City has close to 25 percent of all AIDS cases in the United States and presents the full spectrum of AIDS related problems, problems already reviewed by this Commission. I will not attempt this morning to detail the extraordinary dimensions of the epidemic in several central African countries as others have reviewed the current situation and the prospects for the future. The potential devastation, however, among young men, women and infants in high prevalence countries such as in Uganda and elsewhere in Central Africa is simply incomprehensible. The human tragedy is immense, with the disease hitting individuals across all socioeconomic levels of society. In many of these countries the very limited numbers of educated future leaders stand the chance of being decimated. Many of us in New York City, and the U.S. more generally, see the urgent need for much greater outlays of funding for a wide range of needs including research, drugs, beds, nursing and other health personnel, counselors, prevention education, long term care and home care as was so well documented in the Commission's first report. None of these needs, however, has even begun to be met in Africa nor in other parts of the developing world. In most cases, given current resources and severe economic strains, there is little hope that even minimal needs will be met. Thanks to the critically important and effective efforts of WHO's Global Program on AIDS (GPA), most African countries now have established formal governmental AIDS committees, as described by Dr. Mann yesterday. I will move to 205 a list of specific recommendations rather than go through the rest of my testimony to leave time for discussion. One, the US government, through the US Agency for International Development, (USAID), should continue to fund WHO's GPA at increased levels in order to allow it to expand its important central coordinating role in the worldwide fight against AIDS. USAID, in its programming through intermediaries and as part of direct bilateral country assistance should insure close collaboration with GPA and with the individual country AIDS committees. Three, Congress should appropriate new funds for the international efforts against AIDS. Funds should not be taken from other critically important health and population/ family planning programs. Current funding levels for international AIDS programming are, in my opinion, grossly inadequate and should be dramatically increased. Four. In addition to programming through existing Central Office of Health programs, the AIDSTECH and AIDSCOM programs to be discussed this afternoon, and to direct regional bureau and country programs additional efforts are recommended and they follow: 4.1: Additional funds should be allocated to the Office of Health to expand their central programming through the current AIDSTECH and AIDSCOM programs. 4.2: Through the Office of Health much greater use should be made of the expertise and experience of the several American schools of public health and medicine intimately involved in AIDS related research, services and teaching domestically as well as internationally. Examples of such institutions include Hopkins, Harvard, Columbia, UCSF, University of California at Berkeley and others. 4.3: Because of the very important role to be played by family planning programs, which have the most experienced personnel in dealing with sensitive, sexually related issues, significant increased funding should be made available to the USAID Offiee of Population so that preventive AIDS efforts can be effectively incorporated in most of the family planning programs supported by USAID. In addition, USAID should significantly increase condom distribution as well as funds for research and development of improved condoms and other barrier methods. 4.4: USAID supported efforts should, in my opinion, focus on the following: Improved epidemiologic data collection of which there's great need currently in Africa and elsewhere; improved epidemiologic and demographic modeling techniques for better projections; development of effective preventive 206 strategies through carefully evaluated operations research and demonstration projects; consulting or technical assistance services; mass education efforts; drug and vaccine trials when warranted by basic research developments; and assistance in developing plans for the current grossly inadequate medical services. As detailed in my testimony, the School of Public Health at Columbia and its Center for Population and Family Health have been actively involved in providing assistance to African project development. It has been our experience that development of these projects requires a great deal of technical assistance as there are significant shortages of well trained and experienced public health professionals with expertise in epidemiologic studies and preventive education approaches. In developing intervention strategies we find it essential to be unusually flexible in approach as there are important cultural and political differences in each country. If we are to have any chance of intercepting this epidemic, we must develop strategies against what is actually happening. We must accept reality rather than plan for an idealistic or moralistic scenario which one might prefer, but which in reality does not exist. We do not condone prostitution, adultery, drug use or other practices by developing strategies that decrease the spread of disease among these individuals or groups. Thus, for example, condom use must be advocated as a key component of preventive education messages. Similarly, among IV drug users, much more of a problem in my own city than in Africa, we must explore ways to decrease Iv drug use while at the same time developing innovative strategies such as the proposed clean needle exchange program in New York City. The AIDS crisis is surely the infectious disease epidemic of the 20th century. It can no longer be considered a national problem. The disease knows no boundaries. It will effect millions of Americans and Europeans and many millions more in the developing world, particularly in Africa. We live in one large interdependent world. Thus in addition to our obvious humanitarian concerns and international assistance, it is in our national interest to give major assistance to the international efforts to control the epidemic. Through USAID some AIDS related activities have been initiated, but so much more is needed. I wish to mention one concern that is not in my testimony. That is that the potential for discrimination against individual right is very great, in my opinion, in developing countries, where groups concerned about civil liberties are less well developed than in our country. Safeguards in this area are needed. 207 I thank the Commission for the opportunity to make a presentation today and I congratulate you for the outstanding work you are now accomplishing. With the current renewed commitment, the Commission has been most effective, most visibly with the release of its first review and recommendations, a truly important document for our country. Thank you. CHAIRMAN WALSH: Thank you. CHAIRMAN WALSH: Next, Dr. W. Henry Mosley who is Director of the Institute of International Programs, School of Hygiene and Public Health at Johns Hopkins University. Dr. Mosley? DR. MOSLEY: Mr. Chairman and members of the Presidential Commission, I appreciate this opportunity to respond to the Commission's request to testify on the accessibility and relevance of U.S. supported international research and assistance programs to deal with the problem of AIDS. I have submitted a full written statement to the Commission and will only give a brief summary here. Johns Hopkins is unique in the breadth and depth of both its international health and its AIDS research service and service programs. For example, in our 1987 review of work supported by USAID at Johns Hopkins we identified 23 projects which involve 74 scientists and technical experts who went to 38 countries for work last year. This is the type of activity that is coordinated by the Institute for International Programs. In terms of AIDS research I have submitted documentation which identifies a series of over 22 projects supported by more than $50 million in funding exclusive of patient care, which ranges from basic and applied research to technical assistance in communications. Also our faculty, including our associate dean, assists the state of Maryland in its policy and programming for AIDS control. In terms of training we have 150 students from developing countries at the University every year in the field of public health. All of these students are required to take a course in AIDS in addition to the exposure they get through seminars and contact with the faculty. I want to speak though more broadly about the international capacity of universities to address the AIDS problem and I will refer to the 1987 National Academy of Sciences study on the U.S. capacity to address tropical infectious disease problems, which I think is highly relevant to the issues you are discussing here. 208 The NAS study surveyed about 150 universities and could only identify 20 that had significant international programs in biomedical research, public health or clinical training. Among these, only eight institutions could be categorized as major tropical health centers and only four of these centers, Johns Hopkins, Harvard, Tulane and the University of California which included the campuses at Berkeley, Los Angeles and San Francisco had 30 or more specialists in international health with only Johns Hopkins having more than 50 full time faculty members on tropical health work. Currently few US universities are expanding their international health work and this is largely because of inadequate institutional support and lack of appropriate career structures. As I detail in my written testimony, this reflects recent trends in the decline of U.S. support for international health research programs and also the less use of US universities for international technical assistance programs by the United States Agency for International Development. Presently the resources allocated by the U.S. government to address the AIDS epidemic internationally, though of high quality as you have heard this morning, are surely extremely limited. An example is the joint venture by CDC and the NIH to develop project SIDA in Kinshasa, Zaire. While this has 90 staff, there are only three U.S. scientists in this project. And the research agenda is limited because of the limitations in support. The major NIH response to the global AIDS epidemic, which you have heard about, has been the support to establish up to ten International Centers for AIDS Research which will be located in Africa and Latin America. It should be recognized, however, that because of the relatively limited resources that will be allocated to each of these centers, the funds available will only support a few selected research projects and really will preclude long term international collaborative work by U.S. institutions with U.S. scientists stationed overseas working in conjunction with their third world colleagues. As the Commission members will learn this afternoon, AID has committed $42 million over the next five years in support of two major bilateral technical assistance projects, the AIDSCOM and the AIDSTECH projects. Noteworthy in this context, the U.S. Agency for International Development has only one temporary project officer assigned from CDC to administrate this large AIDS program in the Office of Health. Again, it should be noted that major U.S. academic centers have, for all practical purposes, been excluded from participation in these projects although the need for research is obvious. For example, we have only the most superficial idea of why the disease is spreading so extensively throughout the heterosexual population in Africa. Not only do we 209 lack the epidemiological data to define the high risk subgroups in the population, but there is essentially no social or anthropological research to define the high risk behaviors which might provide the basis for development of appropriate intervention strategies which might be implemented by the AIDSCOM project. Let me go to my recommendations. First, the global HIV epidemic brings into sharp relief every deficiency in our health policies internationally as well as domestically. The US government does not have an overall strategic policy for dealing with AIDS in the developing world. In view of this, my first recommendation is for the Office of Science and Technology Policy of the United States to consult with representatives of those federal agencies concerned with AIDS, the AIDS epidemic in the third world, as well as with nongovernmental advisors to define an effective strategy to support a coordinated research and technical assistance activity in developing countries. Second, the staffing of major government agencies, particularly USAID, the National Institutes of Health and the cpc to deal with AIDS internationally is wholly inadequate to the need. The United States should expand the numbers of full time positions in each of these agencies sufficient to support an international AIDS effort. Third, there are a limited number of academic centers in the United States which have major multidisciplinary programs committed to solving international health problems. Some of these centers are currently engaged in AIDS research and service programs domestically. The United States should develop an international AIDS control strategy that could effectively utilize these academic centers and other professional organizations to build both the scientific knowledge base and the national and international expertise needed to address this problem. Fourth, there is a critical need to establish multidisciplinary international AIDS research centers in developing country settings. Projet SIDA in Zaire is one example of this. But two or three more should be established in Africa and at least one each in Latin America and Asia. These should have sufficient resources in the range of two million to five million dollars annually to support a multidisciplinary team of U.S. and national scientists to take a comprehensive look at the AIDS problem in their regional settings. I just want to note as a final comment that Kinshasa does not represent Zaire or all of Africa anymore than New York City or perhaps Baltimore or San Francisco represents the entire United States, much less all of the Americas. And when you take this perspective, you truly appreciate how minuscule our current 210 research and control efforts are for AIDS in view of the magnitude of the global problem which currently has reached 137 countries worldwide. Thank you. CHAIRMAN WALSH: Thank you. CHAIRMAN WALSH: Our next speaker is Dr. Phyllis J. Kanki from the Department of Biology at the Harvard School of Public Health. Dr. Kanki? DR. KANKI: I'm going to show these slides. I've been asked by the Commission to discuss a little bit of the current scientific information on the West Africa retrovirus, HIV-2. I'd like to begin with the first slide, which shows on the right-hand side the relative relationship of the West African human retrovirus HIV-2 to the prototype AIDS virus, HIV-1. HIV-2 is most closely related to a simian virus, SIV that is found in healthy African primates and this simian virus when inoculated into susceptible Asian primates causes a fatal AIDS like disease. HIV-2 is approximately 50 percent related to the prototype AIDS virus and shares considerable homology at the protein level which allows for a number of HIV-1 antibody tests to detect HIV-2 infected individuals. And I think that's an important point that will be raised later when we get to the question of blood bank screening for HIV-2. An important common feature of these viruses is their ability to infect the T4 lymphocyte. The obvious question that is now being raised is what is the clinical significance of this second human immunodeficiency virus with respect to its infection in people? We have studied over the last three years about 9,000 people in nine West African countries which are located here and about 2,000 people selected from various Central African countries. The green and the dark magenta indicate that we have fairly high rates of the HIV-2 virus in most of these West African countries. It ranges from one to five percent in normal healthy adult populations and ranges from 15 percent to 64 percent in sexually active groups such as prostitutes and STD outpatients. In Central Africa where most of the AIDS and HIV-1 infection has been reported we have virtually no HIV-2 infection when we look at healthy individuals or whether we look at AIDS individuals. So it appears that we have a second endemic region for a second immunodeficiency virus and this virus has been called HIV=-2. We have conducted some seroepidemologic studies with select populations which include the control healthy adult 211 populations, the sexually active risk groups and the diseased groups which we feel would be most prone to fall into the category of AIDS or AIDS-like diseases. And what we see with HIV-2 is depicted on the top panel, we have higher rates of HIV-2 than HIV-1 in most of the West African countries that we've studied. We have seen a seven fold increase in HIV-2 prevalence in the sexually active risk groups over control populations and we fail to see a significant difference in HIV-2 infection between our control and disease population groups. So we feel at present the results from these studies indicate that HIV-2 is showing a slightly different biology than that of HIV-1. And finally, I'd just like to show some of our clinical studies where we've looked at HIV-2 infected prostitutes that were physically examined: by one of our physicians and found to have zero percent lymphadenopathy or virtually no signs or symptoms of AIDS like disease. This is in marked contrast to what we would have seen with HIV-1 infected prostitute populations from Central Africa in those HIV-1 studies fairly high rates, 54 percent or 83 percent, of generalized lymphadenopathy or symptoms suggestive of AIDS were seen. I guess the answer to the question I raised in the beginning is that we just do not know at the present time whether HIV-2 causes AIDS-like HIV-1, whether it will cause AIDS with a longer latency period or whether it actually may induce different types of disease including cancers. The answers to ~ these questions are not yet available from present studies. We're currently into year three of a prospective study with HIV-2 in three different West African countries and we're hopeful that these prospective studies will give us more information about the biology of this related virus. Now, as has been mentioned, there have been some cases of HIV-2 reported both in Europe and most recently 1 case in the United States. In the vast majority of the cases these HIV-2 infected individuals have been of West African origin, which is not particularly surprising. The question is whether or not HIV-2 blood bank screening should be implemented in U.S. blood banks at this time. And for that answer we have tried to look at what would be our estimate of HIV-2 in the U.S. blood donor population. The French Society of Blood Transfusion has recently conducted a large study in nonselected blood donors, they screened 100,000, and found zero percent HIV-2 with about .03 percent HIV=-1, which is a little bit higher than our present rates for HIV-1 in the U.S. They have higher rates for both viruses in risk group blood donors. The CDC has reported examining various high risk groups for HIV-1 and found zero percent of HIV-2. And in a study that I did in collaboration with the U.S. military we looked at 300 212 military recruits that had atypical Western blots that were suggestive of HIV-2 and we failed to find HIV-2. So at present we estimate that the rate of HIV-2 in the blood donor population must be less than 1 in 10 and probably much lower. Now, the HIV-1 ELISA assays will take advantage of the fact that HIV-1 and HIV-2 are related viruses on a protein level and because of that relationship, they will be able to detect HIV-2 infected individuals at a variable rate. We conducted a study looking at about 350 HIV-2 positive samples using the Abbott, Genetic Systems and Dupont assays which are the most common assays employed in our U.S. blood banks today. We found 82 to 84 percent of the HIV-2 positive samples were detected by the currently used HIV-1 blood bank screening tests. When we reduced this to numbers and take into account the estimates for HIV-2 in our U.S. blood donor population, it correlates to an additional $10 million per 10 million blood donors screened to detect one HIV-2 positive individual that would have had an 82 percent chance of being detected by the current test. This may be taken to indicate that we should wait until other assays will be available that will use combined HIV-1 and HIV-2 antigens which would be more cost effective for the present situation in the United States with HIV-2. And now I'd like to just briefly comment about our studies in West Africa and how they have been implemented. Our studies result from an interuniversity convention that was established three years ago between two French universities, the University of Tours and the University of Limoges, the University of Dakar in Senegal and the Harvard School of Public Health. We have three major goals for this convention. One, obviously, is to research human viruses that are associated with significant disease. At present, this means prospective studies on HIV-2, both in adults and in children. And we're also involved in prevention programs. A second feature of the convention is to establish laboratory expertise based in Senegal and run solely by Senegalese. We have been involved in the training and the equipping of a lab which is now capable of serology, including ELISAs and western blots for all of the known human retroviruses as well as various important STDs that are endemic in this area. This type of laboratory support has allowed for not only the confirmation of blood bank screening, which is now going on Dakar Senegal, but also for a number of the research projects that I have described. And finally, the last portion of the convention is to provide education. We've not only been involved in training of the laboratory personnel but also in monthly meetings for STD 213 medical personnel and annual meetings for all of the health personnel in and around the Senegal region on prevention and control of AIDS. We've been truly encouraged that our fairly small efforts at this local level have resulted in expertise and resources that will be self-sustained over a long period of time and we are also encouraged by the fact that we now have local initiation and implementation of programs that will openly address the prevention and control of AIDS in this area. Thank you. CHAIRMAN WALSH: Thank you very much, Dr. Kanki. We will start the questioning of this panel with the Chairman. Are you ready? CHAIRMAN WATKINS: No. CHAIRMAN WALSH: No, you're not ready. All right. Then we'll start on this side. Rich, are you ready? Nobody ready to ask a question? Thank you, Bert. DR. LEE: Dr. Kanki, that was a very valuable little talk. Is HIV-2 in West Africa producing significant disease and what percent of the population would carry it and what percent dies? DR. KANKI: We have been looking for AIDS cases, AIDS up until very recently was very rare in Senegal. Over the last two years we have collected 44 cases of AIDS in Senegal which I will remind you, has very high rates of HIV-2 and very low rates of HIV-1. In those 44 cases the highest proportion of them were HIV-1 and they were travelers from HIV-1 endemic areas. The second proportion of them were negative for both viruses and we had nine out of 44 of those cases that were HIV-2 positive. If we put a denominator on that it means we have approximately nine AIDS cases for at least 400 healthy HIV-2 positive donors in this same area, healthy seropositive individuals. So we believe that this virus may be associated with AIDS, we just don't know how regularly it will cause AIDS and if it will cause AIDS in as regular a manner as HIV-1. There have been case reports published by the Pasteur Institute that have reported on cases that they believe were infected as long as 15 years ago in West Africa and are still healthy at the time of the report. So there are a few indications that this virus may have a very, very long latency if, in fact, it does cause AIDS. DR. LEE: And of those nine cases they all go on to die? DR. KANKI: At present seven of them are alive. The two that have died both had fairly fulminant tuberculosis and it's fairly difficult for us to determine what was the cause of 214 death. But death is a difficult end point in Africa where we have a number of other infectious diseases that can be highly lethal. DR. LEE: So two people died out of 400 cases who are HIV-2 positive? DR. KANKI: Right. DR. LEE: Now, can you give us -- DR. KANKI: That's a very select survey because it's a selection of hospital people. DR. LEE: Can you give us any other little secrets? Are there any other viruses that you're interested in? DR. KANKI: There's certainly HTLV-1l1 virus and we have seen HTLV-1 at fairly high rates, approximately five percent, in Senegal and we also see people who appear to be dually exposed and triply exposed to retroviruses in Senegal. HTLV-1, HIV-1 and HIV-2. DR. LEE: No others? DR. KANKI: No others. DR. LEE: At the moment? DR. KANKI: I think that's enough. DR. LEE: Yes. And are the HTLV-1 cases leukemics? DR. KANKI: Not in all cases. We have seem some neurologic cases of tropical spastic or paraparesis. DR. LEE: Thank you. CHAIRMAN WALSH: Frank? DR. LILLY: Come back to me. MRS. GEBBIE: You want me to pass? CHAIRMAN WALSH: No, I don't. MRS. GEBBIE: Okay. First a specific question to Dr. Kanki. You made some very specific recommendations about testing in the blood bank setting, that is deferring it until a dual test is available, if I understood you correctly, for HIV-2. Is that a recommendation that you've developed out of your own research, is that something that's been shared and explored with 215 blood bankers so they're familiar with it and say yes that's wise policy or is this something that needs to be worked on with them at this point? DR. KANKI: Perhaps I spoke a little too strongly. This is fairly new data and we are bringing it up with members of the blood bank community. And what I mean by the "new data," is the data with fairly large numbers of HIV-2 positive samples that were analyzed with the HIV-1 assays. So I should exercise caution and say that there still needs to be much more discussion with health policy makers as well as the blood bankers themselves to determine how HIV-2 will fit into their present testing algorithm. MRS. GEBBIE: Thank you for that clarification. I appreciate that. My broader question is not one that I'm finding easy to frame. It follows on several areas that we've been exploring of the mix of the very AIDS specific kind of things that are being done with those programs and projects that are related to the basic provision of health services or the basic understanding of health and illness throughout the world. I think even with the academic community we may have the risk of -- since AIDS is what's being funded today, let's all shift gears and look at AIDS and neglect some other more basic kinds of projects that need to be funded. What more do we need to be aware of in the structuring of our interest in stopping this particular virus that we do that while not undoing progress that's been made on some more basic kinds of things that are needed to protect human health around the world? DR. MOSLEY: I think that's a very important question and I believe if you look at the history of public health you would find out that the major advances in public health across all fields were often made during the course of epidemics. Cholera for example was an example of doing that, or even the global efforts in eradication of smallpox which built up certain kinds of capacities worldwide. I believe what an epidemic does is highlights the deficiencies in the system. For example, most third world countries do not have any means of disease surveillance for any diseases, much less AIDS. They do not have the laboratory capacity to appropriately and properly diagnose a wide variety of infectious diseases. They do not have the epidemiological skills, they do not have the associated behavioral science research. All of these deficiencies exist and AIDS just highlights what is going on. Even the quality of blood banking is poor, not just because of lack of testing for HIV virus, but often because of lack of facilities generally for providing sterile blood. 216 Even in the case of immunizations, many of us have visited immunization centers in third world countries where you would find the same syringe and needle used over and over again. In the past this was related to epidemics of hepatitis B, for example, or even staphylococcal infections or Tetanus. There are a few cases where a person died of tetanus from immunization programs. All of these deficiencies are highlighted by an epidemic like AIDS. I think, therefore, that investments in AIDS, building up epidemiological capacity, establishing laboratory capacity, strengthening behavioral science research to study this disease initially, will build capacities which will have long term sustained importance in building up the health infrastructure in developing countries. DR. ROSENFIELD: If I could add, at the present time, from other conditions, it's estimated that as many as 14 million children under the age of five and infants die each year of essentially preventable diseases and that fostered the child survival movement. Less well known, a half a million women each year die from preventable or treatable causes -~- pregnancy related causes for which new initiatives are now being developed. The family planning impact on development, on the health of women and children, on the rights of women to plan and on fertility levels have been a major new development in the past decade and a half. All of these programs have inadequate funding levels at the present time and with the past eight years of budget difficulties, many of these programs have been cut or at least they have not grown. That's why in my testimony I suggested the importance of new monies to develop the types of things that Dr. Mosley just mentioned that are so essential. If we substitute the funds now going to the child survival movement, to the safe motherhood initiative, to immunization programs, to family planning programs, in order to fund AIDS-related initiatives, we'll be making a major mistake in terms of the tragic consequences related to existing health and family planning programs. Thus, I think it is so important that these be additive funds to the existing under funded health and family planning programs. MRS. GEBBIE: As a follow-up, one of the things we've heard a great deal about is the need to coordinate what goes on so that the various projects going into a given country relate to that country's overall strategy and don't compete with each other. There is, at least in my associations with it, in academia a strong desire not to have one's research agenda controlled, to be able to follow wherever the indications lead one. Are the kinds of universities that the three of you represent being brought in appropriately into this kind of coordinated and targeted approach to our studies? Is that 217 happening in such a way that it still leaves you room for the kind of freedom you feel you need or have you been exempted from that? Is that coordination only applying to the direct sort of federal agency support that's going on in those countries? DR. MOSLEY: I don't believe there's a conflict between coordination and the freedom to pursue various research agendas. For example, I think the WHO has been very effective in their global program on AIDS by having countries develop national coordinating committees, and begin to look at their problem in a very broad perspective. Within that frame work then, a great deal of research can be carried out. In fact, I think often the lack of coordination leads to duplication of effort with very, very limited resources. This is one of the reasons even within our own university for international research we have created the Institute for International Programs to coordinate a wide variety of faculty in different academic departments and in different disciplines who are working in different countries. This provides a means of communication and to facilitate their work rather than to hamper it. Also, similarly in the AIDS research program the university has established a committee to coordinate AIDS research and education which, again, tries to bring together faculty from a wide variety of disciplines ranging from the molecular biology to programs in law and ethics and immunizations and so on, to discuss with one another what they are doing and to see to it that there is coordination. Often new collaborations are developed as a result of this. So I do not see any intrinsic conflict between coordination and the academic freedom, shall we say, to pursue research agendas. _ DR. KANKI: Perhaps I could just expand on that a little and that is with respect to our experience in Senegal where we've seen some duplication of efforts with respect to donation of resources. There is a large blood bank center in Dakar where they have had donations of HIV ELISA test kits from at least five different organizations, four in Europe and one being USAID. And in all cases the assays provided were slightly different with different equipment and there was actually no coordination such that one group knew that another group was giving kits. And there was actually no provision for training. So the kits sat there for months without being used. I don't know exactly who should have the coordinating role, but one must remember that for many countries in Africa, there is a very large group of federal organizations in Europe, in France and Belgium specifically, who are also involved in providing the resources to these countries. 218 DR. MOSLEY: Just a comment. I think that type of coordination, hopefully will be provided by the AIDS coordinating committees that are being established with WHO assistance. And I think it behooves all of us that provide assistance in these countries to try to work through the local coordinating board even though sometimes the bureaucracy that will be set up within those committees will be difficult. Nonetheless, we need to coordinate. MRS. GEBBIE: Thank you. CHAIRMAN WALSH: You made reference to the inadequacy and diminishing of funding in the international health field. Tell me this, on AIDS, for example, where do you get most of your funding now? Do you get it from A.I.D., or do you get it from CDC? DR. ROSENFIELD: Our international component is relatively small and it's involved with a USAID funded program of operations research out of the Office of Population. And we have been adding some AIDS activities onto that particular cooperative agreement. Domestically, we have significant federal funding support for research. DR. MOSLEY: At Johns Hopkins almost all of our AIDS funding, the major part, comes from the National Institutes of Health, from several of the institutes of the NIH. Some, only a very tiny fraction, is from USAID at the present time. CHAIRMAN WALSH: I wanted to ask you, since we have so many A.I.D. people coming in today, I wanted to ask you how do you relate to this AIDSTECH? What is that? DR. MOSLEY: AIDSTECH is a technical assistance program that USAID developed. It was sent out on competitive bids last summer. Johns Hopkins joined with Columbia University as one of the competitors, and we were unsuccessful. It was funded to another organization. So, at the present time, Johns Hopkins has no working relationship with the AIDSTECH project directly. AIDSCOM, which is a communications program, was competitively awarded to a group, the Academy for Education Development, but the Johns Hopkins Population Communications Program is a subcontractor on that, and so we work very closely with the AIDSCOM project. CHAIRMAN WALSH: Now, if you want additional funding for an international AIDS project, do you have to apply to AIDSTECH to get it now, or do you apply directly to A.I.D.? 219 DR. ROSENFIELD: Basically, AIDSTECH funding is to that organization and they do not have a plan or a mechanism, I believe, for any major subcontracting to university groups. There is potential for collaboration. We have staff based in Africa, and as they develop their African initiatives they may well interact with us. But, in terms of applying for funds, there really is not the opportunity in the way the AIDSTECH is developed as I understand it, nor is USAID right now open to unsolicited proposals for support of universities or other groups in this area. DR. MOSLEY: I could add that at the present time I am having discussions with the Rockefeller Foundation about a means of setting up a coordinating mechanism to develop international AIDS research centers. In fact, the National Academy of Sciences convened a meeting in January with USAID support, which brought together major donors including the Rockefeller Foundation, the Ford Foundation, the World Bank, the UNDP, as well as a number of representatives from U.S. agencies to talk about the need for international research centers. Johns Hopkins participated in that meeting and we have submitted a proposal to the Rockefeller Foundation to try to play a coordinating role in facilitating the development of such centers, which would be funded from multiple donors within various countries. Obviously, the countries would have to agree to the creation of this and they themselves would have to establish such centers. Our view is that the resources are available from a wide variety of donors internationally and that many countries with some, shall we say stimulation, would be prepared to make a commitment to the creation of multidisciplinary research centers within their countries to pursue the problem of AIDS. CHAIRMAN WALSH: Well, as you both pointed out, and very sensibly, AIDS gives us a great wedge, those of us who are interested in international health, as a means of really doing something that's going to have a much broader effect than just benefiting AIDS itself. It appears that because of the concern of the Congress with AIDS that there may well be even in these budgetary times increasing sentiment to add money to the A.I.D. coffers for international health. Would you have any suggestions for this Commission so that we could at least have some input as to what these appropriations may be as to how they would be utilized?. I'm not making a statement here about AIDSTECH or AIDSCOM, but it just seemed to me that with the vast resources that are already available in this country I couldn't quite 220 understand why they did what they did. But, that's immaterial. It's done now. I wondered if you would like to comment on it, because if they themselves have second thoughts for the future, perhaps we could support their increased funding but also could support it with perhaps some suggestions to the President as to a wiser way to utilize it. DR. MOSLEY: My present understanding is that in the current fiscal year Congress has appropriated another $30 million for AIDS. About half of that will be going to the WHO Global Programme for AIDS, -- CHAIRMAN WALSH: Right. DR. MOSLEY: -- which is certainly quite appropriate. And then, about $7 million for the AIDSTECH, AIDSCOM initiative. And then, $6 million or so, would be for either primarily the Africa Bureau or for a number of missions, USAID missions, in smaller amounts, a hundred or a few hundred thousand dollars each for about 20 countries. Personally, I have some reservations about that last allocation, because I know many of these AID missions just do not have the professional and technical capacity to address the problem of AIDS in their country. And likewise, the countries themselves may have various kinds of wish lists or want lists that may not necessarily be a priority. My concern is that a lot of the funds would be dissipated by this very, very wide disbursement in very tiny amounts, when one visualizes that the amount of six or seven million dollars could with a more coordinated strategy make major inroads in terms of our understanding of AIDS and developing better means of control. CHAIRMAN WALSH: If you and any of your colleagues would like to write some suggestions to us, I have the feeling that Congress may up that to $50 million next year. It would seem a shame to not have the wisdom of people who have wide experience in the field in at least giving some guidance as to how the money could best be spent. Advice can be taken or rejected, but at least this Commission would be in a position to make some suggestions. Would you be willing to do that for us? DR. MOSLEY: Thank you. I will be pleased to do that. CHAIRMAN WALSH: We'd be very grateful. You may call on other colleagues to make suggestions which would be very helpful, I think, to us. DR. ROSENFIELD: One of the great gaps is in the area of epidemiologic data collection. Certainly, major attention in 221 that area, in addition to the prevention efforts and some of the research efforts that are under way. I'd be delighted to assist in that. CHAIRMAN WALSH: Dr. Kanki, do you have any thoughts on it? DR. KANKI: At Harvard, I believe we have no funding from A.I.D. Most of our funding, at least for West Africa, comes from a Department of Defense contract. That's one of the things that we've been extremely cognizant of as we began this international collaboration. We realize that there's incredible fluctuation in the small amount of funding that's available for international use. We do have NIH funding for AIDS, however it is usually ear-marked away from international efforts. With respect to A.I.D., we have had some contact with them at the mission level in Dakar and have found that they at least several years ago were much less enthusiastic about getting involved in the AIDS problem and felt that it had little to do with sexually transmitted diseases. We have received funding for some of our work with the sexually transmitted diseases and we feel that they tend to have, at least at this mission level, a very focused response to the problem which often seems to go around the sentiment and politics of local researchers as well as the local health ministry. CHAIRMAN WALSH: Thank you. Any other comments? DR. PRIMM: I have a question. CHAIRMAN WALSH: Oh, All right. Go right ahead. DR. PRIMM: I wanted to ask Dr. Kanki about HTLV-1 being found now fairly frequently among blacks in the South and among the addict population in the East. What do you see that may portend for those persons who are so infected with that virus along with some of them being found with HIV-1 and 2 concomitantly with HTLV-1? DR. KANKI: I think that HTLV-1, at least in the U.S. at the present time, probably is more of an immediate problem that we have to deal with in the blood bank. HTLV-1 induces adult T-cell leukemia lymphoma, but that has a fairly low penetrance. In other words there are a few people who will actually die of that tumor per lifetime. However, we are recognizing that HTLV-1 has a more broad spectrum of disease and that includes a more acute syndrome with a neurologic component called HTLV associated myelopathy, which has been seen in all of the HTLV endemic areas. 222 Also, there have been handfuls of cases of AIDS, full- blown AIDS that have been reported only with HTLV-1. I think that the diverse potential of a virus that infects the T4 lymphocyte is really just unknown to us at present. Therefore, I think HTLV-1 may be a very important retrovirus that we should be aware of for the future. With respect to its interaction, we have seen that cases of HTLV-1 and HIV-1 concomitant infections have led to a more progressive disease with a somewhat different clinical spectrum. Sometimes these individuals have developed T- 8 proliferative disorders and they have seemed to progress more rapidly through disease. We have not seen that yet in Africa, but we have started studies to look at people who are dually infected. DR. PRIMM: HTLV-1, is it sexually transmitted? DR. KANKI: Yes. All of these viruses are thought to be sexually transmitted as well as through blood products and maternal/infant. I think that most of the prevention control programs for HIV-1 will be effective for HTLV-1 and HIV-2. DR. PRIMM: And the incidence and prevalence among blacks, would you comment on that? DR. KANKI: I can't really say. I haven't been involved in the studies in the U.S. I think that HTLV-1 definitely has a very discrete geographic distribution throughout the world and it probably relates to a virus that has been present for a long period of time but has been moved through very specific population groups throughout the world. DR. PRIMM: Thank you. CHAIRMAN WALSH: Cory? DR. SerVAAS: Dr. Kanki, how soon do you think we will be able to be testing for HTLV-1 in our blood banks, and the information you were giving us, was that about the behavior of HTLV-1 in the Orient or -- DR. KANKI: I'm sorry, I didn't understand the second part of the question. ‘ DR. SerVAAS: All right. You were giving us. information, and then you said you would be looking at it in Africa. Were you speaking about the Orient and how the HTLV-1 T- cell leukemia lymphoma behaves? DR. KANKI: Yes. Most of the information about HTLV-1 alone is based on information from the southwestern islands of Japan as well as the Caribbean at present. 223 I can't comment about the licensing of HTLV-1 assays. I know that there are many that are presently being looked at and I believe that the blood bank centers have decided that they will implement an HTLV-1 assay as soon as one becomes licensed. DR. SerVAAS: Thank you. CHAIRMAN WALSH: Okay. All right. Mr. Chairman? CHAIRMAN WATKINS: I'm taken, Dr. Mosley, by your recommendation. I feel very strongly that a large part of the confusion nationally has been the lack of a strategy to deal with the epidemic. I think we feel fairly comfortable in the Commission that at least we're going to provide some flesh on the bones of national policy. Your recommendation is very timely that there be a similar strategy built that would provide an international strategy. Your recommendation is that the Office of Science and Technology Policy of the United States consult with representatives of those federal agencies concerned with the AIDS epidemic in the third world as well as non-governmental advisors. But, I'm questioning whether that is the right office to develop that strategy for international collaborative efforts in a more coordinated way. Is that the right office, and why did you offer that? DR. MOSLEY: I followed here a parallel by the National Academy of Sciences study when they were reviewing the U.S. capacity to address international tropical disease problems and international health generally. This was the framework and the strategic approach that they had proposed. I paralleled the recommendations feeling that it should be at a high level in the government, not within an agency, for example, such as the USAID. CHAIRMAN WATKINS: The only thing I worry about is budget constraints coming in ahead of the strategy. So often groups like that are subservient to budgetary pressures before the strategy is built rather than building a strategy and deciding how you're going to fund it later. The specificity here alludes me as to why you're picking that particular group to he the focal point of building this international strategy. DR. MOSLEY: I believe an alternative could be the National Academy of Sciences as a policy group that is outside of the fiscal constraints. One of the concerns I have, though, is that many of the problems and the issues that we are dealing with relate to constraints within government agencies themselves: their inadequate staffing; the various types of fiscal constraints that they face; travel constraints, for example, that 224 are actually irrelevant to funding but are decided on other bureaucratic basis. Somehow, it was my view that perhaps an agency within the government might be one that could bring together the representatives of the other agencies to look at both the issues, and also the fiscal and perhaps policy and other constraints that are limiting their ability to work effectively. We have heard some of those this morning already and you probably will hear more this afternoon. CHAIRMAN WATKINS: Dr. Rosenfield, do you have any views on this recommendation that Dr. Mosley has made to us? DR. ROSENFIELD: I agree with the recommendation. I'm not sure what the proper location of such a function ~-- if it's a one-time function, your Commission would be an ideal location. But, beyond the life of the Commission, there's a need to set up that entity. Whether in government or through the National Academy of Sciences, I'm not sure. My reservation on the National Academy of Sciences is that they are purely advisory and their words don't need to be adhered to. Within government, if it was at a high enough level it would indeed, perhaps, have the ability to bring together these different agencies in some form of a coordinated approach. So, I'm in favor of the recommendation. I'm not certain where I'd locate it. CHAIRMAN WALSH: What about the Office of International Health within HHS or something like that? DR. MOSLEY: Pardon me. That again is within an agency, and what we are trying to do is to get above the agencies. DR. ROSENFIELD: It has been difficult. There was an Office of International Health within DHHS. Because it was an office that served more of an advisory and policy function, it did not really have any direct relationship to the international health programs of USAID during its life in the past. CHAIRMAN WALSH: Thank you very much for your views and we will look forward to your writing us if you will do that. If after hearing, thinking, and talking about it, you have some changes or modifications, please don't hesitate to write. DR. ROSENFIELD: We will attempt to submit a joint - CHAIRMAN WALSH: Write to us, will you? DR. MOSLEY: Yes, sir. 225 CHAIRMAN WALSH: Thank you. CHAIRMAN WALSH: The next panel is representing Loret Ruppe and the Peace Corps. You can see how impressive a figure Ms. Ruppe is when we have a panel of five people to replace her. David Scotton, is -- you can all come up here. MR. SCOTTON: Mr. Chairman, members of the Commission, I am David Scotton, the Chief of Staff of the Peace Corps. Regrettably, our Director Loret Miller Ruppe cannot be here. She's out of town with her younger daughter who is undergoing surgery today. She wanted me to tell you that she certainly supports the work of the Commission, and at some future time, if it was deemed appropriate she would like to meet with the Chairman and members of the Commission collectively or individually. I would like to introduce to you our Chief Medical Officer in Peace Corps, Dr. Teresa Van Der Vlugt, who will be giving the Peace Corps' testimony. Also with us is Richard Wall, former country director in Mauritania and Zaire, who is our Agency AIDS Coordinator. And as Dr. Walsh and I were talking last night, our General Counsel, John Scales, because nobody goes to a hearing in Washington without his or her general counsel. MR. SCOTTON: So, Dr. Van Der Vlugt, if you could give our testimony. We'd be happy to answer any questions that you might have afterwards. DR. VAN DER VLUGT: Mr. Chairman and members of the Commission: The Peace Corps was established in 1961. For 26 years it has promoted peace and friendship by sending volunteers abroad to help people of other nations meet their needs for trained manpower. Volunteers are also charged with developing a better understanding of Americans among the people whom they serve, and on returning to the United States, promoting a better understanding among Americans of the people with whom they lived and worked. Volunteers are men and women of all ages and all walks of life who serve for two years living among the people with whom they work. It is this grass roots, "people to people" approach that distinguishes the work of Peace Corps volunteers from other more traditional assistance efforts. To date, more than 130,000 men and women have served in the Peace Corps and through their example demonstrated that voluntary service can be a force for change. While their efforts are individual and apolitical in nature, Peace Corps volunteers contribute to America's long-term foreign policy by increasing trust and understanding between 226 peoples. About 5,400 volunteers and trainees are presently overseas working in 65 countries. As of March 31st, 137 countries have reported 85,273 cases of AIDS to the World Health Organization. Peace Corps is serving in 55 of these countries. In Africa, volunteers serve in 26 of the countries reporting cases. These countries account for 54 percent of the cases reported in Africa. In Inter America, volunteers serve in 17 of the countries reporting cases. These countries account for 21 percent of the cases reported in the Americas, excluding the United States and Canada. In North America, the Near East, Asia, and the Pacific, volunteers serve in five of the countries reporting cases. These countries account for three percent of the cases reported in the area. As has been forcefully noted in these hearings, the implications for the third world are devastating. Declining economic growth in countries with large concentrations of infected people, medical infrastructures, fragile at best, are overwhelmed. Competition for health services and resources are growing. This all adds up to a situation of unprecedented scope and complexity. In 1985, during my visit to our program in Zaire, I met with Dr. Jonathan Mann, then the director of the Project AIDS in Kinshasa, to discuss the implications of this terrible disease for the work our volunteers were doing. In addition, because of the work Dr. Mann and his colleagues were doing in Zaire, We were able to establish a voluntary testing program for our Peace Corps volunteers in order to see if they were, in fact, in danger of becoming infected. I am happy to report that of the 210 volunteers who have offered to be tested, no one has become sero positive. Mr. Chairman, some of those volunteers had been in Zaire for over 36 months. In order to insure that our volunteers and staff are healthy, we have: Incorporated HIV testing as of March lst, 1987, into the volunteer personal health care program. Applicants must show evidence of HIV sero negativity before being medically cleared for service. Volunteers are tested during service when clinically indicated. Volunteers are also tested at the end of their service. We have established policies on blood transfusions, injectable medicines and vaccines for volunteers, enroll volunteers and staff in a "walking donor" blood transfusion program in cooperation with the Department of State. We have established the policy that all volunteers and trainees will be 227 given information on the risk of HIV infection, and specific preventive measures, both prior to departing overseas, and during the course of their service. We required Peace Corps volunteers working in primary health care to abide by the guidelines for preventing the transmission of HIV to health care workers put out by the Centers for Disease Control of the U.S. Public Health Service. Mr. Chairman, other agencies are able to offer financial assistance along with their experts. We are able to offer people. I am deeply concerned that our volunteers remain healthy and safe, as they are the heart of the Peace Corps. I consider them my first priority. The safety of the volunteers and the effective use of their skills in programs aimed at the control and prevention of AIDS is a large task. To help accomplish it, I have created a special office in the Office of International Operations to coordinate the Peace Corps' response. I have indicated to government officials in all the countries I have visited over the past two years that we are standing by waiting to help. Two presidents, in countries in which volunteers serve, have indicated to me they are considering how volunteers could help. I believe that volunteers can play a real role in this fight. I have been supported in this by Dr. Mann himself. In a letter to me in January this year he said, "I firmly believe there is an important role for volunteers to play in the control and prevention of AIDS, not only in Africa but in alli the countries in which they serve." Dr. Mann goes on to say, "I think Peace Corps volunteers could make a real and lasting contribution at national levels and at district levels." There is an attachment of Dr. Mann's letter to Director Ruppe. Mr. Chairman, education is a task Peace Corps volunteers have performed with distinction around the world. Mr. Chairman, it is important to realize that we only reply to requests for programs and volunteers made by host country governments. It is up to them to delineate our role in the fight against AIDS. I must be honest with you, Mr. Chairman, no country to my knowledge has formally requested Peace Corps specifically mount a program aimed at fighting this disease. I am, on the other hand, not surprised or alarmed by this fact either. Most of the countries in which we work are only now beginning to develop comprehensive national AIDS plans and to develop national education campaigns. The issues surrounding AIDS, the fear it engenders, the burden of caring for those who are already ill, and the control and prevention of the spread of the infection are sensitive 228 issues in all countries in which we work. That is why we are proceeding prudently. We are looking for the right thing to do at the right time and in the right way. When our programs have been strong and successful, it is because they have been planned in collaboration with the host government and other donor agencies. Public health programs more often than not have limited resources. In searching for solutions to the problems posed by HIV infection, it is more important than ever before that the entire international community work together and not compete for resources. In closing, there are some things I would like to underscore: the Peace Corps is prepared to reply to requests from host governments to become involved in the fight against AIDS, particularly in education, we help by having our volunteers who work in child survival projects teach the use of the WHO guidelines to assure clean needles and clean syringes for each immunization, Peace Corps was the first international voluntary federal agency to institute a testing policy for its volunteers, Peace Corps has an extensive education program in place to protect the health and welfare of our volunteers. Our tradition is to help people help themselves. There are always risks in working in developing countries. Were the conditions creating these risks not there, these countries would not need our help. It does not serve either these host nations or our own nation to send volunteers out without preparing them to deal with the problems they will encounter both personally and professionally. I would like to thank you, Mr. Chairman, and members of the Commission, for the opportunity to speak to you this morning. I would be pleased to answer any questions you may have. CHAIRMAN WALSH: Thank you, Dr. Van Der Vlugt. Let me see, we'll start on your side, Frank. Do you have anything? Theresa? DR. CRENSHAW: I'd like to reserve my question. CHAIRMAN WALSH: All right. Come on, Kris. MRS. GEBBIE: Two questions. One, while you're very clear that you only respond to requests, I assume there's some contact with countries that lets them know that this is available that in essence can stimulate a request. "Here are 13 things we could do if anybody got around to asking us." To what extent has that happened to get some consideration from countries most affected by this epidemic and short of resources to consider asking for help? 229 The other question has to do with the breadth with which you define what you can incorporate into a specific project. You mentioned one where you're in a country doing an immunization program. You at least make certain that needles are handled very appropriately in a way consistent with preventing AIDS. I can imagine incorporation of AIDS prevention messages into any number of projects targeting: child health or education or so on. Has that been looked at in its broadest possible sense or is that too uncomfortable within the constraints on a mission once it's defined? DR. VAN DER VLUGT: Thank you for the question. I'll ask Dick Wall, who is a special assistant to Loret, to respond to your question. MR. WALL: I think it's important to realize that this is an ongoing dialogue. In public health, agriculture, and all other fields, we continually explore ways that we could help the people in collaboration with the host country government. Our problem right now is that to date no one has said specifically they want us to mount a program doing a particular thing. We are exploring both with USAID's programs called AIDSCOM and AIDSTECH, ways of using volunteers to help promote some of those public health messages. Does that reply to your question? MRS. GEBBIE: That would deal perhaps with the specific project question. What about the incorporation of AIDS prevention related activities into ongoing projects that might not have been specifically set up for that purpose but lend themselves to that opportunity? MR. WALL: We are in the process of exploring how we would do that. We are involved in education. We are involved in a lot of programs that are in rural areas of the country. It's important that the countries themselves decide what messages they want to go out before we can afford to take those messages along. Informally, when we are asked, volunteers respond to those questions. MRS. GEBBIE: Are you pretty comfortable with the growing structures that World Health is setting up to insure the coordination of all activities going into a given country, or from the perspective of the Peace Corps are there some improvements that need to be made in that? MR. WALL: Our public health programming policy has been to collaborate with all agencies. To date, it has been to our advantage to work with WHO in approaching these problems. At this point in time, I don't see that we as the Peace Corps would recommend something differently. 230 CHAIRMAN WALSH: Mr. Chairman? CHAIRMAN WATKINS: We had a recommendation earlier, from Dr. Mosley, that there should be the formulation of such an international AIDS policy. I'd like to know, one, if you agree with that. And, two, do you feel that the Peace Corps has a significant role to play within such a strategy with your volunteers, with the human resources that can be applied particularly to the field of education. And if so, how would you see the Peace Corps! fitting into such a strategy? DR. VAN DER VLUGT: Well, I certainly agree with what you have said. I think I can only emphasize what Dick Wall has mentioned about our ongoing educational efforts throughout Peace Corps, whether they be in specific health areas or in other fields of education. I think it's important that we continue to reiterate that Peace Corps reflects the request of host country governments in our endeavors. Certainly, we support an international health strategy. CHAIRMAN WATKINS: Sometimes the fact that you've not been asked -- I think that's the point you made -- startled me a little bit. You have significant human resources. That is so often the Achilles heel of a program. We've been hearing from medical scientists, people who want epidemiological data, and a lot of technical information but you can't just throw dollars because we don't have the trained human resources, the volunteers, to do this kind of work." Well, here you have an organization not being tapped, which should clearly be an integral part of any international strategy since what we're dealing with here is the social fabric of every society. So, I'm just wondering if we don't have a tremendously valuable resource that is sitting there waiting to be asked. They may not know how to ask the question, Cant you say, "Here's a program we can offer you. Here's the role the Peace Corps can play within it." It seems to me that you should be promoting such a concept, because it touches so much of the work you're doing in so many other fields. MR. SCOTTON: I agree with everything you've said, Admiral Watkins. I guess our problem was that we did not want to get too far out in front until all of the organizations started to get together. But, yes, we do have very valuable human resources out there which the Congress and the Administration has asked us to expand and have specifically told us to expand in the area of medical care delivery and health education. So, to answer your 231 question, yes. We support this type of forum, and we hope this will be one of the recommendations that comes out of this. MRS. GEBBIE: Could I ask for clarification on that issue of expansion in size? MR. SCOTTON: Yes. MRS. GEBBIE: We've had this dialogue so far as if all you were doing were waiting for thousands more people to come in and ask. What is your capacity for additional projects either in number of projects, number of people, over say the next two to three years? MR. SCOTTON: Our plan calls for us to double in size over the next five years. So, while we have 5,500 volunteers out there now, by 1992 we hope to have over 10,000 and a large percentage of the additional growth will be in the health related fields. MRS. GEBBIE: And the average project involves how many volunteers? MR. SCOTTON: Oh, it varies. We have some team approaches with five, six, eight, ten volunteers. And some individual volunteers work in clinics in rural areas. So, there's no set pattern. MRS. GEBBIE: In looking at that recruitment with a specific emphasis on health-related issues, it seems to me you're going to bounce up against some of the health staffing shortages that already exist in this country. We've heard a lot of testimony, for example, about the shortage of nurses and certain specialists. It's the same people that we've been hearing about trying to stretch around domestically that you will then be trying to attract for international work. Have you looked at that? MR. SCOTTON: You're right about the nurses, but you would be amazed at the number of physicians who for their own reasons--and I think some of it may be the malpractice insurance--have indicated that they would like to serve in the Peace Corps. Without an effort, we have in our files right now almost 200 physicians who have indicated they would like to serve in a program like this. CHAIRMAN WALSH: I'm sorry, go ahead. CHAIRMAN WATKINS: I don't know if we have documentation from you, but supposing you were to go to the first international health policy conference sponsored by the Office of Science and Technology Policy, and you were to come equipped to 232 say what role you want to play? What do you see your role in the future as you expand, were you to have resources that would permit you to get into this international AIDS issue in a big way in the variety of countries you serve? Could you develop such a strategy right now in anticipation of what might be there? I think that might be valuable to us to have. I would appreciate it if you could send us a letter that would say, Here's what we see as a valuable contribution the Peace Corps can make in the area of international AIDS epidemic control." As you expand over the next several years, what would you see as a valuable role that you could play, and be specific if you want to in selected countries where you have the expertise as examples. Is that something that you could do? MR. SCOTTON: We would look forward to that opportunity. We'll get on it right away and we'll submit a report to you. CHAIRMAN WATKINS: Thank you. CHAIRMAN WALSH: How about -- Rich, do you have -- MR. DeVOS: I come from the corporate world, and I'm always fascinated -- and I think some of the same human things occur in the government world -- whenever there's a new opportunity, everybody wants to jump into it. I'm not being critical, I'm just very concerned with what happens with what you started with? You started with an organization to help people to help themselves in very specific ways. As I recall, from my background of Peace Corps work and the great dedication of people right down there teaching a guy how to build a fence or build a roof or farm a piece of ground, you were very hands-on. Now, suddenly this great diversion into AIDS. It's a wonderful cause, but I get concerned with what's happening to your regular work? Is it gone? Where's all this energy that's going to get shifted? And what happens to the great cause you represented in the first place of teaching people to help themselves? I admire that, and while I know this is an important one, there's a whole lot of other people that want to work at it and I don't want you to lose focus on where you guys have been and what you've accomplished so magnificently over all these years. MR. SCOTTON: Right. Thank you, Mr. DeVos. That's a good question and a good point and we will not lose our focus at all. We are involved in people to people skill transfer. We don't like to be the person out there giving the inoculation or otherwise administering medical care. We want to teach the 233 people how to do it and supervise the program and transfer the skill. So, we're not talking about changing our focus and having our volunteers actually delivering health services. Instead they would be training and supervising host country nationals who would be delivering the health service. MR. DeVOS: Have you at this point seen any interruption in your regular work because of AIDS in some of these countries that have a high level of incidence? MR. SCOTTON: Not at all. We're still very involved in education, very involved in agricultural development, agriforestry, and areas like that. CHAIRMAN WALSH: Beny? DR. PRIMM: I just had one comment. As I travel around this nation and into all the small hamlets and the slums of our inner cities and these small hamlets where poverty abounds and people are living in run-down housing and shotgun houses and trailers and sewage is in the street, I'm concerned why we don't have an internal Peace Corps, an intra-America Peace Corps. We need that just as badly as we need services to other nations that are less fortunate than we are, right here at home. I could not help but to think of something that my grandmother used to say, that "charity begins at home and then spreads abroad." As we talk and as I reflect on some of the visits that I've made recently -- and particularly to an area like Belle Glade, it's just as bad as it was two or three years ago when the problem of AIDS was recognized in that town and still the kinds of services that they need in that community are not there, the same kind of services that you all are delivering in other nations. I'd like a comment on that just briefly, if somebody would. MR. SCOTTON: Yes, Dr. Primm. There is a domestic Peace Corps. It's the VISTA program, Volunteers in Service to America. Over the years, they have, had help from the Congress and from the state and local governments. So, there is a domestic type volunteer service program. DR. PRIMM: Are they active? MR. SCOTTON: Yes, they are. 234 DR. LEE: Reading the statistics, they're quite impressive. You have 164 people in Nepal and you're in the business of education. It does, I must say, following up on what Admiral Watkins was saying, seem a very natural segue. A hundred and sixty four educators in Nepal could straighten out your prevention of AIDS in about a week, it seems to me. MR. SCOTTON: Yes. We see potentially a role in AIDS education programs as an area in which we could be very, very successful. DR. LEE: From a personal point of view, I want to congratulate all of you. I've had nothing but admiration for you ever since your organization was formed. CHAIRMAN WALSH: I think Commissioner Gebbie has a follow-up question. MRS. GEBBIE: I think we're all interested in how to get you connected in the most productive way. Yesterday we heard about donor meetings, where all the potential donor agencies to a country get together with that country with its plan for AIDS to try and figure out how to coordinate. The more we listened, the less clear it was whether the Peace Corps is represented at those donor meetings. Is that only cash donor agencies? MR. WALL: Those are cash donor kinds of agencies. MRS. GEBBIE: You have not been at that table, then? MR. WALL: We have not been at those tables. I think it's important to realize that we have always been willing to teach whatever those governments wanted us to teach in those ~~ classrooms. If they want us to begin to also incorporate AIDS education into our teaching programs, then I think it behooves the governments themselves to indicate that. It is not up to a volunteer to decide what the curriculum will be. We can encourage them to look at other kinds of ways of approaching that curriculum, but ultimately the government should decide how they want to do that. MRS. GEBBIE: But, it would not be against your charter in any way for you to be a part of a donor meeting, say for an African country that's trying to figure out what to do about AIDS? MR. WALL: No, absolutely not. MR. SCOTTON: We would welcome an invitation to participate. MRS. GEBBIE: Thank you. You ought to invite yourself to the next one. x 235 CHAIRMAN WALSH: Back in the late '50s, those of us at Project Hope always believed that Hubert Humphrey got his idea for Peace Corps from Project Hope because he was very close to us in those days. I don't think he would deny it, so I have great admiration of your ability to continue your philosophy of working with people rather than for them. I feel very strongly that you are in a position, as the Admiral has pointed out so well, to perhaps do more than you even realize or more than the other agencies realize in not only combating the problem of AIDS, but in the creation of this infrastructure which everyone has said is so deficient. That's what you all have been doing for years, not only helping them to build a road and other things I personally am gratified that the Peace Corps has changed to a degree with the times, in that you are educating that infrastructure in a variety of skills. I have always felt that you had a great opportunity in the health field. I only will resent your competition. But, the world is big and there's room for everyone. I know that Ms. Ruppe has wanted for years to have the Peace Corps cooperate not only with other agencies of government, but with private voluntary organizations and has brought about the modification of some of your rules. I can remember many years ago -- I say this primarily for Rich -- when the Peace Corps had some kind of legislation where unless there were 25 people in a program they couldn't do anything. This was years ago. Well, that's ridiculous. Now, I think you've modified it so you can answer a need that is requested. I want to reemphasize, what the Admiral has pointed out, that whether it's the rule or law I too don't feel that you should wait to be asked by a country. You know from your work, as we know from our work, that many times you have to demonstrate to a country that you have certain skills available should they want to ask for them, then you will be able to provide then. I wouldn't be hesitant at all in suggesting to countries that you can help in the education or the infrastructure. As Jonathan Mann said yesterday, he doesn't want any interference in the development of phase 1 plans. But, once the phase 1 plan is in place or is on the way to being in place, then he wants all the help he can get. That's were the Peace Corps can fill in. We hear the people from the schools of public health and I respect them greatly, but they're going to send out other professors. They're not going to send out volunteers. What we need are volunteers out there to work in this infrastructure, 236 because this infrastructure extends all the way down to the villages, not only in the capital city. It starts there, but it extends all the way down. We have got to be sure that we take advantage of the Peace Corps in this thing, because it's a great opportunity. Not for AIDS, and I think I'm the greatest advocate on this panel of using AIDS as a wedge to try to solve other development problems in the health field and to try to provide answers for what we can do in the diseases that are killing far more people than AIDS will ever kill in these countries. The Peace Corps is in an admirable position to do this, and I'm absolutely delighted to hear that you hope to expand in the next five years. I just hope that you do and I hope the silly rule of not letting people stay there long enough to do it has also been abridged so that some of you can stay and see that it's done. I have no questions. I just have commendation for you. MR. SCOTTON: Thank you very much. CHAIRMAN WALSH: Thank you. MR. SCOTTON: Thank you for giving us the opportunity to testify. CHAIRMAN WALSH: Thank you for coming. We will reconvene at 1:30. (Whereupon, at 1:07 p.m., the Commission was adjourned to reconvene later this same day.) A-F-T-E-R-N-0-0-N S-E-S-S-I-0-N 1:48 p.m. CHAIRMAN WALSH: All right. We're going to begin this afternoon's hearings. The subject this afternoon will be on bilateral assistance programs undertaken in the United States. We're privileged to have as our first witness, Alan Woods, the Administrator for the Agency for International Development. Alan? MR. WOODS: Thank you very much, Mr. Chairman. I am pleased to appear before the President's Commission today to discuss the United States Agency for International Development's policy and programs for combating the HIV epidemic and its potential impact on the economic and social prospects of those developing countries that are severely afflicted. 237 A.I.D. is the United States government agency charged with implementing all American foreign economic assistance policies and programs in developing countries. Our objective is to promote and assist developing countries in achieving broad- based and sustainable economic growth and to improve the welfare of their people. The Agency's programs have long included measures to address the health and education needs of people in developing countries. The United States can be proud of its association with some vital health improvements in developing countries, such as the eradication of smallpox, the reduction by one half of infant and child mortality and the increase of 10 - 20 percent in life expectancy. Today, we cannot even think of health or growth in developing countries without considering AIDS. The rapid emergence of the HIV pandemic is unprecedented in our lifetime. It is of global concern, but it is particularly severe ina number of less developed countries in which we have foreign assistance programs. Their budget and human resources are already stretched very thin to meet the needs of their burgeoning population. Our Agency's concern with the HIV infection is two fold. First, it is one of the greatest health problems the modern world faces. Second, the spread of AIDS has serious implications for economic development in some countries. Thus, we take HIV and its tragic consequences very seriously and are committed to fight it for as long as necessary. We have taken several steps to address the problem and to further our understanding of the potential development and foreign policy consequences of the disease that may affect us all. In fiscal year 1986, A.I.D. made the first donor contribution totaling $2 million, to the WHO's global AIDS program. In fiscal year 1987, we developed a $17 million program, including a $5 million contribution to the WHO progran, as well as the development of a major new Agency technical assistance support project. The A.I.D. panel that follows my presentation will discuss in detail the two major components of the project, which are referred to in our Agency as AIDSTECH and AIDSCOM, as well as other activities we now have available to address AIDS. In fiscal year 1988, we plan to spend about $30 million on AIDS, including a contribution of $15 million to the WHO program. In fiscal year 1989, we will spend even more, with a continued commitment of $15 million to WHO. In addition to the provision of financial and staff support to the World Health Organization, we look to the WHO global program on AIDS for country plans within which we carry out our own AIDS activities. In early 238 1987, A.I.D. issued policy guidance on how we would address AIDS. The key components of our program are: - training on HIV and AIDS for workers involved in health and family planning service delivery and in special HIV prevention programs; - procurement and distribution of condoms to meet the additional demand as a result of HIV; - public health education; - epidemiological and behavioral research where it is not being funded or undertaken by WHO or other United States government agencies and national researchers} - operations research to improve our understanding of the most effective sources of information about HIV and program interventions in particular settings; - economic research on the longer-term development and economic effects of the AIDS epidemic, including the potential impact on health budgets, economic productivity, child survival, as well as other issues; and, the prevention of blood transmission. We've also been thinking seriously about the broad international policy issues that AIDS raises for developing countries and, indeed, for the United States. We are faced with a wide range of projections about the current level of infection worldwide, a relatively long incubation period, and uncertainties about the proportion of infected individuals who eventually develop AIDS. Neither I, nor any other policymaker can provide answers today to the unknowns or make predictions. I can frame some questions and I can tell you what we are doing to get the information we need quickly to make policy decisions. For policymakers, I see three primary questions. How bad is it? What can we do? How should we do it? To answer the first two questions, we need information about the disease itself and its progression. We then can construct appropriate models with which to make projections. A.I.D. is taking steps to address the data needs and the model construction. To also address the second question, we are supporting operations research designed to determine the effectiveness of various intervention strategies to prevent further HIV transmission. To answer the final question, coordination between government agencies, international agencies and the private sector in developed and developing countries will be 239 critical. The World Health Organization Global Programme on AIDS has the leadership role in addressing the epidemic internationally. This leadership is critical, and continued U.S. support for this global program will be required. A.I.D., the Department of State, the Department of Health and Human Services, the Congress and other interested parties must continue to coordinate efforts to fight the AIDS pandemic. The next panel will discuss coordination with WHO and other U.S. government agencies and donors in more detail. The social, economic and political implications of high levels of AIDS in some areas form a major set of issues. Will patterns of migration and population settlements change as a result of varied levels of infection and available health care? Will economic and/or agricultural productivity decrease as a result of higher death rates? Will family and social structures change as a result of stress, children without parents, and isolation of individuals or communities? Will the leadership in high-prevalence countries be weakened through death or political difficulties resulting from widespread AIDS- related problems? Will resources be diverted from other health, education and family planning programs to deal with increased levels of HIV and AIDS? Will international investment decline in heavily infected countries? Answering these questions requires not only data and projections about the spread of the disease but also qualitative analyses of human response to the epidemic. The answers have implications far beyond health. They must be handled responsibly lest economic development and foreign policy objectives be jeopardized. Preliminary research results and experience in the field have left us at once encouraged, sobered, and challenged. The growing willingness of people and governments to talk candidly and responsibly about this sensitive issue is encouraging. Also encouraging is the consensus that AIDS will not result in declining population growth in the most severely affected countries. However, the implications of the disease for subgroups within populations of these countries is tragic and sobering. We are challenged by the many unknowns surrounding the disease and the limited kinds of interventions available to combat it. Finally, in a period of overall~budgetary stringency, we are further challenged by the need to enSture that our critical child survival, family planning, and education efforts do not lose ground. Thank you. SQ OS oN ~ ™ 240 CHAIRMAN WALSH: Thank you, Mr. Woods. If you have the time, we would like to give the panel the opportunity to ask you questions -- MR. WOODS: Certainly. CHAIRMAN WALSH: -- before the rest of your panel comes on. May I start with you, Rich? MR. DeVOS: I have a question for you. You say you're going to find out how severe it is. What have you done so far on that? MR. WOODS: I'm sorry, what was the last part of your question? MR. DeVOS: Well, you had three questions you said. . One is that you were trying to make a determination as to how bad it is. Do you have anything you could share with us along that line? MR. WOODS: I think the next panel will go over in some detail the work that we've done in that area. Our work is, I think I could say, as preliminary as yours. It's mainly an assemblage of information we've received from others rather than direct work that we've done ourselves. CHAIRMAN WALSH: Everybody's deferring. You've scared them all off, Alan. Not Ms. Gebbie. You'll never scare her off. MRS. GEBBIE: I don't know whether this is most appropriately directed to you or to the panel that will follow, but the whole issue of coordinated efforts and the use of the donor meetings to plan more appropriately what is done seems to have a great deal of appeal. A lot of people have nodded their heads nicely when we've talked about that. That makes it sound like one of the major issues we might put in a recommendation on has already been taken care of. I'd like to get comments on whether there is something that we should recommend that would make that process better, but also any comments you would have on other recommendations that we might make that would make a difference in what you do. MR. WOODS: First of all, in the business of economic development we spend a substantial part of our time in coordination. I have yet to see any activity or program in which coordination is as good as it ought to be. Certainly, that holds as true for this activity as it does for any other. Because we spend a lot of time in coordination with other donor nations in the area of developing country health 241 mn} problems, the coordination activity is probably better than it is in some other areas. The issue of donor coordination is an important one because we look to the World Health Organization as the world leader in doing what we do. So, it's vital that they be funded appropriately. That's the reason why half of our money this year will go to the World Health Organization, $10 million for their core program and $5 million for programs in specific developing countries, most of them in Africa. MRS. GEBBIE: Are those contributions to the World Health Organization over and above the regular United States assessment, or are they a portion of it? MR. WOODS: They are a separate, specific contribution to the World Health Organization's Global Programme on AIDS. CHAIRMAN WALSH: One of the most frequent comments made by witnesses before this Commission both domestic, and international, has been based on the fact that one of the problems in not only fighting the AIDS epidemic but in fighting any problem in disease is the lack of infrastructure in most of the developing nations. Concomitant with your appropriations for AIDS, do you have any thoughts about increasing the concentration of priority on infrastructure development in the health area in the developing world? MR. WOODS: If I can follow up on that just a little bit, you make a very important point. However if I may, I would say that the issue is an infrastructure that developing countries can afford. CHAIRMAN WALSH: Is what? MR. WOODS: Is an infrastructure that developing countries can afford. It's a very important point with regard to sustainability. If you look at the cost of the United States health system, and you recognize that a quality care system of the sort that we have in the United States costs the tremendous amount that it does, and you see that bilateral donors put about $30 billion annually into all development assistance -- not just health development assistance, but all development assistance -- and you look at the number of people to be served, you would realize through simple arithmetic that the total won't even come close to what those developing country costs are. CHAIRMAN WALSH: No. 242 MR. WOODS: So, part of the building of health infrastructure in those countries is building the economic base that will allow the health infrastructure to be supported by the economic activity in those counties. That is, indeed, a very long-term proposition, and it is something about which we are quite concerned. In the meantime, to be quite frank, we adopt for specific health interventions, including this one, an approach for lack of a better term I would have to characterize as a Band- Aid approach. That is not where we'd like to be, but that is where financial resources allow us to be. So, we have to balance that out. On the one hand, we must be concerned about building that health infrastructure in developing countries. And on the other hand, we must deal with the specific problems such as child survival and AIDS as they are on the plate in front of us. CHAIRMAN WALSH: No, I understand that only too well. MR. WOODS: You would, sir. CHAIRMAN WALSH: But, I think that, again, it would pay, in this atmosphere of coordination, to confer again with the World Bank. Because they certainly made it very clear that they use your reasoning, but in reverse. They said here, in that chair, that economic progress depended upon the health of the people. They made that point at this hearing, and they confessed that it had taken them many years to come to that realization. But, they do realize it now and that is why the World Bank has taken the initiative now in funding health infrastructure development as a means to economic growth. So, they agree with you, but in reverse. MR. WOODS: I don't know that it's actually in reverse. I would describe it as a fabric and that the issues play off one another in positive ways or in negative ways. You cannot separate the health and the education of a population from its economic growth. As countries experience economic growth, we see the health of the population and the educational achievement of those populations also grow. And as those grow, the economy does as well. It is a bit of a chicken and egg scenario, but it really is, as I would describe, the entire fabric of an economic and social structure. CHAIRMAN WALSH: That's good. I'm glad to hear that. Do you have questions now? 243 DR. LEE: Dr. Walsh tells me that you're entirely independent, the Agency for International Development is entirely independent. You're not in any department? MR. WOODS: We take our policy guidance on foreign policy matters from the Department of State, and we get a lot of direction from the Congress. DR. LEE: But, you are funded independently? MR. WOODS: We are funded independently. CHAIRMAN WALSH: And you answer primarily, as you say, to the Congress. MR. WOODS: That's right. CHAIRMAN WALSH: In other words, State doesn't order them how to spend their money. That's what he was asking. DR. LEE: What Secretary is your boss? MR. WOODS: For policy matters, I report to the Secretary of State. For fiduciary responsibility, I report to the President. CHAIRMAN WALSH: Okay. Anything else? All right. Mr. Woods, thank you very much for taking the time to come over. We appreciate it. Thank you a lot. CHAIRMAN WALSH: This panel represents, the Agency of International Development. Our first witness from the panel will be Bradshaw Langmaid, who is the Deputy Assistant Administrator of the Bureau of Science and Technology at A.I.D. Among his other duties, he is responsible for the administration of the funds made available to A.I.D. by Congress for use in the war on AIDS. Brad, please go ahead. MR. LANGMAID: Thank you, Mr. Chairman. I might introduce the panel. On my left is Dr. Jeffrey Harris, who is the Agency's AIDS Coordinator. On his left is Dr. Barbara Torrey, from the Bureau of Census. And on her left is Dr. Bart, who is the Director of Health in the Agency. Behind me are a number of people from our Program Policy and Coordination Office as well as the regional bureaus. So, if there are very particular questions, we have back-up people also. In the interest of time, I thought I would summarize briefly what I have submitted in written form, dealing primarily with the relationships we have with the World Health Organization. I chair the Agency's AIDS Working Group, a body created a year ago to coordinate and guide our AIDS effort. 244 Today, I will be discussing the coordination between A.I.D. and the World Health Organization's Global Programme on AIDS and also the AIDS budget items which have already been touched upon. In February of 1987, the World Health Organization undertook a worldwide effort to control the spread of HIV by establishing the World Health Organization's Global Programme on AIDS, WHO/GPA. In one year, the Global Programme on AIDS has marshalled the support of almost every nation, raised funds and designed and begun to implement a global AIDS strategy. This strategy requires that a strong national AIDS program be developed in every country. The United States fully and actively supports WHO in this effort. This support is a cornerstone of our assistance policy. In FY '86, A.I.D. was the first donor to provide financial support to WHO with a donation of one million dollars to the Global Programme and one million dollars to the regional office in Brazzaville. In FY '87, AID made a $5 million contribution to WHO. The U.S. remains the largest contributor to WHO with an FY '88 contribution of $15 million. U.S. support for WHO/GPA takes a variety of forms. We provide undesignated general budgetary support. We also provide funding for WHO/GPA country prograns. In FY '87, we also made $3 million in condoms available to WHO/GPA and will expect to work closely with it in the future on condom supply and distribution. We also provide extensive technical expertise to WHO. Members of our own staff have been secunded to the Global Programme. Technical experts under our technical assistance contracts, AIDSCOM and AIDSTECH are being made available ona long-term basis to WHO/GPA in specialized areas. Professional staff members of AIDSCOM and AIDSTECH work closely with WHO/GPA providing direct technical support to the staff in the field and by debriefing with WHO/GPA staff after virtually every visit to the field. It is possible in the future that some of our own contract staff will be concurrently resident WHO/GPA representatives in field posts. The coordination is that close. At the local level, the day to day interaction between mission staff and WHO/GPA officials is also close and reinforcing. Many of our ongoing health and population activities work in areas directly affected by the AIDS epidemic and therein become an integral part of the AIDS control effort, although they may not be counted as part of our AIDS progran. Coordination of these activities at the field level is accomplished by our missions working with their GPA counterparts. This coordination is close and continuous. As the worldwide AIDS control effort moves from planning to 245 implementation, this coordination will become increasingly important. Clearly, the leadership of WHO is of critical importance to the worldwide effort. That is why our policy gives such priority to it. At the same time, we recognize that none of us can afford the luxury of building new institutions to deal with the AIDS problem. We needed a process which took the strengths of all collaborators and combined them in a coherent program which provided timely response to the needs of the affected countries. From A.I.D.'s perspective, we felt there were certain assets that we could contribute as a bilateral donor. Our field mission presence and a worldwide established network of operating health and population programs is a major program implementation resource of the Agency. Similarly, our capacities in the area of technical assistance and training, again particularly in the areas of health, population, and public communications, also were also to be important assets. Finally, of course, our worldwide system of procurement and distribution of condoms in the developing world is probably unique. For these reasons, it is important that our AIDS program have a bilateral program component to ensure that these management, implementation, and program resources are available to the worldwide effort. With that, Mr. Chairman, let me turn it over to Dr. Harris to talk somewhat more about the individual projects of our program. DR. HARRIS: Good afternoon. I will describe the Agency's AIDS prevention and control program. Our AIDS prevention and control activities can be divided into two areas. First, those which are aimed specifically at AIDS prevention and control. And second, those which have been added in light of the AIDS epidemic to our ongoing health, population, and nutrition programs. First, our AIDS specific assistance. During 1987 and 1988, AID's Offices of Health, Education, and Population, and our Regional Bureaus have jointly developed an umbrella AIDS prevention and control assistance project called the AIDS Technical Support Project. This project, as you've heard, has two major components dubbed AIDSCOM and AIDSTECH. Both began operations approximately six months ago in October, 1987, with largely distinct areas of expertise and responsibility. Both of them provide short-term consultation as well as long-term resident advisors in country. AIDSCOM, the public health communications component, was awarded to the Academy for Educational Development, which has offices in New York and Washington. Major subcontractors are 246 Johns Hopkins University, the Annenberg School of Communications at the University of Pennsylvania, and the firm of Doremus, Porter, Novelli. Funded by a five year, $15.4 million contract, AIDSCOM will use lessons learned from social marketing and behavior analysis to help national AIDS committees develop effective models of public education, social mobilization, and counseling for AIDS prevention. Operations research will focus on questions such as: What risk behaviors are most susceptible to communication interventions? How can marketing approaches be used in both public and private sector programs? How can community mobilization be focused to support specific risk behavior reduction? How can short-term behavior change be sustained through counseling, support, and incentives? AIDSTECH, the biomedical component, is being executed by Family Health International, located in North Carolina. Authorized for five years and $28 million, AIDSTECH is providing technical assistance in a number of areas: epidemiological surveillance, blood transfusion screening, treatment of sexually transmitted diseases, and the logistics of condom distribution. Importantly, in order to ensure that interventions are sustainable and cost-effective, a project health economist provides consultation on financing of AIDS health care and prevention. AIDSTECH is also responsible for AIDS prevention- related training and dissemination of technical information. As part of its training effort, it will support travel by over 60 participants to the Fourth International AIDS Conference in Stockholm this summer. Most of these scientists and public health practitioners will either serve as chairpersons of conference sessions or present papers on their own work. As of April, 1988, the AIDSCOM and AIDSTECH projects have provided short-term technical assistance to 23 countries worldwide. Countries which have received needs assessment visits or completed technical assistance visits are: 1) in Africa -- Burkina Faso, Burundi, Ghana, Ivory Coast, Kenya, Malawi, Nigeria, Rwanda, Senegal, Tanzania, Uganda, and Zaire; 2) in Asia and the Near East -- Indonesia, the Philippines, and Thailand; 3) in Latin America and the Caribbean -- the Dominican Republic, the Eastern Caribbean, Ecuador, El Salvador, Guatemala, Haiti, Jamaica, and Mexico. 247 In addition, AIDSCOM and AIDSTECH are now organizing long-term projects in many countries. Through AIDSCOM and AIDSTECH, the umbrella AIDS project also plans to provide support to private voluntary erganizations, or PVOs. Recognizing the rapid response capacity of PVOs and their unique ability to carry out projects in the important non-governmental sector, A.I.D. is seeking to stimulate and support PVO-led AIDS prevention and control activities. In December, 1987, AIDSCOM and AIDSTECH conducted a PVO workshop on AIDS program implementation. As a follow-up to this workshop, AIDSTECH has allocated $500,000 of FY '88 funds to a PVO subgrant program. This competitive program will provide up to $50,000 subgrants. Criteria for selection will include likely effectiveness of these proposals in transmission prevention, and the degree to which other matching funds are available. Another major AIDS-specific activity is provision of condoms aimed at AIDS prevention. A.I.D. has an excellent condom procurement and distribution system as part of its family planning program. Rather than duplicate this system for AIDS, we have simply added extra funds. To date, through this system, we have shipped condoms for AIDS prevention to 21 countries worldwide. A large proportion of these have been shipped specifically at WHO/GPA request. This distribution has alleviated shortages which had driven condom prices as high as one dollar apiece on some black markets. Our non-AIDS-specific assistance: The AIDS pandemic is clearly a new problem for a development agency like A.I.D. and has resulted in new programs. The pandemic, however, also has implications for our other health, population, and nutrition programs, some of which are threatened by AIDS and some of which could serve as excellent channels for communicating AIDS prevention messages. For instance, our immunization programs have been threatened by the pandemic. While more and more data indicate that needles and syringes for immunization are very unlikely to transmit HIV, the theoretical possibility remains. To eliminate this possibility, A.I.D. is working closely with WHO and UNICEF to provide the needed supplies and training to ensure that immunizations are given only with sterile needles and syringes. Our family planning programs provide an excellent opportunity to spread AIDS prevention messages at little extra cost. In recognition of this, our Office of Population has supported a variety of AIDS activities through its ongoing projects. These have included operations research to assess the interaction of family planning and AIDS prevention activities, and numerous training and educational activities. 248 The Office of Population has also funded the publication of a special issue of its much respected Population Reports entitled, "AIDS - A Public Health Crisis," and distributed over 200,000 copies worldwide in English, Spanish, and French editions. The report includes information on the steps that health and family planning workers can take to prevent the spread of HIV infection. Almost all of the technical assistance activities I've described thus far have been part of a Washington-managed worldwide support program, even though the activities are carried out in specific developing countries in conjunction with our country to country or bilateral assistance efforts. This is unusual for A.I.D., an agency which is decentralized to allow country-specific tailoring of activity in accordance with needs. We have used this mechanism thus far because AIDS is new, our experience is small, and we needed to create a worldwide response capacity. It was also essential that as experience is gained the benefits of this experience be made available as rapidly as possible. As our country missions build program capacity, we will rely more and more on that capacity. In fact, decentralization is already underway. Several of our missions have already mounted their own AIDS-specific activities and added AIDS-related activities to ongoing projects. Many are also allocating local currencies to augment AIDSCOM or AIDSTECH activities. We expect this process to continue. Another step in this direction is planning by our Bureau for Africa of the HIV/AIDS Prevention in Africa Project, which will provide rapid and flexible assistance to African field missions for needs which could not otherwise be met. In closing, if I could, I'd like to show you five slides and make brief comments. Should I operate the slide projector? CHAIRMAN WALSH: Yes, please. DR. HARRIS: These slides show you briefly where our AIDSCOM and AIDSTECH projects are working thus far or where they have definite plans to work in 1988. The countries in which we're working are shown in yellow. The other countries are shown in grey. The point I'd like to make from this slide is that Clearly we have followed the HIV/AIDS distribution belt both for HIV-1 and HIV-2 in Africa. In Asia, where there is not a lot of infection as you've heard, although it's increasing, we have focused on countries which have large tourist trades and which are likely to be at risk over time. 249 In Latin America, we follow two courses. In the Caribbean, where there clearly is a major problem now, we've worked in the places where there's a problem. In Central America and in South America we've worked in countries, again, with tourism and countries that we feel are likely to be infected in the future. I'd just like to make the point that turning these countries yellow on this slide doesn't mean that they're immunized against AIDS. It doesn't mean that we've done the job. I think you can see that we've been very active and we've accomplished a lot in these six months, but I also think there's a lot more to be done. Thank you. CHAIRMAN WALSH: Barbara? MS. TORREY: Should I speak in the dark? CHAIRMAN WALSH: We're going to get some light now. MS. TORREY: I think I represent a partial answer to Mr. DeVos!' original question to the A.I.D. Administrator. A.I.D has decided to fund the Census Bureau to collect data in a data base on both AIDS and HIV in the developing world. The Census Bureau has an enormous data base of population estimates for all 206 countries around the world. We have both national and subnational data. We do a lot of mortality estimates, so we could begin quite quickly to move into the AIDS area. We immediately started coordinating what we were Going on our data base with WHO and CDC to prevent duplication. The development of the database is so labor intensive and so tedious that they are delighted that they don't have to do it. We are distributing the data on a monthly basis or as often as they want the information that we're collecting. Everyone says to us, "But, there's no data available." It turns out that there's an enormous amount of data on very small sample sizes. What we are doing is collecting these very small samples and putting them together in a mosaic. What you really begin to see when you put it together is the patterns and consistent trends that give us somewhat more confidence in predicting what is going to happen. I have got a few slides that will illustrate the kinds of data in the data base and what we're going to do with it. One of the first things we realized is that the data we were collecting, especially on HIV seroprevalence, had a somewhat different pattern among countries than the AIDS data. And of course it means that the AIDS data has a lot of reporting problems in it. The HIV data is probably going to be our better 250 estimate of what's coming up in the future and what we should be looking for in the future. After we had done a little bit of work on the back of an envelope, we decided about six months ago -- to say, "Okay, given what we know about the natural course of this disease and what we know about Kinshasa today, what are we looking at ten years from now?" We saw this dramatic increase. This was simply done by hand. It's not very professional. But, this was enough to make us realize that either we needed a much bigger envelope to start doing these things with or we needed modeling. What A.I.D. decided to do was to fund a two part section of modeling. The first part is the transmission of the disease. They are funding John Bongaarts at the World Population Council to model the way this disease is transmitted overseas, which is different than it is here as you heard yesterday. The transmission model is going to take advantage of this kind of data. This slide shows you the distribution of the virus by sex and by age. Of course, the striking thing here is that in some of those age groups women have a higher seropositive rate than the men do themselves. It's a different pattern than we've seen before. John Bongaarts' model will be able to take this kind of data, put it in, and work with it to do the projections. His model will also look at different risk groups. His model will be segregated among different risk groups, because the differences among these risk groups is so striking. As you can see in this slide, prostitutes have a much higher rate of seroprevalence than pregnant women do. Pregnant women have a higher rate than older women do, of course, because they are younger themselves. But, what we also realized was that in fact this disease is so much more urban than it is rural, that if you do the simple transmission model and simply do it for a country as a whole you will miss some of the most important problems because it's so concentrated geographically. So, what the Census Bureau will do is add on to the transmission model an urban/rural projection model so that we will be able to get projections of what we think the impact of the disease is going to be by urban and rural areas. Of course, all of this is just a means to an end. The data collection and the modeling is specifically so that A.I.D. can help think through what's coming down the line. Given the long lag time on this virus, the most important thing is to try to anticipate and get ahead of the events so that the scarce 251 allocation of resources can be done more effectively with than without data. Thank you. CHAIRMAN WALSH: Does that conclude your remarks? MS. TORREY: Yes, it does, sir. CHAIRMAN WALSH: Dr. Bart, are you going to be next? DR. BART: Yes. Thank you, Dr. Walsh, and thank you to the gentleman who operates the lights. I'd like to end the formal panel presentation by A.I.D. with a discussion of the Agency's activities in two areas: international research efforts, and the coordination of the U.S. government's international AIDS activities. I think by now the Panel appreciates that research is not the principle mandate for the Agency for International Development. As you've heard from other speakers, very substantial portions of the Department of Health and Human Services budgets are directed towards basic research for drug and vaccine development and toward understanding the immunopathology of the virus and its interaction with the human host. The major concern of the Agency is the development and application of control and prevention tools for developing countries that will both assist in the control of the epidemic and blunt the impact of the epidemic on development. The variations in the epidemiology of AIDS from developed to developing countries necessitates carrying out a specific kind of research, and that is intervention-oriented research relevant to AIDS control and prevention programs and to the Agency's other health, population, and nutrition programs in developing countries. We consider intervention-oriented research of three kinds: first, epidemiologic research; second, operations research; and third, the development and field testing of new prevention technologies. Major areas on emphasis within epidemiologic research includes surveillance and studies of modes of HIV transmission. We do not know where this epidemic is . going. How large is the population whose behaviors make them susceptible to HIV? Will the epidemic soon level off or will it spread slowly throughout the sexually active populations of all counties? I think you've heard from Barbara Torrey about the models of the epidemic that are being developed. Estimates of the course of the epidemic globally clearly do not now exist. However, careful continuous country surveillance of easily accessible high-risk sentinel populations such as pregnant women or sexually transmitted disease patients is required to actually 252 know and understand the dynamics of the movement of this devastating epidemic. The Agency's AIDSTECH project, using methodology developed by the World Health Organization, is now working with the governments of Burundi, the Dominican Republic, and the Philippines to implement sentinel surveillance, and soon with other countries. We must know more about modes of transmission that may be unique to developing countries, particularly because some of the possible cofactors are key elements of our other health, population, and nutrition programs. What role, if any, do breast feeding and various contraceptives play in the transmission of HIV? How much will treatment of other sexually transmitted diseases slow HIV transmission? As part of the efforts to get the answers to these questions, we're working with the Institute of Medicine and with other research organizations such as the World Health Organization, the World Bank, CDC, NIH, the Department of Defense, private foundations and universities, to discuss the establishment of an epidemiologic research network within developing countries which will both investigate issues such as these and enhance the capabilities of these country institutions. The second area of intervention-oriented research is operations research aimed at assessing the impact of intervention programs and improving the Agency's operations. What are the high-risk behaviors in a particular country or culture? Which are most amenable to change? What are the messages that must be conveyed to people to stimulate their modifying their behaviors? What means of delivery should we use to send these messages to maximize their potential for change? AIDSCOM is now working with the Dominican Republic's national AIDS committee and soon other countries to implement behavior change programs and answer these questions. Operations research also seeks to lower costs. For example, it's possible that we can carry out blood transfusion screening in low- prevalence countries more cheaply if we first pool samples from individual specimens and then, if the pool is positive, test individual specimens from those pools that are positive. AIDSTECH is working closely with the Pan American Health Organization to test this pooling technique in several Latin American countries. The third area of research is development and field testing of new prevention technologies. We seek to serve a catalytic role to complement the activities of private industry. For example, where formal banking does not occur and electricity 253 is unstable or unreliable, blood is transfused almost immediately from donor to recipient. A.I.D. is conducting a trial of five rapid, simple HIV antibody tests. Such tests, which require no electronic equipment, are essential for blood transfusion screening in developing communities. Another example of new prevention technology is the development of a non-reusable disposable syringe developed by the Agency for International Development to interrupt blood borne spread. This technology has implications that reach far beyond AIDS. Our immunization program has sought such a device for years to prevent hepatitis B transmission. The AIDS epidemic has given it to us. We anticipate beginning field tests within the next two months. This design, I should say by the way, is being adopted by the Department of Health and Human Services through it's National Institute on Drug Abuse (NIDA) program for domestic use. I'd like to turn now to coordination of U.S. government international activities. Because the Agency for International Development is the principal foreign affairs agency concerned with development assistance, it is uniquely placed to facilitate the coordination of the government's international AIDS efforts. Congress has also recognized this uniqueness and exhorted the Agency to carry out this role. As you've heard from other agencies, there is substantial international involvement in the effort to control and prevent AIDS globally. Through the federal coordinating committee on information, education, and risk reduction, A.I.D. has taken the lead to stimulate the coordination of international activities. The members, as you've heard from Assistant Secretary Windom include representatives of the Department of State, Defense, and Health and Human Services' Public Health Service, have collected data on their international activities in a common format, presented their programs at the FCC meetings, exchanged summaries of countries specific activities, and soon will be discussing various alternative mechanisms for coordination of these activities. These discussions are part of the continuing, and I say "continuing" work of the federal coordinating commission. As a result, the importance of ensuring the full sharing of information about international activities has become a mechanism not only for communication of information about activities, but has become an opportunity to foster a high level of interagency coordination and collaboration. As the last speaker on this panel, I'd like to review, if I might. The Agency's Administrator stated unambiguously that 254 we view the global AIDS epidemic as a threat to development. A.I.D. is working to monitor and project the impact of the epidemic. A.I.D. has mounted a program which aims to control the spread of AIDS and thereby blunt that impact. The centerpiece of our program is our support to the WHO Global Programme on AIDS in its international leadership role. We've also created our own implementation projects which coordinate their efforts through developing country national AIDS committees under WHO leadership. We have accepted the responsibility to coordinate the international efforts of other U.S. government agencies. This coordination will be most important in the area of research. In this area, we've limited ourselves to intervention oriented research which is directly relevant to our program and unlikely to be supported by others. In closing, I want to thank you for giving us the opportunity to present what we are doing and how we are attempting to do it. The panel and I would be pleased to answer any questions that you may have. CHAIRMAN WALSH: Thank you very much. As you know, we are not here to critique you or criticize you in any way. We're here to learn from you because our charge is to bring recommendations to the President about the American posture and what our role should be in the international control of AIDS. And so, in answering the questions please feel free for any of you to comment on any question that you're asked. Remember that our role is to pick your brain and to get all of the suggestions you have, whether you are doing them or not in your agency, whether you feel something can be done better somewhere else, or whether something that is being done somewhere else can be done better in your agency. We need that kind of guidance and advice, so keep that in mind when we do pose our questions. I think I'll try my luck this time on Frank Lilly, on the end. You have no questions? DR. LILLY: Pass. CHAIRMAN WALSH: Well, Ms. Gebbie, you'll come through for us, I know. MRS. GEBBIE: My first question is a fairly specific one to Ms. Torrey. We have already looked at mathematical modeling of this epidemic quite a bit, and it's very clear from that testimony and from other exposures to this approach that the assumptions you make are critical, particularly when starting with the relatively small databases that you are using. Some people are reluctant to start coming out with the kind of answers you are, based on what is currently available. The name of your agency, to my recollection, did not come up at all asa 255 participant in the meetings of mathematical modelers that have been occurring in order to pool approaches and to verify assumptions and so on. Have you been participating in those meetings? MS. TORREY: What can I say? In fact, we worked with A.I.D. to establish the conference which the National Academy put on, and in fact we were instrumental in that. The major mathematical modeling of the disease, epidemiological modeling, of course will be done by John Bongaarts, who is well known and has done a lot of modeling before at the Population Council. Our contribution from the Census Bureau is going to be on urban/rural projection models, and in fact we've done that in great detail in terms of population projections using mortality rates. So, we will not be doing the disease modeling. We're going to be following on what John Bongaarts is doing. MRS. GEBBIE: Thank you. I really hoped that would be the answer. I guess they just weren't throwing your name around. DR. HARRIS: The only thing I'd like to add is that meeting, which is the only really large international meeting I know of -- the one that occurred in October -=- wouldn't have happened without Barbara's legwork. She really made it happen. MRS. GEBBIE: And my recollection is there is a commitment to keep that kind of communication open among the people attempting to model, and that does seem very important. MS. TORREY: Oh, of course it is. Everybody is doing this for the first time with this disease, of course. There's nobody who has a lock on how to do it. MRS. GEBBIE: Two questions more general to the operation of your programs in the world. I've appreciated the strong messages about coordination through the World Health Organization, the attempt to make certain what's invested in both general health and AIDS will be consistent with what's wanted. It seems to me that occasionally you might be approached through your direct contacts in a country or through people with whom you've worked for a long time to do a project that they've decided is brilliant that's AIDS-related. That same program might not be one that looks real exciting to the international pool of experts on AIDS, that for one reason or another it's outside the mainstream of what seems to work, it's unusually different or something. Have you experienced or anticipated that issue of the AIDS-related project that doesn't quite match what WHO wants to do on AIDS this season and how you would sort that out? 256 MR. LANGMAID: Let me take a crack at a two part answer to that. We're approaching the AIDS problem in two ways. One, in terms of designated AIDS activities, that's what we've been describing. Obviously, if you're working in the health or population areas, AIDS comes into your ongoing activities. We have given instructions a long time ago that all of those programs should take AIDS into account. If you're in a sexually transmitted disease project in the population area, obviously you have to take AIDS into account in the overall program. In that respect, we are continuing to do that. Whether there's a country AIDS program approved by WHO or not, we are proceeding to ina sense protect our ongoing investments in health and population. We have also agreed very directly with Dr. Mann that it's crucial that we all work together and that the countries concerned deal with WHO and not try to play one donor off against another donor, We have taken a position that we will not start activities in the absence of a WHO-approved plan or without close coordination with Dr. Mann on the activities. Fortunately, the case you described hasn't come to us yet, although it's been at the margin of a number of issues. If there is a program which we feel is quite important that we want to go forward with, even though there may not be a fully approved plan, we will consult with WHO on it. At this stage, WHO has had initial consultations with virtually every country. So, although there are not approved plans in every country -- medium-term plans, a three to five year exercise -- there are emergency plans, in almost all countries. So, the problem of coordination of individual activities has not been a pressing one for us. MRS. GEBBIE: Another area that comes up a lot in projects even within this country is the issue of funding programs where the funding agency is not a direct participant in the cultural group that's going to benefit. A lot of criticism that the program isn't understood, that you're asking for things that don't fit with our subgroup, or our ethnic minority. Obviously, that's an issue internationally as well, and I would appreciate hearing a little bit about how you assure when you evaluate a program that you've invested in for a while and you're looking at additional investment, that you are looking at it through eyes that are culturally relevant and appropriate to the country that's receiving the aid, as opposed to measuring it by some yardstick we might use here in Washington. 257 DR. HARRIS: I think that would be by trying not to do the programs, but by trying to assist the people in developing countries to do the programs themselves. I think that's our primary safeguard against that. Having resident advisors resident in countries, as both these projects will, is another safeguard. They obviously interact with nationals, country nationals, and they usually have country nationals working directly with them, sometimes salaried by AID, sometimes not. MRS. GEBBIE: And your experience is that that's an adequate and appropriate way to keep that tie-in? MR. LANGMAID: Yes. I think this is the kind of an issue you always have to be sensitive to. I mean, there's no magic solution to it. One of the reasons, when we were looking at how A.I.D. might usefully employ its resources in the AIDS area, was our established track record in the whole area of communications. Work pioneered in the population and the health areas deals very clearly with the problems of social, cultural, and political specificity, and the need to develop the kinds of operations research programs that identify where the problems are and how best to deal with them in a particular culture. We are taking, hopefully, all that experience with us into the AIDSCOM project. As the communications area is probably the most sensitive one of the kind you mentioned. MRS. GEBBIE: My last question, I hope I'm not stealing the next questioner's time or thunder, is the one that really makes this more than an interesting educational experience for me as a commissioner, which it has been. What is it, given everything you've told us, most of which sounds very positive and good, we could say in our report that would make any difference at all to what you do other than, nice job? There must be some things that if we wrote them in the report and they were acted upon, would make it easier for you to do what you're supposed to be doing out there in the world with regard to this epidemic. What are those things? MR. LANGMAID: If I can summarize the areas of major intervention, I'll list where the problems are. As Administrator Wood said earlier, there's always room for improvement in coordination. But, I think frankly, given the emergency we're dealing with and the pressure on all parties, the working relationship with WHO is as good as one could expect. There are frictions. There are differences of opinion. There always will be, but we have a personal relationship with them and an institutional relationship in which we can talk those things through. 258 I think our biggest concern is that the WHO/GPA program maintain the kind of independence and freedom to move on the emergency which is evidenced for the last year and a half. So, I don't have any particular things to suggest that would improve that. I think it's really working quite well. There is no question that resources, both personnel resources, skilled people, as well as dollar resources are always a constraint. We live within that constraint. Recommendations in that area obviously have to take into account all of the other pressures on the budget with which we deal. Those are real, and trade-offs have to be made and there are decisions that I as the Coordinator have to make on AIDS, or Administrator Woods as the Administrator of the Agency has to make on competing clains. But, the resource constraint is with us as with WHO. I think it's illustrative of the nature of the problem that WHO's original budget a year ago was for around $35 million, and bit by bit as they came to reality the final budget ended up for '87 around $25 million. So, there are real in-country constraints as to how fast you can move even if you have money. The WHO budget a year ago was over-~-subscribed. They have carried over into the next year because they frankly, given all the problems and all the needs, could not move forward fast enough. There are those limitations. Lastly, within the U.S. government, there are issues of coordination. It is the problem Dr. Bart alluded to -- and it's a problem which I think all parties are working on, but we certainly welcome an encouragement to continue that work -- to ensure that the tremendous investments being made on the AIDS problem as it concerns the U.S. domestic population, are also brought to the benefit of the developing world as rapidly as possible. A.I.D. is not a basic research agency. We don't intend to be a basic research agency, but we certainly see as our mandate piggy-backing on those other investments to draw from them that which is relevant to developing countries. We will continue to work on that problem. I think all parties have to work on that problen. MRS. GEBBIE: I guess I want to push a little harder. Out of all that, I didn't really hear this is what we should write down. "You should look harder for research to apply," doesn't feel real directed and a pointed kind of recommendation. Are there bodies we should suggest be created or ones that should be given assignments, or is it really a matter of just saying, "Your headed in the right direction. Keep doing more good with as much money as somebody can give you"? MR. LANGMAID: I prefer the last option. 259 MRS. GEBBIE: Okay. CHAIRMAN WALSH: Admiral Watkins? CHAIRMAN WATKINS: Let me follow-up on that a bit and see if there isn't something more specific. We've had witnesses come before the Commission, Ms. Torrey, that have really said the same thing you were saying that the urgent need to know the HIV seroprevalence is the key to being able to focus our attention on the right issues. We have yet to hear anyone recommend that there might be a more aggressive approach in doing the modeling research necessary to begin to build that model in a more concerted way with the appropriate resources to get a handle on where we stand on seroprevalence in a variety of environments that may be totally different from the United States. MS. TORREY: We need all the data we can get on this Gisease. It turns out that there are a lot of data out there. They're not of the right sample sizes. WHO is actually setting up what sounds like an extraordinarily good epidemiological survey estimate procedure of monitoring specific places in trying to track the disease. We have focused almost solely in our data base on Africa, and we're going to start to focus and begin collecting on Latin America. It's a question of how fast to do that. Any funds that are spent on data collection are then not spent in the field, so it's a constant trade-off. I think that's what A.I.D. has to face every day on that. In terms of the modeling, let me just say that we don't know the full natural course of this disease yet. So, even though we're starting the modeling effort, it will have to continue to change as we learn more things about the disease itself. I think that we could be much more aggressive on data collecting. I think the modeling -- it's hard to become too aggressive on it because it's so labor intensive and we don't know enough yet to fully model this disease correctly. But, the data collection can take as much effort as people want to put into it. DR. HARRIS: Can I add to that? Admiral, I think we are actually moving as aggressively as prudence would allow. In October, we funded -- and this is with the pressures of having to think that every effort spent on research or on the modeling effort doesn't go into the field to screen blood or to provide education or to provide condoms, and with a very limited budget. 260 But, we did spend the money to sponsor a conference and to bring in really the best and the brightest from all over the world. We consulted with the National Academy of Sciences. We consulted with WHO. We consulted with CDC. They all participated, and I think we had an excellent conference and we got a good sense of what was going on. Out of that, we then chose the person that was judged by the Conference to be the person clearly farthest along, John Bongaarts. I think John had the segmentation of populations in his model that others didn't have that made this a realistic model for modeling transmission. We're now funding John, we're basically buying as much of John Bongaarts' time as he has available over the next two years to move this model forward and to make it a model that works not just for Africa but for everywhere. Because, if you put together a model that works for Africa and that works for Latin America, then by definition it works for the United States because we have all these modes of transmission. The last thing we're doing is moving to collect data and also coordinating with others to make sure that their data are available to us. We are carrying out sentinel sero surveillance, which is I think the cheapest way to quickly try to figure out what's going on in these developing countries. It's not just cheap in terms of money, but cheap in terms of human resources. We don't have a lot of human resources. And we're also getting WHO's data. So, I think we're actually moving aggressively in that area. Some people would say too aggressively. DR. BART: May I make one last comment, if I might? CHAIRMAN WALSH: All right, go ahead. DR. BART: I think, Admiral Watkins, your questions were especially pointed related to the epidemiologic research needs. We do need to know more. We do need to acquire that information as rapidly as we can in order to be able to design interventions, and that information needs to be population based unlike the small grab samples that much of our information is based on now. I think what we do not know far exceeds what we do know about both the natural history of this disease, it's epidemiology, it's spread. It's clearly an area which no one else will do and we are moving as rapidly as we can. I think your question is especially pointed. There are few lessons that will allow, us in the absence of the 261 epidemiologic research which is fully population-based, to understand and fully design the kind and quality of intervention other than the awareness and risk reduction models that we are working with now. That is, make people aware that there is a problem, define what those risk behaviors are, and offer them the alternatives to modify those behaviors. Those are very broad descriptive interventions, and until we have a more careful appreciation and understanding of the disease, its epidemic, where it's heading, the slope of the curve, and the mechanisms of spread, we will not be able to substantially blunt this epidemic. There will need to be a very coordinated and carefully designed epidemiologic research agenda for the next five to ten years to better understand what exactly is happening. Those will be facilitated very clearly by the modeling that's been described, by the projections that have been made. But, there is no substitute for good, careful surveillance and epidemiologic research. CHAIRMAN WATKINS: If you laid out the points you just made in an institutional process, you have just identified elements of the equation I'm asking to be built more aggressively. It seems to me that until we lay it on in some kind of a disciplined, organized way where everybody can see what we're doing and we know exactly what we have to find out to get this information we're not going to have that drive that you just implied is necessary to get there, even though your collaborative effort and your conferences may be very valuable. I have not seen any hard recommendation that says, "Here's the way you ought to stage yourself to get the best modeling for the future. Here are the answers you have to get. Here it is laid out." and we know that everybody that is involved in this that has to be involved is now focused on those discrete areas and they're being brought together in this kind of collaborative effort. So, coming from the military, I feel that unless you put a disciplined approach like that it tends to sit on the shelf and wander about as a function of conferences rather than being a direct objective of the nation to go after the HIV instead of AIDS. DR. BART: I think it's helpful to reiterate the descriptive statements I made a few minutes ago about the nucleus of such an effort which is now being designed with A.I.D. under the auspices of the National Academy of Sciences. These discussions are now underway in an attempt to bring in all of the relevant national institutions including the World Health Organization, including CDC, including academic institutions such as Harvard and Hopkins to begin to build a coalition through a network of epidemiologically capable institutions. We can bring 262 to bear such epidemiologic skills through institutions in the developing world. CHAIRMAN WATKINS: So, you're recommending the Commission lay mute on this issue, that we don't need to get into it because it's already being adequately addressed at the right level with the right resources and in the right format? DR. BART: You want to address that, Brad? CHAIRMAN WATKINS: Well, that's what it sounds like. MR. LANGMAID: I would like to say that we have the nucleus of such a program under way. Are there resources now available? I think that's yet to be seen. But, I think that the nucleus of the idea that you've just described is recognized by all. Do we have all the tools in hand? I think that -- CHAIRMAN WATKINS: But, the whole thing was recognized by all and it's been a disaster. We do not have a national strategy or policy. We're trying to build it today, and my feeling is that people like you, the pros in the field, you know a lot more than the American people know. Somehow, we've got to get this all on the table these are the national set of objectives. Unless we get some specifics, we're going to assume that everything is fine when in fact we have witnesses come before us that are pleading for more aggressive approaches in this area. CHAIRMAN WALSH: I think what the Admiral is getting at is, where Jonathan Mann and WHO has gotten such worldwide acceptability. They know that they don't have the ideal plan, but they have set objectives. They have laid out something that people can see and get their teeth into. That's why you're all supporting them and you're giving them $15 million. I think that's what the Admiral is asking. Is there a way, with all the resources we've got in this country, that we can get a mechanism like this going that would be a foundation of a national policy? MR. LANGMAID: I guess I'm a little confused, Admiral, because I'm not sure we're answering your question and I'm not sure we are understanding it. The modeling exercise per se identified a number of parameters that one needs finite estimates for in order to do a sound modeling exercise. Many of those parameters are going to come out of research underway at NIH and other areas: the degree of infectiousness, the period of the disease. There's a whole range of issues which one has to have to do that modeling. I don't think in terms of the definition of the model per se that there's any lack of understanding or game 263 plan for developing that data, in terms of others doing the research. I thought I heard you talking more about the epidemiological issues in the developing world. One of the key issues is how do we develop the epidemiological data for Uganda or Zaire or Indonesia or Thailand with different kinds of medical histories of the population. In Africa, with a heavy malarious environment, the incidence is very different. The diseases that come out that show themselves as AIDS in very different ways than in the United States. It is very country-specific. WHO is taking a crack at that by developing some model survey tools to do the epidemiology in those countries. And of course there's a whole range of operations research that we are funding and others are funding which is targeted on specific data needs. The work of CDC is trying to pull that together. But, in all candor, the bottom line limitation in the developing world is a health infrastructure that can't collect reliable mortality statistics. We're talking about an incredibly more sophisticated kind of surveying device for national HIV prevalence being carried out by a health infrastructure which cannot in many countries report with accuracy on what people die from. This capacity is not going to come quickly. It is clearly a priority. In terms of dealing with AIDS, this problem is probably going to be dealt with through targeted operations research on sentinel populations rather than building a whole data base collection system for a national health census. In most African countries, the public health expenditure per person is five dollars or less for the poorest countries. That's the environment in which we're working. The real constraint on how rapidly we go is how many and what the quality of counterparts there are for us to work with to do analysis. I can't make promises that we can build up that capacity very quickly. Obviously, with more resources one can work more vigorously on developing that kind of capacity, but the bottom line limitation tends to be not a knowledge, but their infrastructure. CHAIRMAN WATKINS: Thank you. MRS. GEBBIE: I think I'm trying one more time, but it ties together with this. We are charged with stating out loud in very plain terms, "These are the 322 things that the United States government should do that will make a difference in this epidemic." You introduced a topic to us, actually one we've heard before, around modeling and long-term global estimates of this 264 epidemic. I kind of assume when you introduce a topic to a panel with a charge like ours, it's because you think we ought to do something about it. But, every question we've asked to pin you down kind of slithered off into, "No, there isn't really much to be done but wait." I don't quite believe that. Maybe one of the things we should do is suggest that building an epidemiologic infrastructure worldwide is critical to where we go. You almost just said that, but then you backed off of it. Maybe it's making certain that every single modeler is a mandated member of a national council on modeling, but you sort of said -- that's what we are pushing on so hard. If there's something that needs to be done, please say it very plainly. We may or may not agree with it, but at least we'd have something to hold onto rather than things that shift away from us as fast as we, I think, try to pin you down on it. MR. LANGMAID: I would say that I don't consider the modeling as being in any way the cornerstone of what we're doing in the AIDS area, nor is it crucial to dealing some with the prevention measures. It is important as an education device, as a future planning device. And frankly, my own particular interest in this is the kind of modeling that was done for the population program a long time ago as a way of educating leadership on the dimensions of the problem and the likely directions to take. It is a planning tool. It's a public information tool. We, know enough about the disease at this time to begin programs to prevent its spread. I see that as far more important in terms of the kinds of business we're in than the actual precision of the modeling. The modeling is something we have to work on at the same time, but it's not the highest priority. MRS. GEBBIE: That becomes an important statement, then. That is, don't be preoccupied with modeling, but take what you know and do it. Then, I'll come back to the other question to which you might want to submit written answers later. Are there any obstacles to your doing those things you want to do? And if so, what are they, so we could suggest removal of those obstacles? CHAIRMAN WALSH: Anybody else want to comment on the Admiral's question, or Ms. Gebbie's question? I can't tell whose question it is anymore. MR. LANGMAID: I have nothing more to add. DR. LEE: Let me get you guys off the hook and approach this from a completely different direction. Ms. Torrey, you make a lot of sense to me. Why are you in this A.I.D. panel? Are you part of A.I.D.? 265 MS. TORREY: No. I'm part of the Census Bureau. DR. LEE: So, you're separate? MS. TORREY: Yes, but A.I.D. is funding the work that we're doing for the data base. DR. LEE: I want to know the opposite. Why is A.I. D. trying to get into the AIDS business? You have ten doctors on your staff. You're part of the Department of State. You're a funding agency, as I understand it, for development in underdeveloped counties. Why do we want to see A.I.D. build up a big infrastructure to support AIDSCOM and AIDSTECH? There are so many other people doing this work. Why do we want the State Department in it, and why do you feature yourselves as primary players? MR. LANGMAID: A.I.D., as Ambassador Woods said earlier, is an autonomous agency. Our budget is carried in the budget of the Presidency. The 150 account is in the Office of the Presidency. We are mandated by law with administering the foreign assistance programs of the federal government and dealing with the developing countries in that respect. DR. LEE: All the health programs? MR. LANGMAID: That's correct. DR. LEE: If NIH has a program, or the Public Health Service, or HHS -- MR. LANGMAID: I'm not aware of any NIH programs, and I ask to be corrected by those from NIH, whose main focus is the health status of the developing countries, except those in which A.I.D. is the principal funder or cooperator. NIH has a mandate to deal with health problems of the U.S. and works world-wide in carrying out that mandate. A.I.D.'s mandate is the health and welfare of the developing counties, not the U.S. population per se, although there is an overlap. A.I.D. has major investments in health because, as Ambassador Woods said earlier, the long-term development success of those countries depends upon a healthy and educated population, among other things. So, the degree to which these countries have major health problems, be they the population growth rate, high measles rate, malaria, or AIDS, which affects the quality of health of their population and the capacity of those populations to realize their national aspirations, A.I.D. is concerned with the problem. 266 There is no question that in much of the developing world AIDS is the fundamental health problem of these societies. That is how we get into the equation. DR. LEE: I was not aware that you are the only agency that can deliver these bilateral health programs overseas. If this really is the case, how come you only have ten doctors in your organization? MR. LANGMAID: Largely, because we contract out a good deal or procure the services or support of CDC and others in carrying out our programs. We are running a health program aside from AIDS of something over $200 million a year in the developing world. DR. LEE: Is your main subcontractor CDC in this regard? MR. LANGMAID: No it is not. We have a range of university and commercial contracts and also deal with other parts of the Public Health Service, including CDC. DR. LEE: And do your doctors sit on the coordinating committee there at NIH? MR. LANGMAID: Yes. Dr. Bart is our representative on that coordinating committee. I admit there is room for confusion on this, because we operate programs which are very similar in the same countries. But, the mission of those programs differs. Largely, the mission of the NIH programs is dealing with the problems of a U.S. -- the health of the U.S. citizenry. Our mission is the problems of the domestic citizenry of the country in which we are working. Obviously, what you learn from both is important. But, we are concerned, if you will, with the Ugandan population and the health and welfare of the Ugandan economy in a broad sense, whereas, NIH may be principally concerned with what we can learn as it pertains to the U.S. CHAIRMAN WALSH: Brad, what percentage of the total A.I.D. budget is involved in health, in international health? MR. LANGMAID: If you deal with just the Development Assistance budget, rather than the Economic Support Fund -- CHAIRMAN WALSH: I'm talking about the total AID budget. I mean, you can break it up for me. MR. LANGMAID: ‘Ten to twenty percent. 267 CHAIRMAN WALSH: What? MR. LANGMAID: Ten to twenty percent. CHAIRMAN WALSH: And that's all you have for the whole world? MR. LANGMAID: That's correct. CHAIRMAN WALSH: That's what he's trying to find out. When you are confronted with something as big as the AIDS epidemic is this a situation that this Commission should be recommending perhaps a greater expenditure if we knew and understood clearly how you were allocating your funding, which is what he's trying to find out. MR. LANGMAID: The health and child survival budget combined is around $230 million to $240 million. CHAIRMAN WALSH: And what's your total budget? MR. LANGMAID: The total budget -- it depends on what you want to add in and add out. What would you say, $10 to $12 billion? CHAIRMAN WALSH: No, but Brad, the thing that I think is confusing to a lot of the commissioners that are not as fully aware of what goes on in Washington as some of us are, is that when we recognize the WHO is going to go up to $100 million or whatever it is on AIDS alone in the very near future, and then you're telling Dr. Lee that you're charged with the responsibility of health programs for the entire developing world with a budget of $200 million, it seems incongruous. You follow me? MR. LANGMAID: Yes. CHAIRMAN WALSH: Okay. That's what he's getting at. DR. LEE: Yes. I can't imagine why A.I.D. is funding the Bureau of the Census. MR. LANGMAID: Because they have a data management and analysis capacity which we need. DR. LEE: So, you're giving her a grant? Is that it? MR. LANGMAID: That's correct. It's calleda participating agency service agreement, which is the way government agencies deal with each other. DR. LEE: Okay. 268 DR. PRIMM: I have two or three questions. One is that you showed, Ms. Torrey, in your slides, that there was a greater preponderance of women affected by this problem in certain sections of Africa, particularly the prostitutes, even greater affected than the child-bearing age women. But, both were affected and in some instances more than the men. Now, with that in mind, it would seem to me that A.I.D. would be targeting some of their efforts toward women. I haven't heard anybody talk about women in Africa and the role that they play in doing contraception. What are you all doing with AIDSCOM, AIDSTECH, to target that population besides condoms? Even the women control the condoms really. They either insist that their husbands or their significant others use them or even in that sense they might be abused for even suggesting that. So, what are we doing to empower African women, which is culturally certainly not at all the thing for those nations. And I have a couple of other questions. How many people do you really employ that you have working on AIDS full- time, A.I.D., how many people? Could you use more people working on it, usefully? And then, if you could, how many more people could you use? And what amount of funds could you use usefully to support the needed epidemiological research for improving your prevention and education efforts? Perhaps Mr. Langmaid could answer those questions. MR. LANGMAID: Let me start with the first one you raised in terms of empowering women, and maybe others on the panel may want to add. DR. PRIMM: I would like Ms. Torrey to talk about that too, Mr. Langmaid. MR. LANGMAID: Our population programs deal extensively with women in the developing world in the whole area of maternal health education, birth spacing, breast feeding, as well as in AIDS education and contraceptive delivery. In Africa, frankly, one of the real problems is on the male side more than on the women's side. There's a demand for these services. The population programs deal extensively with them. Our AIDS communications activities would work with governments that will have to deal with high-risk groups. Those high-risk groups in some societies are predominantly women, these programs will have to address the problems of those high-risk groups. Education programs will have to be targeted to their needs. Very specific operations research activities that evolve will be targeted on these high-risk groups. In some 269 societies, it may be female prostitutes. In other societies, it may be other high-risk groups. There is clearly a need to deal with the maternal aspects of AIDS transmission which, again, will deal with the counseling of women. This is very much in our minds as to how we design the programs. We are very, very sensitive that all interventions are specific to the culture in which we operate, and the decision making process of that society. Across the board in health the focus of our programs is empowering the people concerned to take care of themselves better, so they have the information and the tools with which to do that. That's also the focus of our population activities. It's the focus of our child survival activities as well as the focus of our AIDS activities. The question of our staff is easy to answer in the narrow sense. The staff that Dr. Harris has who work full-time on this problem is, I think, four people. There is a full-time officer, William Lyerly, in the Africa Bureau on AIDS. The remaining health staff in the Agency have other responsibilities in addition to AIDS. There are health staffs in each of the regional bureaus. There are health professionals in the Office of Program and Policy Coordination, and of course there are many other health professionals in other parts of the Agency. But, if you're talking about designated, full-time staff on the AIDS problem, you're talking about, in Washington, five or six people at tops, with some of those people working on other problems. If you're talking about overseas, we have no full-time AIDS staff working overseas. We have a number of health officers, who have the AIDS agenda as part of their overall mandate, but there are at this time no health officers overseas working only on AIDS. If you're talking about the contract staff, and many of our contract staff will end up as full-time resident advisors in the field Dr. Harris, may be able to answer in terms of the plans for the two contractors. DR. HARRIS: Those two contractors between them at this point have roughly 20 full-time staff. It's not a huge number. It's about a fifth the number that the WHO program says they have. We would anticipate having 30 full-time direct hire staff as well as their assistants and such. I'm talking about professional staff in the field. We expect to have about ten of those people in by the end of this year, at least in the work plans that we've just gone through after making our initial assessment visits. 270 MR. LANGMAID: I just wanted to add one thing to Dr. Lee's question. Dr. Harris is a CDC public health officer on loan to us from CDC, as is Dr. Bart at the other end of the table. CHAIRMAN WALSH: Dr. Lee wants to get a reprise whenever you're finished. DR. HARRIS: Dr. Primm, I just wanted to answer a little bit about the issue of empowering women. Certainly our family planning programs work with women and will continue to work with women. We also have a technological answer that we're working on. The spermicide is very promising in this respect. As you know, spermicides are virucidal. Nobody knows, though, if spermicides protect people from transmission. We're trying to find out that answer. We're doing that in Kenya today and in Rwanda. We also are funding research into spermicides to see if we can come up with a spermicide that's more virucidal than Nonoxynol 9 is. Those are efforts we're making to make sure that women don't have to depend on men to wear a condom in order to protect themselves from this infection. DR. PRIMM: You all are not working with Masters and Johnson on that? DR. HARRIS: No, we're not, sir. MS. TORREY: What Brad said was right. We are collecting the data and giving it to A.I.D. as fast as we can get it. Our data shows that some of those young adult women had higher prevalence rates than the men did. We are not ourselves in the field. The Census Bureau is working in Suitland, Maryland -- it actually feels like the field -- and it's A.I.D. that's taking the information we're giving them and then figuring out what that means for their programs. DR. PRIMM: The last question wasn't responded to, and that was what amount of funds could you usefully use to support your needed epidemiological studies and research and prevention studies, $5 million, $10 million, $20 million, how much? How much money would you think you would need to make you more effective in doing what you're doing? DR. BART: I don't think we yet have an estimate of what those needs are likely to be. I think we have a process that is actively underway to assess that. As I described earlier, the National Academy of Sciences, together with our agency, is working at that effort. It's a process that's ongoing. It is clear that resources will be required. The dimensions of the resources are clearly unknown, partially 271 because of the need to develop institutions to carry this research out. I think it's important to remember as we look at all of the assistance programs that are being offered, is that we are guests in these countries. We have trouble enough dealing with Staten Island or Louisiana as if they were part of a federal establishment. We're talking about an independent nation that has a mind and programs and plans of its own that we are attempting to assist. That is a dialogue in diplomacy. It's a dialogue in policy. It's a dialogue in technical knowledge base, which has to be developed both gently and aggressively. While we're concerned about a rapidly advancing pandemic that is encompassing this globe, we have a responsibility at the same time that our global efforts are, in fact, successful. While aggressive science needs to be translated into aggressive intervention, it has to be done in a careful, thoughtful way. Throwing money at the problem is not the single solution. It is part of the solution. Manpower is part of the solution. Knowledge is part of the solution. But, as Ambassador Woods described, there's a fabric of interacting with each of those elements that makes for a successful program. Those pieces are just being put into place. We know very little about the pandemic. We know even less about the epidemics in the developing country. We're trying to learn about them. Yes, every one of your questions are pointed and directed at needs, but we don't really know. We don't know how much money it's going to take. We're working to find out what the dimensions of the task are. I think the point that is worthy of underlining is that there are vast epidemiologic knowledge gaps that exist, and intensive work does have to be undertaken as aggressively as possible to fill that gap. DR. PRIMM: Okay. Thank you. DR. LEE: I understand your organization is largely a funding agency. Now, I understand what Ms. Torrey is doing and I understand why she's being funded and I think it's marvelous that she's being funded and I encourage you to fund her. But, why don't you fund these AIDS programs instead of trying to create your own? Rather than create another organization, can't you provide your support directly to indigenous organizations who are working on this problem both nationally and internationally? I don't understand why AIDSCOM and AIDSTECH are being brought up when we have these bodies of incredibly expert people working on this problem. Why does A.I.D. want to get into it? Why don't you just fund it? 272 MR. DeVOS: They're trying to help everybody around the world, and health's a part of the equation. So, that's how they get into it. For economic development, you've got to have healthy people. DR. LEE: Well, I understand them helping people around the world, and we endorse that. But, why do they create their own infrastructure? The bureaucracy is just going to get bigger here. MR. LANGMAID: To avoid just that happening, we use the commercial sector as much as possible to obtain the services we need to run our programs. A.I.D. is a very decentralized agency. We run with field missions. We have field missions in almost every country in which we work. About one-third of our staff is in Washington, and two-thirds of our direct hire staff is overseas. That is largely a management staff with some technical people. To actually implement programs, we generally must procure services from the U.S. government and of the private sector. That is why we have procured the services of the Census Bureau, to obtain their technical expertise in an area of particular interest. That is why we've procured the services of AED for education and for the health communications expertise, because communications activities are probably the only tool we have to stop the spread of AIDS in the developing world. We provide these technical skills to the governments and societies we work with so they can develop effective programs. We are both a contributor of technical expertise and a procurer of that expertise to go with our own in the implementation of our programs. CHAIRMAN WALSH: Rich, do you have something? MR. DevVOS: It sounds like we're attacking you and I think that's unfair, because that's not the goal, all we're trying to get out is duplication. I think someplace this committee is going to have to address duplication, honorably intended; differing people attacking the problem because of its urgency. They're all saying, "Man, we've got to do something. It's affecting our work." And so, I salute you for that, but this committee is going to have to finally say, "Listen, we can't have this group and that group and that group all duplicating each other, because there isn't enough money anyway." So, I get down to duplication and action, which are the things that concern me. We run a nice little business, but our scientific community -- and I have about 200 people in research -- they 273 never get a product ready for market, because there's always a way to make it better. There's always more data they need. And I finally say, "We're going to market next week boys, with what you've got." You finally have to say, "action." We've got to stop the disease, and that's what you're concerned with. We're all here on the same team and that's what you're going to do. But, I hate to see somebody on the streets of Uganda say, "No, no, the A.I.D. bunch is the one you've got to get your condom from instead of the Peace Corps. We're pushing those, so that we get credit." You've got that thing going here. It happens in this town and it happens in business every day. We strive honestly to solve a problem. I think some of the other guys said it well. Let's get down to say, "This is the day, boys." There always will be more data. There always will be more experiences. There always will be another profile to run, but we need a plan of action to stop the spread of this disease, and there are some simple things you do. And I want to salute you for doing something. Cardinal O'Connor would have a lot of fun. He'd have a wonderful time if he were here today and found out you guys were doing this stuff. I'm not going to speak on behalf of the Cardinal. There are simple ways to prevent the transmission of this disease and somehow we've got to get that message across. So, I salute your efforts. I just say that this Commission has got to look at duplication, millions and millions. Everybody comes up and needs another hundred million. Everybody needs another 50 staff. We can employ the whole country on it. And I'm not being funny about it. We've been sitting here for months, and it's just run the tape. We're all here together trying to help people save themselves and I guess I'm kind of running out of time on data, just like I do with the company. End of my speech. It's not a question. MR. LANGMAID: No, I welcome your speech because it's right on in terms of where our focus is. I think I can assure you without qualification that duplication in the foreign assistance side of the game is not a problem. We're not talking about duplicating the efforts of others. Largely, we're talking about where those efforts aren't happening. Part of that issue is competition, not duplication. The LDC scientists who know something about AIDS are probably one, of only two or three in that country, and the supporting staff he has is equally limited. When you go into that country to start a research program or an AIDS control program or an epidemiological program, that same researcher is wanted for all three programs. 274 There is, a legitimate issue of competition for the very limited resources which a developing country has to employ in the protection of its own citizens from AIDS. That is a problem we work on constantly. We are continuing to hear concerns from our field posts that so and so from some other university or from some other department came in offering a program involving the same technical person as is needed to be the chairman of the national AIDS commission or other equally important job. That is why we have a number of coordinating groups to stay on top of this problem to make sure that where there is competition the national government makes the priority choices in terms of their needs. MR. DevoS: I'm glad to know that. It's important. MR. LANGMAID: I would add, as a footnote, I think maybe we have a name identity problem. Because, I would be willing to bet that the condoms you made reference to in the Peace Corps were A.I.D. funded. MR. DevoS: I don't know. Do you stamp your name on them. MR. LANGMAID: Because, we are the largest supplier of condoms. Quite often when you scratch below the surface, we tend to be identified as largely a funding agency, not a program Management agency. We are active in the program management area, and the focus of our program is on education and control programs, not the research side. MR. DevOS: But, your whole budget is $200 million, of which $30 million goes for this. Is that correct? MR. LANGMAID: Our total health budget is around $230 million, and if you add the AIDS amount in it's probably another $30 million. So, a total of $260 million in health and child survival. Our total population budget is $210 million, $215 million? MR. DevoS: So, it is 15 percent of your budget or something like that? MR. LANGMAID: Yes. I didn't mean to be evasive on that problem. When you talk about the AID budget, you're adding the entire Israel program, the entire Egypt program in the Economic Support area, which don't compete in the same sense, dollar for dollar. We tend to refer to the Development Assistance budget, which is the budget item for which these resources compete. That's $1.5 billion. 275 MR. DevOS: That provides a better perspective on all the things you do. MR. LANGMAID: Yes. I didn't want to be evasive, but in all honesty the A.I.D. budget includes a number of things which have their own rationale and are separate from this program, I wanted to give an honest answer to your question. MR. DevOS: Thank you. CHAIRMAN WALSH: We're well over time and obviously you have stimulated this panel. I do think that the questions that you were asked, however, you were asked seriously. When you have a chance to talk among yourselves, if you feel that you would like to offer something to us, please don't hesitate to write us with any clarification or any suggestions. As Rich DeVos has said, we have been listening for four or five months now to suggestions which are to pose a framework for us before our policy recommendations. It is hard, even for those of us who like to think we are Washington-wise, to separate all of the different initiatives that our own government is taking, seemingly without any coordination. Now, we know coordination efforts are taking place, but believe me we have heard enough so that we know there is a lot of duplication. And what we're trying to do is to get the biggest bang for the buck, not just throw dollars at things. We're trying to find out if you think that the epidemiology or the census is the most important. When Dr. Primm asks you the question: "if you had $2 million more available and he doesn't have it in his budget, is that the kind of thing this Commission should recommend, that his budget be supplemented enough to give you enough to do the job?" These are the questions that we're trying to get a straight answer to, because otherwise we get these general recommendations that go up into the hundreds of millions of dollars with no concept of how the money is going to be expended. I'm not going to ask you any questions, because the one I would have asked you is that out of all these millions that are going to, AIDSCOM, I think the next panel is going to raise certain questions. It's a panel on private voluntary organizations that you have set aside the large amount of $500,000 for ten $50,000 grants, to PVOs who think they can play a far more important role in this because they are on-site in many countries throughout the world. I think they may question the wisdom of that decision, and if you want to wait and hear them I would suggest that you do that. So, thank you very much for your help. 276 MR. LANGMAID: Can I add one -- not to try and get the last word, but I do feel the discussion got off track on the priorities issue by focusing on the epidemiological issue. Because, that is not one of our priorities, and we spent a lot of time talking about it in a way which I didn't think shed light. CHAIRMAN WALSH: Well, that's why I thought you might want to write something after you get together with Jeff and the rest of you. MR. LANGMAID: If we had an additional $2 million, we would probably not put one cent of it into epidemiology. We would put it into field programs. CHAIRMAN WALSH: That's the kind of information we need, what kind of field programs and why, and can we help you get it? That's what we want to know. If you can justify it from the standpoint of making us feel it's the wisest investment of American dollars, you can bet this Commission will support it, and they want to support it. But, we are looking for direction of what's the best way to spend the limited resources we have, given budgetary constraints. We have to know, and you're the experts. You're supposed to tell us. So, please remember that's the spirit in which these questions were asked. Thank you very much. (Whereupon, off the record briefly.) CHAIRMAN WALSH: I'm sorry we had to delay you, but I thought you would find the testimony of the previous group illuminating and helpful to you. I don't know whether it was or not. This session is to hear from representatives of private voluntary organizations on what they believe they have to contribute to the war on AIDS. These organizations have all been long established and I think I'm familiar with most of them and most of them have contributed greatly to this country and to the nations of the developing world. CHAIRMAN WALSH: The first spokesman needs no introduction in a sense, because we're all familiar with the American Red Cross. We have Dr. Lewellys Barker, who is representing the International Society of Blood Transfusion and the American Red Cross. Please go ahead. DR. BARKER: Thank you very much, Dr. Walsh. Members of the Commission, it's a pleasure to talk to you today about Red Cross Societies and what they are doing about 277 the AIDS epidemic. I think you've probably already heard. I know you've heard something about the American Red Cross. We, of course, started out trying to make the blood supply safer back in the early ‘80s. At that time, in fact, we didn't call it that, but we embarked on a rather massive public education progran, specifically targeted of course at voluntary blood donors. We, in fact, went from that program targeted to blood donors to a very broad program targeted to the general public AIDS education program. I think we may have been the first large national organization to embark on that kind of program. So, we have a good bit of experience now with large- scale AIDS education efforts, how we can use the resources of a voluntary organization, which we are. Our work force is almost entirely volunteers. We have trouble keeping track of them all, but we know it's well over a million, not counting the close to five million blood donors, as opposed to a total around the country of roughly 20,000 staff. All Red Cross Societies have, as their primary mission, humanitarian relief of people affected by emergencies, all kinds of emergencies: natural disasters as well as man-made emergencies of a variety of kinds. We also have a strong tradition of helping people prepare for and prevent emergencies. In regard to the global pandemic which your hearing is addressing today, the American Red Cross and many other societies which have embarked on activities similar to ours are banded together and working as members of the League of Red Cross and Red Crescent Societies based in Geneva. The League is celebrating its 125th anniversary this year. It has 145 national societies, and 136 of these are actively involved, for example, in voluntary blood donation. I found a map which has some white parts on it, but they are very few and far between and hard to find. Those are the only societies that we are aware of that are not involved in blood donation. The involvement ranges from a full-scale operation of a program that recruits donors, draws blood, does testing, and ships to hospitals for patients as we do in this country and a good many other countries. That's sort of the maximum involvement. At the other end, there are countries in which the Red Cross’ primary role is voluntary donor recruitment and there are various levels of activity in between. We have a blood program office in Geneva, and we work with that office on supporting the development of blood programs in many other societies. That, in fact, is the major role of the League's blood program office. You have in your background material a statement of purposes of that office, and I think 278 you'll see that it draws on the societies that have fairly advanced blood programs in order to either send people out or bring people in for training, send information out, and that's basically the way we operate. We operate as a federation. In recent years, many Red Cross Societies, for example, have supported anti-HIV screening development in countries throughout the world. Those include societies in Western Europe, of course ours, Canada, Australia, Japan, and so forth. The Red Cross involvement, then, is primarily one of coordinating member societies. Virtually all of our publications in the last several years have had AIDS information. We have had a general public education initiative under development at the League now for over a year. As one of our specific strategies, we do seek to provide an information clearing house whereby all societies send in films and print material and make its quality and nature known and available to other societies. In November, 1987, the League General Assembly passed a resolution that clarified the need for Societies to prevent oppression and discrimination against and to offer humanitarian support to people who are HIV carriers, people with AIDS and their families, and you have a copy of that resolution in your material. So, although the Red Cross is a nonpartisan organization throughout the world which prizes its neutrality, we do take an active stand on human rights and legal issues. Finally, I'd like to just draw your attention to a recent and building consortium, the Global Blood Safety Initiative. It involves the World Health Organization, League of Red Cross Societies, International Society of Blood Transfusion, and the United Nations Development Program. This is a new initiative. It has an objective to contribute to the global control of HIV infection and other infections transmissible by blood and blood products by ensuring adequate supplies of essential blood products which are safe, effective, and accessible at reasonable cost. You have basically the charter document, which is only a couple of months old. We do not, in fact, have a well developed budget for this initiative, but I think it is another important step in the Red Cross effort which I would say is characterized by volunteer spirit of all Red Cross Societies in responding to emergencies at the grass roots. This gives us the tremendous ability to leverage resources and also to tie our activities to people in their communities. Our basic principles require humanity, impartiality, and universality, and we intend to collaborate with other major international organizations as demonstrated in the Global Blood Safety Initiative. Thank you very much. 279 CHAIRMAN WALSH: Thank you. Our next presentation will come from Dr. Michael Alderman, who is the Chairman of the African Medical and Research Foundation most of us know as AMREF, as well as Chairman of the Department of Epidemiology and Social Medicine at Albert Einstein, together with Dr. Nyamwaya, who is the Director of Health Behavior and Education and Child Survival Coordinator for Nairobi, in Kenya. DR. ALDERMAN: Thank you, Mr. Chairman. It's a privilege to be here and to participate in these hearings. AMREF, as many of you know, is an organization established in east Africa some thirty years ago. It's grown now to be a regional agency which serves the countries of east Africa with a staff of about six hundred, 93 percent of whom are African. The annual budget approaches $10 million and that supports dozens of projects in about five countries. Our work now takes three primary tacks. One is health education. We do a good deal of training of health workers at various levels, both within Nairobi and in the field. We produce materials locally for local use. We run the largest two way radio service in all of Africa that serves health posts throughout east Africa. Our second primary focus is in community health development, working with localities to try to develop a structure within those localities that could build for better health. Finally, we provide clinical services, usually in support of either government or mission health services established there. I'd like to say a couple of words about the situation that we face, primarily in rural east Africa, how that relates to the AIDS issue, why we think organizations such as ours can play a useful role, and then make some specific recommendations. In east Africa, 85 percent of the population is rural and most of it is very rural. More than half of that population is illiterate and not accustomed to the means of communication that are available here or that we have used. There's a good deal of mobility in the character of east African life and thus, even people who live in cities or towns maintain an association with their rural beginnings and tend to go back and forth. That has real implications for the nature and transmission of this disease. Therefore, lorry drivers who might spend a good deal of their time on the road or in cities also ultimately come back home to wife and children. Workers in the cities often have wives and children back in the rural villages. This kind of mobility is rather constant. Governments in east Africa, to one degree or another, remain sensitive to the problems of AIDS and how to approach it. 280 At the very least, they're certainly reticent about it. Finally, in terms of the general situation in east Africa, health services, for reasons that were mentioned earlier, are largely government health services, and are largely focused in the more urban, rather than rural, communities. In this setting, AIDS is, I'm sure you've heard repetitively over the last couple of days, clearly a spreading menace in the eastern part of Africa, moving around Lake Victoria and further into east Africa. The best guess is that in addition to the blood spread route, heterosexual, multi-partner practices promulgate its spread and the kind of mobility that goes on between urban and rural Africa is perhaps going to facilitate that spread. Even where family planning is an accepted practice, condoms are the least desirable of those and lend a further impediment to the preventive approaches we'd like to take. In rural areas, the public is generally ill-informed, if at all informed, about the presence and meaning of AIDS and the sources of information are not well-organized and developed. Clearly, much needs to be done in this context and you heard a great deal in the last session about the need for knowledge. I'd only comment that it's not the model building that's a problem. We need more information about the nature of the disease, its natural history and its course of spread. That's the collection of data, not the building of models, which grows out of that and, to some extent, is a replacement for the absence of the kind of specific information we need. A very important issue and one that I want to touch on in the recommendation. Prevention needs to be done in education but it's got to be designed to reach the people in a way that's going to be useful and affect change in behaviors that will really impede the Spread of the disease. This all has to be done so as to make sure that the health care system that currently is, inadequately supported, and tries to serve the enormous existing health needs of the community is not diminished. We can't permit the AIDS problem to overwhelm the existing health care system in east Africa. Finally, there are some technical issues like laboratories that have to be built and developed and quality controlled to make sure that they serve the needs of this program. Why are PVOs an important potential resource in this kind of a dilemma? Well, first of all, the PVOs that I'm talking about, AMREF and others like it, are endogenously based and work out of the community, have worked in the localities with people from the localities and also have worked with the governments. Thus, for example, AMREF not only has community health workers and community health development projects going on, not only works with the mission hospitals, but works intimately with the 281 governments of east Africa and we are supported by five east African government funds directly given to us and a member of AMREF serves on the National AIDS Coordinating Committee of all of the countries which we serve. So, we make that bridge from locality to community. Secondly, the governments of east Africa do not have the resources to put public health workers into the rural areas. That's the focus of an organization such as ours, so we fill a need that the government perceives and encourages us to support. We've really done things. For example, in the community health development area, we go into a community, try to identify what the health problem is. In one such environment where infant diarrhea was identified as the problem, with community support we targeted on the need to develop pit latrines and a clean water supply. Using community labor, we achieved these goals and really made a difference in infant diarrhea. It's building that kind of community organization that makes it possible to layer on another thing like doing something about AIDS. It means there is an infrastructure in place that has meaning locally and that relates to a national program that permits activities to go on that would be vastly more expensive and a good deal more difficult to achieve. Finally, the PvOs are also a link between all the health workers, not only the government and official and formal and trained health workers, but there are a whole army of bush doctors, of local healers that would be difficult to reach by government health workers because they're illegal and outside of the system. We have a different relationship with them. They are important players in the game of health. For all of those reasons, I think PVOs are uniquely well set to play a role here. I'd like to make three specific recommendations. one is, I think, that the United States government should invest importantly in dealing with this problem internationally. I think there are at least three reasons for doing this. One is that we're able to do it. Secondly, epidemics have a habit of building across national borders and it makes no sense to deal with it in one place and not another. Thirdly, of course, the United States, through its travel and trade and military service, is contributing and has contributed to the spread of this disease. We have that obligation. Third is in this contribution of the services, the PVOs are different than the U.S. consulting operations such as AIDSTECH and AIDSCOM, of which I've heard a little before. These are U.S. consulting firms which, for example, offer us technical assistance. We don't need any technical assistance. They need technical assistance from us. We're on the ground with the kind of resources and -- 282 CHAIRMAN WALSH: I did understand you. You said they need it from you? DR. ALDERMAN: Yes, sir. CHAIRMAN WALSH: I agree with that. DR. ALDERMAN: I think we do have a kind of experience in thirty years of accomplishment. We've dealt with malaria. We've dealt with sleeping sickness. We've dealt with schistosomiasis and other sexually transmitted diseases. We've had that experience and we have the resources to do it. There was a lot of talk about the need for data and natural history. You've got to have an infrastructure in place that's got the respect and acceptance in the local community to do that kind of data collecting. It can't be organized in some global way or through some national plan, but it needs a local piece of work to make it actually happen. My final recommendation would be one that I guess has been made sufficiently. I think that the United States government activities internationally need to be coordinated. All of those need to be brought together in some way that rationally identifies the problems. What they have to do is identify the problems, then figure out how we're going to get the solutions. The problem is what was said before. We do need to know more about natural history and transmission. How are we going to get that information? I would submit that one of the ways to get that information is to link into the organizations that are on the ground and are doing that kind of work all of the time. You need to help support them to build your own data base. Thank you. CHAIRMAN WALSH: Thank you. CHAIRMAN WALSH: Dr. Nyamwaya. DR. NYAMWAYA: I would like to support what Dr. Alderman said by stressing two points regarding the response by governments in east Africa to the HIV -- medical and AIDS in particular. In the first place, I'm sure several weaknesses are pointed out that AIDS is a very, very sensitive issue. In order for the United States government to assist governments to respond to this particular need, I think it's important that they work through PvVOs that are already in place, PVOs that have been accepted, PVOs which are not going to raise suspicions from within the community and from particular governments. In Africa today, AIDS has become an extremely politicized issue that most governments see as a way through which western governments are trying to have more and more control on what's happening in Africa. If you want to go through the PvOs, it is in most cases, 283 politically acceptable to the community and the governments that we are talking about. Secondly, I would like to stress the fact that most PVOs have a well established health infrastructure. In order to assist communities and governments to reduce the transmission of HIV and AIDS, it's necessary to realize that you don't have to establish a new infrastructure. It's cost effective for infrastructure that is already in place by way of primary health care and the community-based services to be used so that we can achieve better results with less money being put in the establishment of new infrastructure. I wouldn't like to say more except to stress what Dr. Alderman said, that we should go by the track record, instead of setting up new organizations or departments to try to respond to AIDS in developing countries. Let's use what already exists as our way of saving not only money, but time and human resources. CHAIRMAN WALSH: Thank you very much. Our next two speakers come to us, one from Kenya and one from World Vision Relief and Development. Dr. Rufino Macagba, who is the Manager of the International Health Programs Department, and Dr. George Ngatiri, who is the Senior Health Advisor for Africa Health Programs, based in Nairobi, Kenya, for World Vision. Dr. Macagba. DR. MACAGBA: Thank you, Mr. Chairman. In the name of World Vision, I would like to thank you all for this opportunity to testify before the Commission. I'd like to refer you to the eight page -- document that we sent earlier which describes World Vision's work in AIDS overseas. What is World Vision? Briefly, it is a PVO and a Christian humanitarian organization with an international, national and local infrastructure in about eighty countries focusing on child care, relief and development. It was originally founded in the U.S. in 1950 to raise funds for children orphaned by the Korean War. It works at the grass roots level with about 4,500 projects currently. It also has eight USAID-funded child survival projects in eight countries at this time. World Vision's emphasis in its work is the promotion of local self reliance at home and community levels and a strong supportive linkage with local government and non-government institutions. World Vision has a network of professional health staff at headquarters, regional and national levels and also in its major health projects. World Vision has support offices in twelve countries, to raise funds for its programs. About 70 percent of our $110 million budget for this fiscal year is from individual donors’in these twelve countries. 284 Why is AIDS important to World Vision? Because World Vision has made a corporate commitment to focus on child survival and universal child immunization in the next three years. World Vision has a commitment to community health care. Since AIDS is a serious threat to its work in many countries, World Vision is shaken and saddened by the scope of the HIV epidemic, its impact and its destructive effects on families and communities. World Vision's response to AIDS began last year in June when a two month effort of research was undertaken to find out what it is and what we can do about it. As a result of that effort, four specific medical alert papers were written for our staff in Africa, Latin America, Asia and our field offices around the world. Three AIDS policies have been enacted and approved by our international board: one on AIDS prevention, one on immunization and AIDS and one on management of employees with positive HIV test or AIDS. In terms of implementation of these policies, the Chief Executive, the President of World Vision International, started a process to have World Vision field offices begin implementation of these policies. At headquarters, a staff education module with video and case study components was developed and started. The International Health Programs Office began to establish linkages with international bodies like WHO, USAID, AIDSCOM and AIDSTECH. A traveler's kit for World Vision travelers was formed as an optional thing including sterile disposable syringes and gloves in case you have to assist a bleeding victin. The regional responses of World Vision have started. Our latest development in our strategy in this ever-changing situation is first that World Vision would like to participate in the global effort of AIDS education, beginning with its own project communities and staff. Second, we would like to raise resources to assist mission hospitals to have HIV screening capability. Third, we would like to begin the training of counselors, including pastors, for counseling of AIDS victims and their families. We have at present a proposal for a seven country AIDS control project in Africa using our network of field offices and health professionals and local projects in that continent. It will follow the three priorities that we have. Our leaders are watching developments very closely in the global AIDS situation and will modify or change our strategies accordingly. Lastly, I would like to state that, while PVOs should not capitalize on the emotional impact of AIDS to raise funds for 285 their work, they do need resources to do that work. They have demonstrated their capability to work effectively in local communities in developing countries and so we have two suggestions. One is that, like other PVOs, we would like to volunteer our international management and technical network that already reaches the grass roots level and also local and national agencies. Second, in order to participate effectively in the global fight against AIDS, PVOs need matching funds to enable them to utilize their resources and extensive networks to their maximum potential for combatting AIDS. Thank you very much. CHAIRMAN WALSH: Thank you. Dr. Ngatiri, are you going to speak? DR. NGATIRI: Mr. Chairman and members of the Commission, I'd like just to start from where Dr. Macagba left off and give some perceptions on the epidemiology of the AIDS issue in Africa and end up by stating what a PVO can do at the grass roots level. World Vision in Africa is working in twenty- one countries. Out of these twenty-one countries, eleven of them have field offices. I would like to give an example of a typical field office, Kenya, with a budget of about §5 million and about 120 projects. Most of these are development projects. Integrated development projects, not necessarily health. They carry out activities from spiritual up to the needs of the people in that particular community. Mr. Chairman, we look forward to using such an infrastructure to educate the people in the communities on the issues that pertain to AIDS. I'd like to spend a minute giving you some observations that I have made as I worked in Africa on the spread of AIDS and with particular mention to east Africa. This is about the mobility of the natives of east Africa from rural areas to the towns and vice-versa. I'd like to emphasize that mobility is a very dangerous tool in the spread of AIDS. There is what we call the "AIDS highway" in east Africa and there is one called Mombasa. Oil and commodities are supplied from that port to all other countries from east Zaire, Sudan, Uganda, Tanzania, to many other parts. The truck drivers traveling about hauling gasoline and other commodities to those countries stop at motels along the way and in these small towns they have got mistresses. Those mistresses are the reservoir of the HIV and that's one common way that AIDS is spreading. If, from those small towns, people move into the rural communities, AIDS is going to spread very rapidly into the rural communities. We must act now to stop that HIV spreading and causing AIDS. We know that the highway area where those trucks go has been a big, big reservoir. These small towns are a great source of the infection. 286 We have other patterns of spread like the local tourist or the international tourist or the prostitute in big cities like Nairobi. We know that this is a two-way spread and it's becoming a major problem in big cities. There is the casual sexual contact and that person goes to the rural area and then spreads it to the rural communities. We are very much worried about that movement from the towns to the rural areas. Right now we can say that most of it is still contained in the urban centers. By the way, let me say that because of the low seropositivity in the rural areas, we now know for sure that the disease is originating mainly as an urban disease. Then there is what we know happened in Uganda during the Uganda-Tanzania war when in north western Tanzania in the Kegera region the soldiers combatted the whole area and raided a lot of the rural communities. We started seeing a lot of HIV positive cases. The first reported case in 1982 came from that particular area. We are seeing the same thing happening Mr. Chairman, in the northern and northeastern areas of Uganda. Here the soldiers have gone to the north to fight the guerrillas who were hiding in southern Sudan. We have a lot of concern on this. We have a lot of concern on the disease spreading to our rural communities, The people, 85 percent of our population lives in rural areas. Those people have no way of preventing the spread when the soldiers move to spread the disease through these methods I have just quoted, a highway method, a combat method and a local node method. It is spreading the way lymphatic system spreads its antibodies in the human body up to the small lymphatic system. The lymphatic system is spreading it to the other parts. It's unfortunate that we let it Spread farther than what it is now. I'd like to quote what World Vision is trying to do in Africa on AIDS and I'd like to add a few recommendations on what we should do. World Vision is in a very unique situation in these small towns, I have been in 50 percent of them, where World Vision has projects going on. Our main partner agency is usually the church. The church in Africa is a very important organ. The Church meets every Sunday. The pastor and the teacher are the two most important people in AIDS prevention in Africa. This is through AIDS information or education. World Vision usually works with those people, the teachers and the pastors, to be able to disseminate the information in these small rural towns. We think that this should continue. More should be done for those pastors and those teachers so that we can disseminate information to particularly the prostitutes. Actually prostitutes come to church and listen to pastors and therefore we need people who can actually do a bit of work with them not by force but by persuasion and showing them how to stop the spread of this disease. \ ' \ 287 \ ‘ World Vision has been holding seminars. Over the last year, USAID funded a World Vision Workshop on child survival where World Vision got about eight PVOs or more of Africa. Ali of the discussions that we had were discussions about immunization, which is our commitment, and AIDS. Those PVOs learned how they could actually do immunization without fearing the spread of AIDS. We would like that type of thing to be considered whereby there is an exchange of ideas between PVOs and they are discussing what each of them is doing in this issue about AIDS. We have been supplying educational material. AMREF has been good in supplying of these materials. There are some booklets that were produced and we have set up field offices and trained our staff. Those field staff in Sura are training the communities. So we have trained them how to train and would like this to continue. I'd like to give another example. In the Kenya field office where we have a budget of about $5 million World Vision has what it calls annual pastors conferences. In this annual pastors conference we have introduced a whole session on training pastors who work in rural areas on the issue of AIDS. I think the most important thing is we must disseminate accurate information and education as quickly as possible, the right information on this disease and we need to do it the right way and not like what we did at first I'm sure we will be able to combat it. A new step therefore is actually to look at these places called the nodal points, (the small towns) the cities whereby the prostitutes and the truck drivers are disseminating the disease. We should train people who can train other people, maybe the pastors, maybe the teachers, and use them as the people that will give out the information at the grass root level. The second strategy we have is actually to help the missionary hospital which serves between 35 and 65 percent of the health services in Africa. Help those missionary hospitals and churches to have an institutional capability to screen blood and counsel victims and to inform and educate their respective communities. We feel, therefore, that the role of the PVO is so important that it can not be left behind. We feel that the PVoSs have an infrastructure that reaches the grass root and that they are one of the agencies that will be able to reach the maximun number of communities as soon as possible. There is a long standing relationship with indigenous counterparts. World Vision has long standing relationships with the churches and with local communities. This is an ideal way of making sure that AIDS information and education reaches the people with a human face. We believe that the PVOs have fewer 288 bureaucratic hurdles to overcome and can move more quickly and adjust more easily to changes within the local situation. We believe that we have a greater capability to innovate and to be flexible enough to change approaches and strategies of tackling this issue of AIDS because we can move faster. We believe that we have closer contact with the private sector as well as the government. If we are given the funds to do whatever we can do, we know that we can be much more cost effective than other institutions. I would like to end by telling you the urgency of this problem. Let me share with you that I come from Africa and Africa is bleeding. Africa is bleeding profusely because we didn't act yesterday. Please don't wait for tomorrow. Act today. We need help. CHAIRMAN WALSH: Thank you very much, Doctor. The next presentation comes from Project HOPE and the presenter will be someone I know, Bill Walsh. The presentation will be shared, I assume, by Dr. Kaminsky, as well, who is the Director of our International Programs and Bill is Vice President for Operations. MR. WALSH: Thank you, Mr. Chairman. Project HOPE is pleased to have the opportunity to testify before the Presidential Commission. We are very concerned with the impact of AIDS, especially in developing nations. As has been discussed by our colleagues on this panel and by other speakers, there are really three pandemics in the developing world. The first is one of mortality and morbidity. The second is the stress on the inherently fragile health system and health infrastructures that characterize developing nations. The third is the epidemic of fear experienced by some nations with severe AIDS problems as they watch the dissipation of their most valued resource, their people. Project HOPE is committed to the worldwide effort for the prevention and control of AIDS. HOPE is providing assistance to third world countries in the development of their national AIDS plans and in design and implementation of AIDS education programs. We are also undertaking a study to evaluate the effectiveness of educational strategies in selected developed countries. Our testimony describes HOPE's current activities in AIDS education programs. It provides general recommendations concerning U.S. participation in AIDS programs for developing nations. It makes specific suggestions concerning the role private voluntary organizations could play in worldwide efforts. Project HOPE has a thirty year history of helping developing countries to improve their health services. We have 289 conducted health science education and infrastructure development programs in some thirty seven countries on five continents. We are currently operating in sixteen nations. The purpose of HOPE is to explore and implement creative concepts in the areas of education, management and policy as they contribute to the health of people in developing countries. Our mission is based upon the belief that health is essential for social and economic development and, most importantly, for the dignity of every human being. HOPE works only upon the invitation of a country and its medical community. We function in the context of local needs, priorities and cultures. HOPE's programs emphasize the involvement and training of local counterparts and the development of local institutions such as is depicted in this slide before you. HOPE works with ministries of health, universities and schools of health sciences, hospitals, health departments and community programs in both rural and urban settings. Activities range from establishing a system to train and utilize rural health promoters to establishing highly specialized post-graduate medical education programs. HOPE believes in working itself out of a job. We begin projects as a partner with host country counterparts and institutions. As our training programs are completed, we gradually turn over responsibility to our counterparts. The legacy of our efforts is the advancement in the quality and availability of health services, an advancement that does not depend upon continual outside assistance. Project HOPE, like my other colleagues on this panel and many others, is a private voluntary organization or, as we're called, PVO. We work in all facets of development: agriculture, health, education, community development. U.S. PVOs contribute very significantly to third world development. This slide demonstrates this and it shows, as a point of comparison, that in actual fact the expenditures of U.S. PVOs on an annual basis exceed that of U.S.A.I.D. We believe that many PVOs have certain capabilities that would be beneficial to U.S. efforts to assist the developing world in this struggle against AIDS. I feel like I'm just echoing my colleagues on the panel. You would think we had organized this presentation ahead of time because I think they have demonstrated these capabilities that I will now explain briefly to you. Cross cultural working experience. AIDS education programs and policy implementation strategies in the developing world will only be effective if they are instituted in the context of local cultures, languages and customs. Each country's programs must be seen as unique. Indeed, there may be several different strategies or programs in the same country. Although they frequently have agreements with national governments, PVOs 290 usually work at the community level in settings ranging from urban slums to the most rural areas of a given country. They have multilingual staffs with cross cultural working experience and with sensitivity to local people and customs. Partnership philosophy. The United States can not solve the AIDS problems for developing nations. Rather we should help these nations to help themselves in a manner consistent with their dignity as a nation and a people. PVOs know how to work as partners with developing country communities. They have inherent advantages in not being affiliated with either multilateral or bilateral institutions and can have a very direct relationship at all levels within a society. They know what agreements are best made by a handshake er an unspoken word. They're accustomed to adjusting their work style to different milieus and different levels of personnel sophistication. They know how to work with local counterparts to mobilize the community resources and support that will be so necessary in AIDS programs. It is certain that many developing nations will not have sufficient financial resources to implement a comprehensive AIDS program. They are, and will continue to, look to developed nations for assistance. PVOs may be in a position to provide some of the financial resources necessary for the worldwide efforts to combat AIDS. Many have already begun AIDS programs and are being asked every day by developing nations to do more. The nature of the AIDS problems in the developing world varies in severity from country to country. The perceived needs of these countries for outside assistance also varies as their political and community awareness is gradually translated into substantive actions. An important strength of PVOs is their ability to respond rapidly and flexibly to varying needs. They can quickly provide the combination of financial, logistic or professional assistance according to individual circumstances. In most regions of the developing world, there are already PVOs in place with established credibility, working relationships at all levels and grass roots networks. Perhaps PVOs could serve as a kind of rapid deployment force that would be coordinated with the necessarily more deliberate activities of bilateral and multilateral institutions. Unfortunately, many developing nations do not have sufficient expertise in the health sciences necessary to develop and implement AIDS programs. It's this problem of infrastructure again that you've heard a great deal about. This is particularly 291 true in developing nations and particularly outside the capital city and in urban slum areas. These next two slides just give you a quick glimpse of all the many disciplines that are needed to really mount optimum AIDS programs. Project HOPE, as well as other PVOs, have capabilities in all these fields and are in a position to match them with local counterparts and to start AIDS programs effectively and immediately. I'd now like to ask Dr. Kaminsky to come up and describe what Project HOPE is doing in its international AIDS programs. DR. KAMINSKY: Good afternoon. Project HOPE currently has health sciences education programs in sixteen countries around the world. It is our goal to assist in AIDS program development efforts in at least the regions of these countries where our programs are located. We also intend to evaluate the need in other countries and be in a position to respond to requests for technical assistance. The following initial steps are being taken in current HOPE prograns. We have disseminated AIDS education information to all our HOPE consultants and staff serving in each of these countries. As new information becomes available we periodically update because of the rapidly changing situation. We have developed programs to protect HOPE educators and their counterparts in local health care centers and hospitals. They are being consistent with CDC standards. We are providing information, when requested, to ministries of health as well as HOPE-affiliated universities, hospitals and health centers. We have developed a generic proposal which we have titled AIDS Education in Developing Countries, which will provide technical assistance for information systems on AIDS, laboratory protocols, as well as AIDS education curriculum for a variety of audiences. The AIDS education curriculum would be individualized to each target audience and adapted to be culturally specific to the needs of a country. I would now like to tell you about some of our specific country activities. As you will see, they all are involved with the development of the human resources infrastructure in a given country. In the area of medical consultation, conferences have been conducted in the Caribbean area using an interactive teleconference system. These have included guidance to physicians in the diagnosis and management of AIDS/ARC patients. 292 Dr. SerVaas was concerned that possibly information does not reach the state health officers and commissions in the United States. We may have a similar situation in the lesser developed countries. It speaks to the importance of regular, systematic, periodic continuing education for providers. One example of activity that we have implemented in this area is the continuing education assistance provided by HOPE Center and in- country staff in designing and implementing continuing education regional workshops and teleconferences. A Caribbean Regional Teleconference on the "Psychosocial Impact of AIDS" was transmitted to seven countries and included 160 participants. Continuing education workshops on AIDS for physicians, nurses and other health care providers in primary, secondary and tertiary settings have been given on the prevention of AIDS and management of the AIDS patient in the countries of Grenada and Belize. These multidisciplinary workshops -- our work is always multidisciplinary -- focused on HIV screening, clinical diagnosis of ARC/AIDS patients, medical and nursing management in hospital/clinic settings and community follow-up. Strategies for the prevention of AIDS were an integral aspect of these workshops. I would like to digress here for just a moment. The importance of proper assessment, preventive measures, mass education now and possibly vaccine provision years from now, have been addressed rather fully in these last couple of days. But, there is another intervention, to my way of thinking, that needs to be included in a comprehensive approach, which is potentially very critical and which has seen little attention in these hearings. That is case management strategies. I feel that we must pay more attention to case management issues for many reasons. Among them are alternative modes of delivery of medical care services besides hospital-based care should be studied if we are not to run the risk of breaking the bank. It is well known that patients and family members are very receptive to preventive education at the time when they are being treated for illness. Case management, by definition, attempts to mobilize and utilize all community resources in order to resolve multiple facets of complex medical and social problems such as the one we're addressing today. Hopefully, case management study will help us understand the disease better. Although prevention needs to be stressed and I'm not arguing at all with that point, there is a growing case load of patients requiring proper care. Other examples of our activities are in the primary health care area. In El Salvador, Guatemala and Brazil, AIDS information is being disseminated to high risk families and community groups. In nursing education, a very important part of HOPE's work around the world, AIDS content 293 is being integrated into existing basic nursing education programs and public health nursing post-basic programs in Swaziland, Egypt and Grenada. AIDS content has been addressed as a necessary component to be included in planning new baccalaureate nursing education programs in China and Egypt. Project HOPE has assisted medical laboratories in several nations. This ability to collaborate with the development of a laboratory's trained personnel and establish purchasing and inventory procedures makes HOPE an ideal vehicle to assist with efforts to assure safe blood supplies. In health care infrastructure, in Grenada, we have two people of our group of twelve who are spending roughly half of their time in technical assistance, in the development of guidelines and models for the management of the AIDS pandemic in the areas of health economics, materials management and health facilities planning and management. In information systems, in Belize, HOPE has an information system development program which is providing technical assistance to the Ministry of Health on epidemiologic data collection and surveillance. To quote Dr. Mann, "Had AIDS been first reported in Africa rather than the United States, it would have been considered a heterosexual disease and we wonder what we would all be studying today." Others have reminded us of the changing epidemiologic patterns in different parts of the world, and in our part of the world in Central America and in the Caribbean, toward significantly increasing percentages of heterosexual transmission and more female cases. To stress the obvious point: high quality standardized epidemiological studies in all nations are critical to allow for the development of the intervention activities in a reasonable way. A couple of examples of our work in health sciences education include emergency medical services providers and respiratory therapists in Costa Rica being provided assistance in integrating AIDS curriculum into their training programs. The Center for Health Affairs of Project HOPE is currently engaged in a major research effort, the evaluation of alternative AIDS education strategies in selected countries. This study will survey national samples of the general population as well as over sample various high risk populations regarding the effect of alternative educational programs, AIDS knowledge and on AIDS- related behavior. The Center also is currently developing a research agenda that will include a study of how AIDS may be affecting specialty choice by medical students and public attitudes towards people with AIDS. Thus, Project HOPE has developed activities in several countries as our initial response to the AIDS pandemic. We are presently refining these initiatives and are developing new plans 294 and strategies for the future. We, as the others on this panel, are committed to being involved in the worldwide fight against this modern day scourge of mankind. We feel that any international organization must be involved to the extent that their capabilities and their resources will allow them in the fight against AIDS. Bill Walsh, Jr. will now conclude our testimony with the presentation of several thoughts for the Commission's consideration. MR. WALSH: We would recommend the following to the Commission. The Commission should endorse WHO's leadership role in global AIDS prevention and control as well as its goals and strategies for 1987-1991. The United States should make a commitment of not less than five years to provide WHO support for carrying out this project. This support should provide funds for WHO global activities and for selected national program activities in member nations. PVOs should be included as partners in both bilateral and multilateral activities for developing nations. PVOs would be most effectively utilized in those countries or regions where they are already established. They should be invited to work with national AIDS committees. In this way, they will bring the very important capabilities to the AIDS efforts that we described earlier. Concerning U.S. bilateral assistance, we would recommend that support for bilateral and multilateral activities should be in the form of new monies appropriated to U.S.A.I.D. for the purpose of providing assistance to developing nations. The United States should not abandon other critical health and development objectives in developing nations because of the AIDS problems. Such an approach would have the effect of exacerbating the socio-economic impact of the disease and, in fact, will make the development of effective AIDS strategies much more difficult. U.S. bilateral assistance primarily should assist developing nations in implementing their national plans, leaving continual national and regional planning to WHO. U.S. bilateral assistance should include special attention to the western hemisphere and the Pacific Rim in the light of U.S. immigration, commercial, strategic and tourism considerations. U.S. bilateral assistance in Africa should be coordinated with European bilateral efforts with special attention being given to countries with the most severe needs. 295 Relative to key program components, the difficulty in achieving the goal of a safe blood supply in developing nations can not be overemphasized. Laboratory quality control and blood banking generally are very weak points in these nations, especially outside the capital city. Significant outside technical assistance to support training programs for in-country lab personnel will be necessary for this strategy to be successful. There should be a continuation of research into developing inexpensive tests for detecting HIV infection. I'm sure the panel knows the cost of the currently utilized tests are well beyond the individual, or even a developing country's, ability to pay. Community health education capabilities are among the weakest parts of many developing country health systems. With this in mind, as a first step, U.S. assistance should emphasize the education of health providers at all levels so that they may train others in the community. U.S. assistance in training should include support in the development of case management techniques as so well articulated by Dr. Kaminsky. Promotion of exchange of data among developing nations -- I don't mean developed to developing, I mean among developing nations -- is extremely important so that they compare progress and problems with one another. After all, it is their health and progress that we're trying to promote. It is important that these exchanges not be restricted to national level officials and that personnel at the working levels should be able to exchange information freely. Provision of selected services by U.S. institutions is undoubtedly an important part of our strategy. We would only urge that it be consistent with the national AIDS program plans that are developed and only with the approval of the host country. Just a couple of comments relative to the points you've raised in questioning other people. I would certainly recommend that the Commission might consider in its recommendations developing some kind of follow-up mechanism. You've done a good job in bringing a lot of people together. The question is, after we've come together and talked, whether we will proceed to work together beyond the tenure of your Commission. I would certainly recommend that you include some kind of vehicle in this regard and, at the very least, to follow through on the process of consideration that our government will take in addressing your recommendations. I know all of you are very familiar with the legislative process and how many months may pass before there's opportunity to act fully on your suggestions. 296 I would also like to add some perspective on the comments relative to A.I.D. and coordination. Undoubtedly, coordination is extremely important, but I think U.S.A.I.D in general, as I'm sure you've gathered, does quite a lot in the health field with rather limited staff. I would really urge you all in your recommendations to consider, as you've suggested to them in fact, that they perhaps could add staff and that support be provided for that or, as an alternative, or maybe not mutually exclusive necessarily, that perhaps PVOs and some of the universities, people who have testified before you have decades of experience in international work and this should be tapped in ongoing coordination activities. Simply hiring new people off the street, as it were, is not going to necessarily get the calibre that this effort worldwide needs. A.I.D. has some very good people and I think PVOs and universities working with them could work together very well and we could get a lot accomplished. We want to thank you for the opportunity of giving our suggestions. We wish you good luck in your mission. CHAIRMAN WALSH: Thank you. We can have the lights now. I'm going to ask Admiral Watkins to open the questioning on this session, if he's ready. CHAIRMAN WATKINS: I've been tremendously impressed by the symmetry between the concepts that were enunciated in our interim report to the president on community based organizational relationships and what you've told us today. The PVOs seem to have given us the same kind of adrenalin flow feel that we're getting from our own national community-based organizations who are on the front line doing the job. They know what they're talking about. They've been there. They understand what works and what doesn't work. We've made recommendations on a number of things, such as demonstration projects, for community-based organizations. The community research initiative that we looked at in New York is a typical example of how people in the field can contribute to both the health of individuals as well as the scientific data base. It seems to me we have a counterpart here. So I think what my question is supposing, in the private voluntary organizations that are represented here, supposing research resources were made available to your organization, and you were to divine some demonstration projects that we would participate in through the World Health Organization. We would like to fund it, have it monitored, by the PVOs, tell us how they're going to measure the effectiveness and see if we can't parcel these things out in some kind of an organized fashion to get some answers to some of the questions that dog us after, including providing the health and the educational programs that are relevant to the cultures that you're dealing with. 297 Is that something that makes any sense? So, if you can give me some ideas along that line. It might be easiest for Dr. Alderman. DR. ALDERMAN: Yes, sir. About two and a half years ago, when Jonathan Mann was going to WHO, a group of us from AMREF went to Geneva and had a talk with him about utilizing our infrastructure to begin this data collection process, we would use our field programs as a basis for developing a system for current early warning sentinel testing and also establishing bases for the longitudinal studies. With his collaboration, we developed a proposal about two years ago. A.I.D. had, at that time, decided that they were going to provide their resources through WHO, and through 26 consulting operations. WHO then said they would put in half the money if we could raise the other half of the money. We needed about half a million dollars for Tanzania, Kenya and, we hoped, a piece of eastern Uganda, if that were politically feasible. We have not been able to raise the other half of the money that WHO has provided. The large donors in the United States have not so far, at least to our knowledge, been involved in at least African based work such as we're doing. A.I.D. had, we gathered, made the judgment to go through these consulting organizations. It seemed to me if you wanted to know what was going on in east Africa, you wouldn't go to North Carolina to find out a group of people who could help you find out what was going on, but you might want to find out who is working in east Africa, what was already known and how you could quickly link into a system that could both provide data and could be used as a mechanism for prevention and leading into a system. I don't know whether we want A.I.D. to be a help organization. I'm not sure about what the right answer there is. Maybe WHO has the function, but I don't think it's a responsible position for our government to go outside and put in another level that will then look to making appropriate relationships in the field. Maybe we need to put more funds into WHO, but there has to be a central coordinating basis. You talked about parceling things out. Somebody has to say we've got to know where it's spreading in east Africa. There was the "AIDS highway". Well, everybody in east Africa who's working there knows exactly what's going on. It's not a big mystery. We need some resources and capability to be able to collect that kind of information, how it's spreading and where you put your energies in prevention. Those aren't mysteries, but there needs to be some central brain that picks out on the spot what kind of linkages you need to make. I don't think they're very hard to find, but I don't think that their resources are in A.I.D., maybe they're not in WHO. CHAIRMAN WATKINS: Let's say there are fifty entities like yourself in the country that can deliver the kind of quality product you all have. If you were to bring twenty of those 298 together as representative of regions of the world that perhaps the demonstration project would make some sense, would they be able to come up with five solid regional projects where they could work with together in those regions and develop the kind of demonstration projects that I'm talking about and then put up the monitoring and evaluation mechanism through WHO's program on AIDS and do something useful? DR. ALDERMAN: Yes, but you can't link it just to individual project support. It's that coordination. I think your thought about a regional program that has to be self- consciously directed, that's critical and so much of U.S. support in general in regard to international health is strictly project- oriented without sufficient coordination, either across the horizontal or vertical way. I think though you could quite easily go to east Africa, for example, and find the group of local PVOs and their collaborating international and local national organizations that are working quite well ina collaborative way. I think one of the things that characterizes all these things is our PVOs work with the mission hospitals, with the government health service, with the local political structure. We couldn't function otherwise. There's not a problem of local coordination. The problem is somehow or other bringing U.S. resources to enhance that system. I don't know whether the central brain of that ought to be A.I.D. or WHO. CHAIRMAN WATKINS: I'm not pushing for A.I.D. I'm saying is there a place for it? Is there a place in Dr. Mann's organization, for example, that would link with our PVOs for a demonstration project? Because you're here today and represent various organizations, could you give us a strategy recommendation that we could put in our report? For instance, say this is the way we see the PVOS working in the system to help solve the real problems of the world and this is the kind of demonstration project concept that could make a lot of sense and that would show that we're going after the information and that we're going through the right organizations that have the sensitivity and the pulse of the national interest in those nations of the world that we're working in. DR. ALDERMAN: One quick response. I think WHO, through its regional scheme, has the mechanism in place. It needs to be beefed up to do the kind of demonstration planning and coordination that you're talking about. It would need an influx of a lot of resources. I don't know what -- CHAIRMAN WATKINS: Are you in a position to get together with your colleagues and discuss that and perhaps send me a letter saying this is what you should explore? We have the opportunity to explore it with Dr. Mann and others. Perhaps this is something that we could really do some homework on between now and the middle of May, and give us an idea of how you 299 would like to see us come forward with some stronger recommendations to provide that kind of symmetry that I see in this particular concept as matching that of our own national strategy? DR. ALDERMAN: I think it would be irresponsible to come up with a blueprint, but I think that's the line - CHAIRMAN WATKINS: I wouldn't want you to go further than you think, but you can lead us to something. If we don't have all the answers, then let's go find the answers but set up the movement in that direction. If you're willing to do that for us, and perhaps you would be willing to take the lead on that. Would you with the other PvOs that are- represented here today? Do it in a way that obviously you would expect concurrence with your PVO colleagues across the country that they would look and say "that's the way we ought to go". DR. ALDERMAN: I'll track them all down. DR. NYAMWAYA: I just wanted to add that in a number of ccuntries today, PVOs are getting together in trying to respond to AIDS. So in what is going to come up from the PVOs in the United States, due regard has to be given to what is already happening. How do you link up with various networks which already exist? How can you do that because U.S.A.-based or U.S.A.-linked PVOs are just one small aspect of what's happening in the world and you can't base PVOs on one view. So what we are trying to do is how we can link up with whoever is doing what? The regional models of how to work in various socioeconomic conditions. You can not have one model that works all over the world but you can have a series of models, depending on the socioeconomic conditions you are talking about. I think that is possible. CHAIRMAN WALSH: And Dr. Alderman, keep in mind what some of you have pointed out. AIDS is not the only disease going. I think it's very important when you come up with a PVO plan that you really recognize that AIDS is the wedge to get to the infrastructure advancement that you need. I think we have certainly come to recognize that on this panel, haven't we, Jim? CHAIRMAN WATKINS: Absolutely. CHAIRMAN WALSH: Particularly when you get witnesses from the countries involved, they're the ones who keep saying don't forget, AIDS is not the only disease we have. It's tragic but it's not the only one. CHAIRMAN WATKINS: I think that we have to be cautious that we walk the line carefully in those areas where clearly to solve a problem in AIDS we can't be so AIDS specific in the 300 resources, such as in the nursing shortage in the United States, that we can only generate enough nurses just to deal with the HIV epidemic. We don't know how to do that. We have to walk carefully and use AIDS as a window of opportunity that's opening to give us some new approaches to better international health care interaction that will lead to better things for the future in many ways, diplomatically, economically. I don't see any dissimilarity in the concepts that we've been promoting already, so it gives me a feeling of strength listening to you today that we're all in the same boat. DR. MACAGBA: I would like to give some direct feedback to you on the very good concept and idea utilizing part of the WHO grant and capability for PVOs. This could be a possibility for the future, but I would just like to say that historically and currently WHO, as a matter of procedure, works only with governments and with a few collaborating centers around the world which are normally government institutions. So it is possible to make a recommendation of the Commission that for the first time a WHO body would set aside a certain portion of its budget for PvOs, but then that would be a first. Like UNICEF. For the first time this year, a local country office of UNICEF has a budget specifically for PVOs in the country. CHAIRMAN WALSH: Bill. MR. WALSH: I would just like to endorse the idea. I think it's a very good idea. I think that most of the PVOs have established operations, as has been expressed. You're in eastern Africa and we're in southern Africa. You're not really talking about adding resources to WHO because we already have our structures there. We have professionals on site and our networks. What we're really just talking about is developing a regional program that ties in with a global AIDS strategy. That's something we all intend to do anyway. CHAIRMAN WATKINS: Dr. Macagba has made a point which I would see as one of Dr. Alderman's input for his strategy building. I don't see huge resources in the organizational linkage we're trying to set up. There may be some additional resources in how we implement. That's our business to focus this so that it's executable so that we're down to something where the resources can really be put to good work through you all with a properly coordinated effort in various parts of the world where these kinds of experimental programs make sense. It may be exciting enough that we may find that this approach is a future way of doing business on all infectious or other diseases that affect mankind. DR. BARKER: I agree with my friends here that you're definitely pointing us in the right direction with your question. 301 CHAIRMAN WALSH: You all are pointing us in the right direction. DR. BARKER: We all want to work this way, cooperatively with WHO. Actually I think we see this happening at the national level more in the face of this epidemic, at least from our perspective, than we have for a long time. We have worked very closely with CDc in this country, closer than we ever have before. I want to say one thing on behalf of WHO and Jonathan Mann, who, I guess we all had some dealings with. That is that it's hard to tell who had the idea, but I really think they took the initiative on this global safety program to go to the League of Red Cross Societies and the International Society of Blood Transfusion. They call us NGOs, non-governmental organizations, which support the observation that their tradition is to deal with governments. But they're aware of us. I think in the face of what we're facing, they are just as interested in us as we are in working with them. So I think the stars are in the right position basically for us to pursue this line and we certainly want to go this way. MRS. GEBBIE: Just to clarify my own understanding of some of what's going on today, because it forms some of the backdrop for how we might respond, I wasn't clear from your presentation the extent to which voluntary organizations such as yours working in a country would be included in the kind of things that were called donor meetings or review meetings where funding agencies are looking at coming into a country. If you were a service organization in one of those countries, would you currently be invited to the table along with the national government to look at channelling that money in? DR. ALDERMAN: Usually, yes. MRS. GEBBIE: The policy is not to give you cash through WHO. You're still, at the present time, included somewhat in that process. Yes? No? Sort of? MR. WALSH: I think the important point that was made by AMREF is that we're invited by the country itself. We're not invited by the donors. The World Bank doesn't sit down and say, let's have Project HOPE or AMREF in. The one who says that is the government of Kenya or whatever. That's how we get to those. MRS. GEBBIE: That leads right to my next question. One of the policy points we've heard articulated is that WHO only wants to fund those programs which are consistent with their 302 global plan which includes country's specific plans for fighting the epidemic. A rather plain statement that they won't fund anything in a country that doesn't match up with their plan. Is that a comfortable approach for you? Are you finding there are things that you really want to do that aren't making it into those country's specific plans? DR. ALDERMAN: In AMREF in Kenya and Tanzania, we're part of the national AIDS committee. MRS. GEBBIE: I thought I heard somebody say that. That's pretty generally true? DR. NGATIRI: It is the same with World Vision. We are included in the national AIDS committee and they actually ask some reflections from us whenever they want something done. MR. WALSH: I'd like to answer to your question. I think that the perspective that might be helpful in developing countries, it's not that they're so resistant to having a national plan. What they're resistant to is you only need so much advice about what it is you should do. I think that there's plenty of room within the WHO plan to find projects. The important thing is to get into implementation and doing something about the problem and not to just keep talking about the plans. Generally, implementation is their strength. MRS. GEBBIE: My last question is one of those things that I think would be best returned in writing. Perhaps this may be something you would work on jointly. You gave us, Dr. Walsh, a very nice list of fourteen things that could be done. Many of them were very, very appealing but, at least for me, my own level of ignorance of present structure and policy makes it impossible for me to pick out which ones of those would require a statutory change, which ones would require a policy change and which ones require neither of those but simply cash? If you cquld somehow flag them or group them in that way and then if there is a hierarchy among them? Is there really one or two, the most critical to make things happen. Make sure those get marked in some way. It will make it easier when we're dealing with a list that long. I thank you for it. It was very, very helpful. CHAIRMAN WALSH: Burt. DR. LEE: Clarify something for me. NGO, PVO, non- profit organizations. What is the difference? We're going to end up recommending things on PVOs, I can see that coming. Tell us what is a PVO and why is it different from a non-profit organization? DR. BARKER: I'm sorry to introduce some of that alphabet soup. Non-governmental organization, I think, is a very 303 broad term which includes both the non-profit sector and the international pharmaceutical-- DR. LEE: I understand that one. DR. BARKER: That includes everybody who is not government. The non-profit sector is also very broad. It includes things like -- DR. LEE: Anything that's non-profit. So why are you different? DR. BARKER: Voluntary organizations, I think most of us would view as a little bit special. That is to say, they are organizations which do a very large part of their work through volunteers. There are a whole host of voluntary health organizations in this country, heart, cancer, etcetera, etcetera. There are voluntary social service organizations. You're basically seeing a number of voluntary organizations here. They have a special philosophy which is that there are lots of people who would like, one way or another, to spend some of their time helping other people without compensation. That's the common thread of volunteers, but volunteers are in a pretty wide range of functional areas, too. They're not confined to the health field, certainly. DR. LEE: Thank you. Dr. Roy Widdus is in charge of a lot of the AIDS programs for WHO. He's been nodding his head with some of you people and he's been shaking his head with other people. Dr. Widdus, where is your disagreement with some of the things that have been said? DR. WIDDUS: It is generally true that the Worla Health Organization works with governments. We have many ways of working with organizations and entities that are not strictly the Ministry of Health. We have convened, not too long ago, in Geneva, a meeting of what are called non-governmental organizations, PVOs, to work out ways of incorporating these entities into the framework provided by national AIDS committees. I think the majority of instances where I was nodding or shaking my head were not sort of major policy disagreements. The WHO in general is very receptive and interested in folding PvVOs into the framework of activities because, as someone mentioned, they are exceptionally effective in lots of circumstances at the implementation side of things. This has happened in a number of cases where they serve on national AIDS committees. As we move from short term plans to medium term plans in approximately seventy or eighty countries over the next six months or so, we hope increasingly to see PVOs incorporated into the general national strategies in countries. 304 If I can make a brief comment about something that has come up one or two times in a formulation that we disagree with a little bit. It was raised that the WHO will not fund things which are not in agreement with our plan. I think that's not quite the right way of putting it. The WHO lays out general guidelines for the approaches that it feels are sensible to the prevention of AIDS and the reduction of morbidity and mortality connected with AIDS and gives these guidelines to governments. The plans that I talked about are truly government plans. They're not WHO plans given to the government. They're not implemented until the government actually requests that a donor's meeting be held. So, the statement that we don't fund things that are not part of our plan is not quite an accurate way of looking at things. DR. LEE: Thank you, Dr. Widdus. One last question to Dr. Barker. You have a magnificent infrastructure. Dr. Barker has a CV that is incredibly impressive. He has spent almost twenty years in this blood banking work here with the Red Cross. It seems to me that if you were the AIDS czar or you were going to try to coordinate the blood banking on a global basis, you would not try to create some new organization. You would go to Dr. Barker, who would, it seems to me, with a fairly minor switch, open up the valves a little more and handle a great deal more. Is that not the case? DR. BARKER: Well, the czars didn't come out too well, so I'm not sure I want to be the AIDS czar. DR. LEE: The czar is going to pick you. Admiral Watkins is the AIDS czar. DR. BARKER: Good. We would very much like to work with the WHO and that's our intention. As I said, they came to us. They came, not just with intentions. They came with money. So, we really are together. We don't have nearly enough resources at this point to do what we and the International Society of Blood Transfusion would all like to do together. This, incidentally, involves resources of Red Cross Societies in many countries. You're right. DR. LEE: Your system is good and it's in place. DR. BARKER: We do have a lot of good people. DR. LEE: Thank you. CHAIRMAN WALSH: I think you stimulated us enough so that we could keep you here all day but we've already delayed our next panel probably past the shuttles they are trying to get back to New York. I really want to tell you how much we appreciated 305 your presentations because I hope I'm not telling a tale out of school, but when the lights were off and we were watching the presentations and we heard the two excellent ones but prior to the third one, the Admiral kept grunting. He finally turned around and said, "My God, this is what we were hoping A.I.D. would tell us." These were positive suggestions that were open. I don't deny my prejudice for PVOs, believe me, because I think that's where it all gets done in the long run. I see a great opportunity for Pvos, in this instance, to start to work together in a practical way in the field. You may have something going and you can't get the supplies or some of the money and so on, but maybe we can. It becomes a joint operation then. The same thing with all of us. There's no reason why, with a worldwide threat, we expect just WHO and the world to cooperate. We might as well cooperate as PVOs and work together with the resources we each have to strengthen one another. If you've got a regional program started somewhere, great, we ought to be willing to help you. If we have started in this hemisphere and we need some skills that you have, you ought to be able to help us. We ought to be able to turn to one another. I think, between us, we either get the resources and what resources we can't get, I think perhaps we have the clout between us to get them. I think that's what we have to do. So thank you very much. CHAIRMAN WALSH: Would the next panel come up. We apologize to you for delaying -~ I think we get interested in the panels and ask questions. Now, we would like very much to give you all the time that you want, but we are sure that you will probably prefer to get to your recommendations and let us read your testimony. If that's what you want to do, that's fine. But we would like to tell you that we certainly are perfectly willing and plan to stay until 6:30 or later if you want to give us the time because we certainly need your input. So Shep Forman from the Ford Foundation, Director of Human Rights and Governance will be our first presenter. MR. FORMAN: Thank you, Dr. Walsh, Admiral Watkins, other members of the Commission and staff. I want to thank you for your invitation to appear and commend you for the recommendations in your interim report which I should note we found very helpful as we planned our program activities in this area. I'm pleased to be here today to tell you briefly about the Ford Foundation's program on AIDS. As you know, the foundation is an American institution with a global mission aimed at advancing human welfare. About two-thirds of our annual grant making is done in the United States. The other one-third largely in developing countries throughout Asia, Africa and Latin America. My remarks today will reflect that allocation of resources and will describe our U.S. and international programs. 306 I should also note that the Ford Foundation does not generally work in the area of health, but we recognize that AIDS is a major global problem linked inextricably to crucial issues of governance and public policy, human and civil rights, social services and education, community development and quality of life. These are all subjects in which the foundation has developed particular concern and expertise. And it is for this reason that we thought we could be of some help in the global struggle against AIDS. What I'd like to do today is simply outline three special areas of need and opportunity that the Ford Foundation has decided to focus on. The first two will reflect our work in the U.S. The third, our work internationally. But as you'll see, there is some relevance already noted by Admiral Watkins between domestic and international programs. The first program area that we intend to focus on will provide state and local government officials with up to date information on AIDS, especially as regards legal, ethical and public policy responses. Ford Foundation staff jointly with the Robert Wood Johnson Foundation are working now to establish a consortium of public sector organizations including the National Governors Organization, the National Conference of Black Mayors and other public interest groups to provide state and local public officials with information on policy options and probable outcomes in jurisdictions struggling to construct appropriate responses to AIDS. The Ford Foundation is also convening a working group of experts in civil rights, public health, medical ethics, education and law to consider the legal and ethical implications of public policies involving AIDS in this country. They will be asked to deliberate on critical rights and ethical issues surrounding AIDS, to commission legal background papers and serve as a resource for the public and policy makers on these issues of extraordinary complexity and great magnitude. The second, and I think the most exciting U.S. program activity of the Ford Foundation regards support for innovative local initiatives. A significant part of the battle against AIDS, as you've noted, is being waged by community based organizations across the country. To support and encourage these efforts, the Ford Foundation is establishing a special matching grants fund in cooperation with other corporate and independent foundations. Our objective is to form a philanthropic partnership with local and community foundations to stimulate a coordinated community response to AIDS throughout the United States. The fund will provide matching grants to local and community 307 foundations in support of community based social services and targeted preventive education programs. It will encourage medium and long term community planning and the development of promising model programs, evaluate the results and disseminate information on what seems to be working best to communities across the country. The fund will be guided by a group of national and community leaders who we hope will provide ongoing leadership to the nation as it develops its AIDS programs and policies. Finally, we are working through our field offices in Asia, Africa and Latin America to help meet needs in the developing world. Building on established foundation programs in community epidemiology, child survival and reproductive health, our field offices in Brazil, East and West Africa, Mexico and Indonesia are currently working with local public and non-profit organizations to see how we can be most helpful in their efforts to provide preventive education, compassionate care and information leading to appropriate national public policies with regard to AIDS. The foundation is well placed to help identify non- governmental organizations engaged in model health and community programs that can add AIDS to their agendas. In regard to the conversation that I just heard with your previous panel, I would urge you to keep it private, to give these local non- governmental organizations the funds that will allow them to fully develop their innovative and creative program activities. There are some very exciting efforts going on that we know of in Thailand, in Haiti and in African countries that simply need support. And if we can get them support in the most rapid and least bureaucratic way, we'll be doing our best to help fight this disease. While we are receiving some encouraging support from the private sector for our initiatives it is important to recognize that organized philanthropy accounts for only two percent of national income. Foundations can provide the seed capital for innovative preventive education and community service programs, but public funds will be required to bring these to scale. Therefore, we want to endorse the Commission's recommendation that public sector funds be made available to existing national civil rights and community based and minority service organizations. Our experience demonstrates that these organizations have well established communication and education capabilities and are well positioned to take on the AIDS challenge if sufficient resources are made available to then. As Admiral Watkins noted, the same case can be made for NGOs in the developing countries. In addition to addressing the needs of currently effected populations, however, we believe it is also essential to identify potential risk groups and design and implement effective preventative educations programs for 308 them. It is here in identifying the social vectors of the disease that the developing countries may, in fact, be ahead of us. For example, the present focus in the United States is appropriately on special urban populations. Yet social communication between urban neighborhoods and rural communities in this country is continuous, just as we have heard recently in the last panel about Africa. We need to inform people in areas such as the rural black belt in the South and the migrant populations in the southwest of the dangers that may face them. These are regions where health care is least available and needs to be brought up to par. Similar problems exist with regard to immigrant populations and their constant movement across borders. A special effort also needs to be made to reach out to women, particularly those close to IV drug users and other at risk groups, both in this country and abroad. And finally, we need to target all of our nation's youth in public schools and colleges, at job sites and in the streets of their communities if we are to prevent the spread of AIDS to future generations. In closing, let me just say that to meet these goals requires a major leadership role on the part of the federal government. We need the political will to aggressively engage this crisis, both at home and abroad. Leadership at the highest level is needed to frame a positive and compassionate response by government, by the private sector and the public at large. One measure of this leadership is an adequate public commitment of funds for research services and public education. Another is an authoritative voice that tells the nation that AIDS is a global problem that we must all recognize and work together to resolve. One suggestion that we would make in this regard would be to consider establishing an office in the White House to coordinate the public and private initiatives and encourage civil leadership in this country. We look forward to working with you as we develop our AIDS program and as you complete your work. CHAIRMAN WALSH: Thank you very much, Mr. Forman. CHAIRMAN WALSH: Next we have Dr. James Lea, Director of the Program for International Training and Health, Chapel Hill, North Carolina. DR. LEA: Thank you, Mr. Chairman and members of the Commission. I appreciate the invitation to present testimony to you today. One of my responsibilities, as you've said, as a faculty member of the University of North Carolina School of Medicine is as director of the INTRAH program, Program for International Training and Health. 309 Since 1979 INTRAH has participated in the training of more than 40,000 health and family planning workers in 32 countries of Africa, Asia and the Near East with the financial support of the U.S. Agency for International Development. Most of these 40,000 personnel were nurses, midwives, auxiliaries, social workers and others rather than physicians. WHO's global program on AIDS has designated the education and training of health personnel as one of the most vital steps in its country assistance protocols and our program takes very seriously its responsibility to integrate HIV AIDS education into the family planning training programs which we support. I'd like to offer just a few remarks about our experience of the impact of HIV upon family planning service programs, especially in Africa. In Uganda, Kenya, Rwanda, Zaire and several of the 12 other African countries where INTRAH is currently active family planning service agencies are increasingly being drawn into emerging HIV control campaigns. In many respects this is a positive development because as others have pointed out, in many countries these agencies are uniquely positioned and experienced to provide HIV education, information and preventive services. A strong family planning program in Africa is staffed not only by clinicians, but also by professionals and volunteers with special skills in community outreach and in counseling people to make behavioral choices which effect their personal health and their family's well being. And also by persons respected in their communities whose advice on reproductive health matters is generally taken quite seriously. These family planning programs, especially in the non-government sector, are in many countries infrastructures in place and they offer models upon which effective community based citizen action HIV control campaigns could be based. On the other hand, there are grave concerns that the crises dimension of HIV control may overwhelm both public and private sector family planning programs unless great care is taken in soliciting and supporting their participation. Many clinical service providers are without sterile protection as this Commission has heard, and so risk HIV infection from the women who come to their clinics. Many clinics themselves lack the means for properly sterilizing instruments and so the risk of patient to patient HIV transmission can be acute. As a result of these and related factors, many already understaffed family planning and maternal and child health programs in Africa are in danger of losing trained service providers. At the administrative level many directors of family planning programs fear that a link between AIDS and family 310 planning will undermine nearly 20 years of work to gain the confidence of traditional societies in modern methods of child spacing and contraception. They're also weary of emergency edicts which may siphon their resources, co-opt their personnel and suspend their program's productive momentun. International family planning assistance organizations such as ours are concerned that a rush to apply resources to the AIDS crisis, and the rush is definitely warranted, will divert resources necessary to sustain increasingly successful and intrinsically important family planning and maternal and child health programs worldwide. INTRAH and our host country partner organizations are taking action on some of these issues to the best of our abilities. We are seeing that accurate information on HIV transmission, science and symptoms of infection and preventive practices is included in the curricula of all INTRAH supported training for health and family planning personnel. We are helping to increase the emphasis on sterile technique and proper clinical procedures. We are distributing English and French language continuing education materials on HIV and AIDS, preparing a counseling guide which includes methods for teaching HIV prevention and for assisting AIDS victims. And we are supporting the development of a widely adaptable HIV/AIDS teaching module for the basic and in-service training of service providers and their supervisors. And in the face of an epidemic which threatens to decimate and de-establish a major segment of human society we, along with other organizations active internationally in family planning assistance, are involved wherever possible in information sharing and advocacy. There are other vital issues, however, which an organization such as ours cannot address directly and I commend two of them briefly stated to the Commission's attention. First is the issue of the level of U.S. resources which will be allocated to the international HIV control program across the board. The Commission has previously heard testimony recorded in your interim report calling for the expenditure over the next decade of up to $15 billion in the United States alone. That's not unreasonable, but the current past commitment to global HIV control outside of the United States is a minuscule percentage of that amount. I feel strongly that the cost of fighting AIDS and ameliorating its effects in this country will be virtually unlimited unless we make a much more substantial commitment to fighting and ameliorating it everywhere. Its major known transmission routes are too central to both timeless and contemporary human behavior for any of us to believe that HIV will not continue to elude -- immigration restrictions and mandatory testing and to defy the logic of public education campaigns. 311 Until a vaccine or a cure is developed, HIV must be aggressively attacked wherever it is found if it is to be controlled and conquered. This Commission should recommend a major expansion of U.S. financial commitment to the global HIV control effort. Second, I report that I've heard it said that AIDS is this century's natural answer to the rampant population increases now plaguing those countries which can least afford them. They suggest that resources currently allocated to international family planning assistance be reassigned to HIV control or perhaps withdrawn altogether since divine providence now seems prepared to take over that task. Such a position is not only inconsistent with this country's moral character, but it is also ill informed. Scientists at several institutions including North Carolina's Research Triangle Institute have demonstrated that even in a worse case scenario AIDS deaths would not stem disproportignate population growth rates and the chaos and dependencies that they create. In addition, as AIDS kills men and women in their most productive years, the very young and the very old will survive as totally dependent segments of largely dependent societies. There are some compellingly practical reasons why our response to the HIV epidemic should include not only a basic across the board increase to U.S. resource commitments, but also increased support for family planning programs in developing countries. I have elaborated some of these ideas in my written testimony and will be prepared to discuss them eagerly in response to any questions. But I would like to close in the interest of time by urging that the Commission's final report to the President specifically recommend a major increase in the level of international family planning and maternal and child health assistance as a distinct component of a much stronger U.S. financial and technical commitment across the board to the international fight against HIV and AIDS. Thank you very much. CHAIRMAN WALSH: Thank you very much, Dr. Lea. CHAIRMAN WALSH: Dr. Townsend, the Director of Operations Research for Latin America and the Caribbean, The Population Council is our next witness. DR. TOWNSEND: Thank you. The Population Council is an international not for profit agency working in research and development in the population field. Internationally we've seen an initial reluctance to admit the existence of a problem with respect to AIDS change to a mobilization of national AIDS 312 committees and the development of short and midterm plans for prevention. However, financial support for research and specific innovations has been slower to materialize. There's a need for broad based support for AIDS prevention activities and this need highlights the potential role for nongovernment organizations. Specifically The Population Council has initiated four programmatic efforts within the context of the population field. First The Council has begun work on modeling AIDS transmission and John Bongaarts has presented testimony before the Commission on that activity. This includes field work with private volunteer organizations and with governments in collecting data that would help validate those models. Secondly, in our New York office we're initiating a review of contraceptive development activities which should include STDs and AIDS prevention as new criteria for effectiveness. At one time we were largely concerned about developing technology for postponing or delaying births and with this new perspective I think STD and AIDS prevention will become increasingly important. Thirdly, in New York and the field offices in Latin America, Asia and Africa we're reviewing ethical and quality of care issues in AIDS testing and the provision of family planning services which will contribute to AIDS prevention. And finally, in a number of countries, we're working on operations research projects with governments and private voluntary organizations to test innovative strategies for AIDS prevention. Since 1984 with the support from the Office of Population at US A.I.D. The Population Council in Latin America has implemented a program to improve the coverage, quality and cost-effectiveness of family planning and maternal and child health services. Forty-two projects have been developed to date with private and semi-autonomous family planning service providers such as social security systems, health maintenance organizations and PVOs. A total of $3.2 million has been expended on these projects, of which 20 percent has been allocated to AIDS prevention activities. Worldwide, the Office of Population has supported 11 projects in AIDS prevention. Five have been developed in Latin America and the Caribbean by The Population Council, four have been developed in Africa, three with Columbia University, one with Tulane University and two in Asia with the University Research Corporation. Specifically in Latin America the five projects developed have been in the following areas. Two projects have been developed with Ministries of Health in mass media programs 313 to measure the coverage and the impact on behavior of their initial efforts to increase the awareness of the public about AIDS and its prevention and measure the coverage of services in different vulnerable subgroups. Two of these projects are now operating in Mexico and Peru. Two additional projects in Mexico and Colombia are being developed with International Planned Parenthood Federation affiliates on integrating AIDS practices with existing private family planning programs at the community level. We will identify how family planning groups who are already available and working in the community can integrate AIDS prevention and STD education into their existing activities. And thirdly, in‘’Peru we're working with a university supported clinic linking AIDS and STD prevention with women's reproductive health. Currently there's a concern about the risk of AIDS transmission and the IUD. We hope to change the mix of family planning methods which would increase the protection available to women in the community. The total amount of funds allocated to these five projects is $600,000. The Council has utilized $300,000 from the initial US A.I.D. contract on family planning and maternal- child health. An additional $300,000 was made available to us by the Office of Population, A.I.D. to develop two or three more projects. The challenge in Latin America is quite simple. First, people in Latin America know at least that AIDS is an infectious disease. They know that it's transmitted through sexual activity and through blood, but they also believe that it's transmitted through casual contact. They know that AIDS is preventable but they don't know about the safer sex practices that would reduce the risk. Specifically they don't know that the use of a condom will reduce risk. And finally, we have to increase the prevalence of safe sex practices including the availability, accessibility and use of condoms. In Latin America only two percent of married women who are of productive age report the use of a condom during the last month. If we're going to increase that use among married couples as well as unmarried individuals, I think there is a great deal of work to be done in the design of delivery systems and user education. Finally, I would commend the Commission for stimulating the participation of non-government organizations in the national and international dialogue to better define our role and improve the exchange of experience and data. Secondly, I would encourage family planning organizations and donors to develop strategies for AIDS prevention which complement national efforts and meet 314 the needs of special groups. This may include contraceptive research, improved modeling and data collection, and certainly work with the community in the implementation of prevention programs. I think private donors are waiting to see what the United States Government is going to do in AIDS prevention and are looking for a unique role to make a contribution. They've been reluctant to get into this field in the last several years, and were a clear role specified for them, I think there would be a great deal of private support for this work internationally. And finally, additional funding should be allocated through A.I.D. to support nongovernment organizations who have an international presence, who are active in community level services and have the experience in AIDS prevention internationally. Thank you very much. CHAIRMAN WALSH: Thank you, Dr. Townsend. CHAIRMAN WALSH: Now Dr. Yamil H. Kouri who is President of the Latin American Union Against STD and AIDs, and the AIDS Research Coordinator at the Harvard Institute for International Development. DR. KOURI: The Latin American Union Against Sexually Transmitted Diseases and AIDS (ULACETS) is a nongovernmental organization formed by physicians, social scientists and public health workers from all Latin American and Caribbean countries. It is the advisory body on STD and AIDS for the Pan American Health Organization and the regional bureau of the International Union Against Sexually Transmitted Diseases, that is the nongovernmental advisory committee to WHO. ULACETS is formed by 6,000 members throughout this hemisphere and the purpose of the association is to bring together relevant nongovernment members of the scientific community who share the common interests and dedication to eradicate STDs and AIDS that cause so much human suffering, and to promote scientific activities, education, community participation, fund raising and research. From the five classical VDs the categories of STDs have grown to 30 entities. AIDS is an STD. STDs existed long before AIDS appeared and will continue to exist long after AIDS has been conquered. So among the first recommendations is that we must not forget, in the process of combating AIDS to strengthen the public health capabilities to deal with all STDs. A good example was CDC. The STD division within CDC was able to lead the initial efforts against AIDS with the infrastructure it had developed. Other recommendations that I'm sure you've heard many times here are the need for more research, manpower and training, 315 and improved information dissemination. But I'm not here to repeat these recommendations but to convey a message from our colleagues in Latin America. We observe and worry about how rapidly the AIDS issue is becoming a destabilizing factor of a political nature. AIDS is not a common disease, but a disease that has shaken humanity, and the time has come to take a better look at ourselves and our policies. AIDS should provide a window of opportunity for broader and deeper analysis and consideration of the mechanisms by which we establish our priorities. How is it that military expenditures take up a great part of our budgets, and our countries spend more on arms than on education and health? How can our health delivery systems be expected to manage an epidemic as overwhelming as AIDS when they cannot cope even with the already existing endemic problems? How can we justify that some $30,000 is spent worldwide per soldier per year while we spend only $450 per person for education and even less for health care? These considerations have led the Latin American Scientists to sign what has been known as the Quito declaration given during the Sixth Latin American Congress last September in Quito, Ecuador. And we would like to read to your Commission some articles of this declaration that might sound awkward, but nevertheless, policymakers must be prepared to hear the message expressed more and more by Latin Americans. The Quito Declaration starts by stating that extraordinary problems require extraordinary solutions. We, the scientists and health professionals from Latin America, united in the Latin American Union Against STDs and AIDS and interpreting the will of our people declare: Whereas, AIDS has assumed pandemic proportions affecting all regions of the world, representing a threat to health for all, but especially for the young, for mothers and children; Whereas, the AIDS epidemic has been seriously underestimated and is a threat to the achievements in health projected for developing countries, and to the attainment of health for all in the year 2000; Whereas, with millions of people already infected and no vaccine currently available or expected for several years, and as its prevention and control should be based on primary health care within national health systems; Whereas, primary health care delivery systems in developing countries are already overburdened with existing health problems, suffer a severe lack of resources and cannot handle the additional burden of the worst epidemic of this century; 316 Whereas, acknowledging the extraordinary dedication and work of WHO's global program on AIDS and PAHO's regional program on AIDS and based on the statements of the 40th World Health Assembly that endorses the global strategy on AIDS; and Whereas this situation of extreme urgency requires a worldwide concerted effort. Assembled in Quito, we agree to the following: Resolution 1: We request that the leaders of the governments of the United States and the Soviet Union as part of the undergoing arms control treaty, and in demonstration of their dedication to the welfare of humanity donate ten percent of the budget saved through these agreements, to the WHO global progran on AIDS and PAHO regional program on AIDS, to strengthen primary health care and combat AIDS in developing countries -- that their legacy to humanity be to translate resources destined to destruction into resources destined to save lives. Resolution 2: We request that the governments and institutions that hold foreign debts of the developing countries effected by AIDS, who are aware of the potential consequences to some of these countries by an epidemic that effects the most productive part of their population, that they cancel ten percent of their foreign debts alleviating an economic crises in these countries. And finally, Resolution 3: We request that the governments of our own developing countries, in concert with the previous statements, commit to dedicating ten percent of their military expenditures to improve and strengthen primary health care and combat AIDS. We appeal to the conscience of the world and resolve to pursue the obtainment of these resolutions through the institutions, governments and people of our countries. Thank you. CHAIRMAN WALSH: Thank you very much, Dr. Kouri. The last panelist is Dr. Richard Rockwell, Executive Associate, Social Science Research Council, New York City. DR. ROCKWELL: It has become clear over the last years that in addition to the lives it takes and the dollars that it costs, this epidemic will have social, cultural, economic, political and demographic consequences for societies worldwide. And this will be true if prevention and education programs now underway or being thought about are completely effective. And it will be true even if from this day forward no one else is ever again infected by the HIV virus. 317 It's clear that governments will face decisions about these consequences by the mid-1990s. Some of them are facing them today. But it's not clear what knowledge is being generated to assist governments and what foresight is being exercised to inform those decisions. You've had a number of examples put before you of the kinds of decisions that governments are making or will soon have to make. They have just been presented to you as issues, not as research problems, as things to be thought about. For example, it was pointed out that prevention and education programs in Africa will take a great deal of money. It may take money from other programs. It will also take personnel. It will take personnel from clinics and from hospitals that already have high doctor/patient ratios. It must be the case that when those trade-offs are made there will be costs in other aspects of the society: malaria prevention programs, tuberculosis prevention programs, less spending on agriculture, forestry, soils, energy, roads, clean water, sewage disposal and education. If the sources of funding are internal, there's not much money available. If the sources of funding are external, then who is it who will pay and will the people who make these decisions be culturally aware as if they were from the nations themselves, and will they be spending less money on something else? That is, will they be spending less money on development? And ironically it's quite conceivable that spending less money on development in Africa, say, can undermine the effort to prevent AIDS -- the transmission of the AIDS epidemic. This epidemic, because of how it is transmitted and because of the kinds of people who are affected involves all aspects of our societies. But we are not now looking — systematically at very many of these aspects. The Social Science Research Council with financial assistance from the Russell Sage Foundation is now in the midst of what we call a snowball survey of American social and behavioral scientists who are doing research on the social consequences of the AIDS epidemic. We can report three things from that right now. First, there's a narrow spectrum of questions being asked by social scientists. Primarily they're questions about prevention and education and caring for people, and that's great and we applaud that research. There's also demographic research, there's psychological research, there's research on the health care costs. But there is a huge spectrum of other issues that have been identified before the Commission that are also topics for research and we haven't identified very much research going on in those areas. Second, there is much less attention being 318 paid by American social scientists to the world outside the U.S. than is needed. And thirdly, there is a serious need for coordination of these research efforts and for fostering | collaborative projects. Thus, I'd like to summarize a recommendation to you that has essentially seven parts. I've distributed this to staff. It's principally that we've got to get the social sciences going on research on the social consequences of the AIDS epidemic. The most important thing here is to affirm the importance of doing research on the social consequences of the epidemic, to declare that it's not simply a morbid concern, that we're not simply standing along the side of the railroad track and watching the train crash, but that in fact in looking at what the epidemic is doing to this society and to other societies, we may help societies cope in very important ways. We must find ways to coordinate and foster collaboration. We must find ways for Americans to offer technical assistance to their counter parts in other nations and for us to learn from people fighting where the battle is more advanced. Second, we must not limit U.S. funded research to the domestic consequences of the epidemic. It's not in our selfish or our humanitarian interests to do so. Third, this does need money, a great deal and it's not ancillary to biomedical funding and it's not of lower priority. Fourth, the private sector including philanthropic foundations should add their weight to this funding. Fifth, we need long term grants of substantial funding levels. We shouldn't be asking talented researchers to waste valuable time in writing proposals for dribbles of money. Sixth, we should start thinking now about the data we need: the social indicator system to inform the decisions that we are just going to have to make in the 1990s. And seventh, we have to establish a way for people with talent to get into this field of research on a fast track. Fellowships for doing so are one approach that has worked in the past and might be worth trying again. The Social Science Research Council is standing ready to do its part in organizing social scientists worldwide to cope with the social consequences of the epidemic. We've been doing this worldwide for over 60 years. We've seen few or maybe no cases in which we think so strongly that we must find a way to act. Thank you. 319 CHAIRMAN WALSH: Thank you. Now, if you gentlemen will bear with us, we would like to ask you some questions if you've got the time to stay. Ms. Gebbie? MRS. GEBBIE: First, a question for Dr. Rockwell. I have an awareness, of some activity going on through the Institute of Medicine National Academy of Sciences on social science research which sounds a lot like what you're talking about here. You nod like you're aware of that. Can you clarify is there overlap, duplication or are they two separate efforts? DR. ROCKWELL: Well, it would be best for Charles Turner, who is staff -- or Lincoln Moses who is the chair of the committee -- to address that question. But there is not now an organized effort within that committee to look at the kinds of things, the social consequences, that I'm talking about. It's primarily concerned with prevention and education programs, with mounting a study -- MRS. GEBBIE: The methodology kinds of things? DR. ROCKWELL: Well, more than methodology. With mounting a study of sexual behavior of which we have very little knowledge in the United States and the concern with attitudes, attitudes towards sexuality, how they're being shaped by the epidemic, attitudes toward people with AIDS, attitudes towara people with behaviors that subject them to AIDS. But we're talking about lots of things beyond that, including an international scope, a concern for what's happening in developing nations which is not there now you can't put all of that on the platter of one committee. MRS. GEBBIE: Thank you. That's very helpful. As I listened to each of you I heard things that, in many ways, overlapped with what we heard from the panel just previously, although more of you were talking about research than the front line services. I did not sort out of your presentations particular recommendations about what needs to be done, that is, radically different from some of that list of 14 that Mr. Walsh presented earlier and which I think some of you heard. It would be helpful to me if you can get a. copy of that list of 14 recommendations and either identify how it does do what you're saying or whether it leaves off some things that you needed and to clarify what those are. I'm particularly trying to understand things which need doing that are more than just throw more money this direction, but where it's either a policy direction change or a statutory change that's stopping you've each identified as very important from happening. So I address that to all of you and would ask for some written follow-up on that. 320 CHAIRMAN WATKINS: Well, that was my question, too, that we had quite a discussion, I think, because of the lateness of the previous panel that you probably heard all that. And the question is when we talk about PVOs, are we also talking in general about non-profit organizations, in the same context? So maybe you could give me a little feeling of how you see yourself fitting into that prior debate that we had on the PVOs. DR. LEA: If I may, Admiral, I'd just very quickly as a university based international assistance program, I don't really know where we'd fit into that. We're not a non-profit organization, although we definitely don't make any profit at what we do. We're not really a private voluntary organization, so I suppose we'll stand under the NGO banner and let it go at that. But I think we are a member, as are other university programs concerned with the international HIV control effort. We are a member of the informal, to some extent formal network of concerned institutions. We try to maintain close contact with those that are described by various acronyms. So I think that the kind of discussion that you had earlier with our colleagues on the private voluntary organization panel would certainly include us. Our sympathy with the goals and objectives that were described there and our willingness to participate in that level and that orientation. CHAIRMAN WATKINS: Well then in follow-up to what Ms. Gebbie asked you to do, would you be willing, to give us a conceptual framework of how you see your role that might link up with the POVs? The WHO? DR. LEA: Absolutely. CHAIRMAN WATKINS: So I think we need to hear a little bit about that in specific terms since we got quite specific with the prior panel and asked them for an input to the Commission. DR. TOWNSEND: I would support Dr. Lea's comments and I think there's a specific role to play. The fact that NGOs' have a history of working in the community and have an existing international infrastructure is a real advantage. Specifically, the Population Council was invited by WHO to the NGO meeting and we've been participating in that dialogue in the United States and internationally. In the field we've been working with national AIDS committees in helping to identify ways in which we could be of help. Presently, we work more with private groups in Latin America. In contrast, in Asia, we collaborate more with governments. The strategy depends on the structure of services in the region. However, assistance from USAID for AIDS prevention projects was limited when major funding was allocated through the 321 Office of Health to AIDSCOM and AIDSTECH. As a result, we're looking to other agencies for support for this type of activity. MR. FORMAN: Yes, we of course are a not for profit organization but we in the typology of NGOs really are a funding agency rather than operating organization and we fund most of the PvOs or the kinds of PVOs and non-governmental organizations that were discussed around the table today. I would very strongly second your sense that these are an important, extremely important group of organizations to work with both in this country and around the world. The one thing that I would like to stress, however, is that as the host nations -- their national AIDS programs, they can be exclusive of certain kinds of non-governmental organizations for ideological and other reasons which, in fact, can be very vibrant and useful in developing programs against AIDS. And my comment earlier about being sure to keep it private is to make certain that there are means of channeling funds widely so that those organizations who can do the best work are able to take advantage of funds that might be available and not be excluded on particular grounds. CHAIRMAN WATKINS: But you just set up another reason why the linkage between let's say your foundation and some element of the World Health Organization -- assuming this is attractive to them and they'd like to participate seemed to make a lot of sense. You're making a case for it. MR. FORMAN: We have sat at the donor's table with World Health Organization and are in continual communication with them and hope to cooperate closely with them. I would say that in an earlier set of discussions about this topic the World Health Organization did stress that they would hope that other international donors would agree to fund only those institutions which were acceptable under national AIDS plans which, in effect, suggests governmental decisions about who gets funded and who doesn't and that would be a formula under which the Ford Foundation would not be willing to work. We think it's very important that there be independent sources of funding for organizations. CHAIRMAN WATKINS: But I think Roy Widdus was here in the room with us and made the point that he felt it was not quite on target that World Health Organization would prescribe any such MR. FORMAN: I think I'm saying the same thing as Dr. Widdus. CHAIRMAN WATKINS: Yes. MR. FORMAN: That is, he said that the World Health Organization does not proscribe but they subscribe to national 322 plans developed by national governments. In effect it's the national governments that proscribe and I think that we have to be very careful about. CHAIRMAN WATKINS: Yes, I understand. CHAIRMAN WALSH: Well, again, I was going to comment. I think one of the things along that line that it pays to bring out is that while a PVO is a non-government organization, it cannot work in a country without the blessing of the host government anyway. MR. FORMAN: Absolutely. CHAIRMAN WALSH: You did end up with the blessing of the government but you are absolutely right that you cannot apply for a grant to go through that government, most instances the private funding agency is most concerned about accountability. And accountability of funding going through local governments in the developing world is extremely difficult. And so it's generally easier for a private funding agency to work, say, through a university that's in a country or through Project Hope or through someone else because then they know they're going to get accountability. You still get the cooperation of the government and you still do the training and you still accomplish what you want. And I think the other thing is that in line with the Admiral's request most of the PVOs do have good working relationships with organizations like your own. We draw faculty from some 82 different universities in the United States for Hope programs. We've probably worked with many of the people that you have trained in North Carolina also. And so the basis for re-enforcing what the Admiral was asking for I think is there. It's a way of trying to verbalize it and if I can take something that Alan Woods said to weave a fabric of association to give the Commission something positive that we can go in for on the basis that a place is found for the so-called PVO/NGO privately funded local indigenous agency as it develops and as you become satisfied that they will give you accountability. CHAIRMAN WATKINS: I think we're after clearly not trying to force you into a mold that constrains but rather to open doors of opportunity so the people understand what's going on and there is extensive information exchange among NGOS working in the same region. CHAIRMAN WALSH: Let me just add one comment. There is something that we can do with A.I.D. A.I.D. gives a certain percentage of funding to PVOs because that's the way it's legislated. They don't like it, but they're required to give 17 323 percent. And Shep says all the foundations in the United States if they gave everything they had couldn't come up with more than two or three percent of what is needed. And it's going to require public support and one of the things we could consider before this Commission if we could get the endorsement of enough soles is to say that in the battle against AIDS X percent must be done through PVOs or the PVO share instead of being 17 percent, the rest could go to private contractors, the Beltway Bandits, the people like that can get a contract that PVOs can't get. You know, you could increase the PVO share to 25 percent of which eight percent has to be spent on AIDS related projects and you'd really open the door for the University of North Carolina, for lots of people to get in under that umbrella. And that's another mechanism to think about. Kris, do you have another question? MRS. GEBBIE: Dr. Forman, you opened up an interesting area there that, again, may not be something we lay out today but you might want to provide some written comments on. As I understand the policy of the World Health Organization they think funds should be channeled to those programs that are consistent with whatever country X has decided is the way to tackle AIDS. MR. FORMAN: That's correct. MRS. GEBBIE: Not through the country necessarily, but to programs which are consistent with that plan. MR. FORMAN: Yes. MRS. GEBBIE: And that makes a lot of sense because it insures that everything going on there would all tie together. Because AIDS is a very politicized disease in many ways, any one country may decide that approach X will never appear in the written word in their plan because it goes against something in their culture or in their political structure. And yet from our worldwide research funded and done by all these wonderful people down here, we've discovered that particular approach really, really works. And what I think I hear you holding out for is to make sure in whatever is structured there's a way to put some money into that country into whatever that approach is, that may not have in any way the approval of the country. Yet Dr. Walsh points out that the volunteer organizations that are in the country voluntarily if they take money to do that thing, could be in real trouble with the government. How do you tie that together in a way that does what you want and yet gives appropriate integrity to the decision making process of a country that says this is what we want done here and not the other thing? MR. FORMAN: Sure. You're absolutely right. You've put your finger directly on the dilemma of international donor agencies working abroad. 324 The WHO model does make sense in terms of having an effective and efficient means of addressing the AIDS problem regionally and in countries around the world. However, carefully coordinated and controlled programs don't always provide the kind of flexibility and creativity that I think the Commission is looking for in discovering the best means to address the AIDS problem at the local level. What I'm suggesting is that private philanthropies and funds of money they made available in collaboration with but not controlled by those governmental groups can, in fact, play a very important role in stimulating creative local responses. Now, in truth if a government does not want that to occur, they have ample means to prevent it. There are certain countries around the world, in fact, where for historical reasons the Ford Foundation is required to clear all of its grants through a particular government agency or set of government agencies. We don't like to do that, we don't do it in any contracts that we enter into now with state parties. But historically we are committed to that in two or three countries around the world. In virtually every instance we find that there is sufficient space to work. I can only think of three or four instances in the last several years in which a government agency has not approved a grant that we have wanted to make. In some instances there is foot dragging, but in very few cases have we been told outright that we can't do it. In many instances the government, in fact, likes us to be able to do some things which they ordinarily can't do themselves. I think what's important is simply to find the space and the mechanisms to feed resources into countries so that you can get that creative and flexible work done. MRS. GEBBIE: Thank you. I think it's worth pointing out that, again, this is similar to the issue of working with creative community based organizations without doing an injustice to either a local or state or regional plan that's been developed through structures in this country. MR. FORMAN: Absolutely. Absolutely. And when I indicated that we're setting up this national AIDS fund.in this country to work with community based organizations, it's precisely for those reasons. It's to provide flexibility to community based organizations to go out and do their thing. MRS. GEBBIE: Thank you. CHAIRMAN WALSH: Burt, do you have anything? 325 DR. LEE: I'ma learner in this field. CHAIRMAN WALSH: Cory? DR. SerVAAS: I'll yield. CHAIRMAN WALSH: You'll yield also. Everybody yield? Kris, you sure you don't have anything else? MRS. GEBBIE: You don't want these people ever to go home today, is that what your concern is? CHAIRMAN WALSH: No, no. But I want to be sure that you have everything out of your systen. MRS. GEBBIE: No, but I'll quit tonight. CHAIRMAN WALSH: Okay. We can't thank you enough for your tolerance in being here late, but it was important because, again, we are all still learning and we do require the input that you can give us. You know the task we have in nine months to come up with a policy that probably should have taken five years to develop in an ever changing situation and yet by June 24th the Admiral's got to sign that letter that has to go over there. And, we are looking for all the help we can get to be constructive and to put in a very sensible set of recommendations with which this country can live because the worst thing for us to do would be to put something in that ended up on a shelf in the White House. And we're determined not to do that and I preempt the Admiral when I say it because I know that he would not rest doing that. But that's why he is so persistent and we all are so persistent in trying to get solutions that are viable and that will work and that we give the support where it can be mast properly used. We've heard this problem of the shortage of behavioral scientists all over and, we heard it repeatedly and yet we know nothing yet has been done. We know the WHO is running into the shortage of people who could teach behavioral types of lessons, to counterparts and local personnel but where are we going to get them? We don't have them. And it's a question of allocation of our resources to supplement what I think a remarkable job that WHO has done in organizing. I just never have seen anything like it, and I'm no youngster. It's been remarkable. And they have avoided discouragement and we want to help them as much as we can, but we have a responsibility to do a lot of things ourselves as well. So thank you very much and anything you can contribute in response to the Admiral's charge, we'd be most grateful. (Whereupon, at 6:30 p.m., the hearing was adjourned to reconvene tomorrow at 9:00 a.m.) 326 APPENDIX Global AIDS: A Status Report Dr Jonathan Mann, Director, Global Programme on AIDS, World Health Organization, Geneva Address to the United States Presidential Commission on AIDS 18 April 1988 It is amazing and humbling to realize that in the late 1970s, the human immunodeficiency virus (HIV) was spreading silently - unrecognized and unnoticed - around the world; - that by 1981, when AIDS was first recognized, cases had already occurred on several continents - and that the worldwide scope of HIV infection and AIDS was not fully realized until the mid-1980s. Yet, while HIV infection and AIDS had stolen a march upon us, the global response has been rapid - the Global AIDS Strategy was designed and adopted - and in the past year we have witnessed an extraordinary and unprecedented global mobilization to prevent and contro] the disease. I. A GLOBAL PROBLEM To describe global AIDS, it has been useful to divide the problem into three separate yet inter-dependent epidemics: of infection with HIV; of the disease AIDS; and of the reaction and response - social, cultural, economic, and political - to the HIV and AIDS epidemics. This analysis permits us to focus separately on each element and also emphasizes that the third epidemic of reaction is as much a part of the pathology of AIDS as the virus itself. -~2?- On the basis of available information, we believe that HIV is an old if not ancient virus, of unknown geographical origin. The recent history - the current epidemic of HIV infection, the pandemic of global scope, appears to have started in the mid-1970s. From the mid-1970s to the present, we believe that several million people have become infected with HIV. Today, based on available information, we estimate that between 5 and 10 million persons are infected with HIV worldwide. In order to become more precise in our estimation, more valid HIV prevalence data at the national level will be needed. Here we face a very difficult problem - for it has not yet been possible to determine the number of HIV-infected people in any individual country. This task is urgent, for these national estimates provide the scientific basis for predicting the number of AIDS cases which can be expected during the next several years, for targeting prevention programmes, and for determining whether, where and to what extent HIV infection is increasing in the population - which also allows us to measure the effectiveness of prevention efforts. Throughout the world, HIV is transmitted in the same basic ways: through sex, blood and from infected mother-to-child. While variations exist regarding, for example, the dominant mode of sexual spread (heterosexual or homosexual) or the principal route of blood transmission (sharing of needles among intravenous drug users or reuse of contaminated needles for medical injections), the fundamental unity of HIV transmission must be emphasized. in addition, despite intense international scientific scrutiny, no evidence has emerged to suggest any change in these modes of HIV transmission. Finally, there is no evidence to support any inherent racial or ethnic resistance to HIV infection or to the pathogenic effects of the virus. ~3- The transformation of the first epidemic ~ of HIV infection - into the second epidemic of AIDS - is also becoming clearer, Our knowledge necessarily remains limited to the brief period - the decade or less - during which the health status of HIV-infected persons can have been observed. Studies of HIV-infected people have consistently shown that the risk of developing the disease AIDS increases with the length of time they are infected. Expressed in cumulative terms, in the first five years after infection, between 10 and 304 of HIV-infected people develop AIDS; in some studies, nearly 40% will develop AIDS by 7 to 8 years after infection. In addition to AIDS itself, other HIV-related illnesses may occur, including persistent generalized lymphademnopathy, AIDS-related complex (ARC) and neurological disease. Thus, in the first five years after infection with HIV, AIDS-related illnesses may occur in 25-50% of persons, in addition to those who develop AIDS. We do not know if all those infected will ultimately develop AIDS - only the passage of time will clarify the final and complete outcome of HIV infection. The long delay - of years and perhaps of decades - between HIV infection and disease is critical: thus, essentially all AIDS cases occurring in 1988 and nearly all AIDS cases in 1989 will come from people already infected today and probably several years ago. As of 1 April 1988, a total of 85,273 AIDS cases were officially reported to WHO from 137 countries around the world. Of all reported cases, 73% (62,536) are from 42 countries in the Americas, 13% (10,995) are from 43 African countries, 13% (10,677) are from 27 European countries, and the remaining 1% (1,065) are from 25 countries in Asia and Oceania. Fifty countries have each reported more than 50 AIDS cases to WHO, including 18 countries from the Americas, 14 from Europe, 15 from Africa and 3 from Asia and Oceania. -4- ~ The number of AIDS cases reported to WHO continues to rise rapidly. In the past four years, the cumulative number of AIDS cases reported to WHO increased over 15 fold. Nearly 100 more countries report AIDS cases today than four years ago. This not only illustrates the widespread awareness of AIDS but also testifies to growing openness and international cooperation. When the rate of increase, rather than the absolute number of reported cases is examined, it is interesting to note that while the time when the curve starts in each continent differs, the slope of the curve is quite similar. Under the best of circumstances, as many as 90% of AIDS cases actually occurring in a country will be reported to the national health authority. However, in many areas, the number of reported cases substantially underestimates the actual number of cases, due to problems in recognizing or dizgnosing AIDS, or in reporting AIDS cases to national authorities. Taking these factors into account, we have estimated that since the beginning of the AIDS pandemic a little over a decade ago, the actual number of AIDS cases which have occurred worldwide is approximately 150,000. The epidemic is worldwide, yet the current stage of the HIV epidemic is not the same everywhere and three distinct epidemiological patterns can be described. The first pattern - Pattern I - involves Western Europe, North America, some areas in South America and Australia and New Zealand. In Pattern I, homosexual and bisexual men and intravenous drug users are the major affected groups. Sexual transmission is predominantly homosexual; over 50% of -5- homosexual men in some urban areas are HIV infected. While heterosexual transmission is occurring and is increasing in these areas, it currently accounts for a much smaller portion of sexually acquired HIV infections than homosexual transmission. In Pattern I areas, transmission through blood principally involves intravenous drug users. After homosexual and bisexual men, intravenous drug use accounts for the next largest proportion of HIV infections, although in some countries, the majority of AIDS cases occur among intravenous drug users. HIV transmission from blood or blood products is not a continuing problem, as blood for tranfusion is screened and blood products are further treated to prevent HIV contamination. In Pattern I areas, most HIV infections have occurred among men; however, perinatal transmission has been documented, primarily among intravenous drug-using women, sex partners of intravenous drug-using men, and among womén from pattern II areas of the world. Pattern II areas include parts of Africa - principally Central, Eastern and Southern ~ and parts of the Caribbean. In Pattern II areas, sexual transmission is predominantly heteroseuxal and therefore the sex ratio for AIDS cases is approximately equal. In some urban areas, up to 25% of the 20-40 year age group may be HIV-infected, although substantial variation has been observed, especially between urban and rural areas. Further, up to 75 to 90% of female prostitutes in some Pattern II areas may be HIV-infected. In Pattern II, transfusion of HIV-infected blood remains a public health problem. Non-sterile needles, syringes, and other skin-piercing instruments undoubtedly play a role in HIV transmission,. but their contribution to the overall burden of HIV infection is smaller than the contribution of sexual transmission. Finally, as a reflection of heterosexual spread, perinatal transmission is a substantial problem; in some areas, 5 to 15% or more of pregnant women are HIV-infected, - § = Pattern LII areas include Asia, most of the Pacific Region, the Middle East and Eastern Europe. In these areas, HIV seems to have appeared more recently, in the early to mid 1980s. Most AIDS cases in Pattern III areas involve homosexual or heterosexual contact or receipt of imported blood or blood products. In Pattern III areas, the prevalence of HIV infection in high risk behaviour groups, such as male or female prostitutes, is very low. While HIV infection has not yet penetrated into the general population of Pattern III countries, the virus is present in these areas and evidence of within-country HIV transmission is increasing. Therefore, while the modes of HIV transmission are identical, the detailed epidemiology of HIV and AIDS differs substantially around the world. Of course, the description of three patterns requires generalization, for different epidemiological patterns may co-exist within a country, or even within a large city. Also, the three patterns are not immutable. Over time, in the absence of effective prevention strategies, the three patterns might be expected to blend together. Thus, as safe blood and blood products and safe injections and other skin-piercing practices become the rule worldwide, most HIV transmission will be sexual and perinatal. In addition, regardless of which sexual group is most affected with HIV in a given area today, sexual transmission may ultimately reach all groups who engage in risk behaviour. The epidemiology of HIV infection also shapes the health impact of AIDS in each society. In general, AIDS predominantly affects two age groups: 20-40 year old adults and infants and very young children. The impact of AIDS on young adults may be severe in both industrialized and developing countries. Throughout the world, 75-90% of HIV infections and AIDS cases are occurring among 20-40 year olds. As a result, by 1991, ina Pattern I country, the mortality rate among 25-34 year old men wili increase -7- by two-thirds due to AIDS. By 1991, in that same country, the number of deaths from AIDS among men 25-34 years old will be greater than the total number of deaths now occurring in this group from the four current major causes of death - traffic accidents, suicides, heart disease and cancer. In Pattern II countries, a scenario can be used to describe the health impact of HIV among adults. Thus, in a city of 1 million inhabitants, if 10% of the 20-50 year olds are HIV-infected, and assumming that most have been infected fairly vecently, AIDS deaths this year would raise the overall adult mortality rate by one-third. By 1991, even assuming that no additional people become infected, the expected AIDS deaths will raise the adult mortality rate by over 100%. Infants represent another vulnerable population, due principally to transmission from infected mothers, In areas where 5% of pregnant women are HIV-infected, the increase in infant mortality rate due to HIV would be approximately 13 per 1000, which is greater than the total infant mortality rate, from all causes, in many industrialized countries. In populations with higher levels of infection among pregnant women, such as 202%, increases in infant mortality of 50 per 1000 or more may be anticipated. Despite public health strategies to lower infant mortality, HIV-infection rates of 5 - 10 or 20% among pregnant women will cause infant mortality to rise. Thus, the projected gains in infant and child health from public health efforts, including the Child Survival Initiatives, may be tragically cancelled by AIDS. The concentrated impact of HIV and AIDS in young adults and infants will cause a decline in national life expectancies in many industrialized and developing countries. - 8 - Yet the effects of AIDS go far beyond the health statistics. The third epidemic relentlessly follows the first two epidemics. This is the epidemic of economic, social, cultural and political reaction to HIV infection and AIDS. This worldwide epidemic has only started, yet it is an integral part of the global AIDS problen. The societal impact of AIDS is linked to the selective loss of persons in the highly productive - in social and economic terms - years of life. In many cultures, 20-40 year old men and women not only provide economic support to children, but also to older persons for whom the family may be the only form of social security. Thus, AIDS is a particularly dangerous threat to family life - young orphans and the elderly will be left behind without support. Fear and ignorance continue to lead to tragedies: for individuals, families and entire societies, Unfortunately, as anxiety and fear cause some to blame others, AIDS has unveiled thinly disguised prejudices about race, religion, social class, sex and nationality. As a result, AIDS now threatens free travel between countries and open international communication and exchange. Further, in the process of fighting AIDS, we find ourselves re-examining many different aspects of health and social systems. Like a diagnostic test, AIDS has helped us to see the inadequacies and inequities in health systems. For to confront AIDS, we must look again and perhaps differently at social problems like prostitution of women, children and men or intravenous drug use; we must recognize long-standing weaknesses iin health care systems regarding blood, needles and invasive practices; and we find ourselves re-examining the ways we speak to, inform and educate each other about health. AIDS remorselessly highlights our most complex problems, challenges our assumptions and shakes our complacency. In seeking now to project into the future, we are limited by our incomplete knowledge. Nevertheless, using available data we estimate that approximately 150,000 new cases of AIDS will occur during this year. Therefore, the number of AIDS cases during 1988 will equal the total number of cases which have thusfar occurred worldwide. If we adopt the conservative estimate that 5 million people are infected today with HIV, a cumulative total of one million AIDS cases would be expected by 1991. Thus, the period 1988-91 will likely witness over 5 times more AIDS cases than have thusfar occurred. What then, is the potential for spread of HIV? Studies of intravenous drug users, homosexual and bisexual mén, and women prostitutes have shown clearly that if the virus is present in the community and the behaviours that transmit infection are sufficiently common and intense, HIV has the capacity to create explosive epidemics. In addition, HIV infection is lifelong, so the virus can survive in the human population if, during the lifetime of an infected person, it can spread to one other person. This suggests that HIV infection will relatively easily perpetuate itself - unless a curative treatment or a preventive vaccine is developed ~- and neither is likely in the next several years. Thus, HIV infection is likely to remain with us for the foreseeable future. The full impact of HIV will be felt over a period of decades. HIV does not need to spread rapidly in a population to have a tremendous and gradually expanding cumulative effect. The two major factors influencing the risk of individual infection are the prevalence of HIV in the community and the individual's personal behaviour. We do not have precise numbers, but it is likely that several hundred million people around the world may have behaviours which make them potentially vulnerable to infection with HIV. -10- Thus, while it has become fashionable to reassure and state that AIDS will never threaten large populations, we believe that virology, immunology, sociology and epidemiology require us to take the long view — and a more somber view. Let us remember that we are still in the early phases of a global epidemic whose first decade gives us every rational reason for concern about the global future of AIDS. II. A GLOBAL RESPONSE A global problem ~ a global response, AIDS has become a great and powerful symbol for a world threatened by its divisions, east and west, north and south. The World Health Organization has the constitutional responsibility to direct and coordinate international health work. Accordingly, WHO began to focus on AIDS once the international dimensions of the problem were discovered. However, the first major development in WHO's perception of AIDS as a global threat occurred in early 1985. Following the First International AIDS Conference in Atlanta, co-sponsored by WHO, a group of international experts were brought together to help define WHO's role in fighting AIDS. As a result, a special AIDS programme was developed in WHO headquarters. The WHO Global Programme on AIDS has developed the Global AIDS Strategy, which was unanimously approved and adopted as the foundation for global action by the World Health Assembly (May, 1987), the Venice Summit (June, 1987), the United Nations General Assembly (October, 1987) and the World Summit of Health Ministers in London, (January 1988). In addition to marshalling the support of all nations, WHO has mobilized the human and financial resources to begin the rapid implementation of this Strategy around the world, The resulting -~ ll - effort has replaced the chaotic anxiety about AIDS which was typical of 1985 with the structured, purposeful and increasingly powerful work of current national and international AIDS prevention and control activity. As of 1 April 1988, the Global Programme, in collaboration with WHO Regional Offices and country representatives, has provided technical and financial support to over 120 countries, This support is designed to help each country develop, implement and evaluate its own national AIDS prevention and control programme, in conformity with the Global AIDS Strategy. In this manner, immediate support has been provided, national plans for AIDS prevention and control have been and are being developed, and through this process the framework for national and international resource mobilization has been achieved. Now, in contrast to two years ago, Ministries of Health recognize how to plan and how to proceed to make national AIDS programmes a reality. Now, in contrast to two years ago, international development agencies recognize the broad impact and importance of AIDS and have a framework within which they can provide coordinated and useful support to national AIDS efforts in the developing world. To take just one example, Uganda's serious AIDS problem is well-known. Following a request from the Government of Uganda, a WHO team visited the country to review the situation with national officials and scientists. Shortly thereafter, nearly US$500,000 in urgent support - equipment, supplies, financial resources for educational programmes and blood screening - was provided by WHO. These financial resources came from donations to WHO by resource-rich countries, including the United States. Then, WHO helped the Government of Uganda develop a comprehensive national plan for AIDS prevention and control. Once completed, this plan was submitted to international development agencies and a meeting was organized, with WHO support, in the capital city of Kampala in May 1987. Asa result, the entire budgetary needs -12- for the first several years of operation of this plan were pledged. WHO provided professional staff to the Government, who work within the Ministry of Health to support the implementation of the national plan. This key support is part of the privileged relationship between Member States and WHO which has developed during the past 40 years of WHO's work from diarrhoeal disease control and immunization to smallpox eradication. With WHO support, the government's own capacity to fight AIDS was strengthened and the work is well underway. This pattern has already been, or is being repeated in 44 African, 38 American, 6 European, 18 Middle Eastern, and 30 countries in Asia and Oceania. In each country, the specific epidemiological and social situation varies widely, yet the common principles of AIDS prevention and control, embodied in the Global AIDS Strategy, along with the process for plan development, are similar everywhere. The Global AIDS Strategy has three objectives: o to prevent HIV infection; © to reduce the personal and social impact of HIV infection, and to care for those already infected with HIV, and with AIDS; © to unify national and international efforts. The Global Strategy is based on the following principles: o public health must be protected; o human rights must be respected and discrimination must be prevented; o we know enough now to prevent the spread of HIV, even though a vaccine is not yet available; © education is the key to AIDS prevention precisely because HIV transmission can be prevented through informed and responsible behaviour; -13- o AIDS control will require a sustained social and political commitment; o all countries need a comprehensive national AIDS programme, integrated into national health systems and linked within a global network; Oo systematic monitoring and evaluation will ensure that the Global Strategy can adapt and grow stronger as we proceed, ‘ The first objective, preventing HIV transmission, is achievable precisely because HIV is transmitted through specific individual behaviours and through readily indentified practices in the health systen. Individual behaviour is responsible for most HIV transmission. This transmission requires the active participation of two persons; therefore, the chain of transmission can be broken by the individual behaviour of either the infected or the non-infected person. For this reason, the proper focus of prevention is behaviour, not infection status. To prevent HIV transmission, we must inform and educate, to prevent the adoption of risk behaviours, or to help people with such behaviours to abandon or modify them. For this task, a four-part information and education programme will be needed: for the general public, for target groups in the population, for specific individuals and for health workers. Programmes for the general public alert and inform about AIDS; for these programmes to succeed, the media must be well informed and supportive. Yet the behaviours involved in AIDS transmission are private, hidden from others, or frankly disapproved by many societies. Since we cannot know everyone who already has or may develop risk behaviours, everyone should be given information and education about AIDS. These programmes also establish AIDS as a legitimate issue - an issue on the national agenda, worthy of discussion and action. Yet, these broad public information campaigns do not and should not -~ 14 - be expected to produce rapid or sustained behaviour change. The need to speak to an entire population - young and old, rich and poor, women and men, educated and uneducated - inevitably makes of broad public programmes a blunt instrument. Not everyone has an equal risk of HIV infection. Information and education, like any health intervention, should be targeted to where it is most needed. So, we need to know more about the private behaviours of our peoples - and while this can be done, it must be done carefully, with empathy and sensitivity - or vital information will be hidden and nothing useful will be learned. Information and education for target groups must involve their active participation in all phases of the programme ~ planning, implementing and evaluating. The alternative to working with the people you wish to educate is dismal failure. For if people believe that AIDS is a curable disease they will not use condoms. If intravenous drug users do not understand the words you use to describe needles, syringes and other drug equipment, they cannot learn prevention. If adolescents are convinced that AIDS is being used to deprive them of sexual freedom, they may refuse to listen to prevention messages and even counter-react in ways that further endanger their lives. There is a universal lessen - that “we" - whoever we are and regardless of our experience - do not know best how to educate "them". We need an alliance - a dialogue not a monologue - and there are many examples throughout the world to show that when people from target groups are asked to become involved in AIDS information and education programmes, they respond positively, sincerely - and often with great energy and creativity. -~ 15 =- Yet some individuals will need even more, and an even more personal contact - not only to inform and educate, but also to support the difficult process of behaviour change. Counselling - a key component of information and education programmes - must be organized and provided to individuals and small groups. Counselling is a more personal and intimate realm in which the person with high-risk behaviour, the person seeking voluntary HIV testing, the Hiv-infected person, their families and friends, can find information, understanding and support. The fourth information and education component is directed to health workers who must not only meet the challenges of informing and educating others, providing humane care to infected persons and ensuring the safety of practices in the health system but who must contribute actively - through personal and community leadership - to an enlightened public opinion. These are the four components of national information and education programmes; yet by themselves, such programmes are not enough. Prevention cannot live by information alone - information and education programmes can succeed only if there is a supportive social environment and if certain health and social services are made available. A supportive social environment includes tolerance and avoiding discrimination. Those who are infected, or who need help to stop risk behaviour, are also part of our society and part of us. There is no public health rationale to justify isolation, quarantine, or other discriminatory measures based solely on a person's HIV infection status or practice of risk behaviours. Preventing discrimination not only protects human rights, but helps ensure an effective AIDS programme. Discrimination and fear will undermine the entire national information and education programme; thus, discrimination itself can endanger public health. - 16 - Certain health and social services are also needed to support and strengthen people's capacity to make long-term behaviour changes, Examples of' these services include: treatment programmes for intravenous drug users so they may stop abusing drugs; long-term counselling services for infected persons, their sexual partners and their families; voluntary HIV testing services; and condoms. Good intentions are not enough. How realistic is HIV control among intravenous drug users if treatment programmes for drug abuse are not available? How likely is long-term behaviour change without long-term access to counselling, support and advice? How likely is condom use if condoms are too expensive, of poor quality, or simply not available? Thus, national efforts to prevent HIV transmission through behaviour include a four-part information and education programme; a supportive social environment; and needed health and social services. Each is essential; lack of any component will dramatically reduce the national prevention capacity. The second objective of the Global AIDS strategy is to reduce the personal and social impact of HIV infection. This means providing humane care, of a quality not inferior to that for other diseases, to those ill with HIV, and providing counselling, social support and services to those infected but not ill. Reducing the social impact also requires broad social and political commitment, the strength to reject simplistic solutions for AIDS control, and the will to ensure participation of the entire health and social sector in an active programme "Against AIDS - For Health", The third objective of the Global AIDS Strategy is to unify national and international efforts against AIDS. 1987 was the year of AIDS mobilization - at the national and global levels. There is simply no parallel to what was accomplished in 1987, -l7- In addition to supporting national AIDS plan development, implementation and evaluation, the WHO Global Programme has: * ensured that the broad social, cultural, economic and political impacts of HIV infection and AIDS are recognized by national and international organizations, including all components of the United Nations family; * facilitated and promoted biomedical, social, behavioural and epidemiological research on HIV infection and AIDS; * ensured a national and international commitment to information, to developing needed information and for the free and open exchange of this vital information; * developed guidelines regarding a series of complex and difficult policy issues, such as: HIV and international travel; social aspects of national AIDS programmes; AIDS and prisons; HIV infection and breast-feeding; neuropsychiatric aspects of HIV infection; and Screening and testing policies; * emphasized the commitment to human rights as an integral part of the fight against AIDS. The Global Programme on AIDS has now received pledges and funding from 16 countries (in alphabetical order): Australia, Belgium, Canada, Denmark, Finland, France, Italy, Japan, the Netherlands, New Zealand, Norway, Sweden, Switzerland, the Union of Soviet Socialist Republics, the United Kingdom, and the United States. In addition, funding has been received from the United Nations Development Programme (UNDP) and the Sasakawa Medical Foundation. In 1987, many countries stood forth against AIDS. These countries were characterized by strong public health leadership and frankness and openness about AIDS. Within each such country, the words “historic” and "unprecedented" were often heard, for they best described the dimensions, creativity and courage of the AIDS information and education programmes. In - 18- the centre of each such programme, Ministries or Departments of Health spoke to a larger and more interested public than on other health matters in the past and commanded the political support needed to make “openness” a reality. Before turning to the future we salute these public health leaders and their accomplishments. Information and education. In 1987 we saw evidence that heterosexual men and women, homosexual and bisexual men, prostitutes, intravenous drug users, adolescents ~ all can learn and all are capable of changing their behaviour to protect against AIDS. In 1987, we saw that against AIDS, information and education has the potential to succeed as no health education programme has succeeded before. Yet despite some early successes ~ in informing large populations about AIDS, in changing high-risk behaviours in certain groups, in establishing counselling programmes, and in training and educating health workers ~- it is too early for any sense of relief - quite the contrary. It is too soon for self-satisfaction. In 1988 - the prevention challenge is fourfold: o We must open fully the channels of communication in each society, so as to inform and educate more widely, broadly, and intensively. o We must forge - through information and education and social leadership - a spirit of social tolerance - to combat the discrimination that threatens public health. o We must establish social and political commitment to ensure that needed health and social services will be available to sustain behaviour change; the precious fruit of education must not be allowed to wither from neglect or lack of support. - 19 + o We must ensure, where this has not yet occurred, the safety of blood and blood products, injections and other skin-piercing procedures, performed within or outside the health systen. In a few short years, our technical understanding of AIDS has progressed rapidly. We know much about a virus we did not even suspect existed ten years ago. Yet perhaps more importantly, the global, social, personal meaning of AIDS is emerging rapidly, and this human understanding is the basis of our common fight. We have a global strategy against a global disease and we see that, in an extraordinary way, the fight against AIDS is a fight for Health. AIDS must be combatted on its own terms - through achieving changes in behaviours and by ensuring safe practices in the health system. Yet, through this particular disease we are led inevitably and irresistably to larger and more general problems and issues, We are committed not just against AIDS, but for Health; not just for today, but for decades to come. AIDS is a threat, but through it we may realize the promise of health promotion and the potential of primary health care, so that we may come, thereby, yet closer to the dream of health for all. Our opportunity is truly historic. We live in a world threatened by unlimited destructive force, yet we share a vision of creative potential - personal, national and international. The dream is not new — but the circumstances and the opportunity are of our time alone. The Global AIDS problem speaks eloquently of the need for communication, for sharing of information and experience, and for mutual support; AIDS shows us once again that silence, exclusion and isolation - of individuals, groups or nations - creates a danger for us all. - 20 = Against AIDS - will we dominate the disease - all three epidemics - through information, sharing and international cooperation - or will we allow the disease and the fears which it unleashes to dominate us? Against AIDS - will we prevail together, or will we split and cast into the shadows those persons, groups and nations that are affected? Information and education were the focus of the World Summit of Ministers of Health on Programmes for AIDS Prevention which was jointly organized by WHO and the Government of the United Kingdom in London from 26 to 28 January 1988. It was a truly historic landmark not only for AIDS prevention and control but also for health. Never before had such a large number of Ministers of Health met, evidencing an unprecedented political commitment to a health issue. The 148 national delegations comprised 114 Ministers who remained throughout the three-day Summit - Against AIDS, For Health. The London Declaration proclaimed 1988 a Year of Communication and Cooperation about AIDS. In the same spirit, the Director-General has announced that 1 December 1988 will be "World AIDS Day - A time for understanding” during which we will encourage organizations to tell the world what they are doing about AIDS. We look to this day as a time when people throughout the world, working as individuals and together, will see how their efforts are linked in the global struggle against AIDS and feel united in the global community. As the Summit declaration concluded: “We are convinced that, by promoting responsible behaviour and through international cooperation, we can and will begin now to slow the spread of HIV infection.” - 21 - There are already examples of excellent work that has been done, of an impact already evident, and of creativity called forth by this new challenge. The tools for prevention are available to all, They await their full, combined and vigorous use in all countries. We know how next to proceed. The Global AIDS Strategy, fully applied in every country, will start the sequence that leads - through behaviour change - to begin to slow the spread of the AIDS virus itself. Thus, in this year - 1988 - it is possible to enter a new era in our confrontation witn AIDS. This vision unites us all. The global community will win this struggle through a worldwide effort. JMM/dla: 8.4.88 STATUS REPORT ON AIDS IN AFRICA: EPIDEMIOLOGIC FEATURES Thomas C. Quinn, M.D. Senior Investigator, Laboratory of Immunoregulation National Institutes of Allergy and Infectious Diseases National Institutes of Health Testimony to the President’s AIDS Ccmmission on the Human Immunodeficiency Virus Epidemic April 11, 1988 Within a relatively brief period, AIDS has become a global pandemic with over 80,000 cases officially reported to the World Health Organization from 132 countries. | Since many other cases remain unrecognized and unreported, it is estimated that over 150,000 cases of AIDS have probably occurred worldwide with an additional 500,000 individuals with AIDS-related conditions, and an estimated 5-10 million individuals affected with the etiologic agent of AIDS - the human immunodeficiency virus or HIV. It is this latter pool of asymptomatic infected individuals which represent the human resevoir of HIV infection from whom thousands of additional cases will develop and from which millions of other individuals may become infected f ollowing sexual, parentera! contact with asymptomatic carriers. Unfortunately, the vast majority of both asymptomatic and symptomatic infected individuals reside in developing countries where the economic and social impact of this disease will have its greatest impact. Because of the limited financial resources in these countries, the challenge to control this epidemic will be greatest within those areas where traditional efforts to control other infectious diseases for vaccines or other measures have always waned behind more technologically advances countries. Due to the present lack of effective vaccine or curative therapy, it is evident that HIV infection and AIDS will continue to escalate throughout all areas of the world, but it is clear that the greatest increase will be in developing countries where the means to control this disease may be more limited. Five minutes is-not enough time to sufficiently review the current status of HIV _ Infection in Africa, a problem which has already claimed thousands of lives, and where an estimated 3-5 million people are already infected with this potentially fatal virus. Consequently, I have provided the Commission with several recent reports which review in detail the present status of HIV infection and AIDS within some African countries. | will briefly review the salient points of these papers with specific attention on the distinctive epidemiologic features of HIV infection in Africa. Presently 40 of 45 African countries have reported over 9,000 cases of AIDS to the World Health Organization. However, it is generally accepted that thousands of additional cases remain unrecognized and unreported due to inadequate resources for comprehensive surveillance. Nevertheless, the impact of HIV infection can be readily acknowledged by the extremely high seroprevalence rates of HIV in selected populations throughout Central Africa and neighboring countries. HIV infection rates range from 5%- 15% among healthy blood donors, 2-8% among women attending prenatal clinics, 15-25% among men attending sexually transmitted disease clinics, and 27-90% among female prostitutes. In one city in Central Africa where surveillance for AIDS cases has been in place for the last 3 years, it is estimated that AIDS cases exceeded 200 cases/100,000 population in 1987. Even with these disturbing numbers, it is probable that these are minimal estimates since the data reflect only recognized and reported cases of AIDS in several hospitals within the city. Both AIDS surveillance and HIV serologic data can be utilized to reflect the basic epidemiologic trends of AIDS in Africa. As in developed countries, AIDS in Africa primarily affects young and middle aged persons. However, in contrast to the United States, AIDS cases in Africa are equally distributed among both men and women with a sex ratio of 1:1.3. The sex and age distribution of HIV infection in Africa reflects patterns seen with other sexually transmitted diseases in which the incidence and morbidity rates are higher among younger women and slightly older men. These seroprevalence data strongly suggest that HIV infection is predominately common in sexually active age groups and that it is predominately transmitted sexually since there is insufficient evidence for IV drug abuse or bisexuality to explain this distribution of cases and infection. Longitudinal studies on HIV seroprevalence demonstrate the annual incidence rates of HIV infection among selected populations in Africa. Among female prostitutes in Nairobi, Kenya, the rate of infection rose from 4% to 80% over a 6 year period. Among men attending a sexually transmitted disease clinics, the rate rose from 1% to 18% during the same time period. Similarily, among the general population such as pregnant women attending a prenatal clinic, the rate rose from less than 1% to 3% in Nairobi, and from 2% to 8% in Kinshasa, Zaire. Rapid incidence rates in urban areas as compared to relatively stable rates of infection in some rural areas as recently documented in a remote village in Zaire strongly suggest that rapid urbanization associated with both economic and social changes have played a major role in the rapid spread of HIV infection among certain populations. Regardless of geographic region, HIV appears to be transmitted through three routes, sexual, parenteral, and perinatal. There are important regional variations which exist within each of these transmission categories. In contrast to North America and Europe where the predominant sexual mode of transmission has been seen among homosexual men, heterosexual transmission is far more common in Central Africa. Numerous studies have identified the following risk factors associated with heterosexual transmission of HIV in Africa, and to limited extent in the U.S. These include the number of sexual partners, sex with a prostitute, being a prostitute, or being a sexual partner of an infected individual. Whereas anal receptive intercourse is a prominent sexual behavior that is associated with HIV infection among homosexuals in the U.S., this behavior does not appear to play any specific role in HIV transmission in Africa. Cofactors, such as sexually transmitted diseases which induce genital ulceration, are significantly associated with HIV seropositivity. In nearly every study performed among individuals attending STD clinics in Africa, HIV infection was independently associated with the presence or history of genital ulcers. In one recent study, the rate of seroconversion following sexual contact with an HIV infected women was 8% for men with a recent history or clinical evidence of genital ulceration. With HIV seroprevalence rates of 2-8% among pregnant women in Central Africa, increasing evidence of perinatal transmission is being documented. Perinatal transmission of HIV may occur in utero through transplacental passage of HIV, natally at the time of delivery, or postnatally possibly through breast feeding or other routes. Efficiency and risk factors associated with perinatal infection remain unknown and prospective studies” are currently underway in several African countries. Preliminary data from Kinshasa, Zaire and Nairobi, Kenya suggest that approximately 40-50% of children born to HIV antibody positive mothers are infected perinatally. In one study, approximately 22% of children born to HIV seropositive mothers had died by 12 months of age compared to only 3% in the control group born to HIV seronegative mothers. It is thus apparent that HIV infection is an important cause of premature birth and perinatal death in Africa and that transmission from mother to infant appears to be strongly correlated with the clinical stage and immunologic competence of the mother. The importance of blood transfusions and HIV transmission in Africa is exemplified by the 6-18% seroprevalence rate among blood donors in Uganda, Rwanda, Zambia, and Zaire. The impact of this mode of HIV transmission is substantial. For example, approximately 8,900 blood transfusions were given to children with malaria at one hospital in Kinshasa, Zaire in 1986. Since the HIV seropositive rate among blood donors was shown to be 6.3%, one can estimate that 561 seropositive blood donations were given to children with malaria in this hospital setting alone. With assistance from international health agencies, HIV screening via the development of a rapid blood test has been utilized to prevent further transfusions with HIV positive blood. Unfortunately, many other areas of Africa still do not have the resources or assistance from other countries to implement such basic preventative measures of HIV infection. Exposure to unsterilized needles used for medicinal purposes or rituals may also contribute to HIV transmission, but its contribution in accelerating the HIV epidemic in this region has been difficult to quantify. Additional studies are warranted to delineate the attributable risk of HIV infection following exposure to blood contaminated needles and syringes. In review of studies on household transmission and other epidemiologic studies that have been performed in this area, it is evident that there is no evidence for casual contact transmission, or transmission via insect vectors. Finally, the AIDS situation in Africa has been compounded by the appearance of HIV-2 infection in countries of West Africa. Identified in 1986, this related human retrovirus appears to be associated with clinical features ranging from asyptomatic infection to AIDS similar to that described for HIV-1, the predominant strain in the United States. Seroprevalence rates for HIV-2 among residents of West Africa range from 2% to a high of 25% among female prostitutes. Transmission patterns of HIV-2 appear to be essentially identical to that described for HIV-1. Recent studies have identified evidence of HIV-2 infection in Africa, South America, and more recently in the United States. Intensive studies are urgently needed to examine the natural history of this related retrovirus and to determine its pathogenetic role in causing AIDS in West Africa. In summary, it is evident that HIV infection and AIDS have become a major health problem for Africa. In some urban hospitals, approximately 35% of the hospitalized adults and 20% of the hospitalized children are known to be infected with HIV. With limited financial resources in many of these areas, the efforts to control this virus will require an unprecedented coordinated international effort involving all countries. The challenge to control HIV infection is great for all countries, but perhaps even greater for Africa where a greater proportion of the population is already infected, and where the general social, political, and economic context of modern Africa may limit the effectiveness of such control programs. Only an intensive effort by the international health agencies, scientific experts, politicians, and the world population at large will be required to combat this disease. Thank you very much for your attention and I will be glad to answer your questions at this time. April 1988 THE DEMOGRAPHIC IMPACT OF AIDS IN AFRICA John Bongaarts The Population Council New York Background paper prepared for the Presidential Cammission on the Human Immunodeficiency Virus Epidemic According to the most recent United Nations projections, the population size of Africa is expected to grow from 479 million in 1980 to 1.62 billion in 2025, making Africa the fastest growing continent in the Third world.} Unfortunately, these projections are not reliable because they do not take into account the effects of the AIDS epidemic. In this paper an attempt will be made to asses to what extent the demographic future of Africa will be changed by the rapid spread of HIV infection and AIDS. In addition to estimating the rise in the death rate due to AIDS, the impact of the epidemic on the population growth rate and on the population age structure will be examined. These two demographic variables were selected because answers are sought for the following questions: (1) will the AIDS epidemic stop population growth or perhaps cause a reduction in population size in significant parts of Africa, and (2) given that the epidemic primarily affects sexually active adults, will the epidemic produce an age structure consisting largely of the young and the old with a gap in the central age Groups? The demographic impact of AIDS will, of course, vary widely among countries. The largest effect will be seen in populations in East and Central Africa where the epidemic is most severe. On the other hand, in some other countries, e.g., in North Africa, the epidemic may affect few people and the demographic effect may be negligible. A full assessment of future demographic change in Africa would therefore require analyzing separately the course of the epidemic in different countries. No attempt will be made to undertake such a comprehensive country specific analysis. Instead, attention will focus on a computer simulation of the epidemiological and demographic trends in a population with characteristics similar to those of certain countries in Central Africa. Based on the results of this exercise, a few tentative conclusions will be drawn for the African continent as a whole. Before proceeding, it is necessary to describe the key features of the computer simulation model used in the subsequent analysis. Modeling the demographic impact of the AIDS epidemic Determining the future course of the HIV/AIDS epidemic and its demographic impact is a complex matter because a wide variety of behavioral, epidemiological and demographic factors affect the course of the epidemic. A number of investigators have built mathematical models for forecasting the spread of HIV and AIDS as well as for other purposes (e g., intervention assessment). Numerous models ranging in complexity from relatively straightforward extrapolations of past trends to very detailed computer simulations have been or are being constructed.* These models typically include one or more of the following key factors and relationships: High risk behavior HIV infection ! AIDS onset Death ! Demographic impact High risk behavior, such as sexual contact with a prostitute or homosexual, or sharing of contaminated needles among IV drug abusers, puts individuals at risk of infection. Following infection, individuals often remain asymptomatic for a number of years but eventually most infecteds get AIDS. The incubation time between infection and the onset of AIDS for adults is, on average, probably more than 8 years.2 = Even though some AIDS patients survive as long as five years, a majority of AIDS cases die within 2 years after the onset of the disease and virtually all die eventually from AIDS.4 The resulting rise in the mortality rate then affects the population's growth rate, age structure and a variety of other demographic variables. Since existing models were not suitable for present purposes, a new model was constructed. The details of this model are presented elsewhere? but it is useful to summarize the model's key features: - High risk behavior. Since the current version of the model deals only with Africa, homosexuality and IV drug use are assumed negligible. Heterosexual contact is therefore the main route of HIV transmission. To take account of heterogeneity in sexual behavior, the sexual contact rate is assumed to vary with age and marital status, and the population is stratified into groups with different levels of sexual activity. At the core of the epidemic are prostitutes (or other females with high sexual mobility) and their male partners. These two groups infect one another, thus producing a self-sustaining epidemic. From these core groups infection spreads to others, primarily because the male partners of prostitutes have sexual contact with their spouses or other females (polygamy is common in parts of Africa). Finally, infected mothers can infect their newborns either in utero or at birth. HIV infection. The probability of infection in a given period :s assumed to depend on the frequency of sexual contact, the type and infectiousness of the contact group (having sex with a prostitute is more risky than having sex with one's spouse), and the rate of partner change (e.g., marital disruption and remarriage). The infectiousness of a partner is a function of gender (male to female transmission is more efficient than the reverse), cofactors (e.g., genital ulcers and cther sexually transmitted diseases are believed to facilitate infection), stage of disease (individuals with AIDS or symptomatic HIV disease such as ARC are most infectious) and the use of condoms. AIDS onset. The incubation period is a critical determinant of the demographic impact of the epidemic. In the model this highly variable incubation interval is described with a gamma distribution. The mean of this distribution is 9.3 years and 90% of infected individuals are assumed to be at risk of contracting AIDS. These parameters were obtained by fitting a cumulative gamma distribution to observed proportions progressing to AIDS in a San Francisco City clinic cohort of homosexuals which is the longest available prospective study. © Figure 1 presents the observed and model estimated proportions of infected individuals progressing to AIDS by time since infection. Death from AIDS. The interval between the onset of AIDS and death is assumed to be exponentially distributed and all AIDS cases are assumed to die eventually. ’ The average survival time for an AIDS patient is assumed to be 1.5 years. - Derographic impact. Once the excess mortality attributable to AIDS is estimated for males and females in different age groups, a standard Gemographic methodology is available for projecting the demographic effects of the AIDS epidemic. By far the most widely used demographic technique is the so-called cohort component method.’ ‘the results presented below are based on this approach. Projections are made for Single year age and time intervals. In the discussion of HIV infection routes, only sexual and perinatal transmission have been mentioned thus far. Other modes of HIV transmission do exist in Africa, but they are believed to contribute enly a minority of infections. Piot and Carael estimate that perhaps 5 to 10 percent of HIV infections among adults are due to transfusions with infected blood.? This percentage is probably higher among infected infants and children. In addition, injections with contaminated needles ( e.g., for vaccinations) may cause some infections although this is difficult to document conclusively. These facters are also included in the medel, but their effect is assumed to decline over time, because inexpensive screening tests will make it possible to reduce infection from blood transfusions to mich lower levels in the not too distant future. Simulation of a severe African epidemic To examine the evolution over time of a severe AIDS epidemic, a computer simulation was carried cut .in which behavioral, epidemiological and demographic input parameters were set at levels considered to be representative of countries with the highest current levels of HIV infection (e.g. Uganda, Rwanda). Each simulation covered a 25 year span, reuchly corresponding to the peried 1975 to 2000. The analysis is limited to a 25 year interval because the computer simulations indicate that virtually all cf the changes in key demographic and epidemiological variables (e.g., the population growth rate and the prevalence of HIV) occur in the first 25 years after the start of the epidemic and that following this initial period a relatively stable state is reached. For simplicity this state will be referred to as an equilibrium, even though minor changes in demographic and epidemiological variables continue to occur. Two key assumptions were made in all simulations presented here: (1) no effective medical treatment of the disease will became available before the end of this century and (2) ro behavioral change will occur. It is quite possible that either or both of these assumptions are too pessimistic, but alternatives will not be examined. Figure 2 plots model estimates of trends in HIV prevalence for the tctal adult population as well as for prostitutes and their male partners. A lack of reliable time series of observation of seroprevalence makes it difficult to determine whether these trends are accurate. However, it is worth noting that, assuming the epidemic starts in 1975, the model predicts a HIV prevalence of 11 percent for all adults in 1987 and much higher levels for prostitutes and their clients. These estimates are consistent with observed seroprevalence rates in the most heavily affected countries in Central Africa.t1 rf the projection from 1987 to the year 2000 is approximately correct, seroprevalence will reach double its current level in the year 2000, leveling off at 22 percent of all adults. Figure 3a plots the trend in the annual population growth rate as estimated in this simlation. During the 25 year span the annual growth rate dreps from 3.0 to 1.9 percent. Clearly, the effect of the enidenic is substantial, but the population growth rate remains positive. For comparison, Figure 3a also plots the trend in the growth rate that is expected to occur in the absence of an AIDS epidemic. In that case the growth rate is projected to rise very slightly. To examine the demographic determinants of these growth rate patterns, Figure 3b plots the corresponding birth and death rate trends. In the absence of AIDS the birth rate is expected to decline from 48 to 44 and the death rate from 18 to 13 (according to the latest U.N. population projections these levels are typical for Central and East Africa).12 Since, in the absence of migration, the growth rate equals the difference between the birth and death rates at each point in time, these trends imply a rise in the growth rate from 3.0 percent to 3.2 percent as shown in Figure 3a. In the presence of the epidemic only a slightly larger decline in the birth rate is projected, but the death rate is estimated to rise to 26. The related decline in the population growth rate from 3.0 to 1.9 percent per year is therefore almost entirely attributable to the large rise in the death rate. Demographic effects of epidemics of varying sizes As noted, the size of the HIV/AIDS epidemic will vary greatly among African countries because their behavioral and epidemiological characteristics differ. To examine the demographic effects of different epidemics, a set of simulations are carried out in which key behavioral parameters were modified so that the seroprevalence at the end of the 25 year projection period varied from 0 to 30 percent. The result of this exercise are presented in Figure 4. The relationship between the size of the epidemic (as measured by the equilibrium seroprevalence) and the growth and death rates at the end of the projection period are nearly linear: for every 10 percent increase in seroprevalence the growth rate in the year 2000 is reduced by 0.6 percent and the death rate rises by virtually the same amount. The population distribution by age at the end of the 25 year projection interval is plotted in Figure 5 for a range of epidemic sizes. The most interesting finding is the relative invariance of the age structure for different epidemics. A full explanation of this finding is complex and beyond the scope the this paper. It suffices to note that, at least toa demographer, this result is not surprising, because it is consistent with the theory of quasi-stable populations.18 Frem a purely demographic viewpoint the impact of AIDS is the reverse of that observed in large parts of the Geveloping world between the 1940's and the 1970's. During this period the death rate in many developing countries fell sharply while birth rates remained virtually constant. Under these circumstances the population growth rate increased substantially but the age structure remained relatively invariant (i.e., quasi-stable). The AIDS epidemic's main demographic effect is to raise the death rate of adults and children under age 5 (while leaving older children and teenagers relatively unaffected). According to quasi- stable population theory, one would not expect a drastic change in the population age structure as a result of this pattern of AIDS mortality. The discussion up to this point has focused on country level demographic and epidemiological indicators. Within country variations has been neglected even though cities often have much higher HIV prevalence rates than rural areas. Since it is not inconceivable that seroprevalence in some African cities might exceed 30 percent at some time in the future, one might well ask whether population growth rates of cities might tum negative as a consequence of the AIDS epidemic. The answer again is that this is very unlikely because urban growth rates in Africa are typically 5 or 6 percent per year.14 This is much higher than the natural rate of growth, due to migration from rural to urban areas. As a consequence, implausibly high HIV seroprevalence rates would be required to stop population growth in the cities, unless migration is reduced. Conclusion The main conclusion from this analysis is that, given current Gemographic conditions in Africa, population growth rates of countries in this region will remain substantially positive if the sizes of the epidemics remain within the range from 0 to 30 percent HIV prevalence. The simlation of the severe epidemic summarized in Figures 2 and 3 suggest that few if any countries in Africa will exceed this range. A lack of information about the rate of the spread of HIV and its determinants in specific countries makes it impossible to accurately forecast the size of the epidemic in individual populations. HIV prevalence in Africa as a whole could well. be substantially below 10 percent by the year 2000. In that case Africa's population growth rate will be reduced by less than half of one percent. Although this demographic effect is modest, a large mmber of AIDS deaths will occur. A rise of 0.5 percent in the death rate of Africa in the year 2000 would result in an additional 4.4 million deaths per year. In the most severely affected countries the death rate could increase by as much as 1.5 percent with disastrous effects on the health care system, the economy and on the fabric of society. References 1. United Nations, World Population Prospects: Estimates and Projections as Assessed in 1984, Population Studies No. 98. Department of International Economic and Social Affairs, New York. W. Morgan and J. Curran, "Acquired immunodeficiency syndrome: current and future trends," Public Health Reports, 101, 459, 1986, provide extrapolations for the U.S. Examples of computer simulations are: R. Ray and R. Anderson, "Transmission dynamics of HIV infections, Nature, 326, 137, 1987, and K, Dietz, "The dynamics of the spread of HIV infection in the heterosexual population" in of the Community Workshop on Statistical Analysis and Mathematical Modeling of AIDS, Bilthoven, December 1986, G. Medley, et. al., "Incubation period of AIDS in patients infected via blood transfusion," Nature, 328, 719 (1987). R. Rothenberg et. al., "Survival with the acquired immunodeficiency syndrome," The New England Journal of Medicine, 317, 1297 (1987). J. Bongaarts, "A model of the spread of HIV infection and the demographic impact of AIDS" forthcoming in Statistics in Medicine. N. Hessol et. al. "The natural history of human immunodeficiency virus infection in a cohort of homosexual and bisexual men: a 7-year prospective study." in: Abstract Volume of III International Conference on AIDS, Washington, D.C. 1987. “W. Morgan and J. Curran "Acquired immunodeficiency syndrome: current and future trends," Public Health Reports, 101, 459 1986. 10 10. ll. H. Shryock and J. Siegel, The Methods and Materials of Demography, U.S. Bureau of the Census, U.S. Government Printing Office, Washington (1973). A. Piot and M. Carael, see ref. 3, J. Bongaarts, see ref. 6. T. Quinn et. al., AIDS in Africa: An epidemiological paradigm," Science, 234, 955 (1986); P. Piot and M. Carael, "Epidemiological and sociological aspects of HIV infection in developing countries," British Medical Bulletin, 44 (1988, in press). United Nations, see ref. 1 H. Shryock and J. Siegel, see ref. 9. United Nations, see ref. 1. ll 80 7 of infected cohort 60 40 20 0 POoIc! L —- = Cumulotive gamma distribution with mean =: 9.5 years (} = Estimotes from San Francisco City clinic cohort L LY . Me P “ a A = ae oe te ee tt 0 2 4 6 8 10 Years since infection Figure 1: Cumulative gamrna distribution fitted to observed cumulative proportions of infected cohort progressing to AIDS, by duration since infection (observations from Hessol et al, 1987) see eee Prostitutes 80 r Percent infected ao with HIV zgb a / Male partners 60 Fr of prostitutes ot / a 40+ / 30 F All adults 20 10 0 0 3 10 15 20 29 (1975) (2000) Duration of epidemic in years Figure 2: Estimated HIV prevalence rates among all adults, prostitutes and their male partners in a hypothetical model projection of an African epidemic. HPR --—--— No AIDS epidemic Epidemic reaching 22% prevalence in year 25 4r 6r Birth rate % % — OO er er OO Ee yoat Population growth rate voar - —_{ rr OT 4r SF ~~ 3 Ss 2 be —_ a 2+ a Death rate ue ——eney ee — ae 4 — 1 a oO 1 i iL. i wil. o 4. 4 i i i 0 6 10 16 20 26 0 5 10 15 20 26 (1076) Duration of epidemio In years (2000) (1976) Duration of epidemic In years (2000) eTi BP PTIae Figure 3: Projected trends in the annual population rate and in the birth and dwath rates in the presence and absence of an AIDS epidemic. Percent per year EPGRAT 4 44 Percent Population | per Growth Rate Death Rate year ae — | _— S eo ee o 2 a ee - + 1 l L 0 0 10 20 30 HIV prevalence after 25 year epidemic (percent) Figure 4: Estimated population growth rate and death rate at the end of a twenty-five year HIV/AIDS epidemic, as a function of the severity of the epidemic. Percent of total population 15 10 eadelp ee en en me . ly en (le Lo fe ON I-A) fia iy Lat 1 I ‘|. - ra ave rf tis (PLS 50 b 0 40 BO go OO PS pt Pps y er or 0 A ied Of Tp 10 Age Estimated age distetulion of Ue fos feataticna Ul toe end Gla uo year eprlcrike by side ul Whe Gptede trate Size of epidemic (HIV prevalence al 25 years) April 1988 A MODEL OF THE SPREAD OF HIV INFECTION AND THE DEMOGRAPHIC IMPACT OF ATDS Jehn Bongaarts The Population Council The acquired immunodeficiency syndrome, which was first recognized in 1981, has spread to over 125 countries and is now considered a critical global health problem (Mann 1987). Since the health and socio-economic consequences of a further rapid spread of AIDS are potentially very serious, there is an urgent need for more accurate forecasts of the future course of the epidemic. Most existing projections of the incidence of AIDS are based on extrapolations from past trends in reported mmbers of AIDS cases (Morgan and Curran 1986, McEvoy and Tillet 1985). While this approach is likely to provide reasonable results for the short run (e.g., a few years), long-range forecasts have to take into account the complex dynamic processes of HIV transmission and progression to AIDS. A number of investigators have built or are in the process of constructing such detailed models (Anderson et al. 1986, Colgate et al. 1987, De Gruttola 1987, Dietz 1987, May and Anderson 1987, Knox 1986). Under certain simplifying assumptions, analytic solutions to the differential equations on which these models are based can be found (Anderson et al. 1986), but in general computer simulation is necessary. Given the current uncertainty about many of the parameters in these models, their forecasts cannot be considered highly reliable. With the expected rapid growth in understanding of the epidemiology and natural history of the disease, however, models will become increasingly more reliable and useful. One of the main objectives of the model presented in this paper is to project, for periods up to one or more decades, the annual incidence and prevalence of HIV infection and AIDS, as well as the number of AIDS deaths, in a population with given epidemiological, behavioral, and demographic characteristics. In addition, the model projects the impact of AIDS ona variety of demographic variables, including the population size and growth rate, age and sex structure, birth and death rates, life expectancy, and mortality rates of infants and adults in different age groups. An important and directly policy-relevant application of the model is expected to be the assessment of the relative impact of various interventions to stop or slow the spread of AIDS. For example, in an African setting the model could compare the effects of changes in sexual behavior, screening of blood donors for HIV infection, and the elimination of various co-factors that facilitate HIV transmission. Once affordable and effective medical treatment becomes available, its impact can also be evaluated. The paper is divided into three sections. A brief overview of the model is presented first. This is followed by an exposition of the model's mathematical structure. In the final section a hypothetical projection is made for a population with the African pattern of disease transmission. AN OVERVIEW OF THE MODEL A set of epidemiological submodels for various routes of HIV transmission in different sexual behavior groups forms the core of the overall model. ‘These epidemiological components are integrated within a demographic framework that provides estimates of key variables (e.g., the number of individuals in various age groups and the number entering and leaving these age groups) for the duration of the projection. These Gemographic data are essential for an accurate assessment of the size of the epidemic because population change can be rapid, particularly in developing countries. The d ic framework Following an approach that is widely used in demographic projections, the AIDS model divides a population into its cohort components. Each group of individuals born in a given year (a birth cohort) is followed from birth to death, and all events of interest are recorded over the course of the life cycle. Since projection results are desired for whole populations in successive future calendar years, the experience of the different cohorts is examined together at each point in time. Figure 1 gives the Lexis diagram that plots the life lines of successive cohorts by age ard calerdar tine. (These lines are drawn at 45° angles because, for each additional calendar year, cohorts age one year, making the scales of the x and y axis identical.) To obtain estimates of key variables (e.g., mumber of HIV infections or AIDS cases) in a given year t, it is necessary to combine the results from all cohorts alive at that time. Since single-year cohorts are used in the model, the total mumber of cohorts that have to be taken into account in a given year equals the maximum number of years lived by individuals. However, the course of the epidemic among the elderly is of little interest, and in practice the maximm age can be set at, say, age 65.1 The cohort method is routinely used by demographers to project the size and structure of populations by age and sex, as well as a variety of other demographic indicators. Projection periods can extend to a century or more. Organizations such as the United Nations (1986), the World Bank (1986) and the U.S. Bureau of the Census (1986) regularly publish population projections for most countries and regions of the world. ‘These existing projections are a readily available source of demographic parameters needed to apply the AIDS simulation model in specific countries. The AIDS forecasting model duplicates the standard demographic projection methodology and can estimate all demographic variables produced in such projections, taking into account the impact of the AIDS epidemic. An important reason for selecting the cohort approach is that it permits any of the parameters in the model to be age specific. This is necessary because many ,of the epidemiological, behavioral, and demographic determinants of the AIDS epidemic are age dependent. For example, sexual activity typically begins in the mid- or late teens, reaches a peak in early adulthood, and declines thereafter with age. Other variables included in the model, such as the incubation period, non-AIDS mortality, and the probability of giving birth, also vary with age. Heterogeneity in sexual behavior Sexual behavior, and hence the risk of HIV infection, varies widely among subgroups within a population. Groups with the highest risk include homosexuals and prostitutes, while individuals in monogamous unions are not at risk if both partners are faithful and neither was infected at the initiation of the partnership. To take account of this heterogeneity in sexual activity, each cohort is divided into the following strata: Males 1) homosexuals (including bisexuals) 2) heterosexuals with high sexual mobility (e.g., clients of prostitutes) 3) partners in monogamous unions 4) sexually inactive males Females 1) monogamous partners of bisexual males 2) women with high sexual mobility (e.g. prostitutes) 3) monogamous partners of sexually mobile males 4) partners in monogamous unions 5) sexually inactive females It is possible, and in same applications desirable, to stratify further to take into account variation in sexual activity rates within these subgroups (e.g., among homosexuals) . Figure 2 indicates the different routes for sexual transmission of HIV. The importance of each of these routes varies among populations. For example, in the United States and Europe transmission from homosexual to homosexual is the principal source of HIV infection. In sub-Saharan Africa, on the other hand, homosexual activity plays a negligible role and HIV is transmitted primarily by highly mobile heterosexuals. In either case, however, most of the other sexual transmission routes can contribute significantly to the overall incidence of HIV infection. The distribution of individuals among the different sexual activity groups changes as each cohort ages. After being sexually inactive until early adulthood, cohort members enter one of the sexual behavior groups and over time may switch between them. In addition to keeping track of the Gistribution of individuals among these groups, the model also allows the rate of sexual activity (i.e., the frequency of contact) to change as the cohort ages. Infection status All individuals in each cohort and sexual behavior group are assigned an infection/disease status. Figure 3 gives the flow diagram for the different states included in the model. Immediately after entry into a risk group individuals are uninfected. A distinction is made between two uninfected statuses: susceptible and nonsusceptible to HIV infection. This distinction is made on the basis of evidence suggesting that a proportion of individuals in some populations may have genetic characteristics that protect them from the risk of infection even if they engage in high risk behavior such as having sexual contacts with infected partners (Eales et al. 1987). Since other recent studies have not been able to confirm this finding (Delange et al. 1987, Lefrere et al. 1987), it seems likely that such a genetic trait, if it exists at all, will protect at most a small fraction of a population. Exposure to risk of infection among susceptible individuals eventually leads to infection with HIV. In the model, infected individuals are divided into two classes, one that is not at risk of developing AIDS and the other that, after a variable incubation period, will get AIDS. Until fairly recently it was generally believed that a majority of HIV-infected individuals might fall in the first of these classes, but data from the longest prospective studies now strongly suggest that most infected individuals will progress to AIDS eventually (Hessol et al. 1987). Once AIDS develops, death soon follows. The average survival time for AIDS patients is only about 1.5 to 2 years. Although most mortality attributable to an HIV epidemic occurs among AIDS patients, mortality risks are also elevated among HIV infected individuals (who may have ARC or PGL) because their compromised inmmme system raises their risk of dying from other diseases. The model can take this effect into account. (For simplicity, Figure 3 does not show that individuals in all states are continuously at risk of dying from causes not related to AIDS or HIV.) The principal determinants of the speed of progression through the infection states are the infection rate among susceptible individuals and the duration and distribution of the incubation period. The probability of infection through sexual contact is assumed to depend on the frequency of these contacts, the infectiousness of partners, and, for some strata, the rate of partner change. The incubation period is described by a gamma distribution. Other sources of HIV infection The primary mode of transmission considered here is sexual, but there are several other transmission routes that must be included ina comprehensive model: - infected women who become pregnant can infect their newborns either in utero or at birth (and perhaps by breastfeeding as well) - sharing of needles among IV drug users - blood transfusions with infected blood - medical injections with contaminated needles, e.g., for vaccination MATHEMATICAL STRUCTURE OF THE MODEL The set of differential equations describing the dynamics of disease status progression (Figure 3) will be presented first. To simplify the notation, subscripts for cohort and stratum will be deleted, and mortality risks are ignored for the moment, except for AIDS cases. The following variables are defined for a group of individuals in the same cohort and sexual behavior stratum: P(t) = total number of individuals in all disease states (at time t) P,(t) = mmber of uninfected nonsusceptible individuals P(t) = mumber of uninfected susceptible individuals P3(t) = mmber of infected individuals at risk of developing AIDS P4(t) = mumber of infected individuals not at risk of developing AIDS Ps(t) = number of AIDS cases t = time in months e(t) = mmber of individuals entering the risk group per month i(t) = mmber of HIV infections per month a(t) = mmber of new AIDS cases per month d(t) = mimber of AIDS deaths per month r(t) = rate of HIV infection among susceptibles (per month) m = death rate among AIDS cases (per month) Py = proportion of e(t) that is susceptible P2 = proportion of i(t) that can develop AIDS The differential equations for the compartment model summarized in Figure 3 are: ap oF (0) (1-p,) e(t) (1) aP. (t) 20" = p, a(t) - A(t) at 1 (2) AP. (t) 3\" = p, i(t) - a(t) aC (3) aP, (t) 4\ = (l-p,) i(t) at 2 (4) aP_(t) 5 = a(t) - a(t = a(t) (t) (5) with i(t) = x(t) P(t) (6) a(t) = m Ps(t) (7) The only missing equation is the one for a(t). One option for the estimation of a(t) is the convolution integral Xn a(t) = po J i(t - x) Z(x) a&&x (8) ° where Z(x) = distribution of the incubation interval x, (xX, = maximum value for x) This equation is used in several existing AIDS forecasting models and is the most direct way to calculate a(t). (A still simpler approach which assumes infected individuals to be at constant risk of progressing to AIDS must be considered unacceptable, because it implies an exponential distribution of the incubation time. This distribution actually has a very different shape as will be shown later.) However, equation (8) has drawbacks. First, no distinction is made between different stages of the disease among infected individuals. Since infectiousness varies strongly with infection stage, reaching a maximum shortly before the onset of AIDS, it is highly desirable to differentiate between stages. Second, by including equation (8) the model is no longer a Markovian one. This makes computer simulation more complex since the number of past infections have to be stored in the computer's memory for all cohorts and strata. To address both these problems, a different approach is proposed here. Instead of having one homogeneous infectious state with population P3(t), this state is divided into substates corresponding to infection stage. Several systems exist for classifying persons infected with HIV (U.S. Centers for Disease Control 1986, Redfield 1986). For present purposes, four infection stages are identified: a. Asymptomatic, normal immme function b. Asymptomatic, impaired immune function (e.g., reduced Ty, lymphocyte count) c. Persistent Generalized Lymphadenopathy (PGL) a. AIDS Related Complex (ARC) 10 ce ee Although the other systems are more detailed, this simple classification into four infection substates is likely to capture the key aspects of disease progression that are necessary for modeling the incubation process. All individuals are assumed to progress through each of the four states. Let Pe(t), P7(t), Pg(t) and Pg(t) be the numbers of individuals in each of these four substates and let kg, ky, Kg, kg be the monthly risks of exiting from these states. P¢(t) Py (t) Pg (t) Po (t) HIV AIDS Infection te le Onset ———*_ Asymptomatic] Asymptomatic PGL ARC }————_> P2 i(t) (a) (b) | a(t) The differential equations describing the dynamics of progression through the four substates are e =p, i(t) - k, P(t) — =k, P.(t) - k, P,(t) = =k, Pi(t) ~ ky Py (t) 2 = ky Pa(t) ~ Ky Pa (t) with a(t) = kg Po(t) P3(t) = Pe(t) + Py(t) + Pg(t) + Po(t) il (9) (10) (11) (12) (13) (14) The waiting times in each of the substates are exponentially distributed random variables, with means equal to 1/kg, 1/k7, 1/kg, 1/Kg, respectively. The distribution of the incubation time (i.e., the time required to progress through all four substates) is now equal to the convolution of these four exponentials which yields a rather complex expression. However, if kg = ky = kg = kg = k, it is easily shown that the incubation period is described by a gamma distribution. (To prove this the Laplace transforms of each of the four exponential distributions are mitiplied, yielding [k/k + s]4. The inverse Laplace transform of this expression equals a gamma distribution with shape parameter 4 and scale parameter k). That this distribution provides a good fit to an observed pattern of progression to AIDS in a cohort of infected individuals is demonstrated in Figure 4 with data from the San Francisco City Clinic Cohort Study. The best fit for the gamma distribution was obtained with k = 0.43, which corresponds to a mean incubation period of 9.3 years ( = 4/0.43). This is close to the mean of 8.9 years estimated by De Gruttola (1987) who fitted a Weibull distribution to the same data. Also plotted in Figure 4 are the model estimates of the proportions of an infected cohort that are in each of the substates (asymptomatic, PGL, ARC) by time since infection. The advantages of the proposed approach to modeling the progression from infection to AIDS are significant. It is now possible to assign different levels of infectiousness to individuals at different stages of infection, and other relevant variables such as frequency of sexual contact and condom use can also be varied by stage. An important practical implication is that the entire model can be simiated as a Markov chain which allows relatively simple and fast implementation on micro computers. 12 In sum, the simulation of the AIDS disease status model for a stratum with equation (1) - (14) requires specification of p), po, mand k. In the model applications presented later in this paper these parameters will be assumed to have the same values for all strata: p, = 1.0, pp = 0.90, m= 0.055 (mean time to death equals 1/m = 18 months). The value of k is set equal to four times the inverse of the mean incubation time which is assumed to decline linearly from 10 to 5 years between ages 15 and 85, reaching a value of 9.3 years at age 25 (Medley et al., 1987, have documented that the incubation period declines with age). In addition, the infection rate r(t) must be provided. This variable is one of the most important determinants of size of the AIDS epidemic. The mathematical equations for estimating r(t) for different subgroups of the population are presented next. HIV infection rates and sexual transmission The probability that a susceptible individual becomes infected through sexual contact in a given unit of time (month) depends on several factors, including the frequency of sexual contacts, the number of different partners, the probability of choosing an infected partner and the infectiousness of infected partners. Taking account of all these factors in a general infection model that is applicable to all sexual behavior groups would make the overall model extremely complex. Fortunately, substantial simplication can be introduced by dividing the sexual behavior groups into two classes: those with multiple partners and frequent partner change (e.g., prostitutes, homosexuals) and those with a single partner and relatively infrequent partner change (e.g., monogamously married individuals). Different but 13 closely related equations are used to estimate infection rates for these two ae classes: (a) Groups with multiple partners and frequent partner change. A recent analysis of the determinants of HIV transmission rates by De Gruttola (1987) concluded that this rate does not depend on the mmber of partners if two conditions hold: 1) partners are selected at random, and 2) the risk of transmission per contact with an infected partner is much smaller than the reciprocal of the number of sexual contacts per partner. Since current evidence suggest that the risk of transmission per contact is a fraction of a percent (Padian et al. 1987, Wiley 1987), it is reasonable to assume that the second condition holds for homosexuals and other heterosexuals with high sexual mobility. Whether partners are chosen at random, or at least irrespective of infection status is not entirely clear, but in the equations below this is assumed to be the case. (Simple extensions of the present model can deal with non-random selection.) The rate of infection per month among susceptible mmbers of subpopulation A who are at risk of HIV infection by having sexual contact with members of subpopulation B (A = B for homosexuals) equals ra(t) = 1 - (1 = Ra(t))n(t) (15) where n(t) = frequency of sexual contact per month (between subpopulations A and B) Ra(t) = probability of infection per contact The estimation of Ra(t) would be simple if partners are chosen randomly from population B, if all infected partners are equally infectious, if sexual 14 activity does not vary with disease stage and if no practices such as condan use reduce the infection risk. In that case R(t) is the product of the proportion of subpopulation B that is infected, and the probability of infection per contact between an infected and a susceptible individual (p): 5 Ra(t) =p > Py(t)/P(t) (16) re=3 where P,(t) equals the number of individuals in infectious/disease state n in population B. In reality, however, there are several complicating factors: - Gender specificity of infectiousness. As is the case for transmission of gonorrhea, it appears that male to female transmission of HIV is more efficient than the reverse (Wiley 1987, Peterman et. al. 1988). - Cofactors. Genital ulcers and the presence of a mumber of infectious diseases facilitate HIV infection (Plummer 1987, Quinn, 1987). The type of sexual contact also affects the risk of transmission. - Variation in infectiousness. Infectiousness is at a low level throughout most of the incubation period, but then rises sharply during a period of perhaps one to three years before the onset of AIDS (Goedert et al. 1987). Infectiousness may also be elevated for a short period immediately after infection, but this is not well established. - Condom use. While in most populations condoms are used primarily for contraceptive purposes, there is increasing awareness of the protection against the risk of HIV infection provided by condoms. In populations in which this awareness is high, the prevalence of condom use may well rise with 15 infection stage, as persons who know their disease status are more likely to take precautions not to infect their partners. - Variation in sexual contact rate. The frequency of sexual contact is likely to decline in the advanced stages of the disease (e.g., AIDS, ARC). Adding these factors ylelds the following more general equation for the infection risk per contact: 9 9 A(t) = Pg 2 CyIn (1 - Un) Fry Py(t)/[Py(t) + Po(t)+ 2 Fy Pa(t)] (17) r=4 n=4 where p, = standard sex specific transmission risk between infected and susceptible partners (standard assumes C, = I, = F, = 1.0 and Up = 0) n = infection/disease state of individuals in subpopulation B C, = Cofactor multiplier Un, = prevalence of effective condom use I, = Infectiousness miltiplier Fr, = Frequency of sexual contact multiplier Each of the multipliers equals 1 for asymptomatic infected individuals. The large mmber of parameters in equation 17 makes it a bit unwieldy and in the later application to an African population the following simplifying assumptions were made: - The cofactor mitiplier and the prevalence of condom use are independent of the infection stage n (C, = C and U, = U) - I, equals 1.0 for all n except for persons with AIDS or ARC who are 16 assigned the same multiplier value I (I = Is =Ig, I > 1.0). - F, equals 1.0 for all n except for persons with AIDS, whose multiplier equals F (F = Fs, F < 1.0). With these assumptions equation 15 becames: Ra (t) = Ds C(1-U) [P4 (t) + Pg (t) + P7(t) + Pg (t) + I Pg (t) + IF Ps (t) V4 [P(t) - (1-F) Ps(t)) (18) In this simplified equation the number of parameters is reduced to six: P; (for males and females), C, U, I and F. Based largely on a review of estimates of transmission probabilities by Wiley (1987), these parameters were assigned the following values for the simulation of the African version of the model: Pm = 0.001 (male to female) Pe = 0.0005 (female to male) C=3 U=0.1 I= 10 F= 0.0 (b) Groups of individuals with single partners and infrequent partner change. A slightly different approach is needed to model the infection risk for individuals in monogamous relationships. Such individuals have only one partner for the duration of the relationship and the susceptibles among them 17 are not at risk if their partners are uninfected. For monogamous susceptibles who have an infected partner, equation (15) still holds, but the probability Ra(t) is then 9 9 Ra(t) = Ps > Cy In (1-Un) Fr Pa(t))/ £ Fn Prit) (19) rn=4 rre=4 which can be simplified in the same way as equation (18). Among the principal groups to which equation (19) applies are males and females in monogamous marriages (or other relatively stable sexual relationships). Let f, be the proportion of males that is infected at marriage and let f> be this proportion for females. If the selection of marriage partners is independent of infection status then there are four types of new marriages. Proportion Type c, = f fo both partners infected Cp = fy (1-f5) male only infected C3 = fp (1-f£)) female only infected Cy = (1-f,) (1-f9) neither partner infected Only in the second and third of these types of marriages do new infections occur. In the absence of marital disruption the proportion of all marriages with both partners infected rises over time from f) fo at marriage to a maximm of f) f> + £1(1-f2) + fo(1-f)) = f + fo - f1 fo. Since in reality marital disruption and remarriage do occur, individuals who are not at risk in a first marriage may become exposed in later 18 marriages. There are several ways to include the effect of marital disruption into the model. In the simplest case it is assumed that the risk of marital disruption per month and the choice of a new partner are independent of infection status, that the time between marital disruption and remarriage is negligible, and that the proportion remarrying is the same among males and females. In that case the proportion of males that moves from the susceptible/old partner uninfected status to the susceptible/new partner infected status following a marital disruption and remarriage in month t equals s(t) m(t) cyg(t) £,(t) and the number of males that move from the susceptible/old partner infected status to the susceptible/new partner uninfected status equals s(t) m(t) c3(t) (1 - f5(t)), (s(t) equals the monthly risk of marital disruption and m(t) is the proportion of individuals that remarry after a marital disruption). Similar expressions can be derived for females, and straightforward extensions of this simplest case can allow variability in the disruption and re-marriage risks, as well as delays between marital disruption and remarriage. Numbers of individuals in different risk groups The preceding section described the equations for estimating the rate of HIV infection and the subsequent progression to AIDS in various sexual behavior groups. In order to calculate the total mumber of infections and AIDS cases at any point during the projection, the numbers of individuals in each sexual behavior stratum has to be known for all cohorts. These mumbers are derived with a two step procedure: a) Distribution of cohort members among risk groups. 19 In most populations cohort members become sexually active in their mid- or late teens and the sexual activity rate typically peaks in the twenties. Over time individuals can switch between risk groups (e.g. from the sexually mobile to the monogamously married stratum). Since the pattern of life cycle changes in the distribution of individuals among the different risk groups varies widely among populations, no detailed general description of this pattern of movements between strata will be attempted here. Instead, a specific illustration will be provided in the subsequent application of the model to an African population. b) Cohort sizes As noted, the conventional cohort component method for projecting the size and age and sex structure of the population is used in the AIDS model. Detailed descriptions of this methodology can be found elsewhere (Pressat 1972, Shorter 1976, Shryock and Siegel 1973) and need not be repeated here. The principal output of this demographic component of the AIDS model consists of estimates of the mumbers of males amd females (total and by age) at each point in time for the duration of the projection. To make such a demographic projection, the size and age/sex structure of the population at the begiming of the projection interval mst be provided. Future changes in the population's structure depend on trends and age patterns of fertility and mortality. Both AIDS and non-AIDS mortality reduce cohort sizes over time. If, as is often done in developing countries, standard age patterns of fertility and non-AIDS mortality are applied, then only future trends in the overall level of fertility (e.g., the total fertility rate) and mortality (e.g., the life expectancy at birth) need to be provided to calculate the 20 ~~ o™ evolution of the population and its cohort components. If migration levels are not negligible, they can easily be taken into account. In the African application given below the initial population age structure is assumed to be stable’ with a population growth rate of 3.0 percent per year and a life expectancy at birth of 44 years for males and 47 years for females. The total fertility rate, which equals the average number of births over a woman's reproductive life time, is 6.5. During the 25 year projection interval, life expectancy (in the absence of AIDS) increases by 7.5 years and fertility declines by 0.5 births per woman. According to the latest projections of the United Nations, these values for the demographic parameters are typical of populations in Central and East Africa for the period 1975 =-2000 (United Nations 1986). Non-sexual routes of HIV transmission Transmission from infected mother to her newborn is common. In the model the proportion of all newborns with perinatal HIV infection, N(t), is estimated by 49 49 N(t)=b2> f(a,t) W(a,t) ¥(a,t)/ 2 £(a,t) w(a,t) a=15 a=15 where a = age of the mother t = time in years b = probability of perinatal transmission from an infected mother to an infant f(a,t) = age specific fertility rates at time t W(a,t) = mumber of women aged a at time t 21 Y(a,t) = prevalence of HIV infection among W(a,t) Extension of this basic equation can allow for variation in the infant's infection risk by infection stage of the mother. Current understanding of the epidemiology of HIV in Africa suggests relatively low levels of transmission through IV drug abuse and medical injections. Although more common, transmission through transfusions with infected blood probably represents less than 10 percent of all infections among adults (Piot and Carael 1988). However, blood transfusions account for larger proportions of infections among infants. ILL VE_APPLICATION OF DEL Presented next is a simulation of an epidemic in a population with an African pattern of disease transmission. To facilitate implementation of the model on a computer, several simplifying assumptions are made in addition to those already mentioned: 1) There is no homosexuality and IV drug abuse. 2) The life cycle of all individuals is divided into three fixed parts: from birth to age 15, from age 15 to marriage and from marriage to death (the term marriage is used here to denote any socially sanctioned stable sexual union). Sexual activity starts at age 15 and age at marriage is the same for all males and females. 3) All individuals over age 15 are divided into two sexual behavior strata, one with high sexual mobility, the other with low or zero mobility. Before marriage only the highly mobile males and females are considered to be at risk of HIV infection, while after marriage individuals who are not highly mobile are also at risk if they are married to an infected partner. 4) Except for highly mobile females, sexual partners are members of 22 the same cohort. 5) No medical intervention changes the risk of infection or the disease progression (except for a reduction over time in the risk fron blood transfusion due to the increasing availability of inexpensive screening tests)? and 6) Sexual behavior does not change over the course of the simlated epidemic. The input parameters whose specification is required for an application of the model are listed in Table 1. This parameter set is divided into five groups describing, respectively, disease progression, sexual behavior, determinants of infectiousness, non-sexual transmission of HIV and demographic structure. A full discussion of the values chosen is beyond the scope of this paper and in any case for a mmber of them empirical estimates are not available. Data on sexual behavior are particularly scarce. For this reason the results of the simlation must be considered hypothetical and illustrative rather than representative of a particular country in Africa. Selected results of one simulation of the model are presented in Figures 5 and 6 and Table 2. The duration of the simlation is limited to 25 years because the most important changes in epidemiological and demographic variables (e.g., the prevalence of HIV and population growth rate) occur within this period, and thereafter a relatively stable state is maintained. The incidence rates of three key epidemiological events are plotted in Figure 5. The annual number of HIV infections rises rapidly in the early phase of the epidemic, reaching a peak around year 15 and stabilizing at a rate of about 2.2 percent per year by the end of the 25 year projection interval. As expected from the long incubation period, the rise in the incidence of new AIDS cases occurs nearly a decade after the rise in HIV infections. Given 23 the short interval between the onset of AIDS and death, the annual incidence pattern of AIDS deaths closely follows the pattern of annual AIDS cases. HIV prevalence for the total adult population as well as for each sexual behavior group rises throughout the projection interval and approaches equilibrium by year 25 (Figure 6). The period of most rapid change in prevalence coincides with the peak in HIV incidence rates. Not surprisingly, seroprevalence is much higher among females and males with high sexual mobility than in the total adult population. The ratio of female to male infected adults rises from 1.0 in the early years of the epidemic to 1.15 in year 25. Selected results from the demographic projection are presented in Table 2. During the 25 year projection interval the total population grows from 100 to 189.0 million and the mmber of adults from 51.2 to 99.5 million. In year 25, 21.2 million adults are infected with HIV and 2.22 million have AIDS. In the absence of the epidemic, both the total and the adult popula- tion sizes would have been substantially higher. The former would have grown to 212 million and the latter to 108 million. The epidemic clearly lowers both the population size and the population growth rate. However, the annual growth rate of the total population in year 25 is still a very substantial 1.9 percent (down fram 3.0 percent in year 1). The decline in the growth rate of the adult population (from 3.0 to 2.0 percent) is virtually the same as the reduction in the growth rate of the total population. Conclusion Projecting the future course of an HIV/AIDS epidemic and its demographic impact is a complex matter because a wide variety of behavioral, 24 epidemiological and demographic factors affect the course of the epidemic. The model presented here attempts to include all essential determinants of the epidemic. Although mmerous simplifying assumptions were made, the total number of parameters required for a similation of the African version of the model is still 32. Perhaps a few of these parameters will turn out to be unnecessary or sufficiently invariant to be given a fixed value (e.g., the proportion of the population that is susceptible to infection), but it is difficult to see how a reasonably comprehensive model can have many fewer parameters. More likely, the number of parameters will grow as our understanding of the epidemiology and natural history of the disease increases. Future versions of the model that include homosexuality and IV drug abuse certainly will require additional parameters. One significant, but tentative, conclusion can be drawn from the illustrative simulation of the African model summarized in Figures 5 and 6 and Table 2. Despite the fact that seroprevalence among adults reached 21 percent in year 25, the annual population growth rate was reduced by toniy" 1.1 percent. Since seroprevalence in the most severely affected countries of Africa (e.g. Uganda and Rwanda) is currently at or slightly above 10 percent (Quinn et. al. 1986, Piot and Carael 1987) and since the African epidemic apparently started in the mid-seventies, the trajectory of seroprevalence among all adults in these African countries is roughly the same as that plotted in Figure 6 (up to year 12 or 13). If the future course of the epidemic in these countries follows approximately the trend projected here, than we can conclude that population growth rates are unlikely to tum negative in Central Africa. More likely, the population growth rates in Central and East Africa will not drop below half their current values. It 25 should be emphasized, however, that these reductions in growth rates are brought about by very large increases in the death rates. In this simlation of a severe epidemic the annual death rate is projected to reach 2.6 percent in year 25. According to the latest U.N. population projection this is twice the estimated death rate from all causes (not including AIDS) in the year 2000 in East and Central Africa. 26 Footnotes l. 3. The epidemiological submodels project events up to age 65 for all cohorts, but the maximm age in the demographic submodel is 100. A stable population has by definition a fixed age structure. Asa consequence, the annual growth rate of each age group is the same as that of the population as a whole. The age distribution of the stable population A(a) is given by A(a) = e *@ p(a)/ e%4p(a) da where r is the growth rate and p(a) is the probability of survival to age a (Coale 1972). The function p(a) can be estimated with so-called model life tables if the life expectancy at birth is given (Coale and Demeny 1983). In the simulations the risk of infection through blood transfusion is assumed to remain at the given initial value until year 10. It then declines linearly to zero in year 25 of the epidemic, because improved screening of donated blood is assumed to become increasingly effective over time. The sexual contact rates are assumed to apply up to age 30. Thereafter the contact rate declines linearly reaching 0 at age 75 for males, at age 65 for monogamous females, and at age 50 for highly mobile females. See note 3. 27 References Anderson, R.M., R. M. May, G. Medley, and A. Johnson, 1986. A preliminary study of the transmission dynamics of the human immunodeficiency virus (HIV) the causative agent of AIDS. IMA Journal of Mathematics in Medicine and Biology, 3, pp. 229-263. Coale, A., 1972. The Growth and Structure of Human Populations, Princeton University Press, Princeton. Coale, A. and P. Demeny, 1983. Regional Model Life Tables and Stable Populations, Academic Press, New York. Eales, L. J. et al., 1987. Association of different allelic forms of group specific component with susceptibilities to and Clinical manifestation of human immunodeficiency virus infection." The Lancet, 8540, May 2, pp. 999-1002. De Gruttola, V. and K. Mayer, 1987. “Assessing and modelling heterosexual spread of the human immunodeficiency virus in the United States, in: Abstract Volume, III International Conference on AIDS, Washington, D.C. De Lange, G. et al., 1987. "Group-specific component and HIV infection." The Lancet, 8541, August 1, pp. 282-283. Dietz, K., 1986. The dynamics of the spread of HIV infection in the heterosexual population. In Proceedings of the European Community Workshop on Statistical Analysis and Mathematical Modeling of AIDS, Bilthoven, December (forthcoming) . Hessol, N. et al., 1987. “The natural history of human inmunodeficiency virus infection in a cohort of homosexual and bisexual men: a 7-year prospective study," In: Abstract Volume III International Conference on AIDS, Washington, D.C. 28 Knox, E. G., 1986. "A transmission model for AIDS," European Journal of Epidemiology, 2(3), pp. 165-177. Lefrere, J., 1987. "Group specific component and HIV infection," The Lancet, 8541, August 1, p. 283. May, R. and R. M. Anderson, 1987. ‘Transmission dynamics of HIV infection," Nature 326(12), March, pp. 137-142. Mann, J., 1987. "Focus on AIDS,' WHO Features, December. McEvoy, M. and H. Tillett, 1985. "Some problems in the prediction of future numbers of cases of the acquired immunodeficiency syndrome in the U.K., The Lancet, September 7, pp. 541-542. Medley, G. et al., "Incubation period of AIDS in patients infected via blood transfusion," Nature, 328, August, pp. 719-721. Morgan, W. N. and J. W. Curran, 1986. “Acquired immmodeficiency syndrome: current and future trends. Public Health Reports, 101(5), pp. 459-465. Padian, N. et al., 1987. "Male-to-female transmission of human immunodeficiency virus (HIV): Current results, infectivity rates, and San Francisco population prevalence estimates." In: Abstract volume, III, International Conference on AIDS, Washington, D.C. Peterman, T. et. al., 1988. "Risk of HIV transmission from heterosexual adults with transfusion associated infection," JAMA, 259(1), pp. 55-58. Plummer, F.A., et al, 1987. "Genital ulcers and oral contraceptives facilitate male-female transmission of HIV." In: Abstract volume, III International Conference on AIDS, Washington, D.C. Pressat, R., 1972. Demographic Analysis: Methods, Results, Applications, Aldines, Atherton Inc., Chicago. 29 Quinn, T. C. et al. 1987. "Sociological and immunologic studies in patients with AIDS in North America and Africa," JAMA 257, no. 19, pp. 2617- 2621. Redfield, R., et al., 1986. ‘The Walter Reed staging classification for HTLV-III/LAV infection." The New England Journal of Medicine, 314(2), pp. 131-132. Shorter, F., 1974. Computational Methods for Population Projections: With Particular Reference to Devel t Planning. The Population Council, New York. Shryock, H. and J. Siegel, 1973. The Methods and Materials of Demography, Vol. 2, U. S. Bureau of the Census, U.S. Government Printing Office, Washington, D.C. United Nations, 1986. World Population Prospects: Estimates and Projections as Assessed in 1984. Population Studies, No. 98, Department of International Economic and Social Affairs, United Nations, New York. U. S. Bureau of the Census, 1986. World Population Profile: 1985, Department of Commerce, Washington, D.C. U.S. Centers for Disease Control, 1986. Classification system for human T- lymphotiopic virus type III/lymphadenopathy-associated virus infections, Morbidity and Mortality Weekly Report, 35(20), pp. 334-339. United Nations, 1986. World Population Prospects: Estimates and Projections as Assessed in 1984, Population Studies No. 98, Department of International Economic and Social Affairs, New York. Wiley, J. "Models for estimation of transmission probabilities of HIV in epidemilogical studies," forthcoming in Statistics in Medicine. 30 World Bank, 1986. World Development Report, 1986. Oxford University Press, New York. 31 Table 1. I. iI. IIT. IV. V. Disease progression - Proportion susceptible - Proportion of infecteds at risk of developing AIDS - Average duration of incubation period (years) ~ Average interval between AIDS onset and death (years) Sexual behavior - Monthly frequency of sexual contact before marriage? highly mobile males/females ~- Monthly frequency of sexual contact after marriage* highly mobile males/females - Monthly frequency of sexual contact between spouses4 - Proportion highly mobile before marriage (males/ females) - Proportion highly mobile after marriage (males/females) - Age at marriage - Annual risk of marital disruption - Proportion remarrying - Average number of wives per married male Determinants of infectiousness - Standard transmission risk male to female/female to male - Cofactor multiplier - Infectiousness multiplier for ARC and AIDS cases - Frequency of contact mltiplier for AIDS cases - Proportion using condoms Non sexual transmission - Probability of perinatal transmission - Proportion of infections among infants/adult female due to blood transfusian> Demographic structure - Initial population size (millions) ~ Initial population growth rate (percent) - Initial life expectancy at birth in years, (male/female) - Annual increment in life expectancy (male/female) - Annual decrement in fertility rate (births per woman) Input parameters for illustrative projection of African epidemic 10/25 4/100 8 0.4/0.2 0.2/0.02 20 0.02 1.0 1.25 0.001/0.0005 3.0 10.0 0.0 0.1 0.5 0.2/0.1 100.0 3.0 44,47 0.3/0.3 0.02 Table 2. Estimates of selected demographic variables in the first and last year of a 25 year illustrative projection of an African epidemic. Start of End of 25 projection year projection Total population size (millions) 100 189.0 growth rate (% per year) 3.0 1.9 Adult population (15-65) size (millions) 51.2 99.5 annual growth rate (% per year) 3.0 2.0 number infected (millions) 0 21.2 mimber of AIDS cases (millions) 0 2.22 & — > | | | | \ / | 4 / life Lines << / J NN ANA / / 4.7 Lf fee | t 4 Start of year t ——__p projection time (years) FIGURE 1: Lexis diagram of cohort life lines by age and time HIV transmission routes _-» Monogamous partners of Homosexuals s bisexual males Females with high sexual Heterosexuals _ mobility (e.g., prostitutes) with high sexual —_— Monogamous partners of mobility _ " sexually mobile males Partners in monogamous — unions Partners in monogamous oe unions Sexually | ‘ inactive Sexually inactive males females MALES FEMALES FIGURE 2: Principal routes of sexually transmitted HIV infection between subgroups with different sexual behaviors Entry into risk group FIGURE 3: 4 INFECTIOUS (no AIDS risk) 3 AIDS INFECTIOUS | “onset 1 AIDS Infection and disease status flow diagram 100 % ' > 76+ aa i n Asymptomatio Asymptomatio AIDS f (1) (2) e c =660r t e d 3 Cc F ° 26 - 2 h =—_ « Cumulative gamma distribution o yw with mean = 9.3 years r [1 «= Estimates from San Franoleco t Clty oltnic cohort oO ” 4 l i l l 0 2 4 6 8 10 12 Years since infection Figure 4: Cumulative gamma distribution fitted to observed cumulative proportions of infected cohort progressing to AIDS, by duration since infection (observations from Hessol et. al. 1987) Percent per year 3.0 2.5 2.0 1.5 1.0 0.5 0.0 HIV Infections AIDS Cases AIDS Deaths 0 5 10 15 20 25 Year Figure 5: Annual incidence of HIV infection, AIDS and AIDS deaths among adults (15-65) in a hypothetical 25 year projection of an African epidemic. Percent infected with HIV Prostitutes 80 r 7OF Male partners 60 F of prostitutes 50 F 40; 30 fF All adults 20 10 0 l J i ] 0 5 10 15 20 25 (1975) (2000) Duration of epidemic in years Figure 6: Estimated HIV prevalence rates among all adults, prostitutes and their male partners in a hypothetical model projection of an African epidemic. April 8, 1988 ** ABS TRACT ** THE DIRECT AND INDIRECT COST OF HIV INFECTION IN DEVELOPING COUNTRIES: THE CASES OF ZAIRE AND TANZANIA M. Over, Ph.D., S. Bertozzi, B.S., J. Chin, M.D., B. N'Galy, M.D., K. Nyamuryekung’e, M.D.+ to be presented at The First International Conference on The Global Impact of AIDS 8-10 March, 1988 London, England This paper proposes an approach to estimating the direct and indirect cost of HIV-infection per infected person in a developing country and applies this approach in Zaire and Tanzania. It identifies major causes of the possible variation of both direct and indirect costs per case and offers low and high estimates of each cost for the two countries studied. With respect to indirect costs, the paper compares HIV infection to other important diseases. The paper concludes by suggesting how such cost estimates, supplemented by currently unavailable information on cost per case prevented, could be useful to decisionmakers who must choose how much of a limited supply of financial resources to allocate to AIDS prevention and control relative to the prevention and control of other diseases or to investment programs in other sectors. 1 the authors are respectively Economist, Population and Human Resources Department, World Bank, Washington; Consultant, Surveillance, Forecasting and Impact Assessment Unit, Global Programme on AIDS, WHO, Geneva; Unit Chief, Surveillance, Forecasting and Impact Assessment Unit, Global Programme on AIDS, WHO, Geneva; Coordinator, National AIDS Control Programme, Department of Health, Zaire; Coordinator, National AIDS Control Programme, Ministry of Health, Tanzania and are listed alphabetically after the first. April 8, 1988 THE DIRECT AND INDIRECT COST OF HIV INFECTION IN DEVELOPING COUNTRIES: THE CASES OF ZAIRE AND TANZANIA M. Over, Ph.D., S. Bertozzi, B.S., J. Chin, M.D., B. N'Galy, M.D., K. Nyamuryekung’e, M.D. to be presented at The First International Conference on The Global Impact of AIDS 8-10 March, 1988 London, England 1. In this paper we present a summary of preliminary results of studies of the direct and indirect cost of HIV infection in two developing countries.2 Based on only a few weeks effort in each country, the results are subject to revision as more thorough, definitive studies are completed in these countries in the course of their respective national AIDS control programs. But we expect even these preliminary results to be of use to health care planners as they begin to make resource allocations to the prevention and treatment of HIV infection. 2. For the purposes of this paper, we define the direct cost of a disease as the cost of treating those who suffer from it, and we define the indirect cost as the value of the healthy years of life it steals from society. Our goals are, first, to propose an approach to estimating the 1 The authors are respectively Economist, Population and Human Resources Department, World Bank, Washington; Consultant, Surveillance, Forecasting and Impact Assessment Unit, Global Programme on AIDS, WHO, Geneva; Unit Chief, Surveillance, Forecasting and Impact Assessment Unit, Global Programme on AIDS, WHO, Geneva; Coordinator, National AIDS Control Programme, Department of Health, Zaire; Coordinator, National AIDS Control Programme, Ministry of Health, Tanzania and are listed alphabetically after the first. 2 If the presence of AIDS in a country affects the demand for (as opposed to the supply of) its exports, such effects would be additional to those considered in this paper. April 8, 1988 page 2 direct and indirect cost of HIV infection in a developing country, and, second, to present estimates of these quantities for each infected person. Since reliable estimates do not yet exist for the total number of infected persons in any single country in the world, it would be inappropriate to use these estimates per infected person to compute the total national cost at this stage of our knowledge. However, one could compute hypothetical estimates based on a variety of hypothetical rates of HIV infection. Ina longer version of this paper, we will present such hypothetical estimates. DIRECT COSTS 3. A principal finding of the two case studies is that the direct cost per patient varies a great deal, even within a single country, depending not only on the particular clinical symptoms with which HIV infection manifests itself, but also on socioeconomic characteristics of the patient and medical and institutional characteristics of the health care options available to that patient. Therefore, rather than provide a single average figure for direct cost of HIV infection in any country, it is preferable to present a range of estimates together with an explanation of the causes of variation. 4. In Zaire the direct cost of health care per symptomatic HIV- infected person ranges from a low of $132 to a figure twelve times as large of $1,585. (See Table 1.) In Tanzania estimated direct cost ranges from a low of $104 to a figure six times as large of $631. These estimates are expressed in 1987-88 US dollars converted at official exchange rates and attempt to include the financial costs of all resources used in the course of treatment, whether those costs are financed by the patient's family, by the government or by a charitable organization. However, they do not include an additional cost which health systems and their patients will be forced to bear if the epidemic continues to spread - the foregone health care that would have gone to patients crowded out of the system by AIDS patients.” When more in-depth studies are performed, it will be important to examine the "crowding-out” issue more closely. >. The estimates assume that every symptomatic HIV-infected adult will seek at least some treatment from modern sector facilities. The low estimate is distinguished from the high estimate in each country by assumptions regarding the characteristics of the patient and the health care options faced by that patient. For example, in Zaire the low estimates assume that the patient restricts himself or herself to the relatively low cost care of the urban or rural “health zone” system, while the high estimates assume the patient ventures out into the higher-cost private health care market. In Tanzania the range of cost variation is smaller, but 3 In government and charitable health care systems which pay health care workers and other factors of production far less than their opportunity costs, there can be no presumption that the financial costs such as those computed here properly represent the cost of the foregone health care. April 8, 1988 page 3 still important, as patients choose whether to seek the best available modern care pr to remain in the village cared for by relatives. 6. How large are these costs? Although large compared to per capita health expenditures in these countries, these costs should instead be compared to per patient expenditures on other diseases. Studies to make these comparisons have not yet been performed, but we do not expect expenditures per patient for AIDS to greatly exceed those for other serious diseases of adults in the same countries. 7. Figure 1 presents the range of estimated cost for each of the two African countries together with estimates that are available for the United States, England and a caribbean nation, all plotted against gross national product (GNP) per capita on a log-log scale. The figure demonstrates that there is a rough correspondence between the direct cost of HIV infection in a country and that country’s economic situation. Countries in which resources are limited are forced to spend less on each patient; more prosperous countries permit themselves to spend more. The pattern is quite similar to the one that relates overall national health care spending to GNP per capita. 8. As countries turn to the preparation of treatment protocols for AIDS patients, they will want to examine the range of variation of actual costs within their own and neighboring countries. The World Bank and WHO are supporting the development and refinement of cost estimates like those reported here in order to contribute to this process. Countries which are considering recommending treatment protocols which are substantially more expensive than those their physicians are currently applying will want answers to a question not addressed by this paper: How large are the additional health benefits currently obtained by the wealthier countries from their additional expenditures? INDIRECT COSTS 9. The HIV virus, like other pathogenic organisms, deprives individuals of years of healthy, productive life and robs families of their loved ones. By applying a common method to the calculation of these indirect costs for each of the important diseases, one can compare the costs due to each individual disease and use these estimates as one input to decisions on allocating resources across diseases. We perform this computation in three steps. 10. First, we estimate the total number of future years of healthy life lost by an average HIV-infected person and by an individual who contracts each of a variety of other relevant diseases and we discount future lost years to the year of infection or contraction. In this paper we use a discount rate of 5%. We count years lost to disability from each disease as a portion of a year lost to death, although disability typically accounts for less than 10% of the years lost from the more important diseases. The first column of Table 2 presents the results for HIV infection and for 13 of the diseases ‘April 8, 1988 page 4 thought to account for the most years of life lost in African countries. These figures show how many years of life could, in theory, be saved by the prevention or immediate cure of one case of each of these diseases. Note that preventing one case of HIV-infection will save an estimated 8.8 discounted healthy life years. HIV-infection ranks fifth on this measure, after sickle cell anemia, neonatal tetanus, birth injury and severe malnutrition, but ahead of childhood pneumonia, cerebrovascular disease, tuberculosis, measles, malaria and gastroenteritis. Figure 2 facilitates visual comparison among HIV infection and the other 13 diseases with respect to the number of life years which can be saved by averting a single case. 11. Second, we disaggregate the total future life-years lost from each disease into years lost in each of five age ranges which differ in their productivity implications. We assign a productivity weight to each age range relative to the productivity of a healthy adult aged fifteen to fifty.4 After weighting the future life-years lost by their productivity weights, we again discount them to the year of infection or contraction and use the totals to rank the relevant diseases as shown in the third column of Table 2. Figure 3 contrasts the number of productive healthy life years lost per case with the total number of life years lost. Because the productivity weighting procedure discounts the less productive years, it dramatically reduces the number of years of life lost per case for childhood illnesses like sickle cell anemia and prematurity and has a much smaller effect on adult diseases like cerebrovascular disease and adult pneumonia. The effect of productivity weighting on years lost from HIV infection is intermediate between the childhood and the adult diseases, because HIV infection strikes both adults and infants in Africa. According to these calculations, every case of HIV infection prevented saves about 6.6 discounted productive healthy life years, more than preventing a case of all but four of the other diseases. 12. If a decision maker is interested only in reallocations of health care expenditures within the health care budget, there is no need to proceed further than we have to this point. By asking his or her staff to estimate the number of cases of each disease which will be prevented or cured by each of a variety of health care programs or mixes of programs within the available health care budget, the policy maker can choose the program mix which achieves the largest feasible gain of productivity weighted healthy years. However, suppose the decision-maker is located in the Ministry of Finance rather than in the Ministry of Health. This individual would want to know whether to reallocate money away from other, demonstrably productive sectors like transport and communication, to the prevention of diseases or perhaps to the prevention of a specific disease like AIDS. The computations we have done to this date are of no help to this decision. It is necessary to take a third step, attaching a monetary value to each of the productive healthy life years to be saved. 4 Thus, age range zero to five is assigned a weight of zero, age range five to fifteen, a weight of .20, age range fifty to sixty-five a weight of .85 and age range sixty-five plus, a weight of .25. April 8, 1988 page 5 13, There are two competing methods proposed in the health economics ~ literature for valuing years of healthy life in monetary terms, One of these, called the willingness-to-pay approach, has the advantage of capturing a portion of the psychic value that society attaches to saving a life, but the application of this method requires more in-depth study than has been possible to date. The other method, called the “human capital approach,” is based solely on the economic return society receives for a year of the affected individual's labor, which is imperfectly measured by the individual’s annual income. Nevertheless, weighting the productive years of healthy life lost to a disease by the average income per year can at least provide some provisional guidance to the decision-maker faced with the problem of inter-sectoral resource allocation. The problem is to know which average income to apply. 14. Each communicable disease affects a somewhat different socioeconomic cross-section of society. Diseases characterized by airborne transmission flourish in urban more than in rural residential patterns; those requiring insect vectors may affect both areas equally or be less prevalent in urban areas with partially effective vector control programs. However, because social and sexual intercourse are closely related, the incidence of sexually transmitted diseases like AIDS is likely to be more determined by socioeconomic strata within residential areas than by the geographic boundaries of those areas, As a working hypothesis we adopt the assumption that three general groups of the population must be distinguished, the rural, the urban with only a primary education and the urban with a secondary education or above. Table 3 presents estimates for the average wage for each group in each country converted to 1987/1988 dollars and estimates the dollar value of discounted future years of healthy life lost in each of these three groups for each important disease. The ranking of HIV infection in the list of diseases remains unaffected by this procedure - it ranks fifth, with an indirect cost ranging from $890 to $2,663 in Zaire and from $2,425 to $5,093 in Tanzania. TOTAL ECONOMIC IMPACT OF HIV INFECTION PER INFECTED PERSON 15. Table 4 collects in one place the low and high estimates of direct and indirect costs per case for HIV infection and other important diseases and computes their total. The estimates of direct cost per case of HIV- infection are calculated from Table 1 by assuming the conversion rates to AIDS characteristic of the San Francisco cohort, and then discounting those costs to the year of infection, again at a discount rate of 5%. As stated above, the direct cost estimates are not yet available for other diseases. > The "human capital approach” admittedly underestimates the value of the healthy life year of under- and unemployed individuals and perhaps overestimates the relative value of a life-year of an individual whose salary is based more on monopoly rents than on contribution to society. April 8, 1988 page 6 However, as in the case of HIV-infection, we expect the indirect costs to dominate the direct costs for all important diseases. 16. Now suppose that the Ministry of Finance decision-maker knows that a certain quantity of financial resources could alternatively be allocated either to producing a known monetary benefit in the transport sector or to a health care program which would prevent a certain number of cases of a disease such as HIV infection. The figure in Table 4 will then permit that decision-maker to place a minimum monetary value on those prevented cases. In cases where this minimum produces a monetary return from the health sector investment which equals or exceeds that of the equal cost transport sector alternative, the decision-maker would be guided toward the health sector investment. 17. Of course the missing piece in this calculation is the cost of the various possible health care programs per case prevented. In the case of communicable diseases, and especially of epidemics like that of HIV nfecti calculation of this cost t_ take ount of the fact that eac ary case prevented also preve second and tertiary cases Now, while AIDS prevention programs are still in their formative stages, is the time to build in baseline data collection and subsequent monitoring activities, so that the cost per case prevented can eventually be calculated, Table 1. Direct Cost of HIV Infection per Symptomatic Adult (In 1985 US dollars) ° GNP Direct Cost POEL weer newer erennnee Capita Low Mean High Zaire $170 $132 $1,585 Tanzania 290 104 631 Caribbean Island 1,000 2,723 England 8,460 10,200 USA 16,690 27,571 50,380 Sources: Tanzania and Zaire: Joint WHO/World Bank estimates. Carribean Nation: Unpublished correspondance. England: Johnson, Anne M., M. W. Adler, J. M. Crown, "Acquired immune deficiency syndrome and epidemic of infection ...,” British Medical Journal, Volume 293, 23 August, 1986, pp. 491-2. United States, Low: Seage, G. R., "The Economic Impact of AIDS,” Journal of the American Medical Association, December 12, 1986, Vol. 254, No. 22. United States, High: Scitovsky, A., M. Cline and P. Lee, "Medical Care Costs of Patients with AIDS in San Francisco,” JAMA, December 12, 1986, Vol. 254, No. 22. Table 2. DISCOUNTED HEALTHY LIFE YEARS SAVED PER CASE PREVENTED PRODUCTIVITY WEIGHTED DISCOUNTED DISCOUNTED HLYs SAVED HLYs SAVED No. DISEASE NAME VALUE RANK VALUE RANK Q HIV Infection 8.8 5 6.2 5 1 Malaria 2.5 10 1.4 11 2 Measles 3.4 9 1.9 9 3. Pneum. (Child's) 7.7 6 5.0 7 4 Sickle Cell 17.0 1 8.0 1 5 Severe Malnutritn 11.7 4 6,6 4 6 Prematurity 2.0 12 1.0 13 7 Birth Injury 14.7 3 7.7 3 8 Accidents 2.0 11 1.5 10 9 Gastroenteritis 1.0 14 0.5 14 10 Tuberculosis 5.5 8 3.° 8 1l Cerebrovascular 7.4 7 5. 6 12 Pneum. (Adult) 1.5 13 1.2 12 13. Tetanus (Neon. ) 15.3 2 8.2 2 Sources: Except for HIV infection, the diseases are ranked in order of total number of healthy life days lost as evaluated in Ghana Health Assessment Project Team, International Journal of Epidemiology, 1981. Table 3. DOLLAR VALUE OF DISCOUNTED FUTURE HEALTHY LIFE YEARS (In 1985 US Dollars) Urban Urban : Urban Urban : Rural Primary Scndry : Rural Primary Sendry : Adults School School : Adults School School : Average Annual Income: : 144 287 431 ; 391 626 821 : weewew ene eo Pett ete Dew ee em Be ee ewww et eee eee feet e ween enw en ee ewe nencen? No. DISEASE NAME HIV Infection : + 890 1,780 2,669: 2,425 3,880 5,093: 0 l Malaria . : 201 402 603 : 548 876 1,150 : 2 Measles : 273 545 818 : 743 1,189 1,561 : 3 Pneum. (Child's) : 718 1,435 2,153 : 1,956 3,129 4,107 : & Sickle Cell : 1,148 2,296 3,444 : 3,129 5,007 6,572 : 5 Severe Malnutritn : 947 1,894 2,842 : 2,582 4,131 5,422 : 6 Prematurity : 144 287 431 : 391 626 821 : 7 Birth Injury : 1,105 2,210 3,315 : 3,012 4,819 6,325 : 8 Accidents : 215 431 646 : 587 939 1,232 : 9 Gastroenteritis : 72 144 215 : 196 313 411 : 10 Tuberculosis : 560 1,119 1,679 ; 1,526 2,441 3,204 : ll Cerebrovascular ; 818 1,636 2,454 : 2,230 3,567 4,682 : 12 Pneum. (Adult) : 172 344 517 : 469 751 986 : 13. Tetanus (Neon.) : 1,148 2,296 3,444 : 3,129 5,007 6,572 : Sources: Average Incomes: Joint WHO/World Bank Missions to Zaire and Tanzania. Indirect Costs: Obtained by multiplying the average incomes in the first row by the discounted, productivity-weighted years of life lost for each disease from Table 2. Table 4. TOTAL COST PER HIV-INFECTED INDIVIDUAL: (In 1985 US Dollars) : Zaire : Tanzania Row: ewe een ne ween nnee wet meee nn swneee wecnee: No.: Cost Category : Low High : Low High : :DIRECT COST : : : (1): Per Symptomatic HIV+: $132 $1,585 : $104 $631 : (2): Per HIV+ Individual : 47 560 : 37 223 : : INDIRECT COST : : : (3): Per HIV+ Individual : , 890 2,669 : 2,425 5,093 : TOTAL COST : : : (4): Per HIV+ Individual : 936 3,230 : 2,462 5,316 : :>RATIOS : : ; (5): Indirect/Direct : 19.1 4.8: 65.9 22.8 : (6): Total/Per Capita GNP: 5.5 19.0: 14.5 31.3 : NOTES: Row (1): From Table 1, various entries. Row (2): A percentage of the Row (1) figure is allocated to year i according to the assumed percentage of people infected in year zero who would convert to AIDS in that year. The assumed percentages are 0.1% in each of the first two years and 6% in each subsequent year through the tenth. It is assumed that no conversion occurs after the tenth year so that a total of only 48.2% of HIV-positives ever convert. Row (3): From Row (0) of Table 3. Row (4): Sum of Rows (2) and (3) above. Row (5): Ratio of Row (3) to Row (2). Row (6): Ratio of Row (4) to 1985 Per Capita Income. .- DIRECT COST PER CASE Fig. 1. DIRECT COST vs. GNP PER CAPITA PER SYMPTOMATIC HIV-INFECTED PERSON A UNITED STATES 4a $10,000 ana +A CARIBBEAN NATION $1,000 = A: je TANZANIA } of 1 ¢, J { t J | T qT qT | ee ' T “FT T T T $170 $290 $1,000 $8,460 $16,690 1985 GNP PER CAPITA HIGH ESTIMATE 4 LOW ESTIMATE ¢@ 2 FIG. HEALTHY LIFE YEARS SAVED PER CASE PREVENTED ERG a teh Py 20 15- 10: Fig. PRODUCTIVE HLYs SAVED PER CASE PREVENTED CRA AA RRA AY Kays COUN FOI OO MRAM AM RAS (AAA OOOO) RRR TYRE Y LOY) RRR oN eeeereaeeeeeeae We oes eae e sey Py .9,9,0,00 09,46, 6,0,9 09 6 66.0.8 6 66,0 0 9,0,0,6.9,0,86.0.0), XX, OY oot F ART 4066 ei SRR OOOO OOOO OOOO OOOOCK POOCOOON OOOO AAA AEX VY YU XNA YY ere eee oer Ges SOFT C EHH ETE SHHEPO CET EEF FOSSETT ETT SESS HEETEF TCE BOO OOOOOOUIOO) COOOL CODOOOIO COQOOOOUODOOO RA aS SAL A AAT NT IY) A AAA WA Aner ay ° SHCC oO CeCEEHEREOH OHO OCOREE DOCOOOIIOOOC 6 OOOO 2 20 15- + , Oo w Oo ~ TOTAL COSTS OF HIV INFECTION IN $6,000 ° $5,000 $4,000 $3,000 $2,000 $1,000 $0 z ¥ i v 3 ¥ Figure 4 TANZANIA AND ZAIRE Low High TANZANIA ZAIRE ME Direct Cost Indirect Cost The AIDS Epidemic in Africa: The urgent Need to Support Health Interventions in All Countries and Assistance by the U.S. Government Testimony to the Presidential Commission on the Human Immunodeficiency Virus Epidemic April 18-20, 1988 Peter Lamptey, M.D., Dr. PH INTRODUCTION Africa is the least developed of the continents, the one with the worst health status and one with the least financial and human technical resources. It is also the area that is worst hit by the AIDS pandemic. As an African and as a physician who has been involved with public health issues for 17 years, I am grateful for the leadership the U.S. Government has shown by its support of World Health Organization/Global Programme on AIDS and of the U.S. Agency for International Development technical assistance programs, the AIDSTECH and AIDSCOM projects. Of the forty one countries in Africa that have officially reported cases, 24% may be described as high prevalence, 14% as medium prevalence and 62% as low prevalence. Most of the publicity, some of it adverse, have been focussed on the high prevalence countries. As a consequence, WHO and other donors have also concentrated their efforts initially on these countries. Most of these countries have completed their medium term plans, have had donor meeting and pledges of support and are in the process of initiating AIDS intervention programs. On the other hand, the low prevalence countries have been relatively slow in anticipating their needs, and developing their plans; donor support has been lagging and few meaningful interventions are yet to be started. I would like to describe why countries with low to medium prevalence should be treated with the same urgency, and require as much help as the high prevalence countries and identify what can and should be done in these countries. There is no doubt that countries with relatively high prevalence of the disease must act now to slow the transmission of AIDS. There are equally compelling reasons why the low prevalence countries must intervene just as quickly and forcefully. In addition, I would also like to discuss two other areas of special importance: 1. Why the U.S. Government should continue its bilateral and multilateral support for the prevention of AIDS. 2. The strengths and weaknesses of bilateral as opposed to multilateral AIDS programs. A. Low Prevalence Countries In West Africa, where I come from, cases of AIDS in the general population are still relatively rare but the disease is beginning to affect groups with high-risk behaviors, such as commercial sex workers and others with multiple sexual partners. From these we can be certain that AIDS will enter the rest of the population. It is as if we were watching the beginning of a forest fire--small fires that begin in several places but which can be contained by a few individuals with fire extinguishers. If we move quickly we can stop the spread, but even a very short delay will allow the conflagration to grow with greater destruction, and with enormous, and increasing national expense and social disruption in trying to contain the epidemic. We therefore have an excellent and immediate opportunity to contain the disease in people with high risk behavior and reduce its spread to the rest of the population. In the absence of a Vaccine and treatment for AIDS, this approach to prevention becomes even more vital today. In a low prevalence African country, AIDS in some ways is a public health opportunity but a politician's nightmare. It is an opportunity because in a continent whose health resources are already overstretched, the ability to make a small investment and obtain a long-term slowing of the disease is one that cannot be passed over. It is a decision-makers nightmare because, although high risk groups such as commercial sex workers are individuals who desire help, but who live on the fringes of society: it is all too easy to tragically misinterpret efforts to extend education and services in as somehow or another encouraging prostitution. Perhaps we should remind ourselves that in Africa most prostitutes are also mothers and poverty is the scourge that has driven most of them into this occupation. It costs the whole world, especially the countries worst affected, very precious years before we accepted the AIDS problem and started doing something about it. Knowing what we do know, we cannot afford the same delay in low prevalence countries. Now the work has begun, the WHO/GPA has done a remarkable job in responding to felt needs. In the process, it has made the low prevalence countries more aware of and willing to confront their potential AIDS problem. We need to build on this momentum before it slows down. Unfortunately, there is some opposition to a major intervention effort in the low prevalence countries with explanations such as: “~AIDS is still a relatively unimportant disease in terms of morbidity and mortality compared to other communicable diseases, -The AIDS problem is grossly exaggerated by the Western press and the donor community. These are the same comments we heard from the high prevalence countries until the disease went out of control. The rapidity with which AIDS has spread in Eastern and Central Africa indicate that time is of the essence to prevent a similar Situation in other parts of Africa. We forget that only a few years ago the countries that are now high prevalence were at the same stage that the low prevalence countries are today. A timely intervention then would have saved a lot of lives. In fact we may even now be too late for what we thought were low prevalence countries. Data from Mali, Ghana and Burkina Faso show an unbelievably rapid spread of the disease. This now is the time to stop thinking in terms of high, medium and low prevalence countries. All countries are already exposed and severely affected. For some the bomb has already gone off and for some it is ticking loudly but we may not be able to stop it from going off because of complacency and denial by government and donor delay. The low prevalence countries also present us with an excellent opportunity to study and understand the epidemiological, political, cultural and social dimensions of the disease, information that is vital for the global prevention of AIDS. In some ways, AIDS is no different from previous pandemics - it is a communicable disease, and like the Black Death we have no cure for it. It is unlike other pandemics in that it is sexually transmitted and its prevention involves long term behavior change. We may not be able to change overnight social behavior that has been molded over several generations. We must however fill the large gaps in our knowledge of sexual behavior and attempt to change attitudes and practices that would reduce the transmission of AIDS. The low prevalence countries must start now, while we have some lead time. B. Why U.S. Government Support Should Continue a) As a world leader and for its own needs, the U.S. stands to benefit directly from this effort. The essential insight and practical experience that Africa provides will be useful for a better understanding of the disease leading to improvement in approaches to containing the epidemic in the U.S. It is not yet certain how rapidly and how far the heterosexual spread of HIV infection will take place in the USA, but we can be certain, from the shear volume of heterosexual cases in my own continent, that Africa is going to provide the most important information on risk factors, possible changes of infectivity with duration of the disease and the appropriateness of various possible interventions. If non-human primates are to play a role in experiments related to AIDS, these are likely to come from Africa and the necessary scientific work may indeed be conducted in African laboratories. I also suspect that if vaccines or other therapies reach human application, then at least some of the necessary clinical studies are likely to be carried out of Africa. Studies are going to be exceedingly difficult to conduct both for medical and ethical reasons, and I would expect to see American and African doctors working side by side in this complex but important area. b) The economics of several African countries have not yet recovered from the effects of the oil crisis, rapid decline in commodity prices, and political instability. The health budget of most countries are inadequate to meet the current health needs, and the immediate cost of AIDS intervention programs and health care requirement worsen an already precarious situation. International assistance is desperately needed to help balance the domestic costs of health care and AIDS intervention programs. c) AIDS is a global problem, spread in part by international travel and therefore no country, including the U.S. can insulate itself from this pandemic. dad) Africa is desperately dependent upon Americas continued generous humanitarian assistance. Cc. Bilateral vs Multilateral More than any other donor, the United States Agency for International Development (U.S.A.I.D.) has a reputation for acting quickly and forcefully. In the late 1960's U.S.A.I1.D. moved decisively in the field of family planning with measurable long term results; it offered contraceptives and services when other donors were still trying to analyze the problem and count births. U.S.A.I.D. also has a particularly strong record in working with non-governmental organizations (NGO's), and in both the areas of family planning and AIDS, where some interventions are perceived to be controversial, working with local NGO's is an excellent strategy to leverage the availability of local self- help resources. In the case of AIDS, U.S.A.I.D. and its missions have demonstrated a clear understanding of the problem and the urgent need for intervention programs in African countries. I believe the US Government has adopted the appropriate strategy in Africa by putting some of its resources into the multinational programs run by WHO, and some of it into bilateral programs, one of which I now have the privilege of directing, namely the AIDSTECH program which is part of Family Health International (FHI) in North Carolina. Nevertheless, in view of a few of the immediate need, more U.S. resources could be directed to bilateral efforts to assure the greater implementation of high priority projects for early impact. FHI is a not-for-profit institution which receives resources from U.S. foundations as well as from U.S.A.I.D. FHI's policy has been to use non-governmental money to develop pilot projects in potentially controversial areas. I am happy to report that some small pilot projects initiated by FHI with non-governmental funds from the American Foundation for AIDS Research and USA for Africa in Ghana --my country--and in Cameroon and Mali to educate commercial sexworkers and provide them with condoms and spermicides appear to be highly successful. Data are emerging to suggest that the adoption of condoms and spermicides can be sufficiently rapid to present a very genuine opportunity to slow the spread of the disease throughout the whole society. This work demands rapid expansion and I believe we have showed that such interventions are practical and not as controversial in the nations concerned as we might have thought. It is now appropriate for governmental donors to carry on and expand those life saving initiatives. The attraction of bilateral funds is that these provide an essential degree of flexibility and permit collaboration within the public and private sectors. For example while coordinating activities with National AIDS Committees it may well be that local NGO's will be the appropriate bodies for the rapid expansion of some of the early interventions. I find it interesting to note that in spite of their fine global efforts not one of the WHO programs in Africa has yet been able to move in the all important area of preventing heterosexual transmission which is the major source of HIV transmission in Africa. To date, effort has been concentrated in studying the transmission of the disease, estimating the number of infected individuals, and cleaning up the blood supply. All these things are necessary, important and valid uses of the funds the U.S. and other nations are providing to WHO, but I am convinced that we are not going to be able to slow the spread of the disease, particularly in low prevalence countries, unless well-financed bilateral programs are able to respond to what the epidemiology of the disease so clearly tells us must be done immediately with regard to heterosexual transmission. Bilateral support complements WHO's efforts in providing leadership and assistance to country programs and provides an alternate source of assistance. It also supports and strengthens other U.S.A.I.D. funded health programs in these countries. On the other hand, I believe that it should be recognized that the weaknesses of bilateral assistance in AIDS are multiplicity of bilateral donors which: 1. creates a state of confusion and puts an extra burden on countries to coordinate and manage these funding sources, 2. creates undesirable and sometimes unhealthy competition and rivalry, 3. creates multiplicity of agendas, 4. allows countries to play donors against each other. Nevertheless, the experience and success U.S.A.I.D. Missions in providing bilateral assistance in these countries has insured more efficient spending of the U.S. Government money. A current major drawback of bilateral U.S. Government assistance which affects the AIDS crisis is the legal restrictions such as, the Brooke/Alexander Amendment. I believe that AIDS should be treated as an international and humanitarian disaster and no country should be denied any assistance for political, ideological or any other reason. Multilateral programs such as WHO have the advantage of obtaining commitment from the highest levels of government. This strength is also their weakness, in that their programs have to be channelled through government organs. Our experience with family planning and other programs clearly show that non- governmental institutions have an important and essential role to play in the prevention of AIDS. . RECOMMENDATIONS 1. That U.S. Government not only continue but progressively increase its bilateral support through the U.S.A.I.D. and State Department and maintain multilateral support to the World Health Organization Global Programme on AIDS; 2. That priority resources be allocated for the low prevalence countries, as well as high prevalence countries; 3. That there be no restrictions to the use of bilateral funds for the AIDS crisis; countries such as Zambia, and Ethiopia for example require assistance and only need a small fraction of the funds available to other larger countries. U.S. funds should be allowed the flexibility to intervene in high return or high impact project affecting the general population at risk; 4. That the U.S. support programs not abandon nor divert resources from other vital areas such as child survival; if we do, children will surely continue to die. I would like to make a special appeal to the U.S. media. The western press has helped raise awareness of the AIDS problem and contributed immensely by encouraging the generous donor support that is being provided by Western countries. At the same time, the media also have created much damage and added to the AIDS problem by angering politicians, decision makers and health providers in Africa because of misinformation, distortion, irresponsible reporting and sensationalism. As a result, these reports have been partially responsible for the delay by many Africa governments in responding to the AIDS problem. Remember, AIDS is a global problem, if the media's actions contributes in the delay of the initiation of actions that will reduce the spread of the disease in Africa, then the media have contributed in promoting the pandemic in causing deaths. The political, social and cultural facets of AIDS are resulting in more short term obstructions than the epidemiological aspects of the disease. We, as health providers, can only institute interventions to prevent AIDS when policy makers support them. AIDS IN AFRICA: PERSPECTIVES ON CONTROL by Samuel K. Adeniyi-Jones, M.D., Ph.D. National Institutes of Health Bethesda, Maryland Introduction Cases of AIDS have now been reported from at least 47 countries in Africa (1). Even though the number of reported cases most probably represents an under- estimation of the true incidence, a fair picture of the scope of the epidemic is emerging. In some countries in Central Africa--i.e., Uganda and Zaire--full-fledged epidemic is evident; however, in others such as Nigeria in West Africa, it would appear the epidemic is only just beginning. For example, in Uganda as of 1987 roughly 2,000 cases of clinical AIDS have been reported, and many more are feared to be healthy carriers. In contrast to this, only 12 cases of AIDS have been reported in Nigeria, where out of 20,000 individuals tested, only 16 HIV positives were detected. The AIDS epidemic has emerged as a major health hazard | world-wide. In Africa this poses even a more serious threat because of the potential for serious socio- economic damage and possible paralysis of an already fragile health care delivery system. In countries such as Uganda and Zaire, where a large number of cases has been reported, the health care delivery systems are already over-burdened with AIDS patients. The present situation in Africa clearly dictates the need to develop comprehensive and effec - tive programs in each of these countries in order to stem the rising tide of the epidemic. There had been a widely held view that African govermients did not want to face up to the AICS epidemic; however, with improved communication betwen African governnent officials and international health officials, and as the true nature of the epidemic has become more apparent--it is now clear that most governments are demonstrating a willingness to deal with the AIDS epidemic. For example, the present government in Uganda has demonstrated a unique openness that perhaps is unparalleled anywhere in the world. One must understand the reluctance of health officials to divert funds from health budgets which even now are inadequate to deal with conditions such as malaria, malnutrition, and diarrhea. These illnesses already are devastating millions of lives each year. ven though this is the case, it seems obvious that both the morbidity and mortality fron these illnesses may be increased severely because of the immunodeficiency caused by the HIV infection. Such an increase is now being seen with tuberculosis in many parts of Africa where HIV infection is prevalent. Thus there is the need to give priority to AIDS control and prevention--both in those countries where the incidence is high, and in those where it is only just beginning. However, the development of control programs in both situations should be different; and preferably it should be different in each country, as dictated by the course of the epidemic and by the socio-cultural specifics of that country. There necessarily will be two aspects of these programs: 1) An assessment and analysis of the epidemic to include epidemiological surveys, surveil lance programs, determination of risk factors, knowl edge-attitudes-and practice (KAP) ___studies, and establishment of appropriate laboratory capability to do these studies; and 2) Control measures, to include -ssive education programs, screening in blood banks, and clinical manage «nt and counselling of patients and infected individuals within the coumuniti. Because the health care delivery systems in virtually all these countries is poorly developed and already over-burdened, they cannot--in their present state--manage such comprehensive and effective programs. An important early step will be to implement some measure of rehabilitation of the health care delivery system in these countries, to include training of personnel so that an AIDS control program can be integrated into the respective country. This will help develop the necessary infrastructure required to sustain any prograins that have to be implemented. This is in contrast to developing a separate AIDS Control program outside of the framework of the national health care system. Such programs have not worked in the past, and will not work now. It is important that the program come under the direct control of the national health care authorities for several reasons: 1) Only tne people within each country can develop enthusiasm and the spirited will that is required to generate the momentum needed to start and sustain the program, 2) Tne success of such programs requires the full backing of both government and local community officials , and 3) AIDS being a "sensitive" issue--any large influx of foreign experts could be misinterpreted. However, since these countries do not have the financial and technical resources needed for such comprehensive programs, much of this has to come from outside organizations and governments--many of whom have expressed a willingness to help in this effort, both unilaterally through the World Health Organizations (WHO), and multilaterally with the individual governments ana countries. At the present time WHO has been -“volved both in the development of AIDS Control programs, and in the manage : of donations from outside agencies. Some countries have adopted WHO A .S Control Programs (ACP), and in “collaboration with the WHO Special Program for AIDS (SPA), have had or are planning donor meetings and have enbarked on the early part of their AIDS Programs. The WHO SPA has been instrumental in getting wany countries started in their national campaign against AIDS and has provided the necessary financial and technical support for these programs. However, as its program has evolved, certain problems have emerged which need to be resolved for African countries to successfully develop effective programs. One problem has to do with the general approach of ‘the WHO SPA, and the second with the content of the program itself. The main problem with the approach is that WHO SPA insists on controlling the AIDS Programs in all these African countries. It claims to have the mandate from the United Nations to "control" AIDS world-wide. But in reality its mandate is to coordinate AIDS Programs world-wide; and it is in a position to do so effectively. The insistence on controlling programs in each "developing" country will prove counter-productive because it appears as an unnecessary imposition to the countries involved. And of course resistance develops. As an African official said, "How come the WHO is not imposing its programs on developed countries of Europe and the U.S.?" Nowhere else is it better exemplified as in Uganda which has embarked on the WHO's Medium Term Program (MTP) supposedly developed “in collaboration with the WHO," but was in fact developed by the WHO SPA. This program has five main sections, but all these sections are directly run by expatriate officials sent from the WHO. This has created a serious morale problem within the AIDS Control Program among its non-expatriate members. It is conceivable that in some countries a shortage of competent personnel may be a probl en necessitating the use of expatriate personnel. However, this problem can be solved by short, tem training programs while using consultants during this training period. To contro] all aspects of the program created a lot of resistance on the part of many national officials who see the WHO ACP as another attempt to control activities within their countries. The problem goes farther than the host countries. Donor countries have been told that all funds have to be channelled through the Wi0 SPA in Geneva. Agencies who have wanted to fund certain programs not on the WHO priority list have been reluctant to give their donations through Geneva--and, being deprived of the opportunity to have direct bilateral relations, have opted not to donate the money at all. Some of these agencies have had long lasting and effective joint programs with the respective countries. The second problem is that so far the WHO AIUS Control Programs are strongly inclined toward gathering data, and much less toward controlling the epidemic. Those aspects of the program which assess the epidemic: seroepidemiological surveys, surveillance, and laboratory diagnosis+-have been well-defined and well-implemented. On the other hand, those aspects related to epidemic control: education, blood bank testing, and clinical management and counselling services--are under-emphasized. While it is understandable that the initial part of the ACP has been oriented toward defining and assessing the epidemic, it is obvious that only measures aimed at control will play a role in controlling the epidemic. Because of this deficiency, some c..antrie~i that have sought early to implement aspects of controlling the epidem . i.€+, blood bank testing--have encountered resistance from Geneva, and have .ad difficulties including them in their national AIDS programs. WHO does not have the institutional capacity or manpower to inan every program in every country, and should not do so even if it had. For this reason it has been more successful in running seroepidemiological and serosurveillance surveys and control--e.g., educational programs--which require comprenensive planning and national mobilization. Attanpts at running individual health education programs have only served to undermine other health education programs of the Ministries of Health. The solutions to these problems are obvious. The WHO SPA should undertake only to coordinate the AIDS program. With respect to individual countries, it should assist them to develop true national AIDS programs within the multilateral framework established by the WHO SPA. The WHO SPA also shoulda allow individual countries to enter into separate bilateral agreements with each country without having the funds channelled through Geneva. This will enable agencies like the USAID, UNICEF, European Economic Community (EEC), and the World Bank to choose freely which aspect of a country's program it is willing and competent to assist with. The main thrust of the WHO coordinating effort should be directed at epidemiology, surveillance, and laboratory service--the latter of which specifically requires international standardization and continuous noni toring of available tests. Issues such as AIDS education, patient inanagement and counselling, and blood banking require substantial changes in the health care infrastructure; probably they would entail the type of input for which WHO has neither the manpower nor the expertise to handle in each and every country. It is now accepted as conventional wisdom that AIUS education should be an integral part of the general health education program. Presently in most countries the health education units are extremely weak as a result of Jack of resources. An enormous effort will be required to strengthen than so that they can undertake any effective education program, including AIDS education. Agencies such as UNICEF and USAID that have had enormous experience in production of education programs, can help develop national health education programs within which AIDS education will be a comprehensive but integral part. In addition, non-governmental organizations (NGOs) have been successful with health education, especially at the community level. Their programs easily can be integrated into a national AIDS education program. An enormous burden already is being placed--and will continue to be placed--on the health care delivery system due to many thousands of AIDS patients, as well as the many more now HIV positive, who in the near future inevitably will progress to frank AIDS. Most of these patients are being, and will continue to be, cared for either in hospitals or out-patient facilities. The burden of taking care of both the physical and psychological well being of these patients and their families is enormous and difficult even in countries where the financial resources are available. Very little attention is being paid to this now in Africa, perhaps because the resources required to deal with the problem are far beyond the means of these countries. This bur Jen is particularly a problem for those countries in which there is a substant:aily increasing number of patients. Here the issue already is an emer -ncy. Counselling is now accepted as a major component of AIDS patient management. In addition to medical treatment, counselling will help alleviate the enormous psychological suffering of both patients and their families. It will, as well, help create the sort of community support so essential to their well-being. loreover, counselling will serve as a vital component of AIDS education and prevention. Medical management and counselling will require a major international effort--the groundwork of which has to be embarked upon sooner than later. With anywhere from 10% to 20% of blood donors in some countries infected with HIV--a number which undoubtedly will keep rising--the need to deliver safe blood becomes more acute. The best argument for HIV testing in blood banks is that HIV transmission through blood transfusion is a major mode of transmission that can be eradicated. Because the entire blood transfusion system is poorly developed in most African countries, the problan of delivery of safe blood has to be broadened beyond HIV testing. A system must be developed which will deliver safe blood when and where it is needed. This would require a comprehensive plan, and necessary resources have to be organized. Agencies such as the EEC have indicated a willingness to help fund such programs in various countries. It is obvious that there are multiple components of any AIDS control program. This requires a wide range of expertise and enormous resources which ‘no ‘single agency can provide. Recently some WHO officials have stated that the WHO SPA has more money than it can utilize. This has unfortunately been interpreted in certain quarters to mean there are more than adequate funds needed for AIUS contro] in Africa. When the situation is viewed objectively in all its ramifications, it is clear that no amount of resources will be adequate to deal with the problem. If the issue is one of a lack of infrastructure to absurb the financial resources required, then the approach needs to be broadened to include development of the necessary infrastructure. There is a need for all international agencies to respond more vigorously than they are now to the present crisis situation. A certain complacency, generated by a feeling that the problem is too big or complex, or perhaps that the WHO can solve the problem, permeates the international scene presently. Unfortunately, this complacency may be just as influential to the course of the epidemic as the virus infection itself. Some agencies, such as USAID, have fortunately reached tne conclusion that the WHO SPA program alone is not adequate to control the crisis. They have embarked on creating channels for bilateral assistance. However, the funds allocated by USAID to AIUS have been very meager. Yet, USAID is in a unique position to offer assistance. In most African countries, USAID has! well-established relationships with the Ministries of Health and with local communities. Together, they have developed many collaborative programs. In addition, USAID has supported a network of agencies which have a wide range of experience in developing programs with these countries. It is necessary that adequate funds be made available to USAID for direct assistance to national AIDS programs. Since substantial health infrastructure is needed to implement these programs, World Bank assistance coutd be higr _ instrumental. Unfortunately, -19- most African governments are still unwilling to vorrow woney to finance their AIDS program. Sut as was seen recently in Uganda, the World Bank can be quite effective in coordinating funding by donor organizacions. In addition, it can € help develop the framework necessary to support effective nealth programs. For most Africans the first acquaintance with the AIUS epidemic was the widely publicized belief that AIDS originated in Africa. This has unfortunately created an atmosphere that is not conducive to AIDS control, because it diverts attention and efforts from the real public health issue. One can sympathize with most African officials who found this belief in tne African origin hypothesis unacceptable, especially when any attempt on their part to counter this was immediately interpreted as "over-sensitivity" and a reluctance to confront the AIDS issue. Officials in both the U.S. and the USSR are no less sensitive when it is claimed the AIDS virus originated in laboratories in their countries. This politicization is not inconsequential. This problem has become more acute to most Africans as some countries such as the USSR and India have implemented compulsory testing of Africans within their countries, while others such as the United States have instituted testing for all immigrants. Fortunately, much of this politization has died down recently, as officials have realized that the epidemic is raging world-wide, and that we have a collective responsibility to stop it. As with other epidemics of this magnitude, AIDS eradication must be global to be effective. This requires perhaps even more intimate collaboration between nations than we have previously been used to. Our ability to survive this global pandenic wil] depend on our collective will and our ability to show understanding and compassion for human suffering everywhere. For it is only this latter quality which can sustain that collective will. -l1- The United States government recently has been responding more vigorously with more financial input into the control of the AIUVS epidemic in the U.S. The test for the government and the people js whether this national effort can be broadened into a real international concern and effort to meet the challenge of this global epidemic. References 1. AIDS: An International Perspective, Science, 239, 573-586, 1988 The AIDS Epidemic in Zambia Peter L. Perine, M.D., MPH The first evidence for the presence of Human Immunodeficiency Virus-1 (HIV-1) in Zambia was in 1982, when persons with an atypical, aggressive type of Kaposi's sarcoma began to appear at the University Teaching Hospital (UTH) in Lusaka, Zambia. Over the next five years the number of AIDS cases has increased to a reported 709 Zambians with 80 deaths (February 1988), which have disproportionately been members of the professions and the educated. During this time the number of Zambians infected with HIV-1 has also increased dramatically. Medical care in Zambia is provided by the government to all citizens through its 71 hospitals and 845 urban and rural health centers. It is organized as a primary health care system extending to the level of village health workers with a referral mechanism up the pyramid from District level health centers, to Provincial hospitals, and at the national level to the University Teaching Hospital in Lusaka. The total number of hospital beds is 15,348 (including those in 11 Mining Industry hospitals) with an additional 6,320 beds available in Health Centers. Medical care for the 7.5 million people is provided by approximately 800 physicians, 6300 nurses, 1350 clinical medical officers, and 500 health assistants. Impact of AIDS The HIV epidemic in Zambia is seriously taxing its health care facilities. HIV related disease currently accounts for about 10% of all general hospital admissions and up to 30% of admissions to the general medical wards. The immediate problems this presents includes a disproportionate allocation of both diagnostic and therapeutic resources, repeated hospital admissions and treatment with medications that are often in ver, ~:~ . supply. At UTH, HIV cases currently comprise 17% of medical ward admissions and 42% of these patients have active pulmonary or disseminated tuberculosis. Tuberculosis is often the first manifestation of HIV. Diagnosis is difficult because chest X-rays may be normal or atypical in appearance. Although most patients respond to antituberculosis therapy, expensive multidrug regimens are required for the remainder of their lifetime, and hospital stays are prolonged. HIV infected adults with active pulmonary tuberculosis are also sources of exposure for young children sharing their household unless they are rendered noninfectious by chemotherapy. Pregnancy and Congenital Transmission The first large seroprevalence survey for HIV-1 in Zambia tested 322 antenatal women admitted to the labor wards of UTH in late 1985: 35(10.8%) were confirmed HIV seropositive, and approximately 50% of their children proved to he congenitally infected on follow-up at one year. Significant risk factors for HIV-1 infection were the number of both lifetime sexual partners and episodes of STD. Most of the HIV-1 infected mothers were asymptomatic (Walter Reed Stage 1 or 2) and had term pregnancies with no increase in miscarriage or abortion when compared to age and parity~matched HIV-negative pregnant women. Of the 400 HIV seronegative mothers followed postpartum for 12 months, only 6 (1.5%) seroconverted to HIV-1 positivity. Infants born of HIV-1 infected mothers do not differ in birth weight or rate of neurological and social development from other children. Those infected with HIV-1, however, usually become symptomatic within the first year. of life, They rapidly lose weight from a combination of chronic diarrhea, cough and fever which require frequent and often prolonged hospitalization. Six sets of twins born of HIV-1 infected mothers have been identified and in two instances only one twin is or was infected with HIV-1. Virtually all Zambian infants are breast fed for the first 1-2 years of their lives and most receive BCG, measles, polio and DPT vaccinations during their first vear. An ongoing study shows no evidence that the attenuated vaccines (BCG, polio and measles) act as opportunistic pathogens in HIV-1 infected children. The measles vaccine provides solid protection against measles; no child immunized has developed measles whereas several nonimmunized HIV-1 infected children aged 8-15 months have been admitted to UTH with severe measles. Heterosexual Transmission Of the 7,939 men evaluated at the STD clinic at UTH since September 1985 for HIV-1 approximately 60% were seropositive; the corresponding figure for women attending the STD clinic is 50%. The only sexual practice acknowledged by both men and women, with few exceptions, is heterosexual intercourse. Homosexuality and bisexuality is denied by aimost everyone except among 20-30% of men in prison, The anfrequency of rectal gonorrhea and/or syphilis in STD clinics tends to substantiate the rarity of anal interccurse in nonincarcerated adults. In 1986 we reported an increased risk of HIV-1 infection in patients who presented at the UTH STD clinic with genital ulcerations caused by Hemophilus ducreyi, Herpes simplex virus, syphilis or nonspecific causes, as compared to STD clinic attendees without genital ulceration. This data and that reported from Kenya suggested that genital ulcers facilitate heterosexual transmission of HIV-1. A two year followup of this series of genital ulcer and other STD clinic patients, however, showed that only 5 of 44 (11.4%) genital ulcer patients had seroconverted to HIV-1 compared to 6 of 29 (20.7%) STD patients who had nonulcerative venereal diseases. The incid: :e of HIV-1 is not significantly different in these two groups of patients but it is approximately 5 times greater than the 1.5% annual incidence observed in antepartum women who delivered at UTH. Nonveneral Transmission The potential for nonvenereal transmission of HIV in urban and rural settings has been intensely studied in Zambia. The households of patients diagnosed as having ARC or AIDS at the UTH STD clinic (UTH) in Lusaka were clinically and serologically evaluated for HIV-1 infection. In the 150 households of male index cases, 92{61.3%} of their spouses were also infected, compared to 57(73.1%) of the spouses of the 78 female index cases. The more advanced the clinical stage of illness in the index case, the greater was the probability that the spouse was also infected with HIV-1, and the more likely that the spouse was also symptomatic. Of 144 children under J years of age, 36(25.0%) were infected with HIV-l. All of their mothers were infected with HIV-1 and were the last to be born in the family with one exception. None of the 120 children between 5 and 10 years of age were infected with HIV-1. There were no HIV-1 infections in families other than those transmitted by heterosexual intercourse between spouses or by birth from infected mothers. Concern about the potential for HIV transmission by insects prompted a large seroprevalence survey of school children living in Mansa, a small town located in northeastern Zambia near the Zaire border. In this community malaria is transmitted every day of the year. A total of 3,296 children were tested for anti-HIV-1 antibodies; 16(1.03%) of 1555 boys and 15(0.86%) of 1741 girls tested were seropositive for HIV-1. As expected, more than half of the school children had high titers of antibody to the surface Sporozoite antigen of P. falciparum. No child manifested signs of ARC or AIDS, although about one half had spleenomegaly and most were anemic and underweight for their height as a conseauence of repeated boyts of P. falciparum malaria. At least three of the HIv-1 infected school-aged children had received blood transfusions at some time in their life and several others acknowledged sexual exposure; no risk factor for HIV-1 has yet been identified in the HIV-1 infected children, but epidemiologic investigations of them and their families are incomplete. Hepatitis B Virus (HBV) and HIV-1l As in many African cultures, the residents of Mansa scarify their skin for decorative, ritual, and tradition medicinal purposes using unsterilized instruments. This begins in infancy and is almost universal. Scarification likely contributes to the transmission of HBV which is endemic in the community; 43 (57.3%) of 75 Mansa children under 6 years of age had either Hepatitis B surface antigen and/or Hepatitis B core antibody. The prevalence of Hepatitis B surface antigen progressive declined from 4 high of 45.3% of those under 6 years of age to a low of 13.3% of persons 36-40 years of age, while the prevalence of Hepatitis B core antibody increased from 20% of those under 6 years of age, to over 70% of those 41 years or older, The prevalence of these HBV antibodies is significantly greater than in age and sex-matched urban patients attending the STD clinic at UTH in Lusaka. There is no doubt that HBV causes early morbidity and mortality from postnecrotic cirrhosis and Nepatocellular carcinoma, One possible effect of HIV-1 coinfection with chronic hepatitis B infection may be to modify the immunopathology of the latter, increase hepatitis B viremia and thereby increasing the risk to transmitting hepatitis B virus to sexual partners and household contacts. Household Survey for HIV and Other Retroviruses We have conducted a HIV-1 seroprevalence survey among 223 randomly selected households in Mansa. 40 (17.9%) of these hc.seholds had one or more members infected by HIV-1 for a total of 92 (9.9%) copositives out of 925 tested; 24 (6.9%) of the 348 males and 68 (11.8%) of 577 women tested were infected with HIV-1. None of the 325 sera tested were positive for HIV-2 and only 1 of 100 persons tested for HTLV-1 was positive. The average age of the adult men (>15 years) tested was 35.1 years, with a median age of 32; the corresponding figures for women was an average age of 26.1 years and a median of 24 vears. Proportionately more women than men are infected from 6 to 30 years of age but men predominate thereafter. Only 9 (2.5%) of 358 children under age 15 years in the household survey in Mansa were infected with HIV-1 and no child between the ages of 4 and 11 was infected. The 4 infected infants identified in this survey were all male and ranged in age from 8 months to 3 years; all were born of HIV seropositive mothers. Three of the 5 HIV-1 infected 15 year olds admitted sexual exposure. Nineteen (8.5%) of the 223 households had more than one member infected with HIV-1, accounting 62 (67.2%) of the 92 seropositive persons, which represents a highly significant clustering of HIV-1 cases. Twelve (50%) of the 24 seropositive men had a history of STD as compared to 13 (19%) of the 68 seropositive women, a difference which was also significant, In contrast, only 1 (4.2%) of 24 infected males had been given a blood transfusion, compared to 17 (25%) of infected females. Although it is premature to draw conclusions about the transmission of HIV-1 in Mansa, our data indicate that heterosexual intercourse and congenital/perinatal transmission are the principal modes of its transmission. Because screening of blood donors has only recently been instituted at the Mansa hospital, transmission of HIV-1 by contaminated blood has also likely to have been significant. Most blood transfusions are given to young children with severe anemia caused by malaria or to women experiencing hemorrhage during pregnancy or delivery. Despite frequent exposure to unsterilized instruments such as razor blades for scarification, there is little evidence that this practice transmits HIV-1. Since the lowest age~specific prevalence of HIV-1 in Mansa and Lusaka are prepubesent school aged children between 5 and 15 years of age, educational programs concerning AIDS and other STDs should be most effective if they are made part of the elementary curriculum. Prevention and Control Every patient identified by serologic tests as being infected with HIV-1 is told about his or her infection when the confirmatory test is positive. At UTH, each such patient is encouraged to attend three counseling sessions in which she or he is informed about the modes of disease transmission, the lack of a cure, and advised also how to prevent transmission and possibly limit disease progression. Patients are encouraged to bring their sexual partner(s) or spouses in for HIV testing and to use condoms to lessen heterosexual transmission. During counseling most patients come to accept the reality of their disease and prognosis, but many also seek therapy from traditional healers which may involve considerable expense. Most patients accept their prognosis and modify their sexual and social behavior to avoid transmitting the virus. Infected women are informed about the risks of congenital infection and the potential adverse effects of pregnancy on themselves and their fetus. Because children are so cherished in Zambia, most infected women continue to become pregnant in hopes that the child will be free of the infection. Children are so highly desired that health education focused on protecting the health of the unborn may be especially effective in modifying sexual risk behavior in adults, President Kenneth Kwanda of Zambia, as the current President of the Organization of African Unity, has urged that member nations take urgent steps to educate their people about AIDS to prever*: its transmission, as education is the only means of controlling the epiaemic. “o be effective, educational programs must be focused on children before they become sexually active. This education must be sensitive to the social and cultural traditions of various tribal and ethnic groups. The Zambian Ministry of Health has produced thousands of AIDS educations posters which are displayed in public buildings, clinics, hospitals and businesses, and national television programs regularly feature discussions with health professionals and educators about AIDS. Two national conferences on AIDS and counselling of AIDS patients have been held in Zambia since 1986 and another is planned this year. Summary HIV is epidemic in Zambia among both urban and rural populations. Transmission is predominately by heterosexual intercourse and during pregnancy. Transmission by transfusion of infected blood will decrease significantly once screening tests are made available to all hospitals and health centers. Hospitals cannot now or soon will not be able to treat HIV-1 patients requiring hospitalization. The health care system faces critical shortages in personnel, supplies and equipment, and its facilities are rapidly deteriorating because of lack of maintenance. This forcing the family to assume responsibility for patient care at home. Available epidemiologic data suggest that the slope of the epidemic HIV-1 infection curve may be falling, but the number of projected AIDS cases among those already infected by HIV-1 may have catastrophic socioeconomic consequences in the next decade. At a recent meeting in Lusaka involving 27 different “donor" agencies a coordinated effort was initiated to provide funds to the Ministry of Health for screening and prevention of HIV-1. This includes provision of diagnostic reagents, vehicles, professional and technical training, educational projects, and prevention (condems). The United States pledged $360,000 for commodities but has been constrained from giving more because the Brooks amendment prohibits financial aid to Zambia as its payment of interest on its debt to the U.S. has not been paid for the past 24 year. USAID is anxious to provide Zambia with more assistance for HIV-1 disease control active efforts, and perhaps this commission could ask Congress to exempt Zambia from the Brooks amendment law and allow USAID to fund urgently needed prevention and control activities. TANZANIA ZAIRE 250 Km radius 125 Kin\radius ANGOLA cout west i RHODESIA -BOTSWANA <<} " NORTH Clinical Features of HIV Disease in Zambia S. K. Hira, MD. Consultant Dermatologist N. Ngandu, M.Sc, Lecturer, Medical Statistics D. Wadhawan, M.D., MRCP Senior Lecturer, Medicine B. Nkowne, M.D. Lecturer, Community Medicine K. S. Baboo, M.D. Senior Lecturer in Community Medicine J. Kamanga, Dip. Cl. & Med. Sc. R. Macuacua, B.sc. School of Medicine University of Zambia B. Mpoko, B.sc, University Teaching Hospital P.O. Box 50001 Lusaka, Zambia P. L. Perine, M.D., M.P.H. Professor of Tropical Public Health Uniformed Services Univeristy of the Health Sciences Bethesda, MD 20814-4799 ABSTRACT Among 1107 patients with serologically confirmed HIV-1 infection evaluated at University Teaching Hospital, Lusaka, through December 1986, 103 (9.3%) had AIDS, 958 (86.5%) had AIDS-related complex, and 46 (4.2%) were asymptomatic. The male to female ratio of cases was 1.5:1 and women were younger (mean age 26.2 yrs), than men, Clinical features in decreasing order of frequency were weight loss, persistent cough, persistent generalized lymphadenopathy, multidermatomal herpes zooster, diarrhoea, candidiasis, and Kaposi's sarcoma. The WHO clinical casé-déefinition for the diagnosis of AIDS in Africa had a low predictive value for the 103 Zambians with AIDS, but for all those infected by HIV, the positive predictive value was 76.4%. LINICAL FEATURES OF HIV DISEASE IN ZAMBIA: Introduction The acquired irmune deficiency syndrome (AIDS) a global health problem. Opportunistic infections which typify immune deficiency caused by the human immunodeficiency virus (HIV) have appeared in Africans in significant numbers only within the past 4 years, Although the pathogenesis of HIV infection is Sittiiar in all patients with HIV disedse, the epidemiology and clinical presentations vary, especially in Africa (1). We havé analyzed in our report the clinical presentation of HIV infected patients in Lusaka, and have tested the reliability of the WHO clinical case-définition for the diagnosis of AIDS in gambia (2). Patients and Methods The study was conducted at the AIDS clinit attAched to dermato-venerealoygy division at the University Teaching Hospital’ (UTH) in Lusaka, between August 1985 and December 1986. Consecutive patients referred because of clinical suspicion of immune deficiency from medical, pediatric, obstetric and surgical departments, Those admitted to medical wards were also entered into the study. After an informed consent was obtained, a standard questionnaire was administered to all patients and a physical examination was performed. Serum was tested for HIV antibody by enzyme-linked immunosorbent assay (Abbott Laboratories, North Chicago, IL) and Western blot analysis; a specimen was considered positive if p24 and gp4l1 protein bands were present on Western blot. Results Of the 1652 patients referred through December 1986, 1107 (67.9%) were positive for HIV antibody by ELISA and Western blot. Of these, 103 (9.3%) had an opportunistic infection or aggressive Kaposi's sarcoma and were diagnosed as AIDS, 958 (86.5%) were diagnosed as ARC and 46 (4,2%) were asymptomatic. Among the AIDS/ARC patients, 869 (81.9%) were aged between 20 and 39 years (mean age 31.4 years) and male to female sex ratio was 1.5:1. Females were younger (mean age 26.2 years) than men and there were 34 children under the age of 4 years. The common clinical features among patients presenting with AIDS/ARC in decreasing order of frequency were weight loss, persistent cough, persistent generalized lymphadenopathy, multidermatomal herpes zoster, diarrhoea, candidiasis, tuberculosis and Kaposi's sarcoma (Tables 1 & 2). With respect to the relationship between clinical features and HIV infection, there was no significant difference in the clinical features between men and women. However, there were significant differences in clinical presentation among the different age groups, except for cough, diarrhoea, candidiasis and tuberculosis. All of the symptoms and signs listed in the tables had high specificities (70% or more) in patients aged 25 to 39, years except for weight loss, which had the highest specificity only in the age group of 15-19 years. The positive predictive values showed similar patterns and specificity values, with all the features having predictive values of 70% or more in 25-39 year age group. The combination of weight loss (10% of normal body weight) in the presence of chronic diarrhea, persistent fever and/or generalized lymphadenopathy had a very high specificity (90% or more) and positive predictive values (70% or more) for HIV-related disease/infection. The provisional World Health Organization clinical case-definition for diagnosis of AIDS in Africa (2) was applied to 103 patients with AIDS who had been diagnosed on the basis of opportunistic infections, including tuberculosis or aggressive Kaposi's sarcoma, and to the remaining 1004 patients with HIV infection. The WHO clinical case-definition for the diagnosis of AIDS had a low positive predictive value for Zambians with AIDS (Table 3), but, for all HIV infected patients, the positive predictive value was 76.4%. Discussion The clinical manifestations of HIV-1 infection vary in different populations (1,3). Profound weight loss and dermatologic manifestations are commonly reported in Africans (4,5), while generalized lymphadenopathy and pulmonary symptoms are frequently seen in the United States (6). All of the clinical features listed as major and minor criteria for the clinical case-definition of AIDS by the World Health Organization (2) for use in Africa have high diagnostic specificity and a positive predictive value for HIV infection in Zambia, but most of them have low sensitivity. Colebunders et al (7), evaluated the WHO clinical case-definition for AIDS in HIV-positive medical in-patients in Zaire and found a sensitivity of only 51%, a specificity of 90%, and positive predictive value of 74%. This low specificity and low positive predictive values were obtained for patients with AIDS indicating a major difference in the c:.nical case-definition for AIDS is HIV infection. This is because disseminated tuberculosis and aggressive Kaposi's sarcoma are not included in the WHO clinical case-definition and because the clinical features of ARC are combined in clinical case-definition for making a diagnosis of AIDS. Although the WHO clinical case-definition in its present form will lead to overdiagnosis of AIDS in Zambia, it should guide the clinician to request the appropriate laboratory tests to establish the diagnosis of AIDS. l. References Quinn IC, Mann JM, Curran JW, Piot P. AIDS in Africa: An epidemiologic paradigm. Science 1986; 234:955-63, World Health Organization. Acquired immunodeficiency syndrome (AIDS); WHO/CDC case definition for AIDS. Wkly Epidem Rec 1986; 61:69-76. Pallangyo KJ, Mbaga IM, Mugusi F, et al. Clinical case definition of AIDS in African Adults. Lancet 1987; 11:972. Serwada D, Mugerwa RD, Sewankambo NK et al. Slim disease: a new disease in Uganda and its association with HTLV-III infection. Lancet 1985; ii1:851-2, Hira SK, Wadhawan D, Kamanga J et al. Cutaneous manifestations of human immunodeficiency virus disease in Lusaka, Zambia. J Am Acad Derm (in press). CDC. Revision of the CDC surveillance case definition for acquired immunodeficiency syndrome. MMWR, 1987; 36:1s-18s. Colebunders R, Mann JM, Francis H et al. Evaluation of a clinical case~definition of acquired immunodeficiency syndrome in Africa. Lancet 1987+ 1:492-4, Table 1. Presenting Symptoms in 103 AIDS Cases, Attending the AIDS Clinic University Teaching Hospital, Lusaka, 1985-1986. Symptoms* Number of Cases % Weight loss 71 . 68.9 Persistent cough 58 56.1 Tuberculosis 27 26.2 Aggressive Kaposi's 38 36.9 Candidiasis 42 40.8 Persistent diarrhoea 34 33.0 Herpes Zoster 36 35.0 *Some patients had more than one symptom Table 2. Presenting Symptoms of AIDS-Related Complex Cases in 958 Patients attending the AIDS Clinic, University Teaching Hospital, Lusaka, 1985-1986, Symptoms * Number of Cases % Weight loss 556 55.2 Lymphadenopathy 469 46.6 Persistent cough 369 36.6 Persistent diarrhoea 284 28.2 Herpes Zoster 256 25.4 Candidiasis 80 7.9 *Most patients had more than one symptom. Table 3. Validity of the WHO clinical case-definition of AIDS in Zambia. Sensitivity (%) Specificity (%) Positive predicitive value Meeting case-definition criteria (n=467) AIDS n=41 HIV infection N=426 39.8 32.2 73.5 79.8 8.8 76.4 10 Short Report OUTCOME CF PREGNANCY AND VERTICAL TRANSMISSION OF HUMAN IMMUNODEFICIENCY VIRUS IN ZAMBIA S.K. Hira, M.D. Consultant Dermatovenerologist D. Chikamata, M.D, Chairman, Department of Obstetrics and Gynecology G.H. Bhat, M.D Consultant Pediatrician University Teaching Hospital Lusaka, Zambia P.L. Perine, M.D. Professor, Tropical Public Health Uniformed Services University Bethesda, MD, USA 20814-5799 OUTCOME OF PREGNANCY AND VERTICAL TRANSMISSION OF HUMAN IMMUNODEFICIENCY VIRUS IN ZAMBIA Hira SK, Chikamata D, Bhat GJ, Perine PL SUMMARY Between September 1985 and February 1986, 78 (8.6%) of 908 women delivering at the University Teaching Hospital (UTH) in Lusaka, Zambia, were seropositive for Human Immunodeficiency Virus-1 (HIV) antibodies by ELISA and Western blot analysis. Sixty-two cord-blood specimens from newborns of seropositive women were available for testing and 58 (93.5%) were positive. Subsequently, 36 sets of seropositive mothers and their babies were followed reqularly for at least 1 year. Six (16.7%) infants died at 3 to 12 months of age, at least two due to AIDS. Of the remaining 30 infants, 12 (40.0%) were seronegative at 9-12 months of age, and they were asymptomatic. Among the 18 seropositive infants at 1 year of age, 6 (33.3%) had hepatosplenomegaly. All infants had received live attenuated vaccines during the first 8 months of life without apparent iil effect. Fourteen (38.8%) of the 36 seropositive mothers developed AIDS related complex within the year following delivery, compared to only one of the 10 seropositive fathers, indicating that pregnancy may accelerate the course of HIV disease. INTRODUCTION Human Immunodeficiency Virus-1 (HIV) may be transmitted from an infected mother to her fetus during pregnancy or childbirth (1-2). Studies involving small numbers indicate that approximately 20 to 50 percent of infants born of infected mothers will also be infected (3). We report here the outcome of pregnancy and the frequency of vertical transmission of HIV in Zambia, 2 PATIENTS AND METHODS Between September 1985 and February 1986, 908 antinatal women (mean age 23.6 years, range 16 to 25 years) at UTH were tested for HIV antibody. A detailed history and physical examination was performed on seropositive women who consented to the study. Sera from the mother, live and stillborn infants and available fathers, were tested for anti-HIV antibodies and by ELISA and Western blot analysis at birth, 6, 9 and 12 months after delivery. RESULTS Of 908 women, 78 (8.6%) were confirmed seropositive for HIV. Adverse pregnancy outcomes occurred in 12 (15.4%) of the seropositive mothers compared to 115 (13.9%) of the seronegative mothers, not a statistically significant difference. (Table 1). Only 62 cord+blood specimens of infants born to the 78 HIV-infected women were available for testing and 58 (93.5%) were positive. Subsequently, 36 sets of seropositive mothers ahd their babies were followed. Fourteen of the 36 mothers developed clinical features of AIDS~related complex in the year following delivery. Six (16.7%) infants died at 3 to 12 months of age, at least two with opportunistic infections and 12 (40.0%) became seronegative between 912 months of age and were asymptomatic. Of the 18 remaining seropositive infants at one year of age, 6 had hepatosplenomegaly and one had generalized lymphadenopathy; none had neurologic deficits nor delayed development. Ten of the 22 fathers examined and followed were seropositive for HIV; only one developed ARC or other evidence of symptomatic infection. All children born of mothers enrolled during the 6 month entry period received live attenuated vaccines without complications, beginning with BCG at birth, oral polio at 3, 4 and 5 months, and measles at 8 months of li. . DISCUSSION This study documents the high risk of ver-.1cal transmission of HIV without apparent teratogenesis or fetal wastage increased above that of noninfected mothers. The most important finding in this study is that at least 40% of the infants born of HIV-infected mothers appear to have escaped infection by clinical examination and as measured by loss of HIV antibody during the first year of life. Because of the high risk of vertical transmission of HIV and the potential deliterious effect of pregnancy on the rate of disease progression, all HIV infected women are advised against future pregnancies. All infants received live vaccines without any apparent complications. Although live vaccines may be hazardous in HIV-infected infants (4), we believe the benefits of immunization clearly outweigh the risks in Zambia. REFERENCES 1. Lapointe N, Michaud J, Pekovic D et al. Transplacental transmission of HTLV-III virus. New Engl J Med 1985; 312:1325-26. Cowan MJ, Hellmann D, Chudwin D, et al. Maternal transmission of acquired immune-deficiency syndrome. Pediatrics 1984; 73:382-86. Recommendation for assisting in the prevention of perinatal transmission of human T-lymphotropic virus type III/lymphadenopathy-associated virus and acquired immunodeficiency syndrome. MMWR 1985; 34:721-31. Halsey NA, Henderson DA. HIV infection and immunization against these agents. New Engl J Med 1987; 316:683~-85. Table 1. Adverse pregnancy outcome in HIV infected and noninfected mothers. HIV Positive HIV Negative {n=78) (n=830) Abortion 3 28 Stillbirth 4 26 Low birth weight 5 33 Prematurity - 28 Total 12(15.4%) 115(13.9%) NO EVIDENCE OF NONSPOUSAL HOUSEHOLD TRANSMISSION OF HIV IN LUSAKA, ZAMBIA S.K. Hira, M.D., B.M. Nkowane, M.D., J. Kamanga, Dip. Cl. & Med. Sc. D. Wadhawan, M.D., F.A.C.P., D. Kavindele, M.D., R. Macuacua, Bs.C., G. Mpoko, Bs.C., M. Malek, M.D., *P.L. Perine, M.D. University Teaching Hospital, Lusaka, Zambia and the *Uniformed Services University of the Health Sciences Bethesda, Maryland 20814-4799 ABSTRACT Persons living in the same household of index patients with AIDS or ARC in Lusaka, Zambia, were clinically and serologically evaluated for HIV-1 infection. In the 150 households of male index cases, 92 (61.38) of their spouses were infected, compared to 57 (73.1%) of the spouses of the 78 female index cases. The more advanced the clinical stage of illness in the index cases, the greater was the probablility that the spouse was also infected with HIV-1, and the more likely that the spouse was symptomatic. Of 144 children under 4 years of age, 36 (25.0%) were infected: all had infected mothers and were the last to be borne in all but one household. None of the 120 children 5 to 10 years of age were infected. The study indicates an increasing risk of HIV transmission to an uninfected spouse with increased progression of disease in the infected partner and that the efficiency of sexual transmission from an infected women to her husband was as high as that from an infected husband to his wife. There were no HIV infections that could not be attributed to transmission but means other than heterosexual intercoyrse between spouses or children borne of infected mothers. INTRODUCTION: The epidemiology of Human Immunodeficiency Virus-1 (HIV) in Africa indicates that it is transmitted mainly by heterosexual intercourse (1). The evidence to support bidirectional sexual transmission of HIV includes isolation of the virus from both semen and vaginal secretions of infected men and women (2,3). Reports of the isolation of HIV from the saliva and tears of patients with ARC (4,5) has raised the possibility of alternate modes of HIV transmission, and has heightened concerns about its possible nonvenereal transmission among family contacts, especially in developing countries where crowded dwellings and poor hygiene make intimate nonsexual contact within households inevitable, To evaluate the potential modes of HIV transmission in families of patients with acquired immunodeficiency syndrome (AIDS) and its related complex (ARC), we investigated the spouses and children of patients with AIDS/ARC for evidence of HIV infection and disease. PATIENTS AND METHODS: Between August 1985 and June 1987, individuals in 244 households of index patients with AIDS or ARC were evaluated and followed at Dermatovenereology Clinic at the University Teaching Hospital in Lusaka, Zambia. Married spouses were enrolled from 228 households; they were the spouses of 31 patients with AIDS, 188 patients with ARC and 9 asymptomatic seropositive individuals who consented to a medical evaluation and testing for HIV infection. Also, 264 children under 10 years of age in 154 families were medically evaluated and tested for HIV infection. The remaining 90 households either had no children, or the children were not currently living with their parents. Medical - evaluation included history and physical ex. ination, and serological testing for antibody to HIV by ELISA (Abbott Laboratories, North Chicago, IL); all seropositive sera were confirmed by Western blot analysis. Thirty HIV antibody- negative spouses of patients with AIDS/ARC were also tested by ELISA for the p24 presence of protein of HIV in their serum (Abbott Laboratories, North Chicago, IL). RESULTS : Spouses of patients with AIDS were more likely to have symptomatic HIV infection (ARC), than spouses of patients with ARC, who were more likely to be asymptomatic (Tables 1,2, & 3). The longer the duration between the diagnosis of AIDS/ARC in the index patient and the testing of his or her spouse, the greater the chance of the spouse's being infected with HIV (Tables 4 § 5). All 30 antibody negative spouses had negative ELISA assays for the p24 structural antigen of HIV. All of the couples continued to have sexual intercourse, but none used condoms or other forms of barrier contraception. Among 154 families of index patients who were evaluated and tested, 35 families had 36 children who had either ARC or asymptomatic HIV infection. All the infected children were less than 4 years of age and were the "last-bornes" in their families, except in one family where both children, 1 and 3 years old, were infected. Thus, of 144 children under 4 years of age, 36 (25.0%) were infected. Failure to thrive, chronic cough, weight loss, diarrhoea and recurrent fever were the common clinical features in the 23 children with ARC. Among the seropositive children, the male to female ratio was 1:1.3. Parents of children with ARC were more likely to have symptomatic HIV infection, than parents of children with asymptomatic infection. DISCUSSION: Although infected male spouses had a significantly higher number of sexual partners than their noninfected counterparts, there was no significant difference in past episodes of sexually transmitted diseases. A significantly higher number of male than female spouses of index cases were found infected. We were surprised by the high rate of infection among marital partners regardless of the sex of the index case. This suggests that female-to-male transmission is as efficient as male-to-female transmission. Infected spouses of patients with AIDS were more likely to have clinical features of ARC and spouses of patients with ARC were more likely to be clinically normal, so that the longer the elapsed time between the diagnosis of AIDS or ARC in the index case, the more likely that the spouse's HIV infection was symptomatic. The Western blot analysis of sera from our HIV patients, showed the reactivity intensity of the p24 band was markedly less with sera from AIDS patients compared to those with ARC infections, while the intensity of the env-derived bands was equal for both stages of infection. This could signify a loss by the patient of the ability to regulate HIV replication resulting in an increase in infectivity. Despite parental infections, none of the children over 5 years of age group were infected, suggesting that transmission of HIV by close personal contact between parents and their children does not occur. In other studies, we have found that up to 60% of children borne of HIV seropositive mothers are perinatally infected (6). REFERENCES : 1. Quinn TC, Mann JM, Curran JW, Piot P. AIDS in Africa: an epidemiologic paradigm. Science 1986; 234:955-63, Ho DD, Schoolay RT, Tota TR, et al. HTLV-III (human T-cell leukemia virus) in the semen and blood of a healthy homosexual man. Science 1984; 226:451-53. Vogt MW, Markus W, Witt DJ, et al. Isolation of human T cell lymphotropic virus type III/lymphodenopathy-associated virus from cervical secretions of women at risk for acquired immunodeficiency syndrome. Lancet 1986-I, 525-27. Mann JM, Quinn TC, Francis H, et al. Prevalence of human T cell lymphotropic virus type III-lymphadenopathy associated virus in household contacts of patients with confirmed acquired immunodeficiency syndrome and controls in Kinshasa, Zaire. J AMA 1986; 256:721-24. Groopman JE, Salahuddin SZ, Sarngadharan MG et al. Isolation of HTLV~III from saliva of pre-AIDS, AIDS and healthy homosexual men at risk for AIDS. Science 1984; 226:447-49. Table 1 Index patients with AIDS/ARC versus spouses. Diagnosis Males Infected Females Infected index patient n=150 spouse (%) n=78 spouse (%) AIDS 22 17 (77.3) - 9 9 (100.0) ARC 126 74 (58.7) 62 43 (69.4) Asymptomatic 2 1 7 5 seropositives Total 150 » 92 (61.3) 78 57 (73.1) Table 2 Clinical diagnosis in infected female spouses. Diagnosis Infected female spouse index patient AIDS ARC Asymptomatic Total AIDS (n=22) 0 12 5 17 ARC (n=126) 0 32 42 74 Asymptomatic 0 0 1 1 seropositive (n=2) Total (%) - 4d (47.8% 48 (52.2) 92 Table 3 Clinical diagnoses in infected male spouses. Diagnosis Infected male spouse index patient AIDS ARC Asymptomatic Total AIDS (n=9) 0 7 2 9 ARC (n=62) 0 20 23 43 Asymptomatic 0 1 4 5 seropositive (n=7) Table 4 Duration between diagnosis of index patient and testing of infected female spouse, Duration since diagnosis ARC Asymptomatic of index patient 0-6 months 19 40 7-12 17 6 13-18 8 2 Table 5, Duration between diagnosis of index patient and testing of infected male spouse. Duration since dx ARC Asymptomatic of index patient O-6 months 17 21 7-12 6 4 13-18 4 4 19-24 1 0 THE CANADIAN RESPONSE TO AIDS 1. ACTIVITIES OF THE DEPARTMENT OF NATIONAL HEALTH AND WELFARE The first Canadian case of AIDS was diagnosed in February, 1982. Retrospective diagnostic review indicates that the first case of AIDS occurred in Canada in 1979, and by the end of 1982, 22 cases had occurred. As of March 21, 1988, a total of 1,664 case reports were received by the Federal Centre for AIDS. A profile of AIDS in Canada is appended (appendix 1). The initial response of the federal government to the emerging AIDS problem followed shortly after the first diagnosed case. The Laboratory Centre for Disease Control (Canadian CDC) was the focal point for this response, with support in the form of research funding from the National Health Research and Development Program and the Medical Research Council. In September, 1983, a National Advisory Committee on AIDS (NAC-AIDS) was established to provide the Minister of National Health and Welfare with advicé on the measures necessary to address the problem, and to develop recommendations for health care workers, laboratory workers and others dealing with patients and specimens. In this task, NAC-AIDS Committee benefitted from Similar guidance being issued by the Centers for Disease Control in Atlanta. There continues to be a close and positive association between the health agencies of both countries. The Laboratory Centre for Disease Control (LCDC) also issued the first of three versions of a pamphlet entitled "AIDS in Canada. What You Should ‘Know", produced annually, which received considerable public distribution through physicians and nurses, health care institutions and public health services, supermarket displays, and inclusion in promotional kits given to college students. In total, about 1.5 million copies of this brochure were distributed across Canada. The Department also received $1.5 million in supplementary funds for the purchase of flow cytometers or cell sorters to assist facilities across Canada to undertake research and diagnosis. In the first two years, the federal government's activity waS primarily oriented to epidemiological and biomedical research, laboratory services and support to the medical community. This emphasis was reflected in the composition of the NAC-AIDS, and in the advisory committees established at that time in the Provinces of Ontario and Quebec. In 1984, Lcpc commissioned a study to evaluate the developing response situation, and to determine priorities for future action. This directional planning exercise outlined 3 program activities and organizational concerns considered necessary to maintain a responsible and effective response to the problem. In the fall of 1985, the House of Commons Standing Committee on National Health and Welfare began hearings on the problem of AIDS in Canada. The Committee heard testimony from scientists, clinicians, government officials and others in the course of developing 23 recommendations for federal government action. During the same period, the Minister of National Health and Welfare, on the advice of the NAC-AIDS, and based on the results of the directional planning review, developed a program of enhanced response to AIDS for Cabinet consideration and approval. The Standing Committee tabled its report, AIDS in Canada (appendix 2) on May 4, 1986, four days after the Minister announced the establishment of the National AIDS Program. The National AIDS Program provides for $39 million over five years (1986 - 1991) allocated as follows: - $23 million for research, administered by the National Health Research and Development Program. - $4 million for public education, provided as a contribution to the Canadian Public Health Association. - ¢4 million for the support of community based AIDS organizations, administered by the Health Promotion Contributions Program, Health and Welfare Canada. - $4 million for the enhancement of laboratory capability in Canada, providing funds for the upgrading of biocontainment facilities, the training of laboratory personnel, the testing and evaluation of diagnostic kits, the development oof diagnostic reagents, and the provision of a national diagnostic reference service. These funds also supported the work of the LCDC as a WHO Collaborating Centre for AIDS. - $4 million for the operations of a National AIDS Centre. The Centre was created as a Bureau within LCDC, with a mandate limited to the maintenance of surveillance and epidemiological research programs, and coordination of AIDS activities within the Department of National Health and Welfare. In September, 1986, the Minister responded to the Standing Committee Report with a complete description of action taken and contemplated with reference to the Committee's recommendations, under the National AIDS Program (appendix 3). ul The National AIDS Program reflected the prevailing viewpoints expressed in many forums to that time. 70% of the funds within the Program were allocated to what was essentially a biomedical and clinical research program and complementary laboratory activities. In providing the Canadian Public Health Association with all the funds allocated for public education, the government recognised the Association's reputation and experience in public health education. It also reflected an assessment of the unreceptive public climate for direct government involvement in the dissemination of sexually explicit information. The limited mandate of the National AIDS Centre reflected a government view of the issue that circumscribed it within the overall mandate of the Department of National Health and Welfare. The significant feature of the National AIDS Program was, and is, its flexibility and breadth. Rather than concentrating on a single dimension of the AIDS issue, the Program addresses all major areas of concern. The early ability of the Program to adapt to changing needs and Priorities was apparent in the activities of the National AIDS Centre. Beyond the literal confines of its mandate, the Centre was able, with the funds provided, to respond to a wide variety of emerging demands and initiatives, principally fron the social service sector and page 6 national non-government organizations like the Canadian Hemophilia Society and the Palliative Care Foundation. In addition to providing a secretariat to the NAC-AIDS, the Centre was able to draw together expert working groups and specialists to supplement thé Advisory Committee's scientific advice and recommendations. One example of the collaboration engendered under the National AIDS Program was the achievement of Canadian involvement in clinical trials of AZT, or Retrovir. Canada does not readily attract clinical drug trials, particularly in AIDS, in no small part because the United States offers a much larger population base in which to conduct such trials. Pressure on the Canadian government to make AZT available for clinical trials was intense through 1986. At the instigation of the National AIDS Centre, a meeting of clinical researchers, drug regulatory authorities and the drug manufacturer was arranged, and up to $1 million in research funds was made available for AZT research. The first meeting led to a series of sessions that resulted in both Original research on the drug and the means to make it available under a treatment protocol within 40 days of the suspension of trials in the U.S. One year after the introduction of the National AIDS Program, a process of review began that led to the current restructuring of the federal government's response, and the creation of the Federal Centre for AIDS as a structure separate from LCDC. The review addressed: (a) the gap that had developed between the declared mandate of the National AIDS Centre and the activities it had assumed, (b) the increasing involvement by other Departments and agencies of the federal government in maintaining the national and international response to AIDS, - (c) a growing number of public policy issues requiring guidance or direction on the part of the federal government, (d) the question of whether the current profile of the National AIDS Program reflected the necessary balance and strength of resources to meet the scope and seriousness of the problem as experienced and predicted. That review process has led to a series of new proposals now being considered by the federal Cabinet. The proposals include the following: a) development of comprehensive national preventive education strategies, supported by a national AIDS education program based in the Federal Centre for AIDS. The Canadian Public Health Association will continue to deliver AIDS education programs in a complementary manner. b) support for innovations at the community, local and provincial level designed to enhance the integration and quality of health social and allied services for HIV infected persons and their families c) enhanced funding for epidemiological research, clinical drug trials and vaccine development d) increased support for Canada's contribution to the international response to AIDS, through the World Health Organization and through the Government of Canada's sponsorship of the Fifth International Conference on AIDS to be held in Montreal in June 1989. Current activities and achievements of the federal government under the National AIDS Program include: a) support for research projects and related scientific activities totalling $7.7 Million (appendix 4) b) support for community based AIDS organizations engaged in education and the provision of extensive personal support sérvices to infected persons and persons with AIDS, and for the establishment of the Canadian AIDS Society, a national umbrella organization for Canadian community based groups (appendix 5) c) epidemiological studies in respect of sexually active women and health care workers accidentally exposed to HIV, and an important investigation of recent seroconversions among Canadian hemophiliacs that led to the identification of contaminated factor VIII concentrate and new measures for the acquisition of concentrate supplies. d) preparation of a major report on palliative care for persons with AIDS, expected to lead to a series of demonstration/evaluation projects in selected Canadian settings (appendix 6) 10 e) specialized reports oriented to the psychosocial dimensions of the AIDS problem. An example is appended (appendix 7) f) Canadian collaboration in preliminary human trials of a promising candidate vaccine, for which Canada also undertook essential animal investigations. --- Il 11 2. LABORATORY ACTIVITIES The Federal Centre for AIDS has been designated as World Health Organization Collaborating Centre for AIDS and is, therefore, part of the international scene with respect to laboratory activities. The laboratory also serves as the National Retrovirus Reference Centre. Activity first commenced in the AIDS field in 1984 when the HIV antibody test was first developed. Until testing kits became commercially available, all antibody testing, within Canada, was performed by the Centre. This was due to a most generous gift from Dr. Robert Gallo, providing us with sufficient material for our laboratory to develop a testing procedure. AS commercial kits became available, other laboratories in Canada were trained in the use of this test. In order to keep testing under control, each province was asked to designate one or more laboratories which would undertake the testing program for that province. In this way the manufacturers were told that testing kits could be sold only to the designated laboratories. Training in Western Blot technique was offered by the FCA. The laboratories also were instrumental in co-developing the immuno fluorescent antibody test with Institut Armand Frappier in Quebec. This alternative confirmatory test is now used a 12 relatively extensively in Canada but “not to the exclusion of Western Blot which is still the preferred confirmatory test method. The laboratories also developed techniques from culturing HIV and peripheral blood lymphocytes and other tissue. Once again, this technology has been passed on to the larger provincial public health laboratories. As the National Reference Centre, interdeterminate or borderline specimens are evaluated, commercial kits are examined and evaluated, proficiency testing and quality control programs are offered to participating laboratories. In the Centre's Infectious Immunology Laboratories, a service is offered to undertake cell sorting by flow cytometry. Research in flow cytometry is also undertaken. 13 3. RESPONSE IN THE FEDERAL-PROVINCIAL CONTEXT , The provision of health and social services resides exclusively under provincial jurisdiction in Canada. The federal government contributes to the financing of health services through block funding arrangements under the Canada Health Act, and to the financing of social services through the more controlled provisions of the Canada Assistance Plan. An extensive network of federal-provincial advisory committees, principally inthe health domain, provides the forum for coordinated planning and issue management between the two levels of government. Municipal health and social services receive funding and policy direction through provincial authority and municipal councils. In respect of AIDS, intergovernmental cooperation is achieved through the Federal-Provincial-Territorial Advisory Committee on AIDS, reporting to the Council of Deputy Ministers of Health. (The senior non-elected Public Servants) Formally established in the fall of 1987, this committee was preceded by an Ad-Hoc. Advisory Committee whose membership and frequency of meetings were generally determined by the issues at hand. The work of the current advisory committee is supported by various sub-committees and working groups, and secretariat support is provided by the Federal Centre for AIDS. 14 AS currently constituted, the Advisory Committee's work has been limited to date to establishing general priorities for cooperative action, and addressing a few key and immediate concerns. It is clear that the advisory committee will have an influential role in the determination of national collective strategies for preventive education, and in the assessment of developments in such areas as testing policy, the quality of care and the availability and management of new therapies. Under the National AIDS Program, the federal government has provided direct assistance to the provinces in the establishment or enhancement of AIDS laboratory facilities and capability, the development of educational materials in the context of the general public and school education programs, and through the National laboratory reference services of the Federal Centre for AIDS, in the confirmation of diagnostic tests. The federal government maintains a national surveillance system for AIDS case reports providing the provinces and territories with specific and aggregated data and analysis. To this end, all jurisdictions are linked by a computerized case reporting and information network provided by the federal government. »- 15 15 4. PROVINCIAL GOVERNMENT INITIATIVES ON AIDS A) Public Education In March, 1986, the combined expenditure by all provinces and territories on AIDS education amounted to just over $1 million. On March 22, 1988, the Government of Ontario announced a $7 million, 2 year public education program, joining other provinces that have made Significant investments (approaching $15 million) in this effort in the past two years. The dramatic increase in educational expenditure and initiatives coincides with a shift in public opinion toward support for public education and AIDS education in the school system, over the same time period. A summary of activities of each provincial government is appended (appendix 8). Of particular note are: - Ontario, which established the Ontario Public Education Panel on AIDS in 1986, and has produced comprehensive é¢ducational material adopted for use in other jurisdictions across Canada and by non-government organizations. - The North-West Territories, which, with federal government assistance, implemented a carefully crafted and culturally varied program to address Inuit, Dene, Indian and White communities in the North 16 - Nova Scotia, which has undertaken a unique program of public hearings as a basis for developing AIDS policy and programming. B) Development of Health and Social Services Beyond the provision of established health care and social services, the provinces have taken few direct initiatives to adapt or develop AIDS related services. The Government of Ontario has been the most active, providing financial assistance for the establishment of an AIDS hospice, Casey House, in Toronto and for several metropolitan Toronto hospitals to coordinate service delivery. Ontario and British Columbia have invested substantial funds in the enhancement of laboratory facilities. C) HIV Antibody Testing Most provinces have endorsed positions on Hiv antibody testing presented ina report to Health and Welfare Canada and reviewed in the Federal-Provincial-Territorial Advisory Committee on AIDS (appendix 9). This represents a significant stép, -because the federal government's jurisdiction does not extend to the application of universal testing policy across the country. --- 17 17 At this time, the Government's position on mandatory or compulsory testing is that HIV antibody testing should be performed under conditions of informed consent with pre and post test counselling services available. | There is considerable pressure from the public to institute screening of immigrants, but in accordance with scientific thought and the WHO's statement On this issue, it is recognized that testing will not arrest the transmission of AIDS. Similarly health care workers are increasingly demanding testing of patientS on admission to hospital. The FCA has endorsed the cDc's for the Recommendations for the Prevention of HIV Transmission in Health Care Settings. (Appendix 10) 18 S. THE PRIVATE SECTOR RESPONSE TO AIDS A) Workplace Policies and Programs In the fall of 1987, the federal government convened a conference of private and public sector employers and business organizations to review the current state of workplace policies and programs. At that time, only a handful of Canadian corporations had developed determined responses to AIDS. Following the conference, two special reports are being prepared with private sector collaboration. The first is a general resouce for all employers, dealing with policy and educational program development, due to be completed in the summer of 1988. The second is oriented specifically to small businesses, which face unique problems and challenges in dealing with AIDS. This is due for completion inthe fall of 1988. In addition, the Federal Centre for AIDS is working with particular private sector groups, such as the food industry, the insurance industry, mining and forestry, to develop responses appropriate to their needs and circumstances. B) Legal Issués Canada has not yet experienced litigation involving AIDS and the workplace. Two cases have been heard by labour arbitration tribunals (appendices 11 and 12). --- 19 19 C) Private Sector Education Initiatives Two sectors have been pre-eminent in the support of AIDS education and awareness programs. Manufacturers of condoms in Canada have distributed large quantities of free condoms in promotional campaigns involving community based AIDS organizations, and have invested in professional education and research. The life and health insurance industry has become involved with organizations like the Canadian Public Health Association, the Ontario Public Education Panel on AIDS and ' others, to provide financial support for audio-visual, artistic and other educational projects. As part of its public education program the Canadian Public Health Association introduced a sponsorship program to enlist the collaboration of the private sector. Response to date has been minimal. 20 CONCLUSION ~ At this time a proposal to enhance substantially the Federal Government's National AIDS Program has been placed before the Cabinet. If increased resources are provided, then an energetic, high profile governmental program will commence. These activities will include comprehensive national preventive education and epidemiological strategies as previously outlined. . TESTIMONY FOR PRESIDENTIAL COMMISSION, APRIL 18, 1988 The Epidemiology of AIDS in the Americas Introduction The Region of the Americas is composed of 44 countries and territories in different stages of development, including two of the most developed countries in the world, the United States and Canada. Only one or two of the countries in the Americas can be counted among the poorest countries in the world. Most nations are further along in the developmental spectrum and sone may be classified as “in transition" between developing and developed nations. In spite its geographic diversity and extension, the Region of the Americas has some unique unifying characteristics. Of the 655 million people of the Americas, 61.44 live in Latin America; 260 million people in 18 Latin countries share Spanish as their official language and have a common 450 year old cultural and historical Spanish-American heritage. This influence reaches the Sourthern border states of the United States, some of its larger metropolitan areas, and the Commonwealth of Puerto Rico. Portuguese is spoken by 140 million people in Brazil, the largest country in Latin America, which borders on all but two of the countries in South America. Besides the United States and most of Canada, English is spoken by six and a half million people distributed in 18 countries and territories in the Caribbean Basin. A small proportion of the total population of the Americas speak other languages, principally, French, Creole, Dutch and a host of native American languages. Nevertheless, 99% of the population can communicate with each other in a Romance language (mostly Spanish and Portuguese) or in English. It is important to understand that the AIDS epidemic in the Americas takes place within this rather unique social and cultural context. The overall health status of the population of the Amricas is also marked by geographical diversity resulting in an epidemiological mosaic of health problems. The population in Latin America are still affected by a multitide of infectious diseases including malaria, dengue, Chagas disease, diarrhoeal disease and multiple respiratory infections which contribute to high morbidity and mortality in certain population groups. At the same time, the popylation is aging rapidly and most countries have surpassed WHO's global life expectancy goals set for Health for All by the Year 2000. A consequence has been the appearance of chronic diseases as major public health problems. Finally, massive urbanization has been occurring during the last 20 years, bringing with it social and environmental stresses, including severe atmospheric pollution, chemical contamination of the environment, urban violence and general breakdown and changes of traditional family structure and social mores. The AIDS epidemic is superimposed on this disease/health profile, EPIDEMIOLOGY OF AIDS The attached tables present the epidemiology of AIDS in the Americas. The Pan American Health Organization initiated Regionwide AIDS surveillance in 1983. Only officially reported cases of full blown AIDS have been tabulated. Surveillance of HIV infection has not been carried our in a systematic fashion as yet, As in all other Regions of the world, ‘the number of AIDS cases grossly underestimates the magnitude of the problem. PAHO estimates that between two and two and one half million persons are infected in this Region. -~3- Approximately 500,000 to 750,000 are located in Latin America and the Caribbean. Table 1] reveals that the Andean group of countries has reported a total of 334 cases as of February 16, 1988. The Sourthern Cone countries have reached a total of 206, while Brasil has reported a total of 2,458 cases. Table 2 reveals that the Central American countries and Panama have reported a total of 191 cases while Mexico. has reached 779, The Latin Caribbean countries which include Cuba, Dominican Republic and Haiti have reported a total of 1,513 cases. The non-Latin Caribbean coutries have reported a total of 753 cases (Table 3). North America reported a total of 54,633 cases with the great majority coming from the United States (Table 4). Thus, since the initiation of surveillance in 1983, a total of 60,867 cases and 33,209 deaths have been reported. The overall case fatality rate is 50%. Table 5 compares data from 1986 and 1987 and reveals the percentage increase in the number of reported cases, Although reported cases from North America increased by 13%, several other subregions reported dramatic increases, e.g., 20.7% in the Sourthern Cone countries, 139% in the Latin Caribbean, and 118% in the Central American Isthmus. Figure 1] reveals that five countries, the United States, Brazil, Canada, Haiti and Mexico have contributed approximately 97% of all the cases in the Region, With the exception of Montserrat and the British Virgin Islands, evidence of the spread of AIDS virus is being found in all the countries and territories of the Americas, - 4 ~ Today the world has tracked its epidemic by monitoring the total number of accumulated cases since 1981 when the epidemic began. The total number of cases by country is not particularly useful for making comparisons between countries because the total does not consider the size of the population which gives rise to the AIDS cases. Calculating the ratio of reported cases for a given calendar year to the median population estimates for that year provides a better method for comparison. PAHO data reveal that the Caribbean Region with 52.6 cases per million is second only to the North America subregion with 66.6 AIDS cases per million population as shown in Table’ 6. Yet even this average obscures signicant differences between the countries. For example, there were 7.5 AIDS cases reported per million population in 1987 in Brazil while the ratios in French Guiana, Bermuda, the Bahamas were in the range of 240-400 AIDS cases per million population. Sexual transmission Initially, AIDS cases in Latin America were reported among male homosexuals and bisexuals with a history of travel outside Latin America and the Caribbean. The first cases, many of which had already been diagnosed in Europe and North America were found in Mexico, Colombia, Argentina, Brazil, and other Latin American countries from 1982 to 1985. This pattern of predominant male sexyal transmission continues in North America and most countries in the Southern part of South America (Chile, Argentina, Uruguay and Paraguay), as well as the Andean countries (Venezuela, Colombia, Ecuador, Peru, and Bolivia). An important difference between the countries in Latin America and North America is the proportion of bisexual males which ranges from 15 to 25% of all AIDS cases. Many of them are married or have stable female partners. Furthermore, seroprevalence studies to detect the presence of HIV antibodies in some groups of homosexual and bisexual men, most of then volunteers, have disclosed rates of infection ranging from 8.3% in the Dominican Republic in 1986, 204 in Costa Rica in 1985 to 1986, 37.54 in Brazil in 1987, and 30.9% in Mexico in 1987. Although this contrasts with the very high rates (above 70%) of HIV infection among some homosexual groups in some areas of the United States, the data may only indicate a later introduction and dissemination of HIV infection among homosexual men in Latin American and Caribbean countries, Thus, HIV prevalence rates in some prospective studies have gone from below 54 to the present rates of 10 to 20% in studies conducted in countries such as Argentina and Uruguay. The proportion of cases in which heterosexual transmission of HIV is implicated is still below 10% of all cases in most countries in Latin America. However, in the Caribbean and parts of Central America, significant numbers of AIDS cases and HIV infections in women are being detected. As an example, during 1987 twenty four cases of AIDS were diagnosed in Jamaica, of which ten occurred in women. Prevalence of HIV infection in STD clinic patients has not been systematically evaluated outside of the United States and Canada. Studies in female prostitutes have shown HIV infection rates ranging from 0 in some studies in Mexico and Argentina, to a high of 494 in one limited study of prostitutes in Haiti. Transmission Associated with Blood and Blood Products In some countries, between 5 and 10% of all cases of AIDS are presumed to be secondary to blood transfusions, notably in Costa Rica, Mexico, Brazil and Jamaica. HIV antibody prevalence among blood donors is highly variable, ranging from 0.004 among 4,000 donors in Argentina, 0.1% in more than 1,400 blood samples in Barbados, to as high as 1.5% in the Dominican Republic and 7,34 among some paid blood donors in high risk areas of Mexico City. The contribution of contaminated needles and syringes to the transmission of the AIDS virus among IV drug abusers appears to be less significant in Latin America than in the United States. Less than one percent of AIDS cases are believed to be associated with IV drug abuse in Latin America, as opposed to 174 in the United States of America. Transmission in Children The cases associated with perinatal transmission in Latin America and the Caribbean are still few. For example, less than one fifth of cases in infants and children have been associated with perinatal transmission in Brazil. In Mexico, 164 of cases occur in infants of infected mothers. However, limited studies in Haiti have found prevalences of HIV infection of 3 to 8% in pregnant women. The majority of cases in children have thus far been associated with transfusion of blood and blood products, and in rare cases, with sexual abuse and child prostitution. In contrast, more than 754 of pediatric cases in the United States can be traced to a parent with HIV infection or engaged in one of the high risk behaviors, principally IV drug abuse, THE REGIONAL RESPONSE The Regional Offices of WHO are fully participating components of the Global Program on AIDS. For example, the Pan American Health Organization, WHO's Regional Office for the Americas, executes the Regional Program on AIDS in the Americas, The PAHO/WHO program has mobilized a total of 5.1 million dollars since early 1987 from WHO's non-regular funding sources for AIDS prevention and control activities in this Region. In countries where there has already been epidemiological and political recognition of the HIV problen, the PAHO Regional Program on AIDS provides technical assistance and financial support for the formulation and execution of national programs. This work will be strengthened and broadened to assist other Member States already engaged in confronting the HIV epidemic. By June 1988, all countries and territories in the Americas will have initiated national AIDS Prevention and Control Programs, An additional $5 million has been obtained for AIDS research in Latin America and the Caribbean through a special contract between PAHO and the U.S. National Institutes of Health's, National Institute of Allergy and Infectious Diseases. This contract emphazises peri-natal and heterosexual transmission research as well as studies of the interaction of AIDS infection with other endemic diseases, PAHO has been very active in promoting AIDS education throughout the Region. PAHO organized the first Pan American Teleconference on AIDS which was broadcast to over 650 sites in all major countries and territories in the Western Hemisphere. For the first time in the history of PAHO and WHO, approximately 45,000 rank and file health workers participated in a PAHO/WHO technical scientific meeting. PAHO is currently organizing the Second Panamerican AIDS Teleconference which will take place in Sao Paulo, Brazil, September 7 and 8, 1988. With WHO's financial assistance PAHO has established two AIDS Information/Education Exchange Centers to act as resources in support of national educational strategies. In this Region, the AIDS problem has been approached in a manner which will permit the accomplishment of as much as possible, as quickly as possible. Certan protocols and certain procedures has been by-passed and eliminated, Given the urgency of the HIV pandemic, PAHO believes’ that countries cannot follow traditional “business as usual” approaches. PAHO and WHO have made a commitment to its Member Countries in this Region and they in turn are now committing themselves to confronting this unprecedented epidemic. AIDS IN THE AMERICAS Number of cases and deaths By subregion and country Notified by February 16, 1988 LATIN AMERICA ANDEAN AREA Bolivia Colombia Ecuador Peru Venezuela SOUTHERN CONE Argentina Chile Paraguay Uruguay BRAZIL TABLE 1 CASES 5,481 334 6 153 30 44 101 206 120 63 - 16 2,458 (1 of 5) DEATHS 2,218 176 3 53 17 29 74 102 59 29 4. 10 1,319 TABLE 2 AIDS IN THE AMERICAS Number of cases and deaths By subregion and country Notified by February 16, 1988 LATIN AMERICA CENTRAL AMERICAN ISTHMUS Belize Costa Rica El Salvador Guatemala Honduras Nicaragua Panama MEXICO LATIN CARIBBEAN‘ Cuba Dominican Republic Haiti ‘Puerto Rico inchided in USA (2 of 5) CASES - DEATHS CONTINUED 191 10 4 4 43 24 16 6 30 28 71 27 0 0 27 19 779 231 1,513 282 6 3 352 38 1,155 241 TABLE 3 AIDS IN THE AMERICAS CARIBBEAN SUBREGION Notified by February 16, 1988 Number of cases and deaths by country (3 of 5) | TOTAL CASES=753 DEATHS=458 COUNTRY CASES DEATHS COUNTRY CASES DEATHS Antigua 3 3 Martinique 27 17 Bahamas 176 83 Neth. Antilles 22 13 Barbados 55 34 | Saint Lucia 6 3 Cayman Islands 3 2 ‘St. Christopher -Nevis 1 0 Dominica 5 3 St. Vincent & ; 9 6 French Guiana 84 60 Suriname Grenadines 5 Grenada 8 5 Trinidad & Tobago 227 163 Guadeloupe 74 36 Turks & Caicos 5 3 Guyana 5 2 Virgin Islands (US ) 7 wns Jamaica 30 20 TABLE 4 AIDS IN THE AMERICAS Number of cases and deaths By subregion and country | Notified by February 16, 1988 (4 of 5) CASES - DEATHS . NORTH AMERICA 8 54,633 30,533 - - : ‘Bermuda : 7 _ - . 7 1 - : a | 5 1 Canada 7 : 4500 812 : USA" —i—i<“‘i*«=~SWGNS—SC*«i I "Puerto Rico included in USA TABLE 5 AIDS UN THE AMERICAS Reported cases in 1986 and 1987 with percent increase TOTAL LATIN AMERICA Andean Area . southern Cone Brazil | Central American Isthmus Mexico Latin Caribbean CARIBBEAN NORTH AMERICA " 1987 data not complete. 1986 17923 1812 110 42 867 62 423 308 252 15859 . 1987 20994 , 2673 233 129 1068 135 373 735 379 17942 Percent Increase 17 48 112 207 23 118 -12* 139 50 13 FIGURE 1 AIDS IN THE AMERICAS Number of reported cases by country Notified by February 16, 1988 All Others Mexico 779 Haiti 1,155 Canada 1,500 Brazil 2,458 | TABLE 6 AlDS IN THE AMERICAS Cases Reported Per Million Population By Subregion TOTAL LATIN AMERICA Andean Area Southern Cone Brazil Central American Isthmus Mexico Latin Caribbean | CARIBBEAN | NORTH AMERICA 1987 CASES 20994 2673 233 129 1068 135 373 735 379 17942 CASES PER Million 30.5 6.5 2.0 2.5 7.5 4.9 4.5 31.1 52.6 66.6 PRESIDENTIAL COMMISSION ON THE HUMAN IMMUNODEFICIENCY VIRUS EPIDEMIC “THE PANDEMIC IN THE AMERICAS: DESCRIPTION, RESPONSES AND IMPLICATIONS" AIDS IN MEXICO DR. JAIME SEPULVEDA April 18, 1988 AIDS IN MEXICO I. Fhe Problem The first case of AIDS in Mexico was diagnosed in 1983 in a foreigner, who had onset of symptoms two years earlier. Since then, 1,233 cases have been reported to the General Directorate of Epidemiology. The incidence rate is exponential, with a doubling time of 7.5 months from 1985 to the present. Estimates of the number of AIDS cases indicate that more than 20,000 new cases will occur in 1991, with more than 35,000 accumulated cases by that year. While the first cases reported were associated with foreign contacts, since 1985 the spread can be attributed to endogenous transmission. Each of Mexico's 32 States has reported at least two cases; most are concentrated in the largest cities: Mexico City (37%), Guadalajara (14%), and Monterrey (6%). Young adults between 25 and 44 years old account for 70% of the cases. Of the 47 cases (4%) in children, 10 are associated to perinatal transmission. This proportion of pediatric cases is three times the rate found in the United States. Eighty two cases (7%) have occurred in women; thus, the male-female ratio is 14:1. The risk groups include homosexual and bisexual males (80%); heterosexuals (7%); recipients of blood transfusion (78%); hemophiliacs (3%); children through perinatal transmission (18); homosexuals who are also drug abusers (1%); and intravenous dfug abusers (0. 4s). the proportion of transfusion associated cases doubles that of the United States. The trends observed have shown the largest growth in cases associated with heterosexual and perinatal transmission. At the present moment, AIDS cases are: o¢curring in people from every socio-economical stratum and are. beginning to.appear in rural areas. The growth rate in women has increased Significantly in recent months. Serological surveys conducted across the country in different population sub-groups have yielded the following results: homo and bisexual males showed a prevalence between 1% and 33% (Mexico City); seroprevalence in male prostitutes ranges between 2% and 16%; female prostitutes show a low prevalence of 1%; hemophiliacs, between 28% and 678; prisoners, between 0.5% and 1%: recruits, 0.58. Paid blood donors had a high prevalence of 7% before the ban on blood commerce, while voluntary donors had only 0.18%. II. The Response The Ministry of Health designed a National Committee for the Prevention of AIDS (CONASIDA) responsible for the elaboration of national policies and programs. Epidemiological surveillance in Mexico is now based, by Federal Law, in mandatory notification of AIDS cases and HIV infected people... Sixty five screening laboratories have been implemented, including a National Reference Laboratory for confirmation of positive results and Supervision of laboratory performance. Our national blood supply is now considered to be safer due to mandatory screening of this tissue, since 1986. As mentioned above, following the discovery of such high seroprevalence rates among paid blood donors, a law was passed by Congress banning this trade. There is a central, confidential registry of cases which serves as data base for the monthly epidemiological bulletin, published Since early 1987. All seroepidemiological surveys have been designed and conducted by CONASIDA. The first strictly representative survey on a national scale will be completed in Mexico and results presented in Stockholm this June. A sutvey of knowledge, attitudes and, practites about AIDS was undertaken in five different population sub-groups in six large cities. Results shdw an increasing knowledge about condoms as a preventive measure for AIDS. However, few people incorporate knowledge irito practice. The educational campaign has been directed to groups with high risk practices, health personnel, and the general public. Material produced includes flyersr posters, audiovisuals, radio and television spots. A National Information Center was created in Mexico Cityr with others following in several States. The main services provided by these centers are free confidential testing, counselling, and a hotline. A mass-media campaign for the prevention of HIV transmission, with the participation of greater sectors of the societyr including actors and other well-known personalities, was recently launched. Finally, a Regional Documentation Center was created, with support from WHO and PAHO, to concentrate, organize and disseminate information regarding AIDS to serve Mexico and other Spanish speaking countries. We gracefully acknowledge economic support for our program from WHO, PAHO, USAID, The Population Council, NIH, and above all, the Mexican Government. EPIDEMIOLOGY OF AIDS IN HAITI (1979-1987) J. W. PAPE*, M. M. DESCHAMPS, M. STANBACK, R. I. VERDIER, S. JEAN AND W. D. JOHNSON JR. CORNELL UNIVERSITY MEDICAL COLLEGE NEW YORK, NEW YORK AND GHESKIO, PORT-AU-PRINCE, HAITI. ABSTRACT THE FIRST CASE OF KAPOSI'S SARCOMA (KS) AND THE FIRST CASE OF OPPORTUNISTIC INFECTION (OI) WERE DIAGNOSED RESPECTIVELY IN JUNE 1979 AND IN FEBRUARY 1980. FROM 1979 TO 1987 THE STUDY GROUP ON KAPOSI'S SARCOMA AND OPPORTUNISTIC INFECTIONS (GHESKIO) HAS EVALUA- TED AND ‘TREATED 739 DOCUMENTED CASES OF AIDS 80% OF ALL RE- PORTED CASES IN THE COUNTRY. ONLY 8% OF ALL PATIENTS (61/739) HAD kK. S. THE MAJORITY OF AIDS CASES (90%) ARE BETWEEN 20 AND 40 YEARS OLD. IN THE LAST THREE YEARS THE PERCENT OF AIDS CASES WHO ARE RESIDENTS OF CITIES OUTSIDE THE CAPITAL OF PORT-AU-PRINCE HAVE ALMOST TRIPLED. WITHIN THAT PERIOD A CHAN- GING PATTERN FOR THE ACQUISITION OF AIDS HAS EMERGED IN HAITI. BISEXUALS AND RECIPIENTS OF BLOOD PRODUCTS WHO ACCOUNTED EARLIER FOR 73% OF ALL AIDS CASES ONLY REPRESENT 11% OF PATIENTS; IN CONTRAST DOCUMENTED OR ASSUMED HETEROSEXUAL TRANSMISSION HAS GRADUALLY INCREASED FROM 26% IN 1983 TO OVER 80% SINCE 1985. AS A RESULT OF THIS, THE PERCENT OF WOMEN WITH AIDS HAS DOUBLED SINCE 1979. IN HAITIAN CHILDREN HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IS THE RESULT OF VERTICAL TRANSMISSION- IN THAT SETTING HIV IS ASSOCIATED WITH AN EXCESS OF BOTH MISCARRIAGES AND POST NATAL DEATHS. SEROPREVALENCE PATTERNS OF HIV SUGGESTS THAT THE INFECTION IS OF RECENT ONSET IN HAITI BUT IS NOW WIDESPREAD WITH HIGHER RATES IN URBAN AREAS IN LOWER SOCIOECONOMIC GROUPS IN PATIENTS WITH TUBERCULOSIS AND IN PROSTITUTES. TABLE 1 AIDS CASES DIAGNOSED IN HAITI* YEAR KAPOSI'S SARCOMA OPPORTUNISTIC INFECTIONS TOTAL 1979 2 0 2 1980 2 5 7 1981 7 9 16 1982 5 35 40 1983 8 53 61 1984 11 103 114 1985 8 136 . 144 1986 10 178 188 1987 ** 8 159 167 61 678 739 * BY THE CORNELL-GEHSKIO STUDY GROUP ** SELECTIVE ENROLLMENT SINCE 7/87. MEAN AGE (YEARS) PERCENT FEMALES (%) TABLE 2 AIDS IN HAITI KAPOSI'S SARCOMA 31 12.0 OPPORTUNISTIC INFECTIONS 33 29.0 TABLE I AIDS CASES IN TRINIDAD AND TOBAGO BY YEAR: ADULT FAEDIATRIC TOTAL me tah ces cam ct ee anle Lin tee came wow sien come mene sla em oleh mpm com unt mem eam semn shen anu sm Som seen came enn de a ares wrt ale na dete a ae Sa MALE FEMALE MALE FEMALE 1982 8 Q) Ly 0 8 1984 19 0 O 0 19 1985 Z6 4 3 i AS 1986 56: 15 3 1 73 1987 36 & 3 4 49 TOTAL 154 we 9 7 194 men roms lems coe HOMOSEXUAL / BISEXUAL MEN HETEROSE XUAL INTRAVENOUS DRUG ABUSER BLOOD TRANS INFANTS UNKNOWN OR TO BE DETERMINED TABLE III AIDS CASES IN TRINIDAD AND TOBAGO BY YEAR AND RIS#F CATEGORY 19B2 1984 B8¢1m0%) 19(100%) 34 Q 0 4 O Oo O QO Q 1 0 QO 5 QO oO 1 (75.5%) (11.472) (2.8%) (14.27%) (2.8%) 1986 1987 {to Aug 20) 48(65.7%) 17(035.4%) 1S(20.5%) 15(31.2%) O 1(2,0%) 4(35.4%) 0) A(S.47) 6(12.5%) =2(2.7%) 9(18.7%) YEAR 1979-1983 1984-1987 TABLE 3 AIDS IN HAITI PLACE OF RESIDENCE PORT-AU-PRINCE (8) OUTSIDE PORT-AU-PRINCE (%) 89 11 70 30 TABLE 4 eerieeeinsteglepemimlaee CHANGING PATTERN OF AIDS IN HAITI: INCREASED HETEROSEXUAL TRANSMISSION 1983 1984 1985 1986 1987* All % % % % % % n 38 104 132 185 100 559 Bisexuality 50.0 27.0 8.0 4.0 1.0 13.0 Transfusion 23.0 12.0 8.0 7.0 10.0 10.0 IVDA 1.0 1.0 1.0 0.0 1.0 1.0 Heterosexual* 5.0 6.0 14.0 16.0 15.0 13.0 None of the above ** - 21.0 54.0 69.0 73.0 73.0 64.0 i +} * Heterosexual transmission is assumed in these patients who were prostitutes or had a spouse with AIDS. ** Heterosexual transmission is the most probable source of infection in the patients reporting none of the aforementioned. TABLE 5 SEX DISTRIBUTION OF PATIENTS WITH AIDS IN HAITI ? YEARS 1979-1982 1983-1985 1986-1987 N 10/65 86/319 108/355 204/739 ( & FEMALES) (15.0) (27.0) (30.0) See 28.0 HIV STATUS OF CHILDREN % HIV + TABLE 6 PREVALENCE OF HIV ANTIBODY IN HAITIAN CHILDREN OF HIV SEROPOSITIVE AND SERONEGATIVE MOTHERS SEROPOSITIVE MOTHERS SERONEGATIVE MOTHERS* (n = 183) (n = 232) HIV + HIV - ' HIV + HIV - 64 211 0 392 30.0 0.0 * 60% of the seronegative mothers had a seropositive spouse. TABLE 7 MISCARRIAGES AND POSTNATAL DEATHS IN SPOUSES OF HAITIAN AIDS PATIENTS HIV SEROPOSITIVE SPOUSES n 126 MEAN AGE (YEARS) 29.7 PERCENT OF WOMEN WITH 80% ONE. OR MORE LIVE BIRTHS MEAN NUMBER OF LIFETIME 2.4 PREGNANCIES MISCARRIAGE RATE* 29% NUMBER OF MISCARRIED 12% PREGNANCIES MEAN NUMBER OF LIVE BIRTHS 2.2 PER GRAVID WOMEN POSTNATAL DEATHS 26/268 (21%) HIV SERONEGATIVE SPOUSES 96 30.8 80% 13% 5% 2.7 22/232 (10%) * PERCENT OF WOMEN WITH A MISCARRIAGE SINCE 1978. TABLE 8 HIV_SEROPREVALENCE IN HAITI* n Mean Age (Yrs) HIV (3%) 1. Adults bled (1977-1979) 191 27 0.0 during dengue outbreak 2. Healthy adults (1985-1987) » Urban Hotel workers 25 45 12.0 Factory workers 84 30 BO Pregnant women 1240 29 8.4 Mothers of sick 502 29 12.0 infants | Other adults | - High socioeconomic 24 35 0.0 - Low socioeconomic 190 33 13.0 »- Medical workers 57 40 0 ” 2152 27 9.0 | - Rural ; | Mothers of sick 97 25 3.0 infants Pregnant women 117 27 3.0 Blood donors 245 32 4 Other adults . 91 29 1 650 30 3 * antibody to HIV utilizing the Eliza (whole virus) and radio immunoassay (p 24, gp 120) TABLE 9 HIV _SEROPREVALENCE IN SPOUSES ‘OF AIDS Female -spouses of male AIDS Male spouses of female AIDS n 425 86 % HIV positive 52.0 50.0 TABLE 10 HIV SEROPREVALENCE IN SELECTED GROUPS IN HAITI Groups Leprosy Tuberculosis Urban Rural Prostitutes 157 129 112 139 Mean age 40 32 34 24 HIV (%) 5.0 45.0 15.0 53.0 CONCLUSION HIV INFECTION AND DISEASE IS OF RECENT ONSET IN HAITI BISEXUALITY AND BLOOD TRANSFUSION ARE NO LONGER THE MAJOR RISK FACTORS FOR ACQUIRING HIV. FOR THE PAST 4 YEARS - HETEROSEXUAL TRANSMISSION HAS BECOME THE MAJOR MODE OF SPREAD OF HIV. » OVER 5 TO 10% OF HEALTHY URBAN WOMEN IN SOME URBAN AREAS ARE INFECTED. - INFECTED WOMEN HAVE TWICE AS MANY MISCARRIAGES AND TWICE AS MANY POSTNATAL DEATHS AS NON INFECTED WOMEN. - IN HAITIAN CHILDREN HIV INFECTION IS THE RESULT OF VERTICAL TRANSMISSION. . HIV INFECTION IS NOW WIDESPREAD WITH HIGHER RATES IN URBAN AREAS, IN PATIENTS WITH TUBERCULOSIS AND IN PROSTITUTES. TABLE 1 AIDS IN HAITI YEARS CASES (MONTH No, 1979-1981 <1 1982-1983 4 1984-1988 30 TABLE 2 AIDS IN HAITI: PLACE OF RESIDENCE OUTSIDE YEARS PORT-AU- PRINCE PORT -AU- PRINCE % % 1979-1983 89 11 1984-1987 70 30 TABLE 3 CHANGING PATTERN OF AIDS IN HAITI: INCREASED HETEROSEXUAL TRANSMISSION 1983 1984 1985 1986 1987 Total % % % % % % Homo/Bisexual 50 27 8 4 1 13 Blood transfusion 23 12 8 7 10 10 IVDA 1 1 1 0 1 <1 Heterosexual 5 6 14 16 15 13 Probable heterosexual 21 54 69 73 73 64 TABLE 4- CHANGING PATTERN OF AIDS IN TRINIDAD AND TOBAGO*: INCREASED HETEROSEXUAL TRANSMISSION 1983 1984 1985 1986 1987 % % % % % Homo/Bisexual 100 100 85 69 40 Blood transfusion 0 0 3 6 0 . IVDA 0 0 0 0 2 Heterosexual 0 0. 10 22 36 Probable heterosexual 0 0 2 3 22 * Courtesy of Dr. C. Bartholomew. The number of cases in 1983-1987 was 8, 19, 40, 69 and 42, respectively. The 1987 data is to August 20. TABLE 5 SEX DISTRIBUTION OF AIDS PATIENTS IN HAITI YEARS PATIENTS | FEMALES No. % 1979-1982 10/65 15 1983-1985 86/319 27 1986-1987 108/355 30 Total 204/739 28 TABLE 6 SEX DISTRIBUTION OF AIDS PATIENTS IN TRINIDAD AND TOBAGO* YEARS PATIENTS FEMALES No. % 1983-1984 0/27 0 1985-1987 23/151 15 *Courtesy of Dr. C. Bartholomew. TABLE 7 SUMMARY 1. HIV infection and disease are of recent onset in the Caribbean. 2. Homo/bisexuality is no longer the major risk factor for acquiring AIDS. 3. Within a 5 year period heterosexual transmission has become the major mode of HIV spread. ‘These findings have serious implications for countries where other modes of transmission are still predominant. HIV SCREENING AND ITS USE IN PUBLIC HEALTH PROFESSEUR A. POMPIDOU COUNSELLOR FOR THE FRENCH MINISTERY OF HEALTH COORDINATOR FOR NATIONAL AIDS PROGRAMM 3073 CASES OF AIDS HAD BEEN RECORDED IN FRANCE BY THE 31 ST DECEMBER 1987, WHICH BREAKS DOWN TO 56 PER MILLION IN HABITANTS. FRANCE IS THEREFORE THE MOST SEVERELY AFFECTED BY THIS NEW VIRAL INFECTION AMONG EUROPEAN COUNTRIES. THE PREDICTION ARE ANOUNCING 10 000 TO 15 000 AIDS CASES AT THE END OF 1989 ; BUT IT IS NECESSARY TO UNDERLINE THAT DURING THE NEXT 4-5 YEARS, THE TREMENDUONS INCREASE OF AIDS CASES, WILL MASK THE DECREASE IN THE PROGRESSION OF CONTAMINATION WHICH IS ALREADY OBSERVED. THIS DECREASE IS OBSERVED AMONG HOMOSEXUAL COMMUNITY AND THE CONTAMINATION THROUGH HETEROSEXUAL CONTACTS IS NOW STABILIZED IN FRANCE. NEVER THE LESS THE FACT THAT AIDS IS A REAL CHALLENGE FOR THE PUBLIC HEALTH IN FRANCE, ENGAGED FRENCH GOVERNMENT AND ESPECIALLY Mrs MICHELE BARZACH MINISTER IN CHARGE OF HEALTH AND FAMILY TO SETTLE A COORDINATION STRUCTURE AND A STRONG NATIONAL PROGRAMM ON AIDS, AS EARLY AS JANUARY 1987. THE COORDINATING ORGANIZATION REPRESENTS TWO MAJOR COMPONENTS. - A NATIONAL COMITEE OF REFLECTION WHOSE FONCTION IS TO ADVISE THE MINISTER ON THE IMPORTANT DECISIONS TO BE TAKEN IN THE FIGHT AGAINST AIDS. IT MEMBERS INCLUDES SCIENTISTS, SPECIALISTS OF ETHICS, EDUCATION, COMMUNICATION AND LEISURES AS WELL AS REPRESENTATINES FROM FIRMS, INSURANCE COMPANIES AND THE CLERGY. - THE NATIONAL COORDINATOR IS RESPONSIBLE FOR THE FOLLOWING - ENSURING THE COMPLEMENTARITY OF THE WORK CARRIED OUT BY THE DIFFERENT MINISTERIES - COORDINATING INTERNATIONAL RESEARCH AND COOPERATION - ESTABLISHING TIES WITH PRIVATE ASSOCIATIONS AND ORGANISATIONS : NGO'S FOUNDATIONS INDUSTRIAL GROUPS THE AIM OF FRENCH NATIONAL AIDS PROGRAMM IS BASED UPCN TWO MAIN ASSERTIONS. - PUBLIC HEALTH MUST BE PROTECTED - PATIENT AND HUMAN BEING MUST BE RESPECTED THE ASSESSMENT OF THESE TWO MAJOR PRINCIPLES COULD NOT SEEM REALISTIC REGARDING ITS APPLICATION TO AN INFECTIOUS ' DISEASE. NEVERTHELESS THE CHALLENGE IS MADE POSSIBLE BY TWO REASONS - AIDS IS AN AVOIDABLE DISEASE - A CURE IS NOT IMPOSSIBLE TO FIND OUT. THESE TWO POINTS INDUCE THE MAJOR COMPONENTS OF THE AIDS PROGRAMM, - PREVENTION INCLUDING - INFORMATION ~- EDUCATION ~ SCREENING —- RESEARCH AND CARE FACILITIES ~ INTERNATIONAL COOPERATION PREVENTION AND RESEARCH ARE THE ONLY MEANS WE HAVE TODAY TO LIMIT THE PROGRESSION OF THIS AVOIDABLE BUT DEADFULL NEW VIRAL DISEASE. I - THE NATIONAL PREVENTION CAMPAIN IS COMPOSED OF : 1°) TWO LARGE MEASURES : - A NATIONAL INFORMATION PROGRAMM BASED UPON SENSITIZATION OF TEE WHOLE POPULATION USING ALL MEDIA, VIDEOS AND LEAFLETS. - A PROGRAMM OF EDUCATORS FORMATION (FOR FACE TO FACE INFORMATION). 2°) TWO PUNCTUAL MEASURES :; - AUTHORIZATION OF ADVERTIZING FOR CONDOMS AND ORGANIZATION OF QUALITY CONTROL. ~ SYRINGES SALE IN DRUGSTORES WITHOUTH PRESCRIPTION OR IDENTITY CONTROL. THE AIM OF THESE MEASURES IS TO AVOID CONTAMINATION BY SEXUAL CONTACTS AND CONTAMINATED BLOOD FROM I.V. DRUG USERS. 3°) NO MANDATORY SYSTEMATIC SCREENING (MANDATORY TESTING IS ONLY PERFORMED FOR BLOOD DONORS | AND ORGANS, TISSUES OR CELL DONORS). BECAUSE THIS REPRESENTS :; - A POOR EFFICIANCY IN AREAS WHICH ARE FEWLY INVOLVED | BY THE INFECTION (5 OUT OF 20 REGIONS REPRESENTING 80 $% OF THE WHOLE POPULATION). ~ A FALSE SECURITY CONTAMINATION CAN OCCUR RIGHT AFTER A SCREENING TEST. - AN INCITATION TO CLANDESTINITY FOR HIGH RISK GROUPS. r - NO INCITATION TO RESPONSABILIZATION. a THE EVALUATION OF THESE MEASURES IS THE FOLLOWING : WITHING ONE YEAR : ~- CONDOM'S SALE : 38 POUR CENT INCREASE - SYRINGES' SALE : 3 TIME INCREASE - ACCESS TO VOLUNTARY TESTING : 3 TIME INCREASE. 4°) A LARGE ACCESS TO HIV SCREENING ~ 100 CENTERS FOR FREE AND ANONYMOUS SCREENING (ONE IN EACH ADMINISTRATIVE AREA). IN THESE CENTERS : PRESCRIPTION AND POSITIVE RESULT GIVEN ONLY BY PHYSICIANS. - 300 CONSULTATIONS IN HOSPITAL ALL OVER THE COUNTRY. - ALL PHYSICIANS ALLOWED TO PRESCRIRE SCREENING TESTS REIMBURSED BY SOCIAL SECURITY SYSTEM. A POSITIVE ELISA TEST IS SYSTEMATICALLY CONTROLED BY WESTERN BLOT. THE CONFIDENTIALITY IS GUARANTIED BY MEDICAL SECRET. 5°) WHEN TO PROPOSE THE HIV TEST ? DURING KEY PERIODS OF THE LIFE : - PRENUPTIAL EXAMINATION OR HOSPITALISATION FOR PATIENTS (IN SUCH DEPARTEMENTS AS SURGERY, GYNECOLOGY, EXPLORATIONS) MUST TESTING BE PROPOSED AND ALL THE RESULTS GIVEN TO INFORMED INDIVIDUAL. - PRENATAL EXAMINATION : TESTING MUST BE PROPOSED IF ANY DOUBT REGARDING CONTAMINATION BASED UPON QUESTIONING THE PATIENT. COUPLES DESIRING TO PROCREATE MUST BE PROPOSED TO: BE TESTED IF ANY DOUBT REGARDING CONTAMINATION. FRANCE IS MORE FAITHFULL IN A TARGETED AND CORRECTLY PRESCRIBED TESTING PROGRAMM. FOLLOWING THE RECOMMANDATION OF WHO AND EUROPEAN COUNCIL, SYSTEMATIC SCREENING OF FOREIGNERS HAS BEEN REFUSED BY ALL HEALTH AND FOREIGN OFFICE MINISTERS IN EUROPEAN COMMUNITY. THIS PROGRAMM, BASED UPON SENSITIZATION AND RESPONSABILISATION WILL PREVENT PUBLIC HEALTH IN THE RESPECT OF PATIENTS AND OF HUMAN PERSONALITY. THE PRESCRIPTION OF AN HIV TESTING TEST IS SOMETHING, THE CONSEQUENCE OF WHICH, CANNOT BE NEGLICTED. IF THE SEROPOSITITY IS NOT ACCEPTED BY THE TESTED PERSON AND BY THE POPULATION AS WELL, THE RESPONSABILIZATION WILL NOT OCCURE LEADING TO QUARANTINES. AFTER TESTING, THE ONLY WAY TO DETERMINE CHANGES IN COMPORTMENTS FROM INDIVIDUALS AND POPULATION WAS TO ORGANIZE MEDICAL CARE, AND RESEARCH DEVELOPMENTS WITHOUTH FORGETING THE GLOBAL ASPECT OF THE PANDEMY. . II - RESERACH AND CARE FACILITIES CARE FACILITIES ARE ORGANIZES MOSTLY WITHIN 22 PILOTE CENTERS 6 IN PARIS 14 ALL AROUND THE COUNTRY AND 2 IN ANTILLAS AND GUYANA. IN THESE CENTERS PATIENTS ARE NOT QUARANTEENED BUT SPREAD OUT IN ALL THE DIFFERENT DEPARTEMENTS REGARDING THEIR OWN SYMPTOMATOLOGY. OUT PATIENTS ARE MONITORED IN DAY CARE UNITS. LABORATORIES FACILITIES ARE INCREASED IN IMMUNOLOGY AND VIROLOGY UNITS. THE PILOT CENTER IS THE MAIN POINT OF A NETWORK INCLUDING THE REGIONAL HOSPITALS. THE PILOT CENTERS ARE THEMSELVES COORDINATED WITH THE OTHER PILOT CENTERS ALL AROUND THE COUNTRY IN ORDER TO EVALUATE. THE COSTS AND TO ALLOW MULTICENTRICE’ STUDIES. RESEARCH IS UNDER THE RESPONSABILITY OF MINISTER FOR RESEARCH AND UNIVERSITIES. A SPECIFIC PROGRAMM HAS BEE RADED FOR ~ BASIC AND CLINICAL RESEARCH - TREATMENTS AND VACCINE AS WELL AS SCREENING TESTS. wn 50 DIFFERENT TEAMS ARE WORKING ON AIDS LABORATORY RESEARCH AS WELL AS ON SOCIO ECONOMICAL IMPACTS. III - INTERNATIONAL COOPERATION IS A NECESSITY REGARDING THE GLOBAL IMPACT OF AIDS. ~ SPECIAL SETTLEMENT HAS BEEN SIGNED BETWEEN PASTEUR AND N.I.H. ~- AGREEMENT HAS BEEN SET UP BETWEEN FRANCE AND GERMANY AS WELL AS GREAT BRITAIN. FOR AIDS RESEARCH. - FRANCE PARTICIPATE TO THE EUROPEAN COMMUNITY PROGRAMMS ON AIDS AND IS SUPPORTING THE WHO'S GLOBAL PROGRAMM ON AIDS. YET AGAIN, AS REGARDS THE FIGHT AGAINST AIDS, WE HAVE TRIED TO PLAN FOR THE FUTURE AND TO ACT. I WOULD LIKE TO BRIEFLY REMIND YOU OF THE OTHER MEASURES WE HAVE ADOPTED : 1°) THE MANDATORY DECLARATION OF CONFIRMED AIDS CASES. 2°) THE LAUNCHING OF AN INFORMATION AND SENSITISATION CAMPAIGN AIMED AT THE MEDICAL AND AUXILLARY MEDICAL PROFESSIONS AND AT THE PUBLIC AS A WHOLE. 3°) THE SETTING UP OF 22 HIV INFORMATION AND CARE CENTRES, WITH IMPROVED MEANS AS REGARDS PERSONNEL AND EQUIPMENT. 4°) THE AUTHORISATION TO MARKET AZT, WHICH, WHILE NOT CURATIVE, HAS PROVED ITS EFFICIENCY IN TREATING AIDS. 5°) THE AUTHORISATION TO ADVERTISE CONDOMS AND THE AUTHORISATION, VALID FOR 1 YEAR, TO SELL SYRINGES WITHOUT EITHER A PRESCRIPTION OR IDENTIFICATION CONTROLS. FINALLY, A LARGESCALE TRAINING AND INFORMATION PROGRAMME FOR SOCIAL WORKERS HAS BEEN STARTED. A TOTAL OF MORE THAN 900 m FF HAS THUS BEEN SPENT IN 1987 ON AIDS RESEARCH, PREVENTION AND CARE. INDEED, INTERNATIONALLY, FRANCE PLAYS A LEADING ROLE IN THIS FIELS. IN FRANCE, WE HAVE THE FIRM INTENTION OF RESPECTING A CERTAIN NUMBER OF FUNDAMENTAL PRINCIPLES. FIRSTLY, THE DESIRE TO PROTECT PUBLIC HEALTH WHILE RESPECTING THE DIGNITY OF THE PATIENT AND, IN MORE GENERAL TERMS, THE HUMAN BEING. THAT IS AN IMPRESCRIPTIBLE PRINCIPLE AND THE HONOUR OF CIVILISED SOCIETIES REQUIRES THAT THEY GUARANTEE IT UNDER ALL CIRCUMSTANCES. SECONDLY, THAT AIDS IS A DISEASE AND NOT SOME NIGHTMARE FROM THE DARK AGES OR A PRODUCT OF THE SUBCONSCIOUS. AS WITH ANY DISEASE, IT MUST BE FOUGHT BU STRICTLY RESPECTING MEDICAL DEONTCLOGY AND BY PROTECTING THE LINK BETWEEN THE PATIENT AND HIS DOCTOR. THIRDLY, THAT AIDS MUST ON NO ACCOUNT BE USED AS A POLITICAL PLOY. THE FIGHT AGAINST AIDS WILL DEMAND BOTH TIME AND CONTINUITY. TO OVERCOME IT, WE MUST ACT. A COHERENT OVERALL STRATEGY IS NEEDED, NOT STERILE CONFLICTS. FOURTHLY, THE ABSOLUTE NECESSITY TO FORESEE, PLAN FOR AND MAKE REASONED CHOICES. WE MUST ALSO BEGIN NOW TO PLAN FOR THE MATERIAL AND MEDICAL MEANS WHICH WILL BE REQUIRED TO COPE WITH THE INCREASE IN THE NUMBER OF INFECTED PEOPLE IN THE YEARS TO COME. OUR FIFTH PRINCIPLE CONCERNS THE DELIBERATE CHOICE MADE BY THE FRENCH AUTHORITIES TO INFORM PEOPLE WITHOUT CREATING A PANIC REACTION, TO MAKE THEM AWARE WITHOUT BEING PATRONISING AND ESPECIALLY TO ENCOURAGE THE INDIVIDUAL TO ASSUME RESPONSIBILITY FOR HIS OWN ACTIONS. 1 THE RESULTS ALREADY OBTAINED, SUCH AS THE MODIFICATIONS IN THE BEHAVIOUR OF HOMOSEXUALS OR THE INCREASE IN THE USE OF CONDOMS, CLEARLY DEMONSTRATES THAT THE ROAD TAKEN, THOUGH NOT THE MOST SPECTACULAR, HAS BEEN EFFECTIVE. THIS FRENCH PROGRAMM IS BALANCED TAKING ACOUNT NOT ONLY OF PREVENTION, HEALTH CARE AND RESEARCH BUT OF SOCIO ECONOMICAL AND CULTURAL ASPECTS. APPROACHING SUCH A PROBLEM, IT IS NECESSARY TO BE FAST BUT NOT TO HURRY UP TO MUCH IN ORDER TO AVOID IRREVERSIBLE OR UNADEQUATE DECISIONS. IT IS NECESSARY TO TAKE ACCOUNT OF ALL THE CONSEQUENCES OF THE DECISIONS BEFORE THEY ARE ADOPTED. AS SAID RECENTLY J. MANN DIRECTOR OF G.P.A. "CONFRONTING AIDS NECESSITADE TO BE STRONGER THAN FEAR AND MORE OVER TO FEAR QUARANTINE OR DISCRIMINATION." IN ORDER THAT EACH COUNTRY COULD FIND THE PROPER WAY TO LIVE WITH AIDS. i — Testimony of CAPT MICHAEL E. KILPATRICK, MC, USN. Research Area Manager for Infectious Diseases and Special Assistant for Overseas Laboratory Affairs, Naval Medical Research and Development Command, Naval Medical Command, National Capital Region, Bethesda, Maryland The prevalence and incidence of HIV in specific countries is a sensitive area, both politically and economically. Today I will present an overview of HIV prevalence and incidence data in Asia, along with the limitiations there are on the accuracy, completeness or interpretability of these data. As is true of HIV data from all parts of the world, we only See small parts of the total population evaluated, and in general the evaluation is only done at one point in time. The disease with which we are concerned today is not in a static state in our world. Terms are still being clarified. Testing capability is variable. Fear continues to be a major adversary for the determination of factual information. Regional “coordination ard cooperation must be developed. Education is our sole weapon. The data in my report represent the dedication and scientific excellence of hundreds of medical personnel in Asia and around the world. Technology transfer, laboratory training and political awareness and honesty have produced this information database. The focus and future direction of these efforts will be determined in large part by the conclusions of the Presidential Commission on the AIDS Epidemic and similar organizations throughout the world. The World Health Organization (WHO) has taken a decisive position to gather, sunmarize and publish data on HIV for all member governments in the WHO Western Pacific Region. The Virus Information Exchange Newsletter for Southeast Asia and the Western Pacific publishes current data. The First International Congress on AIDS in Asia and Other Sexually Transmitted Diseases was held in Manila, Philippines in November 1987 and provided a forum for open exchange of data. I will start with a summary of the number of AIDS cases reported in the Asia area as of November 1987. Australia 622 China 2 French Polynesia 1 Hong Kong 4 India 17 Japan 5d Republic of Korea 1 Macao 1 Malaysia 1 New Zealand 54 Philippines 19 Singapore 2 Tonga 1 The laboratory confirmation of these cases of AIDS is presumed on my part since that information is not available. For the Australia and New zealand cases, data indicate the majority were male homosexuals or bisexuals. In Japan, the majority were hemophiliacs. Almost all other cases were said to have been in foreigners in the reporting country or residents who acquired AIDS outside of the country and then returned home. The next data to be presented are the HIV prevalence for the various countries. One should not attempt to compare these rates between countries because there is wide variability in the population groups which were sampled, perhaps even bias in selecting individuals from these groups. The data are as follows: Country Australia Brunei China French Poylnesia Guam Hong Kong India Japan Macao New Zealand Papua New Guinea Philippines Republic of Korea Singapore Taiwan Tonga * Western Blot ** Enyme~Linked Immunosorbent Assay No. HIV Seropositive 17,741 2 4 29 4 118 126 298 256 52 ll 14 54 Test Used WR* ELISA** No. Examined Prevalence or Tested Rate Per 1900 362,389 48.9 3,926 8.5 6,500 9.6 13,118 2.2 543 7.3 377,232 8.3 40,874 2.9 2,213 8.4 1,398 2.8 65,366 9.8 216,784 8.05 116,788 g.1 77,788 0.7 1,841 8.5 The data from Australia do not define the population groups sampled and are based on positive samples from sera tested. More than one sample: could have been submitted on an individual. No denominator data or descriptors of populations evaluated are available from Japan or New zealand. The usual divisions of the populations groups have been 1). blood donors, 2). hemophiliacs, 3). homosexuals, 4). bisexuals, 5). female prostitutes and 6). others. It is not clear how individuals belonging to more than one category are handled. In French Polynesia, all 29 HIV positives were among 945 sampled with known risk factors. In Hong Kong, 50 positives were hemophiliacs and 55 were other; no homosexuals or prostitutes were evaluated. In India, over 98% of the positives were from prostitutes. In the Philippines, 47 positives were from prostitutes; no hemophiliacs were tested. In Korea, 7 positives were from prostitutes and 3 were from overseas workers. In Singapore, 9 positives were from homosexuals. In Taiwan, 17 of 775 homosexuals were positive, 31 of 317 hemophiliacs were positive and none of 2,836 prostitutes were positive. The last data I have to present are the incidence of HIV positivity in prostitutes in the Philippines. In a project involving the Philippine Ministry of Health and Naval Medical Research Unit Number TWO, 3,271 female prostitutes who tested negative for HIV in 1986 were tested again one year later. Seven were found to be positive, for an annual incidence of 2.1 per 1968 in this highly selected population. Education must remain as the principle objective. The scientific community must become educated to perform HIV testing with standardized methods and quality control. Population groups studied should be completely categorized with standard descriptors. Incidence studies mst have standardized intervals and mist evaluate specific risk factors. Statistical évaluations need to be done in a manner which is universally accepted. The media need to be educated to understand the complexities inherent in a seemingly simple statement about HIV rates. The general population needs to be educated that what is currently being measured in HIV studies is the humoral response to the virus; we still don't know the variability of interval between virus exposure/virus infection and HIV antibody production. There are yet so many basic questions to be answered about HIV. Prevalence rates give us a static retrospective picture. Incidence rates put some motion to that picture and focus it closer to the present. It is essential that research programs continue to measure for transmission of this virus. International cooperation is basic since our world's population is so mobile. The HIV epidemic will continue to be a medical, social and political challenge in the years to come. Question lL: Answer 1: Question 2: Answer 2: What is the evidence that the U.S. military is responsible for the presence of the HIV virus in the Philippines? The introduction of HIV virus into one region from another is an extremely difficult, if not impossible, fact to prove. There are minor antigenic variations of the HIV virus which some investigators believe may fall into geographic areas— perhaps the influenza virus could serve as an analogy, i.e@., the Hong Kong or London strains. Studies have not been done to map and follow movement of antigenic variations of HIV. The HIV seroprevalence studies in the Philippines found the majority of the positives in the prostitute population. All but one or two of the positive prostitutes worked in the vicinity of the two U.S. military bases. There is no information on the geographic mobility of these women. Sexual contact was primarily, but not exclusively, with U.S. personnel. The focus should be to educate and prevent the further transmission of HIV within a geographic region or between regions. What sort and degree of HIV antibody testing should be done in Asia? Testing for HIV antibody should have the same basic goals in every area of the world. The baseline seroprevalence studies should be done, most importantly in the individuals in high risk groups or with high risk behavior. Subsequent testing to determine incidence rates should continue so that educational efforts and preventive measures can be increased in specific areas. There are major obstacles to this sort of testing, however. First there is the cost with today's technology. Then, the majority of the world cannot maintain or operate that technology. Next is the maintenance of the database, and then there are the human and civil rights issues. International cooperation for the common good is a basic ingredient. NAVAL MEDICAL RESEARCH AND DEVELOPMENT COMMAND ORGANIZATION MANUAL 1. Introduction: In accordance with OPNAVNOTE 5450 of 7 June 1974, the Naval Medical Research and Development Command was established on 1 July 1974, to manage Research, Development, Test and Evaluation (RDT&E) programs for the Navy Medical Department. 2. Mission: To plan, manage, and direct Research, Development, Test, and Evaluation (RDT&E) programs concerning the health, safety, and readiness of Navy and Marine Corps personnel in the effective performance of peacetime and contingency missions, and to perform such other functions or tasks as may be directed. 3. Status and Command Relationships. The Naval Medical Research and Development Command is a shore activity in an active (fully operational) status under a commanding officer. a. Echelon of command: 1 - Chief of Naval Operations 2 = Commander, Naval Medical Command 3 - Commanding Officer, Naval Medical Research and Development Command, Bethesda, Maryland ~ b. The Commanding Officer, Naval Medical Research and Development Command is subject to the area and regional authority of the Commandant, Naval District, Washington, D.C. 4. Functions. As directed by the Commander, Naval Medical Command: a. Command Navy Medical Department research and development laboratories and activities, and support their RDT&E missions by providing and exercising accountability for manpower, funds, facilities, and equipment resources. b. Direct, plan, program, budget, and document the Navy medical research and development program. ce. Determine the requirements for, and recommend the procurement, training, assignment, and distribution of research and development personnel. d. Perform staff functions for, and advise the Commander, Naval Medical Command on RDT&E matters. e. Provide professional medical and dental guidance in the planning of Navy and Marine Corps weapons systems, life support systems, and personnel protection. tw f. Implement Medical Department policies and oversee the use and protection of human subjects utilized 1n research and development studies conducted by, within, and for the Department of the Navy. a. Execute Medical Department responsibilities in relation to the use and protection of animals utilized in research and development studies conducted by, within, and for the Department of the Navy. * h. Direct and coordinate efforts to ensure a smooth transition of research assets and activities required to support Medical Department mobilization missions. i. Develop and maintain mechanisms to ensure rapid and effective dissemination of research derived information to all appropriate end users. j. Coordinate research efforts by subordinate activities with other Navy commands and offices, other government agencies, civilian organizations, and foreign governments. k. Provide or undertake such other functions as may be authorized or directed. 5. Component Activities: The following Echelon IV and V activities are under the cognizance of the Naval Medical Research and Development Command: a. Echelon IV: Naval Aerospace Medical Research Laboratory, Pensacola, FL Naval Biodynamics Laboratory, New Orleans, LA Naval Dental Research Institute, Great Lakes, IL Naval Health Research Center, San Diego, CA Naval Medical Research Institute, Bethesda, MD Naval Submarine Medical Research Laboratory, Groton, CT U.S. Naval Medical Research Unit No. 2, Manila, Republic of the Philippines U. S. Naval Medical Research No. 3, Cairo, Arab Republic of Egypt b. Echelon V: Naval Medical Research Institute Detachment, Lima, Peru Naval Medical Research Institute Toxicology Detachment, Wright-Patterson Air Force Base, OH U.S. Naval Medical Research Unit No. 2 Detachment, Jakarta, Indonesia g. Office of the Infectious Diseases Research Area Manager of (1) Research Area Manager, Infectious Diseases (403) (a) Is directly accountable to the Commanding Officer for mission execution, but reports to the Director of Research and Development as line supervisor. (b) Coordinates the planning, development and administration of RDT&E directed toward the epidemiology, immunology, rapid diagnosis, treatment, vaccine development and control of infectious diseases of military importance. (c) Maintains liaison with the appropriate Naval Medical Command operational codes, the Navy Environmental Health Center, the Marine Corps, the Army Medical R&D Command, the Uniformed Services University of the Health Sciences, the Office of Naval Research, the Office of Naval Technology, the Armed Forces Epidemiological Board, the Armed Forces Pest Management Board, and the National Institute of Allergy and Infectious Diseases. (d) Monitors the in-house and contract infectious diseases RDT&E program and keeps performing organizations advised as to requirements and priorities. (e) Serves as the Navy representative on the Joint Technology Coordinating Groups (JTCGs) for Infectious Diseases of Military Relevance, and for Medicial Biological Warfare Defense for the Armed Services Biomedical Research Evaluation and Management (ASBREM) Committee to coordinate RDT&E in areas of infectious diseases and biological warfare defense. (f) Serves as the Commanding Officer's Special Assistant for Overseas Laboratory Affairs as a collateral duty. (2) Assistant Research Area Manager, Infectious Diseases (403A) (a) Is directly accountable to the Commanding Officer for mission execution, but reports to the Infectious Disease Research Area Manager as line supervisor. (b) Assists in the management and oversight of Infectious Diseases Research Programs. (c) Assumes cognizance over Infectious Diseases Program matters when the Research Area Manager is absent from the Command. When acting in this Capacity the Assistant shall have full authority to function on behalf of the Research Area Manager in all program matters. ‘(d) Serves as the Liaison Officer to the U.S. Army Medical Research and Development Comnand and is responsible for integrating the Navy clentific program areas where the U.S. Army serves as executive agent for the Jepartment of Defense (Infectious Disease, Biological Warfare Defense, and Combat Dentistry). NAVMEDCOMINST 5458.137 MISSION, FUNCTIONS, AND TASKS OF U.S. NAVAL MEDICAL RESEARCH UNIT NO. 2, MANILA 1. Purpose. To promulgate the mission, functions, and tasks of the Naval Medical Research Unit No. 2, Manila under the mission established by OPNAVNOTE 5458 Ser 99B26/144897 of 27 Feb 79. 2. Mission. To conduct research, development, test, and evaluation in infectious diseases to enhance the health, safety, and readiness of Navy and Marine Corps personnel in the effective performance of peacetime and contingency missions in Southeast Asia, and to perform such other functions or tasks as may be directed. 3. Status and Command Relationships. The Naval Medical Research Unit No. 2, Manila is a shore activity in an active (fully operational) status under a commanding officer. a. Echelon of command: 1 Chief of Naval Operations 2 - Commander, Naval Medical Command 3 = Commanding Officer, Naval Medical Research and Development Command 4 - Commanding Officer, U.S. Naval Medical Research Unit No. 2, Manila, Republic of Philippines b. The Commanding Officer, U.S. Naval Medical Research Unit No. 2, Manila has command authority over the branch facilities listed in enclosure (198). ¢. The Commanding Officer, U.S. Naval Medical Research Unit No. 2, Manila is subject to the area coordination authority of the Commander in Chief, U.S. Pacific Fleet and the local coordination of Commander, U.S. Naval Forces, Phillipines. 4. Functions. As directed by the Commanding Officer, Naval Medical Research and Development Command, Bethesda, MD and under the cognizance of the Commander, Naval Medical Command: a. Conduct research programs in infectious disease which directly relate to military medical requirements and operational needs. 15 NAVMEDCOMINST 5458.137 b. Conduct interactive biomedical research with other Army and Navy medical research and development laboratories specifically in the areas of preventive medicine and epidemiology, and tropical medicine and infectious diseases. c. Develop and maintain the capability to provide infectious disease risk assessment information and conduct research and development to improve the prevention, diagnosis, and treatment of infectious diseases in the Fleet and Fleet Marine Force. d. Maintain a technology base and scientific and technical expertise in infectious disease and tropical medicine to provide advisory assistance when requested. e. Provide or undertake such other appropriate functions as may be authorized or directed. 5. Tasks. a. Direct, manage, and support the U.S. Naval Medical Research Unit No. 2 Detachment, Jakarta, ID. 16 — | RESERRTHAND TECHNOLOGY WOR. UNIT SUMMARY O..Tt OF SUMMARY 860220 1 AGENCY ACCESSIOMI? KEPORT COATHUI SY MAUL DD-DR&EE(AR) 636 1, OATE PREV 4 KINO OF 4 SUMMAAY 6 WORK [? REGRAOING § DISS NINSTAN O LEVEL OF SUM / SUMMARY SUMMAAY scTyY SECUAIT Y A WORK UNIT N/A A. New U U CX on” OES PROGRAM E LEMeNT PROJECT NUMBER TASK AREA NUMBER WORK UNIT NUMGEA — wrt y 63105A 3M463105DH29 AA O01 1 COs... AIBUTING contamuting | DA LRRDAP FYS/-01 "YT TITLE (Peecede with Secunty Chaasfication Code) (U) Epidemiology of HTLV-ILI/LAV infection in the Philippines 12 SUBJECT ARLAS 0605 Clinical Medicine; 0603 Biology; 0613 Microbiology 132 START OATE 14 ESTIMATED COMPLETION DATE 15 FUNDING ORGANIZATION 16 PERFORMANCE METHOD _ 8601 8902 Das | C * CON TAACT/GRANT 16 RESOURCES ESTIMATE 1 OATE EFFECTIVE | exPrAaTion FISCAL YEARS |« PROFESSIONAL WORKYEARS | & FUNDS (in thousands, a CONTRACT/GAANT NUMBER _ TYPE |. AMOUNT 86 0.6 650 . KINO OF AWARO 1. CUM/TOTAL 87 19, RESPONSIBLE 000 ORGANIZATION | { 20. PERFORMING ORGANIZATION { -WaAME U.S. Army Medical Research and a NAME Development Command - AOORESS finciude rip code) FT Detrick, Frederick, MD Naval Medical Research and Development Command bo. ADDRESS Attn: U.S. Naval Medical Research Unit No. 2 21701-5012 APO San Francisco 96528 NAME seNeomsigce INDIVIDUAL c. NAME OF PRINCIPAL INVESTIGATOR TELEPHONE NUMBER (include area code) &. TELEPHONE NUMBER (include area code) , (301) _ 663-7567 771-6792; 818-2881 . Gensmat USE FIC f. NAME GE ASSOCIATE INVESTIGATOR (if evcslabie} _ \ eranvrenitian APPLICATION: = eMAMMANALOTO. Ce Cf evodlable) - KEYWORDS (Precede EACH with Secunty Clasufication Code} (U) RAI; (U) Virology; (U) Immunology; (U) AIDS; (U) RILV-TII/LAV; (U) Volunteers: (U) Infectious Diseases - TECHNICAL OBJECTIVE 24. APPROACH 25. PROGRESS (Precede text of cach with Secunty Clessificatiqn Code) 23. (U0) This study will determine the prevalence and transmitted AIDS in a high risk group (prostitutes) in the Philippines. incidence of heterosexually These data will provide an assessment of risk for the 17,000 active duty DOD personnel stationed in the Philippines as well as the 50,000 to 100,000 troops which take liberty at Subic Bay each year. long term follow up of HTLV-III/LAV seropositive study subjects will provide AIDS disease incidence and fdentity the potential impact of tropical infections on Che progression of AIDS. HILV-III/LAV virus isolates will be collected for genetic characterization and determination of antigenic variability. 24. (U) Prostitutes operating in the immediate area of the two U.S. bases will be screened anoually for BILV-LII/LAV antibody. Seropositive subjects will be followed every 3 months with quantitive serology and virologic cultures, clinical examination and immunological studies. Seropositive subjects who contract a tropical infection will be carefully followed to determine the impact of tropical diseases on subjects with HTLV-III/LAV infection. Virus fsolates will be referred to a DOD consultant laboratory for nucleic acid analysis. 25. (U) N/A was, 1498 GW Ole 4 f-o1s aren ree TESTIMONY TO THE UNITED STATES Pi ESIDENTIAL COMMISSION ON THE HUMAN IMMUNODEFICIENCY VIRUS EPIDEMIC by Ann 0. Hamilton Director, Population and Human Resources Department World Bank The World Bank, more formally known as the International Bank for Reconstruction and Development (IBRD), was established in 1945. It is owned by its member governments -- of which there are now 151 -- with voting power linked through their capital subscriptions to their relative economic strength. The Bank obtains funds by borrowing in the capital markets of Europe, Japan, the United States, and the Middle East. These funds are then loaned to the governments of member countries which request them and which present acceptable proposals for the use of the borrowed funds. In our fiscal year 1987, the IBRD committed loans totaling $14.2 billion dollars to finance development projects in 78 member countries. IBRD loans have a maturity of 15-20 years, including a 3-5 year grace period, and an interest rate which is adjusted every six months to reflect the average cost of Bank borrowings. The present interest rate is 7.72%. The Bank Group also has a "soft loan” window, called the International Development Association (IDA). IDA is financed by contributions from the wealthier countries, including the United States, and lends mostly to the world’s poorest countries (those with GNP less than $790 per capita). It is administered by the same staff as the IBRD, and the same criteria are used in project selection. In fiscal year 1987, some $3.5 billion was loaned on IDA terms, These terms provide for a 10-year grace period, a 50-year maturity and, in lieu of interest, a service charge of 0.75% a year. Most African countries, including those most affected by AIDS, qualify for IDA terms. Some of the countries in Latin America that are most affected by AIDS borrow from the World Bank at IBRD rates. The Bank has come increasingly to recognize that good health is itself both a fundamental ingredient and a fundamental goal of the development process. Thus, investments in reducing the rate of population growth, in improving nutritional status, and in reducing morbidity and mortality make a direct contribution to the well-being of a population. Furthermore, it is increasingly apparent that the prevention or cure of many diseases can release a country’s productive potential for the development process. April 16, 1988 | page 2 World Bank lending for the population, health and nutrition (PHN) sectors has grown rapidly since its inception in 1980. Annual lending has more than doubled from about $100 million a year in the early years of the decade to about $220 million a year in the last three-year period. (See Table 1 and Figure 1.) The projections of the country departments of the bank for the period 1988-90 suggest that annual lending will have again tripled by the last years of the decade, to a total of about $750 million a year. In the African countries south of the Sahara desert, which include the countries most affected by AIDS, annual PHN lending has increased three- fold since the early years of the decade and will rise again three-fold by the later years. Table 1. AVERAGE ANNUAL WORLD BANK LENDING IN THE POPULATION, HEALTH AND NUTRITION SECTORS (Millions of Current US Dollars) Increase Projected Increase FY81-84 Projected FY81-84 FY85-87 to '85-87 to '88-90 to ’88-90 Africa 19.0 59.0 210.5% 198.7 236.7% Asia 45.5 109.0 139.6% 178.7 63.9% EMN 12.5 18.7 49.3% 70.7 278.6% LAC 26.3 35.0 33.3% 306.3 775.2% TOTAL 103.3 221.7 114.7% 754.3 240.3% This growth is even more impressive when taken as a share of total World Bank lending. From a very low level in the early years of the decade, the PHN share has doubled to 1.4% during recent years and is projected to more than double again, attaining over 3%, in the next few years. (See Table 2 and Figure 2.) Because the World Bank's goal is overall development, most of our projects in the health sector are broad, aimed at reinforcing the country’s efforts to combat a wide range of its disease problems. Like other donor agencies, the World Bank has emphasized strengthening of national capability to extend basic preventive and curative services to the general population of developing countries. At the same time, in order to help promote the sustainability of these investments, the Bank has placed considerable emphasis on the strengthening of the national institutions which plan, manage, and finance their health care systems. April 16, 1988 page 3 Table 2 WORLD BANK LENDING IN THE POPULATION, HEALTH AND NUTRITION SECTORS AS A PERCENT OF TOTAL WORLD BANK LENDING Projected 1981-84 1985-87 to ‘88-90 Africa 1.0% 3.1% 4.7% Asia 0.7% 1.5% 2.3% EMN 0.5% 0.7% 1.4% LAC 0.8% 0.8% 4.7% TOTAL 0.7% 1.4% 3.2% Against this background of the Bank's mandate and its activities in the health sector as a whole, I would like to describe the place of AIDS- control activities in our projects. The appropriate role for World Bank financed projects in the struggle against AIDS is conditioned by three facts. First, our terms -- even IDA terms -- are more burdensome than the grant financing which is currently available from many other donors to finance AIDS control programs. Second, the typical World Bank loan is large, ranging from $15 million in Africa to $35 million in Latin America and $55 million in Asia. Third, because we appraise in depth and reach agreement with the borrowing country on virtually all aspects of a project -- economic, financial, technical, managerial, and institutional -- the preparation and negotiation of a World Bank project normally requires 12 to 24 months. These facts suggest that World Bank projects will typically address medium- and long-term issues raised by the struggle against AIDS, in the context of the overall health problems of the country. Countries which cannot obtain enough grant financing to cover the entire cost of their AIDS control program are the most likely to request Bank Group financing for this purpose. However, in these countries, and in those whose AIDS programs are fully funded by grants, World Bank projects are designed to strengthen the national health care system within which the AIDS program must function. The World Bank’s continuing focus on management and finance of the entire health system will undergird the AIDS prevention programs while simultaneously protecting important programs targeted at other diseases or population groups. AIDS components of broader health projects are currently under discussion in over twenty countries. Projects in two seriously affected countries -- Burundi and Brazil -- have recently been agreed with the governments of those countries and approved by the World Bank’s Board of Directors. Figures 3 and 4 display the breakdown of financing between the AIDS component and the other major components of both of these projects. April 16, 1988 page 4 Note the prominent role of institutional strengthening. The $2 million AIDS component in Burundi represents 42% of the cost of its AIDS program. In Brazil the $9.3 million AIDS component constitutes 8.5% of its AIDS program. The World Bank supports WHO's leadership role in the global struggle against AIDS. Since the inception of WHO's Special Programme on AIDS, now called the Global Programme on AIDS, the Bank's staff have cooperated actively with GPA in many countries to assure the coordination of Bank-financed operations with GPA-supported national AIDS plans. The Bank has also supported GPA directly by participating in its analysis of the economic and demographic impact of AIDS. You heard some of the preliminary results of that collaboration this morning in the presentation of Dr. Over. I am hopeful that our budgetary situation, which is currently under active discussion within the Bank, will permit us to continue and expand our collaborative efforts. Whatever our budgetary situation, however, we in the Bank who are associated with the health sector remain committed to vigorous collaboration with GPA, UNDP, and other donors -- including prominently the U.S. Agency for International Development -- in assisting less developed countries in their struggle against this new threat to their prospects for development. —_s Figur 1 AVERAGE ANNUAL PrN LENDING (Millions of current dollars) 1981-34 15 4588-90 Projected PAareica Nesta Fa ow &Y tac Figure PHN LENDING AS PERCENT TOTAL , BY REGION 1981-84 1 1988-99 Projected Arica Rasta FA ew AY Lac AIDS (11,92) Health Education (8, 44) Institutional Strengthening (12.94) Population Data (6.34) HCH & Fan, Ping (61.34) BURUNDI 1988 HEALTH PROJECT {6 Million Other Communicable Diseases (80,07) BRAZ Figure 4 AIDS (3.9%) 983 ENDEMIC DISEASE PROJECT $218 MILLION Institutional Strengthening (49,62) Operational Research (0.64) Community Mobilization (4.9%) DP ITED _ ATIONS . . Distr. Governing Council GENERAL of the . . pP/1988/1 United Nations 8 December 1987 Development Programme ORIGINAL: ENGLISH Special session 16-18 February 1988, New York Item 2 (a) of the provisional agenda PROGRAMME MATTERS Coroperation against AIDS Report of the Administrator A. Introduction 1, The Governing Council was advised at its thirty-fourth session that the Administrator of the United Nations Development Programme (UNDP) would collaborate with the World Health Organization (WHO) and other agencies in the efforts to fight the disease known as Acquired Immunodeficiency Syndrome (AIDS). in its decision 87/28 of 19 June 1987 entitled "Co-operation against AIDS", the Council noted that concrete proposals would be submitted at its special session in February 1988, The Administrator is hereby submitting proposals for consideration by the Council. Additional information on activities at the country level will be made available to the Council at its special session. 2. First identified in 1981, AIDS has now become a world-wide epidemic. Eight countries reported cases of AIDS in 1981; as of 1 November 1987, 62,811 cases of AIDS had been officially reported to WHO from 127 countries. No cure has yet been found for AIDS. This epidemic, which has no geographic, social, racial or cultural boundaries, demands a global response, 3. WHO is leading the global fight against AIDS. During the Third Meeting of Participating Parties for the Prevention and Control of AIDS, which took place at WHO headquarters, Geneva, on 27 and 28 April 1987, the Administrator made a commitment on behalf of UNDP to join in an international campaign to faght AIDS. = The participants in this meeting included representatives and officials from veloped and developing countries, and from WHG, UNDP, the United Nations .ldren's Fund (UNICEF), the United Nations Find for Population Activities \UNFPA), the World Bank, the United Nations £da‘zational, Scientific and Cultural —_ 87-32836 2628 (EF) Jae DP/1988/1 English Page 2 Organization (UNESCO), the European Economic Community (EEC) and several non-governmental organizations. 4. At the Third Meeting of Participating Parties, UNDP pledged support for global and regional activities, and amnounced its intention to request the resident representatives to take up the matter of AIDS with the national authorities and international agencies concerned, in close co-operation with WHO. Resident representatives have been contacted and advised on how best to assist Governments in this programme. 5S. On 15 May 1987 the Fortieth World Health Assembly endorsed the establishment of a Special Programme on AIDS as well as the Global Strategy for the Prevention and Control of AIDS (resolution WHA40.26). 6. At the invitation of the Administrator, extended during the Third Meeting of Participating Parties, Dr. Jonathan Mann, Director of the WHO Special Programme on AIDS, briefed the Governing Council during its thirty-fourth session in June 1987 on the global AIDS situation and its implications for international co-operation. In its decision of 19 June 1987 entitled "Co-operation against AIDS", the Council took note of the statement by the representative of WHO and noted with satisfaction the response of the Administrator to collaborate with WHO and other agencies. As Stated above, the Council noted further that concrete proposals would be submitted to its special session in February 1988 (decision 87/28 of 19 June 1987). 7. The Economic and Social Council, in its resolution 1987/75 of 8 July 1987, drew the attention of the General Assembly to World Health Assembly resolution WHA40.26; called upon all States to take’ active measures to prevent and control AIDS in line with the global strategy; and urged all appropriate organizations of the United Nations system, including the specialized agencies, as well as bilateral and multilateral agencies and non-governmental and voluntary organizations, to Support the world-wide struggle against AIDS in close co-operation with WHO in its role of directing and co-ordinating the urgent fight against AIDS. B. Backaround 8. According to WHO, the number of AIDS cases so far diagnosed is much smaller than the true number of people actually infected with the AIDS virus. Symptoms of the dread disease may not develop for five or more years after an individual is infected with the AIDS virus. It is projected by WHO that by 1992 as many as 3 million people may be stricken. Many more millions of people are now infected with the virus, most of whom do not know it. 9. As stated in WHO publications, the AIDS epidemic affects both industrialized and developing countries and it threatens economic and social development through its impact on adults 20-49 years old, men and women in their prime working years. 10. The world-wide AIDS epidemic also threatens public health. WHO has noted that when the AIDS virus infects pregnant women, infant mortality rises; in some areas, an alarming percentage of children are being born with AIDS. The interaction of fuse DP/1988/1 English Page 3 the AIDS virus with other diseases sparks optbreaks of otherwise controllable infections, and the care of AIDS patients places enormous burdens on already limited health resources. Fear and ignorance of AIDS break down vital social relationships between communities, families and individuals and may even lead to political problems at the national and international level. ll, When the AIDS issue 1s addressed, the following considerations should be borne in mind: (a) AIDS, wnile not having been identified in all countries, must be regarded aS a spreading epidemic; (6) While the present morbidity and mortality of AIDS cannot compare with other communicable diseases such as malaria, schistosomiasis, diarrhoeal diseases, respiratory infections and others, the rate of Human Immunodeficiency Virus (HIV) infection 1s growing alarmingly; (c) The personal and societal stress caused by AIDS will require exceptional commitments and counselling skills at government, community and family levels; (d) For advice on AIDS programmes UNDP will rely on WHO, which is the leading and co-ordinating international organization. Other partner agencies such as UNICEF, UNFPA, tne World Bank and UNESCO will be consulted, as appropriate; (e) The orime responsibility for AIDS programmes rests with the national authorities, C. UNDP co-operation against AIDS 12. UNDP support to AIDS programmes is based on the following global strategy: (a) prevention of HIV transmission; (b) reduction of morbidity and mortality associated with HIV infection; and (c) reduction of the impact of AIDS on the socio-economic conditions of countries. 13. In view of the unprecedented nature of the AIDS pandemic and the urgency surrounding it, and the need therefore to act quickly to meet the changing needs in continuous consultation with WHO and other agencies, UNDP has taken early action in a number of areas, 14, UNDP participation in national AIDS programmes is guided by the strategies outlined in the WHO document of March 1987 entitled "Special Programme on AIDS: Strategies and structure - projected needs". 1/ In order to give maximum flexibility to the WHO Special Programme on AIDS, global and regional projects have been launched under preparatory assistance. -b- 15. The UNDP global and regional programmes nave allocated $3.5 million and are currently supporting AIDS activities thet are s€ general value and importance and of direct relevance to country projects. ‘nese activities include dissemination of global messages on AIDS; promotion of internm:.anal consensus and exchange of Jesse DP/1988/1 Englisn Page 4 information; epidemiology and impact assessment; promotion, co-ordination and Support of research; laboratory support for research and prevention; intersectoral co-operation; preparation of guidelines and educational materials; and centrally managed missions tc assist develcping countries in the preparation and initiation of country-specific AIDS plans and programmes. 16. Steps are currently being taken to establish a joint UNDP/WHO programme progressively to make blood supelies safe throughout the world by assisting with the anstallation of up-to-date blood screening and testing facilities. It 1s expected that other multilateral, bilateral and non-governmental organizations, patticularly the International Red Cross and the Red Crescent, will participate in this urgent effort. 17, With regard to national programmes, the resident representatives have been requested to examine the possinility of including, wnere appropriate, an AIDS component in existing UNDP-assisted projects and/or to design a new project dealing with AIDS exclusively. At the country level UNDP 1s supporting programmes which - depending on the case - include: creation of a broadly representative AIDS committee; epidemiolcgical assessments; resource assessments; establishment of Surveillance programmes; development of laboratory capability to support epidemiological and diagnostic work; strengthening of the capacity of national health systems to recognize, diagnose and manage HIV infections and associated clinical manifestations; educational programmes and services for health workers at all levels; and prevention programmes. 18, The AIDS component of UNDP country programmes is planned and imovlemented in full consultation with, and bearing in mind the activities financed by, tne Governments themselves and other donors. As experience in AIDS programmes is being gained, more detailed approaches may be considered for future funding of AIDS programmes. BD. Management and co-ordination 15. The Special Programme on AIDS was created by WHO as a focal point for global ALDS prevention and control. The Director of the Special Programme on AIDS, who reports directly to the Director-General of WHO, will ensure that the Special Programme will be co-ordinated with and benefit particularly from: (a) other WHO research and operational programmes, including those supported by UNDP; and (b) the programmes of other multilateral, bilateral and non-governmental agencies, 20. UNDP headquarters and the field offices are fully committed to collaborate, as appropriate, with WHO - the leading international agency on AIDS - and other interested multilateral, bilateral and non-governmental agencies in the preparation and implementation of programmes to combat AIDS. Notes 1/ = WHO/SPA/GEN/87.1. UNITED | DP NATIONS iN Governing Council V v Distr. Xf iY of the GENERAL SS United Nations Development Programme DP/1988/1/Add.1 5 February 1988 ORIGINAL: ENGLISH Special session 16-18 February 1988, New York Item 2 (a) of the provisional agenda PROGRAMME MATTERS Co-operation against AIDS Report of the Administrator Addendum I. INTRODUCTION 1. Since the preparation of document DP/1988/1, a number of developments regarding the role of the United Nations Development Programme (UNDP) in the Prevention and control of the disease known as Acquired Immune Deficiency Syndrome (AIDS) have taken place. The Administrator wishes to bring these to the attention of the Governing Council. They include the proposed World Health Organization (WHO) UNDP Alliance to Combat AIDS and two specific global project recommendations (UNDP/WHO AIDS Pinancing Facility and Global Blood Safety Initiative) related to AIDS, which are included in this document. The Administrator also wishes to bring to the attention of the Governing ‘Council the action taken by the General Assembly on AIDS, resulting in General Assembly resolution 42/8 of 26 October 1987, the recently concluded World Summit of Ministers of Health on Programmes for AIDS Prevention, and the heightened global concern about the impact of this disease on general public health and economic areas. IZ. WHO/UNDP ALLIANCE TO COMBAT AIDS 2. On the occasion of the fourth meeting of participating parties of the WHO Special Programme on AIDS, held in Geneva on 12-13 November 1987, the Director-General of WHO proposed that UNDP and WHO should combine forces in support of national aids programmes, UNDP will bring its experience and expertise to bear * multi-sectoral approaches to Socio-ecezsmic Cevelopment in support of WHO as the 88-02683 0006d (E) fave DP/1988/1/Add.1 English Page 2 international leader in health policy and in scientific and technical matters related to health, specifically in its mandate to direct and co-ordinate the global fight against AIDS. The Administrator agreed to provide full UNDP support to Governments and WHO, especially at the field level, through the network of UNDP Resident Representatives, who also serve as Resident Co-ordinators for the United Nations system operational activities for development. The policy framework for this initiative, which has been given the name WHO/UNDP Alliance to Combat AIDS, appears in the annex to this document. As the policy framework indicates, the collaborative activities which are envisaged are consistent with General Assembly resolution 42/8 of 26 October 1987 which, inter alia, confirms that WHO should direct and co-ordinate the global battle against AIDS and requests the Secretary-General to ensure a co-ordinated response by the United Nations system to the AIDS pandemic in close co-operation with the Director-General cf WHO. On 19 January 1988, the policy framework of the Alliance was brought to the attention of the WHO Executive Board by the Director-General of WHO, at which time the concept of the Alliance was endorsed. _ 3. While the precise details of an agreement between WHO and UNDP covering the Alliance have not yet been fully elaborated, general ‘agreement has been reached that UNDP will support WHO in assisting Governments in formulating, co-ordinating, implementing, monitoring and evaluating national AIDS plans and mobilizing the required external resources. UNDP, through its field offices, will further assist ; WHO in helping the Governments concerned, to ensure that all external support is an © integral part of national AIDS plans and the WHO global strategy on AIDS. In carrying out these responsibilities with WHO, UNDP will assist Governments in seeking to ensure that such offers of support are consistent with the national AIDS plan and Governments’ overall development priorities, plans and resource corte allocations. WHO has the sole responsibility for providing the technical and policy inputs which may be required by Governments for the development, implementation and evaluation of national AIDS plans. - -" . 4. Subject to the approval of the Governing Council, it is envisaged, as part of the Alliance, that UNDP will make available to WHO resources on a reimbursable basis, in an amount of up to $2 million, for a facility to bridge the time between firm pledges of external support for country-level AIDS activities and the receipt of these pledged resources. Other aspects of the envisaged Alliance include the provision by the WHO Global Programme on AIDS (WHO/GPA) of technical and policy guidance to the Resident Representative, who, acting in his or her capacity as UNDP Resident Co-ordinator, will assist Governments in seeking to ensure that assistance ? from all organizations of the system is co-ordinated within the framework of national AIDS plans. It is expected, under the terms of the proposal, that UNDP Resident Representatives will provide office facilities for the leader of the national WHO/GPA staff and may also provide appropriate administrative, accounting and logistical support to national and WHO/GPA teams, subject to the reimbursement to UNDP by WHO of identifiable additional expenditures incurred in the provision of such support. 5. Finally, the Alliance envisages focal points at the headquarters levels of { both UNDP and WHO (in the UNDP regional bureaux and in WHO/GPA) in order to facilitate communication and co-ordination in the implementation of this Alliance, The UNDP Division for Global and Interregional Programmes will serve as a focal poir® for UNDP collaboration with the Office of the GPA Director. feos DP/1988/1/Add.1 English Page 3 III, UNDP/WHO FINANCING FACILITY 6. As noted in paragraph 4 above, the WHO/UNDP Alliance to Combat AIDS envisages a facility to finance national activities between the time of the receipt of firm Pledges of external support for country level activities and the actual payment to the WHO/GPA established trust fund for that country within a six-month time-limit. This will be particularly important between the end of the support to the national short-term plan and the beginning of a medium-term plan. To support WHO in this vitally needed bridge financing, the Administrator recommends that the Governing Council approve a reimbursable global sraject in the amount of $2 million. Funds from this project will be made available to WHO as required for the above-mentioned purpose and will be reimbursed by WHO to UNDP immediately on their receipt. Because of the very rapid expansion of programmes to combat AIDS in many developing countries (where it is expected that approximately 80 medium-term plans will enter into the implementation phase by the end of 1988) the demands on this facility may exceed the $2 million recommended by the Administrator. If this proves to be the case, the Administrator intends to review this financing modality and will make recommendations to the Governing Council at future sessions. It should be stressed, as indicated above, that advances will be made only against firm pledges of donors, pending the receipt of payments by the donors concerned. There is no risk to UNDP. 7. In light of the urgency of the AIDS pandemic, the Administrator recommends ipproval of this global project. IV. GLOBAL BLOOD SAFETY INITIATIVE 8. Paragraph 16 of document DP/1988/1 refers to steps being taken to establish a programme to make blood supplies safe throughout the world in order to stem the spread of AIDS and other diseases. A number of steps have been taken in recent weeks to launch this new programme, including consultations convened by WHO/GPA with representatives of UNDP, the League of Red Cross and Red Crescent Societies, the International Society of Blood Transfusion, and the Health Laboratory Technology Unit of WHO. It has been agreed that these organizations will become the core of a broader consortium of organizations, including a wide spectrum of international organizations familiar with the technical, economic and structural needs and concerns of Government and medical personnel throughout the world. This global consorcium is expected to attract financial support from private sector groups as well as from traditional supporters of public health efforts. 9. Those familiar with previous efforts to improve blood safety in developing countries have identified the basic reason for the general lack of success of such efforts: too much attention has been paid to supplying hardware, itself often inappropriate or incompatible at specific locations. Instead, sustainable ‘systems should be built through comprehensive plans for national blood supply and transfusion systems. Such plans must include provision for training in technical -- and managerial aspects as well as plans for meeting their recurrent costs. The bjective of the proposed Global Blood Safety Initiative is to contribute to the obal control of the AIDS pandemic by f#zilit=ting the establishment and further ~evelopment of blood transfusion services capz: lea of ensuring adequate and safe blood supplies. /ove DP/1988/1/Add.1 English Page 4 10. In order to move this initiative forward, a consultative meeting is planned during the first half of 1988, at which time interested parties will be provided with information on the present status of blood transfusions world wide. They will also have before them a draft document on strategies for strengthening blood transfusion systems as well as specific proposals for consortium activities at the country level, linked to medium-term national plans for AIDS prevention and control. ll. To assist in achieving this objective, the Administrator recommends to the Governing Council a global project entitled Global Blood Safety Initiative, to be financed as part of a $3.5 million commitment from UNDP to support AIDS activities (see document DP/1988/1, para. 15). The total project cost will be $700,000, coming specifically from $350,000 already earmarked from the global indicative planning figure (IPF) and $350,000 already earmarked from Special Programme Resources (SPR). These funds will be utilized for the preparation of the consortium meeting and for preparing and financing activities recommended by the consortium. 12. The Administrator recommends that the Governing Council approve this project. V. OTHER MATTERS 13. The Administrator wishes to draw to the attention of the Governing Council that, in response to paragraph 6 of General Assembly resolution 42/8, the Secretary-General has designated the Under-Secretary-—General for International Economic and Social Affairs to serve in his personal capacity as the focal point at United Nations Headquarters for activities related to the prevention and control of AIDS. UNDP has participated in meetings on this subject which have been convened by the Under-Secretary—General and is a member of the United Nations Steering Committee under his chairmanship. The purpose of this Committee is to co-ordinate United Nations activities in support of the WHO Global AIDS Strategy and to identify possible joint activities and linkages between individual programmes in this field. Arrangements are also being made which envisage inter~agency co-ordinating mechanisms at the global and local levels in order to give full expression to the Secretary-General'’s call for harnessing, in close co-operation with WHO, the capacity and experience of the United Nations system in technical co-operation at the country level. 14. The Administrator also wishes to inform members of the Governing Council that: UNDP was represented at a senior level in the recently concluded World Summit of Ministers of Health on Programme for AIDS Prevention, which took place in London from 26 to 28 January 1988. awe DP/1988/1/Add.1 _ English Page 5 Annex WHO/UNDP ALLIANCE TO COMBAT AIDS: POLICY FRAMEWORK 1. The prevention and control of AIDS requires urgent, world-wide action, first and foremost in the health sector. AIDS also has profound social and economic implications. Its control therefore requires political commitment at the highest level, and appropriate social and educational measures. WHO has assumed its constitutional role of directing and co-ordinating the global fight against AIDS. Its Global Strategy for AIDS, approved by the 40th World Health Assembly, includes a wide range of research and development activities in diverse health and related socio-economic and behavioural fields, as well as operational support to countries based on existing and emerging knowledge in these fields. This support aims at strengthening national capacities to set up and operate national AIDS plans, governmental focal points for this purpose being ministries of health fulfilling their function of directing and co-ordinating authority on national health work with their related multi-sectoral health councils, in accordance with World Health Assembly resolution WHA33.17. 2 Countries engaged in AIDS prevention and control have expressed concern about unco-ordinated, ill-timed or inappropriate offers of external assistance to combat AIDS. Similarly, in order to ensure relevant, effective and efficient action, donor agencies have insisted on well-co-ordinated activities in countries as a pre-requisite for their support. 3. To ensure a well-co-ordinated, multi-sectoral approach in the global fight against AIDS, the United Nations General Assembly (UNGA) confirmed WHO's directing and co-ordinating role and urged bilateral and multilateral agencies, including those of the United Nations system, as well as non-governmental and voluntary organizations, to support national and international action against AIDS in conformity with WHO's Global Strategy. The UNGA further requested the Secretary-General of the United Nations, in close co-operation with the Director-General of WHO, to ensure co-ordinated response by the United Nations system. 4. A key component of the reforms taking place in the United Nations system is co-ordinated, complementary and harmonious action by all its bodies. Within that system, UNDP plays the lead role, at the country level, regarding social and economic development. Moreover, the UNDP Resident Representative in any country is at the same time the Resident Co-ordinator of the United Nations System's Operational Activities for Development. UNDP is therefore the natural body to ensure co-ordinated support by the United Nations system regarding socio-economic matters in countries. 5. WHO, through its Global Programme on AIDS (GPA), and UNDP are therefore forging an alliance to control AIDS globally, combining the strengths of WHO as international leader in health policy and in scientific and technical matters elating to health, and of UNDP as leadcr in socio-economic development and of each : its Resident Representatives as co-ordinats- of United Nations operational activities for development in countries. "foe DP/1988/1/Add.1 English Page 6 6. This alliance will support countries in developing, implementing, monitoring and evaluating well-co-ordinated, multi-sectoral national AIDS plans in line with the Global Strategy. It will also help countries to énsure co-ordinated support for such national plans by all external partners, including those of the United Nations system. In this way, all partners will find their rightful place, in their field of competence, in the fight against AIDS. Me/2 (6 UNDP CONTRIBUTIONS TO THE AIDS PROGRAMME (WHO/GPA) 1. Global Programme (DGIP; $ 500,000 2. Special Programme Reserve (SPR) 500,000 3. Regional Programmes: Regional Bureau for Asia and the Pacifie (RBAP) 1,400,000 Regional Bureau for Africa (RBA) 600,000 Regional Bureau for Arab States and the European Programme (RBASEP) 400,000 Regional Bureau for Latin America and the Caribbean (RBLAC) 200,000 TOTAL $3,600,000 The Governinae Council 1. Takes note with annroval of the report of the Administrator on co-operstion against the disease known as acquired immunodeficiency syndrome (AIDS) (DP/1988/1 and Add. 1), esoecially the information provided on the World Health Organization/United Nations Development Programme alliance to combat AIDS, and of the statements made by the Administrator, by the Director of the Soecial Programme on AIDS of the World Health Organization, and by the Under -Secretary-General, Department of International Economic and Social Affairs; 2. Avcoroves the following project recommendations: (a) Co-operation against AIDS: Assistance for a global project - UNDP/WHO Financing Facility (DP/PROJECTS/REC/27) ; (b) Co-operation against AIDS: Assistance for a global project - Global Blood Safety Initiative (DP/PROJECTS/REC/28) ; 3. Requests the Administrator to submit an interim progress report to the Governing Council at its thirty-sixth session (1989) on the implementation of the project recommendations contained in DP/PROJECTS/REC/27. =e iE hl! - STATEMENT OF FRANK E. YOUNG, M.D., Ph.D. COMMISSIONER OF FOOD AND DRUGS U.S. PUBLIC HEALTH SERVICE DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THE PRESIDENTIAL COMMISSION ON THE HUMAN IMMUNODEFICIENCY VIRUS EPIDEMIC WASHINGTON, D.C. APRIL 18, 1988 Thank you, Admiral Watkins and Dr. Walsh, for inviting me here today to join this distinguished array of experts in examining the global impact of the AIDS epidemic. As in your earlier hearings, the work and contribution of this Commission has drawn praise from a wide range of individuals and groups concerned about the HIV epidemic. Although the Food and Drug Administration's responsibilities do not include a lead role within the Federal government for international affairs, we believe some of our activities will contribute significantly to the global efforts to conquer this terrible affliction. The three areas in which we most frequently work with foreign countries are in information sharing with our sister health agencies in nations throughout the world, in technical assistance and cooperation, and in the export of drugs produced in the United States. I'll describe those efforts fully for you today; but first, let me summarize for you FDA's primary mission. As you know, in the battle against AIDS, FDA has focused its resources on streamlining the evaluation of new AIDS drugs, vaccines, and diagnostics--to facilitate their approval for marketing in the United States. Our goal is to have sufficient resources to ensure that every AIDS-related product--and we are seeing the promise of more and more of them--will get immediate and expedited review by FDA's scientists. And with the gratifying support we have received from within the | 2 Administration, the Congress, industry, the public, and this Commission, we hope to realize that goal rapidly. We are also devoting increased resources to the inspection and testing of condoms and surgical and examination gloves--both imported and domestically produced. We are striving to better inform consumers and AIDS patients about the different kinds of fraudulent AIDS products being sold today. And we are conducting research that will assist us in better understanding how this terrible virus affects mankind. INTERNATIONAL DRUG DEVELOPMENT I believe FDA's most significant contribution to the worldwide AIDS epidemic will be the rapid and thorough review of new AIDS therapies being developed in the United States. The key word here is developed. Indeed, based on my work with the World Health Organization and other international bodies, I believe that when a truly effective AIDS drug or vaccine is developed anywhere, we will all learn about it. At that time, the means will have to be found to make it available to all the world's citizens. FDA staff have done some studies in recent years that shed light on the international development and dispersion of new drugs. Let me share some of that information with you--as well as the 3 qualification that we really have no basis at this time for predicting the extent to which it can be extrapolated to AIDS therapies. The first point to make is that there is limited international dispersion of new drugs--because of economic, competitive, and marketing considerations. We have observed that many new drugs simply do not offer sufficient therapeutic promise to attract attention beyond the country in which they are developed. In fact, based on a study we did of drug approvals in 11 advanced industrialized nations over a 14-year period, only 25 percent of the 700 new molecular entities we studied were approved by a majority of the 11 countries. The majority of the new molecular entities were approved in only 1 or 2 of those 11 nations. However, drugs developed in the United States have the best record for achieving quick dispersion to a majority of industrialized nations. Those drugs approved most quickly by the greatest number of countries are, logically, those that offer important advances in therapeutic benefit. For example, captopril for the treatment of hypertension was approved in all 11 countries within 2 years of the year of its first approval. In addition, acyclovir, an antiviral drug for the treatment of herpes, was approved by 7 countries within 2 years of the year of its first approval. 4 As our only example of an effective antiviral against HIV, zidovudine (AZT) has proven quite successful in gaining multi- national marketing approvals. According to zidovudine's manufacturer, 9 of the 11 countries involved in the FDA study approved the drug within 6 1/2 months of its first approval. As of March 15, 1988, (just a year later), a total of 47 countries had approved the drug. Because AIDS is such a terrible disease, with no effective cure today, we believe that effective AIDS drugs will gain similar widespread and rapid approval. Of course, it should be noted as well that many new AIDS drugs are expected to be antivirals, which, unlike antibacterial drugs, are particularly difficult to develop, test, and produce. As such, their development may be beyond the means of many of the world's nations, and their production costs may be a limiting factor in the dispersion to all in need of AIDS treatments. FDA staff have acquired considerable information on international development of AIDS therapies through contacts with regulatory authorities and scientists from other countries and through the monthly WHO drug circulars and the quarterly WHO Drug Information Bulletin. The world has recognized AIDS as a critical public health problem, and we know of at least one example of international cooperation in research, testing, and marketing. Last September major research companies from three different countries-~Cambridge BioScience in Worcester, Massachusetts (a 4, 5 frog prominent American biotechnology firm), Institut Merieux in Lyon, France (which makes and sells vaccines globally, particularly in Africa), and Connaught Laboratories of Ontario, Canada (another major worldwide vaccine distributor) --entered into agreements to jointly develop and test an AIDS vaccine by using several different strategies. This kind of collaboration is an indication of the worldwide sense of urgency that AIDS has inspired, and promises the earliest possible development and dissemination of effective AIDS-related products. COOPERATION AND INFORMATION SHARING FDA staff have developed and encouraged both formal and informal information networks. I believe FDA is widely recognized as one of the leading regulatory agencies in the world. Our policies and actions significantly affect international trade and the regulatory policies of other countries in the product areas we regulate. For those reasons, we make special efforts to be sensitive to the international implications of our national policies. We regularly provide information to other governments, international organizations, and foreign exporters concerning our current programs, legislative requirements, and regulatory actions--including the reasons for these actions. We readily share our expertise with other governments and, in some 6 circumstances, provide technical assistance requested by foreign governments to improve their regulatory systems. Through our foreign visitor program, our International Affairs Staff scheduled meetings with over 500 visitors from 50 different countries during Fiscal Year 1987. Other countries and international organizations also send us information on regulatory matters and on international meetings, so that information sharing is a two-way street. Since 1980, FDA officials have attended biennial meetings of the International Conference of Drug Registration Authorities. These meetings permit officials from developed and developing countries to understand different national approaches to drug regulation and harmonize some aspects of these approaches. In addition, the annual Tripartite Meeting of officials from the United States, Canada, and the United Kingdom provides an opportunity for intensive exchanges of information on regulatory, research, and educational efforts among those nations. Within the last decade, substantial progress has been made through the World Health Organization in developing mechanisms for sharing information about drugs and drug regulatory systems among the countries of the world. FDA has also cooperated ina number of programs under the auspices of the World Health Organization.” For instance, we participated in formulating the 7 WHO Certification Scheme for Pharmaceuticals Moving in International Commerce. This system, adopted by WHO in 1975 and ratified by more than 100 countries, permits an importing country to obtain from the government of an exporting country information on the marketing status of a drug. We also work closely with WHO, as part of WHO's Action Program on Essential Drugs, to help other countries develop national policies and regulatory systems for assuring that high-quality drugs are available for their citizens. I am especially proud of my role as the U.S.-appointed representative on the WHO Executive Board and as member of the U.S. delegation to the annual meeting of the World Health Assembly. I consider my work with WHO to be among my most significant duties, and my participation and that of my staff emphasize the importance we place upon addressing worldwide issues involving pharmaceutical availability, safety, effectiveness. Specific AIDS-Related Activities In recent years, many of our international efforts have focused specifically upon AIDS. The World Health Organization interacts with the Public Health Service Executive Task Force on AIDS, which is directed by Assistant Secretary for Health Dr. Robert Windom, who will be speaking to you tomorrow. Dr. Paul Parkman, 8 Director of the FDA's Center for Biologics Evaluation and Research, is FDA's representative to the AIDS task force. In March, Dr. Windom concurred with the WHO proposal to name the Center for Biologics Research and Evaluation as a WHO Collaborating Center on AIDS. In conjunction with WHO, FDA's responsibilities will include undertaking studies of diagnostic tests and the safety of blood-derived products; providing services and consultation on blood testing; training laboratory and public health personnel; and organizing AIDS-related meetings on behalf of WHO. FDA scientists have participated in several international meetings on AIDS, the last of which, the Third International Meeting on AIDS, was held in Washington, D.C., in June of 1987. We will, of course, attend the next international meeting this summer in Stockholm--represented by at least 14 scientists, some of whom will present papers. Although our travel funds are limited, we have sent scientists overseas whenever possible to assist our colleagues in other nations. For example, a blood expert recently traveled to a WHO session working on guidelines for blood transfusions; a blood testing expert attended WHO working groups in Stockholm and Geneva to assist in work on HIV testing; and a vaccine specialist was in Mexico and Geneva recently to support efforts aimed at developing an effective AIDS vaccine. Because foreign travel is 9 often not possible, our scientists frequently correspond with their overseas colleagues about AIDS issues. We include AIDS-related information as part of quarterly mailings around the world, using an extensive mailing list that has been developed over many years. For example, we recently distributed through that system an update on the status of testing and approvals of AIDS therapies; a report on the first U.S. AIDS case from the HIV-2 virus; a summary report of the Third International Conference on AIDS; and the Surgeon General's Report on AIDS. Individuals on a smaller mailing list receive AIDS-related information as soon as it becomes available. In addition, fast- breaking information on AIDS is relayed by telephone or telex between Canada, the United Kingdom, and the United States, under an agreement last year between the Tripartite countries. DRUG EXPORTS The last subject I want to cover with you today is the export of drugs, vaccines, and diagnostics to other countries. Actually, there are three different categories of exported drugs. First, drugs approved by FDA for marketing in the United States can be freely exported to other countries. Second, unapproved drugs to be exported to other countries for investigational purposes require FDA authorization. And third, unapproved drugs can be exported for marketing in certain countries--with FDA 10 authorization--under a new Federal law. Let me explain the procedures involved in the last two categories. Exports of Unapproved Products for Investiqational Use FDA has two procedures for the export of unapproved products for investigational use. FDA permits the export of unapproved new drugs, vaccines, and diagnostics as part of the studies a drug sponsor will perform in conjunction with an investigational new drug application (IND) approved by FDA. Under a different procedure, regulations permit a foreign government or a U.S. drug firm to request export of a drug for experimental purposes by foreign investigators. To gain export approval, the U.S. company or a foreign government must certify that the drug may be legally used for the intended investigational purpose in the receiving country. Complete safety and efficacy data on the product in question need not be supplied, but FDA must either receive from the exporter enough information to determine that the drug is appropriate for the investigation, or the government of the importing country must certify that it has received adequate information about the drug and the proposed use. During Fiscal Year 1987, FDA received 212 applications for such exports, of which 11 involved AIDS-related products. For example, last spring the government of Zaire requested 50,000 test kits for detecting HIV antibodies in blood samples. 11 Although the manufacturer of these kits had not at the time applied to FDA for approval of this test for marketing in the United States, we granted this export approval to a nation that badly needed a quick and simple test kit. The test procedure requires no sophisticated equipment, takes only about two minutes to perform, and may be especially suitable for use in the rural areas of less developed nations. Its initial cost is expected to be significantly less than the cost of the existing ELISA and Western Blot tests. In Zaire, where studies show that up to 18 percent of blood used in transfusions is HIV contaminated, and where routine ELISA testing has been prohibitively complicated and expensive, such a simplified test could be critical in diagnosing AIDS-contaminated blood and thereby curbing the spread of this deadly disease. Export of Unapproved Products for Marketing In 1986, Congress gave FDA authority to approve, under certain conditions, the export of unapproved drugs and biologics for marketing in foreign countries. Earlier legislation provided the authority for the export of medical devices. Under the 1986 Act, the Drug Export Amendments, FDA may authorize the export of unapproved drugs and unlicensed biologics to countries whose drug regulatory systems have approved them for sale. 12 I testified at the time in favor of this legislation as an appropriate way, with certain safeguards, of allowing the results of U.S. research to benefit foreign populations, some of which suffer from diseases not endemic to our country. Before the passage of this legislation, the United States had the most restrictive drug export policy of any major developed nation. Our implementation of this law has been helped considerably by WHO efforts in recent years to ensure the dissemination of vital drug information and to assist health professionals and government regulators in making appropriate risk/benefit decisions to protect the health of their citizens. The channels of communication between national drug regulatory authorities have improved greatly, allowing even small nations to make informed decisions about the drugs they select for use in their countries. The 1986 act designated 21 developed countries that can import U.S.-manufactured drugs that FDA has not yet approved. To gain FDA authorization for export, the U.S. manufacturer must be actively investigating the drugs, and the drugs must be manufactured under conditions in compliance with FDA's Good Manufacturing Practices. However, under the new law, no drugs that have been denied FDA marketing approval can be exported. 13 During Fiscal Year 1987, FDA received 43 export applications under this new law. As of March of this year, 4 AIDS-related products have been approved for export to 13 different countries under the Drug Export Amendments. CONCLUSION As a physician, researcher, public health official, and member of the WHO Executive Board, I want to stress, above all, FDA's compassion for all people with AIDS. We will continue to give the highest priority to the review of AIDS drugs, vaccines, and diagnostics. We will expedite all reasonable requests for the testing in foreign lands of experimental AIDS therapies, as well as requests to export unapproved AIDS products for marketing in other nations. And we will strive to assist any government, in any part of the world, that needs our help in combatting this terrible disease. This concludes my formal statement, and now I will be pleased to respond to any questions you may have. STATEMENT OF ROBERT E. WINDOM, M.D. ASSISTANT SECRETARY FOR HEALTH U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THE PRESIDENTIAL COMMISSION ON THE HUMAN IMMUNODEFICIENCY VIRUS EPIDEMIC APRIL 19, 1988 Mr. Chairman, members of the Commission, thank you for the opportunity to appear before you to discuss the Department’s role in international research and surveillance programs. As you are aware, President Reagan has identified AIDS as this Admin- istration’s number one public health priority. As the Assistant Secretary for Health, one of my foremost duties is the oversight of AIDS related activities within the Public Health Service (PHS). Many of these are international in scope, since AIDS is a disease that transcends geographical and political boundaries. This was clearly emphasized at the recent World Summit of Health Ministries in London, which I attended and where over 130 countries reported AIDS cases to the World Health Organization. We have every reason, therefore, to approach this as a global problem. Today, I want to tell you about our efforts in the international arena. International collaboration has always been an integral part of PHS programs. One of the most fruitful examples of such interactions was the identification of the Human Immunodeficiency Virus (HIV) as the etiological agent for AIDS by scientists at the National Institutes of Health in the United States and the Pasteur Institute in France within 2 years after the recognition of AIDS as a new clinical condition. Since that time, there have been numerous collaborative studies and exchanges of information between PHS researchers and their international counterparts. Page 2 Such collaborative exchanges of information have also been useful in the development of epidemiological studies, diagnostic tests, drug evaluation, and vaccine development programs. OVERVIEW In general, many of our international activities do not have ‘separate appropriated funds, but instead are the results of informal relationships developed from the need to share information. Most are funded from existing agency budgets through grants and fellowships rather than with specific allocations. There are, however, many, projects being supported by the various agencies from their own funds for international collaborative studies. The PHS works very closely with the World Health Organization (WHO) and the Pan American Health Organization (PAHO). Many of the WHO and PAHO AIDS projects, such as the National Institutes of Health’s (NIH) collaborative effort with PAHO to study AIDS in the Caribbean are funded through the PHS. In addition, several PHS agencies have been designated by WHO as collaborating centers for AIDS & HIV, and in the future those agencies will be participating in studies providing scientific advice and, providing or exchanging research reagents with WHO and WHO-sponsored investigators. Page 3 As early as 1984, PHS started one of its largest cooperative efforts, Project SIDA (the French acronym for AIDS). This is a joint effort by NIH, the Centers for Disease Control (CDC), the Institute of Tropical Medicine, Antwerp, Belgium, and the Zairian Ministry of Health to study AIDS in Zaire. Data from this project clearly demonstrated the heterosexual transmission aspects of the virus. Recently the Government of Zaire, CDC, NIH, the Armed Forces Institute of Pathology, and the Belgian Institute of Tropical Medicine undertook a major study in Kinshasa, Zaire to promote further understanding of the epidemiology of AIDS in Africa. Similar studies as well as less formalized collaboration are under way in other African countries. In another arena, Department scientists are continually participating in international AIDS related meetings and symposia. Many, including myself, will be participants in the upcoming 4th International Conference on AIDS which will be held in Stockholm in June. Presentations and workgroups with an international composition will cover nine areas of importance to the AIDS Epidemic including: pathogenesis and immunology, anti- viral therapy, problems in the developing world, prevention, clinical management, psycho-social aspects, and health care and society. Page 4 Most recently, the AIDS Coordinator in my office has initiated plans for using computers to communicate electronically between the PHS and its international counterparts to further enhance the rapid exchange of information. He personally meets with his non- U.S. counterpart coordinators on a regular basis. A very special subset of international collaboration is represented by the AIDS specific training of many foreign scientists at our agencies’ laboratories, This program started at the very beginning of the epidemic and has since significantly increased. As you can see, the range of problems being addressed by the international] community is, indeed, broad. I would like now to discuss some of the specific efforts which are under way at several agencies within the PHS. NIH The NIH and all its institutes are involved in numerous inter- national collaborative efforts, some of which will be discussed in greater detail by Dr. Western and Dr. Blattner. However, I would like to briefly mention a few of these projects. Cooperation between NIH and the Pasteur Institute not only led to the identification of HIV as the cause of AIDS but also to the subsequent development of tests to measure antibodies to the AIDS Page 5 virus. This has contributed enormously to our ability to help ensure the safety of the blood supply and to enable us to track the spread of the disease. - One of NIH’s major international efforts is through the John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC), which was established in 1968 to provide a focus and organizational mechanism for NIH activities in international biomedical research. Among the general purposes of the Fogarty Center are: ° To further international cooperation and collaboration in life sciences research programs, conferences, and seminars. o To facilitate the assembly of scientists for discussion, study, and research relating to the development of health sciences internationally. I oO To provide postdoctoral fellowships for research training in the U.S, and abroad and promote exchanges of senior scientists between the U.S. and other countries. Page 6 Let me tell you about two of the Fogarty Center’s FY 1987 efforts on AIDS. oO First, the organization of the 3rd International Conference on AIDS, which was attended by more than 7,000 persons from the international community. oO Second, the development of guidelines for awarding FY 1988 AIDS research fellowships for individual scientists and institutional grants for collaborative AIDS research. Just recently, FIC invited applications from U.S. Institutions with interest in developing international training programs in epidemiology related to AIDS for foreign health scientists, clinicians, and allied health workers. I will not elaborate further on the collaborative research efforts sponsored by the Fogarty Institute since Dr. Western, will describe some of these in his testimony. NCL Clinical trials of Anti-AIDS therapeutics by National Cancer Institute (NCI) and international scientists led to the approval of AZT as the first drug of proven efficacy to be used against AIDS. The Epidemiology Program of the NCI uses the research Page 7 contract mechanism to support bilateral research studies such as those in the Caribbean Basin where NCI is helping to define epidemiological issues. African studies by NCI grantees have led to the discovery of the HIV-2 class of viruses in West Africa. NIAID In June 1987, the National Institute of Allergy and Infectious Diseases (NIAID) and the PAHO began a 5 year research contract entitled “Studies of Human Immunodeficiency Virus (HIV) and Related Retrovirus Infection in Latin America and the Caribbean." This Institute has also launched a program for International Collaboration on AIDS Research (ICAR) which is open to U.S., research institutions and is designed to encourage multi- disciplinary collaborative research with foreign institutions. At least 70% of the research must take place outside of the U.S. and the research areas are broad and flexible. ADAMHA Within another agency, the Alcohol, Drug Abuse and Mental Health Administration (ADAMHA), the National Institute of Drug Abuse (NIDA) entered into an interagency agreement with the Mexican Minister of Health to initiate a surveillance and prevention .program to help stem the spread of AIDS among IV drug abusers Page 8 along the U.S. Mexican border. NIDA also sponsors a computerized filing system of ongoing research studies which is international in nature. The National Institute of Mental Health (NIMH) through the Center for AIDS Prevention Studies (CAPS), has initiated the Rwanda Project. They are studying risk behavior and information, attitudes and beliefs about AIDS, in a cohort of seronegative females with either HIV seropositive or HIV seronegative partners. These women will later be tested for changes in their antibody status and monitored for the subsequent development of ARC or AIDS. It will be valuable to have this information about cultures different from our own. FDA As discussed by Dr. Young yesterday, the Food and Drug Administration (FDA) will be collaborating with WHO to further advance the knowledge base of diagnostic tests and the safety of blood-derived products. In addition, the FDA does permit the export of unapproved products for investigational use. This provides another avenue for the advancement of knowledge and the development of potentially useful data on new products. Page 9 CDC As a source of expert technical knowledge in disease prevention and control, CDC has provided assistance in the development of AIDS strategy plans for many countries including Colg@mbia, Haiti, Panama, Rwanda, and the Sudan. CDC also assisted PAHO by investigating the HIV prevalence in plasma from paid donors in Mexico. In collaboration with WHO, CDC helped in planning national programs to assess high-risk sexual behaviors in various populations. In other major programs, CDC provides training in AIDS surveillance and in the serodiagnosis of HIV infections. These programs have involved such countries as Australia, Canada, France, the United Kingdom, Brazil, Mexico, and Egypt. We have Dr. Heywood here with us today to further elaborate on CDC activities. As a final example, in a PHS interagency effort, CDC, FDA, and NIH are collaborating to develop HIV vaccine efficacy studies in Africa which will complement the PHS national efforts. Federal Coordinating Committee Finally, I would like to discuss an interdepartmental working group, the Federal Coordinating Committee (FCC), which I established in 1986 as a way to update other Federal Departments and agencies on our PHS AIDS activities. The FCC also serves as a forum for these groups to discuss international implications of Page 10 key policy and operational issues. Currently represented on the FCC are seven departments: the Departments of Agriculture, Defense, Education, Justice, Labor, State, and Housing and Urban Development; and six agencies, ACTION, Agency for International Development (A.I.D.), Environmental Protection Agency (E.P.A.), Office of Personnel Management (OPM), United States Information Agency (USIA), and Voice of America. Over the past year and a half, the FCC has become a major conduit for information exchange both within the U.S. Government and with other nations. Now, because of its expanded role in both international and workplace issues, I would like to increase its membership, and have invited all Federal departments and agencies to participate. Regarding international coordination, A.I.D. has recently asked through the FCC for an enhanced collaboration with the PHS. A.I.D. is responsible for directing the economic assistance activities of the U.S. with the developing world and recently received a mandate by congress to coordinate efforts with other Federal agencies regarding AIDS issues, and to ensure that domestic AIDS efforts that are relevant, be shared with developing countries. It also requires A.I.D. to share with U.S. entities its knowledge of international activities. To establish this information flow, A.I.D. will use the FCC as a forum to Page 1l gather specific AIDS data from FCC components involved in international efforts, like DOD and HHS. A.I.D. will then share information emanating from the FCC with the international community. Currently, budget information and brief project reports regarding international AIDS activities are being prepared for A.I.D. by the FCC member agencies and departments. CONCLUSION Let me conclude by saying that the Public Health Service is committed to doing all that we can in the international arena to contain the further pandemic spread of HIV and the resulting devastating disease which has already so seriously effected many regions of the globe. We will continue to use our energies and our resources by sharing information and collaborating with the world community of scientists to achieve this end. No greater priority exists. Thank you Mr. Chairman. This concludes my formal statement. I will be happy to answer “any questions you or any of the Commission members may have. “INTERNATIONAL EFFORTS IN AIDS RESEARCH AT THE NATIONAL INSTITUTES OF HEALTH" Statement of KARL A. WESTERN, M.D., D.T.P.H. Assistant Director for International Research National Institute of Allergy and Infectious Diseases National Institutes of Health before the PRESIDENTIAL. COMMISSION ON THE HUMAN IMMUNODEFICIENCY VIRUS EPIDEMIC April 19, 1988 Mr. Chairman, members of the Commission, I am here today to provide an overview of international efforts in AIDS research supported by the National Institutes of Health (NIH). The NIH is the apency of the domestic U.S. Public Health Service responsible for basic and clinical biomedical research and research training in these areas. The authority of NIH to conduct international research is the International Health Research Act of 1960 (P.L. 86-610). This act authorizes the NIH to "advance the status of the health sciences in the United States and thereby the health of the American people through cooperative endeavors with other countries in health research, research planning, and research training". The NIH is a decentralized agency consisting of fifteen (15) institutes or centers which carry out research and five (5) divisions which provide research support. (TABLE ONE) In FY 1987, the total NIH appropriation was $ 6.18 billion, of which 260.9 million (4.7%) was specifically for AIDS research. This figure is expected to increase to $ 467.8 million in FY 1988 and § 587.6 million in FY 1989. NIH research is carried out intramurally, by NIH scientists in our own laboratories or extramurally through competitive research awards to academic institutions. Intramural research accounts for only 15 percent of the total NIH budget. The remaining 85 percent is distributed through investigator- initiated research grants, NIH research contracts to conduct applied research, and cooperative agreements which are developed by investigators - but -provide-for significant NIH -staff--participation in their management. With the exception of the Fogarty International Center (Fogarty), NIH Page 2 t does not have an international research account. All foreign awards and international collaboration are funded out of each Institute’s domestic research budget. (TABLE TWO) presents NIH international AIDS research funding for the six components of NIH (NIAID, NCI, NICHD, DRR, FIC, and NHLBI) reporting international activity in a recent survey. Overall, in FY 1987 international AIDS research constituted $ 6.5 million of the $ 260.9 million (2.4%) of the total NIH AIDS research budget. This percentage is expected to be approximately 4.5% in FY 1988 and 1989. NIH conducts international exchange and collaborative fashion in five ways. The first and most immediate is direct collaboration with NIH intramural laboratories and scientists. The second is through competitive extramural awards to foreign investigators. Foreign investigators are eligible to apply for NIH grants awards and receive the same scientific peer review as domestic applicants. In order to be funded, foreign grant applications must be scientifically approved by the initial review group and be in the top 50% of approved grants in that trimester. Foreign institutions are eligible to participate in NIH cooperative agreements. Federal contract law, however, specifies that contracts must be awarded to U.S. contractors unless there are no qualified U.S. responders or the workscope can only be carried out by a foreign investigator. The third NIH approach to international collaboration is through domestic research awards with a foreign component. This often occurs spontaneously in the regular investigator-initiated grant process. From time to time, individual institutes may develop a special emphasis award program to promote international research collaboration. NIAID’s new International Page 3 Collaboration in AIDS Research (ICAR) Program, which I shall mention shortly, is the most recent example of promoting international research through domestic U.S. institutions. Fourthly, while NIH prefers to foster international collaboration through scientist-to-scientist channels, we do utilize bilateral agreements between the U.S. and foreign governments in biomedical research or science and technology. Fifth, but not least, NIH works in close collaboration with multilateral agencies, particularly the World Health Organization (WHO) and the WHO Special Programme on AIDS (SPA). (SLIDE ONE) At present, NIH international AIDS research activities are concentrated in epidemiology (natural history/risk assessment), virology, pathogenesis (co-factors), treatment (development and evaluation of anti- viral agents and immunomodulators), and vaccine development. The FIC will also soon launch an international research training program in AIDS. (SLIDE TWO) NIH currently supports AIDS related research in thirty-five (35) countries shown in this slide. These projects and activities are summarized individually in Annex One to my written deposition. NIAID is engaged in collaboration in AIDS with seventeen (17) countries at present. (SLIDE THREE) The major NIAID projects are summarized in the next two slides. As a result of the observation in 1982 that AIDS was occurring in heterosexual Haitian men with no obvious risk factors, NIAID and the Pan American Health Organization (PAHO) brought together Haitian and U.S, investigators in Washington and Port-au-Prince to share information. -This has resulted in NIAID grant support to Cornell University to study the epidemiology of AIDS in Haiti. Last year, NIAID initiated a research Page 4 contract with PAHO and the PAHO/WHO Caribbean Epidemiology Centre (CAREC) in Port of Spain, Trinidad & Tobago to study the natural history and epidemiology of AIDS in the 19 CAREC participating governments. The NIAID- PAHO contract also provides for similar studies in Latin America. Shortly after initiation of AIDS studies in the Caribbean, AIDS was observed in 1:1 ratios in heterosexual Central African men and women seeking medical attention in Europe. Project SIDA (the French acronym for AIDS) is a multidisciplinary study initiated in 1984 by the NIAID Laboratory of Immunoregulation (LIR/NIAID), the Centers for Disease Control (CDC), the Institute of Tropical Medicine (Antwerp), and the Zairian Ministry of Health. Project SIDA, based in Kinshasa, has clearly documented heterosexual transmission of AIDS from men-to-women and women-to-men. Efforts continue to elucidate risk factors for transmission, the natural history of HIV-1 infection, and the immunopathogenesis of AIDS in the African setting. NIAID has also recently initiated a research contract to support the University of California/San Francisco in the study of heterosexual HIV-1 and AIDS in Rwanda. To promote further international scientific collaboration in combatting AIDS, later this year NIAID will announce the first five program project grant (PO-1) awards in the International Collaboration in AIDS Research (ICAR) Program. The ICAR Program will link the U.S. institution to foreign counterparts in Latin America and Africa. At least seventy (70%) of the research must be conducted outside the USA in a truly collaborative fashion. Perinatal and pediatric HIV infections, heterosexual transmission, geographical variation in HIV isolates, correlation of HIV variation with Page 5 infection and expression of disease, and the role of co-factors in susceptibility to HIV infection and development of AIDS will be of special emphasis to the ICAR Program. (SLIDE FOUR) During the past year, AIDS research has been added to existing bilateral biomedical research agreements with France (INSERM), the Federal Republic of Germany, and Japan. Today, for example, an NIAID staff scientist is leaving for Bonn to participate in the scientific review of AIDS research proposals submitted to the West German Federal Research Ministry. In July, an AIDS Panel will be added to the U.S.-Japan Cooperative Medical Sciences Program. Less formal collaboration has also developed with Canada, Sweden, and the United Kingdom in AIDS research. I should emphasize that these bilateral agreements with other industrialized countries differ from the collaborative research previously described in developing countries in the emphasis on basic AIDS research, the development of drugs and vaccines, and clinical trials. Japan represents a special situation because of its considerable pharmaceutical infrastructure to develop drugs and biologicals, but so few cases of HIV infection or AIDS that Phase II and Phase III studies may have to be conducted in the USA. By contrast, European institutions are expected to develop protocols comparable to thase conducted in the USA and participate in multi-center trials of drugs and vaccines. Since Dr. William A. Blattner of NCI will testify next, I will not discuss the international AIDS activities of his Institute (SLIDE FIVE). (SLIDE SIX) At present NICHD- funds a research grant to the University of Washington to investigate the effect of HIV infection on maternal and child Page 6 health in Kenya and the University of California/San Francisco to study the perinatal transmission of HIV in Rwanda. Planned starts in FY 1988-1989 include the role (if any) of breast feeding on HIV transmission in Africa and the screening of newborns for HIV infection in Spain, where intravenous drug abuse is a major risk factor. (SLIDE SEVEN) DRR cupporte international AIDS research through its domestic network of Regional Primate Centers. Simian AIDS (SAIDS) is the focus of DRR activity. NHLBI is cooperating with scientists in France and the Federal Republic of Germany in studies on the pulmonary manifestations and complications of AIDS. (SLIDE EIGHT) During this year, the FIC has received funding and will initiate: 1) an International Postdoctoral Research Program in AIDS and 2) International Training Grants in the Epidemiology of AIDS. These awards will be made to US institutions to conduct the international research training in the USA and overseas. The FIC is also prepared to fund international AIDS activities in domestic research grants and the ICAR Program on a case by case basis. Before concluding, I would like to mentidn that the NIH has recently been honored by being designated a WHO Global Collaborating Centre for AIDS Research, Dr. Anthony S. Fauci, Director, NIAID arid the NIH AIDS Coordinator is the principal scientific contact. At NIH we look forward to even closer collaboration with WHO in the application of research advances to the prevention and control of the AIDS pandemic. Thank you very much“for your atterition. I will be pleased to answer any questions you may have now or at the conclusion this morning's panel. {AID APPENDIX I BID Project Title Country (where Pawticipating Institutions Budget History (Award Number and (impiemented) . ' 'U.S. and. Foreign) FY87(Act.) FY88(EST) FY89(EST) brief description) zOl AL Zaire Centers for Disease Control $1,866,368 $1,937,000 $2,012,000 00361-05 Ministry of Health, Zaire Epidemiologic, Immunologic Institute of Tropical Medicine Aspects of AIDS in Africa Antwerp, Belgium Armed Forces Institute of Pathology 5RO1 AI CA 22624-03 Haiti Cornell University 713,601 860,000 929,000 Natural History of HIV infection in Haiti NOL AI 72449 Latin America Pan American Health 1,215,856 1,274,000 1,240,000 Studies of HIV Organization (PAHO) Infection and Other Related Retroviruses YO1 AI 70009 Rwanda UCSF 201,825 1,009,000 1,287,000 Epidemiological U.S. Army Fort Detrick Studies of AIDS . RO1 AI 25287-01 England Harvard University 247,267 294,000 305,000 Structural Studies 4,244,917 5,374,000 5,773,000 of HIV Envelope Glycoprotein Planned New Starts (FY88, FY89) RFA International To involve countries: 5 Awards to be made 3,715,000 3,863,000 Collaboration on AIDS Africa Research (ICAR) Latin America Asia/Pacific Europe UO] AL 25690 International Collaborator 353,000 368,000 National Cooperative Drug Discovery Group (NCDDG) RFA NCDDG 1,361,000, 1,416,000 NLAID BID Project Title Country (where Participating Institutions Budget History (Award Number and) (implemented) (U.S. and Foreign) FY87(Act.) FY88(EST) FY89(EST) Brief description) Planned New Starts (FY88, FY89) RFC Expression of Viral Proteins $1,900,000 > 686,000 RFC Seroprevalence/Pregnant Women 1,300,000 1,352,000 RFA Genetic/Racial/Environmental 996,000 Factors in HIV Disease 1,990,000 RFA New NCDDGs _. 4,244,917 14,003,000 16,444,000 | Project Titte Country Participating _Ipstitutions _Budget Mistory (Dollars in Thousands) = FY87(Act.) FYBB(EsL.) FYS9{Lst ) 5 ROY CA30264-06 Sweden Karolinska Institute 13 15 15 immune Cffecter Mechanisms 3n CBY Carrying Paticeats The interactions between Epstein-Barr virus (EB¥) infected cells and the host immune system in normal and immunodefective persons are being studied with the goal of understanding the mechanism of EBY pathogenesis. Thus, the ability of individuals with a spectrum of immunodeficiencies to }imit EBV proliferation should enable the investigators to determine which aspects of the host immune response are important in the response to EBY. AIDS and ARC patients represent one of severa] cateyories of immunodeficient individuals to be studied. 5 RO) CA43464-02' Venezuela St. Luke’s-Roosevelt Institute 102 110 0 for Health Sciences, Columbia U., Novel Retroviruses ‘ Inst. Venezolano de Investigaciones from South America: Ciantificas, Venezuela HTLV-type Viruses Dr. Volsky has detected antibodies reactive with purified HIV-1/LAV, but not HTLV-1, in native populations in Venezucla not at risk of AIDS. The population groups include aboriginal Amazonian [ndians, other inhabitants of rural inland areas, and patients with malaria and Chagas’ disease. A retrovirus, related to, but distinct from U.S. isolates of HIV-1, has been isolated from lymphocytes of some of these individuals. Biological and molecular characterization of the South American retrovirus (SA-RV) isolate will continue and additional isolations attempted. SA-RV may represent a new member of the family of human retroviruses whose pathogenicity is presently unknown. It could also represent an ancestor of AIDS-associated viruses. Alternatively, the natural history of HIV-1/LAV-type virus infection may change upon transmission into a different environment and population. 35 CA39805-03 West Africa Harvard School of Public Health 207 219 228 {Senegal Univ. of Dakar, Dakar, Outstanding Ivory Coast, Senegal, HW. Africa; Investigator Award Burkina Faso, University of Kinshasa, Uissauh) Kinshasa, Zaire Dr. Essex will continue his seroepidemiological surveys of HIV-1t and HIV-2 in Central and West Africa. Different viral antigenic markers are being evaluated tor their prognostic value in m@Mftoring the clinical cause of HIV infections. In sam cities m Central Africa, HIV-1 seroprevalence approaches 50%. HIV¥-2 seroprevalence is as high as 60% ta some‘selec ted populatcons of prostitutes im West Africa. Cross-reactive epitopes are prosent on the envelope qpl20’s of HIV-1 and HV 2, and natural infection with HIV-2 sometimes induces antibodies that cross-react with HIV-1. IS Summary of NIH Efforts Relaled to International AIDS Research NCI ea Project Title Country Participating Institutions Budget !listory (Dollars in Thousands) FY87(Act.) FY88(Est. } FY89(Est.) £01CP05400 Denmark; Univ. of West Indies; 9] 95 103 Greece; Gorgas Memorial Inst.; Epidemiology of Haiti; Inst. of Cancer Res. Human HBLY Jamaica; (Denmark) ; lymphotropic Kenya; Univ. of Innsbruch; Viruses: ATL Lambia; Univ. of Athens; . AIDS and Nigeria; Medical Research Inst.; Cancer Tanzania; London School of Trepical Hyg.; Trinidad; Univ. Med. School (Ghana); Zaire; Univ. Hosp. (Zambia); Inst. of Tropical Medicine (Belgium) Human retroviruses are emerging as etiologic agents of human malignancies. ftuman T-lymphotropic virus type I (HTLV-1) 1s linked to adult T-cell leukemia (ATL). HIV, the etiologic agent of AIDS, is associated with Kaposi’s sarcoma and certain forms of Hodgkin’s and non-Hodgkin’s lymphoma. This research is focused on characterizing the relationship of this class of virus to human malignancy. A major focus of HIV research has been on cohorts at high risk for AIDS followed longitudinally since the very beginning of the AIDS epidemic. Results of studies have documented major modes of transmission of HIV in homosexual men, in hemophiliacs, and in drug users and their heterosexual partners, and from mother to offspring. The natural history of progression, the predictors of risk, and the incidence of various outcomes have been defined. Low T- helper cell counts are predictive of AIDS risk and may contribute to heightened transmission of HIV. Among various cofactors, an immunogenetic marker appears to be associated with heightened AIDS risk. 201 CP05536 Germany Kumamoto University 54 Ss? 6] (Japan) ; Immunologic Studies: Univ. of Paris; HIV Neutralizing Anti- Univ. of Essen bodies and Vaccine Development In studying immune surveillance mechanisms operative following human immunodeficiency virus (HIV-1) infection, the focus has been on HIV-1 neutralizing antibodies which were first detected in 1985. In a limited survey, HIV-l-infected individuals with high geometric mean neutralizing antibody titers had lesser dise®% manifestations. Subsequently in pedialric AIDS cases, a relationship of neutralizing antibodies and a stable clinica! state, as opposed to a poor one, was observed. In a retrospective investigation of H1V-1-seropositive thalassemia patients, neutralizing antibodies also were associated with a nefter clinical outcome. Ongoing long-term prospective studic of HIV-T-infecled individuals ia the U.S. and Ge ny ae vimed at el dating any protective role of HIV-1 neutralizing cntibadies, HUT Project Title Country Participating Iggtitutions Budget History (Dollars in Thousands). vo FY87(Act.) FY88(Est.) FYB89(Cs1.) NOICPS1030 - Nigeria; Medical Research Council 277 300 325 Tanzania; fpidemiology Jambia; Surveys for New Guinea; Human Retro- Colombia viruses The purpose of this contract is to provide a mechanism for performing descriptive surveys of human retroviruses in relationship to cancer. The approach employed is to undertake targeted surveys in specific, largely overseas, geographic locales to follow-up on leads from various sources. For example a recent published report suggested very high rates of HILV- I with unusual epidemiologic features in Papua, New Guinea. Under the auspices of this contract a study to pursue this lead has been developed with the Papua New Guinea Institute of Medical Research. In another circumstance a possible cluster of adult T-cell leukemia has been identified in Cali, Colombia, and this research contract was utilized as a resource for funding a series of descriptive surveys to characterize this possible lead. Thus, the purpose of this contract is to provide a flexible mechanism for pursuing etiologic leads of the relationship of human retroviruses to cancer. NOICP61022 , Trinidad Caribbean Epidemiology 269 269 285 Center Epidemiology of Human T-Cell { eukemia/Lymphoma Virus in Trinidad and the Caribbean Region This contract serves as a second site in the Caribbean basin for conducting epidemiologic studies of HIV. This site was selected because of unique epidemiologic opportunities available in the nation of Trinidad - Tobago. A cohort of 100 gay men ascertained in 1983 were analyzed for HTLV-I and HIV. flevated rates of HTLV-I and very high rates (40%) of HIV were observed, suggesting homosexual transmission of both viruses. The risk factors for HTLYV-1 differed from those of HIV for HILV-I, increased transmission was assu tated with a number of life-time sexual partners and duration of homosexuality and the presence of a venercal disease, while HIV seropositivity was correlated with contact with a U.S. homosexual] in the lasi year. The high rate of HIV in the population, compared to HTLV-1, potnt to the fact’ that HIV 1s much more efficiently transmitted than HTLV-I1. Hey meaeed Li Countr Participating Institutions _Budget History (Dollars in_Thousands)_. Praject, litle Lountry Participating as} FY87{Act.) FYB8(Est.) FY89(Est.} oe ' a = NUICPSTO09 © Ghana University of Ghana 14 14 14 Studies on the Epidemiology of Potentially Oncogenic and Immunosuppressive Viruses in West Africa This contract represents a continuation of a long-standing collaboration with the University of Ghana Medical School. Begu’ in 1965, the project wa$ initially in-house research, but since 1979, the project has been funded through a contract. for many years the major focus was on Burkitt’s lymphoma and factors that might be related to it, especially studies of the Epstein-Barr virus and malaria. During the last contract period the emphasis shifted to studies of human retroviruses. NOICP31006 , a Jamaica University of West Indies 311 325 345 Human T-Cell Leukemia/ 1ymphoma Virus in Jamaica The primary objective of this project is to clarify the role of HTLV in the etiology of ATL. Secondary objectives center around determination of prevalence of infection in healthy donors, including clustering; determination of prevalence of infection in patients with ATL and in contro) groups of patients with other malignancies or autoimmune disorders; definitior of risk factors through studies on the prevalence of infection in the first degree relatives of HTLV-positive cancer patients, longitudinal studies on infants of HTLV-positive and negative mothers, and studies on HLAtypes on lymphocytes of patients and controls; and determination of the mode of transmission of infection. ° NC | Project Trtle Country Participating Ipgtitutions Budget History (Dollars in Thousands) _ ° bye FY87(Act.) FYS8(Est.) FY89(fst.) j , NO1CP31015 Panama - Gorgas Memorial Institute 192 200 210 of Tropical and Preventive Epidemoaloqy of ; Medicine \ Human T-Cell} Leukemia Virus in Panama The Gorgas Memorial Laboratory in Panama City will supply support to this project by assisting in collecting samples on patients with various malignancies suspected to be linked to HTLY and from corresponding normal populations. Studies will be undertaken to determine the distribution of HTLY infection in Panama to see whether virus clusters occur in regions of the country and in households. NO1CP67866 - Canada Raylo Chemicals, Ltd. 280 290 300 Preparation of Anti- AIDS Drugs for Clinical Studies The project is for the development of existing or new processes, procedures and techniques for the preparation of compounds needed by the Program for clinical use, and the synthesis of varying amounts of materials not readily available in the quality or quantities required. This project is part of the DTP’s program to procure bulk chemicals and drugs for the treatment of AIDS and the study of drug action. This project provides the means to obtain nearly any type of chemica! compound and the ability to provide large quantities of very high purity drugs. Assignments of materials for preparation will originate with the Drug Synthesis and Chemistry Branch, NCI and will involve a wide variety of chemical structures. Many of the preparations will involve multi-step sequences and all materials prepared will be fully characterized. Solubility and stability studies and cost data wil] be provided upon request. SUMMARY OF NHL@I INTERNATIONAL ACTIVITIES DEALING WITH AIDS Scientists in France and the Federal Republic of Germany are cooperating in studies of the pulmonary -aspects of AIDS. The cooperation involves joint meetings, the development of informaticn according to agreed-upon protocols, and reciprocal visits to participating laboratories in the United States, France, and Germany. The study protocol is being developed jointly. The study will deal with the pulmonary complications of HIV infection over a period of five years. Both France and Germany will each provide data on 200 individuals, The variables to be studied are the types, incidence, course, and outcome of pulmonary disorders associated with human immunodeficiency virus (HIV) infection in individuals from high risk roups. Both uninfected and HlV-infected individuals will be studied. HIV-infected participants will be randomized into routinely and intensively screened groups in an attempt to determine if early detection of pulmonary abnormalities may bé of value in reducing the severity of these disorders. Pip - NHLBI t (U.S. and Foreign) ticipat Country (where (implemented) . P (Avard Number and) brief deseription) Seven US institutions. One French institution located at Hopital Beaujon, Clichy. Pulmonary Aspects of AIDS France Project under terms of NIH-INSCRM Agreement Pulmonary Aspects of AIDS Federal Republic Seven US institutions. Project under terms of of Germany One German institution located US-FRG Agreement at Klinikum der Johann Goethe University in Frankfurt. Planned New Starta (FY88, FY89) None anticipated under the bilateral agreements involving NHLBI NOT- HR The contract numbers for the US projects are: 76029 - Data Center * The US side is only paying costs of Joint meetings and travel. paying for the clinical data collection in their respective F&intries. with the US data at the data. center in Chapel Hill, North Carolina Budget History Pirect Costs - Fourks sy FY87(Act.) FY88(EST) }Y89 (EST) 0 $8,000 $9,000~ * * $6,500 $8,000 The French and German governients are These data will be analyzed alony o elate o Internat al AIDS Researce ap - MICHD Project Title Country (where cory GF An 688) (Avard Number and) (inp lenented) (U.S. and Foreign) FY87(Act.) FY88(EST) FY89 (EST) brief description) HD - 23 fla - of Kenya ul. of beshinartom £273 "a0 7% IDS Viruc amd, Aided Chill Hau ly Dn Merce ‘A study of He peindd Tram S$ mrcssion of Hiv . : in fechion frm. moller th ch: id) Planned New Staxts (FY88, FYS9) | | Hiv Brasst Feeds gud tae wf fids mh 6° ¥0d in Vee bunch Spars { Qoe Hiv Ser eenm) j PSO 2 sunmayy of NIK Efforts Related to Jnternational AIDS Research BID -vivision af Research Resources Rrojece Ticle Country (where Participating Institutions Budget H{story (Award Number and) (implemented) (U.S. and Foreign) Fy87(Act.) FYS6(EST) FY89 (EST) brief description) POIRROOT6S Kenya Emory University, Atlanta, GA $ 19,000 § 19,000 $19,000 “ketrovirun serology and Yerkes Regional Primate Res. Ctr. virus fsolation attempts in nenluinan primate popubkarions." PST RKOOL Ob Indonesia University of Washington, Seattle 105 ,756 60 000 60,000 “Tndonesia Project (SaATps)." Planned New Starts (FY86, FY89) BID FIC Project Title Country (where (Award Number and) (implemented) brief description) Il International Conf. United States in AIOS Planned New Starts (FY88, FY69) Institutional Post- doctoral Fellowship Program International Collabora- tion in AIDS research International Training in AIOS Epidemiology Internatiunal Companents of Domestic AIDS Research International] Conferences support to young investi-~ gators ta attend 1V Internatic 11 Conference on AIDS to be determined to be determined to be determined to be determined Sweden (U.S. and Foreign) PHS Agencies and WHO to be determined to be determined to be determined to be determined Swedish Ministry of Health and ial Affairs ;National Bactey ‘logical Labore srysKarolinska Tretituretartiine let Budget History FXB7(Act.) FX88(EST) EX89 (EST) Be , O00 TestimonyAfor the Presidential Commission on the Human Immuno- Deficiency Virus Epidemic “Response to the Pandemic by the United States: the Public Sector Research and Surveillance Programs" NCI AIDS Research Program: International Activities troduction: The National Cancer Institute has made significant contributions to the fundamental understanding of the HIV epidemic: 1) co-discovery of the etiologic agent 2) therapeutic break-throughs, and 3) understanding risk of factors for transmission and natural history. To achieve these successes inter-institute and inter-institution cooperation have been central. The international scope of these activities include collaborative research studies involving NCI scientists and grantees, training activities involving foreign Nationals, and free sharing and availability of laboratory reagents necessary for advancing understanding. Bil al ternationa search Studi Basic Science and Vaccine Development: The Laboratory of Tumor Cell Biology, headed by Dr. Robert ¢. Gallo is the foremost retrovirology laboratory in the world and conducts a wide-ranging program of basic and molecular biologic research aimed at understanding the fundamental hiology of HIV with the ultimate goal of providing insights necessary to develop effective therapies and an effective vaccine. The international focus of this work derives from several initiatives. Historically during the early 1980's Dr. Gallo's laboratory provided reagents and resources and training to international collaborators, including those at the Institute Pasteur, which ultimately contributed to the co-discovery of the human immunodeficiency virus by Drs. Gallo and L. Montagnier. As an outgrowth of this process Drs. Gallo and Montagnier continue to interact scientifically on a regular basis sharing new information necessary for: -promoting continued progress and cooperation. As part of this process there is in place an international "“hotline" between Dr. Gallo's lab and Or, Montagnier's lab in Paris. A task force for vaccine development, headed by Dr. Gallo involves a coordinated program of international cooperation with key scientists from the U.S. and countries of Western Europe who meet on a regular basis to discuss new data and approaches for the virus is introduced and how it is propagated. In this way we were able to show in both Trinidad and Jamaica that HIV was first introduced into the male homosexual population through contact between US and West Indian gays. Subsequently, the virus has been transmitted among this community in these countries, but with significant secondary transmission through bisexual contact into the sexually active heterosexual population. One of the interesting observations from our initial studies in Trinidad was the recognition that among the small group of persons coinfected with both HTLV-1 and HIV that the presence of coinfection appears to be associated with an accelerated risk for AIDS development. This may correlate with the fact that in the test tube cells infected with the HTLV-1 virus are exquisitely sensitive to the killing effects of HIV. Thus a unique opportunity to understand a potential cofactor of significance in these populations, as well as among frequently coinfected parenteral drug abusers in the U.S. has been identified. ‘The recent pattern of AIDS cases and HIV infection in Trinidad points to an emerging epidemic of heterosexual HIV infection. We are currently conducting a study of the most sexually active populations to determine whether HIV can be efficiently transmitted and sustained in the heterosexually active population. Such a study may provide new information on the risk and risk factors for heterosexual transmission without the confounding effect of parenteral drug abuse or needle reuse. As part of our activities we are working closely with the Ministry of Health in promoting effective anti- AIDS transmission messages by providing information critical to assessing which groups are at greatest risk and require major intervention. In Jamaica we are continuing to monitor a large population based- survey for evidence of emerging HIV infection. In addition, in the future we may be able to monitor populations of migrant farm workers who may be exposed to the HIV virus when they come to the United States. This data may be useful for educational campaigns to prevent the transmission of the virus back to Jamaica. Studies in Africa: NCI studies Africa have provided some of the first quantitative information concerning the scope and extent of HIV infection in some urban areas of Central Africa. In addition, evidence developed by NCI grantees utilizing serologic tools was a major factor in leading to the discovery of the HIv- 2 class of viruses in West Africa. There are other prelimina data from other geographic locales that suggest additional examples of HIV-like agents which may be present in other populations and which may. provide important -clues to the pathogenic aspects of this family of viruses. In these studies, as in the Caribbean basin direct research collaborations are established with local scientists, and clinicians with access to populations of interest. Current activities are focused on studies to evaluate the spread of HIV from urban to non-urban areas and to define risk factors and behaviors which might contribute to this spread. In particular, data concerning patterns of sexual behavior as well as rates of infection are international bilateral AIDS research. Of this $344,000 funds grants, $1,923,000 funds research contracts, and $152,000 covers intramural research costs. Oversight of NCI AIDS Research The National Cancer Advisory Board provides oversight and advice to the NCI Director concerning all aspects of the policy and research focus and future course of the Institute. A special AIDS Subcommittee of the Board provides specific direction for AIDS related issues. For each of the Divisions of the National Cancer Institute there is a Board of Scientific Counselors who oversee and advise the Directors of each Division. It is fron this pool of scientists that teams of site visitors review the progress and research of each intramural NCI laboratory at least every four years, to insure continued productivity and high quality approaches. As new initiatives are developed, intramural researchers present research concepts that require funding to this Board of Scientific Counselors who review the merits of each proposed activity and approve funding for the development of contracts or RFA's depending on whether this is an intramural or extramural activity. In addition, NCI has a targeted grant program, with particular focus on issues related to pathogenesis anti-retroviral drugs and therapeutic approaches. Another focus of these activities is on the discovery of new retroviral agents as well as studies to understand the interaction between HIV virus and other putative cancer causing viruses with the potential for fundamental research insights. arin f Reacents Since many of the important discoveries related to HIV have come from intramural NCI scientists and extramural NCI grantees, these investigators have been a source of vital research reagents which have been freely disseminated widely to scientists both within the United States and abroad. Following the discovery by Dr, Gallo and colleagues of the H9/HTLV-IIIB continuous producer cell line, NCI made it a top priority through the Frederick Cancer Research Facility to rapidly scale up proeduction of the virus with the specific intent of making this reagent available widely to the worldwide research community. This tradition of sharing continues. A list of recipients of reagents from various NCT laboratory operations is provided as part of the background information. o usion In summary, NCI has focused it's AIDS research agenda on issues related to fundamental understandings of the virologic, molecular, therapeutic, vaccine, and epidemiologic aspects of the AIDS epidemic. To this end our bilateral international activities have focused on identifying productive collaborators in targeted overseas locales to undertake collaborative research studies of fundamental importance. Through the development of vaccine development. Dr. Gallo is also often a frequent international speaker at symposia, conferences and meetings all over the world and thus promotes the dissemination of new information as well as the furtherance of international cooperation in addressing the AIDS epidemic. Treatment of AIDS: In the area of therapeutics NCI has taken a leadership role through innovative approaches aimed at utilizing in vitro screening tools to identify candidate agents with potential anti-AIDS therapeutic efficacy. As a result early Clinical trials conducted by Dr. Sam Broder and his team of US and international scientists led to the approval of the first potentially effective anti-AIDS drug, AZT. Other drugs identified through this similar approach are now in various phases of being tested. In addition to this approach, NCI working closely with the National Institute of Allergy and Infectious Diseases, has developed a drug discovery program which integrates the collection of potential therapeutic agents from all over the world for screening as possible anti-AIDS agents. In addition, many of these same compounds are also being screened aS possible anti-cancer agents. Thus a dual attack on two major public health problems is being addressed in a cost effective and efficient way. As part of this program the drug discovery group seeks out foreign scientists who have access to new chemical agents or old folk remedies with potential therapeutic efficacy. Interntional Epidemiology Studies: The Epidemiology Program of the National Cancer Institute has targeted its resources towards domestic and international studies aimed at answering specific questions concerning risk factors for virus infection, cofactors for disease outcome, and insights concerning the natural history of infection. Often unique research opportunities exist in international settings for addressing specific issues. To conduct these international studies, NCI utilizes the research contract mechanism to support collaborative bilateral research studies. ies t ibbea sin: A focus of these studies has been in the Caribbean Basin, particularly in Trinidad and Jamaica. In these collaborative studies, NCI plays a critical role in defining epidemiologic issues and works closely with our overseas collaborators at national or international institutions. For example when these projects were initially established in the early 1980's, the major focus was on HTLV-1, the etiologic agent of adult T-cell leukemia ard a multiple sclerosis-like neurologic syndrome called Tropical Suastic Paraparesis. During the course of our studies, HIV infection has been introduced into these countries via contact with persons infected from the US. We have collaborated with our colleagues to address issues concerning the new introduction of HIV into these populations and have worked Closely with members of the Ministry of Health in each of these countries. Our approach is to undertake “argeted research studies to provide information of a prototypic nature that will help public health officials in other countries to understand how important to modeling the future course of the epidemic in Africa and elsewhere. A major focus of NCI epidemiology efforts are in studying issues relating to immune deficiency and cancer. One such focus is on the issue of Kaposi's sarcoma as an immunodeficiency related tumor. The epidemiology of this AIDS-associated cancer suggests that there is an etiologic agent responsible for this form of cancer. Studies to identify individuals potentially infected with this putative Kaposi's sarcoma agent are an ongoing focus and new virus isolation techniques utilizing the best approaches available in the laboratory of Dr. Gallo are being undertaken in several locales. In addition, we are investigating a possible multi-national study in conjunction with the International Agency For Research on Cancer (IARC) to investigate emerging patterns of possible HIV-associated cancers in Africa. The initial focus of this study will be to determine patterns of change in Kaposi's Sarcoma incidence in traditionally Kaposi's endemic and nonendemic areas of Africa. In summary, the NCI approach to international AIDS research involves the development of targeted epidemiologic studies aimed at addressing specific etiologic issues where such opportunities exist in overseas locales. The process involves the establishment of targeted research protocols funded through research contracts or grant mechanisms, AS protocols are developed these are reviewed for scientific quality and for compliance with U.S. Public Health Service requirements for protection of human subjects. Our overseas collaborators present projects to local institutional review boards and ministry of health officials per local requirements. As part of this activity NCI is committed to encouraging the transfer of technology to our overseas collaborators, either through the development of laboratory approaches or through applied training in epidemiologic research approaches. In this way, we hope to facilitate the creation of a cadre of trained scientists who will contribute in the future to addressing the needs of their countries for dealing with the AIDS epidemic. i Pp rams NCI currently has in Bethesda 56 foreign nationals and 21 guest researchers and one- volunteer from different countries of the world. The one million dollars invested in covering salaries of these individuals provides an important resource of scientists- in-training, who not..only are actively -contributing to se0lving the’ AIDS problem, but also create a pool of highly trained scientists who will return to their country of origin with a level of expertise necessary for dealing with this epidemic into the next century. CL I tional S Budge A total of $2,419,000 are currently being spent by NCI for such a research strategy, NCI hopes that. it will continue to provide new information of importance to ‘the future control of the AIDS epidemic. AIDS NCI Percent NATIONAL CANCER INSTITUTE - Percent AIDS is of the NCI Obligations (Dollars in Thousands) 1982 1983 1984 1985 1986 1987 2,406 9,790 16,627 26,874 45,050 68,483 986,564 986,811 1,081,460 1,177,853 1,210,284 1,403,413 0.20% 1.00% 1.50% 2.30% 3.70% 4.90% Testimony to The Presidential Commission on the Human Immunodeficiency Virus Epidemic "Responses to the Pandemic by the United States: The Public Sector, Research and Surveillance Programs” Centers for Disease Control April 19, 1988 Mr. Chairman and members of the Presidential Commission, I am Dr. William Heyward, Chief of the International Activities of the AIDS Program, Center for Infectious Diseasés, Centers for Disease Control (CDC). I am pleased to appear before you today to discuss CDC's international activities designed to assist in the prevention and control of Acquired Immune Deficiency Syndrome (AIDS) from 1984 to 1987 and our proposed activities for FY 1988. Since it was first reported in 1981, AIDS has been recognized worldwide, with severe health and economic consequences. The detrimental effect of AIDS has been global, and its impact on some developing countries has been dramatic. Currently, the World Health Organization (WHO) has reported approximately 80,000 cases of AIDS in 135 countries and has estimated that 5 to 10 million persons are infected with HIV. The need for a global effort to combat AIDS is urgent. The 1986-87 World Health Assembly charged WHO to provide leadership in the global struggle against AIDS. WHO has quickly assumed this role as the lead organization to coordinate the international prevention and control of human immunodeficiency virus (HIV) infection and AIDS. At WHO's request, CDC detailed Dr. Jonathan Mann to WHO to serve as Director of the Global Programme on AIDS (GPA/WHO). The AIDS Program, Center for Infectious Diseases (CID), CDC has been designated by WHO as a WHO Collaborating Center for AIDS. In FY 1987, CDC AIDS Program staff, at the request of WHO, made 15 short-term consultations to WHO headquarters in Geneva and additional consultations to regional offices to provide technical assistance to the GPA. In addition, CDC has responded to requests for assistance on HIV surveillance and prevention and control from Brazil, Sierra Leone, Guatemala, Ecuador, Spain, Chile, Dominican Republic, Columbia, Rwanda, Haiti, Mexico, Panama, Sudan, Guinea, Burkina Faso, Ivory Coast, Tanzania, Uganda, United Kingdom, Federal Republic of Germany, France, Australia and Japan. To further provide assistance and a focal point for coordination of epidemiology and research in international AIDS, CDC has recently developed an International Activities Office in CID. CDC is presently involved in a major AIDS project in Kinshasa, Zaire (Projet SIDA) which has led to a greater understanding of the epidemiology of HIV infection and AIDS in Africa. Projet SIDA, which began in 1984, is an international collaborative effort between the Government of Zaire, CDC, the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), the Armed Forces Institute of Pathology (AFIP), and the Belgium Institute of Tropical Medicine. The project employs approximately 90 persons, including 85 Zairian nationals, and has an annual total budget of $1.6 million. CDC provides a senior medical epidemiologist to Zaire to serve as the project director. Projet SIDA has maintained an AIDS surveillance system and has conducted epidemiologic studies on HIV infection and AIDS in Kinshasa. Studies conducted by the project in Kinshasa show that heterosexual transmission accounts for 80 percent or more of the AIDS cases, blood transfusion and reuse of needles accounts for 5-15 percent, and mother to child transmission accounts for about 5 percent. CDC collaborated with Projet SIDA to examine the genetic relatedness of HIV from different geographic locations. Genetic analysis of virus isolates from Zaire, together with analysis of other HIV isolates from the U.S. and elsewhere, provides important epidemiologic data as well as valuable information for vaccine development. A protocol for evaluating the safety and efficacy of immunizations (BCG, DTP, OPV,- measles vaccine) in HIV-infected and uninfected children was initiated by Projet SIDA in September, 1987. The findings have worldwide significance since inadequate immune response to vaccine antigens in these children could affect control of other immunizable infectious diseases. Other CDC international AIDS activities supported in FY 1987 included: o Assistance in developing and reviewing national AIDS plans for Colombia, Haiti, Panama, Rwanda, and Sudan. o Technical assistance and consultation in laboratory testing capability in Rwanda. o Assistance to the Pan American Health Organization to investigate the prevalence of HIV infection in paid plasma donors in Mexico. o Assistance to WHO in developing a protocol and data collection instrument to measure high-risk sexual behaviors in various populations. The data will be used to assist in planning national programs. © Training in AIDS surveillance activity for Australia, Canada, France, and the United Kingdom. o Courses in the serodiagnosis of HIV infections: Brazil (participants were from a number of South American countries), Mexico, Egypt (participants were from a number of Middle East and North African countries). Our FY 1988 objectives include: o Continued support to and through Projet SIDA. o Epidemiologic and laboratory studies of HIV-1 and HIV-2 in Ivory Coast and Burkina Faso to determine the prevalence of HIV-2 infection and the incidence of AIDS-like disease associated with this infection. Using Projet SIDA as the model, a research and prevention project. for HIV-1 and HIV-2 will be established in Abidjan, Ivory Coast in June, 1988. A project director has been selected and limited funding has been identified to initiate the project. o Training courses on the serodiagnosis of HIV infections: Brazil (regional), Pakistan (regional). o Continued assistance to WHO, A.I.D. and other international institutions by providing consultative or technical services for effective AIDS prevention programs for an estimated 10-15 countries. In closing I would like to quote from Dr. Halfden Mahler's (Director General, WHO) presentation at an informal briefing on AIDS to the 42nd Session of the United Nations General Assembly, October 20, 1987: "The scientific work to master AIDS, like the disease itself, is now firmly and irrevocably international. In AIDS, there really is no longer any such thing as purely local or even purely national research. Looking to the future, we must also work to ensure that the fruits of international research - drugs for treatment and vaccine - will be available to the entire world". Thank you. STATEMENT PRESIDENTIAL COMMISSION ON THE HIV EPIDEMIC WILLIAM H. BANCROFT, MD COLONEL, MEDICAL CORPS DIRECTOR DIVISION OF COMMUNICABLE DISEASES AND IMMUNOLOGY WALTER REED ARMY INSTITUTE OF RESEARCH 19 APRIL 1988 Admiral Watkins and Members of the Commission: It is a pleasure to appear before you today and discuss the Department of Defense Research Program on Retroviruses. I was asked to describe the goals of our research program and how it is organized. BIOGRAPHICAL SKETCH: I earned my MD degree from the University of Nebraska where I completed a residency in Internal Medicine and studied Clinical Oncology. Since 1968 I have been assigned to the Walter Reed Army Institute of Research involved in the development of improved diagnostic tests for hepatitis, and vaccine testing and evaluation of hepatitis A & B, dengue fever adenvovirus respiratory infections. Following an assignment to the SEATO Medical Research Laboratory in Bangkok, I returned to the Walter Reed Army Institute of Research to serve as Chief, Department of Virus Diseases. Since 1984, I have been Director of the Division of Communicable Disease and Immunology, with the principle responsibilities for the development of vaccines for malaria, shigella, meningitis, dengue, hepatitis and gram negative bacterial shock and since 1985, organization and implementation of a research effort for retroviruses. I serve as an attending physician to the Infectious Disease Service of the Walter Reed Army Medical Center and as an adjunct Professor of Preventive Medicine at the Uniformed Services University of Health Sciences. ORGANIZATION: In response to congressional mandates and direction from the Assistant Secretary of Defense for Health Affairs, the US Army Medical Research and Development Command tasked the Walter Reed Army Institute of Research with the development and execution of a retrovirus research program. Within the Institute, all laboratory work is under the direction of COL Donald Burke, Chief of the Dept Virus Diseases, who has appeared before the Commission in the past. Epidemiological studies are conducted by COL Richard Miller in the Division of Preventive Medicine. All clinical studies are directed by COL Edmund C. Tramont, Chief of Infectious Disease at the Walter Reed Army Medical Center. Both in-house and extramural work are coordinated through my Division. UNIQUE; ROLE OF MILITARY: The military is made up of men and women from all states, who travel throughout the world. They are predominantly heterosexual and have shown a declining incidence. of drug abuse since the introduction of mandatory drug screening. The unique policies of screening all civilian applicants for military service, the active duty and reserve forces; for referral of infected military personnel to medical centers for clinical evaluation; and entry into a centralized database provide the information needed to estimate the prevalence of antibody and the incidence of HIV infection in the age groups at greatest risk of infection. Over 70% of the antibody positive soldiers are asymptomatic and able to carry out their duties. We feel our role in the study of HIV infections is to direct our attention to the infection during the earliest stages. | RESEARCH AREAS | | The five areas of emphasis are: Improved Methods of Diagnosis. In support of the screening program, we are looking for easier and less expensive confirmatory tests to replace the Western Blot. In addition, we seek an assay for the seronegative, virus positive blood donor. Ultimately, an assay will be needed to differentiate vaccine recipients from infected individuals. Natural History of Infection. Natural History includes the usual progress of disease from the time of infection to its conclusion and determination of how HIV infection influences the performance of duties. Patient progress of infections is monitored by a Walter Reed Clinical Staging System which spans the entire period of infection. Epidemiology in military populations. To date, the work has centered on the determination of antibody prevalence rates within the active duty force and in overseas populations with whom US military may have contact. Treatment. Clinical studies of antiviral drugs are carried out at medical centers and a multi-center study by the Veterans Administration. One goal is to try to delay the development of immunodeficiency and thereby extend the asymptomatic period of infection. Another goal is to reduce the likelihood of viral transmission. Vaccine Development. Investigators in the WRAIR has considerable experience in vaccine development and testing. If an HIV vaccine candidate becomes available, the military may be a suitable population in which to test it. Present emphasis is on determining the host cell range of viruses isolated during early and late stage infections. Another project focuses on the host-virus interactions that regulate the latent period. DISTRIBUTION OF EFFORT Research funds are divided between intramural laboratory work, extramural research contracts and clinical studies carried out through a grant to the Henry M Jackson Foundation of the Uniformed Services University of Health Sciences. The intramural work focuses on diagnostic tests, immune responses, virus characterization, and analysis of epidemiologic information. The Jackson Foundation provides essential research personnel for natural nistory | and treatment studies. The extramural contracts provide vital additional information on all five areas of interest. EXTRAMURAL CONTRACTS: Extramural contracts are for either independent research in an outside institution or provide direct support of the inhouse program. Currently, there are 48 research contractors and 12 support contracts. Extramural Research Contracts are submitted in response to a standing solicitation known as the Broad Agency Announcement. This document contains information on the range of research interests of the USAMRDC, not just retroviruses. It also provides instructions on how to prepare and submit ' research proposals. Each proposal is reviewed for scientific merit by a panel of civilian expert consultants in virology, epidemiology, and/or clinical studies. Proposals passing scientific review are reviewed by senior program staff for program relevance. Following the second review, proposals are recommended for funding by USAMRDC. Since 1986, 167 proposals have been reviewed; 49% merited scientific approval and 32% were recommended for funding. Extramural Support Contracts are solicited by Requests for Proposals for specific types of work. The HIV screening of civilian applicants and the Active Force are performed through support contracts but not paid with research money. Research funds pay for antiviral drug screening, primate studies and certain administrative tasks Like research contract reviews. BUDGET : Tnis program was first funded with FY86 money through a supplemental appropriation to the Defense Budget. Although money has been provided from tnree fiscal years, overlapping authorizations have led to a funded program only since July of 1986, $33.0m Table 1 shows there has been a steady decline in the funding from $36=" in FY 86 to $8.8 Min FY 89. Tables 2 and 3 indicate how the money was distributed. Sustaining the established program will require at least $20 Ma year. CONCLUSION: The USAMRDC Retrovirus Research Program capitalizes on the strengths of traditional military infectious disease research to play a unique role in the national effort to control the epidemic. The program studies patients in the earliest stages of infection, before immunodeficiency is manifest. This program will continue to provide important information relevant to military and public health policy formation if it receives adequate funding in future years. . Ta. FY86 FY87 FY88 FY 89 MILITARY AIDS RESEARCH PROGRAM OBLIGATIONS AND DISBURSEMENTS (AS OF 31 MARCH 88) DATE REC'D AMOUNT. ($K) o OBL JUL 86 33,678 100 APR 87 18,590* 79.6 OCT 87 - FEB 88 4,865 12 JUN 88 6,509 OCT 88 8,823 *$3.5M withheld and released Feb 88 ~) Table USAMRDC HIV RESEARCH Budget Distribution 86 Intramural 2040 Extramural 30,999 Jackson Foundation Admin Support 575 TOTAL 33,614 Funding Auth 33,678 Balance 64 87 5,950 6,744 5,683 111 18,488 18,590 102 88 4,129 4,042 239 8,410 11,365 2,955 - BUDGET DISTRIBUTION BY AREA DIAGNOSIS NATURAL HISTORY EPIDEMIOLOGY TREATMENT VACCINE ADMINISTRATION Table 12 20. 45. 1. 86 -3 4 ™~] é 32.0 33.9 0.6 88 7.0 21.8 16.4 46.9 2.8 TESTIMONY OF COLONEL DONALD S. BURKE, M.D., TO THE PRESIDENTIAL COMMISSION ON THE HIV EPIDEMIC, 19 APRIL 1988, WASHINGTON, D.C. Admiral Watkins and Members of the Commission: I am honored to appear before you here today to testify on " THE RESPONSE TO THE PANDEMIC BY THE UNITED STATES: PUBLIC SECTOR RESEARCH AND SURVEILLANCE PROGRAMS." — BIOGRAPHICAL SKETCH: I received my MD degree from Harvard Medical School in 1971, and completed my Internship and Junior and Senior Residencies in Internal Medicine on the Harvard Medical Services at the Boston City Hospital and the Massachusetts General Hospital. After training as a Research Fellow in Inféctious Diseases at the Walter Reed Army Institute of Research, I spent 6 years in Thailand conducting medical research on _ epidemic tropical virus diseases. I am currently Chief of the Department of Virus Diseases at the Walter Reed Army Institute of Research in Washington, D.C., where I am responsible for the scientific Cirection of the retrovirus research program of the US Arny Medical Research and Development Command. I also serve as an Attending Physician at the Walter Reed Army Hospital where I provide medical care to patients with AIDS and other manifestations of HIV infection. TESTIMONY : I. Background: The Department of Defense has a long-standing commitment to medical research on diseases that are indigenous in foreign countries. The US Army maintains medical research laboratories in Kenya, Thailand, and Malaysia, the US Navy maintains laboratories in Peru, Egypt, Indonesia, and the Philippines, and the Uniformed Services University of the Health Sciences has ongoing cooperative studies in Pakistan and in Zambia. Often the military medical research laboratory is used as a home base for studies conducted in neighboring countries. Research projects are approved through formal agreements with the host governments, and are conducted with the close cooperation of local national physicians and scientists. Research work focuses on disease hazards that might be encountered by US military personnel operating in foreign theaters of combat. There is a long history of US military leadership in scientific research on tropical diseases such as malaria, hepatitis, mosquito-borne viruses, and diarrheal diseases. Results of the research efforts are of direct benefit to the cooperating host government as well as to the US military. During the past two years this network of US military medical research laboratories has been utilized to define the epidemiology of retroviruses in South America, Asia, and Africa. In addition to the research work being conducted by military medical scientists, the Army has also awarded contracts to some civilian groups for research on retroviruses in foreign countries. II. Direction and scope of involvement: The following table 1 is a summary of medical studies on retroviruses that are supported by the Department of Defense. As the lead agency for research in infectious diseases, the Army has responsibility for DoD program direction and coordination. To date the DoD has obligated and disbursed $ 5.9 million for research on HIV in foreign countries. Funding of the military overseas retrovirus research program has been closely coordinated with the National Institutes of Health. — I thank you for your time and attention. Signed, DAnitd S. Beef COL Donald S. Burke, M.D. Chief, Department of Virus Diseases Walter Reed Army Institute of Research Walter Reed Army Medical Center Washington, D.C. 20307 -5100 Tele (202) 576 -— 3012 / 3655 / 3757 TABLE 1. MEDICAL RESEARCH STUDIES ON RETROVIRUSES IN FOREIGN COUNTRIES SUPPORTED BY THE US DEPARTMENT OF DEFENSE. PRINCIPAL COUNTRY ORGANIZATION INVESTIGATOR DESCRIPTION ONGOING MAJOR HIV STUDIES BRAZIL YALE BLACK SEARCH FOR NEW RETROVIRUSES IN THE AMAZON EGYPT NAVY WOODY HIV-1 EPIDEMIOLOGY (W.H.O. REFERENCE CENTER) JAPAN NAVY BRODINE HTLV-I EPIDEMIOLOGY (OKINAWA) PERU NAVY WIGNALL HIV-1 EPIDEMIOLOGY PHILIPPINES NAVY HAYES HIV-1 EPIDEMIOLOGY SENEGAL HARVARD KANKI HIV-1 / HIV-2 INTERACTIONS ZAMBIA USUHS PERINE HIV-1 CLINICAL AND EPIDEM STUDIES FORMAL STUDIES CONDUCTED KENYA ARMY WHITMIRE HIV-1 EPIDEMIOLOGY THAILAND ARMY TAYLOR HIV-1 SEROPREVALENCE Testimony before The Presidential Commission on the Human Immunodeficiency Virus Epidemic April 19, 1988 By: Allan Rosenfield, M.D. DeLamar Professor and Dean Columbia University School of Public Health AIDS in sub-Saharan Africa (and New York City) As the Dean of a school of public health ina U.S. urban area with one of the highest HIV seropositive preva- lence rates in the world, and director of a center involved ina large program of service and applied research in sub-Saharan Africa, I am pleased to have the opportunity to speak on some of the key issues facing sub-Saharan Africa, with comments on the relationships between our work on the AIDS epidemic in New York City, and in Africa. As this distinguished Commission knows full well, New York City has close to 25 percent of all AIDS cases in the United States and presents the full spectrum of AIDS related problems, problems already reviewed by this Commission. Early in the AIDS epidemic, the majority of AIDS patients in New York City were gay white males. More recently, we have seen that I.V. drug using minority popula- tions have become the largest group of AIDS patients in the City. Similarly, primarily in these same poor minority populations, we are seeing increasing numbers of women and infants who are HIV positive. While most of these women are either IV drug users, or partners of infected high risk men, they present a tragic and growing problem. While there obviously are many cultural and other differences, since the AIDS epidemic in Africa is a heterosexual one, there will be some lessons learned in New York about approaches to. con- trolling the spread of the infection among heterosexual populatians which may be .relevant in Africa. I will not detail the extraordinary dimensions of the epidemic in several central African countries, as others will review the current situation and the projections for the future. The potential devastation, however, among young men, women and infants in high prevalence countries such as Uganda, is simply incomprehensible. The human tragedy is immense and the disease has hit individuals across all socioeconomic levels of the societies. In many of these countries the very limited numbers of educated future leaders stand the chance of being decimated. Many of us in New York City, and in the U.S. more generally, see the urgent need for much greater outlays of funding for a wide range of needs including research, drugs, beds, nursing and other health personnel, counselors, prevention education, long-term care and home care, aS sO well documented in the Commission’s first report. None of these needs, however, have even begun to be met in Africa, nor, in most cases, given their current resources and severe economic constraints, is there much hope that even minimal needs will be met. Thanks to the critically important efforts of WHO’s Special Program on AIDS, most African countries now have established formal governmental AIDS Committees. These committees, usually coordinated by the local Ministry of Health, but involving other ministries and often private agencies as well, have a series of vital functions to perform. These include, with some variation from country to country, the collection of epidemiologic data on prevalence; the development of projections for the future; planning for needed health care services; and planning preventive educa- tional efforts. The donor community, including WHO, the UN family of organizations, bilateral agencies and private foundations, is essential to the efforts beginning to be undertaken. The challenges are simply immense and local resources (funds, facilities and trained personnel) are so tragically limited that the donor community has a uniquely critical role to play. As the largest bilateral donor, the U.S. Government, through the U. S. Agency for International Development, (USAID) should assume a premier leadership role. In this effort it needs to make the greatest use possible of recipi- ents of research and operational awards. It should be noted that the U.S. has made a significant financial contribution to WHO’s Special Program for AIDS and this should continue. It is very important that WHO contin- ue to play the major leadership role in this epidemic, as it did for example, in the successful Smallpox eradication program and in other key international health initiatives. At the same time, USAID directly, and through its various recipients, must also play a pivotal role in this fight, assisting governments and private organization. I have a small number of recommendations that I consider of great importance: 1. USAID - funded activities should be closely coordinated with the WHO-assisted local government programs, so as to ensure the most effective campaign against the epidemic. Such an effort at collaboration appears to be underway already. 2. The U.S. Congress should provide additive dollars to the USAID budget. It will be a terrible mistake to build an AIDS budget at the expense of USAID’s other health and population programs such as child survival, family planning, malaria, etc. For all of these programs, current U.S. budgetary problems have led to leveling off, or in many cases cuts, in very important programs of assistance. These should not be cut further; rather, even in the fiscal climate of the 1980’s, the Presidential Committee should recommend that Congress allocate significant new funds as an important part of the overall U.S. effort to combat the AIDS epidemic. Given the dramatic fiscal needs for the domestic AIDS battle, such a recommendation for international assistance is difficult, but absolutely essential to our overall efforts to control this devastating world-wide epidemic. Currently, the initial AIDS-specific, USAID-funded programs have provided rather limited funding to two organizations through programs called AIDS TECH and AIDSCOM. The funding levels are inadequate, however, allowing for Only small numbers of professionals to work on the efforts. More importantly, the vital role to be played by American universities (particularly their schools of public health and medicine) is essentially being ignored. As I will discuss below, using Columbia as an example, many universities have increasingly large programs of research, education and prevention focused on AIDS, many aspects of which are highly relevant internationally. While significant funds domestically are being devoted to basic research, internationally the bulk of U.S.-assisted efforts should be devoted to such areas as the better collection of epidemiologic data; development of effective prevention strategies through operations research, demonstration projects, and technical assistance; mass education campaigns; drug and vaccine trials (when warranted by basic research development); and assistance in the provision of needed medical services. ) While these are only a brief overview of some of the areas of crucial importance for a U.S. Program of assis- tance, the costs of even these efforts require large expen ditures of funds, well above those funds already being allocated. The funding required, however, is small when placed in the perspective of the potential worldwide devas- tation of this disease and when compared with other domestic expenditures. It may be useful to the Commission to review briefly the involvement in AIDS of the Columbia University Health Sciences, which includes the School of Public Health (SPH), the College of Physicians and Surgeons (P&S), and the Psychiatric Institute (P.I.) as an example of the importance of the American university in these efforts both domestical- ly and internationally. Being located in New York City, we are faced daily with the tragic consequences of this epidem- ic. Molecular research scientists at P&S are actively involved in some of the more basic research questions which will, in time, help to lead to effective drugs and vaccines. a The P.I., in collaboration with units throughout the Health Sciences, coordinates one of three National Institute of Mental Health (NIMH) supported AIDS Centers for research on this epidemic. The SPH has taken the responsibility for the development of social science and epidemiologic research and for demonstration preventive programs in our high risk Hispanic and black communities. Among the issues we have studied are: sexual practices and mental health effects of AIDS ina group of gay men ‘in New York City; a longitudinal study of AIDS and its effects on a black Harlem population; the effects of caring for AIDS patients on physicians and nurses; and the role of primary care physicians in AIDS prevention efforts. In conjunction with the NIMH-supported AIDS Center and in collaboration with the New York State Department of Health, the School is in the process of developing model prevention/education programs aimed at a recent immigrant Hispanic population (mainly from the Dominican Republic) that surrounds the Columbia Presbyterian Medical Center and a predominantly black population that surrounds the Harlem Hospital. These efforts may well provide cultural insights that could prove most useful in work in developing countries. For example, we are now working with health authorities in the Dominican Republic, developing prevention strategies that would be applicable in the recent immigrant population from the Dominican Republic in northern Manhattan and urban residents in Santo Domingo. Recently tuberculosis has been noted to have increased Significantly in New York City, in many of the cases in HIV positive individuals with compromised immune systems, a mechanism for this increase is clear. This will likely be a truly severe additional problem of the HIV epidemic in Africa and would be another area where the New York experi- ence will be of great relevance. The School’s Center for Population and Family Health (CPFH) has a_ large USAID-funded program of operations research in the areas of family planning and primary health jn sub-Saharan Africa. This program, funded through USAID’s Population Office, has been encouraged to build AIDS-related activities into our other projects. In Uganda, in an area of the country where AIDS was first found and where the prevalence of HIV infection is thought to be very high, we are developing a project to collect better epidemiologic data and to develop a model preventive education program. This project is being conducted in collaboration with the Ugandan National AIDS control program. The Columbia contri- bution includes epidemiologic, anthropologic and programmatic assistance to the Ugandan authorities. In Senegal, HIV infection is still relatively uncommon (although there appears to be some infection with HIV-2). There we are developing a project in a large slum area in Dakar, with a population of about one million people (out of a total population in Senegal of about 8 million people). Here along with the collection of prevalence data, we are assisting local officials in developing prevention messages tied to a family planning initiative. The CPFH also is involved in an Africa-wide training program for health care managers and evaluators. We have developed a training module on AIDS and we are currently undertaking an evaluation of how the trainees have put their AIDS training into practice. It has been our experience that the development of these projects requires a great deal of technical assis- tance, as there are significant shortages of well-trained African public health professionals with expertise and experience in epidemiologic studies and in preventive education approaches. In developing intervention strate- gies, we have found it essential to be unusually flexible in approach, aS there are important cultural and political differences in each country of overriding importance. If we are to have any chance of intercepting this epidemic, we must develop strategies against what is actually happening. We must accept reality rather than plan for an idealistic (or moralistic) scenario which one might prefer, but which in reality does not exist. We do not condone prostitution, adultery, drug use or other practices by developing strate- gies that decrease the spread of disease among these indi- viduals or groups. Thus, condom use must be advocated among all those who are not monogamous. Similarly, among IV drug users, (much more a problem in the U.S. than in Africa) we must explore ways to decrease I.V. drug use, while at the same time developing innovative strategies such as proposed clean needle exchange (now carried out in Holland, without any apparent increase in drug use). The AIDS crisis is surely the infectious disease epidemic of the twentieth century. It will affect millions of Americans and Europeans and many millions more in the developing world, particularly in Africa. We live in one large interdependent world and I believe it to be of utmost importance that the U.S. government’s approach to helping solve the problem include a significant international component. Through USAID, some AIDS-related activities have initiated, but so much more is needed. In this regard, as above, greater use should be made of universities with international experience and expertise. For this devastat- ing and complex disease, the resources of key American universities can be of great importance and they should be encouraged to participate in USAID’s fight against the epidemic. I thank you for the opportunity to make a presentation today. I congratulate you for the outstanding work you now are accomplishing. With the current renewed commitment, the Commission has been most effective, most visibly with release of the first review and recommendations, a most important document indeed. 35/b:14 “4 THE JOHNS HOPKINS UNIVERSITY > SCHOOL OF HYGIENE AND PUBLIC HEALTH z dav ‘e *, Gey INSTITUTE FOR INTERNATIONAL PROGRAMS . , ars ," po Testimony Prepared For * es : ‘ "Presidential Comission on the Human Immunodeficiency Virus Epidemic. For the Panel “Recipients of Bilateral Research and Operational Awards" April 19, 1988 by W. Henry Mosley, M.D., M.P.H. Director Institute for International Programs ; Johns Hopkins University School of Hygiene and Public Health Baltimore, MD .» % Introduction I appreciate this opportunity to respond to the Commission's request to testify on the accessibility and relevance of international research and assistance programs funded through the Department of Health and Human Services, the Department of Defense, the Agency for International Development, and other agencies. I have worked in the field of international health for the past twenty-three years. Fourteen years were spent in long-term assignments in Bangladesh, Kenya, and Indonesia. I have had direct working experience with U.S. government agencies including nine years as a U.S. public health service officer with the Centers for Disease Control. I will begin by describing the scope of the international health program at Johns Hopkins University and then follow this with a description of the breadth: and depth,of experience and expertise that we have in AIDS. This will O15 North Wolfe Street © Baluumore, Mars land 21205 Telex 7102340022 PL BESG BAL © Cuble Address PUBEHYG « felephoane (3401) 855 TON4 3/28/88 Testimony for the Presidential Commission on the 2 Human Immunodeficiency Virus Epidemic give some perspective on Hopkins’ institutional potential to contribute to an international AIDS control effort. Before addressing the specific questions raised by the Commission on the strengths and weaknesses of the international AIDS research and technical assistance programs currently being supported by HHS, DOD and AID, I will give an overview of the recent trends in U.S. international health activities to put the AIDS initiative into a broader context. Finally, I will offer some proposals which may be considered by the Commission as it formulates its policy positions and recommendations. Johns Hopkins University Johns Hopkins Unversity is the leading academic center in international health in the United States. There are over sixty full-time faculty and more than two dozen senior technical professionals engaged in international research, training, and technical assistance projects, and more than 150 Third World students in graduate studies in public health. Academic programs are directed by the Department of International Health, while interdepartmental projects are coordinated by the Institute for International Programs (IIP). Recently the LIP completed an analysis of research, training, and technical assistance projects being implemented by the University in calendar year 1987 with funding from AID's Office of Health, Office of Population, and Office of Nutrition. Twenty-three projects and programs were identified involving 74 faculty members and technical experts working in 38 countries. The scope of the international health research program is wide-ranging and includes: measures to improve the dietary management of diarrhea in rural settings; field testing of new and improved vaccines for cholera, rotavirus and measles; investigations of the health benefits of vitamin A supplementation; evaluation of the safety and efficacy of contraceptives; field studies of ivemectin for the control of onchocerciasis (river 3/28/88 Testimony for the Presidential Commission on the 3 Human Immunodeficiency Virus Epidemic blindness); demographic evaluation of the impact of health intervention programs; and field studies on maternal/infant transmission of AIDS virus, among other topics. Each of these studies is carried out in close collaboration with investigators in Third World countries. To facilitate this Johns Hopkins has instituted formal agreements for long-term collaborative research with twelve leading universities or research centers in a dozen countries in Africa, Asia, and Latin America. Our training and service operations are equally extensive. Since 1973 the Johns Hopkins Program for International Education in Gynecology and Obstetrics (JHPIEGO) has operated one of the largest training programs for physicians, nurses, and paramedical personnel in the world. More than 50,000 health professionals in over forty countries have been trained in the modern methods of fertility control, laying the professional and technical groundwork for the implementation of national family planning programs worldwide. Through the Population Information Program, over 120,000 readers in developing countries are reached with annually with six issues of Population Reports which provide definitive information about advances in contraception, family planning, and child health programs. Noteworthy, the issue of Population Reports in highest demand has been the August 1986 edition addressing the topic of "AIDS: A Public Health Crisis” which provided Third World health professionals, administrators, program managers, and policymakers with authoritative and up-to-date information on AIDS including practical recommendations for public information and control measures. Johns Hopkins has also been a major innovator in mass communication of public health information through the Population Communication Services (PCS) program. Over a dozen technical experts work in collaboration with ministries of health and communication professionals in more than twenty countries \ 3/28/88 Testimony for the Presidential Commission on the | 4 Human Immunodeficiency Virus Epidemic assisting in the production of printed media and radio and television broadcasts to provide public information and motivation for improved health and family planning practices. This past year the PCS program received the "Better World Society" award for the production of two rock video songs sung by Latin American stars Tatiana and Johnny. These songs were designed to encourage adolescents and young people to postpone sexual relations. and childbearing and seek advice and counseling. Both songs were hits throughout Latin Amer ice and-had - remarkable influence on-millions ‘of. teenagers.: ' re! Johns Hopine University Resources and Activities. in. AIDS | Johns Hopkins Medical Institutions have beén actively involved in AIDS research and prevention since 1983. Currently, approximately $40-million dollars, primarily from the National Institutes: of Health, have been allocated or awarded to JHU to support over twenty research projects. The majority are large-scale epidemiological studies directed by Dr. Frank Polk, and the remainder are clinical investigations or basic biomedical research. The epidemiological investigations range from longitudinal studies of the natural history of AIDS in gay men and intravenous drug abusers to investigations of methods to reduce the risk of AIDS among prison inmates and blood transfusion recipients. The Johns Hopkins international AIDS research program began when the National Institutes of Allergy and Infectious Diseases of the NIH and Johns Hopkins University School of Medicine established a research laboratory within the Division of Infectious Diseases at Johns Hopkins Hospital specifically designed to address research issues on AIDS. Dr. Thomas Quinn from the NIH was assigned Director of this laboratory because of his expertise in sexually transmitted diseases and immunology. This laboratory has become a WHO reference center for HIV serologic testing and collaborates with researchers 3/28/88 Testimony for the Presidential Commission on the 5 Human Immunodeficiency Virus Epidemic from the Tropical Medicine Institute in Belgium, the Pasteur Institute in France, the British Medical Research Council in London and The Gambia, and AIDS researchers in Uganda, Sudan, Nigeria, Kenya, India, the Philippines, Brazil, Argentina, Peru, and several Caribbean countries. In 1983, Dr. Quinn joined with doctors Piot and Curran to establish the multidisciplinary research in Kinshasa, Zaire referred to as project SIDA. This project has generated much of the information we currently have about the AIDS epidemic in central Africa. In 1984-85, Dr. Quinn established a series of collaborative studies with epidemiologists and virologists at CAREC, a PAHO-sponsored research laboratory in Port of Spain, Trinidad. Studies there ate examining the transmission of HIV infection within the Caribbean basin, particularly among female prostitutes and migrant farm workers. Because of the critical concern with perinatal transmission, Dr. Neal Halsey from the Department of International Health has designed prospective studies of several thousand Haitian women, 8% of whom are infected with HIV. The spécial interest is in prognostic serological indicators ‘relating to the sevetity of infection among: women and the transmission of the virus to their infants. This work has NIH support. Most recently, Dr. Alfred Saah from the Department of Epidemiology has developed a proposal to be funded under the NIH International Centers for AIDS Research (ICAR) program to follow babies who will be born of HIV-infected mothers and fathers in Malawi. Again the concern is to assess the risk of transmission of HIV to the neonate and to study the natural history of HIV infection in the mother and child. To coordinate the wide ranging AIDS program, the AIDS Research Group was established almost two years ago by Dr. Andrew Sorensen, Associate Dean of the School of Hygiene and Public Health. Currently this group includes more than 30 scientists in fields ranging from molecular biology, to psychiatry, to law 3/28/88 Testimony for the Presidential Commission on the 6 Human Immunodeficiency Virus Epidemic and ethics, who meet biweekly to discuss research strategies and new initiatives. In December 1987, the Trustees of Johns Hopkins University announced the formation of the Johns Hopkins AIDS Institute to coordinate all research and clinical care related to the disease. Academic Centers for International Health Research ~- The National Need Johns Hopkins is unique in the breadth and depth of its international health research program. To put a discussion of the potential for an international AIDS research effort into a broader context, let me refer to the 1987 National Academy of Sciences (NAS) study on The U.S. Capacity to Address Tropical Infectious Disease Problems which critically examined national resource capacities and needs in the area of international health. This study is highly relevant to the issues being discussed here, and I would commend it to the Commission. A few points will be highlighted as they directly relate to U.S. capacities and strategies for international AIDS research and technical assistance. The NAS study surveyed about 150 U.S. universities and could only identify twenty that had significant international’ programs in biomedical research, public health or clinical training. Among these, only eight institutions could be categorized as tropical health centers, which met the criteria of having institutional facilities including both a medical school and a school, department, or division of public health with collaborative relationships with similar institutions in developing countries for training and research. Only four of these centers--Johns Hopkins, Harvard, Tulane, and the University of California (including campuses at Berkeley, Los Angeles and San Francisco)--had thirty or more specialists in international health, with , only Johns Hopkins having more than fifty full-time faculty members in tropical health work. The NAS study noted that, with rare exceptions, few 3/28/88 Testimony for the Presidential Commission on the 7 Human Immunodeficiency Virus Epidemic U.S. universities are expanding their international health work, largely because of inadequate institutional support and lack of appropriate career structures. In fact, only the largest centers can afford to have faculty members overseas for long periods of time, so most contributions by U.S. academics are short-term. Professional Capacity for International Health Research A detailed analysis of U.S. professionals with expertise in the field of tropical diseases by the NAS highlights the serious deficiencies we face at the present time. A national survey indicated that there may be as many as 2,500 persons working on tropical diseases in the United States; however, if we accept the NAS study's judgment that expertise in tropical infectious disease is "dependent upon knowledge of the problem in its setting", that is, "an appreciation and firsthand knowledge of the interactive effects of ¢limate, socio-economic factors, culture, and local medical infrastructure on health, are vital to the understanding of tropical infectious diseases", then the number of international health professionals drops to, perhaps, 500. More importantly, from the standpoint of AIDS, where human behavior is the key factor, the NAS study suggested that there were probably only "several dozen" professionals in the social sciences with experience in international health. They included in this category medical sociologists, anthropologists, health economists, medical geographers, psychologists, and public health behavioral scientists. If we look at the trends in international experience among tropical disease professionals, we see a disturbing pattern. Among those persons ages 40-69, almost two-thirds had developing-country experience, while among those in their thirties, only one-third have had professional experience overseas. While it is difficult to draw firm conclusions, the pattern suggests that 3/28/88 Testimony for the Presidential Commission on the 8 Human Immunodeficiency Virus Epidemic tropical disease experts are increasingly focusing on laboratory and biomedical research in the United States because of declining opportunities for international health research in Third World countries. There are a number of historical trends that may account for these patterns which are directly relevant to the current strategies of U.S. government agencies in addressing the AIDS problem internationally. In the 1950s and early 1960s, the United States along with other governments was heavily committed to malaria eradication programs, and many U.S. health professionals were involved in this global effort. Subsequently from 1965 through the late 1970s, hundreds of U.S. health professionals gained long-term international participating in the global smallpox eradication program. Over this same period of time, the National Institutes of Health supported several major international collaborative research programs involving U.S. universities and international institutions through the International Centers for Medical Research and Training (ICMRT) program. (In 1973, Training was dropped and these were designated ICMRs until the program terminated in 1980). Concurrently, the NIH with support from AID and in collaboration with CDC developed the Cholera Research Laboratory in Dhaka, Bangladesh, which in 1979 became the International Center for Diarrheal Disease Research, Bangladesh. These major international research and technical assistance programs not only brought to the world such major advances as the eradication of smallpox and the development of oral rehydration therapy for diarrheal diseases, but also provided the training ground for a high proportion of the international health leaders in the United States today, some of whom are now directing their efforts to the control of AIDS in the Third World. 3/28/88 Testimony for the Presidential Commission on the 9 Human Immunodeficiency Virus Epidemic U.S. International Health Strategies in the 1980s The 1980s could be considered a turning point in U.S. international health research and technical assistance strategy. The NIH has dropped the ICMR program (which had provided the opportunity for long-term, broad-based, multidisciplinary, collaborative research internationally) in favor of the far more narrowly focused International Center for Infectious Disease Research (ICIDR) projects which are investigator-initiated with limited funding precluding significant long-term overseas assignments. It is this same pattern which is now being followed by NIH with the more recent International Centers for AIDS Research (ICAR) program. Like the ICIDRs, the ICARs provide limited short-term funding (less than $100,000 a year over a five-year period) which only provides the opportunity for a few research projects to answer specific biomedical questions. While the scientific quality of these projects will be high, they do not in any way represent a coherent programmatic approach to a health problem. This was noted by the NAS study cited earlier which observed, "Today's federal programs and institutions are not designed to track a tropical disease problem from its biomedical origins through to the point of choosing among alternative protective measures." In the area of international technical assistance, AID has similarly been moving away from broadly~based intervention programs like smallpox eradication whose impact will be measured in terms of actual health improvements in the population toward highly selective intervention activities that are process-oriented and narrowly focused. For example, in its 1985 Report to Congress on Child Survival, AID describes its international health assistance strategy as one focused "on a limited, manageable mix of proven technologies that promise substantial and direct health benefits for infants and children", Most important among these technologies are the so-called "twin engines" of 3/28/88 Testimony for the Presidential Commission on the 10 Human Immunodeficiency Virus Epidemic oral rehydration therapy for diarrhea and immunizations which together received more than 60% of all child survival dollars in 1986. The technocratic approach of these efforts coupled with a short-term time frame results in many of AID's current programs being implemented through limited (five-year) contracts or cooperative agreements with management contractors or private voluntary organizations. Not surprisingly, the focus of efforts by these contractors and organizations is primarily on day-to-day operational and logistical problems. They are not asking critical scientific questions, or producing new knowledge, or developing new scientific talent, and they are not equipped to take on new health problems like AIDS where the scientific foundation for interventions does not exist. One great weakness with U.S. health efforts internationally relates to the implementation of large-scale intervention programs with almost no solid scientific foundation. A major example is the Expanded Program of Immunization (EPI) which in many countries in the world is being implemented without any epidemiological surveillance to determine what, if any, impact the efforts are having, much less being supported by social science research which may define the factors constraining the effective delivery, acceptance, and utilization of the vaccines in communities. Most disconcerting, we are on the verge of a biomedical revolution which promises to pour forth many new highly effective immunization agents including, hopefully, an AIDS vaccine, yet we do not have the scientific foundation and technical capacity to effectively deliver the products we have in hand to Third World populations. An Assessment of International AIDS Research and Technical Assistance The background information presented above provides a framework and perspective to examine the present state of international research and 3/28/88 Testimony for the Presidential Commission on the 11 Human Immunodeficiency Virus Epidemic technical assistance in dealing with the global epidemic of HIV infection. It should be clear that resources within the U.S. government to address the AIDS epidemic internationally, though of high quality, are extremely limited. An example is the joint project by CDC and NIH in collaboration with the Armed Forces Institute of Pathology and other investigators to develop Project SIDA in Kinshasa, Zaire. This research provided the first clear documentation of the magnitude and extent of the AIDS epidemic in central and eastern Africa. It should be noted, however, that the NIH and CDC combined have placed only three U.S. scientists and a few supporting technicians in this critically important effort because of limitations on resources and scientist positions. Because of its focused research agenda, Project SIDA is not able to effectively assist the government of Zaire in developing and implementing an overall national strategy for AIDS control. Besides supporting a few investigator-initiated research projects in Africa and Latin America, the major NIH response to the global AIDS epidemic has been the support of the ICAR program to establish up to ten international collaborative research projects, primarily in Africa and Latin America. As noted earlier, these are patterned after the NIH's ICIDR program which, because of resource limitations, (less than $100,000/year for five years) permit international collaboration only on a limited scale and on an abbreviated segment of the research spectrum. It should be recongized that the ICAR projects cannot be considered as an international AIDS research program since they represent a series of investigator-initiated projects without any overall research strategy. Furthermore, NIH has no plan for coordination among the individual research projects. In a similar vein, the projects of the DOD are limited in scope largely to protect the military establishment. An exception is the research by the Uniformed Services 3/28/88 Testimony for the Presidential Commission on the 12 Human Immunodeficiency Virus Epidemic University in Zambia, but again it neglects the critically important behavioral dimension of AIDS. As the Commission members have learned, AID has committed $42-million dollars over the next five vears in support of two major bilateral, technical assistance projects; $14-million dollars is for a communications program (AIDSCOM), and $28-million dollars is for technical assistance in AIDS control, the AIDSTECH project. Noteworthy, AID has only one project officer to administer this large AIDS program in the Office of Health, and this represents only a part of his program responsibilities. In its conception, the AIDSTECH project was very broad based and had the potential of mobilizing major U.S. institutional resources in a coherent and coordinated effort to address the AIDS problems internationally. The scope of technical assistance expertise that was identified by AIDSTECH encompassed program design and administration, epidemiology, training, morbidity surveillance, logistics, immunology, hematology, laboratory testing and blood banking, management information systems, operations research, social sciences, economics, health financing and evaluation. At the time AID announced the Request for Applications to undertake the AIDSTECH project, Johns Hopkins University made a determination that in spite of our extensive international resources and technical capability in AIDS, the most effective implementation of this program would require enlisting the resources of other major academic, scientific, technical and management instititions in the United States. Thus, Johns Hopkins joined with Columbia University in submitting a proposal which drew in as collaborating institutions the American Red Cross, the Population Council, the Program for Appropriate Technology in Health (PATH), Drew Postgraduate Medical School, John Snow Incorporated (a management firm), and ABT Associates Incorporated (an economics consulting firm). We were able to 3/28/88 Testimony for the Presidential Commission on the 13 Human Immunodeficiency Virus Epidemic identify more than fifty highly qualified professionals who were prepared to commit full or part-time to this endeavor. At least one other organization competing for this project also drew together from a number of leading AIDS research centers a broad range of professional expertise in AIDS and international programs. Much to our surprise AID, apparently following a trend in recent years of taking a limited technocratic approach to international health projects, selected a contractor with no academic base and very limited AIDS experience to implement the AIDSTECH project. Ina subsequent competitors debriefing, Johns Hopkins was informed by AID that a major count against our proposal specifically related to our plan to involve some of the major AIDS and international health research centers and operational organizations in the United States in a concerted attack on the global problen. The AIDS communications project (AIDSCOM) is being implemented by a competent agency in the area of mass communications; however, one must recognize that the AIDSCOM project is severely handicapped by the lack of a scientific foundation on which to base a communication strategy. While it is clear that large populations in Sub-Saharan Africa are already infected with HIV, we have only the most superficial idea of why the disease is spreading so extensively throughout the heterosexual population. Not only do we lack the epidemiological foundation to establish the high-risk subgroups in the population, but there has been essentially no social and anthropological research to define the high-risk behaviors which might provide a scientific basis for the development of appropriate intervention strategies. In summary, given the vast lacunae in our knowledge about AIDS transmission in the Third World, one has to question whether the recent allocation of tens of millions of dollars for the purchase and distribution of 3/28/88 Testimony for the Presidential Commission on the 14 Human Immunodeficiency Virus Epidemic condoms and for narrowly focused technical assistance programs and communication activites by AID represents the most effective use of the limited international health resources available from the United States to cope with the problem. | Structural Constraints to an International AIDS Control Effort As well documented in the NAS study cited earlier, clear lines of authority for U.S. international health activities have never been established and the United States has no coherent international health policy. One reason is because international health initiatives are so intimately tied to broader foreign policy issues (e.g., centralization of foreign assistance programs, scientific collaboration as an instrument of-foreign policy, funding of PHS international programs, and U.S. participation in multilateral organizations). While lack of a clear, comprehensive, national policy for U.S. international health involvement has not restricted various government agencies from undertaking special initiatives, it should be clear from this analysis that the actual resources allocated for any particular problem such as AIDS will be subject to internal limitations of agency funding and competing demands, as well as external events. In 1978) the Institute of Medicine Committee on International Health observed that: l. there is no U.S. goverment organizational unit at present responsible for gathering and analyzing information on the nature and extent of these activities; 2. there is no clear U.S. international health policy to guide and relate direct investments in international health activites to bilateral program planning and U.S. participation in the 3/28/88 Testimony for the Presidential Commission on the 15 Human Immunodeficiency Virus Epidemic international health program policy decisions of multilateral agencies; and 3. there are no policies and no mechanisms to plan and coordinate program decision-making across agencies and to take account of other program actions or other governments and private organizations. The situation is unchanged today, and the lack of coherent response to the AIDS epidemic internationally is the consequence. Recommendations l. 3. The global HIV epidemic brings into sharp relief every deficiency in our health policies internationally as well as domestically. The U.S. government does not have a strategic policy for dealing with AIDS in the developing world. In view of this, the first recommendation is for the Office of Science and Technology Policy of the United States to consult with representatives of those federal agencies concerned with the AIDS epidemic in the Third World as well as with non-governmental advisors to define an effective strategy to support a coordinated research and technical assistance activity in developing countries. The staffing of major government agencies, particularly AID, NIH, and CDC, to deal with AIDS internationally is wholly inadequate to the need. The U.S. should expand the numbers of full-time positions in each of these agencies sufficient to support an international AIDS effort. There are a limited number of academic centers in the United States which have major multidisciplinary programs committed to solving international health problems. Some of these centers are currently engaged in AIDS research and service programs domestically. The United States should develop an international AIDS control strategy that could effectively utilize these academic centers and other professional organizations to 3/28/88 Testimony for the Presidential Commission on the 16 Human Immunodeficiency Virus Epidemic build both the scientific knowledge base and the national and international expertise needed to address this problem. There is a critical need for the establishment of multidisciplinary international AIDS research centers in developing country settings. Two or three should be established in Africa, and at least one each in Latin America and Asia. These should each have sufficient resourcés ($2-million to $5-million dollars annually) to support a multidisciplinary team of U.S. and national scientists to take a comprehensive look at the AIDS problems in their regional settings. THE BIOLOGY OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 2 (HIV -2) Phyllis J. Kanki DVM DSc. Department of Cancer Biology Harvard School of Public Health Boston, Massachusetts, USA Introduction Our recognition of the existence and properties of exogenous human retroviruses has increased dramatically in the last decade. After the identification of HIV-1 as the causative agent of AIDS, we have gained a new appreciation of the unique and complex properties of this pathogenic human retrovirus. In addition, the relevance of related animal retroviruses has gained new importance. Early in 1985, a related virus, Simian Immunodeficiency Virus (SIV, previously termed STLV-3) was found in immunodeficient macaque monkeys. SIV was found to have major viral antigens that were similar and cross-reactive with the viral antigens of HIV-1 (1). SIV was therefore demonstrated to be the closest known retrovirus to HIV-1. SIV is known to induce immunosuppression in the Asian macaque monkey, however, in its natural host, the African Green monkey it appears to be relatively nonpathogenic (1-3). The existence of a primate relative of HIV-1 found in high numbers of naturally infected African primates suggested the possibility that people might also be susceptible to infection with an SIV related virus. In 1985, a new human T-lymphotropic retrovirus was discovered in Senegal, West Africa (4). We described antibody reactivity in healthy Senegalese that demonstrated strong antibodies to the env, gag and pol antigens of SIV. These same samples when reacted with HIV-1, only showed weak cross-reactive a:.tibodies to the gag and pol antigens. It was therefore, recu. ‘2d that these individuals had been exposed to a virus more closely related to SIV and more distantly related to the prototype AIDS virus, HIV-1 (4,5). Subsequently, Clavel and colleaques (6) demonstrated similar SIV antibody reactivity in two AIDS patients originating from West Africa. This new human retrovirus has now been termed Human Immunodeficiency Virus Type 2 (HIV-2) (7). Various strain names have been given to HIV-2, including: HTLV-4, LAV-2, SBL-6669, HTLV-4 (ST), it is now believed that these are all the same virus type. All HIV-2_ strains thus far identified are serologically cross- reactive and therefore serology-based studies are not thought to be Strain-specific (8-10). VIROLOGY OF HIV-2 The antigenic relatedness of both SIV and HIV-2 to the prototype HIV virus prompted both the discovery and further classification of these related viruses (1,4). Subsequent genetic analysis has shown HIV-2 to be most closely related to SIV (less than 20% difference) and more distantly related to HIV-1 (approximately 50% difference) (11-13). Similar to HIV-1, these related viruses demonstrate tropism to the T4 lymphocyte (1,5,6). The overall genetic organization of all three virus types are similar with the exception of a unique open reading frame termed "X" found in both HIV-2 and SIV (11-13) (Figure 1). The major viral antigens of HIV-2 have been identified by immunoblot and radioimmunoprecipitation analysis; they bear striking similarity and cross-reactive epitopes with the viral antigens’ of HIV-1 (4,5). The gag encoded products include a p55 myristylated precursor, a major core protein, p24-26, and an amino-terminal myristylated gag protein, p15 (4,5,14). The pol-encoded proteins, readily distinquished by immunoblot and radioimmunoprecipitation of virus preparations include a p64, p53 and p34 (endonuclease) (5,15). The most highly immunogenic antigens are the env-related glycoproteins which includes a gp160 precursor, the mature: envelope protein the gpl120 and the transmembrane gp32-40. There appears to be polymorphism in the env-related glycoproteins, similar to what was reported for different strains of HTLV-1 (4,5,9,16). The gag and pol genes are well conserved for both HIVs and SIV (11- 13). The gag and pol encoded proteins exhibit broad serological - cross-reactivity. It is the presence of gag and pol antigens in various HIV-1 serologic assays that enables the frequent detection of HIV-2 antibodies which are cross-reactive to those conserved epitopes. The env genes of HIV-1 and HIV-2 show less conservation at a genetic and antigenic level, whereas HIV-2 and SIV show a high degree of conservation (11-13). Sequence analysis of several HIV-2 and SIV strains have demonstrated “a “stop codon in the middle of the open reading frame encoding the transmembrane protein (12,13,17); this corresponds to the smaller transmembrane protein size that is seen with certain HIV-2 isolates (16). HIV-2 isolates SBL-6669 and HIV-2(ST) are reported to have two smaller molecular weight glycoproteins that are thought to ‘respond to two different size transmembrane proteins, a gp32 and a gp40 (9,16). It is not known whether these two glycoproteins are in fact transmembrane proteins. If so, the presence of two different sized transmembrane proteins may indicate that these cell lines contain a mixture of virus strains or one virus strain capable of modulating expression of the transmembrane stop codon. It is still to be determined if the stop codon is seen in viruses in vivo or if it represent an in vitro artifact. If the former, it will be important to determine if potential modulation of the stop codon can affect the functional properties of this virus. Nucleotide sequence comparison between HIV-1 and HIV-2 or SIV have revealed conserved regions scattered throughout the envelope gene (12,13). It is still not known whether these regions will correspond to immunogenic domains capable of illiciting a cross-protective response to all virus types. Although in limited studies it has been shown that HIV-2 positive sera is capable of neutralizing various HIV-2 strains and additionally neutralizing some HIV-1 strains at lower titer, whereas the neutralizing response of HIV-1 infected individuals appeared to be type-specific (18). The close antigenic relationship of HIV-1 and HIV-2 has created new problems for serologic diagnosis. Currently employed HIV-1 immunoassays have shown variable ability in detecting HIV-2 antibody positive samples depending on the testing format and antigen preparation (19,20,16). HIV-1 recombinant-based and/or competition type assays are frequently more type-specific and therefore do not readily detect HIV-2 antibody positive samples. Most of the commonly used commercial first-generation HIV-1 antibody ELISA assays will detect over 80% of HIV-2 positive samples (19,20,16). This probably results from the fact that HIV-2 antibody positive sera frequently contain high titer antibodies directed at the cross-reactive epitopes that exist between the virus types. At present, immunoblot and/or radioimmunoprecipitation analysis with both HIV-1 and HIV-2 virus types and the presence of antibodies to the env products is necessary to distinquish the virus infections. More rapid and economical techniques are needed to distinquish between HIV-1 and HIV-2 not only for general surveillance but also to better delineate the clinical significance of HIV-2 infection. Molecular studies have demonstrated the presence of six accessory genes with variable homology to the HIV-1 genes (sor, tat, art/trs, Sorf/F, R, and X). Functional evidence of tat activity has been shown for HIV-2 and SIV-2, similar and cross-reactive with HIV-1 tat (21,13). The function and immunogenicity of the other accessory genes is still under study. Comparative analysis of these regulatory genes’ function and correlation to the biological effects of these related viruses may provide important clues on the pathogenicity of HIV-1. BIOLOGY OF HIV-2 HIV-2 was given its name to indicate its close relationship to HIV-1 this was based on similar cell tropism, antigenic and genetic properties (7). However, the ec tive ability of HIV-2 to induce’ immunodeficiency is still under active study. Preliminary surveillance studies have already demonstrated significant rates of HIV-2 infection in West Africa. Therefore, it is of critical importance to determine the clinical significance of HIV-2 infection and evaluate its potential as a second AIDS causing virus. The health status of individuals from which virus has been isolated is but one means of assessing the pathogenic potential of a virus. HIV-2 isolates have been made from healthy individuals and AIDS patients originating from West Africa (4,6,9). Clavel and coworkers (36) have described 30 HIV-2 infected West African patients admitted for treatment to a hospital in Lisbon, Portugal. 6/30 West African patients did not show any symptomology associated with immunosuppression. Of 17/30 diagnosed~ AIDS cases, the chief symptom was chronic diarrhea often with weight loss of more than 10 kg in one year. Esophageal esophagitis was found in 8/17 AIDS cases and 8/17 demonstrated some type of respiratory disorder. 4 of the 17 AIDS cases had Kaposi sarcoma, a relatively rare finding in Central African AIDS cases. Thus, the clinical picture of endstage AIDS patients found to be infected with HIV-2 has been _ similar to that of HIV-1 induced AIDS. In follow-up clinical studies, described by Brun-Vezinet and colleaques (24), 2 of 3 HIV-2 positive AIDS cases were still alive and stable 3 years after the diagnosis of AIDS. This seemed to indicate a possible difference in the pathogenicity between HIV-1 and HIV-2. Unfortunately, it is difficult to adequately assess the pathogenic potential of any suspected agent with isolation of select disease patients alone. In West Africa, seroepidemiologic surveys (n=8900) conducted in major urban areas of Senegal, Guinea, Guinea Bissau, Mauritania, Burkina Faso, Ivory Coast, Gambia, Cape Verde and Benin (Figure 2) have demonstrated moderate to high rates of infection with HIV-2 in all countries surveyed except Mauritania (25-27). For these studies, serologic diagnosis was accomplished by immunoblot and/or radioimmunoprecipitation analysis with both HIV-1 and HIV-2 antigens. In general, the prevalence of HIV-2 was higher than that of HIV-1 in any West African country surveyed when control healthy or sexually active risk groups were examined. However, HIV-1 was more frequent in the few AIDS patients or suspect cases that were examined; these individuals were frequently of Central African origin or had a history of recent travel in Central Africa; 19/19 AIDS cases in Senegal from 1986-1987 (16). In the countries surveyed the HIV-2 prevalence in healthy adult populations varied from 0.2-9.2% whereas rates of HIV-1 were much lower. Limited studies conducted in select rural populations of Senegal have failed to demonstrate comparable rates (0%) of HIV-2 seropositives when compared to urban populations, indicating that HIV-2 infection may be more predominant in urban settings as compared to rural settings (16). Similar observations have been made with HIV-1 in Central African populations, where lower and more stable seroprevalences of HIV are found in rural populations (28). Almost 80% of sub-Sahara' Africa resides in such a rural setting, it will therefore be of paramount importance to better define the modes of HIV transmission between these distinct populations. This will be of critical to the planning and implementation of AIDS control and prevention in Africa. HIV-2 prevalence was higher in sexually active risk groups such as female prostitutes and sexually transmitted disease patients when compared to healthy control populations (25-27). In some urban centers of West Africa the prevalence for HIV-2 in female prostitutes ranged from 15-64%. All individuals were examined at the time of the serum sampling and were found to be without signs or symptoms of AIDS. The prevalence ratio of sexually active risk groups compared to control populations was 7.4 (X2=297, p<0.0001) Therefore, HIV-2 appears to be sexually transmitted like HIV-1 and in Africa this is thought to be primarily heterosexual transmission. Large-scale seroepidemiologic studies allow for the evaluation of large numbers of individuals of varying health status and its potential association with virus. In our studies, there was no significant difference between the prevalence of HIV-2 in immunosuppressed individuals or AIDS patients when compared to healthy controls from the same geographic locale (25-27). Since, it is recognized that AIDS in West Africa is still relatively infrequent, we investigated the possibility that some other associated disease entity might better illustrate the potential immunosuppressive properties of HIV-2. It has been well-recognized from numerous studies in Central Africa that tuberculosis is highly associated with HIV-1 infection and AIDS (29). 40-70% of tuberculosis cases examined in Zaire were shown to be HIV-1_ seropositive. We therefore hypothesized that since tuberculosis was also endemic in West Africa, this population might also show an increased association with HIV-2 seropositivity. In Senegal, Ivory Coast and Guinea Bissau (n=345) there was no_ significant difference between the seroprevalence in control populations compared to that in tuberculosis patients (25). This is in marked contrast to what is seen in comparable studies in Central Africa with HIV-1; indicating a striking difference in the pathobiology of HIV-2 from that of HIV-1. In Burkina Faso and Ivory Coast significant rates of infection with both HIV-1 and HIV-2 are seen in risk populations (25-27). In these countries a number of individuals were found who _ possess antibodies with strong reactivity to the env antigens, particularly the gp120, of both HIV-1 and HIV-2 (25,26). This type of serologic profile may be indicative of either infection with an intermediate type of virus, double exposure to both HIV-1 and HIV-2 Or unusually high-titer cross-reactive antibodies to both. Isolation of both HIV-1 and HIV-2 has not been demonstrated to date (25,26,30). It is therefore not known if some individuals may have been exposed to both viruses but maintain persistant infection with only one type. Or, if previous infection with one virus type may induce some cross- protective immunity and/or interference phenomenon. In many parts of the world the poten:ial for infection with both HIV- 1 and HIV-2 may exist in ceriain ri - populations. It is not known 1G what the interactive effect of HIV-1 and HIV-2 will be in vivo. Prospective follow-up studies with virus isolation and characterization as well as clinical monitoring will determine if interference, double infection or recombination with these viruses occurs and its effect. Preliminary studies on the hematological and immunological status of HIV-2 infected prostitutes in Senegal “Rave been completed (31). Generalized lymphoadenopathy and clinical symptomology of AIDS was not present. Comparison to seronegative prostitutes and minor surgery patients were made and significant elevations were seen in T8 lymphocytes ( p=.03), IgG (p=.001) and B2-microglobulin (p=.03). The mean T4 lymphocyte count in seropositive prostitutes was lower than in seronegatives prostitutes (757 vs 1179, p=.15), but this difference was not statistically significant and appeared to be correlated with age. No significant differences were noted between seronegative and seropositive prostitutes in blastogenic response to various mitogens. Antilymphocyte antibodies above background were not ‘present in either population. Clinical examination of over 62 HIV-2 infected West African prosititutes has failed to demonstrate an increase in AIDS-related signs or symptoms or generalized lymphadenopathy (31). This is in contrast to similar studies conducted on Nairobi prostitutes with HIV-1 infection, where 54% of the seropositive prostitutes were found to have generalized lymphoadenopathy on _ physical examination (32). In Rwandese HIV-1_ prostitutes, clinical 11 examination revealed 83% generalized lymphadenopathy and 38% Signs or symptoms suggestive of HIV-like disease. (33). It therefore appears that the natural history and clinical course of HIV-2 infected individuals may vary significantly from that of HIV-1. It is yet to be determined, if the biology of HIV-2 will differ from HIV-1 only in its latency and incubation period. Despite the lack of association of HIV-2 with AIDS or related disease groups it is still possible that this T-lymphotropic retrovirus is capable of inducing disease but perhaps with a long latency and decreased attack rate. The lack of abnormal clinical findings in HIV- 2 infected individuals could be explained by a very recent introduction of this retrovirus into the population. Retrospective studies conducted in populations of Dakar, Senegal in the mid-1970's demonstrate that HIV-2 was present at least 18 years ago. Furthermore, we have found that the age-specific seroprevalence to HIV-2 in seropositive female prostitutes in Dakar increases with age (10). In prostitutes over the age of 50 the HIV-2 seroprevalence rate was close to 100%. This age-specific seroprevalence curve is indicative of an endemic virus present in the population for at least several generations. This is consistent with the relatively high rates of HIV-2 infection found in healthy adult control populations. Therefore, the results of epidemiologic and prospective clinical Studies indicate that HIV-2 is not identical to HIV-1 in pathogenicity as was once reported . Further follow-up studies are necessary to define the natural history and clinica! significance of HIV-2 infection. 12 This will be critical to health policy decisions in many West African countries where HIV-2 infection is common as well as in other parts of the world where this virus is sure to become more widespread. As public health officials worldwide become involved in detection of HIV-2 infected individuals up-to-date information on the biology of HIV-2 and its potential for disease will be important to counseling efforts. HIV-2 Distribution Outside of West Africa HIV-2 infection at the present time appears to be most concentrated in West Africa. Serologic surveys conducted in other African nations such as Zaire, Burundi, Tanzania, Zambia, Kenya, Cameroon, Congo, Equatorial Guinea, TChad, Ethiopia, Angola and Malawi failed to demonstrate evidence of HIV-2 infection (34-37), despite variable levels of HIV-1 infection (Figure 2). In many of these areas, HIV-1 infection and AIDS is quite high (Figure 3), however there were no cases of HIV-2 seropositivity (34). Rare cases of HIV-2 infected individuals have been detected in Europe usually in individuals with connections to West Africa (38- 40). Studies by the French Society of Blood Transfusion surveyed 100,114 blood donors and found .02% HIV-1 and 0% HIV-2. Limited studies conducted in the United States failed to identify HIV-2 in groups of prostitutes, homosexuals and Haitians, although it may be that the risk groups for infection with this virus may differ from that of HIV-1 (41,16). It is likely that increased international travel will 13 no doubt enhance the spread of HIV-2 outside of West Africa. With this recognition, the screening of US blood donors for HIV-2 has been raised. We have recently conducted a study to determine the ability of the HIV-1 screening ELISAs presently used in blood banks. 346 western blot confirmed HIV-2 positive samples from West Africa were tested on Abbott, Genetic Systems and Dupont HIV-1 ELISAs. 82.4%-84.1% of the HIV-2 positive samples were detected by all three of these HIV-1 ELISAs (see below). HIV-2 DETECTED BY HIV-1 ELISAS 120 5 wm, a © 1004 4 3 * = 80 = aS oj 7 6 = lto 8% P. Kanki References (1) Kanki PJ, McLane MF, King NW Jr, Letvin NL, Hunt RD, Sehgal P, Daniel MD, Desrosiers RC, Essex M. Serological identification and characterization of a macaque T- lymphotropic retrovirus closely related to HTLV-II. Science 228:1199-201, 1985. (2) Kanki, P. J., Kurth, R. Becher, W., Dreesman, G., Mclane, M. F. Essex, M. Antibodies to simian T-lymphotropic virus type II in African green monkeys and recognition of STLV-III Viral proteins by AIDS and related sera. Lancet ii, 1330- 1332, 1985. (3) Kanki, P. J., Alroy J., Essex M. Isolation of T-lymphotropic retrovirus related to HTLV-III/LAV from wild-caught African green monkeys. Science 230: 951-954 (1985). (4) Barin F, M'Boup S, Denis F, Kanki P, Allan JS, Lee TH, Essex M. Serological evidence for virus related to simian T- lymphotropic retrovirus III in residents of west Africa. Lancet ii:1387-9, 1985. (5) Kanki PJ, Barin F, M'Boup S, Allan JS, Romet-Lemonne JL, Marlink R, McLane MF, Lee T-H, Arbeille B, Denis F, Essex M. New human T-lymphotropic retrovirus related to simian T-lymphotropic virus type III (STLV-ITYAGM). Science 232:238-43, 1986. (6) Clavel, F., Guetard, D., Brun-Vezinet, F., Chamaret, S., Rey, M.-A., Santos-Ferreira, M.O., Laurent, A.G., Dauguet, C., Katlama, C., Rouzioux, C., Klatzmann, D., Champalimaud, J.L., and Montagnier, L. Isolation of a New Human Retrovirus from West African Patients with AIDS. Science 233:343-346 1986. (7) Biberfeld, G., Brown, F., Esparza, J., Essex, M., Gallo, R.C., Montagnier, L., Najera, R., Risser, R., and Schild, G.: Meeting Report, WHO Working Group on Characterization of HIV-Related, Retroviruses: Criteria for Characterization 16 (8) (9) (10) (11) (12) (13) (14) (15) P. Kanki and Proposal for a Nomenclature System. AIDS: 1:189- . 190, 1987. Kanki, P.J., Essex, M., and Barin, F. Antigenic Relationships Between HTLV-3/LAV, STLV-3, and HTLV-4. In: Vaccines 87, eds. Chanock, R., Brown, F., Lerner, R., and Ginsberg, H., Cold Spring Harbor Press, Cold Spring Harbor, New York ,1987. Albert, J., Bredberg, U.. Chiodi, F., Bottiger, B., Fenyo, E.M., Norrby, E., and Biberfield, G. A New Human Retrovirus Isolate of West African Origin (SBL-6669) and Its Relationship to HTLV-IV, LAV-II, and HTLV-IIIB. AIDS Research and Human Retroviruses 3:3-10, 1987. Kanki, P. J., West African Human Retroviruses related to STLV- HI. AIDS I: 141-145, (1987). Franchini, G., Collalti, E., Arya, S.K., Fenyo, E.M., Biberfeld, G., Zagury, J.F., Kanki, P.J., Wong-Staal, G., and Gallo, R.C. Genetic Analysis of a New Subgroup of Human and Simian T-Lymphotropic Retroviruses: HTLV-IV, LAV-2, SBL6669, and STLV-III acm AIDS Research and Human Retroviruses 3:11-17,1987. Franchini, G., Gurgo, C., Guo, H.G., Gallo, R.C., Collalti, E., Fargnoli, K.A., Hall, L.F., Wong-Stall, F., and Reitz, M.S. Sequence of Simian Immunodeficiency Virus and its Relationship to the Human Immunodeficiency Viruses. Nature. 328:539- 543,1987. Guyader, M., Emerman, M., Sonigo, P., Clavel, F., Montagnier, L., and Alizon, M., Genome Organization and Transactivation of the Human Immunodeficiency Virus Type 2. Nature 326:662-669,1987. Allan, J. S., Kanki, P. J., in preparation. Allan, J. S., Coligan J. E., Lee, T-H, Barin, F., Kanki, P. J., M'Boup, S. Mclane M. F., Groopman, J. E., Essex, M. Immunogenic nature of a pol gene product of HTLV-III/LAV-Blood 69: 331-333, 1987. 17 (16) (17) (18) (19) (20) (21) (22) (23) (24) P. Kanki Kanki, P. J., and Essex M., in preparation. Hirsch, V., Riedel, N., Mullins, J. The genome organization of STLV-3 is similar to that of the AIDS virus except for a truncated transmembrane protein. Cell 49:307-319, 1987. Weber, J. N., Clapham, P. R., Whitby, D., Tedder, R. S., Weiss, RA. Neutralization of African HIV-I and HIV-2; presented at Aids_in Africa, Naples, Italy 1987. Denis, F., Barin, F., Gershey-Damet, G., Rey, J-L., Lhuillier, M., Mounier, M., Leonard, G., Sangare, A., Goudeau, A., M'Boup, S., Essex, M., and Kanki, P. Prevalence of Human T-Lymphotropic Retroviruses Type III (HIV) and Type IV in Ivory Coast. Lancet 1:408-411, 1987. Denis, F., Leonard, G., Sangare, A., Gershey-Damet, G., Rey, J. L., Soro, B., Schmidt, D., Mounier, M., Verdier, M., Baillou, A. and Barin F. Comparison of ten HIV enzyme immunoassays for detection of antibody to HIV-2 in West African sera. J. Clin. Miciobiology, in press. Arya, S.K., Beaver, B., Jagodzinski, L., Ensoli, B., Kanki, P.J., Albert, J., Fenyo, E.-M., Biberfeld, G., Zagury, J.F., Laure, F., Essex, M., Norrby, E., Wong-Staal, F., and Gallo, R.C. New Human and Simian HIV-Related Retroviruses Possess Functional Transactivator (tat) Gene. Nature 328:548- 550, 1987. Clavel, F., Mansinho, K., Chamareét, S., Guetard, D., Favier, V., Nina, J., Santos-Ferreira, M-O., Champalimaud, J-L., and Montagnier, L. Human Immunodeficiency Virus Type 2 Infection Associated with AIDS in West Africa. New Eng. J. Med. 316:1180-1185, 1987. Hahn, B., Kong, L., Lee, S-W, Kumar, P., Taylor, M., Arya, S., Shaw, G. Relation of HTLV-IV to simian and human immunodeficiency associated viruses. Nature 330: 184- 186 1987, Brun-Vezinet, F., Rey, M.A., Katlama, C., Girard, P.M., Roulot, D., Yeni, P., Clavel, F., Alizon, M., Gadelle, S., Madjar, J.J., 18 (25) (26) (27) (28) (29) (30) (31) (32) P. Kanki Harzic, M., Lenoble, L. Lymphadenopathy-associated virus type 2 in AIDS and AIDS-related complex. Lancet 1:128-132, 1987. Kanki, P.J., M'Boup, S., Ricard, D., Barin, F., Denis, F., Boye, C., Sangare, L., Travers, K., Albaum, M., Marlink, R., Romet- Lemonne, J.-L., and Essex, M. Human T-Lymphotropic Virus Type 4 and the Human Immunodeficiency Virus in West Africa. Science 236:827-831, 1987. Denis, F., Barin, F., Gershey-Damet, G., Rey, J-L., Lhuillier, M., Mounier, M., Leonard, G., Sangare, A., Goudeau, A., M'Boup, S., Essex, M., and Kanki, P. Prevalence of Human T-Lymphotropic Retroviruses Type III (HIV) and Type IV in Ivory Coast. Lancet 1:408-411, 1987. M'Boup, S., Summary of presentation for Aids in Africa, Naples, Italy, (1987). Kanki, P. J., M'Boup, S., Barin, F., Denis, F., Marlink, R., Romet- Lemonne, J-l., Essex, M. The biology of HIV-1 and HIV-2 in Africa in Aids in Africa, S. Karger, in press. Quinn, T.C., Mann, J.M., Curran, J.W., and Piot, P.; Aids in Africa: an Epidemiologic Paradigm. Science 234: 955-963, 1986. Rey, M.A., Girard, P.M., Harzic, M., Madjar, J.J., Brun-Vezinet, F., Saimot, A.G. HIV-1 and HIV-2 double infection in French homosexual male with AIDS-related complex (Paris, 1985). Lancet i:388-389, 1987. Marlink, R., Ricard, D., M'Boup, S., Kanki, P., Romet-Lemonne, J- L, N'Doye, I., Diop, K., Simpson, M-A, Greco, F., Chou, M-J, DeGruttola, V., Hseih, C-C, Boye, C., Barin, F., Denis, F., McLane, M-F., and Essex, M. Clinical, Hematological, and Immunological Evaluation of Individuals Exposed to Human Immunodeficiency Virus Type 2 (HIV-2). Aids Research, in press. Kreiss, J.K., Koech, D., Plummer, F.A., Holmes, K.K., Lightfoote, M., Piot; P., Ronald, A.R., Ndinya-Achola, J.0., D'Costa, L.J., Roberts, P., Ngugi, E.N., and Quinn, T.C. AIDS Virus 19 P. Kanki Infection in Nairobi Prostitutes: Spread of the Epidemic to East Africa. N. Engl. J. Med. 314:414-418,1986. (33) Van de Pierre, P., Clumeck, N., Carael, M., Nzabihimana, E., Robert-Guroff, M., De Mol, P., Freyens, P., Butzler, J.-P., Gallo, R.C., and Clumeck, N: Female prostitutes, a risk group for infection by the human T-cell lymphotropic virus type III. Lancet, 1985-II, 524-527,1985. (34) Kanki, P.J., Allan, J., Barin, F., Redfield, R., Clumeck, N., Quinn, T., Mowovindi, F., Thiry, L., Burny, A., Zagury, D., Petat, E., Kocheleff, P., Pascal, K., Lausen, I., Fredericksen, B., Craighead, J., M'Boup, S., Denis, F., Curran, J.W., Mann, J., Francis, H., Albaum, M., Travers, K., McLane, M.F., Lee, T- H., and Essex, M. Absence of Antibodies to HIV-2/HTLV- 4 in Six Central African Nations. AIDS Research and Human Retroviruses. 3 (3):317-322, 1987. (35) Mbhalu, F., Bredberg-Raden, U., Mbena, E., Pallangyo, K., Kiango, J., Mbise, R., Nyamuryekunge, K. and Biberfeld, G. Prevalence of HIV Infection in Healthy Subjects and Groups of Patients in Tanzania. AIDS 1 (4):217-222, 1987. (36) Mbhalu, F., Bredberg-Raden, U., Mbena, E., Pallangyo, K., Kiango, J., Mbise, R., Nyamuryekunge, K. and Biberfeld, G. Prevalence of HIV Infection in Healthy Subjects and Groups of Patients in Tanzania. AIDS 1 (4):217-222, 1987. (37) Gurtler, L., Eberle, J., Deinhardt, F., Liomba, G.N., Ntaba, N.G., Schmidt, A.J; Prevalence of HIV-1 in selected populations and areas of Malawi; presented at Aids in Africa, Naples, Italy, 1987. (38) Couroce, A-M. HIV-2 in blood donors and in different risk groups in France. Lancet i: 1151, 1987. (39) Werner, A., Staszewski, S., Helm, E.B., Stille, W., Weber, K.., Kurth, R. HIV-2 (West Germany, 1984). Lancet i:868-869, 1987. (40) Tedder, R. S., O'Connor, T. HIV-2 in UK. Lancet i, 869, 1987. 20 P. Kanki (41) Schochetman, G., Schable, M.S., Goldstein, L.C., Epstein, J., Zuck, T.F. Screening of U.S. populations for the presence of LAV-2. presented at 3rd International Conference on AIDS, Washington D. C., USA, 1987. 21 STATEMENT OF ALAN WOODS ADMINISTRATOR AGENCY FOR INTERNATIONAL DEVELOPMENT BEFORE THE PRESIDENT'S COMMISSION ON THE HIV EPIDEMIC HEARINGS ON THE HIV PANDEMIC APRIL 19, 1988 Introduction Thank you Mr. Chairman. I am pleased to appear before the President's Commission today to discuss the Agency for International Development's (A.I.D.) policy and program for combatting the HIV epidemic and the potential impact of this pandemic on the economic and social prospects of those developing countries that are severely afflicted, A.I.D. is the United States Government agency charged with implementing all American foreign economic assistance policies and programs in developing countries. Our objective is to promote and assist developing countries to achieve broad-based and sustainable economic growth and to improve the welfare of their people. The Agency's programs have long included measures to address the health and education needs of the citizens of developing countries. The U.S. can be proud to have been associated with some important improvements in health -2- in developing countries, for example the eradication of smallpox, the reduction by one half of infant and child mortality, and increases of 10-20% in life expectancy. Today, we cannot even think in terms of health or development in some developing countries without considering AIDS. The rapid emergence of an HIV pandemic is unprecedented in our lifetimes. It is of global concern, but is particularly severe in a number of less developed countries in which we have foreign assistance programs. These same countries' budgets and human resources are already stretched very thin in the effort to meet the basic needs of their burgeoning populations. A.I.D.'S Approach to the HIV Pandemic The Agency's concern with HIV infection is twofold. First, it is one of the greatest health problems the modern world faces, Second, the spread of AIDS could have serious implications for economic development in some countries. For these reasons, we have taken HIV and its tragic consequences very seriously and will remain committed to fighting it as long as is necessary. We have taken several concrete steps to address the problem directly and to further our understanding of the potential international development and foreign policy consequences of the disease that may affect us all. In FY 1986, A.I.D. made the first donor contribution totalling $2 million to the WHO AIDS programme. In FY 1987 we developed a $17 million program, including a $5 million contribution to the WHO programme as well as the development of a new major Agency AIDS Technical Support Project. The A.I.D. panel which follows will discuss in detail the two major components of the AIDS project, which are referred to as "AIDSTECH" and “AIDSCOM," and other activities we now have available to address AIDS. In FY 1988 we plan to spend $30 million on AIDS, including a contribution of $15 million to the WHO programme. In FY 1989 we will spend over $30 million with @ continued commitment of $15 million to WHO. In addition to the provision of financial and staff support to WHO, we look to the WHO Global Programme on AIDS as the framework within which we carry out our own AIDS activities. A.I.D. Policy In early 1987, A.I.D. issued policy guidance on how we would address AIDS. The key components of our program are: -training on HIV and AIDS for workers involved in health and family planning service delivery and in special HIV prevention programs; -procurement and distribution of condoms to meet additional demand as a result of HIV; -public health education; -epidemiological and behavioral research where such -4- research is not being funded or undertaken by WHO or other USG agencies and national researchers. -operations research to improve our understanding of the most effective sources of information about HIV and the best program interventions in particular settings; -economic research on the longer term development and economic effects of the AIDS epidemic; including the potential impact on health budgets, economic productivity, child survival and other issues. -prevention of blood transmission. International Policy Issues We also have been thinking seriously about the broad international policy issues which AIDS raises for developing countries and indeed for the U.S. We are faced with a wide range of projections about the current level of infection worldwide, a relatively long incubation period, and uncertainties about the proportion of infected individuals who eventually develop clinical AIDS. I cannot, and I do not think any other policy maker today can, provide answers to the unknowns or make reliable future predictions. I can frame some questions and I can tell you what we are doing to get the information we need quickly to make policy decisions, For policy makers considering the issues there are three primary questions: How bad is it? What can we do? How should we do it? -5- In order to answer the first two questions -- how bad is it and what can we do? -- we first need information about the disease itself and its progression. We then have to construct appropriate models with which to make projections. A.I.D. is taking steps to address both the data needs and the model construction. In order to address the question of what we can do, we are also supporting operations research designed to determine the effectivenesss of various intervention strategies to prevent further HIV transmission. The final question is how to do what needs to be done. Coordination between government agencies, international Organizations and the private sector in both developed and developing countries will be critical. The WHO Global Programme on AIDS has the leadership role in addressing the epidemic internationally. This international leadership is critical, and continued U.S. support for this global program will be required. In addition, we must establish appropriate roles and methods of coordination and collaboration within our own government with respect to the international aspects of the disease. A.I.D., the State Department, the Department of Health and Human Services, the U.S. Congress and other interested parties must continue to coordinate our best efforts to fight the unprecedented tragedy with which the HIV pandemic has confronted us all. Coordination with WHO and with other U.S. government agencies and donors will be discussed in more detail by the panel from whom you will hear next. -6§- Social, Economic and Political Issues The social, economic and political implications of high levels of AIDS in some areas form a major set of issues. These include: -Will patterns of migration and population settlements change as a result of varying levels of infection and available health care? -Will economic and/or agricultural productivity decrease as a result of increased death rates? -Will family and social structures change as a result of stress, children left without parents, isolation of individuals or communities? -Will the leadership in high prevalence countries be weakened through death or political difficulties resulting from widespread AIDS-related problems? -Will resources be diverted from other health, education and family planning programs in order to deal with increasing levels of HIV and AIDS? -Will international investment decline in heavily affected countries? -7- Understanding these issues requires not only data and projections about the spread of the disease, but also qualitative analyses of human response to the epidemic. The answers to these questions have implications far beyond health. And they must be handled responsibly lest economic development and foreign policy objectives be jeopardized, Conclusion Preliminary research results and experience in the field have left us encouraged, sobered and challenged all at the same time. The growing willingness of people and governments to talk candidly and responsibly about this very sensitive issue is encouraging. Also encouraging is the consensus that AIDS will not result in negative population growth in the most severely affected countries. However, the implications of the disease for subgroups within the populations of these countries is tragic and sobering. We are challenged by the many unknowns surrounding the disease and the limited number of interventions available to combat it. Finally, in a period of overall budgetary stringency, we are further challenged by the need to ensure that our critical child survival, family planning and education efforts do not lose ground. Statement of W. Bradshaw Langmaid Deputy Assistant Administrator Bureau for Science and Technology Agency for International Development on The HIV Pandemic and A.I.D.: Global Coordination and Commitment before Hearings on the HIV Pandemic The President's Commission on the HIV Epidemic April 19, 1988 The Agency for International Development (A.I.D.) is pleased to have the opportunity to appear before the Commission today and present its acquired immune deficiency syndrome (AIDS) prevention and control activities. I am happy to introduce the other members of the panel. Dr. Jeffrey Harris is the Agency's AIDS Coordinator. Dr. Harris will be describing our major AIDS control activities, in particular our twin technical assistance implementors, AIDSCOM and AIDSTECEH. Dr. Barbara Torrey is Chief of the Center for International Research at the U.S. Bureau of the Census. Dr. Torrey will explain how the Agency is tracking the spread of the human immunodeficiency virus (HIV) and monitoring the effect of AIDS on the economies and societies of developing countries. Dr. Kenneth Bart is the Agency Director for Health. Dr. Bart will describe our program of epidemiologic and operations research, and also A.I.D.'s role as coordinator of international AIDS activities across the U.S. agencies. I chair the Agency's AIDS Working Group, a body created a year ago to coordinate and guide our efforts. Today I will be discussing the coordination between A.I.D. and the World Health Organization's Global Programme on AIDS and also A.I.D.'s budget and prioritization process for providing bilateral assistance. 1 A.I.D. AND WORLD HEALTH ORGANIZATION COORDINATION In February 1987, the World Health Organization undertook a worldwide effort to control the spread of HIV by establishing the World Health Organization Global Programme on AIDS (WHO/GPA). In one year the Global Programme on AIDS has marshalled the support of almost every nation, raised funds, and designed and begun to implement a global AIDS strategy. This strategy requires that a strong national AIDS program be developed in every country. The United States fully and actively supports WHO/GPA. This support is a cornerstone of our assistance policy. In FY 1986, A.I.D. was the first donor to provide financial support to WHO/GPA with a donation of $1 million to WHO/GPA and $1 million to the WHO regional office in Africa. In FY 1987, A.I.D. made a $5 million contribution to WHO/GPA. The U.S. remains the largest contributor to WHO/GPA with a FY 1988 contribution of $15 million. U.S. support for WHO/GPA takes a variety of forms: ° We provide undesignated general budgetary support for the WHO/GPA worldwide program. In FY 1987, the U.S. $5 million contribution represented 20 percent of such general budgetary support. ° We also provide funding for the WHO/GPA country programs. In its 1988 program, the WHO/GPA anticipates $26 million being spent on worldwide activitzes and $40 million being committed to country AIDS activities. In our FY 1988 contribution to WHO, we have’'reserved $5 million as a budgetary contribution for these country activities. oO In FY 1987, we made $3 million in condoms available to WHO/GPA. The countries receiving this support were drawn from the WHO/GPA list of priorities, and the condoms were provided through the WHO/GPA resident representative. ° We have also provided extensive technical expertise to WHO/GPA. Members of our own A.I.D. staff have been secunded to WHO/GPA. Technical experts under our technical assistance contracts, AIDSCOM and AIDSTECH, are being made available on a long-term basis to WHO/GPA in specialized areas. Professional staff members of the AIDSCOM and AIDSTECH contracts work closely with WHO/GPA by providing direct technical support to WHO/GPA staff in the field, and by debriefing with WHO/GPA staff after virtually every A.I.D. 2 field trip. It is possible that in the future some of the AIDSCOM and AIDSTECH resident representatives in the A.I.D. field missions will serve concurrently as WHO/GPA technical advisors. ° At the local level, the day-to-day interaction between mission staff and WHO/GPA officials is close and reinforcing. Many of our ongoing health and population activities work in areas directly affected by the AIDS epidemic and therein become an integral part of the AIDS control effort, although they may not get counted as part of our overall AIDS program. Coordination of all these activities at the field level is accomplished by our missions working with their WHO/GPA counterparts. This coordination is close and continuous. As the worldwide AIDS control effort moves from planning to implementation, coordination will become increasingly important. A.1~.D. BILATERAL ASSISTANCE EFFORTS Clearly, the leadership of the WHO/GPA is of critical importance in the worldwide effort to control AIDS. That is why our policy gives such priority to support for the GPA activities. At the same time we recognize that none of us could afford the luxury of building new institutions to deal with the AIDS problem. What was needed was a process which took the strengths of all collaborators and combined them in a coherent program which provided timely response to the needs of affected countries. From our perspective, we felt there were certain assets which we could contribute as a bilateral donor. Our field mission presence and a worldwide established network of operating health and population programs is a major program implementation resource. Similarly, our capacities in the area of technical assistance and training, again particularly in the areas of health, population and public communications, were felt also to he important assets. Finally, of course, our worldwide system for procurement and distribution of condoms in the developing world is probably unique. For these reasons, it is important that our AIDS program have a major bilateral program component to ensure that these management, implementation, and program resources are available to the worldwide effort. In FY 1987, Administrator McPherson approved an initial program level of $9 million for AIDS projects at A.I.D. As our field missions became involved in the program, these resources grew so that by the end of the year $12 million dollars had been committed to A.I.D.-managed projects and 3 programs. The allocation of these funds is summarized in the attached table. In all, assistance was provided to 30 countries, half of which were in Africa In FY 1988, the Congress appropriated $30 million for AIDS activities in developing countries, of which $15 million is reserved for WHO/GPA and $15 million for bilateral assistance efforts. Of this, $3 million has been allocated to the Africa Bureau, and $2 million to Latin America and the Caribbean. The Office of Population has been provided with $3 million for condom procurement. The balance, $7 million, has been provided to the Office of Health at the Bureau for Science and Technology for its worldwide AIDS control activities. Attached to this statement is a listing of the countries in which we are now working or plan to work during Fy 1988. We all work within resource constraints. In the developing world there are always dollar resource constraints, but frequently of equal importance are the human and managerial resource constraints. As the control and prevention of the spread of AIDS involve issues of particular social, political, and cultural specificity and sensitivity, these limitations become even more important. These realities dictate that we prioritize our efforts. Therefore, we are giving highest priority to those countries: where the infection is already widespread; or which are close to areas of extensive HIV infection; or which have high-risk groups with a high potential for the further spread of HIV. Countries with major urban populations or on major transportation routes between urban populations must be given particular attention. The prevalence of other sexually transmitted diseases is an important cofactor in the spread of HIV and therefore an important proxy for understanding where prevention and public education programs need to be concentrated. All these factors are taken into account in the allocation of our bilateral AIDS control resources. With this by way of background, I would now like to ask Dr. Harris to describe our specific activities in more detail. STATEMENT OF JEFFREY HARRIS AIDS COORDINATOR AGENCY FOR INTERNATIONAL DEVELOPMENT BEFORE THE PRESIDENT'S COMMISSION ON THE HIV EPIDEMIC HEARINGS ON THE HIV PANDEMIC APRIL 19, 1988 Good Afternoon. I will describe the Agency's AIDS prevention and control program. Our AIDS prevention and control activities can be divided into two areas: first, those which are aimed specifically at AIDS prevention and control; and second, those which have been added, in light of the AIDS epidemic, to our ongoing health, population, and nutrition programs. AIDS-Specific Assistance During 1987 and 1988, A.I.D.'s Offices of Health, Education, and Population and our Regional Bureaus have jointly developed an umbrella AIDS prevention and control assistance project, the AIDS Technical Support Project. This project has two major components, dubbed AIDSCOM and AIDSTECH. Both began operations in October 1987, with largely distinct areas of expertise and responsibility. Both provide short-term consultation as well as long-term resident advisors. AIDSCOM, the public health communications component, was awarded to the Academy for Educational Development, which has offices in New York City and Washington, D.C. Major subcontractors are Johns Hopkins University, the Annenberg School of Communications at the University of Pennsylvania, and the firm of Doremus, Porter, Novelli. Funded by a 5-year, $15.4 million contract, AIDSCOM will use lessons learned from social marketing and behavior analysis to help national] AIDS committees develop effective models of public education, social mobilization, and counseling for AIDS prevention. Operations research will focus on questions such as: What risk behaviors are most susceptible to communication interventions? How can marketing approaches be used in both public and private sector programs? How can community mobilization be focused to support specific risk behavior reduction? How can short-term behavior change be sustained through counseling, support, and incentives? AIDSTECH, the biomedical component, is being executed by Family Health International, located in North Carolina. Authorized for five years and $28 million, AIDSTECH is providing technical assistance in epidemiological surveillance, blood transfusion screening, treatment of sexvally transmitted diseases, and the logistics of condom distribution. In order to ensure that interventions are sustainable and cost-effective, a project health economist provides consultation on financing of AIDS health care and prevention. AIDSTECH is also responsible for AIDS prevention-related training and dissemination of technical 2 information. As part of its training effort, it will support travel by over 60 participants to the Fourth International AIDS Conference in Stockholm this summer. Most of these scientists and public health practitioners will either serve as chairpersons of conference sessions or present papers on their work. As of April 1988, the AIDSCOM and AIDSTECH projects have provided short-term technical assistance to 23 countries. Countries which have received needs assessment visits and/or completed technical assistance are: 1) in Africa -- Burkina Faso, Burundi, Ghana, Ivory Coast, Kenya, Malawi, Nigeria, Rwanda, Senegal, Tanzania, Uganda, and Zaire; 2) in Asia and the Near East -- Indonesia, the Philippines, and Thailand; and 3) in Latin America and the Caribbean -- the Dominican Republic, the Eastern Caribbean, Ecuador, El Salvador, Guatemala, Haiti, Jamaica, and Mexico. In addition, AIDSCOM and AIDSTECH are now organizing long-term projects in many countries. Through AIDSCOM and AIDSTECH, the umbrella AIDS project also plans to provide support to private voluntary organizations (PVOs}. Recognizing the rapid response capacity of PVOs and their unique ability to carry out projects in the important non- governmental sector, A.I.D. is seeking to stimulate and support PVO-led AIDS prevention and control activities. In December 1987, AIDSCOM and AIDSTECH conducted a PVO workshop on AIDS program implementation. As a follow-up to this workshop, AIDSTECH has allocated $500,000 of FY 88 funds to a PVO subgrant program. This competitive program will provide up to $50,000 subgrants. Criteria for selection will include likely effectiveness in transmission prevention and the degree to which are other matching funds are available. Another major AIDS-specific activity is provision of condoms aimed at AIDS prevention. A.I.D. has an excellent condom procurement and distribution system as part of its family planning program. Rather than duplicate this system for AIDS, we have simply added extra funds. To date, through this system, we have shipped AIDS condoms to 21 countries. A large proportion of these have been shipped specifically at WHO request. This distribution has alleviated shortages which had driven condom prices as high as $1 apiece on black markets. Non-AIDS~Specific Assistance The AIDS pandemic is clearly a new problem for a development agency like A.I.D. and has resulted in new programs. The pandemic also has implications for our other health, population, and nutrition programs, some of which are threatened by AIDS and some of which could serve as excellent channels for communicating AIDS prevention messages. 3 Our immunization programs have been threatened by the pandemic. While more and more data indicate that needles and syringes for immunization are very unlikely to transmit HIV, the theoretical possibility remains. To eliminate this possibility, A.I.D. is working closely with WHO and UNICEF to provide the needed supplies and training to ensure that immunizations are given only with sterile needles and syringes. Our family planning programs provide an excellent opportunity to spread AIDS prevention messages at little extra cost. In recognition of this, our Office of Population has supported a variety of AIDS activities through its ongoing projects. These have included operations research to assess the interaction of family planning and AIDS prevention activities, and numerous training and educational activities. The Office of Population has also funded the publication of a special issue of its respected Population Reports on "AIDS - A Public Health Crisis" and distributed over 200,000 copies worldwide in English, Spanish, and French editions. The report includes information on the steps that health and family planning workers can take to prevent the spread of HIV infection. Almost all of the technical assistance activities I have described thus far have been part of a Washington-managed worldwide support project, even though the activities are carried out in specific developing countries in conjunction with our country-to-country, or bilateral, assistance efforts. This is unusual for A.1I.D., an agency which is decentralized to allow country-specific tailoring of activity in accordance with needs. We have used this mechanism thus far because AIDS is new, our experience is small, and we needed to create a worldwide response capacity. It was also essential that, as experience is gained, the benefits of this experience be made available as rapidly as possible. As our country missions build program capacity, we will rely more and more on that capacity. In fact, decentralization is already underway. Several of our missions have already mounted their own AIDS-specific activities and added AIDS-related activities to ongoing projects. Many are also allocating local currencies to augment AIDSCOM or AIDSTECH activities. We expect this process to continue. Another step in this direction is planning by our Bureau for Africa of the HIV/AIDS Prevention in Africa Project, which will provide rapid and flexible assistance to African field missions for needs which could not be otherwise met. TESTIMONY BEFORE THE PRESIDENT'S COMMISSION ON AIDS APRIL 19, 1988 BARBARA BOYLE TORREY CHIEF, CENTER FOR INTERNATIONAL RESEARCH U.S. BUREAU OF THE CENSUS WASHINGTON, D.C. 20233 The AIDS epidemic in developing countries differs considerably from the epidemic in the United States. Its natural history also is different from the many other epidemics in the developing world. Therefore, the Agency for International Development (A.I.D.) is sponsoring the Center for International Research (CIR) at the U.S. Bureau of the Census and the Population Council to describe accurately the unique epidemiology of this disease in developing countries and estimate its future population impacts. Reliable information on AIDS overseas will be essential to helping A.I.D. allocate its own scarce resources efficiently and to assisting governments of developing countries combat the disease more effectively. There are four steps in the development of the information needed: AIDS/HIV Impact Data Base. CIR is systematically collecting and coding all data that now appear in medical journals, international conferences, in other data bases, and other sources of data. The data will be coded for sample size, age-sex characteristics, geographic distinctions, and reliability. (Attachment 1 provides an example of the program and the data output.) The data are available monthly on diskette, in hard copy, and in any other form A.I.D. wants it. Both the World Health Organization (WHO) and the Centers for Disease Control (CDC) have proposed coordinating this data base with their own data gathering efforts. Development of a Transmission Model of AIDS. The transmission model will be developed by John Bongaarts at the Population Council in New York. This mode] will describe how the disease spreads and estimate the incidence and prevalence of AIDS, as well as mortality rates from HIV infection rates. The adult population will be stratified according to type of sexual exposure; and other sources of infection, such as in utero and infected blood will be taken into account. This model of the transmission of HIV infection and subsequent development of ADS will project the potential impact of AIDS on a national basis for each country. Urban-Rural Projection Model. The principal way infection is spread to remote rural areas is through the migration of infected persons from high prevalence to low prevalence areas. This geographic spread of HIV infection cannot be accurately modeled by a single-region projection model. CIR will integrate the Bongaarts' model of the transmission of HIV with an urban-rural demographic projection model. (Attachment 2 includes more specifications of the model.) The population projections will form the foundation for the examination of the impact of the spread of AIDS on the population. Country Reports on the Population Impact of AIDS. Analytical reports will be prepared for specific countries based on the data collected in the data base and the estimates of future population impacts from the modeling efforts. The reports will estimate the impact of AIDS on select population subgroups and on each geographic region; preliminary estimates of impacts on education groups and work force in urban and rural areas will be made and will be illustrated with maps and charts to provide a concise visual image of the impact. Preliminary Data Findings from the AIDS/HIV Data Base and Some of its Implications The work on the data base has just begun; we have concentrated on entering the most recent data for Africa. (Attachment 3 is a paper based on the present data in the data base.) Almost no data from the rest of the world has yet been entered. But, what data we do have suggests that in Africa: -- the level of HIV seroprevalence rates is not always related to the number of AIDS incidence cases. Uganda, which is reporting many more cases of AIDS per 100,000 population than Zambia, has lower HIV seroprevalence rates for healthy adults in Kampala than in Lusaka. The reporting of AIDS cases varies so widely that HIV seroprevalence estimates may be a better indicator of the future disease impacts. -- HIV seroprevalence is higher in major urban areas than in rural areas. But the seroprevalence rates in some rural areas, such as in Rwanda and Central African Republic, are higher than the urban areas of other nearby countries, such as Cameroon and Gabon. The data also show high HIV seroprevalence along the truck routes that cross national boundaries. -- HIV seroprevalence rates are consistently higher for prostitutes, barmaids, and STD patients than they are for pregnant women or blood donors. They are higher for single blood donors than for married blood ‘donors. There is a possible indication that the small sample sizes of some of the HIV surveys may be overestimating the seroprevalence rates. As larger and better surveys are done, the reliability of the estimates of seroprevalence will increase. Because the AIDS epidemic affects young, sexually-active adults in urban areas _disproportionately, its social and economic impacts will be concentrated in: -- urban areas, which are the centers of the modern economy, much more than the rural areas; -- better-educated people, who gravitated to urban areas, more than the less- educated people in the rural areas; and -~- the adult labor force who are the major source of support for the young and the old in all societies. AIDS is becoming the leading cause of death among adults in Africa. If the HIV seroprevalence rate were to reach 10 percent nationwide in African countries (this in much higher than any country in Africa is now), the population growth rate would be reduced from an average of 3 percent per year to about 2 percent. Africa would still be the fastest growing region of the world. The problem of the AIDS epidemic and population growth will coexist rather than substitute for each other. We need to know much more about the distribution of this disease both geographically and among population groups. We need to know how it is transmitted in order to anticipate what its future impacts are likely to be. While individually each piece of information may be of limited utility for national assessment purposes, together they form a composite assessment of local situations. This makes the data base and modeling efforts an essential part of combating this disease and ultimately containing it. STATEMENT OF KENNETH BART AGENCY DIRECTOR FOR HEALTH AGENCY FOR INTERNATIONAL DEVELOPMENT BEFORE | THE PRESIDENT'S COMMISSION ON THE HIV EPIDEMIC HEARINGS ON THE HIV PANDEMIC APRIL 19, 1988 I would like to end the formal panel presentation by A.I.D. with a discussion of Agency for International Development activities in two important areas: coordination of U.S. Government activities in the international AIDS arena, and research efforts. Coordination of U.S. Government International Activities Because the Agency for International Development is the principal foreign affairs agency concerned with development assistance, it is uniquely placed to facilitate the coordination of the Government's international AIDS efforts. Congress has also recognized this uniqueness and has exhorted the Agency to carry out this role. As you hear from other agencies, there is substantial international involvement in the effort to control and prevent AIDS globally. Through the Federal Coordinating Committee (FCC) on Information, Education, and Risk Reduction, A.I.D. has taken the lead to stimulate the coordination of informational activities. The members, including representatives of the Departments of State, Defense, and Health and Human Services, have collected data on all their international activities in a common format, presented their programs, exchanged summaries of country-specific activities, and discussed various alternative mechanisms for coordination of activities. These discussions are part of the continuing work of the FCC. As a result, the importance of ensuring the full sharing of information about international activities has become a mechanism not only for communication of information about activities but has become an opportunity to foster a high level of interagency coordination and collaboration. Research I would like to move now to A.I.D.'s research effort. Research is not the principal mandate of the Agency. As you have heard from other speakers, very substantial portions of the Department of Health and Human Services' budget are directed toward basic research for drug and vaccine development and understanding the immunopathology of the virus and its interaction with the human host. The major concern: of the Agency is the development and application of control and prevention tools for developing countries that will both assist in the control of the epidemic and blunt the impact of the epidemic on development. The variations in the epidemiology of AIDS from developed to developing countries necessitate carrying out a specific kind of 2 research, i.e., intervention-oriented research, relevant to AIDS control and prevention programs and to the Agency's other health, population, and nutrition programs in developing countries. Intervention-oriented research can be considered as three kinds of activities: (1) epidemiologic research, (2) operations research, and (3) development and field testing of new prevention technologies. Major areas within epidemiologic research include surveillance and studies of modes of HIV transmission. (I hesitate calling surveillance a type of research because it is one of the basic tools of public health practice.) The importance of basic surveillance should be highlighted, however. We do not know where this epidemic is going. In Africa, how large is the population whose behaviors make them "susceptible" to HIV? Will the epidemic soon “level off" or will it spread slowly but surely throughout the sexually active populations of all countries? We are developing models of the epidemic to estimate the course of the epidemic globally. However, careful continuous country surveillance of easily accessible, high-risk sentinel populations, such as pregnant women or sexually transmitted disease patients is required to actually know and understand the dynamics of the movement of this devastating epidemic. Our AIDSTECH project, using methodology developed by the WHO, is now working with the governments of Burundi, the Dominican Republic, and the Philippines to implement sentinel surveillance, and with other countries soon. We must know more about modes of transmission that may be unique to developing countries, particularly because some of the possible co-factors are key elements of our other health, population, and nutrition programs. What role, if any, do breastfeeding and various contraceptives play in the transmission of HIV? How much will treatment of other sexually transmitted diseases slow HIV transmission? As part of the effort to get the answers to these questions, we are working with the Institute of Medicine and with other research funding organizations, such as the WHO, the World Bank, CDC, NIH, the Department of Defense, private foundations and universities to discuss the establishment of an epidemiologic research network within developing countries which will both investigate issues such as these and enhance the capabilities of these country institutions. The second area of intervention-oriented research is operations research, aimed at assessing the impact of intervention programs, and improving the Agency's operations. What are the high-risk behaviors in a particular country or culture? Which are most amenable +o change? What are the messages that must be conveyed to peoples to stimulate their modifying their behaviors? What means of delivery should be used to send these messages to maximize their potential for change? AIDSCOM is now working with 3 the Dominican Republic's national AIDS committee and likely other countries soon to implement behavior change programs and answer these questions. Operations research also seeks to lower costs. For example, it is possible that we can carry out blood transfusion screening in low-prevalence countries more cheaply if we first pool samples from individual specimens and then, if the pool is positive, test individually specimens from those pools that are positive. AIDSTECH is working closely with the Pan American Health Organization to test this pooling technique in several Latin American countries. The third area of research is development and field testing of new prevention technologies. We seek to serve a catalytic role to complement the activities of private industry. For example, A.I.D. is conducting a trial of five rapid, simple HIV antibody tests. Such tests, which require no electronic equipment, are essential for blood transfusion screening in developing communities, where formal blood banking does not occur, blood is transfused almost immediately from the donor to the recipient, and electricity is unstable or unreliable. Another exciting example is our new non-reusable syringe, a technology with implications that reach far beyond AIDS. A small, inexpensive metal spur was developed that can be retro- fitted on to existing disposable syringes to ensure they won't be reused. Our immunization program has sought such a device for years to prevent hepatitis B transmission. The AIDS epidemic has given it to us. We anticipate beginning field testing within the next two months. This design is being adopted by HHS through the NIDA program for domestic use. As the last speaker in this panel, I would like to review. The Administrator stated clearly that we view the global AIDS epidemic as a threat to development. A.I.D. is working to monitor and project the impact of the pandemic. A.I.D. has mounted a program which aims to control the spread of AIDS and thereby blunt that impact. The centerpiece of our program is our support of the WHO Global Programme on AIDS in its international leadership role. We have also created our own implementation projects which coordinate their efforts through developing country national AIDS Committees, under WHO leadership. We have accepted the responsibility to coordinate the international efforts of other U.S. government agencies. This coordination will be most important in the area of research. In this area, we have limited ourselves to the intervention-oriented research which is directly relevant to our programs and unlikely to be supported by others. 4 Thank you for having given us this opportunity to present what we are doing. The panel and I would be happy to answer any questions you may have. no 2 per ob oe oe STATEMENT ON RESPONSES TO THE EPIDEMIC BY THE PRIVATE SECTOR: PRIVATE VOLUNTARY ORGANIZATIONS FOR THE PRESIDENT'S COMMISSION ON THE HUMAN IMMUNODEFICIENCY VIRUS EPIDEMIC Lewellys F. Barker, M.D. Chief Medical Officer American Red Cross and President International Society of Blood Transfusion April, 19, 1988 Washington, DC Dr. Walsh and members of the President's Commission on the Human Immunodeficiency Virus Epidemic, thank you for the invitation to testify today. My name is Dr. Lewellys Barker. I am Chief Medical Officer for the American Red Cross, responsible for all biomedical services including blood services and transplantation services, and I have served as an advisor to the League of Red Cross and Red Crescent Societies’ Blood Program for the past ten years. I am also a member of the World Health Organization's Expert Committee on Viral Diseases and President of the International Society of Blood Transfusion, which is composed of approximately 1500 individual and institutional members from over eighty countries and including the majority of experts in blood transfusion around the world. As the Commission has previously heard, the American Red Cross has been to the forefront of actions to protect our nation's blood supply from contamination with the AIDS virus, starting with donor education activities over five years ago and universal donor testing three years ago. The American Red Cross also took very early leadership in the field of public education about AIDS when it initiated a program in 1985 with goals to (1) provide the public with reliable, factual information about AIDS, (2) address and correct myths and misinformation about AIDS, and (3) help slow the spread of the AIDS epidemic. This public education program has been disseminated by volunteers in Red Cross chapters throughout the country. Our education efforts are especially targeted to reach young people, minorities and people in the worksite -- fellow employees and employers. Although it is hard to be precise, we conservatively estimate that our public education program has reached well over 50 million people. The American Red Cross has also been addressing the global AIDS epidemic through its support of and work as a member of the League of Red Cross and Red Crescent Societies, which has its headquarters in Geneva. THE WORK OF THE RED CROSS IN DEVELOPING COUNTRIES The League of Red Cross and Red Crescent Societies (LRCRCS) is an international federation of 145 national societies of which over 136 actively promote voluntary, non-remunerated blood donation as part of their humanitarian purpose. Twenty four of these member societies maintain total responsibility for their country's national blood programs. Examples of Red Cross national blood programs include the Canadian, Finnish, Swiss, Dutch, Belgian, Japanese and Australian Red Cross. Six Red Cross societies have major but less than total responsibility; thirty six operate one or more blood centers in their country; and eighty, or the majority, are involved in some voluntary blood donor recruitment activity. About thirty percent of the world's blood for transfusion is collected by Red Cross and Red Crescent Societies. Most industrialized countries and a minority of developing countries have national blood transfusion services which: serve the needs of their hospital patients. In many developing countries, however, it is a matter of formidable difficulty to achieve this level of service because of lack of organization and lack of operating funds. As described in the attached statement of purpose (Attachment I), the League's blood program can be summarized as: promoting voluntary, non-remunerated blood donation; providing an information clearinghouse; assisting in blood transfusion development projects; and maintaining collaborative relationships with other international organizations concerned with blood transfusion. Underlying these functions is the principle of working through the national societies in each country and providing the opportunity among national societies for those with the technical, professional and financial resources to support their sister societies. All of these purposes, which were designed before the AIDS epidemic was known, have importance in the struggle to control the spread of HIV. Examples of Red Cross Societies supporting blood transfusion development activities in developing countries include the Belgian and Norwegian Red Cross in Rwanda; the German FRG Red Cross in Uganda; Finnish Red Cross in Ethiopia and Somalia. -The American Red Cross, Nordic Red Cross and the League have provided videos and 4 information packages to be made available for all sister societies. Examples of Red Cross societies providing support for development of anti-HIV screening programs in third world countries include [although this is an incomplete listing, at this time]: Norway, Sweden, Finland, Denmark, the Netherlands, Belgium, the Federal Republic of Germany, Austria, Switzerland, France, UK, Canada, USA, Japan and Australia. The American Red Cross has assisted the Colombian Red Cross with their HIV testing guidelines; the Costa Rica Society is particularly interested in community education materials; the Paraguay Society requested the provision of a testing equipment; and recently since the Mexican government decided to designate their national blood program as the total responsibility of the Mexican Red Cross, we have provided assistance to this greatly expanded Red Cross effort. The majority of our further support has been the provision of AIDS community education materials to approximately fifty national societies in the Americas and English-speaking Africa. WORK OF RED CROSS IN. COORDINATING PROGRAMS WITH OTHER SOCIETIES AND HOST COUNTRY ORGANIZATIONS A significant portion of the Red Cross movement involves the coordination of member societies, of facilitating joint meetings and conferences, and of building consensus and the joint implementation of global coordinated programs. Since June 1987, the League has sponsored six conferences on AIDS for the Western European Societies in Brussels, in Benin and Zimbabwe, Africa; in San Juan, London and in Warsaw. With specific regard to AIDS, the League Secretariat has three strategies: assisting the cooperation between Red Cross and Red Crescent Societies; providing an information Clearinghouse on needs; and developing documents to support AIDS community education. A November 1987 meeting of the League General Assembly passed a resolution that clarified the need for societies to prevent oppression and discrimination against and to offer humanitarian support to people who are HIV carriers, people with AIDS and their families (Attachment II). A meeting of East European Red Cross Societies in Warsaw, acknowledged their involvement in addition to education for prevention of HIV spread and assistance to HIV-positive people, to taking an active stand on human rights and legal issues. The main achievements during 1987 included: - Cooperation and coordination with the World Health organization and other intergovernmental and non-governmental organizations; - Development of policies and strategies (synthesised 6 in the Draft Resolution) ; . Development of "Basic Messages" about AIDS which National Societies can adapt as necessary and include in existing training programmes; . Organization of four workshops (two in Europe and two in Africa) to inform National Societies about "recent developments" and facilitate the exchange of experiences and ideas; . Collaboration with the Nordic and European Task Forces on AIDS; . Collation and dissemination of relevant information materials -- pamphlets, posters, and videos -- and the production of an AIDS information Kit and a regular AIDS update; . Exchange of information about Red Cross/Red Crescent involvement with the AIDS pandemic between National Societies and with other interested groups and organizations; . Development of appropriate technical support for National Societies, with particular reference to blood transfusion services and laboratory screening; . Development of discussion papers on the impact of AIDS on Human Rights issues (a special study carried out by the Henry Dunant Institute). During 1988-89, it is anticipated that the League Secretariat will pursue an active coordinating role within the Federation and ensure effective cooperation with relevant 7 intergovernmental (particularly WHO) and non-governmental organizations. It will continue to facilitate the flow of information to and between National Societies, work towards ensuring continuity of messages within the Federation and assist, as required, with the provision of technical support for the development, implementation and evaluation of appropriate policies and strategies. An essential responsibility of the League's Blood Program is our coordination with WHO, with ISBT and other organizations, and particularly in the matter of AIDS. In that regard, I wish now to focus on a recent and building consortium - the Global Blood Safety Initiative; this is a consortium which involves the World Health Organization League of Red Cross and Red Crescent Societies, the International Society of Blood Transfusion, and the United Nations Development Program (see Attachment III). This joint effort is by far the most important development toward the global control of transfusion associated HIV infection. This is a major coordinated step toward a worldwide effort to safeguard blood from contamination by the AIDS virus and other diseases. It is not only a needed opportunity to work together, but it also enhances the possibility of attracting financial support from private sector groups as well as from traditional supporters of health issues. A major international conference sponsored by the League and planned for this spring will provide the opportunity to bring together all interested groups to help in this consortiun. Recently League activities include the development of guidelines on specific subjects such as meeting the blood needs of expatriates and League delegates to the field, alternative methods for treating acute blood loss, and the prevention of HIV spread by blood transfusion, all of which are undergoing the WHO expert Committee and League review processes. In closing, what has been in the past and presumably will continue to be a benefit of the Red Cross movement and specifically in response to the AIDS pandemic, ....are three characteristics of our role. The Red Cross volunteer spirit in responding to emergencies and its grassroots tie to the people in their communities in each country; our basic principles require humanitarianism, impartiality and neutrality; and our intention to collaborate with other major international organizations is demonstrated in the "Global Blood Safety Initiative." - Anima African Medical & Research Foundation 4 ~SA 420 Lexington Avenue * New York, N.Y. 10170 « (212) 986-1835 AIDS IN AFRICA: A PVO RESPONSE TESTIMONY before the President's Commission on AIDS 19 April 1988 Michael H. Alderman. M.D. Chairman AMREF/USA David Nyamwaya, Ph.D Director, Health Behavior and Education Department AMREF Mr. Chairman, members of the Commission, I am Dr. Michael Alderman, Chairman of the Board of the African Medical & Research Foundation (AMREF/USA). I also serve as Chairman of the Departments of Epidemiology and Social Medicine at Albert Einstein College of Medicine and Montefiore Hospital. My collegue is Dr. David Nyamwaya, Director of AMREF's Health Behavior and Education Department. Dr. Nyamwaya is based at our operational headquarters in Kenya. This testimony will present an overview of the AIDS crises in Africa and describe a private voluntary organization's (PVO) potential to assist in addressing the crises. I would first like to briefly identify AMREF and what it does, the current status of AIDS in Africa as we see it, as well as the political ramifications of the epidemic. This will be followed with specific references to the experiences and qualifications needed by PVOs to effectively help in curbing transmission. In particular, AMREF's AIDS programs over the past eighteen months will be reviewed along with specific plans for the future. I will conclude with some general comments on the characteristics and capabilities needed if PVOs are to mount an effective response to the AIDS problem. AMREF - THE BACKGROUND: AMREF is a private voluntary organization that was founded in the United States in 1957. With its field headquarters in Nairobi, Kenya, AMREF has been working for over 30 years to improve the health of the rural poor in East Africa. AMREF's field staff today numbers more than 600, of whom 93% are African. Over 40 distinct projects are being carried out in -2- the areas of public health, health training, clinical services, research, and health learning materials development. AMREF Currently has activities in Kenya, Uganda, Sudan, Somalia and Tanzania. In the past, activities have been undertaken in Ethiopia, Zambia, Zimbabwe, Botswana, Lesotho, Malawi, and Zanzibar. Funding is generated from both the private and public sectors. Besides USAID, many other government and international donor agencies provide support. These include the governments of Kenya, Tanzania, the Netherlands, Germany, Sweden, Canada, Denmark, United Kingdom, Norway, UNICEF, UNDP, World Bank, and the European Economic Community. AMREF is the only non-sectarian, private voluntary organization that receives direct cash grants annually from the Ministries of Health in Kenya and Tanzania. Private sector support comes from major foundations such as Carnegie, Ford, Pew, and William Penn, from corporations, and from the general public. One important factor which distinguishes AMREF from other PvVOs is its firm roots in the field. Rather than develop a large institutional base in New York, AMREF established its technical Support capabilities in East Africa. This has resulted in AMREF being viewed by governments, UN agencies, and non-governmental organizations as a non-political, internationally sponsored regional resource. It is a position which permits and encourages collaboration and communication across national boundaries. Perhaps AMREF"s greatest strength lies in its health education programs. A whole range of outreach, regional training, materials production, and clinical programs keep AMREF in touch with literally -~ 3- thousands of health workers. In addition, AMREF has the largest two-way radio system in Africa, linking remote health centers to Nairobi headquarters. AMREF feels that 1ts success in carrying out rural health programs can be attributed not only to its regional presence in East Africa but also to the following: insistence on being involved in the design stage of any project it will later help implement; working closely with Ministries of Health and other agencies; remaining flexible and low-cost in approach; advocating a balanced health program incorporating clinical services with community healt: training and preventive health; utilizing modern communication and light aircraft to serve remote areas of East Africa. AMREF is organized into five departments: Community Health, Clinical Services, Training, Health Behavior and Education, and Health Planning. There are special units for Evaluation and Operations Research, Family Planning, Nutrition, Environmental Health Support, Continuing Education, Malaria, Health Learning Materials, Distance Teaching and Teacher Training. Projects and consultancies which require work of staff from several departments and units can draw upon the full range of technical, administrative and financial resources within AMREF. To provide an example of AMREF's comprehensive approach, I would like to refer to our community based health care project being carried out in the Kibwezi area of Kenya. Kibwezi's population is approximately 150,000. Many are migrants who moved from other parts of Kenya during the past 20 years. With few health facilities and practically no services available, AMREF cooperated with the - | - Ministry of Health and the Swiss Government in building a health center to serve as focal point for a community based project. With a grant from USAID, over 200 village selected primary health care workers have been trained with the health center serving as referral point. A nutrition rehabilition program was incorporated into the Kibwezi scheme with assistance from the William Penn Foundation. Family planning interventions have included the training of traditional birth attendants and local shopkeepers as motivators. A water development component was integrated into the overall program with help from AMREF's Environmental Health Unit. A recent child survival grant has allowed for intensive immunization and ORT activities. With this brief background on AMREF, let us now examine the AIDS crises in Africa. AIDS IN AFRICA: It is estimated that two-three million people in Africa are carrying the AIDS virus and conservative figures place deaths since the epidemic began at 50,000. Privately, it has been stated that deaths might be as high as several hundred thousand. Current projections point out that between 10 and 30 percent of the people exposed to the virus can be expected to develop the disease within 5, and up to 50% in 7 to 8 years. This could mean in the near future, 1.5 million more persons with AIDS based on existing infections alone. During the past year, virtually every African country reported AIDS to the World Health Organization (WHO). In 1987, 37 African nations reported 8,652 cases. AIDS is endemic in much of Central and East Africa. Evidence from studies done in Zaire, Rwanda, Burundi, Tanzania, Uganda, and ~5 - Kenya prove the virus has already infected substantial segments of the young adult population in these countries and there are a growing number of cases who have developed AIDS. The prevalence of infection among women of childbearing age presents a potentially devastating set of problems. Four through 15% of adult women in some endemic areas are believed to be positive. Hospital studies in a number of the above countries are showing that in some cases, 50% of the infants born to infected mothers are themselves infected with the HIV virus. It does not require much imagination to project a vast pool of orphaned children, many of whom will themselves face a bleak future. The distribution of AIDS cases reflects the prevalence of infection in these areas but is, in itself, only the tip of the iceberg. It is assumed that there are 50-100 infected individuals for each clinical case. This large pool of unidentified but infected men and women represents the greatest hazard for transmission and spread of the epidemic. The pattern of AIDS cases differ somewhat from country to country, but there is an overall picture that is consistent in its most important features. Specifically, AIDS in Africa is best understood as a sexually transmitted disease. While the experience in the USA and Europe is that AIDS began among homosexual and I.V. drug abusers, these groups are not significant factors in Africa. -Rather, the prevalence and distribution of AIDS cases in Africa suggest widespread, bi-directional heterosexual transmisson as the principle route of spread of this infection. _ Cases are divided equally betwee: male and female. Incidence ~6- peaks in the sexually active years and retrospective studies of heterosexual contacts of AIDS victims reveal high rates of infection. In addition, high prevalence rates have been found among prostitutes in Kenya, Uganda and Zaire. In Kenya, prospective studies show these rates are rising rapidly. The speedy transmission of the AIDS virus can be attributed to frequent, multi-partner heterosexual activity. The high incidence of other sexually transmitted diseases in certain African countries is also a consideration in the transmission of AIDS. Additional factors seem to play an important role in this epidemic. As many as 10% of blood donors have been found positive in endemic areas and, given practices of frequent transfusion, this forms another important route of transmission of the infection. In Kampala, the capital of Uganda, 11% of donor blood is sero-positive. The high rate of infection combined with the medical practice of ordering frequent blood transfusions in East Africa can be identified as important elements in the spread of this infection. Medical injections with inadequately sterilized needles seem likely to be another significant means of spread. Indeed, studies show higher prevalence of infection among those with histories of large numbers of injections. In this regard, there is definite concern for child immunization programs in Africa. WHO, USAID, Britain's ODA, and other donor agencies have been promoting campaigns against measles, tetanus, whooping cough, and other childhood diseases. Vaccines normally stimulate the body's defense system to produce antibodies against the target disease. Children, shose immune systems can be broken down by AIDS, may be unable to - 7 - produce such antibodies. Moreover, the effect of immune stimulation among HIV infected youngsters in not yet well understood but may, of course, be dangerous. AIDS IN AFRICA - A SENSITIVE ISSUE: In a number of African countries, there is great concern over certain issues associated with the AIDS epidemic. Two in particular have received widespread attention. These are (1) arguments over the origins of the disease and (2) unauthorized publication of AIDS research studies conducted in Africa by non-Africans. Particularly in poorer countries with heavy dependence on trade and tourism, there must be a recognition of the sensitivities and perceptions of governments and the public. Just as in the U.S., there is also political reality to AIDS in Africa. In order for a PVO or any other agency to successfully undertake AIDS programs in Africa, local concerns must be a number one priority. In the countries where AMREF is active, namely Kenya, Tanzania, and Uganda, there has been a change in the AIDS political climate over the last few months. National AIDS Committees have been established. They are defining the problem and developing Strategies to curb transmission. There is greater recognition of the potential magnitude of the problem and a commitment to seeking resources, both human and financial, to assist in curbing transmission. These developments are, however, progressing at different speeds in the various countries. In order to provide effective assistance, an organization must be acutely aware of sensitivities and understand h.w to cperate culturally. By necessity, successful voluntary aget.:es have had such characteristics. PVOS - A POTENTIAL AIDS RESOURCE: A limited number of private voluntary organizations have the potential to be valuable resources in the struggle against AIDS. For a PVO to have a role, a number of factors must be considered. An agency must have (a) a proven track record in the countries where assistance is needed (b) previous experience in the health sector (c) community based programs (d) an integrated infrastructure to support such programs (e) indigenous staff (f) linkages to local organizations (g) the ability to work at a national level. We feel that the above will be used as criteria by African governments in identifying organizations that can be helpful and by donor agencies in determining which PVOs to fund. There are PVOs which have 25 or more years of experience working in countries seriously impacted by the AIDS crises. Some of them have been implementing health programs involving both direct delivery of services as well as health education and training. In Africa, the voluntary agencies have tended to focus their programs on the rural areas, where over 80% of the continent's population lives. Most importantly, the PVOs have traditionally been community based, with strong ties at the grass roots level. Given the lack of data from rural areas and the need for community based sero-prevalence studies, PVOs might play an important part in determining the epidemiological scope of the AIDS problem. Given the need to deal with AIDS in Africa on African terms, it +S important to note that many PVOs rely on African staff members in the implementation of their projects. They also have strong links -~ 9 - to indigenous non-governmental organizations. Unfortunately, many PVOs have not functioned at national levels. Given the key role being played by the National AIDS Committees, and the political implications of the problem, it is those PVOs experienced in working with central Ministries of Health and Ministries of Education that will be in the best position to respond to requests for assistance. AMREF is an organization that meets all of the criteria described above. For nearly two years now, we have been working with governments in East Africa in responding to the need to curb transmission. AMREF's AIDS programs, while still relatively small, involve a number of our technical departments. Following is a summary of our efforts, a plan of action for the future, and a Jisting of constraints which could limit responses to the problem. AMREF AND AIDS: Few organizations, government or PVO, are better positioned to respond to the AIDS problem in Africa than AMREF. With forty different health projects being implemented in Kenya, Uganda, Tanzania, Sudan, Somalia, and Ethiopia, AMREF has developed expertise in the areas of training health- professionals and paraprofessionals, health education, and materials development. As previously stated, AMREF's programs are carried out in close collaboration with Ministries of Health in all of the above mentioned countries. AMREF has also provided technical assistance to Ministries of Health in southern Africa and has helped governments carry out national level continuing health education programs in Kenya, Uganda, and Tanzania. Representatives from government and donor agencies j:iin AN"EF staff on all project oversight committees. Official re!32tions and working relationships - 10 - are maintained with the World Health Organization and UNICEF. Any AIDS interventions undertaken by AMREF are only done with complete concurrence of government, research institutes such as the Kenya Medical Research Institute, National AIDS Committees, national government hospitals such as Kenyatta in Kenya and Mulago in Uganda, and in cooperation with WHO. Backing has been received for AMREF's AIDS program from the Kenya Medical Research Institute, the Kenya National Committee on AIDS, the Health Education Division of Kenya's Ministry of Health, and the Director of Medical Services of Uganda's Ministry of Health. To date, three of AMREF's departments have been implementing a number of AIDS projects. O£f£ prime importance is the Health Behavior and Education Department headed by Dr. Nyamwaya. One of his staff sits on the Health Education Subcommittee of Kenya's National AIDS Commission. Others produce a variety of health education materials. These appear in AMREF publications such as Defender and in a twice weekly newspaper article published in the Kenyan daily, Standard. The column is entitled "Dr. AMREF". In cooperation with other AMREF departments and Uganda's Ministry of Health, a booklet entitled “Avoid AIDS" has been produced. Sample AMREF materials are attached. The Clinical Department has been able to take advantage of AMREF's existing services to rural health facilties in East Africa. While not yet able to do the desperately needed scientific community based sero-prevalence surveys, random blood samples have been collected for HIV testing. An epidemiologist with AIDS experience has been added to the department. He will play a key role when -~ lj] - permission is granted and resources become available for community based surveys. A number of workshops have been held to train laboratory technicians in Uganda and Tanzania. AMREF's Training Department has, for a number of years, been offering correspondence courses for rural health workers. Asa result, it has established links to a vast number of isolated rural health workers. The Training Department has the means and reach to educate this large number of health providers who are the backbone of African health systems. We fill a gap for continuing education because governments often do not have the resources to upgrade the skills of those in service. AMREF has developed an AIDS component which has been integrated into these distance teaching modules. AMREF's responses to date have been limited by two factors - the caution of African governments in developing their national programs and most importantly, by a lack of funds. These constraints will be addressed shortly. In anticipation that the constraints will ease, AMREF has developed a three part program which could increase our involvement dramatically. The components to our proposed program include: increased health education efforts; additional training; epidemiological prevalence surveys. AMREF's health education efforts will concentrate on slowing the transmission of AIDS by focusing on the following: (1) Training all cadres of rural health workers to help in limiting AIDS transmission via community education campaigns (2) The. promotion of contraception which prevents sexual transmission of the AIDS virus (3) Promoting health treatment practices (i.e. needle use) that are safe (4) Creating an environmer: * the more careful use of blood - 12 - transfusions, and eventual protection of the blood supply (5) Developing laboratory capabilities to allow the screening of blood for the AIDS virus. More specifically, AMREF will concentrate on the preparation of appropriate health education materials for various cadres of health workers and community groups, the distribution of prepared materials, the promotion of AIDS control through use of radio and other mass media, behavioral change to help reduce transmission through various sexual practices, the promotion of safe sex practices, conducting workshops for laboratory technicians on techniques for proper testing of blood samples. When requested, AMREF has the infrastructure and personnel in the field ready to assist governments conduct sero-prevalence surveys focusing on targeted rural and urban areas. We hope to address the following: the issue of prevalence, attempting to identify routes and factors that determine the distribution of viral infection; the risk factors for viral infection; the natural history of AIDS from viral infection to disease as well as the course of the disease itself. Using a hospital and health center network that has been built up over 30 years, AMREF's clinical staff will continue to collect discarded blood samples. In addition, utilizing the links through our community based health care projects, population based data will be collected. Village health workers will be mobilized to help -determine behavioral patterns. In order to effectively carry out this program, AMREF must move in step with the National AIDS Committees. We have already elaborated on this point and the need to be sensitive to government - 13- concerns. More worrisome is the lack of Funds available to PVOs in support of their AIDS programs. For nearly two years now, AMREF has been trying to generate resources from U.S, private and public donor sources for AIDS interventions in Africa. Donor responses to date have been disappointing. USAID has yet to commit itself to the direct support of PVO AIDS programs. Initially, all USAID AIDS funds were channeled into WHO's Special Program on AIDS. More recently, two large contracts have been awarded to American consulting groups whose base of operations are in the United States. These are the AIDSTECH and AIDSCOM projects. The U.S. Government should now seriously consider channeling some of its AIDS funding through PVOs. To date, AIDSTECH and AIDSCOM allow PVOs to seek techincal assistance from the contractors. In AMREF's case, it seems highly unlikey we would need such assistance from organizations that have far less experience than we do. AMREF and a number of other PVOs also have the kind of track record, indigenous staff, and African government contacts that U.S. consulting groups often cannot match. We are in a much better position to assist African governments. From our perspective, it seems that USAID needs to consider the criteria listed above in assessing an agency's ability to respeénd to the AIDS crises in Africa. A mechanism needs to be developed quickly for funding PVO efforts. We would like to conclude this testimony with a series of recommendations that are aimed at enhancing PVO capabilities to contribute towards curbing the erread AIDS in Africa and at the - 14 - U.S. Government's need to play an increased role internationally. RECOMMENDATIONS: Following is a list of five recommendations that are based on AMREF's experiences in East Africa. Three of these relate directly to PVOs. If implemented, they could possibly enhance the AIDS programs that some PVOs are trying to develop and strengthen those that already have been developed. Two are of a broader nature and address the need for the U.S. Government to play a greater role in the global AIDS problem. (1) The United States Government, as an. urgent matter of national interest and humanitarian concern, should maximize support of efforts to contain and overcome the AIDS epidemic worldwide; (2) PvOs that have an indigenous base, with existing capacity and infrastructure, should be identified and encouraged through the Commitment of USAID funds to develop programs of service, education, and research that have local government support; (3) African governments should be encouraged to identify and develop collaborative plans and projects with PvOs. Specific funds to support this effort should be made available; (4) In addition to AIDSTECH and AIDSCOM, USAID should encourage a limited number of PVOs to take advantage of a broad range of appropriate AIDS expertise existing at American academic institutions. Such collaboration would link specific technical capabilities with effective means of translating those skills into locally useful prorgams; (5) Along with its suppport for WHO, the U.S. Government should establish an International AIDS Support Unit. Such a unit could coordinate efforts by USAID, NIH, CDC, and other public agencies and - 15 - could quickly respond to requests from third world governments for | assistance in identifying clinical and fundamental research issues . ‘ \ of local concern. AMREF would like to thank the President's Commission on AIDS for this opportunity to address the growing epidemic in Africa. We appreciate the Commission's focusing attention in the United States on AIDS as a worldwide problem. Those of us that work in Africa will need to channel:a great deal of energy and resources into meeting the challenge to control this deadly disease. Thank you. + -BMREE ‘ rey, ee Pry a ae Tera aes EE ee pyanrad sporatyfia P paler cpipat! ra yaw fia epee ah Fh be Fa eat ae ke op fiat coat ibe, \ 9 AIDS is a disease caused by Human Immunodeficiency Virus (HIV). It is always fatal, as there is, to date, no effective cure or vaccine. AIDS IN KENYA Information for Visitors A. IN EUROPE AND IN AMERICA High risk people are homosexuals, drug addicts and haemophiliacs. B. IN EASTERN AFRICA 1. Transmission of the virus occurs between sexual partners of both sexes—man to woman, woman to man. (NB: there are few homosexuals). The greater the number of different partners, the greater the risk of contact with the virus. Co-existing sexually transmitted diseases increase the risk of transmission. 2. Bloodis an important source of transmission: — Transfusion — Use of blood-contaminated instruments: needles and syringes, scissors, razors, toothbrushes, acupuncture needles, knives used for ritual or therapeutic scarifications. 3. Mothers who carry the virus run a greater than 50 per cent risk of transmitting it to their child at birth. 4. There is no evidence for transmission of the virus by insect bites. 5. The most affected countries in Africa are Zaire, Zambia, Rwanda, Burundi and Uganda. C. IN KENYA 1. AIDS exists but clinical cases are still rare. 2. The percentage of people positive for HIV, though constantly increasing, is still low in the general population in Kenya. 3. High risk people are prostitutes, their clients, and promiscuous individuals. PREVENTION Education of the population: — The Government, the Red Cross and other Non-Governmental Organisations (NGOs) in Kenya are making a vigorous effort to educate and inform the population on the disease and appropniate preventive measures. L ted tel spre itl aes se L bat OE els “oe aa aad cart aie, ae oo 2. Sexual Transmission Visitors should avoid any form of sexual contact outside their normal relationship. They should avoid sex with prostitutes and casual acquaintances. Visitors who do indulge in casual sexual practices should make use of condoms (rubbers) and contraceptive foams, and jellies, which may offer some protection. However, they must be aware of the risk they are taking. 3. Careful use of blood products Transfusion: all donor blood is screened for AIDS in the major private hospitals: Nairobi Hospital; Mombasa Hospital; Aga Khan Hospitals in Nairobi, Mombasa, Kisumu; Nakuru Memorial Hospital; and in the major Ministry of Health hospitals: Kenyatta National, Nairobi; and all Provincial Hospitals: Mombasa, Nakuru, Kisumu, Kakamega, Embu, Nyen, Garissa. The techniques used are the same as those used in blood banks in Europe and North America. However, in Kenya, as in every country in the world, transfusion should only be given if absolutely necessary. In many cases sterile intravenous fluids (which are of high quality and are readily available) can be used to correct blood loss. If a blood transfusion is absolutely necessary, request blood from family members or friends (whose blood will in any case be tested). 4. Infection The private and Government hospitals (listed above) use sterile disposable needles and syringes; or re-usable equipment, which is sterilized using accepted techniques. However, when on safari, it is advisable for a group member to take a set of disposable syringes and needles in case of emergency. 5. In General — don’t have your ears pierced and don’t get tattooed — beware of acupunture and electric depilatory practices — don't share razors and tooth brushes — avoid the use of razors at hairdressers or barbers; normal hairdressing practices are perfectly safe. THE RISK All normal social contacts are completely harmless—here, as in the rest of the world. For the thousands of residents who live and travel in Africa, there is no fear of catching AIDS. The only risks come from casual sex or from the use of unsterile needles or blood transfusion. Bloo” transfusion is rarely required, even in an emergency. To give an example inthc ast year, only a single patient out of nearly 600 rescued by the Flying I) ctor. -1:ce has required emergency transfusion (with blood already screened f~ ‘'DS). TO THE HIV EPIDEMIC 7 TONS RESPONS | rs io b t the Presidential Commission Hearing on a L, Macagba, M.D, MPH. nternational Health Program = cs - I t, Inc. and Developmen . Ngatiri, M.D, M.P.A. “ te. - George -egion Health Programs nternational and Develcpment, Inc. WOELD VISION'S RESPONSE TO THE HIV EPIDEMIC 1. INTRODUCTION 1.1. What is World Visien? 1.1.1, lt is a Christian humanitarian organization focussing on childeare, relief and development in about 80 countries. 1.1.2. It was founded in the U.S. in 1950, to raise funds for children orphaned by the Korean war. 1.1.3. Tetal projects: about 4500 Assistance to Children and Families 3019 NS41D-funded Chiid Survival Projects 8 Community Development 1097 Emergency Relief and Rehabilitation 123 Evangelism and Leadership 251 t.i.4. Number of children in child and family assistance programs: about 500,000 1.1.5. Tecal staff: 4216 1.1.6. Health prefessiona! staff: Headquarters: 3 Regional staff: 4 Africa (2), Asia ‘1), Latin America (1) ational health program coordinaters: about On af 42 field offices. ublic health professionals in UJSAID-funded ws bi child survival projects: 15 a in 1.1.7. Suppert Offices in 12 countries including the 0.S., Canada, Australia, New Zealand, Hong Fong, Britain, Finland, Germany, Netherlands, Southern Africa, Singapore and Japan. 1.1.8. Field Offices in 42 countries in Africa, Asia and Latin America. Why is AIDS important te WV? 1.2.1. World Vision has made a corporate commitment to focus on child survival and universal child immunization in the next 23 years. — * Ras . to — x td Vision began a commitment te community health e with emphasis on prevention in 1976. Page 1 1.2.3. AIDS is seen as a serious threat to the health of children and families in WV project communities, the staff of partner agencies, and employees of WV. 1.2.4. WV is shaken and saddened by the scope of the HIV epidemic, its impact on victims, and its disruptive effects on affected families and communities. 2. WORLD VISION'S RESPONSE 2.1. Faet-finding on AIDS 2.1.1. In June, 1987, WV's head of corporate planning and technical services requested the gathering of available information on AIDS and the writing of a technical paper on its potential effects on the work of Werld Vision. 2.2, Writing of region-specific medical alert papers on AIDS 2.2.1. For WV health staff in Africa t. t to to bh For WY health staff in Latin America WV heaith staff in Asia tw to 3 rz oO hte 2 tf ro “Ty Oo “4 WV managers and effices F> wo International Beard approval of Policies on AIDS to .2.2. &V Pelicy on AIDS Prevention -— August, 1987 Focus on pregram of education on AIDS prevention for staff, partner agencies and project communities. Protection of staff from the disease. Suppert and encouragement of compassion to victims and their families. 2.3.2. WY Policy on Immunization and AIDS - August, 1987 WV immunization programs will continue to be pursued vigorously. Follows recommendations in the WHO/ONICEF Statement on Immunization and AIDS. 2.2.3. WV Policy on Management of Employees with Positive RIV Test or AIDS ~ March, 1988 Establishes principles, genera! and specific guidelines. Follows country's laws and regulations governing AIDS in the workplace. Pase 2 Protects confidentiality of information. Emphasizes compassion for victims and their families. 2.4. Implementation Program 9.4.1. Chief Executive Decision on AIDS Education, Staff Protection and Compassion for AIDS Victims. In August, 1987, the President of World Vision International requested his line vice-presidents to begin implementation of the AIDS prevention policy. t => tr . Headquarters Response In September, 1987, WV's Training Department developed and began implementing a staff education module on AIDS, including a video presentation and case studies on AIDS in the workplace. In Octeber, 1987, WV produced a staff education booklet on AIDS. bo 4.3. Support Office Responses About the same time, wv /US developed and implemented a similar AIDS education for staff. to rE & . Regional Responses Africa Region Office of Regiona! Vice-President has requested field offices te respond to President's request and AIDS prevention pelicy. Field Offices have begun looking into and utilizing local resources for AIDS education. Latin America Region Regional Vice-President has requested his field offices to develop AIDS education and staff protection strategies in support of WV policy. Asia and Middie East Region Regienal health program coordinator has done a country by country profile on WV opportunities for health program development - 3. NEW DEVELOPMENTS IN WY AIDS STRATEGY 3.1. First Priority: AIDS education of staff, partner agencies and project communities. Page 2 4. tt 3. ~ tu? n 4 3 4. an a 2. Second Priecrity: Assisting mission hospitals to have HIV screening capability. . Third Priority: Training of counselors, including pastors, for counselling of AIDS victims and their fam: lies. Propesal for a seven-country AIDS control project in Africa 3.4.1. WV has developed a concept paper to do a three-phased preject for AIDS control in 7 countries. é 3.4.2. Phase one will focus on WV's first priority of AIDS education mentioned above. .4.3,. Phase two will seek funding to help mission hospitals t2 have HIV screening capability. M:ssion hospitals in Africa provide 35-65% of the total health care in their respective countries. i.) ‘4.4, Phase three will focus on the training of counselors, including pastors, to counsel HIV victims and their families. Red Alert Status: WV's leaders are watching developments in the HIV epidemic closely and will modify or change corporate strategies :f warranted by the global and regional situation. WV¥'s pel:icy on funding of its AIDS program is that it will not capitaiize on the disease to raise funds for its work. HUswever, it realizes that rescurces are needed to do the jek. 3.6.1. It has an international management and technical network that reaches the grassroots and indigenous agencies. 3.6.2. It would welcome matching funds to enable it to utilize this network to its maximum potential for combatting AIDS. PERCEPTIONS ON EPIDEMIOLOGY AND STRATEGIES TO CONTROL AIDS IN AFRICA 4. 1, World Vision in Africa Pago 4 4.1.1. WV works in 21 countries in Africa and has field offices in 1] countries. Most field offices relate to national AIDS committees for information and education of staff, partner agencies and projects. 4.2. Observations on the Epidemiology of AIDS in Eastern and Southern Africa: 4.2.1. There seem to be four patterns of spread of HIV infecticn: The "AIDS highway" pattern runs along the major highways trasporting goods from ports such as Mombasa to Kenya and neighboring countries, such as Zaire, Rwanda, Burundi and Dganda. The long-haul truck drivers habitually yeep mistresses along the way, including their points of origin and their destination. This has produced a "nodal mode" of transmission to towns and major stops along the highways, similar to the spread of infection through the lymphatic system. The “combat pattern" gees where the soldiers go. During the Tanzania-Uganda war, AIDS cases surfaced in the communities adjacent te military concentrations. These were the communities at the western border between the two countries. The current hostilities in northern and northeastern Uganda are showing the same pattern. The "tourist—prostitute pattern" is a two-way transmission between tourists and prostitutes in capital cities. it 1s interesting to note that AIDS did not seem te originate in the countryside but rather in capital cities and ports of entry. The “local node pattern" transmits HIV through the promiscous lifestyle of mistresses and prestitutes in the nodal towns and cities. The focal farmers (mostly males), local traders (mostly female) and rural school teachers (mostly male) may get HIV infection when they go to town. In the cities and larger towns, local residents who patronize prostitutes Page §$ would get the disease and transmit it to their spouses. 4.3. WV AIDS Strategy in the African Context 4.3.1. A unique characteristic of Africans in Eastern and Southern African countries is that they listen to their spiritual leaders more than any other person. Even prostitutes often go to church. Most of them have children and practice their profession to support their family. The training of pastors and other spiritual leaders to play an active role in AIDS education and counselling can make a , Significant impact in Africa. 4.3.2. Two regional child survival workshops sponsored by WY in Africa have included major sessions on AIDS, to train WV health program staff and project coordinators.. &.i.2, Copies of AIDS education booklets are being distributed to field offices and staff, and ways to use them most effectively are being explored. 4.4.4. The Kenya field cffice included sessions on AIDS in the annual meeting with its partner agencies most of which are churches, in 1986. Other field offices are expected te follow. 4.3.5, WY field offices have also begun to establish professional linkages with nat:onal AIDS committees, for two-information exchange and utilization of available resources. 4.4, New Strategies that need to be developed: 4.4.1, Focus on “noda! points" cf spread. WV has childcare and family assistance projects in at least 50% of the nodal points in henya. Target groups will include truck drivers, mistresses and prostitutes, local farmers, school teachers and traders. Pastors and spiritual leaders will have a special! role, as explained above. bo 4.4. Help the missionary hospitals and churches to have an institutional capability te screen, ccunsel and inform their respective conhmunities. 5. THE ROLE OF PVOs IN THE FIGHT AGAINST THE HIV EPIDEMIC Fage &