THE PRESIDENTIAL COMMISSION on the HUMAN IMMUNODEFICIENCY VIRUS EPIDEMIC H EARI NG November 24, 1987 PRESIDENTIAL COMMISSION ON THE HUMAN IMMUNODEFICIENCY VIRUS EPIDEMIC COMMISSIONERS ADMIRAL JAMES D. WATKINS, CHAIRMAN UNITED STATES NAVY (RETIRED) COLLEEN CONWAY-WELCH, Ph.D. JOHN J. CREEDON 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. HIS EMINENCE JOHN CARDINAL O'CONNOR BENY J. PRIMM, M.D. REPRESENTATIVE PENNY PULLEN CORY SerVAAS, M.D. WILLIAM WALSH, M.D. PRESIDENTIAL COMMISSION ON THE HUMAN IMMUNODEFICIENCY VIRUS EPIDEMIC The Hearing was held at the National Academy of Sciences Lecture Room Washington, D.C. Tuesday, November 24, 1987 COMMISSION MEMBERS PRESENT: ADMIRAL JAMES D. WATKINS (Ret.), CHAIRMAN THERESA L. CRENSHAW, M.D. RICHARD M. Devos KRISTINE M. GEBBIE, R.N., M.N. FRANK LILLY, PH.D. JOHN CARDINAL O’CONNOR BENY J. PRIMM, M.D. PENNY PULLEN, M.D. CORY SERVAAS, M.D. POLLY L. GAULT, EXECUTIVE DIRECTOR COMMISSION MEMBERS NOT ATTENDING: COLLEEN CONWAY-WELCH, PH.D. JOHN J. CREEDON WILLIAM B. WALSH, M.D. I-N-D-E-X OPENING REMARKS Admiral Watkins, Chairman WELCOME Samuel 0. Thier, M.D., President Institute of Medicine, National Academy of Sciences REPORT BY THE AMERICAN MEDICAL ASSOCIATION ON THE PREVENTION AND CONTROL OF AIDS AND MEDICAL ETHICS Alan R. Nelson, M.D., Chairman American Medical Association COMMISSIONER BUSINESS REPORT OF THE COMMISSION FINANCE WORKING GROUP Mr. Richard DeVos, Chairman REPORT OF THE COMMISSION INTERNATIONAL WORKING GROUP Read by Ms. Polly Gault, Executive Director Prepared by Dr. William Walsh INTRODUCTION OF PHYSICIAN REVIEW COMMITTEE Admiral James D. Watkins (Ret.)., Chairman Presidential Commission on the HIV Epidemic INTRODUCTION OF THE PRELIMINARY REPORT AND FUTURE HEARINGS Admiral James D. Watkins (Ret.)., Chairman Presidential Commission on the HIV Epidemic INSTITUTE OF MEDICINE REPORT CONFRONTING AIDS: DIRECTIONS FOR PUBLIC HEALTH, HEALTH CARE AND RESEARCH Roy Widdus, Ph.D., Project Director Confronting AIDS, Director, Division of International Health, Institute of Medicine, Special Advisor, World Health Organization Heather Miller, Ph.D., Program Officer Committee on Behavioral/Social Science Education Robin Weiss, M.D., Coordinator Designate of AIDS Activities ADJOURNMENT PAGE 41 46 50 51 59 76 103 115 FT PROCEEDINGS (9:00 a.m. ] MS. GAULT: Good morning, ladies and gentlemen and distinguished members of the President’s Commission. My name is Polly Gault. I serve as the Designated Federal Official, and in that capacity it is my privilege to declare this meeting open. Chairman Watkins. CHAIRMAN WATKINS: Good morning to our many guests here today. Today the Presidential Commission on the HIV Epidemic will consider in detail the work of two of our nation’s most prestigious and respected scientific and medical groups; the American Medical Association and the Institute of Medicine of the National Academy of Sciences. First, on behalf of all of the Commission members I want to thank Dr. Thier who is with us this morning and his fine staff for their generosity and helpfulness in allowing us to use their facilities here at the Academy. We will try to do so with a minimum disruption of the important work going on at the Academy. Secondly, I would like to thank in advance the presenters that will appear today. It is at some considerable personal inconvenience that both Dr. Nelson of the American Medical Association, and Dr. Widdus of the Institute of Medicine have adjusted their own schedules to provide us with very valuable insights; and we greatly appreciate that special effort. Today’s meeting will focus on two excellent comprehensive national reports on the HIV epidemic. It is of particular assistance to the Commission as we begin to narrow our focus. In this connection the Commission intends to concentrate their work on areas which they believe have not been adequately addressed in the past, either by government or the private sector. Certainly, there is much in the work of the AMA and the IOM that does not need to be duplicated by the Commission. Additionally, today’s session will help us organize and place in proper perspective much of what we learned in our visit to Miami earlier this month. All Commissioners who were able to attend those meetings felt that they learned much about the very specific concerns of those in the front lines of dealing with AIDS whether they be patients, family members, health care providers or staff and volunteers with the many community-based organizations. We need to take what we learned in Miami and relate it to the works that we will be discussing here today. So again, I want to thank Dr. Thier for all his support; we’re looking forward to a continuing close relationship with the IOM and the National Academy. I would ask Dr. Thier now if he would like to make any opening remarks he may have. Dr. Thier. DR. THIER: Thank you, Admiral Watkins. I’m Sam Thier, President of the Institute of Medicine, and on behalf of the Institute and the National Academy of Sciences I want to welcome the Commission this morning. The Institute and the Academy have had a long and deep interest in the issue of AIDS and in how this nation might mobilize its considerable resources to address the problem in the most effective fashion. The Commission, in its role as Advisor to the President of the United States, is in an ideal position to play an important function in seeing that the various issues facing us are addressed and that the Administration, the government and the public hear what we should be considering in addressing those problems. The issues are complex. Your time is short. We will do everything we can, not only to welcome you but to be of any help as a resource that we can. What you’re addressing is, I think, of tremendous moment to this country and I wish you the very best of luck in your efforts. CHAIRMAN WATKINS: Thank you very much, Dr. Thier. Do any of the Commission members have an opening statement they would like to make this morning for the record? [No response. } CHAIRMAN WATKINS: Very well, then let’s get on with the first presentation this morning. The American Medical Association has two reports that we’re anxious to hear about from Dr. Alan R. Nelson, Chairman of the American Medical Association who has been kind enough to be with us this morning to make these presentations. The first report will be on the prevention and control of AIDS, an interim report which we have all read. A report of their Board of Trustees dated 21 June 1987. And he will follow that directly with their most recent report of the Council on Ethical and Judicial Affairs dated 12 November. We’re going to try to take advantage of Dr. Nelson’s presence today to give us insight on that most recent and impor- tant report. We will hold our questions then until after he makes a presentation on both reports. So we will proceed now with Dr. Nelson. Reports by The American Medical Association on the Prevention and Control of AIDS, and Medical Ethics DR. NELSON: Thank you very much, Mr. Chairman. As the Chairman indicated, my comments will integrate the two reports since our efforts, as far as the HIV epidemic is concerned, does represent a continuum and much of our work is, of 2 course, ongoing. I am a physician in practice of Internal Medicine in Salt Lake City. I'm also Chairman of the Board of Trustees of the American Medical Association. With me is Mr. Kirk Johnson who is General Counsel for the AMA. We, of course, appreciate this opportunity to appear before the Presidential Commission on the HIV Epidemic to discuss our interim report on the prevention and control of AIDS, and to apprise the Commission on other AMA initiatives which bear directly on the primary focus of the Commission. That is, to recommend measures that federal, state and local officials can take: first, protect the public from contracting HIV infection; second, assist in finding a cure for AIDS; third, care for those who already have the disease. As President Reagan stated before the American Founda- tion for AIDS Research, "The Commission will help crystallize America's best ideas on how to deal with the AIDS crisis." A similar goal has been the aim of AMA's many activities on AIDS. The interim AMA report which we have been invited to discuss is keyed to this national objective, as identified in its title, "The Prevention and Control of AIDS." In developing the recommendations contained in our report, we have sought to balance two separate, sometimes competing, concerns. First, the person who is afflicted with the disease needs compassionate treatment. Those who have the disease and those who have been infected with the virus should not be subject to irrational discrimination based on fear, prejudice or stereotype. Second, and of critical importance, the uninfected must be protected. Those individuals who are not infected with the AIDS virus must have every opportunity to avoid transmission of the disease to them. In our opinion, while providing a judicious balance, the report provides protections for both populations based upon the current state of medical and scientific knowledge. Before I review the specific recommendations I would like to discuss the fundamental requirement to which this Commis- sion must address itself, the need for a national policy on AIDS. Given the growing dimensions of the crisis and given limited national resources, it is imperative that a national policy be developed jointly by the public and the private sectors. Such a policy must seek, in a cost-effective way, to achieve fundamental national goals: prevention, treatment and cure and adequate research in all three areas. A coherent national approach to this modern killer is needed; a blueprint for a national response, not piecemeal solutions. Such a national policy must have certain characteris- tics: The policy must be comprehensive, proceeding simul- taneously on the fronts of prevention, treatment and research. The policy must be coordinated between the public and private sectors and between the different levels of government. A national policy does not necessarily mean a federal policy; there are important roles at all levels of the health care system and at all levels of government. Nor does it necessarily mean uniformity; on certain issues different approaches should be tried to determine efficacy. The policy must be carefully balanced. For example, concern for the person with the disease must be balanced with concern for those who do not have the disease but who may become infected. Similarly, careful consideration must be given to directing scarce resources to increased prevention, even as increasingly large resources are necessarily devoted to research and treatment. The policy must be based on scientific information and medical judgments. Although policy choices must inevitably be made, they should be formed on the best available information and on extensive public health experience in dealing both with AIDS and with other contagious diseases. Next, the policy should be nonpartisan. Although it may be tempting to play on fears and prejudices, public figures and officials both inside and outside the health community should avoid exploiting the crisis for partisan political advantage. The policy should be capable of continuous review and modification as more and better information becomes available. Our nation is looking to this Commission to articulate a national policy such as that I have just described; or in the President’s words, "To crystallize America’s best ideas on how to deal with the AIDS crisis." I would now like to describe to you some of the recommended responses to the many difficult issues posed by the HIV epidemic which the AMA adopted as an Association policy this past June. If you would like to discuss anything that appears in the AMA report I will be happy to do so. For now, however, I intend to concentrate on the major recommendations which have the most bearing on the Commission’s mission. Clearly, one of the most important subjects addressed in our report was that of testing for the HIV antibody. We concluded with recommendations that: 4 -- one, voluntary testing should be available to all; -- two, testing should be mandatory for blood, organ and tissue donors, for immigrants to the United States, military personnel and prison inmates; -- three, routine, but voluntary testing should be provided at sexually transmitted disease clinics, drug abuse clinics, pregnant women at high risk areas, early on, and to certain individuals seeking family planning services. Essential to any testing program is appropriate counseling on ways to reduce the risk of infection, on responsible behavior for those who are infected, on strategies for coping with the infection, on the necessity for notifying sexual partners and other contacts regarding possible infection. Informed consent should be knowingly and willingly given prior to testing. We believe that our testing recommendations fit very nicely with the main purpose of testing: to identify infected individuals for treatment and protection of third parties; to offer education and counseling aimed at modifying high risk behavior; to obtain epidemiological information; and to protect the nation’s blood, organ and tissue supply. The question often arises as to why the AMA has not endorsed widespread mandatory testing. Mandatory testing has been proposed for those seeking marriage licenses or for hospital admissions, for instance. We believe that health care resources would be better focused elsewhere in the battle against HIV. Mandatory testing of low incidence populations would divert finite testing and counseling resources from high risk individuals who volunteer for testing because they have reason to believe they might be infected. There is also a chance that false positive results would be unacceptably frequent, with irreparable adverse results to innocent parties. Finally, the estimated cost for uncovering one valid case of infection within a very low incidence population would be extremely high. But will voluntary testing work? We believe that voluntary testing is working already. One indication is that in many areas, the capacity for testing and counseling cannot meet the demand. The greatest threat to the success of voluntary testing and counseling is that individuals will resist learning their serologic status if safeguards for maintaining confidentiality and protection against discrimination are not assured. It is for this reason that the AMA has made these recommendations: -- one, reporting of positive results of HIV testing to public health officials should be anonymous, or if carefully implemented with strict protections for confidentiality, with identifying information; -- two, laws must be adopted to encourage as much uniformity as possible in protecting the identity of HIV-infected individuals, except where the public health requires otherwise; -- three, anti-discrimination laws must be clarified or amended to cover those who test positive for the antibodies to the AIDS virus. Discrimination inhibits the control of AIDS by discouraging voluntary testing. It also has the destructive effect of removing those who are otherwise productive members of society from the workforce or otherwise denying them involvement in fundamental aspects of normal life. The AMA has taken a strong stand on discrimination and we have backed this up in the courts. In three recent cases the AMA has filed amicus briefs supporting an interpretation of existing constitutional, federal and state law to encompass individuals with contagious diseases in general and AIDS or HIV infection in particular. And I am pleased to report that in all of these cases the courts reached the outcome we advocated. This includes a decision by the United States Supreme Court which acknowledged and adopted the AMA’s suggested analysis for evaluating employment decisions involving individuals with contagious diseases. Copies of these amicus briefs have been made available to each member of the Commission, along with other AMA materials that I will describe in more detail later. Our efforts to ensure the fair treatment for individuals infected with HIV extend to the treatment by the medical profession as well. The tradition of the AMA, since its organization in 1847, has been, "Where an epidemic prevails, aphysician must continue his or her labors without regard to the risk to his own health." The AMA Council on Ethical and Judicial Affairs has just recently addressed the question of the physician’s ethical obligation towards individuals who are infected with HIV. The Council has now stated, in a clear pronouncement, that a physician may not ethically refuse to treat a patient whose condition is within the physician’s realm of current competence solely because the patient is infected with HIV. Perhaps nowhere else is the judicious balance between the rights of the individual and the imperatives of public health more difficult to achieve than on the issue of contact tracing or partner notification. As a general rule, the AMA believes that unsuspecting contacts of a person who has been found to be infected with HIV should be informed of their risk. It will not be responsible, in every case, to rely on the infected individual to convey a suitable warning. Where intervention is indicated, public health officials should be able to act on mechanisms analogous to those used in the past by public health authorities to warn contacts concerning sexually transmitted diseases. We believe specific statutes are needed that will, consistent with essential confidentiality and anti- discrimination protections, provide a method for notifying unsuspecting partners; protect physicians from liability for refraining to convey notification to a partner or contact; establish clear standards for when a physician should notify public health authorities; and provide clear guidelines for public health authorities to undertake partner notification or contact tracing. Contact tracing provides a very specific individual form of information on HIV infection. There also is an urgent and critical need for more scientifically sound data on the prevalence and spread of the virus in the population as a whole. At the present time only those cases that meet the current CDC surveillance definition of AIDS are reported to that institution. Since AIDS is the terminal and fatal stage of HIV infection, it represents only the tip of the iceberg. How large the base of that iceberg really is, that is, how many people are actually infected, can only be estimated from the number of reported AIDS cases. If economic and medical plans are to be made available for the future, reliable projections must be available. How sufficient or exaggerated these plans may be depends on the accuracy of current and future estimates of HIV infected persons, particularly as to the extent of its spread into the low risk heterosexual population. The cdc itself is unsure about the accuracy of its estimates. We believe that the CDC’s estimates, however, are firmly based on scientific methodology, and only better and more extensive data will permit anyone to improve upon the CDC’s work. Not only are accurate estimates of HIV-infected persons needed, but so too are reliable data on the rate of conversion of asymptomatic seropositive persons to clinical 7 illness, including AIDS, that requires increased medical care. This information is important for the formulation of plans to provide for the costly care of future patients. In order to obtain accurate information in HIV infected persons on the rate of conversion from asymptomatic to clinically severe illness, baseline data on their serologic status must be obtained as early as possible, not after clinically manifest disease is present. We believe that local health officials would benefit also from reports of HIV seropositivity, for example, to determine if testing programs are reaching a significant infected population. Accordingly, the AMA recommends that individuals who are found to be seropositive to HIV should be reported to appropriate public health officials on an anonymous or confidential basis, with enough information to be epidemiologically significant. States may, in addressing their particular problems, require reporting by name. In any event, measures to provide confidentiality and protection against discrimination are essential to the success of any reporting program. And even with confidentiality and anti-discrimination safeguards in place, such reporting could deter some from seeking testing and counseling. The final recommendation that I will mention is one on which I would expect the greatest consensus. This recommendation is that public funding must be provided in an amount sufficient (1) to promptly and efficiently counsel and test for AIDS, (2) to conduct the research necessary to find a cure and develop an effective vaccine, (3) to perform studies to evaluate the efficiency of counseling and education programs on changing behavior, and (4) to assist in the care of AIDS patients who cannot afford proper care or who cannot find appropriate facilities for treatment and care. Federal funding for FY 88 to deal with AIDS may reach $1 billion. This amount is simply not sufficient to meet the challenge presented on the four points I have just identified. The federal government’s role is especially crucial to meet the need for essential, basic scientific research. It may be that, on certain other issues, the deep divisions over the appropriate national policy may not be as easy to resolve as the need for resources. We suggest, however, that a clear message by this Commission regarding the need for adequate federal resources will be most constructive and widely supported. We realize, of course, that the Commission is looking beyond the federal government. The formulation of a national policy is not limited to consideration of federal legislation. National policy embraces a role for states and local governments as well as for participation by the private sector. Measures taken at the state and local level have a particular benefit of an awareness of the nature of local conditions. Our national policy on AIDS should preserve the flexibility needed to adopt measures that best suit local conditions. In conclusion, the recommendations contained in our report are not merely abstract principles or debating points. The AMA has made every effort toward implementation. Where specific actions are recommended, such as organizing conferences or drafting legislation, these actions have been or are being carried out. Policy recommendations are guiding our active support of legislation on HIV testing, counseling, confidentiality, anti-discrimination, education, treatment and research, and in our amicus briefs in selected AIDS-related litigation. I hope that the presentation will leave the Commission with a clear picture of AMA’s resources and record of commitment to the public health challenge of AIDS. As this Commission combines the talents of its membership to develop its final product, we ask you to keep organized medicine in mind. We stand ready to integrate our efforts into the national effort and we look forward to participation with the Commission in this regard. We have provided each Commissioner with a package containing examples of the materials which have been generated as a result of our commitment to combating HIV infection. I would like to very quickly describe the material you have before you. First, we provided you with the sources I referred to during this presentation--report YY on prevention and control of AIDS. Report of our Council on Ethical and Judicial Affairs which is analogous to our Supreme Court; and the three legal briefs in the cases where the courts ruled on the basis of accurate scientific and medical knowledge and granted relief from discrimination. In addition, we have included several examples of the products of our efforts to communicate accurate scientific and medical information throughout the medical profession and to the public. The combined reprint of information on AIDS to the practicing physician, which I had an opportunity to review again yesterday on the airplane and found it outstanding in terms of its currency, the amount of information, technical information that it provides for a physician. An AIDS issue packet to try and help the physicians talk with the media and the public. Part of our efforts to equip physicians to be credible, accessible sources for AIDS information at the local level in their service organizations, schools, student groups and so forth. Our communication efforts are aimed at physicians, the public at large, and at our patients. I would like to present a short video sample of three such targeted communications. A 30 second public service announcement targeted at young people on abstention and "safe sex." A 90 second video news release on the recent AMA report on the ethics of treating AIDS patients. This was made available by satellite to every television station in the nation. And a seven minute excerpt of an AMA video update on AIDS that has happened on the Hospital Satellite Network and Lifetime Medical Television. This program was aimed at physicians who have never treated an AIDS patient. Finally, science has always been a fundamental component of the AMA. This final item, AIDS From the Beginning, documents the scientific contributions of the medical and scientific community on AIDS. A bunch of this work originally appeared in the Journal of the American Medical Association. And following those very brief television clips, I will be pleased to answer any questions that any members of the Commission may have. [Showing video] CHAIRMAN WATKINS: We will proceed with the questions now. And for the Commissioners I would like to follow the following protocol. We’re going to have a number of questions for Dr. Nelson. I would like to have each Commissioner who desires to ask questions to try to pick two; and let’s have the other Commissioners then ask questions as they need to in follow-up to any answers that Dr. Nelson may give us, so that we can take those questions to ground. Then we will repeat the cycle, so you will have plenty of opportunity here. So I would like to start the questions, then, and I would hope that the Commissioners would feel free to follow-up and chime in, but let’s devote our attention to these particular questions and not drift off to added questions that you may want to ask a little later on. Let me start out with a couple of questions. You are urging that the Commission take on the rather momentous task of, perhaps, addressing the subject of a national policy on AIDS, comprehensive coordinated balance based on scientific information, extensive public health experience has to be brought to bear, it has to be nonpartisan. 10 You also mention in your report, in your recommendation three that you were going to sponsor a major conference on education. First I would like to know, what was the result of that recommendation and where do you stand on that conference? Has that been held and is there a report? DR. NELSON: We had one major conference on HIV in April in Chicago, and we had about 800 registrants, and that has been held. I think the proceedings have been published. The conference on education is scheduled in Washington, D.C. in March, and the staff planning is underway now for that. We have every intention of having that conference. CHAIRMAN WATKINS: Is it your intention, Dr. Nelson, from that conference to build a national education strategy concept to put -- to build some kind of skeletal framework that would do the very thing you’re recommending in your report because it seems to me that if education, as you say in your report, is the primary weapon at this particular time, then that may well be the focal point that could bring together the variety of entities public and private that you talked about as being essential to bringing this together. And isn’t there an opportunity there, and is that your intention? DR. NELSON: There is certainly a tremendous opportunity for that to highlight our commitment to education, both professional and public. There also certainly would be an opportunity thereby bringing together the important contributors and to constitute the basis for continuing initiatives. So, yes, I think your conclusions are absolutely correct. CHAIRMAN WATKINS: What are you doing right now regarding the education of the doctors in the profession? I see your book, which we haven’t had a chance to review. Is that the substance of your educational program or do you have some more rigid formal mandatory kind of concept that is coming to fruition where the knowledge of the doctors around the country is enhanced by such an educational program? Because my understanding from our own medical advisory team that we haven’t gotten there yet in the education of our own doctors on the subject of AIDS. DR. NELSON: That will be a continuing challenge, as all continuing medical education is. Virtually every issue of American Medical News has a contribution that relates to HIV infection and virtually every -- I imagine every -- issue of the Journal of the American Medical Association -- JAMA -- and the specialty journals have major papers and articles about HIV. Of course, we monitor the state medical society scientific meetings; there’s a great deal of attention being paid. The challenge to educate the physicians is one that we 11 understand, and I don’t think that we ever will have accomplished it to our satisfaction. I think that we can say with some confidence that we are making significant headway in that area. One of our challenges is to educate physicians to the point where they can serve as reliable sources of information for their patient about this illness. I suppose then that I would have to say, this is an effort that is acknowledged as being important and integrated throughout the entire Federation Specialty Society, state and county medical societies, the AMA, all of our publishing policies are directed toward what we have accepted as one of the highest priorities for the AMA, which is professional education and public education surrounding this illness. CHAIRMAN WATKINS: Is that a formally established structure of integration of the various regional and local activities, so that you can share those views and have a little more positive control over what might be going on out there, or do you leave it up to published journals that float around and you hope people will read them? DR. NELSON: No, we provide the technical information. The AMA Board has approved an action plan that we have a series of resolutions that are considered. And at this meeting of our House of Delegates which is our representative assembly being held next month in Atlanta there are seven or eight major reports on HIV, all the way from funding to current scientific information. So, it’s broadly based. It does not involve a single curriculum that has been adopted at that top and then implemented throughout. Rather we serve as facilitators and providers of information and technical assistance; and then the entire profession can implement that. MR. JOHNSON: Well, we have had regional seminars throughout the country where we send communicators, physicians who are experts. We have had about five of them in various Places in the country and we have plans to do another five more. We get local physicians. We go through a working process the entire day to bring them up to date. The organized nature of it is that we are a federation of state medical societies and county medical societies and all the information that Dr. Nelson has described is presented to the state and county societies with information and issue packets and a description of how you make this information available to the physicians at the local level. So to that extent, it’s extensive. DR. NELSON: I would have to also say, Mr. Chairman, that we receive between 6 and 800 requests for interviews a month 12 at the AMA. Our communication division receives them and then various spokespersons from the AMA will fill those requests for interviews. And as Chairman I make those assignments. AIDS information, AIDS policy is certainly on the -- well, it would be the single largest subject on which information is requested. When we meet with Editorial Boards, as I did twice in the last two weeks, once in Corpus Christi, Texas and once in Grand Rapids, Michigan, the thing that we talk about most is the public policy issues, ethical issues, and that is the means of getting the information out to the public, not only to the profession. CHAIRMAN WATKINS: Well, this is why I get back to the initial question. If you believe strongly that a national policy on AIDS is necessary, it seems to me you believe strongly that there is an urgent need for a national education policy that’s integrated and less fragmented than we have today including the education of health care professionals of all types including the education of the iceberg group that you talked about--the various target groups that have to have special counseling, special educational program, perhaps mentoring in the kind of thing that we aren’t even prepared to do in many cases, getting out on the street and doing the intervention -- carrying out the intervention strategies that we know are the only kinds that will work under certain circumstances. I’m talking about that kind of integration of an education policy. It seems to me that has to be articulated if your $1 billion is going to have any significance, and while that may be extrapolated from state information and so forth, in the IOM report, for example, they talked about it. It just seems to me that here is an area that cries for a national strategy on an urgent basis to begin to put some flesh on the bones of the words that are in the various documents and get out of the fragmentation of education which is at the focal point of interest. So, I would just like to have your feeling about how strong this meeting is going to be, this conference, and can we count on that in coming up with something that’s more integrated, and not necessarily focused only on the technical expertise within the medical profession but try to lean on the medical profession, come forward with a much broader policy in its totality covering the whole complex of education that I mentioned earlier. DR. NELSON: I would certainly be able to say that we agree with you in your point of the importance. We would be committed to participating in the formulation of such a national education policy. 13 I think that you can be confident that the content of that conference would lend itself to be an important contribution in that direction. CHAIRMAN WATKINS: Supposing the Commission were to make a recommendation in our report that there’s an urgent need to bring the best of our educational minds together, and the technical talent at the highest level to scope out a national strategy on education as a first step in the prevention business as well as in the intervention business for those that are still afflicted and still we have been unable to affect the behavioral change. Do you think that is something that we should do ona rather urgent basis, if in fact you believe, as your report says, that education is our primary weapon right now? DR. NELSON: Yes, I do. CHAIRMAN WATKINS: Do you think it’s needed? DR. NELSON: Yes, I do. I don’t think there’s any question. As a matter of fact, I guess I said that several times in several different ways, but I’11 come right down and say, absolutely. I think that is the highest priority and absolutely the Association would be receptive to working with other conveners to provide assistance in that direction. CHAIRMAN WATKINS: Dr. SerVaas. DR. SERVAAS: In line with our chairman’s suggestion, I wonder if the AMA could do a poll of our members and see how many of our members -- or all physicians; maybe not just our AMA members -- to see how many would vote yes in a poll if we asked them, would you be willing to do free anonymous or confidential AIDS testing for any people who wanted it, their patients or others, who feel that they should be tested. Some people have complained to me in California and other states that when they went to their private physician to get tested, because of the long wait that you mentioned, that it cost $100 by the time they were finished getting their AIDS information. And I think that in view of the crisis, that is unconscionable, that a girl who maybe wants to get pregnant and can’t afford to find out and also hasn’t time from her job to go wait in line, and wait in line, and wait for weeks or months. I think could we poll -- could the AMA poll -- I’‘ma member of the AMA, and I have never seen any kind of poll about AIDS of the membership, and I’m just asking. This was done in the syphilis epidemic 50 years ago, and you’re all too young to remember that, but they did poll all the physicians in Chicago, and they found that 93 -- or unanimously the physicians said, yes, we will test everyone for syphilis free, and then they were 14 reimbursed, if necessary by Medicaid or Medicare or whatever the coffers were called in those days. But I’m very anxious to follow up on our chairman’s question a little beyond just education, but also educating those who are AIDS positive, what they can do to keep from becoming full-blown ARC or AIDS or ADC. CHAIRMAN WATKINS: Let me go back to the protocol I’d like to follow. I asked a couple of questions on a broad base. I’d like to stick to that, and then we’ll go to a specific question from Dr. SerVaas on what might be better done in the area of education for those with the virus that are asymptomatic at this point to enhance their lifespan, to give them some hope. So let’s take that on separately. But I think there may be other questions about the first discussion on education that we had. MRS. GEBBIE: Yes. With regard to education, two questions. First, are you working directly with any of the national education groups in thinking about your meetings or in thinking about education strategies? Have you established any liaisons with any of the federations of teachers or with school principals or with any of those groups that might really be experts in education? DR. NELSON: I frankly cannot tell you the degree to which contacts have been made at the staff level in terms of implementing our public education effort. We have an extensive coalition activity being developed in terms of adolescent health initiatives, and a good bit of that relates to sexually transmitted diseases. Part of that, of course, interfaces with our AIDS efforts. We have a huge education component of the AMA. As a Chairman of the Board and a practitioner, I can’t tell you specifically the level of communications. But we will provide that answer for you. MRS. GEBBIE: Another question about a liaison. Other professional groups are struggling with some of the same issues for their own practitioners. There have been headlines recently about dentists being reluctant to treat AIDS patients. Nurses are going through the same thing. Have you, or have you thought about, establishing a liaison with the other national professional associations, to look at common professional education or access problems where you might combine forces to achieve something? Instead of working on it individually. 15 DR. NELSON: Mr. Johnson provided me with some information. MR. JOHNSON: What I whispered was that the National Dental Association and the American Hospital Association had both contacted us, and we have pledged to work with them to work out joint statements and joint policies if that is possible with regard to these issues. That is a very central part of what we are trying to do in our AIDS policy. MRS. GEBBIE: I am pleased with that. I would urge you to look, as broadly as you can, at the various professions that might become involved to focus it. CHAIRMAN WATKINS: Will they be participants at your forthcoming conference on education? MR. JOHNSON: The concept of this conference is bring forward, first, experts in education, because it is not enough to know the substance of a message: you’ve got to be expert, sophisticated enough, to make the message work. Then there will be the groups who represent the interest groups that are involved: physicians, other health care workers, educators. The idea is to have a fairly universal attempt to get at education from -- not just physician education for physicians. CHAIRMAN WATKINS: Any other questions as a follow-up? Dr. Crenshaw? DR. CRENSHAW: I understand that, in California, the CMA is considering requiring continuing education units in AIDS for relicensure. We are a state that has a certain number required periodically for relicensure. Do you think that in states that have these requirements for physicians that it would be advisable, and might help to accelerate their learning process about AIDS, if this was a part of the relicensure process -~ a certain number of educational credits on AIDS information? DR. NELSON: I would think that it would be better for us to approach the education for this illness in the way that we approach our curricula and licensure requirements for other important problems that we have to have current information about. I am worried about state licensing authorities setting our curriculum, whether it is for continuing education or basic medical education. I think that there would be voluntary private sector initiatives, but I would prefer to see, rather 16 than having continuing education Brownie points, while they are still being used in some states, have been criticized as not being very effective in getting the job done. I think that it is important for us to continue to emphasize the obligation that physicians have to maintain competence in their education and training for this illness, as well as others. But I would not link it to licensure. CHAIRMAN WATKINS: Cardinal O’Connor? CARDINAL O’CONNOR: I have listened very carefully. I would appreciate it if the Chairman would clarify, once again, precisely what Dr. Nelson is being asked about the national education policy. Are you talking about a policy that would be put to work through the school systems, for instance? A policy of education directed toward the ordinary person? You seem to distinguish this from the education of physicians, or the education of persons with AIDS. I wasn’t quite sure of the thrust. CHAIRMAN WATKINS: My question was all of the above. My feeling is that we talk about education rather glibly, "Education is the sole weapon," and so forth. Yet, when we go out into the field and listen, we see a variety of educational forms, and we see variety in educational effectiveness. It’s in the mind of the beholder in many cases because there is a flurry of activity to put brochures on the street. It is difficult to evaluate how meaningful those brochures are to target groups, for example. My national education policy concept would include all of the things that the Cardinal is raising. I would say that it is not curricular in nature. It is much more of a framework, an overarching framework. We need to focus on all of these things in some kind of an integrated way, so that we can share the benefits of the programs that we know are successful; that we can focus on those in greater form; that we can begin to focus resources on education in a balanced way across the spectrum of all of these things. It seems to me that those can be racked up. They are in a variety of reports now. And, depending on the interest group, if it is a nursing group or of it’s any other health care provider, or a social worker, or so forth, we need to know how many counselors we need for the future. We need to know how to train individuals to work in some of these difficult areas that Dr. Primm, for example, is an expert at. 17 It seems to me that kind of an integration, just in its framework alone, would tell people: Here is what we are talking about in education. It is all of these things. When we talk about it loosely, we have to get more definitive. Some of the educational practices are putting out a brochure where the individual is not literate to read it or to understand it, or to be able to even find that person who is not in the school, if it happens to be the young people that we want to get to. That is what I am talking about. A variety of people that have to be brought together that understand these things, and are out there, at the grass roots level, trying to deal with real issues. Whole people issues. That is the kind of strategy I am talking about. Not so much that you put all of the flesh on those bones, but you would lay out a framework and say. This is necessary, and here is the AMA portion of this which we are going to get on to, but we want to be a participant in all others, since we are directly coupled with health care providing. CARDINAL O’CONNOR: Do you know of any model, any area in which we have a national policy on educating the public at large, and a variety of target groups? We have a broad spectrum of public relations approaches. The forest fire approach with Smokey the Bear, for example. The non-smoking approach that has been spearheaded by the Surgeon General’s Office. But these, it would seem to me, are still kind of ad hoc things dependent very largely on the good will of advertisers, or the particular interests of various educators, public figures, and so on. I have been sitting here trying to articulate in my own mind any national education policy that we have in any area, and I can’t think of it. Even in the detection and treatment of cancer. I wouldn’t call it a national education policy. I would say that probably radio and television have done more to educate the public on detection and treatment of cancer than we have done in our schools. Conceivably, we have done a lot in medical schools and such. But I have a particular target group in mind. I am not sure if you are ready to move into that. I have a responsibility for a major medical college, for 17 hospitals, for nine nursing homes, and for 14 child care centers. 18 I am deeply interested in education along these lines. I am trying to fit that within the framework of a national policy. Some kind of uniformity in materials, or a certification by AMA that these are, indeed, meritorious educational materials; that they provide accurate information, whether it be by way of television, pictorial information, or written information. I am deeply interested -- CHAIRMAN WATKINS: I hope it would not be that detailed at the outset. I hope it would be more a packaging up of what has to be done. We have had a lot of experience now, and it seems to me that trying to frame that in some sort of conceptual way that permits the kind of allocation of resources you were recommending, and the IOM recommends, requires tremendous effort in the area of education. There are bills on the Hill that put large dollars against education. Do we really know what it is? Have we defined it to Capitol Hill, to the state legislatures, and to the local levels, so that they can begin to understand how it is packaged up in a variety of forms? That is more what I am interested in. I am not interested in forcing on the local people with local needs a curricula development thing that is a standard across the nation in any way. That is not what I am talking about, because I believe very strongly that should be a grass roots concept, generated for grass roots needs for the local area. On the other hand, I do think some broad national policy on education is not a bad idea across the board anyway. Where do we have the health care promotion and education in our system today? The Presidential Commission said that half of it was gone from the nation. So where is the repository for dealing with it in many cases? Where are the teachers in this field? Where have they gone? Do we need to bring them back in a lot of ways? So there are broader concepts of the educational process here that seem to me to have great merit right now. I don’t know that we have one. Maybe highway safety is about the only one. I don’t know where else we have some kind of a national focus. But maybe it is time to do it. If we believe very strongly that this is the most serious epidemic that has faced the world, then it seems to me it might be time to develop a concept like that. You seem to be favorably disposed toward such a concept. 19 DR. NELSON: I want to make several points. First, from early on, the American Medical Association understood that currently the only effective answer to this illness is prevention. Second, in order to provide accurate information to their patients, and also to provide high quality care, we have and will continue to have a major challenge in providing scientific information, ethical information, to our physicians. Third, that our obligation goes beyond that; and that we have an obligation to provide information about the prevention and treatment of this illness to the public. That was responsible for our public service announcements; it is responsible for us encouraging physicians to be involved at the local community level and health education in the schools; in assisting in development of appropriate curricula, with school boards and the other responsible segments at the local level -- according to the local level’s needs. We understand the urgency in facilitating a national conference on education in relation to this illness. Out of that may come some components, or some elements, of an education policy if the rest of society -- certainly, if there is going to be a move in that direction at the national level, the medical profession has an obligation to be a participant at that table, to represent the medical aspects. That was the basis of my comments. DR. PRIMM: Mr. Chairman? CHAIRMAN WATKINS: Yes, Dr. Primm? DR. PRIMM: I had a question for Dr. Nelson. It seemed to me that your statements included a pro-contact tracing statement that you would recommend to your member body. How do you plan to have your member body actually implement the contact tracing? That’s number one. The second is, how do you plan to target those special populations that seem to be disproportionately affected by infection, and certainly by this disease, to your member body? Have you had any contact -- I noticed you said the National Dental Association you were working with -- have you had any contact with the National Medical Association, which is primarily a minority medical association, of which I am a member, in order to bring about some unified effort to target those special populations that primarily that group is responsible for the care in this nation? 20 CHAIRMAN WATKINS: Dr. Primm, let me just reiterate. I think it is very important that we stick to the topics and close them out. I would say that we have talked about my topics enough. I think that Dr. SerVaas had the next issue. I would like you to hold your two questions on contact tracing and how to target the disproportionate groups in certain areas -- just hold that, and I will get to you after Dr. SerVaas. Two questions from Dr. SerVaas. The first has already been asked. You might want to repeat it. It is on the subject of education for the HIV-infected individual. DR. SERVAAS: I think the AMA has done a great job on educating physicians. This book that you all have in your packets now came out several months ago in my mail. I think that it is an excellent book, and I like all the articles that have been appearing in the AMA to educate doctors. They can’t help it if some doctors don’t read; and not all doctors are members of the AMA. But I think the AMA has done a tremendous job educating doctors. But my two questions were: could the AMA, to get more attention focused on education, could we poll the members of the AMA and say to the members -- like they polled their doctors in the syphilis epidemic -- and say, "Would you be willing to test free, and could you collect from some government bureau, knowing that to run the test would be done by the state boards of health?" It is a very inexpensive test. It cost the Navy 81 cents or something when they tested. That way, could we ask the members if they would be willing to do it free, and let the public know that they can go to any doctor in the land and get a free AIDS test, and get counseled. We could then eliminate all reasons for not being tested by the people who want to be tested voluntarily. I particularly feel we need to be worrying about Dr. Primm’s girlfriends of the AIDS-positive drug addicts. And the girlfriends and the wives who are getting pregnant, not knowing that they are AIDS positive. I think we should reach those people. My second question is: could we also ask the AMA if we could suspend the reciprocity rules that keep do-gooder doctors in Florida from going and donating their services at Belglade to get the place cleaned up, to get them tested? 21 These girls that we saw in Belle Glade are pitiful. They don’t have enough money to care for these girls--the men either. Could we get a State of Florida reciprocity, for a short time only, and for Belglade only, and try cleaning up Belle Glade with missionary-spirited doctors who want to go in and help? There are many doctors who want to be of service who can’t be in Florida because if they are from Indiana or Ohio, they can’t go down there and practice free. And also suspend -- see what the AMA would think of suspending the insurance policy, and get some Good Samaritan rules in effect -- for this emergency only -- that allows people to practice without keeping expensive insurance up. So we could have the public sector go down and take care of a place like Belglade. Could we do that in the AMA? DR. NELSON: Let me address your question from two standpoints. First, the feasibility of surveys -- and we have done surveys all the time. Certainly at least we can do some sort of statistically significant survey. That is, it is possible for us to do some survey that would identify the proportion of private physicians who would be Willing to provide this level of voluntary care. I think that it goes beyond just drawing the blood and sending the test as we have indicated in our testimony. There is a certain amount of counseling that is absolutely essential if we are going to do testing. I think that our commitment to volunteerism extends into the care of these patients, too. Whether providing free care for those who are unable to afford to pay for physicians, or whether it involves physicians donating their time to participate in voluntary clinics to provide testing. Those are areas that we will continue to encourage our members to participate in, to provide services for those who need their help. I don’t know whether we can send out a letter to all physicians asking them to respond as to whether they would be willing to do free tests in their office. It may be that we could get the information through some sampling technique. We certainly will continue to encourage physicians to provide care for those who need it, including participating in systems to provide testing. DR. SERVAAS: This was done 50 years ago. They did poll all the physicians, and the physicians did answer. It was a 22 very successful way of finding out the extent of the epidemic; also finding out that the people would go in and be tested, and volunteer to be tested if they knew they could have it done free. We could reimburse very inexpensively. If we want to put the counseling on the public health officers, why don’t we put the counseling as a separate procedure, but not have the testing be a bottleneck? DR. NELSON: Any time that we engage in prevalence testing that involves large numbers of low-risk population, we run into a real problem with false positive. And with the possibility of destroying someone’s life based upon the information that is not accurate because of a certain, basic, irreducible minimum inaccuracy in any human endeavor. I think that our policy at this point is for us to increase our activity in prevalence surveying so that we know where this illness is going, and what the prevalence numbers are, better than we do now. We would continue to support the CDC’s activities in that regard, and we would continue to urge that clearinghouse capability be made available so that the wealth of scientific study information that is becoming available is integrated to give us better numbers than we have now. But the AMA does not have one, single recommendation in terms of how to get a handle on prevalence at this moment, other than to support the activities. DR. SERVAAS: I wanted to respond to your comment about false positives. We, in this Commission, have been told by the Department of Defense that false positives are not a problem; that it is one to three out of 100,000 tests on the false positives. You can even take that further and test those one out of three out of the 100,000 on Western Blot, and get it to only one out of a million false positives. We have false negatives when the antibodies are not up. But false positives are not a problem in destroying anyone’s health. We don’t need to tell anyone they are positive until their Western Blot confirmatory test has been done. Then it is not a problem. We should not confuse people into thinking that they can get a wrong answer when false positives aren’t necessary. We are told by the Department of Defense that this group can forget about the false positive problem; that it is one out of a million, taken to the extent, but it is one to three out of 100,000 Western Blot confirmatories. 23 DR. NELSON: I was speaking to the test being repeated on the ELISA and being confirmed with Western Blot. But even then there is a certain irreducible minimun. DR. SERVAAS: What? DR. NELSON: It has been in the article in JAMA. Of course, one can marshall his or her literature to support whatever the contention is. But perhaps one in 20,000. If that is the case, then as a practitioner from Utah, where it is a relatively low-incidence area, that would begin to give me a problen. DR. SERVAAS: But the Defense Department, who have done the testing, have not found one out of 20,000 where the testing has been done. MRS. GEBBIE: Dr. SerVaas? I was not here for that testimony from the Department of Defense. I think Dr. Nelson is much closer to what a broader view of people’s views are on false positives. I don’t think that is what he is here to debate today. If that is going to be an issue, we need some other witnesses and a broader scope of laboratory people to discuss false positivity. I just really urge you not to get into that debate this morning. DR. SERVAAS: As a physician, Mrs. Gebbie, I think it is very important that we don’t mislead the public in educating that our tests aren’t valid, but -- MRS. GEBBIE: I think your posture is misleading, and that’s my point. DR. SERVAAS: I believe that we need to face up to that before we start spreading out wrong information about false positive tests. It is very important. MRS. GEBBIE: My point is, without appropriate witnesses here, the way you posed the question to Dr. Nelson is, in and of itself, misleading. I am concerned that if we pursue it farther without better expertise, we will not be helpful. CHAIRMAN WATKINS: Let me step in. I think this is very important. The Commission is going to hold, on the 10th and 11th of December, hearings on prevalence. They are going to be organized by the working group chaired by Mr. DeVos. That actual meeting will be chaired by Mr. John Creedon. We will have an extensive discussion in this very area because I think it is clearly related to prevalence. We have to know what our 24 a | objectives are in the testing process; whether we have valid samples. We have to listen to that, and we have to listen to a lot of testimony. I don’t think we are going to resolve that issue here this morning. I would like to, unless there are other guestions specifically on that issue, I would like to shift to the second question of Dr. Nelson. MR. DEVOS: Admiral, let me have just one question for a minute on that. Dr. Nelson, as head of the AMA, I hear this discussion going on, how you are supposed to educate the world. We certainly desire your input on how that should be done. It seems to me the primary responsibility you deal with is education of a physician, as your primary responsibility. My question is, is that the consensus of a majority of doctors? It is 80 percent of them? Do you have any feeling for that -- the base of support on the report that you have given to us? I have talked to my local physicians. They say, "I don’t like this," or "I don’t like that that they are doing." Is there some range on that? Is that really a pretty unanimous thing from the medical profession of this country? DR. NELSON: The report that is the content of my testimony -- with the exception of those few ethical questions -- was adopted by our House of Delegates, which is a representative assembly, and which has one physician representing each thousand physicians, or a fraction thereof, as well as additional physicians representing all of the major national specialist societies. That is the policy-making body for the AMA. While in any democratic society there may be those who disagree with the policies that are set by the leaders, nonetheless this does represent the policy that was adopted by our policy-making body. MR. DEVOS: My concern is, is this a 60/40, or is ita pretty unanimous sense of direction? DR. NELSON: The report was overwhelmingly adopted by our House of Delegates. MR. DEVOS: I think that is important. You guys are the front line of the persons in the medical field. You are the front line of defense on all of these things. If there isn’t some sense of unanimity amongst that group that this is the direction for them to go as a profession, then the rest of us all get mixed up out here. I hope that what you are saying -- and I believe you -- that it represents where the medical profession is in this country, this is their position, this is what they think should 25 be done. I think, to get that unanimity is your number one challenge. Then, as they marshall their forces, we can go together to reach the rest of the people. DR. NELSON: They voted in an open plenary session after a reference committee statement. It may involve some disagreement, but that was worked out in a vote on this document. MR. DEVOS: I appreciate that. But we need that unanimity amongst that group; that they are marching to the same drummer on this thin, so the rest of the American people can develop the level of confidence that the medical profession is united on this way to attack the problem. And you are telling me that that is so, generally, yes? DR. NELSON: To the degree that a democratic process adopted this. MR. DEVOS: All right. Thank you. CHAIRMAN WATKINS: Now the second question on reciprocity laws--did you get that sufficiently articulated to you by Dr. SerVaas to be able to answer that issue? We picked that up in the Belle Glade experience in Florida. It seemed as though their demands were minimal. But the prospect of doing something special in a very isolated, unique area in the country would be very powerful in the sense it could send some hope to those areas that are afflicted seriously. That is the context in which the reciprocity question came up. I would like to have you address that now if you would, please. DR. NELSON: I really don’t know anything about Florida’s reciprocity statute. So I really can’t say anything other than I commented in general toward the concept of volunteerism and private sector initiatives to try and provide care where there are gaps in the availability of that. CHAIRMAN WATKINS: My understanding is there is a proscription against the migratory medical movement of skills and specialties across borders into states and counties. That might be the issue here. Certainly you must be aware of any kind of law that would preclude you, for example, as an AIDS expert, to be welcomed, to be able to move into the Belle Glade area. They are having tremendous problems getting the skills they need: one, to live in the area; and two, this business of skill needs perhaps aren’t there to the extent they need to be to solve one particular problem in the country. 26 It is small enough to be able to devote a few hundred thousand dollars and make a big difference. And to show us, perhaps, that we have an opportunity to do something special across the spectrum of health care. DR. NELSON: Kirk, do you want to comment on California licensing laws? I mean Florida. MR. JOHNSON: I thought the problem in Florida was that doctors were trying to get out of there because of the malpractice rates. But I do think that this is an issue to raise with the state licensing board. It is a kind of thing we can turn to the Florida Medical Association to handle emergency matters raised with the state licensing board to see if there is some way to handle particular problems, particular emergencies that you could get physicians from outside the state. That is a matter I think we would have to raise with the state licensing board because it is a matter of statute. Although not all states do have restrictive reciprocity laws. It is a matter to be raised with the licensing board and with the Florida Medical Association. We would be happy to pursue that. CHAIRMAN WATKINS: Good. Thank you. I would like to move on now. Dr. Primm is next. Then we will go to Dr. Lilly. Dr. Primm asked two questions. One on contact tracing, and one on disproportionate target groups. DR. PRIMM: Particularly on contact tracing, how would you advise your membership to implement your recommendation -- which seems to be pro-contact tracing? How did you plan to implement that? That was number one. The other one was the disproportionate representation of certain population groups among those who are both infected with HIV, and those who have gone on to full-blown AIDS. What is being done to target that group in terms of education and in terms of cooperative efforts on the part of your organization and the National Medical Association? And, particularly, the group that I am particularly interested in is IV drug users. I thumbed through your document, and I saw one mention. That was only an epidemiology of IV drug users, and they make up 25 percent of those thus far diagnosed according to the cpc. I think there needs to be a focus on that group, which I have really never seen come out of the AMA. I am asking for some clarification on that issue. 27 DR. NELSON: The contact tracing recommendation accommodates the fact that various states have different statutes that relate to reporting and contact tracing. We have completed work, and will be submitting to our House of Delegates model state legislation that provides for reporting, contact tracing, and clearly identifies the obligations -- and also the protections -- afforded to physicians who report patients who are HIV positive so that contact tracing can occur. This will be provided, then, to the states as model state legislation. It will be appropriate for some states to implement such legislation depending on their own circumstances. The role of the AMA is to encourage physicians to comply with the law, to make available model legislation that will clarify physicians’ responsibilities, and also their rights, in terms of notification and tracing. Then the local areas will accommodate that according to their needs appropriately. Insofar as the NMA is concerned, our executive committee met with their executive committee in July in New Orleans. The primary topic of discussion was AIDS, and much of that had to do with intravenous drug use--the problems that are associated with that. Particularly the difficulty in achieving behavior change. We meet with the representatives of the NMA on a regular basis. At our last couple of meetings this was an important topic of discussion. At our House of Delegates next month there are resolutions that deal with intravenous drug use and AIDS. So that will be debated further then. Out of that, I think, will come some recommendations. That is an area that is extraordinarily difficult to solve, as you know. I am not so sure that the AMA has an answer to that, other than to express our commitment to continue to try and work on correcting that problem. CHAIRMAN WATKINS: Mrs. Gebbie had a follow-up question on that same issue. MRS. GEBBIE: To follow up on the whole contact notification area. Even in states with good reporting laws, and a long history of requiring reportable diseases, it is often estimated that as much as 60 percent of gonorrhea is never reported to the state health agencies so no follow up can happen. What process do you have in mind, or what assurance can you give, that if the laws are passed physicians will be more cooperative on reporting, and allowing contact notification to go on through health agencies on HIV infection than has been our history with other STDs? 28 DR. NELSON: Just that we will promise to do our best. I think that physicians understand that this is a different kind of problem than the one we have been confronted with in the past. I have to assign some reasonable level of diligence and responsibility for my colleagues in coming to grips with this. And I hope -- MRS. GEBBIE: But you sense there is an interest to follow up on this one, perhaps a little more thoroughly? DR. NELSON: Yes, I think so. I think that this is an area that physicians are extraordinarily concerned with. We are frustrated in some states by having statutes that prevent -- or at least would seek to prevent -- even a reasonable amount of communications among health workers caring for persons with the illness. If physicians are going to provide decent quality of care to persons with this illness, we have to be able to use a team approach and share information about patients with other members of the team. We are frustrated in having some states have statutes that we think are unreasonable in that regard. MRS. GEBBIE: I share that concern. CHAIRMAN WATKINS: Second question. I think we better move on, because I want to get the other Commissioners, Dr. Primm. The second question? DR. NELSON: I answered them both, I think. DR. PRIMM: You did. I didn’t think sufficiently enough for me, but -- DR. NELSON: I did the best I could. DR. PRIMM: Well, I think we do need a more definite commitment from the American Medical Association, particularly on an area on substance abuse. That’s what I was trying to get to. I should hope that, as a physician in this country, and with the substance abuse so prevalent among the population, and so closely associated with HIV infection, that we begin to focus on that as physicians a great deal more. That is the kind of commitment I thought I would try to extract from you if that were possible, but I -- DR. NELSON: No. You can extract it from me. Insofar as our report clearly states in the public awareness portion -- and we are getting back to education -- I was thinking more in terms of some other direct, more forceful way of dealing with this problem. 29 But in the public awareness part of our report, it clearly states education and counseling aimed at high risk groups must be the first priority. So we understand the urgency of the point you make. CHAIRMAN WATKINS: Okay. Dr. Lilly? DR. LILLY: I would like to actually bring up two issues. Eventually I would like to come to the issue of discrimination. But first I would like to bring up something that you alluded to very briefly in your talk. You stated that the national policy that you recommend we develop should be capable of continuous review. That’s a very difficult subject as far as I am aware. Among the questions about that are, by what body? How is this body to be selected? What kind of structure will it have? And to whom should it report? I find those very difficult issues, and I just wonder the views of you and the AMA are on that subject. DR. NELSON: We identified in our report the need for a national commission that would have the responsibility for integrating, coordinating, and accomplishing this kind of review. To some degree, then, this Commission has the capacity or the potential -- if not the capacity, perhaps yet it has the potential -- to fill those needs. The important policy consi- deration that we highlighted was the need for this integrated, national focused capability. We are optimistic and encouraged by the accelerating activity of this Commission, and we think it is entirely possible that this body may fill some of those patient needs. DR. LILLY: It seems to me that any commission like that would need to have -- well, for example, are you recommend- ing that that commission oversee the scientific research and recommend directions that a researcher should take? If so, that requires a great deal of expertise. I think any kind of a commission, as this crisis goes on, will need increasing levels of expertise instantly available to it, if not within the commission itself. I am just wondering in that case, then how does one structure such a commission? How do you select the members? A very important question--to whom does this commission report? DR. NELSON: I think that we just aren’t prepared to deal with some of the details, albeit very important details. Our recommendations were phrased in rather general terms, and the bottom line on all of these was that we expected this to be evolving, and our reports will be on a continuing basis. I think that the questions that you raise will constitute the basis for some subsequent -- you ask very important questions. They are critical. At this point, though, we aren’t prepared to be 30 able to define the lines of authority and the totality of responsibility or how it is funded. But it needs to be done. DR. LILLY: I just think that there is a lot of expertise now, and that the government is getting advice from many different quarters, for example. I think that that is dispersed and subject to taking what one likes to hear, at present time. If there are any more questions on that issue? CHAIRMAN WATKINS: On that particular subject? Let’s move on then. What is your second question? DR. LILLY: My second question has to do with discrimination. You have talked at considerably more length about discrimination than you did about this business of the continuing review of the national policy. It seems to me that there is no question that we need firmer guidelines in this country about the problem of discrimination. I am wondering, to what extent do you think that existing legislation copes with that? Since, in my view it doesn’t cope very well with it, I am wondering if you agree with that, and have recommendations as to where to go with that? On what basis is the anti-discrimination recommendation going to come forth? Currently one of the main ones that is talked about is the equating AIDS as a handicap, and, therefore, the inability to discriminate against handicapped people is extended to people with AIDS. I am just wondering about a number of these technical details about discrimination. Our ultimate question is, what kind of legislation is needed on that subject? DR. NELSON: Let me begin, and then I will ask our general counsel to flesh it out. I will be brief. Existing legislation does not cope with this very well. We have achieved some major gains with our amicus activity, or activity in the courts, which Mr. Johnson can comment on further. The model legislation that relates to physicians’ responsibility to report to authorities and case finding also will have provisions that clearly protect persons who are AIDS infected from discrimination. So that will be part of the legislation. There will be a quid pro quo, a balanced piece of legislation that identifies responsibility for reporting, case finding, and protection from discrimination. You are quite right. There are gaps. That is the reason why we will be providing, within a few weeks, our model legislation. 31 DR. LILLY: If I can interrupt just a second. You are talking about the quid pro quo here. Now, isn’t the necessity for reporting essentially going to make grounds for making something, to whatever extent, public? Isn’t that going to open the door for discrimination? DR. NELSON: If a state decides that case finding is necessary for its public health, then it must also have in place statutes that protect the person who is infected from discrimination. That was the point I was trying to make. Kirk, do you want to add to that? MR. JOHNSON: I think that, although the situation can be improved, we are doing a much better job on discrimination. The Supreme Court decision earlier this year, with regard to the handicapped, and whether someone with a contagious disease can be considered handicapped under Section 504 of the Rehabilitation Act, which covers all federal programs -~- any program with federal assistance -- and all federal employees, has been pretty successfully interpreted by the courts to protect not only people with AIDS, full-blown AIDS, but also, recently, those who are seropositive but are asymptomatic. That is one specific proposal we have made with regard to improving the protection against discrimination for those who have the AIDS virus. That is, that if you are seropositive, you should also be protected from irrational discrimination. Section 504 sets up a balancing test, which is not a bad one. It says that you don’t discriminate based on fear or prejudice or some irrational view. You do individualized medical evaluations to determine if, in fact, someone is handicapped in the first place; and AIDS victims, patients with AIDS, have been almost universally now considered to be handicapped, as that has been interpreted. But then you also measure whether or not the person is otherwise qualified to work. That includes an assessment of the risk to third parties. So far, the medical evidence is pretty conclusive that casual contact does not spread AIDS. So the cases have almost uniformly been resolved in favor of those employees, or those persons in federal programs, who have AIDS, who have been dismissed or been discriminated against. I think as that case law develops, we are going to find -- at least in the federal sphere -- there is quite adequate protection. These cases need to build on each other, and they are, beginning with the Supreme Court case, Arline vs. Nassau County, which involved a woman with tuberculosis. 32 nT We have the recent case of Mr. Chalk, in San Francisco, who has now been reinstated in his school. The Ray family in Florida--those children were reinstated, although they have since left. So Section 504 has been pretty effective. There is a recent case now involving someone who is seropositive and considered handicapped. We would support that extension. With regard to the states and non-federal employers, most states pass laws which were modeled on Section 504 over the past decade. There is protection -- substantial protection; not complete, not perfect -- in most states today for persons who are considered handicapped, not to be the subject of irrational discrimination. The picture could be a lot a worse to be honest with you. I think it is improving. I think the state commissions and the medical community has done a pretty good job in trying to protect patients from irrational discrimination. DR. LILLY: I am not sure that I am talking about the legal discrimination at this moment now. Let me go back to the Arcadia case. Yes, on all available legal grounds, those kids are protected. But, in fact, they felt it necessary to leave. Thinking of another case that is very near home for ne, my home institution has expertise and has raised the money to establish an AIDS clinic for treatment of families affected by AIDS, for example. The neighborhood in which my institution exists has let it be known very clearly that that is not going to happen. There is no legal basis for preventing it from happening. Yet, clearly it is not going to happen. What kinds of measures can we take to fight against that kind of discrimination? MR. JOHNSON: I still think education -- we go back to that first. There is a recently poll in The New York Times that showed the level of passion of the public generally, with regard to patients with AIDS, has risen dramatically. A great majority of the American people do not believe that someone with AIDS should be discriminated against in any sense. DR. LILLY: But I think the great majority of American people don’t know anyone with AIDS. DR. NELSON: We, of course, would be more authoritative in speaking to what the medical community will 33 state in regards to members of the profession and our obligation not to discriminate. We have made a very forthright statement which you have seen. We understand, at the same time, that physicians are human, and that we are setting a very high standard which we will strive to achieve. Currently, we are comforted by the fact that we don’t know of instances where persons with AIDS are not receiving medical care because physicians and other health workers aren’t available, by their choice, to care for them. We also understand that the relationship between a patient and physician requires a level of closeness, and a caring of such intensity that some physicians may not be able to provide high quality care because of a level of carefulness that simply impinges on that relationship. In that instance, then physicians should refer the patient to someone who can provide that closeness. CHAIRMAN WATKINS: Dr. Nelson, we are going to move on. As is customary, we canceled the break in order to get the other questions out on the floor. Cardinal O’Connor is next. But, before we do that, what I would like to do is we will stick to just the Commissioners now. We don’t have much time remaining, so that they can get their two questions on the floor and have the dialogue that they feel comfortable with. But I would like to open the door to the American Medical Association, through you, to allow us to ask questions of the AMA from this hearing that we have been unable to address because of time constraints -- much as might be done on Capitol Hill -- and submit them for the record, if you could, to us. Would that be an acceptable process to follow? DR. NELSON: We would be very pleased to do that. We can assure you that we would respond promptly and completely. CHAIRMAN WATKINS: We really have a lot of questions, and it is going to be impossible to cover them all here. But you have one of the most prestigious organizations in the country. We are relying heavily on it, as you know, in many areas for advice. We will want to come back to you, and perhaps we will set up the same arrangement with the National Academy and Institute of Medicine later on today. We are going to want to dialogue with you a lot more, and like to keep the hearings effectively open. 34 But I wanted to just give the Commissioners a feel that they need not be constrained today to get all the questions on the floor at this time. So Cardinal O’Connor, you are next. CARDINAL O’CONNOR: Before I move into my question, which I will now abbreviate in light of what you said, I would like to make a follow up comment to the line of reasoning that Dr. Lilly was pursuing. It relates to discrimination and to what to me is an equally critical matter. I don’t want to make a statement. I want to raise a question, and express my own concern. Dr. Nelson, with your remarks about disclosure, you limit disclosure recognizably to very restricted circumstances. I am increasingly worried about any disclosure on the part of a physician of any information given him. I think that we are severely reducing an option that desperate patients have to talk to somebody knowledgeable about their problem. I don’t know the answer to this. I understand the ramifications of a physician’s not acting in a manner that some people might think to be responsible, not transmitting the information to appropriate authorities, or to other people who may have a right to know. The prior right of a patient to confidentiality and the confidentiality that will give him or her a sense of security about seeking treatment -- it seems to me that, more and more, this is going by the board in our court adjudications, in the regulatory procedures being imposed on physicians and other professionals. It worries me very much. I would like now raise my question about the advocacy role of the AMA. The Chairman just mentioned your tremendous prestige throughout the country. I wonder if that prestige is being used, and that the advocacy arm of the AMA is being used in some crucial areas now. Dr. Primm, I think very appropriately, raised the question about IV drug users. I am not sure that we really do have a national drug program. We have had a lot of talk about a national drug program. It has been announced repeatedly by the White House; I don’t say this critically of the White House, but I am not sure if we are seeing a major follow-through, major educational programs, major expenditure of funds. I think when we talk about the contracting or transmitting of AIDS by IV drug users, we have to put this into the broader context. We really have a significant, serious, national drug problen. We have a certain amount of effort to prevent the arrival of drugs into the country. But how serious is the overall effort? Has the AMA concentrated on this? Taken the issue up with governmental authorities? I have a patient right now who is almost certainly dying, and who apparently contracted AIDS by IV drug use five years ago. There has been an 35 incubation period for five years, which is something that worries me about testing, by the way. Now he is dying. I have seen a very significant increase in the number of IV drug users with AIDS. I get frustrated when I ask myself if we are taking drugs seriously, or if we are just throwing up our hands and saying, there is no answer. The twin question to this, to give you both at once, within the area of advocacy is: we have talked in here before, tangentially, about the exorbitant cost of AZT. I am given to understand -- my data may be erroneous -- that the single pharmaceutical company that handles it, developed it -- in large measure at least -- aided by a tremendous expenditure of governmental funds. Yet, that particular pharmaceutical company, I understand, retains a monopoly. Has the AMA the capability, or the willingness through its advocacy arm, to question the government and the pharmaceutical company on this? I think the cost is outrageous. Again, as someone whose primary interest is patient care, and who is trying to come up with the monies in some of our hospitals to provide patients with AZT who can’t procure it otherwise. This is of great concern to me. Would you comment on the advocacy potential of AMA in each of these two areas? DR. NELSON: The national efforts to change the numbers on drug abuse are a very high priority with us. We are forming coalitions as part of our adolescent health programs. They have targets, dates, in which they are certain to change those numbers. We obviously have testified in Congressional hearings and have participated in this area in a range of forums, and we will make available to you that record. Insofar as the availability of drugs and the cost, obviously we are monitoring the range of research being done, the drugs that are being evaluated. We have regular meetings with the leaders of the pharmaceutical industry, and discuss with them the costs, the amount of their expenditures that are devoted toward research, and so forth. I can’t comment on that particular medication because I don’t know the numbers that were involved in the development or what it costs to produce the drug. You would have to ask those manufacturers that question. I just don’t know. I can’t answer your question. CARDINAL O’CONNOR: Is it appropriate for you, is it too delicate for you to give an opinion about the government efforts in regard to drug control in the United States? DR. NELSON: Illicit drug control? Yes. CARDINAL O’CONNOR: I am talking about the IV drug use which, ultimately, is responsible for the transmission of AIDS, in many instances. Our drug program -- drug abuse is clearly a national health problen. 36 fT DR. NELSON: Absolutely. CARDINAL O’CONNOR: I am perfectly willing -- and I don’t say this facetiously -- to withdraw the question, if you think it is inappropriate for you to answer. Do you think that the United States government is seriously attacking the drug problem in the United States? DR. NELSON: That is a judgment -- I suppose that I would be more comfortable in saying that this is obviously an area that requires the greatest commitment on the part of all of us, because of the magnitude of that problen. CARDINAL O’CONNOR: That’s all I have. CHAIRMAN WATKINS: Do you have any questions? MRS. GEBBIE: I have a couple of questions. These questions also have some opinion behind them. In your recommendation six, you talk about where voluntary testing should happen. You use the terminology "patients with sexually transmitted diseases" just as an example. We have had a lot of problem around AIDS and HIV infection in getting people to understand that it isn’t certain classes of people, it is people who practice certain high risk behavior that need to be worried about. Only about half or less of the people that have sexually transmitted diseases go to sexually transmitted disease clinics. The rest are just ordinary patients in ordinary doctors’ offices. My concern about your choice of words is that this focuses attention on the sexually active person who comes to a public clinic, and not to the sexually active person who comes to Dr. Schnerdlap’s office and says, "Treat my symptoms." I want that doctor to also think of offering voluntary counseling and testing. Has that problem with your language been raised before? If not, do you see the point? Is there any hope of getting this wording broadened, so that physcians understand we mean any sexually active person who might have been at risk of this infection? DR. NELSON: It has not been raised in those words. I agree with your point. Recommendation seven says as a matter of medical judgment, physicians should encourage voluntary HIV testing for individuals whose history or clinical status warrant this measure. 37 I think probably a point you are making is that we should emphasize more to physicians throughout the country the need for them to be aware of their obligation to recommend, or suggest, or discuss voluntary testing in the private setting. I agree with that. MRS. GEBBIE: Second question/comment. Around the area of confidentiality. Public health clinics and public health agencies have looked into this. As we explore where confiden- tiality is breached around health care and medical treatment records, we have found at least as many -- if not more -- allega- tions of those breaches happening from records in the hands of hospitals and practitioners outside of public settings. In fact, investigative public health records have rarely, if ever, been put out into the public sector. It is my impression that we need to completely rethink the way doctors, nurses, hospitals handle the information that comes in their hand--both the written record and just the knowledge that accumulates in their head. To what extent has that been thought through by the AMA? Are you prepared to really become aggressive with our members about both their own offices and about hospital medical records to thoroughly assure confidentiality in that area? DR. NELSON: It is something that we continue to emphasize. It is something that we continue to be frustrated at our inability to provide the kind of protection that we tradi- tionally have wanted to do because of the number of people who have access to records, and the willingness that some patients have to sign a blanket release of information without any clear understanding of what the implications might be. Physicians, more and more, are putting less and less on their records in an effort to assure confidentiality in the face of an uncertain future. By the same token, we have more and more responsibility to document our decisions because of the risk of possible professional liability action. I don’t have an answer for you. Again, I would have to say that you make a point that we understand and struggle with, and that we will continue in our ethical pronouncements to make it clear that physicians have a responsibility to protect sensi- tive information related to patients. We have said that over and over and over again in our opinions of our Ethical Council, and we will continue to work on it. MR. JOHNSON: If I could just add on this? As I men- tioned earlier, we are talking to the American Hospital Associa- tion about some sort of joint action on AIDS and issues in the 38 hospital. Confidentiality is one of the key issues that we will be addressing together, and try to cover your concerns. MRS. GEBBIE: I would appreciate if you get something in writing on where you are going with that, and the Commission would receive a copy. MR. JOHNSON: Yes, we will certainly provide that. CHAIRMAN WATKINS: Dr. Crenshaw, we have about five minutes left. DR. CRENSHAW: I have two questions. The first is about the AMA’s anticipation of available health care personnel to meet the growing demands of the HIV epidemic. I read, about six months ago in the AMA newsletter that at that time the AMA was predicting a doctor glut. I heard over the months disquieting anecdotal reports, and other information, that indicates that some of the most popular internship and residency matching programs have not been filled. I have heard anecdotal reports of, for example, two dermatology residents in Florida that AIDS burnout caused them to shift from that particular specialty to another, and exodus from the infectious disease specialties. In relation to that, has the AMA done a prospective study factoring in the impact of AIDS? If not, would you? Do you assess this situation in the way that I am describing it? And, most important, what could be done proactively to alter the trend in a favorable direction? That is the first issue. The second is, I am puzzled -- and I would appreciate your comments -- on why the availability of interoperative transfusions, which has been with us for well over a decade, has not been made more clear to the general public, and encouraged by physicians? I understand that it is cost effective if someone requires more than two units of blood. Most procedures can be done in this fashion, where a patient gets their own blood back during surgery that is suctioned from their abdomen or chest within two-and-a-half minutes or so. The majority of major hospitals have these facilities available, and insurance covers them if it covers transfusion. Why has there been so little emphasis on this? I do understand it is emerging now. 39 DR. NELSON: In terms of manpower, the AMA has modeled manpower projections according to various supply and demand figures, various scenarios. That is available, and we can make that available to you. We have not specifically introduced the HIV epidemic as a specific variable in any of those models. Perhaps the reason for that is because we are still uncertain about the current prevalence. You asked whether it would be possible for us to do that. I think the answer to that is yes. I think that is something I will take back as a suggestion. So far as the residency and the impact of a relatively large volume of patients with AIDS, and its impact on the residency activity, we are hearing anecdotes of that becoming a factor in the selection of a training program. Not so much because the prospective residents are fearful of being in contact with persons with AIDS, but simply because it decreases the amount of time available for experience with other illnesses. They think, then, that the rest of the experience that they have to gain is diminished to a point where the residency is less rewarding to them, or attractive to them. That is a problem that we don’t have an answer to yet. We are beginning to sense that to be a problem, and the AMA, of course, is in communication on a regular basis with residency review committees. We are a participant in the accreditation process through which residencies are accredited, and we have ongoing dialogue with the American Board of Medical Specialties and AAMC. That is a topic of conversation that we are discussing. I don’t have an answer for you. On interoperative transfusions, why haven’t they been highlighted more? I am not so sure that I have an answer for you. I can make available for you, if you wish, a summary of the amount of communications that we have had on it. I remember some, but I can’t tell you the amount. Whether or not physicians throughout the country should be more vigorous in identifying that as an option for patients who are going to have elective surgery, I can certainly see some reason to do that. As a practitioner, I frequently have patients ask about that capability. There are obviously other alternatives, such as directed use of donated blood from other individuals, members of the family, and so forth. That, again, I suppose is something that as you properly point out requires more emphasis. 40 DR. CRENSHAW: I recently heard from a Red Cross presentation that directed donations was not considerably safer than undirected donations. I would just like to encourage the AMA to look into this both the cost effectiveness and the feasibility. I think it really would help people who are eligible for this type of transfusion, particularly bypass surgeries, cardiac surgeries, to feel more comfortable about going in for procedures that they might otherwise avoid. DR. NELSON: We will make your suggestion available to our board. At the very least, I am sure that we can ask one of our counsels to do a study on that whole question about the cost effectiveness efficacy, and whether or not that ought to constitute the basis for a stronger public position that we take. DR. CRENSHAW: Thank you. CHAIRMAN WATKINS: Thank you very much, Dr. Nelson, for an hour-and-a-half of answering questions. We will then follow up with a number of questions to the AMA that we would like to have answered based on your report. Both the report on AIDS, as well as the ethics, the recent report. The interim report, as well as the recent report on ethics. Is that satisfactory to you? DR. NELSON: Yes. We appreciate your invitation for us to continue to make available to you information. We will do so. I also can assure you we will respond promptly to any specific request pursuant to this meeting. CHAIRMAN WATKINS: Thank you. Thank you very much, Doctor. I would like move right into Commissioner business, and press on now, for the next 45 minutes, as one of our Commission members has to leave. Our first item on the agenda is to have Mr. Richard DeVos, Chairman of our Financing Working Group, give us a very brief report on where he stands now, and what is coming up for us in his area of concern. Commission Business: Report of the Commission Finance Working Group MR. DEVOS: Mr. Chairman and Commission members, the group that we have been asked to head up deals really with three portions of this particular problem of finance. There are a lot of fancy ways to say it. I guess it comes down to who gets it; who pays, and how much; and how are those who are ill going to be cared for. That’s a pretty simple report. [Laughter. ] We are delighted that three of our Commission members are chairing subgroups in this group. Mr. Creedon is working on 41 the matter of incidence and prevalence. He is holding on December 10 and 11 here in Washington a complete hearing with a variety of people on this subject to try and get our hands around what Dr. Nelson referred to as this unknown question of this incidence and prevalence problem. We are going to attempt to come to grips with that. We have people who are going to come and present information to us on that. Dr. Francis, from CDC and the California State Health Department, along with Dr. Fauci, of NIH. We have a Dr. Sivak, from the New York Medical College; Nancy Hessel, from the San Francisco Department of Health; and Mr. Warren, of the Pharmaceutical Manufacturers Association, coming for that. In addition to that, we have Dr. Curran of CDC; Dr. Axelrod, the New York Commissioner of Health; Dr. Langmuir, from Chilmark, Massachusetts; and Dr. Osterholm, from the Minnesota Department of Health. I guess you can get a rough idea of how broad a group that is. Along with others: Dr. Joseph, from New York; Dr. Wiley, from Berkeley; Robert Neumann, from Beth Israel Medical Center; Don Edwards, from the National Minority AIDS Council; Jane Delgado, of the National Coalition of Hispanic Health and Human Services; and Mr. Paul Kawata, of the National AIDS Network. So you can see we have an extensive group of people lined up to appear before the Committee at that time, to help us get our hands around the matter of incidence and prevalence. In addition to that, we have two other subgroups. Colleen Conway-Welch is dealing with the question of how much it is going to cost to care for people, and what are the best ways to care for them. That group will be holding its meeting later in January, probably, as they move forward, once we get our hands around the matter of incidence and prevalence. And Penny Pullen, our Commissioner from Illinois, is going to work on the entire project of who is going to pay for this; how should this be allocated between the insurance industry, the public and the private sectors. Once we get our hands around the incidence, the method of care, and the whole problem of costing, we can figure out how it is going to be paid for. So we are moving forward on all of those units, Mr. Chairman. I hope I will have more information forthcoming in the very near future. CHAIRMAN WATKINS: Any questions from the Commission about the approach that Mr. DeVos’ group is taking? Mrs. Gebbie? 42 MRS. GEBBIE: Just one thing. Instructing on the incidence prevalence given -- the discussion earlier this morning on true and false positives. I think it is very important that a very good discussion by a laboratory expert on true-false positives be a part of that hearing, so that people have some framework for understanding then how you interpret a series of findings. MR. DEVOS: I think someone is going to have to determine if that really belongs in this subgroup or not. I can’t tell you that right now. We are working on the financial side, and the prevalence. If that belongs in there, I am sure we will be glad to incorporate those findings. CHAIRMAN WATKINS: Mr. DeVos, we will pick that up on the staff. We will pick up Mrs. Gebbie’s recommendation. We will see which of the three hearings that most suitably belongs in, and then we will let you know. We will try to identify the expertise, through our medical review committee, of who we should bring to bear on it. I think it is a very important issue. It is one of what the Miami people call the "afraids" -- those issues that people are most concerned about out there. I think if we can eliminate some of those afraids by getting some facts on the false positives or negatives them we will be better off in dealing with that issue later on. So it is related, but I am not sure it is something that belongs here. MR. DEVOS: We are happy to deal with whatever you like. My problem around here is that it seems everybody gets broadly involved in everything. I am trying to focus us in on an area, SO we can get some answers in one area, instead of trying to be everything to everybody, instead of getting some specifics. We are happy to take your assignment, but let’s see if we can’t get some -- CHAIRMAN WATKINS: We may have to set aside a separate morning for that hearing. I am not sure which of the categories we are working under that it will fall most appropriately, but we will figure it out. MR. DEVOS: I go out with Mr. Creedon’s work with setting this all up. I know that Penny, as well as Colleen, will do excellent work as well. I understand there is one other thing we have been asked to take a look at. That has to do with AIDS in the workplace and employment policy. I understand that, if I am correct, is the additional assignment we would work on. We will have to get some people to specifically work on that element of this as well, if that is per your instructions. We will proceed with that as well. 43 CHAIRMAN WATKINS: Yes, that is correct. MR. DEVOS: So we will be working on AIDS in the workplace and the employment policies as they apply nationally. CHAIRMAN WATKINS: Dr. Walsh is not with us on the next -- excuse me, Dr. Crenshaw? DR. CRENSHAW: Correct me if I have overlooked this already, but in your financial analysis, are you also going to be taking an in-depth look at the hard costs of prevention, education programs, and so forth? MR. DEVOS: I don’t think that is a part of our assignment, on a broad education basis. We are looking principally at how many people get this, how are we going to care for them, and pay for the ones who have it. I think prevention is another subject. But I am not sure it is our mandate on this one, Theresa. It may be, but we didn’t factor that in. That is another whole huge subject. CHAIRMAN WATKINS: I think we have to divide this financial regime up in an orderly way. I think when we get into the prevention and education issue, which we will spend three days on sometime early in the year, that is probably the best place. We may end up having you go back and help us out in the financial analysis when we come up with some kind of recommendations in that area and take a look at it. But at this point in time, it is not in your charter to expand beyond that which we initially assigned you. It did not include this broad an area. It is clearly an important area, and has to be integrated because we are talking about a billion dollars being proposed by one of our prestigious medical organizations in the country -- and, therefore, we have to deal with it. It is in our charter, also, to come to grips with that kind of a financial estimate on education. But I think we might better put that in another section. MR. DEVOS: I would prefer that we just try to get our hands around how many people have it, and how we are going to take care of them, and pay for it. Then maybe we can go somewhere else on the other items. CARDINAL O’CONNOR: May I? CHAIRMAN WATKINS: Yes. 44 CARDINAL O’CONNOR: I am not quite sure what you mean when you say how we are going to take care of them. You are talking about, presumably, a disposition of funds. But that impinges on a whole philosophy of patient care. MR. DEVOS: Cardinal, Colleen -- who is, as you know, the Dean of Nursing at Vanderbilt in Nashville -- has got that one. They are working at method. In other words, we are going to have hospice, home care -- how are you going to fund that; medical costs. She is trying to put her hands around that as to the various ways in which you can administer that, so you can put a handle to the cost. That is a big assignment; I understand. CHAIRMAN WATKINS: I would like to propose to Cardinal O’Connor that we allow him, with Dr. Conway-Welch, to chair one day of hearings on care aspects that he brings up. I think he is most knowledgeable in that area. If he would be willing to accept that assignment on a date mutually acceptable, I think it would be very important for the Commission to have him chair that particular issue he raises. That will be scheduled early in the year. MR. DEVOS: We would be delighted. Because he probably has more knowledge of it than anybody else around the table. CARDINAL O’CONNOR: I would be happy to assist her when she chairs. {Laughter. ] CHAIRMAN WATKINS: Dr. Conway-Welch has requested Your Eminence, so I bring it up in that context. She has already asked me to ask you to please chair one day. CARDINAL O’CONNOR: I would be happy to reply to her that I would be happy to assist her. {Laughter. ] CARDINAL O’CONNOR: I didn’t know that the Chairman was CHAIRMAN WATKINS: Let the record show that he has indirectly accepted what Dr. Conway-Welch has requested of hin. CARDINAL O’CONNOR: I will assist her. She will make a wonderful chairwoman. 45 CHAIRMAN WATKINS: I would like to move on. DR. LEE: Mr. Chairman? CHAIRMAN WATKINS: Yes, Dr. Lee? DR. LEE: Mr. DeVos, it is interesting, I think, in the context of your hearing, that the Treasury Department, about a year ago, did this exact thing: an extensive analysis of what the epidemic is going to cost this country. They might be interested contributors to this particular conference. Also, the JAMA does have a finance committee. I don’t know if they have been invited. They have worked the figures on this, too. MR. DEVOS: I think our goal is to take all that data and see if we can’t come up with one central answer from this Commission. And we certainly call on them as well for their input. The first hearing, as defined now, is on prevalence and incidence, which will take place within a couple of weeks. If we can determine that, then everything extrapolates out of that. That one is going to be very important that John Creedon is running. Then we will get all the experts on all the others. CHAIRMAN WATKINS: Any other questions? [No response. ] The second item of Commission business is on the status report from the International Working Group. Dr. Walsh is not here today, but he has given us a brief written report that I would like the Executive Director to read for the record. Commission Business: Report of the Commission International Working Group MS. GAULT: We have just distributed the document that Dr. Walsh dropped off last night. Unfortunately, he has a group of international health care experts in today, so he could not be with us. I am going to read what he has given us. I think that he might want the opportunity to expand on this a little bit, since it is just a quite brief summary. It is of interest because the meeting that he attended in Geneva, on November 12 and 13, was about the establishment of a Global Commission on AIDS. So, for the record, I am going to read verbatim from Dr. Walsh’s notes. "The primary purpose of the meeting in Geneva was the establishment of a Global Commission on AIDS, as well as a working committee of countries and organizations participating in international work on AIDS. 46 "It became apparent early on that this was not to be accomplished because of the basic disagreements involved with the potential make up of the Commission, as suggested in the written correspondence. "Spirited but good-humored discussion was held, and a decision was deferred until after the first of the year. The remainder of the conference was devoted to the description of the development of the strategy of the global war on AIDS, the formation of the Geneva staff, the creation of regional field offices, and the discussion of the budget for the next year. "Voluminous supporting data on all of these points will be provided to members of the Commission. In summary, a projected size of the Geneva staff will be 41 professionals and 49 support staff. This will be independent of the staff in the regional field offices. "The projected budget for the next fiscal year will rise from $45 to $66 million, all of which will be collected by special voluntary assessment. The majority of donor nations present indicated their willingness to contribute again in the next year, and several indicated they would increase their contribution. "The Swedish delegate pledged a doubling of the Swedish contribution for fiscal year 1988. The United States contribu- tion, which was made through the Agency for International Development for the present fiscal year was approximately $6 million. "The American delegation did not indicate the level of their commitment for the upcoming year. "There was ample manifestation of increasing concern about the numbers of reported cases from all countries. But, once again, it was emphasized that in many nations death from other, and so-called "usual" causes were far exceeding the anticipated death rate from AIDS. It was further emphasized to all present by both Dr. Mann and Dr. Mahler that the outlook for either an appropriate vaccine or successful therapeutic agent was, quote, dim indeed. "The schedule of regional meetings was presented, and it was apparent that Dr. Mann will do all in his power to push education as his prime weapon in every area of the world for the foreseeable future. Prevention rests in education." MS. PULLEN: Mr. Chairman? CHAIRMAN WATKINS: Yes, Ms. Pullen? 47 MS. PULLEN: Since Dr. Walsh does not refer in this document to the organization from which it springs, I am assuming this is the World Health Organization. Is that correct, or is it an ad hoc international group on AIDS. MS. GAULT: I believe the World Health Organization was the sponsoring organization, yes. MS. PULLEN: When he is talking about the size of the Geneva staff and that sort of thing, he is talking about WHO’s AIDS program? MS. GAULT: I believe he is talking about a new entity that would be set up separately. MS. PULLEN: Spun off WHO? MS. GAULT: Yes, but really established separately; probably chartered separately. MS. PULLEN: Thank you. CARDINAL O’CONNOR: Do we know what the debate was on the composition of this entity that you speak of? MS. GAULT: He doesn’t make reference to it specifical-ly. Over the phone he said that it was the same type of debate about who gets represented, who are the experts in the area; the same type of debates that have occurred in this country over compositions of state commissions, federal commissions, and the like. CARDINAL O’CONNOR: There was no great international clamor that this Commission be part of that group? MS. GAULT: I think as the Commission’s representative in this meeting, I believe that he felt that his status as an observer was most helpful. CHAIRMAN WATKINS: If this Commission becomes the focal point of international need, we will have achieved our purpose. (Laughter. } To date, it hasn’t had that stature. I assure you that we will do our best to be requested by the other nations of the world to participate with them. At that time, we will decide who wants to stay on the Commission in perpetuity. We look forward to that opportunity. [Laughter. } 48 DR. SERVAAS: Mr. Chairman, last night we talked about the AIDS positive individual. Dr. Primm had a suggestion about alcohol. I would like to pass out our effort to all the Commission members to show what hope there would be, what things AIDS positive individuals can do to hope to prevent going on to get AIDS or ARC or ADC. If any of the Commission members have anything to add to this or delete from this list of things, but I think in education, this could be very effective. You mentioned hope. I think our minister at home who has AIDS wishes that we would stop talking about it being always fatal and giving, especially to the AIDS positive people, all the things they can do to keep from getting ARC and AIDS. CHAIRMAN WATKINS: We will certainly accept this input from you, Dr. SerVaas. It will be an area of great interest on the part of the Commission, I know, as we approach the educational programs. We will put it in that context. If there is something we can do earlier to indicate a need, if there is a need today to focus on this particular issue with the HIV- infected individual, education can certainly do that. DR. LEE: Thank you, Cory. This was in response to something I asked about a month ago. I knew of Cory’s interest in this, and asked her to list as many health maintenance reasons as possible that would encourage people to be diagnosed early. In other words, what are the advantages to being tested and diagnosed as early as possible after infection? Commission Business: Introduction of Physician Review Committee CHAIRMAN WATKINS: Thank you , Dr. Lee. The next item I would like to address this issue which I raised at the October 16th meeting, at which I stated I was in the process of assembling a group of advisors from the medical community to advise the Commission on AIDS-related technical and health care issues. The team has now been established. I’d like to announce their names at this time. First is Dr. James L. Baker from the Johns Hopkins University School of Medicine. He provides care for AIDS and other patients in an emergency department setting. He is active in AIDS-related research at Hopkins. Dr. Baker is working with the Commission on a full time basis as our Coordinator for Medical and Scientific Affairs. He provides the primary liaison with the medical community. He also chairs our newly created Physician Review Committee, which helps the Commission in its day to day staffing efforts. I’d also like to name the Review Committee members, who I should note are donating their time and expertise to this 49 Commission. Some of those are here today. After I announce who they are, I’d like those present today to stand, and for Dr. Baker to raise his hand, if he would, to let everyone know who he is and who his people are. Dr. John Johnson, is a specialist in pediatric immunology, Director of the Pediatric AIDS Program at the University of Maryland. Dr. Philip Pierce, is Director of the AIDS Clinic at Georgetown University Hospital. Dr. Timothy Townsend, is a pediatrician, and the hospital’s epidemiologist at Johns Hopkins. Dr. David Henderson, is Coordinator of AIDS activities at the National Institutes of Health, Clinical Center. Dr. Gerald Friedland is Professor of Medicine and Co-Director of the AIDS Center at the Albert Einstein College of Medicine. Dr. John Bartlett is Professor of Medicine and Director of AIDS Patient Care at Johns Hopkins Hospital. Dr. Alfred Saah is an Associate Professor of Epidemiology at Johns Hopkins School of Public Health and a collaborator in the multi-center AIDS cohort study. This team will be available to the Commission to assist in providing access to accurate medical data ona continuing basis. They have been working, they have been extremely effective to the Commission. We are proud to have them. Dr. Baker, if you will, stand up with the team members who are here today: Dr. Baker. Dr. Townsend. Dr. Pierce. Dr. Johnson. Are there any questions regarding the Physician Review Committee and their staffing responsibilities to me and to the rest of the Commission? Dr. SerVaas? DR. SERVAAS: I have another question to bring up. It doesn’t involve staffing. CHAIRMAN WATKINS: Let me finish with the scheduled business and then we will have any new business that you want to bring up. Any other comments about our Physician Advisory Group? DR. LEE: I want to commend you for getting together such an outstanding and impressive group of physicians. Their individual and combined expertise is this field is extraordinary, and I welcome the opportunity to work closely with then. 50 CHAIRMAN WATKINS: I agree. I really think this is a tremendous group. We met about ten days ago. Their willingness to participate and to take time out of the valuable work they are doing to come with us, because they recognize the importance of this assignment, and the fact that they can really influence national policy, and they recognize fully that the recommendations coming out of this Commission particularly in their area of expertise will also be referred to a higher level medical review group, some of the top people in the nation. We will have good balance in our final report. They are the day to day staffing expertise that will lead us, I hope, to a report finally in June, that will receive the nod of approval from the best in the nation as well. DR. PRIMM: Admiral, is that the final list of persons that will be technical -- CHAIRMAN WATKINS: It is not a final list. Dr. Baker has been told by me that when we need a health care provider of any kind, social worker, for example, with experience in the area to help us on something, that he will call that person in, so if you have ideas of additional contact points for him, particularly those who serve in the Washington/Baltimore area, we want to have access. We are not interested in a lot of travel expenses. We have the talent in the area. These doctors have been recommended to us by the AMA in post-consultation. We feel comfortable that we have a good balance but we know there have to be additional support. It could be somebody from the nursing profession. It could be a social worker, a number of people with different skills that can support us in that area. Any recommendation you have, please give to Dr. Baker and he will bring them aboard. Commission Business: Discussion of the Preliminary Report and Future Hearings CHAIRMAN WATKINS: The most important item of Commis- sion business today, the new business, and then we will go to Dr. SerVaas’ point, is on the discussion of the Preliminary Report. I have that discussion prepared for the Commission. I would like to go through it now. As all the Commissioners know, we were tasked in the President’s Executive Order to submit a Preliminary Report to the President no later than 90 days after the Commissioners were sworn in. At the time I accepted the President’s request to assume chairmanship of this Commission six weeks ago, I was most concerned about our ability to meet the December 7th date for the preliminary report. The Commissioners shared my concern. 51 Nevertheless, we all subsequently agreed that we should assert whatever effort was deemed necessary to meet our preliminary reporting responsibility. We have done exactly that and the report will be submitted on time. Our informal discussions with White House staff indicated that the Preliminary Report concept was included in the Presidential Executive Order, so that after a short period of time, the President would know where the Commission stood in its deliberations and where it was headed in more specific terms, for the remainder and probably more substantive portion of its term. The objective over the past few weeks has been to attempt to focus the Commission’s very broad mandate on a finite set of emerging issues raised during our first three months of site visits, hearings and report reviews. By so doing, a road map to achieve all tasks by June 1988 could then be structured. This road map will become the centerpiece of the Preliminary Report to the President. Despite my short tenure as Chairman, I feel confident that we have been presented with sufficient material thus far to permit development of such a road map that will guide our activities over the remaining six months. In particular, our most recent hearings and site visits in Florida helped identify issues that those on the front lines of AIDS feel are most important. These individuals include persons with AIDS and their families, the community based care providers and support group, most of whom are volunteers, the more traditional health care providers, biomedical researchers, state and local officials, and many other citizens with views on the HIV epidemic. A number of issues repeatedly raised in Florida and during prior site visits and hearings called for some immediate as well as longer term attention, and will serve to solidify our future agenda. Over the next few days, each of you Commissioners will be asked to participate in drafting the Preliminary Report. Staff work has already commenced, as you are all aware. In that regard, each of you will be asked to review our planned activities, to convince yourselves that we are covering what you consider to be the most urgent near-and long-term issues, which can ultimately lead us to a more meaningful final report. In this regard, I expect suggestions for Preliminary Report inclusion will be based largely on items of concern raised by the many witnesses who have already appeared before us. Because of the overwhelming interest expressed by Commissioners in virtually every expected topic to be covered in the future agenda, I would like to offer to each Commissioner the 52 opportunity to chair or co-chair one or more hearings in areas of your personal interest and expertise. For example, Dr. Primm has indicated his interest in chairing hearings in December on IV drug abuse and AIDS. I would hope that other Commissioners would also take the opportunity to chair hearings on subjects of particular interest to then. As a related matter, I would also propose that those Commissioners who chair these hearings assume the added task of helping the staff coordinate final report material in their selected areas of interest, as the next few months unfold. Your willingness to chair such hearings and assume some burden of report coordinating responsibility, as well as your request for specific testimony to be included in any of these hearings, should be forwarded to me as soon as possible. I would like to open that brief discussion on the preliminary report and where we are headed now to the Commission for any comments they might like to make. Dr. SerVaas? DR. SERVAAS: If you are asking for volunteers, I would like to volunteer for prevention with special emphasis on identifying the accuracy of the question we said we were going to take up later, getting the experts in as Mrs. Gebbie reported. CHAIRMAN WATKINS: Any other comments? DR. LEE: Jim, I am very interested in these legal and ethical matters. I don’t know how we plan to structure that. I think we have to give it some thought. It may not as appropriate to have a doctor chair a session on legal matters as it would be to have an attorney chair it. I don’t know who we have. Maybe it is appropriate. I would love it myself. CHAIRMAN WATKINS: As you know, I pointed out in the October 16th hearings that the first order of business was to get this technical/medical staff on board and working. This was absolutely critical. We needed that. The Executive Director and I and the other staff members need that on a day to day basis. We have found it to be invaluable so far. I also pointed out at that time that we would probably be moving into a similar concept with legal. Financial is coming along under Mr. DeVos and he is assembling his team of experts in that particular complex field. We are right now searching for the right member of the staff that has the proper credentials in the legal area to work with us and perhaps also develop some kind of an advisory team along those lines that might come in on the same pro bono basis as the doctors. I think it is unfolding. Certainly, it is 53 going to be a key area of interest. My experience with lawyers is that you would make a very fine chairman to help them frame their thoughts, Dr. Lee. DR. LEE: I would like to help them focus their thoughts. I’ve spent some time in New York with the legal profession in the last couple of weeks, some intense meetings. The issues that come out of this -- discrimination, liability, ethics, etc. -- really are going to be among the most interesting for our Commission. CHAIRMAN WATKINS: This is a very important element of our deliberations. As you know, it is on the schedule and it is a very key part of the mandate, to look at the legal as well as ethical and medical and financial and other aspects, social aspects of the disease. MR. DeVOS: This isn’t an attempt to get even, is it? {Laughter. } DR. LEE: In a way! {[Laughter. ] CHAIRMAN WATKINS: It focuses heavily on liability of doctors. DR. LEE: Liability caps, I am particularly interested in. {Laughter. } CHAIRMAN WATKINS: If there is no other discussion, I will assume -- Dr. Crenshaw? DR. CRENSHAW: I provided you something in writing a ‘bit ago that you have in your files, the areas particularly are education strategies and behavior modification, and in particular a focus on our children and our teenagers along with that aspect, and the psychological and societal concerns as they affect the quality of life of those who are affected and those who are having to deal with that, which includes health care workers. There are a few others that I will provide for you in writing. CHATRMAN WATKINS: We accept your willingness to chair one of the hearings in that area. We will work it out, because there is going to be a number of people very interested when we get into the field of prevention as well as care. I want to have everybody feel some ownership in the final report that comes out, so we all feel we have given our pound of flesh appropriately to this effort. I encourage you all to come in. 54 We will work out the hearing schedule so you can all ensure that you feel comfortable that the right witnesses are before us, because we are going to base our final decisions on what comes before us, not what we may think in our own minds is important. We have to hear it. If we don’t hear it is important from the floor, then it is not going to be important in the report. We have to lean on what is before us, and it is incumbent upon us to select a cross section of witnesses that give us a balanced view across the spectrum of each of these issues and we are willing to accept that. We want you to participate. We want you to chair. We want you to be very much a part of this report. That is the context now that we are working in, rather than trying to establish a whole host of working groups which become somewhat of an administrative nightmare. I think it is better that the Commission stay focused as a group on these important issues. The Commission stands in temporary recess. [Brief recess, during which Commission members and staff assisted an individual who had fallen and been injured at the back of the room. ] CHAIRMAN WATKINS: The Commission will now come to order, please. We will wrap up our business. We completed the only new item of business that I had. Now, Dr. SerVaas? CARDINAL O’CONNOR: Excuse me. There is a very, very strong tendency and I think it is frequently fatal for an interim report to be considered in essence as the first draft of a final report. From that point on, one merely expands that or modifies it. I would think it would be exceedingly important for this to be clearly labeled as an interim report, doing what you are talking about doing here, which I think is a very good idea, simply providing a road map, showing what we have been up to and directions in which we seem to be moving, but not providing the kernel of proposals, recommendations, findings, so that we are then virtually set in concrete, either in reality or in perception. I would urge you as Chairman that any publicity given to this interim report, it be stated with excruciating care that this is a report on what we have been up to and is in no way a first draft of the ultimate report. CHAIRMAN WATKINS: I share your views 100 percent, Cardinal O’Connor. I think if I haven’t transmitted that same concept to the rest of the Commissioners, I would hope they would raise it now. I think you have hit on the key point of our preliminary report, as it is called in the Executive Order. You have framed it exactly right. That is the intent. The drafting 55 that is now in process is proceeding along that line. You haven’t had the opportunity. A few of the Commissioners have been able to help us in the drafting process. More will be working with us in small groups tonight so we can continue our staffing effort. We will be communicating with each one of the members to make sure they feel comfortable with that report for its submission on the 7th of December. Any other comments along those lines? Does anybody disagree with that as the framework? That certainly has been my intent all the way that would be the concept. [No response. } CHAIRMAN WATKINS: Dr. SerVaas, do you have a new item of business for the Commission? DR. SERVAAS: I do. I’d like to ask all of the Commission, I talked last night at dinner with Dr. Primm and he has shown an interest in going with me and any other Commission members in New York who want to do this, to the Magazine Publishers Association, which is a very large, influential body, representing a lot of magazine publishers, and/or going to Magazine publishers individually, like Forbes, Rolling Stone, Cosmopolitan, and getting in the centerfolds of their magazines a survey, so that we could help to get to the President an idea of what the public -- if we could get maybe 20 or 30 million responses. I am passing out 10,000 responses we have from the centerfold from the Saturday Evening Post, it has a very small circulation compared to Reader’s Digest, Rolling Stone, and all the other magazines. We want to involve Madison Avenue. I think we could all add or subtract from the questions we put out here, but they are questions like at what age should children be taught about AIDS. Surprisingly, there is a really great consensus. We were surprised at that. We asked questions like do you practice anal sex for reasons to prevent pregnancy, and we were surprised how many of our readers did that, and then we asked do you practice anal sex for reasons other than to prevent pregnancy and we had an even larger number answering, over 1,000 said, yes, they did, other than to prevent pregnancy. That tells you something that even Theresa Crenshaw may not know, how many people in the country practice anal sex. Only a small percentage of those who used to, do it now, which is exciting, because it means we are getting somewhere with education. I would like to ask your permission to do this as an ad hoc committee of the Commission, and if not, independently as individuals. If the Commission would appoint a committee and if 56 Dr. Lee and the Cardinal and Frank Lilly, anyone in New York who wants to go and help us to get a lot of insight on what the people of America are doing and what they want and what they believe, and put any new questions in, each magazine would not need to put the same questions in, as long as they overlapped enough so that we would get huge numbers of people and their views on what they want on the socioeconomic problems of AIDS as well as the education, where all of us have a stake, the American people. If we can give that to the President, it would sort of get him off the hook and we would not need to present a rubber stamp on everything that has already been done. We could do something creative and original so that the President could say 40 million Americans believe this. We think going to the magazines of America and maybe some newspapers, we could get that consensus, referendum, if you will. CHAIRMAN WATKINS: Let me say I think it has to be clear that when we are presented with something like this, in open session for the first time, although we have seen some of these surveys, we have to take it and staff it with the Commissioners. We have to decide whether this fits our agenda for the future. We are submitting a Preliminary Report to the President; it tells him where we are going, where we have been. If this fits into one of the important near-term agenda items that we find essential to carry out our mandate, fine. If it is just a survey to get information and doesn’t seem to fit into the context of the Commission’s structure and schedule, then I think it is going to be more difficult. We just have to take time. I don’t think the Commission right now is going to endorse any need for a national survey until we have decided what we are trying to say. What is the point of the survey? I’m not saying that it doesn’t have very good rationale. I am merely saying we have not had a chance to discuss it, where it fits into the scheme of things. I’d like to postpone any decision today until we have had a chance to look at this and each Commissioner has had a chance for input on it. Does anyone else have any comment? DR. LILLY: I just have two quick comments. I think any such proposal should not be undertaken lightly. If we were going to do something like that, we need a great deal of input from statisticians who know how to construct surveys that turn out meaningful results and that type of thing. It is not some- thing to be done casually. Point number two, I’m not sure it is the Commission’s task to sample the public opinion. I think if anything we need to lead and not to follow the public on major issues. 57 DR. SERVAAS: May I respond that the scientific data on magazines is very, very complete. We have many, many surveyors who survey for advertising reasons. They know exactly what the demographics are for Rolling Stone, for Cosmopolitan, Reader’s Digest, any publication that we have. We can have a scientific program. We don’t need to follow the public on scientific matters. We certainly should follow the American public on ideas about educating our children, at what age do we want to educate our children. We certainly can find out a lot from this kind of survey, where we could give 50 million names of people in America who want certain things for AIDS education that we couldn’t get any other way. We have looked at the Hudson Institute survey and we have looked at other surveys in the Commission. What I am asking is, could we look at this as a possible avenue or approach that would not cost a lot of money but would give us a lot of informa-tion in a rather short time. CHAIRMAN WATKINS: Let me say the Commission will take the recommendation and take a look at it. We will get input from the other Commissioners. I want to see where it fits in the strategy that we have now agreed to, the general concept, to report to the President, and we will pick it up at a future open hearing. The hearing is now in recess until after lunch, at which time we will be hearing from Dr. Thier, and Dr. Widdus, on the Institute of Medicine, National Academy of Sciences’ report, Confronting AIDS. (Whereupon, at 11:50 a.m., the hearing recessed for lunch, to reconvene this same day at 1:00 p.m.) 58 AFTERNOON SESSION [1:05 p.m. ] CHAIRMAN WATKINS: The Commission will now come to order. For the single agenda item this afternoon, we have with us Dr. Roy Widdus, Project Director, Confronting AIDS. He is also Director of International Health, Institute of Medicine. He is Special Advisor to the World Health Organization. He has with him Dr. Heather Miller, Program Officer, Committee on Behavioral/Social Science Education. Also Dr. Robin Weiss, Coordinator-designate of AIDS Activities, and Dr. Mary Jane Potash, Program Officer for Drug and Vaccine Development. We thank you very much, Dr. Widdus, for coming before our Commission this afternoon. We have all read Confronting AIDS, a very thorough report. We know that the Institute of Medicine is in the process of updating it. The Commission is awaiting your testimony. I know we will have many questions. I will be following the same procedure on the questions announced earlier. I will probably ask the first two. We will have two per Commission member. We will give precedence to those Commission members who didn’t have an opportunity to ask questions this morning. We will try to get to as many of the questions as we possibly can in the time allotted until 4:00 this afternoon. We will want to promptly terminate at that time for travel purposes. With that introduction, we welcome you to the Commission and we very much appreciate the work you have done with Dr. Lee and our staff, and the liaison we have had with the Institute of Medicine in preparing our thoughts. Institute of Medicine Report Confronting AIDS: Directions for Public Health, Health Care, and Researach DR. WIDDUS: Thank you. I will be describing for you this afternoon some of the past activities of the Institute of Medicine and National Academy of Sciences in the AIDS area, and then moving at the end to describe some of their current activities. The past activities are largely under the auspices of a committee called the Committee on National Strategy for AIDS, and this is a committee established by both the Institute of Medicine and the National Academy of Sciences. Those organizations are sister organizations and operate under a charter granted in 1863. That charter imposes a responsibility to advise the Government in the areas of scientific concerns and also to initiate activities that the memberships of those bodies feel is important to the national interest. 59 The membership of NAS, as you probably know, represents very distinguished scientists across the field of basic research. The Institute of Medicine also has members in the basic research area, but also contains leaders in health care and public health and other health related professions and ethics. The point I am trying to make in the early part of my talk is that the report which you have, Confronting AIDS, is the basis of a very broad consultation, with a large proportion, per-haps the majority of the biomedical and public health communi- ties, and it is essentially a consensus document. Positions arrived at in that report were to the great- est extent possible based on data, our expert judgments represent very well thought out broad judgments and what I think represents a broad constituency. If we had to make recommendations in areas where there was not a great deal of data, we tried to do so in an investiga- tive fashion, and I will mention this when I talk about the questions on AIDS among drug users. We have emphasized the committee composition included biomedical researchers, clinicians, public health, epidemiolo- gists, individuals connected with health care financing, aspects of law and ethics concerned with the epidemic and behavioral sciences, individuals from the educational field. The committee backgrounds included individuals from the private sector, both from for profit, not for profit, such as universities, and service industries like the insurance industry. In the public sector, we had representatives of Federal agencies, individuals previously involved in Federal agencies and individuals concerned with state activities. We operated through a steering committee composed of four individuals from the health care and public health panel and four individuals from a research panel and four at-large members. The research and public health panels each had additional members bringing their membership totals up to 12. There was an epidem-iology working group that met twice and a financing working group that met once. Our activities in building the broad consensus which is represented in Confronting AIDS included the background papers on the state-of-the-art in particular areas; east and west coast public hearings; as I mentioned, two epidemiology workshops; and one financing workshop. At the panel meetings, there were many 60 individuals who were called in to provide testimony. I think we consulted approximately 200 people as advisors and consultants. A list of most of those are included in the back of the report. I will very briefly state some of the very major conclusions of the report so that it sets the scene for what I am going to do which is to go through the individual chapters, mention their major conclusions and add any additional new information. One of the major conclusions from surveying the field was that it was unlikely at that time vaccines would be available before five years from when the report was published. There is a considerable amount of pessimism, I think, about the prospects of vaccines. I think even though we are a year later, I don’t think the prospects of vaccines have improved significantly. You will probably ask, are some vaccines safe to be in trials at the moment. Those are very preliminary investigations. The movement is something into a preliminary investigation such as phase one clinical trial, but by no means indicates it is likely to be a useful therapeutic or preventive product in the future. In the area of drugs, azidothymidine had just become available at the time we published our report. That is now used and is prolonging life among some AIDS patients. AZT, while it is a very encouraging step, it is certainly not by any means an ideal therapeutic for AIDS. Many patients are not able to tolerate the side effects. We do not yet know whether AZT will be useful for other sorts of AIDS patients, than those with pneumocystis carinii pneumonia; and we do not yet know, although it is under trial, whether it will be useful in asymptomatically infected individuals. The Institute convened a meeting approximately two months ago where we looked at the prospects for drug development and what was needed to promote that area. The information that was presented at that meeting was that a large number of other drugs are in various stages of development, but it doesn’t appear as though there will be anything within the next year or two to supplement the usefulness of azidothymidine. Anything that will be available perhaps after a year or two from now is likely to be of the same category of drug as azidothymidine. In other words, it will be a reverse transcriptase inhibitor, and will have probably some of the same side effects, perhaps not to the same degree. General thoughts in drug development are that there is going to be an incremental and relatively slow process. The unfortunate prospects or the less than glowing prospects for drugs and vaccines were coupled with the fact that our committee examined the then recently made CDC estimates on the future of 61 the epidemic and found that those estimates were probably the best that could be made at that time. These estimates predicted there would be by 1991 something like 270,000 cases of AIDS with about 170,000 deaths. Our committee then concluded there was an exceptionally important problem to be faced in dealing with the AIDS epidemic and they focused their recommendations around two or perhaps three major areas. We laid out a series of actions that could be taken to slow transmission within particular groups and slow transmission from already infected groups into new groups. I will detail those in a minute. To accompany the immediate campaign to slow the trans- mission of the virus, we recommended a massive program, a long term program of research for prevention and treatment. Although drugs and vaccines look a long way off, there were many things that could be done to enhance the prospects of getting to those quickly. Our committee also found that in reviewing the totality of the national response, there was a need for integration of all the efforts and additional guidance. AIDS, as you have no doubt discovered, is an epidemic, a disease, which cuts across many different sectors, it cuts across all the aifferent Federal agencies, cuts across the activities of the for profit and not for profit private sector, and that many groups such as those in universities can contribute to the national response. There was at that time no mechanism for integrating the efforts for reviewing what was going on, for filling gaps, and we recommended such an activity be established. Let me move now to try to go through the more detailed content of the report. I will emphasize or I will mention some of the major conclusions that we came to and also try to add information which may have emerged in the last year since the report was published. In many ways, an enormous amount of new information has been developed in the last year and that process is undoubtedly likely to continue in the coming years. In other ways, however, much of the new knowledge base has merely sort of solidified, made more secure things that were suspected at that time, that being so, I think it is fairly safe to conclude that nothing has happened in the accumulation of new information which would invalidate the conclusions in our reports. To start dealing with our knowledge base about the disease, you first have to mention that we knew at the time we published our report that the disease AIDS was caused by a virus 62 which went by the designation "human immunodeficiency virus." In the last year it has become clearer that there is a second human immunodeficiency virus genetically distinct, that is now causing disease in West Africa. We do not know how widely this virus is distributed although extensive work is under way. We know the virus, HIV- II, has spread both to Europe, Brazil and the United States. The modes of transmission of that virus are similar to HIV-I. We are not yet certain, however, over what period of time HIV causes disease and in what proportion of patients. Let me move to our knowledge base on HIV-I in those two regards. It is now clearer than it was a year ago or 18 months ago that the mean time to disease is probably longer than we were estimating it to be last year. The current recalculations of the time between infec- tion of an individual and their progress to what is termed AIDS is probably more likely the four or eight years rather than the four or five years that was being predicted. We still have not had the time to follow individuals for much longer than seven or eight years after they were initially infected, so we don’t know what the long end of the tail will look like. The other important aspect of the natural history -- CHAIRMAN WATKINS: Excuse me. Is that the 50 percent point? Is that what you’re saying? That after eight years, the mean time would be for 50 percent -- DR. WIDDUS: No. If one takes a series of individuals at a particular point in time, and you know when the point in time that they were infected. If you follow those individuals over time, a certain proportion of them will show disease. We have not been able to follow them much longer than seven or eight years so far, but going back and looking at different cohorts and looking over time at when they start showing disease, on average, that length of time is about eight years. CHAIRMAN WATKINS: Does that mean that 50 percent approximately at the eight-year point will have contracted AIDS? DR. WIDDUS: I am moving to answer that question now. The damage that the virus causes to the immune system seems to be progressive. Very shortly after infection 90 percent of individuals, although still healthy, can be shown to have some abnormality in their immune system. That abnormality gets progressively more severe, and individuals pass through a variety of stages, some more quickly than others, until they reach what 63 is clinically defined as the most severe galaxy of symptoms, which is termed AIDS. The two major -- there are three major stages through which individuals pass over a period of time. The first stage is the asymptomatic phase, which can last for years, where although you might clinically detect changes in their immune systen, they are generally healthy. The second stage is what I have called AIDS-related complex, where they have a relatively mild set of symptoms that don’t fall into the CDC definition of clinical AIDS. This last stage is when individuals progress to very severe stage of disease, a complex of opportunistic infections and cancers and are likely to die within a relatively short period without treatment. That period after AIDS diagnosis is about two years. The period of the asymptomatic phase and the AIDS- related complex phase is, as far as we know now, on average about eight years. Turning to the proportion of individuals who will demonstrate disease in any particular period of time, as I said, we have not been able to follow individuals for much more than about six, seven or eight years after they were infected. At that six- or seven-year point, cohorts that have been followed, the groups of men that have been followed demonstrate that approximately 35 percent of individuals in six to seven years after initial infection will progress to the clinical definition of AIDS. In addition to that group, within six to seven years, another 35 to 40 percent of individuals will have seemingly progressed more slowly to the AIDS-related complex, a milder set of symptoms. I should add that studies of individuals with AIDS- related complex show that a high proportion of individuals, once they have progressed to AIDS-related complex, are likely to progress to AIDS with a few years. Unfortunately, what I am presenting is a relatively grim picture where, if we are following individuals for more than six or seven years, as we are doing, it seems very likely that not only will the estimate that the Institute of Medicine Committee made of 25 to 50 percent of individuals initially infected in five to ten years progressing to AIDS, but it is quite conceivable that the proportion of individuals who will over 10 to 15 years progress to AIDS is going to be considerably higher than 50 percent. We do not know yet and cannot say that everyone that is infected will progress to AIDS. That is a possibility that we cannot rule out at this time because we have not been able to 64 follow individuals long enough. We do know that as we follow individuals over time, the picture looks unfortunately grimmer. In terms of the epidemiology of the disease, we know, I think, that our case reporting of AIDS in the United States, while not perfect, is very good. The case reporting of AIDS, however, reflects a situation where infection was going on six, seven, perhaps 10 years ago. We are not able to build a picture from AIDS cases now of what was happening in terms of infection, and the various federal agencies have been moving over the last year or so to try and build up a better picture of what is happening in infection in various groups now. We don’t have a particularly good picture, however, of what is happening with infection as opposed to AIDS cases, and in certain groups such as heterosexuals that have no other risk factors, a picture of what is happening in infection would be exceptionally useful in terms of target intervention efforts. Evidence in the last year has solidified our belief that the modes of transmissions are limited to sexual inter- course, anal and vaginal, to transfer of blood products, and to Maternal to fetus or infant transmission. I think questions that were still being raised a year ago about whether vaginal intercourse was an effective means of transmitting the virus have now been laid to rest. There are studies within the United States as well as other developed countries that show male to female and female to male trans- mission. We are now, in fact, even getting to the point where there are a sufficient number of studies that we will soon be able to estimate with reasonable reliability, I think, the relative efficiencies of the various modes of transmission, male to male, male to female, female to male, and also be able to estimate the enhancing effect of certain things that are known as co-factors, such as other sexually transmitted disease lesions which may enhance the probability of an infection being transmitted on a particular sexual encounter. Those things are in hand, although we will not have really reliable estimates of risks, if you like, for a few years yet. The groups within which transmission has been occurring, as I said, we don’t know a great deal about. We do know that cases are still predominantly occurring in the homosexual group and the IV drug users. Cases are increasing more rapidly amongst heterosexuals than in those other two groups. Yet, again, I will say that we don’t know what is happening to infection. There have been in the last year some cases of trans- mission in health care workers, and these have raised particular 65 concerns. Also transmissions amongst laboratory workers working with high concentrations of the virus. These, I think, do not add a new route of transmission to our knowledge, but they demonstrate that blood, infected blood on mucous membranes or on lesions on people’s hands is probably somewhat more efficient as a means of transmission than we had originally expected it to be. It perhaps emphasizes the need to make sure that individuals working in health care settings and with the virus are fully aware of the self-protective measures they should take. I think one of the things that, to me, has emerged in the last year is the way we should look on what is happening at the moment. We have a virus that is being introduced into or is widely spreading in the human population for the first time. What we see as a pattern of AIDS cases will very much depend upon three things. It will depend upon the time of introduction of the virus into that population; the rate with which it spreads within that population; and the time between infection in individuals in that population and disease. Another factor will affect the overall picture of the epidemic, and that is the rate of spread between what might be regarded as relatively discrete populations. So we have a picture of the AIDS epidemic that is built up of many subpictures, and we should think of these perhaps as subgroups in which the rates may be different and the time courses for the spread of infection may be different. We may see a very rapid buildup in cases in the homosexual group and in the IV drug using group and be tempted to ignore, to pay less attention to, a buildup in the heterosexual community. That would be perhaps unwise in the long run, because in the long run -- and I’m talking perhaps now about 10, 20 years or more -- the number of susceptibles within the heterosexual community is perhaps very large. Heterosexuals are at risk. The heterosexuals that are at highest risk are obviously those that are at risk of other sexuallytransmitted diseases; and particularly, obviously one can identify those as the populations that attend STD clinics. There are other heterosexual groups that are at risk, and the disease may spread perniciously in the broader population through the use of prostitutes or the activities of bisexual men. Even if those possibilities now seem to be emerging relatively slowly, we should not ignore then. I will move to the chapter that we entitled "Altering the Course of the Epidemic." There are various ways in which one can alter the course of the epidemic. Altering the course of the epidemic is critically dependent upon altering behavior. It is not identify- ing individuals -- identifying individuals is not necessarily a part of altering behavior of the groups that are at risk. Methods for slowing the transmission that were focused upon in our report are education -- that is, both education for awareness of the general public, and what does and does not transmit the virus. That will have some benefits to prevention. One of the main benefits of education of the general public, it would reduce anxiety if people know that they are at very low risk of contracting the disease, or perhaps no risk of contracting it through casual contact. Understanding AIDS better as an infectious disease which poses relatively little risk to major segments of the population will, I believe, reduce discrimination, and reduction of the potential for stigmatization is perhaps one of the most important things which is critical to being able to slow the transmission of the disease. The more we drive this disease underground, the less cooperation we will get from groups whose cooperation is essential to slowing the spread of the virus. Education for prevention, as well as to the general public, is also obviously needed. It needs to be targeted very directly to some of the higher risk groups. To those groups, the information needs to come through multiple channels. It needs to come from credible sources, and one has to remember in some instances the federal government is not necessarily a credible source to drug users. Ex-addicts are able, perhaps, to communicate more readily with current addicts than people that are not as aware of what are the motivations within that community. For some groups, the language that has to be used to convey the message will be very direct, and we should not shrink from that, because conveying a message in language or attempting to convey a message in the language that a recipient does not understand is tantamount to not even trying to convey the message. The methods that can be used to slow the transmission of the virus with intravenous drug users are multiple. The obvious first priority, I think, given that intravenous drug use 67 is a societal ill in and of itself is to reduce intravenous drug use. One wants to get as many individuals as possible into treatment programs where the use of IV drugs will be eliminated, and so their use of needle-sharing will be eliminated. As well as expanding treatment programs, one also needs to expand pro- grams of prevention to tackle those teenagers, perhaps, who are perhaps thinking of experimenting with intravenous drugs, not to start down that road. Finally, there is the difficult area of individuals who, because treatment programs presently are not big enough to take all the individuals that want treatment, individuals are still out addicted to drugs. One wants to prevent transmission in that group. A sensitive way -- a difficult topic to consider -- is how to reduce needle-sharing in that group. The avail- ability of sterile needle equipment is illegal in many areas, but it is thought that the availability of clean equipment would reduce sharing. One of the concerns in that area is the availability of the equipment used to inject intravenous drugs would increase drug use itself. There are individuals that argue both sides of this question, and I think that the data that is available at the moment is perhaps not sufficient to support one side convincingly over the other. Our committee recommended very carefully controlled experiments, making needles more available to intravenous drug users, and tracking within those groups both the incidence of infection, whether reducing sharing had an impact on the transmission in the group, and also to see what impact it had upon drug use within those groups. Here we might draw upon experience in European countries, where some of these approaches have been tried. Let me move to the question, a final, very powerful tool in slowing the spread of the virus. That is, serologic testing and antibody testing, as it’s called. This is a diffi- cult area and has received a great deal of debate. It is also an area, particularly an area where I think we could waste a great deal of money and effort approaching it ineffectively. Our committee felt that the real value of serologic testing was not that it would permit us to identify individuals as infected, because the mere fact that you have identified Someone as infected does nothing about the behavior, and it also does nothing about the process of counseling those individuals, whose behavior may constantly put them at risk. The real potential value of serologic testing is as an adjunct to counseling for behavior change and risk reduction. AIDS is a disease of behaviors. That has been said over and over 68 again. It needs to be taken very much into account when one is designing plans for testing. Individuals who have put themselves at risk of being infected are, by far and away, in the best position to identify themselves as potential candidates for testing. Most people’s behaviors are not public, and it is very difficult to identify who has undertaken behaviors that have put them at risk across the very broad population. If we could encourage people who have put themselves at risk because of their behavior to come forward and be tested, then we would have an excellent opportunity to counsel those individuals in the highest risk groups about those behaviors that need to be changed in order to slow the transmission of the virus. If an individual comes forward, and goes through a counseling program, that is the ideal time to convince them about the risks that they are undertaking, and about what measures they can adopt to change their behavior, to lower their risks. If they go through testing, and are found to be sero- positive, that is obviously the ideal time to tell them not only ways that they can reduce the probability of passing the disease on, but also is a time that we can give them ways of changing their behavior in order to preserve their health. There are many things that will be of benefit to infec-ted individuals that can be conveyed at the time of testing. For example, if an individual and his or her physician are aware that he or she is infected, they can be particularly alert and on the lookout for the early signs of opportunistic infections. I think it is fairly clear that treating opportunistic infections aggres-sively and early in their course enables or results in the indi- vidual having a better likely outcome from the individual episode of opportunistic infection. In order to encourage individuals to come forward for testing, we have to take account of the things which discourage them from coming forward for testing. The discouragements are obviously the potential for discrimination and the potential for social stigmatization. To the maximum extent possible, we should ensure that the names of individuals that come forward for test- ing are treated in a confidential fashion. Some individuals may even require that anonymity be preserved. However, even in an anonymous testing situation, we still have the opportunity for counseling for behavior change, and that can be useful. 69 Another area that you may look at is the question of laws which discourage discrimination against infected individuals in terms of provision of health care, provision of insurance, provision of housing. If we can put into place things which encourage and give people in the high risk groups confidence in confidentiality, confidence that they will not be discriminated against, then we will include these people into the general societal effort to slow the transmission of this disease. If those individuals are excluded from society, they are much more likely to behave in a fashion which is not to the overall benefit of society. In regard to the provision of health care, what I think was outlined in our report still has a great deal of validity. Our committee felt, as a matter of principle, that all indivi- duals that were infected with this virus, when they became sick were entitled to care. The most efficient form of care utilizes community-oriented approaches, reducing hospitalization to an absolute minimun. That is not only in the best interest of the patient, it is in the best interest of the financial planning for caring for the increasing number of patients. At the time that our report came out -- and I think we still need to stress the fact that planning for the increasing number of patients is not moving forward in a particularly systematic fashion, nor is the question of how will the burden of caring for the patients be equitably financed. These are areas where we have activities underway in conjunction with the government, and we will obviously be very happy if members of the Commission wish to attend in the deliberations of the workshops we anticipate holding. Another aspect of care that is, I think, increasingly emerging is the psychosocial stress that the provision of care imposes upon health care providers. We have both anxiety of individuals that are starting to treat AIDS patients, starting to come in contact with AIDS patients, and we have the question of the burnout of individuals who have been intensively involved in caring for patients. This is becoming increasingly apparent, I am told, in those centers which have handled a large number of patients, and is likely to spread across the country as more and more places get more AIDS patients. Attention to research needs identified a number of particular areas that needed attention. The National Institutes of Health and other federal agencies have moved to address some 70 of these, but some are not yet adequately addressed, and some will need continuing attention, not just on a one-year basis, but for five or 10 years into the future. Early in the epidemic, much of the funding that was directed towards AIDS was essentially stolen from other health care research. This particularly and severely affected basic research in immunology, virology, and cell biology, and that unfortunately is a very short-sighted approach because much of the progress we have been able to make on AIDS and the HIV virus was grounded upon the basic research that had been done in the decade or two before we discovered the virus. And to pull funds now out of basic research and shift them to AIDS is essentially undercutting the underpinning of future progress in AIDS. That is fortunately a message that has been heard at National Institutes of Health and in the Congress. It, however, needs to be repeated every time there is an appropriation, because it is very easy to seemingly save money by diversion rather than by adding new money to what is a new problem. All of our other health care problems have not gone away. The urgency for solving them is still the same. In the natural history area, we obviously needed work on pathogenesis, to determine exactly how the virus causes the damage. We now need that sort of work on a second virus which may not act in precisely the same way. We also need pathogenesis work on some of the viruses such as SIV, simian immunodeficiency virus, which is a potential model for AIDS. We need a considerable amount of epidemiologic work, particularly surveillance for HIV infection. That is going to be critical for targeting interventions for risk reduction in the future. We need to know exactly what is happening now, not to be forced to a situation of trying to infer what happened five to 10 years ago from AIDS cases when we are not even sure we are catching them all. One of the critical things in testing drugs and vaccines will be animal models. One was available a year ago, and it is being pursued, that of the simian immunodeficiency virus in monkeys. Within the last year another possibility for animal models has emerged through the discovery of a feline immunodeficiency virus in cats which could be actively pursued, and funds should be devoted towards that. In both vaccines and anti-virals, the critical thing at the moment is still to actively pursue all of the possibilities. We are not in a position with either drugs or vaccines to be able to select those things which are most likely almost certain to be affected. We need to pursue a very wide range of activities in order to have the most likelihood of getting to effective drugs 71 and vaccines in the shortest possible time. I will make a comment in a minute about the management of the research effort in that regard. One of the obvious things in order to pursue research with the virus and research in animal models are the facilities in order to conduct these experiments. Many of you have probably read recently about the concerns of workers at the National Institutes of Health, that they were working in very cramped conditions, and those conditions might lead to lapses in the procedures which are recommended for handling this very dangerous virus. We need to ensure that those people that are pursuing research which is very important to the health of the nation have the adequate facilities themselves to pursue that research without putting themselves at risk. There are not only facilities at the NIH for virus containment, but it is also expanding facilities around the universities and research institutions in the nation, so that those who want to pursue research and have good ideas to pursue are able to do it at minimal risk. We need also increased facilities for primate containment when we are infecting animal models with viruses that are potentially transmissible to humans. Training is obviously an important area in biomedical research and is critically important in supplying the next generation of researchers that are going to move to AIDS. In the research area, let me move back to the question of slowing the transmission of the virus. One of the obvious, really major needs is to know how to give people information which has an impact upon their behavior. You can increase their awareness. You can increase their knowledge of a disease, but we need to know what are the most efficient mechanisms of inducing behavior change rather than just imparting information. So we need a lot of social science research in that area. We need to know more about prevalence of behaviors that transmit the virus, and we need to develop ways of measuring things which are difficult to measure, things -- people are reluctant to answer questions about their sexual behavior. We need to develop in the social science area effective ways of assessing intervention. One of the most significant areas of expanding knowledge in the last year has been in terms of AIDS as a global 72 epidemic. In the last year, the number of countries reporting cases of AIDS has risen from 80 to 127. The numbers of cases in each of those countries has expanded greatly, and it is now estimated by the World Health Organization that 5 to 10 million individuals in the world are infected with the virus that causes AIDS. We have no reason for suspecting that individuals in other parts of the world will progress in any smaller proportion to AIDS than will individuals in the United States. So there are 5 to 10 million individuals infected now. Even if we were able tomorrow to stop the spread of infection, there would be an incredibly large number of individuals around the world who would die of AIDS. In many areas of the world, particularly Central Africa, the pattern of infection with the AIDS virus is signifi- cantly different than the pattern that occurs in the United States and Europe and Australia. The pattern in the developing countries of Central Africa is that the numbers or the sex ratio cases in male cases and in the female population is approximate unity; in other words, equal numbers of men and women are in- fected. For that and a variety of other reasons, it is suspected that in Central Africa and in some other parts of the world the predominant mode of transmission is heterosexual sexual intercourse. That mode of transmission may be supplemented by transmission through the blood supply, and it may be supplemen- ted by various skin cutting or skin piercing activities, but the statement holds that the predominant mode of transmission in some developing countries is almost certainly heterosexual transmis- sion. The pattern of AIDS around the world is that the most severely affected countries seem to be or the most severely affected areas seem to be urban areas in Central African countries. It is reported that in those countries in urban areas, small cities, big cities, between 10 and 20 percent of pregnant women coming in to deliver in a healthy fashion are infected. A high proportion of those babies are infected, and a high propor- tion of those women go on to full-blown AIDS. Obviously, there is a high level of infection amongst their sexual partners. It needs to be emphasized that the prevalence of infection in rural areas in many of these countries is not nearly as high as the infection prevalence in urban areas, and we’re not talking about 10 to 20 percent of the whole population of the 73 country. We’re talking about perhaps 10 to 20 percent of a fraction under 20 percent. The World Health Organization has moved in the last year to expand incredibly and effectively its activities in what they call their Special Programme on AIDS. As of November 1987, 151 countries in the world have established committees, national committees, cutting across all of the different sectors, public and private, federal and universities, have established these national AIDS committees. One hundred twenty-seven countries had requested assistance from the World Health Organization. Twenty-six countries had developed relatively long-term plans for tackling various problems, and in five countries those long-term plans were actively being implemented. I have not said much about the number of cases that have been reported globally, and that is for a deliberate reason. Even in the United States, while our reporting is fairly good, it does not pick up all of the AIDS cases. The health care systems in developing countries--many of them only devote under $10 per capita per year to all of their health needs for their population. This means that obviously these health systems do not have supporting systems or even care delivery systems anywhere near as sophisticated as what we are accustomed to. In these poorest of the poor countries, AIDS is going to have an incredible and impact upon their ability to even provide the meager health services that they presently do, and it will have an important social impact in these countries. I mentioned Central Africa. Latin America is an area where AIDS is not as prevalent but, in fact, as has been reported from virtually all of the countries of Latin America, some countries have a considerable number of cases. Brazil, in fact, I think is now over 2,000. The Caribbean has a very large number of cases, perhaps in aggregate approaching 2,000. One of the things that we see happening in countries in Latin America is that the pattern initially emerges as cases predominantly amongst homosexuals and IV drug users but seems to be moving much more rapidly than in the United States to grow and spread in the heterosexual communities. In Asia, there have been, so far, relatively few cases reported, but there are also indication from sero prevalence surveys that the infection is prevalent even in countries that have not yet reported AIDS. 74 What I’m building is, in fact, a picture of the global environment in which no country can anticipate that it will stay free of AIDS; that every country, both developed and developing, stands to benefit from cooperating in terms of stopping the Spread of AIDS; and I think there are many motivations to the United States to be actively involved in global efforts on AIDS. We stand to benefit from research done in other countries. The technical assistance that we provide to other countries may well be undermined if we do not actively move and actively help them to grapple with their own AIDS problems. The World Health Organization can play a unique role in facilitating research and facilitating intervention in a very sensitive area in many of the countries of the world where AIDS is still a sensitive problem, but there is also the opportunity for the U.S. to supplement its contributions to the WHO through bilateral efforts. The messages from our report I think are still valid. We need an intensive, truly national effort to slow the transmission of the virus through many of the mechanisms that I’ve mentioned. We are moving effectively towards a long-term research effort for prevention and treatment, and we need to -- because AIDS cuts across so many different agencies and both the public and private sectors, we need a mechanism for insuring the planning and integration of efforts goes on in the most efficient fashion. I was asked also to mention some of the continuing efforts within the Institute of Medicine and the National Academy of Sciences. We have an array of activities, some of which are in place now and some of which are in development. Because of the present information that has occurred in the last year, the councils of the NAS and IOM decided that we should try to produce before the late spring of next year an update of the report Confronting AIDS. To do this, we have established what we call an AIDS activities oversight committee, and that will be managed in the coming year by Dr. Robin Weiss. Its chairman is Dr. Ted Cooper. It has a relatively small membership. The membership of that committee is, in fact, supplemented by approaching 80 or 90 correspondents who, for us, are keeping under review their specific areas of expertise. They are providing information on important recent progress and needed actions which will be incorporated into the update of Confronting AIDS which will be developed next year. 75 We have also been active in the area of drug and vaccine development. A symposium or conference was held August 31st and September 1st at which individuals from the federal government, the pharmaceutical companies and universities had a very productive, often quite heated exchange of views about what were the best methods of pursuing drug and vaccine developments. We anticipate holding on December 14th and 15th a similar activity to look at prospects and needed actions in the area of vaccine development. An invitation is extended to any Commission member who wishes to attend that meeting to participate in it. Each of those activities will result in a small letter report which will be available publicly. We have also held an activity in, I think, an incredibly important area, which is attempting to predict the future impact of the disease. This is an area where mathematical models can be very helpful to us in showing us what is likely to be the pattern of the disease in the future in different groups in different countries. We are, in fact, cooperating with the Office of Science and Technology Policy on the development of a broader, longer term effort in modeling the spread of infection and modeling the ikely impact of disease, and you will be kept informed of those activities. There is on the list of things you have a variety of things that are under various stages of development, such as a workshop on the financing of AIDS care, which we will be doing in conjunction with the Health Care Financing Administration and, we hope, the health insurance industry. Any questions you have on those can be directed either to me or Dr. Robin Weiss either during the meeting, after it or by letter. DR. MILLER: I am Heather Miller. I am here from the Commission on Social and Behavioral Sciences in Education. We have just begun an activity to review issues that pertain to the educational efforts. We will be looking at three broad areas. Our committee had its first meeting in October. As you see, we’re in the very beginning of our process. We’re going to be looking at lessons learned from other prevention programs for other diseases and trying to identify aspects of those programs that could perhaps be applied to the prevention of AIDS. We will be looking at what we know and don’t know about the behaviors associated with the transmission of the virus. We will be looking at current measurements of the prevalence of those behaviors. 76 We will be looking at what is and what is not known. We will be looking at the quality of those data, and we will be trying to assess what might be appropriate in terms of methods that could be pursued to gather more data in the behavioral areas. Lastly, I believe this group will be looking at the opportunities and constraints for participation of various organizations and institutions in efforts to prevent the spread of AIDS. If you have questions regarding that activity, you can direct them either to me or to Dr. Charles Turner, my colleague, who is here today who will also be working on that project. DR. WIDDUS: That concludes our presentation. We/’1ll be glad to try and answer questions before I become too hoarse to do so. CHAIRMAN WATKINS: Thank you very much, Dr. Widdus, for that very thorough presentation. I would like to open with a couple of questions myself, and I’d like to try to move expeditiously through our members with two questions each. I’d like to start over here with Ms. Pullen, if she’d like. If any member feels that they need to pass along to the next member, please do so so they can be prepared. I’d like to move as expeditiously as possible and focus on the specific question that the Commissioner is asking, and let’s not shift off to other questions so we can take it to satisfaction of the Commissioners that we have run it out about as far as we need to go. We have about an hour and 50 minutes, so that gives us about ten minutes each for all of the questions, no matter how many times we cycle around. So I’d like to try to cut off debate when we feel we have reached the apex of productivity on the question. You recommend "epidemiological surveillance" in your report to determine prevalence. What do you mean by that, and how are you going to obtain that, staying within all the guidelines that you talk about in other areas about testing practices, confidentiality, discrimination and the like? It seems to me that we’re going to be holding hearings here shortly on the incidence and prevalence, and it may be that your insights of what you’re really talking about to get a good handle on prevalence in the nation, while it’s very important, 77 when we get down to below the veneer of the statement, how to obtain the data in such a way that we have a good picture of what’s going on in the country today without the mathematical models that we now see in the press which may be off by a factor of two. I don’t know how valid all that is, but I think the oscillations around modeling when necessary and that’s all you have are fine, but are you talking about some new concept of epidemiological surveillance that needs further explanation? Maybe there is a way to get on with something a little more concrete where we could really know where we stand right now. DR. WIDDUS: I think one of the critical things that needs to be borne in mind as one contemplates gathering information about the prevalence of infection is that you’re not going to be able to sample every individual in the country and then sort of to know from that what the prevalence of infection is and be able to know then what the prevalence in each subgroup is. One of the things that’s been done over the past few years is to take what are called samples of convenience. These can be samples of people that are in hospitals. They can be drug users that are coming in for treatment -- and to determine the prevalence of infection in those groups. Those measures, however, are only representative of that group sampled. They will not tell you in the case, for instance, of drug users coming in for treatment, what is the prevalence of infection of drug users out there still on the street that are not coming in for treatment. I think the critical thing for you to bear in mind as you move to your meeting on surveillance and incidence is that any studies that are done have to have a clear basis, clear picture of what is the group that you are taking a sample from and is that sample taken from the group in a fashion which is not biased. In essence, the message is the sampling has to be done in groups or amongst individuals that are representative of some knowable part of the overall population. CHAIRMAN WATKINS: But has the IOM, perhaps, come up with a strategy of doing just that that is statistically valid and that allows voluntary and anonymous participation in such a way that you get closer to the baseline of information you’re looking for? In other words, have you thought through enough to come in working with those experts in the field to say yes, there 78 is a way to do that and to do it expeditiously either by a family of surveys that surround the kinds of things you talked about or by some other technique? It seems that it is still adrift to me. Maybe I’m wrong, but that’s the impression I get. Have you really focused on that and tried to put a task force together to really come to grips with that issue so that we could put aside the issue of discrimination and the like and get on with anonymity, get in with valid data, maybe encourage national leadership to get on television and encourage people to participate under this regime as total anonymity and yet we need the data desperately and this is how we would do it expeditiously, through a variety of techniques? DR. WIDDUS: The Institute of Medicine and National Academy of Sciences have not addressed the design of a national sero survey. Some of my colleagues and I have written in this area, putting forward suggestions which have gone to CDC, and they have considered the design of national sample sero surveys which would theoretically give you that sort of information if one was able to conduct them with the appropriate level of cooperation from the people that you are trying to sample. I think it is critical to remember that participation in those efforts would need to be voluntary and that there is a danger in wasting a considerable amount of money if you try and pursue a full-fledged national sero survey and then find out that a high proportion of the individuals or a significant proportions of the individuals that you want to sample are, in fact, declining to participate. I think that any plan for a national sero survey has to take into account that possibility and be designed so that first you develop a questionnaire that can be tested upon individuals to see if they are willing to answer questions in the fashion which they are posed. It then needs to go to a pilot study to see if you can get the full level of cooperation, and only then, when you are convinced from your pilot study that you are undertaking something which would be feasible and you would get a valid result would you undertake a full-fledged study. That process is not a simple process and would take a considerable amount of time to implement effectively ina stepwise fashion. The other possibility of doing a "family of surveys" as proposed by the Centers for Disease Control is, as I men- tioned, to know exactly what the groups you are sampling are 79 representative of. If you can design a family of surveys that do cover all of the groups of interest, then you could probably get some useful information from such a family of surveys. But many of the groups that one wishes to know some- thing about the prevalence of infection in are not a convenient sample to get by convenience sampling. For example, you will not be able easily to identify bisexual married men through convenience sampling without a considerable amount of -- if you do it on a voluntary basis, they might come forward, but they may not have the same character- istics as the broader population of married men, some of whom are not coming forward. So that the answer to the question is that when you recommend epidemiological surveillance to determine prevalence, you do it in a context that is not as clean as you possibly would like it technically but you’re just kind of saying press on with what we’re doing and extract the best data we can from hospital samples in an anonymous way and other kinds of things that are already ongoing. Or do you say that there is something new in your mind which says we need to devise a new method by which we can get a better data base, because this Commission is asked to make a lot of projections of costs and so forth to the President and cabinet heads as to where the nation might be going, and it’s very difficult if we’re going to have such significant ups and downs as some may project right now. So this is why I think it’s extremely important that we flesh out your concept of surveillance to determine prevalence. DR. WIDDUS: I think I wouldn’t endorse the testing of every sample of blood that was taken anonymously, because many of those samples of convenience, one doesn’t really know what the group is representative of. I have not followed in recent months the suggestions that were made earlier in the year for pursuing in a stepwise fashion a national sero prevalence survey. I personally think that it’s worth pursuing up until the point that it is demonstra-ted that it will not give us a valid result. CHAIRMAN WATKINS: Thank you. DR. WIDDUS: If I might add, my colleague, Charles Turner, is in the room. Do you want to add anything, Charles? DR. TURNER: No, thank you, Roy. 80 CHAIRMAN WATKINS: Ms. Pullen, do you have questions you’d like to ask Dr. Widdus or his teammates today? MS. PULLEN: I’11 try to keep this directed in such a way that your answer can be brief enough that you can still answer some others. You talked about the Institute looking at health care delivery. When we were in Florida recently, we had testimony presented to us from a variety of sources that indicated that sometimes the network model is not as closely knit as the term "network" might imply; that a case management model might be a feasible cost effective and quality efficient means of devising health care delivery for people with AIDS. I wonder whether the Institute of Medicine has looked at those models and others and given an evaluation yet for their applicability to this problem? DR. WIDDUS: We haven’t looked at the case management model. We were aware in conducting our report that most of the network model testing had been done in areas that might be termed, considered quite unique and that it might not be applicable to all parts of the country. I think consideration of the relative benefits and deficits of each sorts of model of care will be included in the workshop on provision and financing the care that we are negotiating with HCFA on. MS. PULLEN: Also, you talked about, very briefly, about training and research grants. We have had presented to us the idea that too much of the research is centralized at or through NIH. Others say there is a great deal of research, both government funded and not, going on in various places around the country, not all of which is directed by NIH. Can you give us an idea from your perspective of whether or not the research is sufficiently diversified, whether it is truly as centralized as we’ve been told, whether that’s a good idea or whether that’s really not happening? DR. WIDDUS: In 1981 through 1983 as concern with the virus was mounting, it was mostly mounting within those agencies, within the Public Health Service that had responsibility for tracking public health threats. The broader scientific community was looking on it as something that was interesting but was not at that time shifting the focus of its research towards the problem, towards the sort of scientific questions. 81 What occurred was that the responsibility for taking the first steps on discovering the virus, developing the tests which enable us to sort the tracking antibody in formation, et cetera, those were done within the federal government because no one else was really paying a lot of attention to it. The other things which have been done recently which legitimately fall upon the federal government are enabling research, making available the facilities for testing drugs, et cetera, through the establishment of a network of AIDS drug testing units. Many of these things that are national responsibilities automatically fall back upon the National Institutes of Health and need to be done early in the phases of the epidemic before the full scientific community had gotten fully engaged. That presents you with a picture where seemingly most of the activity is going on within the federal government, but it is going on within the federal government for a particular reason. Our committee did raise concerns that there was a need for shifting some of the resources as the situation evolved towards investigator-initiated research, initiated within the broader university academic community. That shift is starting to take place, and I think that the concerns which were probably expressed to you have diminished in the last year and will further diminish as the situation unfolds. MS. PULLEN: Thank you. CHAIRMAN WATKINS: Any more questions in follow~up to Ms. Pullen’s questions of Dr. Widdus? (No response. ] CHAIRMAN WATKINS: All right, Dr. Lilly. DR. LILLY: For my first question, I’d like to repeat a question that I asked this morning of Dr. Nelson who, in his report, recommended a continuing review of national policy on AIDS. I’d like to know to what extent your reports and your deliberations have involved themselves with that question of just what type of body should be created to answer this ongoing question about national policy on AIDS? What kind of body? Should it be an individual, an AIDS czar? Should it be a committee, a commission? How should it be selected? What kind of structure should it have and, perhaps, primarily, to whom 82 should it report? I’m wondering to what extent your deliberations have concerned themselves with that problen. DR. WIDDUS: That was a major issue that was con- sidered by the committee that produced Confronting Aids, and it tried to address that question in terms of what would the body be responsible for doing. Briefly, our committee felt that there were exceptional strengths in many parts of the federal government: Centers for Disease Control; National Institutes of Health; various other agencies where exceptional strengths had been demonstrated in the mobilization of resources, community groups, and that there were other groups that could be mobilized like industry to provide in the workplace education. Much of the work to be done in the scientific area was most appropriately done through the existing mechanisms, through the National Institutes of Health and CDC, particularly, all playing their part. What was needed was a body not to tell them what to do, but to make sure that all of the different things that were going on in different parts of the national effort were, in fact, part of the cohesive whole. We didn’t consider that what was needed was a top hand director. What was needed was monitoring the situation so that attention could be drawn to gaps and that some cohesion was brought to the whole thing. Because this body needed to span both public and private sectors, we felt that it should not be part of the federal system. It obviously had a great responsibility to the general public, and it had a great responsibility for providing guidance to both the executive and the legislative branches. We conceived that what was needed, therefore, was a presidential commission to report either to the President directly or a joint presidential/congressional committee to report to both bodies. Its activities we felt would be public. One of the responsibilities that would reside or one of the capacities that we felt was critically important to reside with the commission was the capacity to act in catalytic fashion to bring together agencies, groups that needed to thrash out differences and to provide this forum for, if you like, policy development, policy analysis, in an ongoing fashion. This was a primary need. The situation was evolving all the time and is still evolving, and I think the need for a body that will not have a finite existence but will continue to monitor the situation, continue to guide it through giving advice, is still legitimate. 83 DR. LILLY: Thank you. My other question is related but, in fact, fairly different. You made a number of recommendations about what the biomedical community needs with respect to the AIDS crisis and, of course, your committee consisted of a goodly number of people who are major experts in that area. Our committee lacks that expertise and obviously is not in a position to make recommenda- tions on whether we should emphasize research in immunology, biology or whatever else. How do you think that -- what kind of structure do you feel that this committee’s recommendations with respect to the needs of the biomedical community, how should that be put together? Just to quickly run down a few of the things that strike me as possibilities for that, one thing that you mentioned was the need for facilities, further facilities. Is that something that we should pay a great deal of attention to? Something that you didn’t mention that strikes me as a possible serious problem is the problem of communication within the field of experts. As a person who is involved in at least some aspects of this, I find it very difficult to obtain infor- mation as to just what is known in some cases, or I’m contin- ually being surprised by something that is known that the people I know don’t know. Then one other thing is the process for budget de- velopment, the fact that, for example, things that the NIH or some other public agency may need or may feel that they need. That information gets to Congress only as filtered through the OMB, for example. Is that something that we should pay attention to? DR. WIDDUS: All of the above. We will, in the course of our update of our report, be producing, I think, a document on research needs, research areas which will be, hopefully, of use to you. Some of the things which come to mind in terms of not specifically biomedical research but sociology, the research environment, the environment in which research is being done. You mentioned as I was writing down the question of communication. I think that is critically important. I think perhaps a certain amount of money from the NIH could be devoted towards convening at regular intervals all of the scientists in a particular area and ensuring that they exchange information. We are trying to do a little bit of that with NIH in our vaccine conference and the drug conference. 84 Communication of scientific information to the public, communication of what is going on in biomedical research to potential recipients of drugs and vaccine and to the general public, I think, is a very important area that has received insufficient attention. There is, as came out in our drug conference, an enormous amount going on which not only is the public unaware of but most of the scientific community is unaware of. Someone facetiously suggested that it might be a good thing that the National Institutes of Health Centennial will be over soon so that their public relations people can get back to that effort. But it is sorely needed and, I think, would do much. Better communication of what going on would do a great deal to enhance the public’s confidence that the effort is truly an adequate one and it is on the right track in general terms. Another area that is important, I think, is to facilitate the entry of new scientists into AIDS research. Someone, Howard Temin, I believe, suggested an AIDS research starter kit, which gives us the virus and sort of a list of where to get all your other reagents. But there is a perception, perhaps probably mistaken, in amongst graduate students that AIDS research is difficult to get into. If, in its communications efforts, the National Institutes of Health developed information on where you can get reagents, what sorts of grants are available and got back to scientists, that would be another major effort. The other area, I think, in the biomedical community which will be increasingly important is that, although the United States has a very major effort in biomedical research, it is not the only country in the world that could man significant bio- medical research. There are targeted efforts at drug and vaccine development in the United Kingdom. There are significant efforts in the Nordic countries on drug trials. There is the French program, a nationally managed program on research. For the biomedical community and NIH to devote some effort towards international scientific communication would be a good thing, too. CHAIRMAN WATKINS: Dr. Widdus, you are going to be addressing these things in much more specific terms than you did in the last report in the broader context of the continuing body. You call that a catalytic body. You’re going to get inside that a little bit perhaps in the area of biomedical research and present such a continuing leadership concept that be might a subelement of the larger catalytic body that you are recommending in your Confronting AIDS. Is that what I’m hearing? DR. WIDDUS: We are trying to serve that need until the broader body is created, trying to be helpful in promoting information exchange. CHAIRMAN WATKINS: JI think there is a frightening specter of large bodies sitting on top of existing entities that have been important in the field for many years, and I’m just wondering if we can’t bite the elephant in smaller pieces and have a particular group like yours come up with a modular concept inside that broader charter that you might have for a continuing body that would look at just that one area alone. Because it seems to me that if you could set in motion a concept of integrated cooperation between the fractionated groups now in the variety of areas that Dr. Lilly talked about, it would be very helpful as a model in a lot of other areas such as education that we talked about with Dr. Nelson earlier. I’m just mentioning that because I think every time we hear that, we want to establish a large group that is going to come together and advise the world from the United States’ point of view on this epidemic. I think it frightens a great number of us, and we’re not sure what to do with it until we see a piece of it that is fleshed out to the point where we can say that is a model inside a concept that may have as many as five or six entities like biomedical research that also need the same kind of integrating concept. Then I think we can say if we once do that, we might package you up as one of the six modules in this national body that would mix with others, and we’d have some kind of an entity already defined without trying to define that structure with a huge staff and the fears and apprehensions of all the entities that work in this field being brought to bear. I don’t know how you feel about that, but I think that these kinds of discussions with you would be very beneficial to the Commission as we approach our final report to the President. Maybe in your interim, your next report on your update, you can give us a little better feel for this description rather than in these broader terms that are a little bit frightening unless we know what you’re really thinking. 86 DR. WIDDUS: I think had I expanded a little more, I would have said that, obviously, we will not be able to encompass through a half a dozen or through ten individuals all of the relevant disciplines that we’ll need on an overarching commission; that such a commission would have to function through specific entities, some connected with science, some connected with public health matters. I think this is an area that is probably very worth pursuing with Dr. Thier and Dr. Cress. CHAIRMAN WATKINS: Thank you. Any other questions on this particular issue that Dr. Lilly raised? Dr. Crenshaw? DR. CRENSHAW: In your report, Confronting AIDS, you raised the question about the role of macrophages in the disease of AIDS and HIV. I’d appreciate it if you’d elaborate on what has been learned since the time of your report, because I understand that Dr. Gallo and a group in Vienna and also in Oslo has done some extensive research since then and, if I understand it correctly, it turns around some of our perceptions that a tear or a rip is required in the mucous membranes for transmission to occur; that macrophages act like Trojan horses in the surface of the mucous membranes and can introduce infection in that manner without direct semen to blood. If you could comment on that and also the role of macrophages in bridging or mediating central nervous system infection. DR. WIDDUS: Dr. Potash will answer. DR. POTASH: Well, I think the question of what is the initial cell which is infected has not been settled; that is, whether it’s the T-4 lymphocyte that we know bears the HIV, whether it is a macrophage which also bears the T-4 antigen and can be infected or whether there are other sites of cells which initially contact key blood stream or the fluids. Of course, this is an area of active research. What we do know about macrophages is that they are, as you describe a Trojan horse in that they can house the virus for some period of time. The degree of infection within a macrophage, in fact, currently depends upon the age of the macrophage and whether or not the macrophage, per se, can act as the source of other infection. I think the other point which you brought up which is perhaps the central element of research right now concerning the macrophage is its ability to permit the infection to enter the central nervous systen. These days, it seems like AIDS is a disease not only of the immune system but of the nervous system and that we need to 87 focus research on this macrophage traffic. We need to focus research on how the virus moves and on whether whatever drugs or other therapies we’re thinking about will also act on macrophages, which have a very different kind of biology from the T-4 cell. As far as I know concerning the specifics of a tear or a rip, it seems like the degree of exposure of virus particles, the number of virus particles is still one of the best determinors of whether an infection will be transmitted, but, in fact, there is hot debate right now about whether it is free virus or encapsulated cellbound virus which is, in fact, infectious. So I’m going to answer the best way I know how, which is it’s the subject of research right now. DR. CRENSHAW: Do we know the aliquot of concentration virus required to induce infection? DR. POTASH: The only experiment that I know -- and please correct me about this. The only experiment that I know attempted to transfer virus in a very limited number of chimpanzees because, of course, chimpanzees are a very limited, very valuable resource. In that experiment, the lowest dose which was used was able to transfer an infection. I don’t know what that dose was. DR. WIDDUS: I don’t, either. That type of information may be derivable from some of the work that was done in Australia on artificial insemination, but I am not familiar with certain statistics on that. DR. CRENSHAW: Maybe I lost you, then, in the process, but did I understand you to say that whether or not the rat was infected depended upon the amount of virus exposed to that amount and then, secondly, we have no idea what amount is required for infection? DR. POTASH: I don’t think we know the lower limit. CHAIRMAN WATKINS: Any further questions? Cardinal O’Connor. CARDINAL O’CONNOR: Yes. I would like to propose what is really a request rather than a question, one to Dr. Widdus and one to Dr. Miller. To Dr. Widdus, I work closely with a number of persons with AIDS, and I see and listen to a great number of others who fear that they are vulnerable. 88 I am concerned that we are not putting out sufficient information about the state of the art. Many patients and others who feel vulnerable tell me that they feel that because of interagency warfare, perhaps, in various of the agencies down here. Some would say that because they believe the President is not really sincere about this whole movement, and he actually doesn’t want progress made. Others would say that because the agencies have assumed too much authority, there’s an ultraconservatism in research and then in the processes of the FDA in making possible responses, vaccines or whatever, available. I can understand it from a laboratory point of view, from a researcher’s point of view, from an agency point of view that question itself or request for information might seem insulting. But from the patient’s point of view, who is lying there dying or in acute distress or from the point of view of people who fear the future for themselves, can’t we do more than we have done about telling the public what the state of the art 1s and why, if a particular vaccine or medical therapeutic approach is not being released, why it’s not being marketed, why such is the case? There are even patients, as I’m sure you know, who say, well, it is my body, it’s my life, and if there’s any possibility at all of either prolonging my life or taking me out of this misery, then I’m willing to take the chance. Am I articulating this clearly enough? DR. WIDDUS: Yes, very clearly. One of the things which emerged out of the conference that we held on drugs was an incredibly useful exchange between Dr. Frank Young, the Commissioner of the Food and Drug Administration, and a representative of a gay organization who had just described the thirst for information that you mentioned. This centered around what I call the bathtub drugs, where people are self-medicating with things that are not yet available through clinical trials. It was a very useful exchange of information between these two individuals, and I think that will lead to greater information coming out of the Food and Drug Administration on the reasons that certain drugs are not yet being put into trial. A similar sort of message was given to the National Institutes of Health about getting out more information on what was in the pipeline. I think the scientific community and the federal regulatory agencies are becoming more aware of this need to not 89 only do their job but to explain what their job is, explain how they’re doing it, and explain what is going on in a much nore effective and timely fashion. I think that things are moving in the right direction and that perhaps we can add to the emphasis on that in our update, and I think it’s something that you could encourage amongst the federal agencies, also. CHAIRMAN WATKINS: I think it’s one of the most important, most urgent of our near-term items. If I had to list the top three issues that have come up more than any other in the over 200 presentations before this committee, it’s been why do so many people say that the European countries, for example, are so far ahead of us? Why does California feel that they have to pass a law? Why do we hear people with AIDS saying, “Look, I’m on Ampligen, I’m on a protocol down in Philadelphia, and I went out of the cancer stage and I feel good again. I’ve prolonged my life. I’m not on the placebo, I’m on the Ampligen. It’s making me feel better, and yet my friends can’t get in the protocol because they don’t qualify." They are AIDS cases and they’re not taking those right now or whatever the rules are. What I’m wondering is don’t we have something of some urgency here that needs to be clarified, and maybe the Institute of Medicine can put special emphasis on this because it’s coming up time and time again. It’s going to be one of our major issues of near-term focus because we hear that everything AIDS-related is 1-AAA priority at the FDA, and on the other hand we hear from the grass roots person with AIDS who seems to know a great deal about the various experimental drugs or at least feel they do and feels there’s some merit in their colleagues taking certain drugs that are not yet approved but seem to have some -- gives them some assistance in prolonging their life and getting their spirits and their strength back. I think somehow we haven’t come to grips with that yet, and we really need some help on that to give some advice, because we’re going to be asking a lot of questions during our various hearings on these issues, and we certainly -- we’re not trying to put anybody on the spot. We’re just trying to get the facts. We’re trying to separate wheat from chaff in this issue, and it comes up repetitively. I think the Commissioners would agree, this is one issue that almost comes up every single time we bring witnesses before us. 90 But there is something not quite right there in the way we're handling it, and maybe there has to be a special protocol, because the fatality of this disease doesn’t fall into the natural category of -- at least at this point in tine. I don’t know that, but maybe there’s a way to look at that ethically and from perhaps a liability standpoint and all the other technical rules that is very hard to explain to the people with AIDS who feel that that should not be a bar to them taking something that they feel will help them out and that seems to have merit in treating other kinds of diseases or ailments of various types. CARDINAL O’CONNOR: Within that same question and framework, let me just add this and then I’11l go on to my next point, if I may. It’s hard to say these things without seeming to imply insult, and that’s certainly not intended but it is not merely a matter, I think, of giving whatever information there may be and explaining why such and such therapy should not be used but doing whatever we can to give the public confidence that there is no interagency warfare, that a particular agency which is vying for funds or prestige is not concealing things. Human nature is human nature, and whatever we can do to open this up, I think, is terribly important. If I may move to my second, and this is a piece of totally unsolicited but very sincere advice for Dr. Miller. As you, from a social science perspective, move into approaches for prevention, please for a moment -- please for a moment rescind from thinking you know what my moral position would be or what my pragmatic position would be. I just want to talk experientially for a moment. Probably the greatest and most ineffective experiment in history was carried out by the armed forces over a period of at least a dozen years from at least the beginning of World War II, if not before, through Korea in attempting to control venereal disease. It was enormously ineffective. The primary approach was the use of horror movies to show the results of various types of venereal disease on the human body and then the dispensation of condoms, period. Now, I’m not interested at the moment in getting into a discussion about condoms from either a moral or a pragmatic perspective. I want to say only that this approach didn’t work, 91 and it was tried with literally millions of men, primarily, in the military. It was not until penicillin came along and was combined with precontact counseling that venereal disease came under con- trol in the armed services. Now, again, rescinding from the utility or the morality of condoms, I would simply ask that since you said you will be studying various other programs and models that you look at the data, because it is enormous; it is horrendous in many ways, the huge amount of data collected through those many years. I was very much part of those years, so I’m not speculating, and I know, therefore, under highly controlled circumstances what worked in that particular situation. There may be absolutely no applicability at all, but I would hate to see us start again on a massive program, whatever it might be if there’s a strong possibility that it won’t work, a possibility based on empirical data, albeit in another set of circumstances. So I will conclude and want to repeat very strongly lest there be misunderstanding, I am not at this point taking any position on any approach toward prevention of the contracting or transmission of AIDS. I am simply suggesting that there is here an enormous amount of data on contracting and transmitting venereal diseases, because I personally believe that today so much of the AIDS disease is contracted through IV drug use and transmitted through IV drug use, even if what I had to say has any applicability to other means of acquisition or transmission, it wouldn’t have applicability to a great number of cases. DR. MILLER: I hear what you have to say, and I concur that there have been many stories that would cause one to believe that there are few successes. I think the case of sexually transmitted disease -- the story of sexually transmitted disease has not been a great one. Right now we have Dr. Louellis Barker, who is one of the vice presidents of the Red Cross, who is going through the data and through the history of the venereal disease prevention program within the armed services, and we will be looking very closely at that body of data. I think that the issue of the level of fear and the message that is used to convey a piece of information concerned with preventive activities or health behaviors is also another area that is very, very important. There is a body of knowledge in the literature that surrounds the health belief model. It looks at what is referred 92 to as external cues of pieces of information that come to the individual from the external environment. The level of fear that is imbedded in that cue that the individual perceives has a significant effect on whether or not that individual will then convert intention to take action into real action. Clearly, if you imbed the level of fear too high, people cannot accept that and they won’t do anything. If you don’t make it high enough, it’s not perceived to then really be a risk. So then what we have is a very careful balancing of allowing the individual to perceive a risk, perceive the need for doing something without terrifying them so much that they are then unable to act upon that perception. CARDINAL O’CONNOR: Well, you have another variable in the whole fear syndrome. DR. MILLER: There are many variables here. Sexual behavior, if you just look at sexual behavior and leave the drug use behavior apart, is a very, very complex set of behaviors, and it’s going to vary within ethnic groups, it’s going to vary within age groups, it’s going to vary within sexual orientation groups. I think to lump it together is to do a disservice to the issue. Our committee will be teasing apart those behaviors, hopefully finding threads that will lead to appropriate messages concerning prevention activities. CARDINAL O’CONNOR: My essential concern is in what was apparently the high positive correlation between frightening by way of the horror movies and then saying here’s the answer. That’s where we have to -- that’s the model that I think we can’t simply transfer. It didn’t work then, and I think we have to question whether it will work. It is not for me to say whether it will work now because I don’t have that kind of experience, but I do have the experience with the other and the many other variables that come into counterbalancing fear, such as peer pressure below decks in the ship. That’s a very delicate experience that you haven’t been exposed to. (Laughter. ] DR. MILLER: Very true. CHAIRMAN WATKINS: Mrs. Gebbie. 93 MRS. GEBBIE: I think my first question is also directed at Dr. Miller. The Confronting AIDS report identifies two or three areas for major research in the social behavioral area: sexual patterns; use of needle exchange programs with IV drug users and so on. Yet, I haven’t seen the social science research community fired up the way I’ve seen the biomedical research community. You see people talking about we can’t get access to money; we’d really love to research it. I don’t hear that same thing from social scientists. In part, it might be that we haven’t focused attention on funding in that area, but I’m not certain that’s it. Do you have a feel for whether it’s merely a lack of infusion of adequate funds that would induce more people to study there, or are there some other factors that have kept that re- search community from focusing on this problem? DR. MILLER: I think, again, it’s a complex situation, but I think that, fundamentally, at the base of this there is not the infrastructure within the social science community that one finds in the biomedical research community; that this is an area that has not received great attention in the past either in terms of support for training individuals to go into this field or in terms of supporting research in this area. I think that AIDS has highlighted probably better than anything the need for the incorporation of behavioral scientists into the development of preventive strategies. Clearly, this is not going to be the only disease that is going to be influenced by the individual’s behavior. We have smoking as another clear example of this, and there are many other diseases for which you can look to changes in the indivi- dual’s behavior to influence the prevalence of those diseases within communities. So I think at the heart of this is well-trained individuals and a research tradition in these fields that is supportive. I think in the case of AIDS it’s particularly bad because doing sexual research has been a stigmatized area in the past. It has not been viewed as a legitimate form and, indeed, it’s been perceived as with some stigma attached to it. So I think that support, external support for individuals going into this area will enhance both the quality and the quantity of the work that will be going on. MRS. GEBBIE: I think that to the extent you crystal- lize what that infrastructure is that is needed in that social 94 science area, parallel to what may be there in the biomedical, it will be very helpful for us to hear that and see whether there are some pieces of that that we could find ways to support. DR. MILLER: Our group will be looking at those issues and will perhaps be able to help you out with that. MRS. GEBBIE: My second question, let me direct it to Dr. Widdus. You mentioned the, I think it is, six countries that have not only written a long-range plan for AIDS but are going about trying to implement it. Through your international health interests, are you prepared to give any kind of critique of those attempts to give us some clues as to what makes a good long-range plan work on a national basis or what is different about those countries that we should know before trying to translate to our own what might work, or is that such a long-range question we couldn’t possibly have answers in time to be helpful in our tasks? DR. WIDDUS: Two comments. The long-range plans that I spoke about, medium-term to long-range plans are plans which are being developed with the collaboration of WHO in developing countries. I think that there is not the -- there is probably something to learn from monitoring those, but it will be informa- tion that is developed over the next three to five years rather than within the next six months. There could probably be a useful exercise undertaken to look at those countries, Europe particularly, and Australia, that have undertaken outside WHO auspices, if you like, not necessar- ily with WHO major involvement, undertaken educational efforts; the United Kingdon, France, Switzerland, Australia, and there are a few others that could be looked at for lessons. Some of the preliminary information was presented at the last international AIDS conference, and part of the message that comes from that is that you need to convey messages through multiple panels, through credible sources, and you need to keep doing it again and again and again so that people -- it becomes part of their general informational awareness that this disease exists. I think one of the things that has significantly changed the prevalence for smoking is that the whole social climate in regard to smoking has changed. It isn’t that people have been -- have seen one piece of information like a sort of a warning on a cigarette packet and taking action. The accumulation of all that information about smoking and about the risks it entails has changed the social climate so that people’s -- they are a median of their behaviorship. 95 With regard to Cardinal O’Connor’s point, the educa- tional campaign in Australia was, in fact, probably ill designed in terms of relying on a message of fear to induce behavior change, and I think that that has been shown that people’s awareness of it as a problem goes up very rapidly. It also goes down very rapidly, too, and as soon as the message becomes commonplace, the fear of it, the strength of the message loses its impact. I think -- we are not in the process of looking at those, but I think it could be a very useful exercise to under- take, to review these other campaigns. MRS. GEBBIE: Thank you. CHAIRMAN WATKINS: One of the few if not the only bene- fit of being Chairman of the Commission is that you can ask a question without being recognized by anybody. I am going to take advantage of that now. You talked in your statement about counseling on health care practices, how important that was. It seems to me that one of the areas that is grossly neglected is counseling the HIV positive on health care practices other than what you said was advising that person of the typical symptoms they might be aware of as they transition to ARC. That doesn’t seem to me to be very positive. Isn’t there a concept within the medical community that says that just maintaining good health care practices and your own fitness tone and so forth may well be an assistance to give you a little bit more longevity and time and perhaps we can extend you to the point when the technical experts find a partial cure or an extension or something. Isn’t there a more positive way to counsel the HIV positives? Can’t we say, "Here is a program for you that we think is essential. No smoking. We want you to exercise every day that keeps your body toned up. We want you to avoid this kind of exposure." You are affecting the behavior but you are not coming down on that behavior hard. You are effecting a different kind of concept which is much more positive. There may not be any technical value, and I don’t know that because I am not a medical expert, but it seems to me intuitively that if we keep ourselves healthy and keep that consciousness up, it may never have been there with these individuals, and you bring them into a new regimen of self- discipline in just maintaining their own physical health, rather than saying, we should alert you to the symptoms of where you might have neurological problems and so forth. 96 It seems to me there is a lot to be done there. I am wondering how aggressive the medical profession is in dealing with that aspect. I don’t think they are big on physical fit- ness. I have never seen the medical profession step out on the subject of fitness and how important it can be to their health, because it generates in itself a consciousness that may not have been there otherwise. It just seems to me that there is something there. I would like to have your comments on that. Is there some merit to exploring that a little more and getting a positive signal out there for good health practices, other than sexual behavior constraints, which is also important. DR. WIDDUS: I agree with you completely and I was remiss in not mentioning that aspect of what should be included in counseling for sero-positive individuals. The general ap- proach is promoting healthy behavior. CHAIRMAN WATKINS: Do we know in fact today that a good health program for individuals who are HIV positive will enhance their longevity and health? Do we have any feeling that makes sense? DR. WIDDUS: I think we have a feeling that it will probably be beneficial and particularly beneficial in terms of their capacity to deal with the psycho-social stresses. It will give them a feeling of being more in charge of what is happening to them, which is in itself an antidote to depression. CHAIRMAN WATKINS: Is there something that could be put out in the educational milieu right now, that is more specific, that says, here are some highly recommended programs that come from competent medical authorities that say this makes a lot of sense, we don’t have all the data, we would like to run the tests over the next ten years and finally give you a report in 1995, but in the meantime, why don’t you follow this procedure because it makes a lot of sense. It seems to me that is a very positive thing that can be done, to send some signals out there that maybe there is hope for those individuals to extend their lives. DR. WIDDUS: I don’t know that the content of such a program has yet been defined. I think it is probably in the process. Dr. Miller has a comment. DR. MILLER: One of the things that would be important, there are several factors that occur to me in thinking about this. One is we really don’t know. I don’t believe there is data to show that implementation of an educational program or 97 a diet or whatever is going to really increase the quality or the quantity of life in the sero-positive person I think you have to be careful in qualifying that. There is also a tendency in some data that I collected that indicates some men think that by keeping a good health profile, by keeping themselves healthy, that would be sufficient to prevent getting the infection. I think you really have to distinguish between those two things. Taking vitamins and exercising is not going to prevent the disease. There are other things that you need to be doing and they are more important in the prevention of the disease, and however, you can be doing these other things. I think the primary point you are making is a very important one, not only do we need to appeal to the sense of altruism in individuals who are already infected, asking them not to pass on this virus to others, but I think we need to appeal to their self-interest as well. If you know you are sero-positive, share that information with your physician so that if you do exhibit the following symptoms, he will know to institute treatment immediately and effectively, thereby increasing your capacity to survive that opportunistic infection and increase your longevity. CHAIRMAN WATKINS: That would certainly be a major contributor to encouraging voluntary testing for those who are in the high risk areas. Unless we lay the groundwork for the rationale as to why you want to come forward, and that is just one, there may be others, it seems to me we haven’t done all the homework we ought to do to encourage people to come forward, because it is in their own best interest. DR. MILLER: Yes. DR. WIDDUS: Just to mention one individual who has thought considerably about this, Don Hopkins who was at the Centers for Disease Control, has thought about this aspect of counseling. You may want to get in contact with him. He is now at the Carter Center at Emery University. He was previously Deputy Director at CDC. DR. PRIMM: Was he not here at the Academy working for a while with you? DR. WIDDUS: He is on the AIDS Activities Oversight Committee and has done a number of things for the Academy over time. DR. POTASH: Concerning sero-positive people, particu- larly healthy asymptomatic sero-positive people, in physicians 98 who have experience with other patients, they tend to be counsel- led on the basis of other kinds of immunodeficiency states. For instance, a lot of anti-cancer therapies negatively affect the immune system, so there is a literature concerning how to care for an immuno-suppressed, immuno-incompetent person. There is a past that physicians can draw on and at least some in terms of people, a number of AIDS patients or a number of sero-positive patients do draw on that literature. CARDINAL O’CONNOR: Mr. Chairman, since you raised this, I demand a right, because it always gives me pleasure to disagree with you in public. {Laughter. ] I am worried about that concept, unless you make a lot of distinctions about the condition of the patient at any given time. The overwhelming number that I deal with are fortunate they can raise a fork or a spoon. Even when they have gone through one of various acute stages so you can no longer keep them in the hospital and they leave, they go home or out on the streets, they are tremendously debilitated. I wouldn’t want to raise an expectancy that is simply not able to be materialized, that they could perform any kind of exercise. CHAIRMAN WATKINS: I agree. I was primarily focusing on the asymptomatic HIV positive person. I was talking about the individual who finds out in the counseling process they are HIV positive. Is there a positive counseling program at that point? CARDINAL O’CONNOR: You have to make that distinction. There is another point. Once they have reached that terribly debilitated state, the last thing in the world you want to do is impose a demand on them and then blame them for not being able to meet that demand. So many of them feel so much guilt, they feel so helpless and vulnerable and useless and rejected, that if you say, "Come on, you could do it if you really wanted to do it," and they can’t do it, that only exacerbates the problem. CHAIRMAN WATKINS: I think I had in mind asymptomatic with no other debilitating symptoms at this point, clinical symptoms, that would permit this to take place. I was thinking that we haven’t focused enough on the HIV positive asymptomatic counseling as being something other than telling them to wait until ARC comes. Your comment only included, "Advise them of the symptoms of decay in their own system," and it seemed to me that was probably not the only thing we should be telling that person at that particular point. DR. SERVAAS: Mr. Chairman, could we ask Dr. Weiss to send the Commission the literature or the references on this advice? 99 CHAIRMAN WATKINS: Consider it sent. DR. WEISS: We can certainly identify some peer reviews. DR. PRIMM: We are talking about immuno-depressant studies done on cancer patients? DR. WEISS: The question, if I understand correctly, what kinds of regimens are useful for patients who are for a variety of reasons immuno-suppressed. CHAIRMAN WATKINS: Dr. Lee, you are up to bat. DR. LEE: Mr. Chairman, your Commission is conspicu- ously out of condition. (Laughter. ] CHAIRMAN WATKINS: I resent that! (Laughter. ] DR. LEE: I think we should have a fitness study at the start of your reign and at the end. Thank you again, Dr. Widdus, and Heather. We owe you our thanks because you gave us some terrific assistance a month ago, and you and the other members of your team have done a won- derful job again today. The key questions I was going to ask have been asked by the other side of the table. The main one was integration, how are we going to make a really valid recommendation about integration of effort. When we talk to people, everybody is scared of the con-cept of an "AIDS Czar." Dr. Fauci has told me he does not want to be the czar. The NIH, which distributes all the federal funds for biomedical research, is in a precarious position to act as czar. That is why at least I tend to look to an organization like the Institute of Medicine which is not really disbursing funds and has no particular ax to grind as far as I can tell other than trying to determine the truth on any given issue. Politics seem to be at a minimum. They are certainly there but they seem to be at a minimum. Chairman Watkins asked you, and I would ask you again, please give us some help on that integration issue. You gave me a very disturbing new statistic here on the eight year median disease from infection. In my own 100 mind, with everything that I know about this disease, I thought, based on all previous reports, that it was going to be less than half of that. What is the present determination as far as you can tell, of the median time between infection and a positive antibody result? DR. WIDDUS: That would vary with individuals, but it is within the range of six weeks to six months. There has been some recent information or it was a recent publication suggesting that there may be a much longer time between infection and the demonstration of antibody. That paper caused a considerable amount of concern, but I think individuals at the National Institutes of Health who have gone back and done a careful examination of the techniques used in that paper and have some concern about the interpretation that the author has placed on it. The author’s interpretation was that maybe a year or two years before someone after infection shows up with antibody. I think that the suspicion is that the tests which were used to detect antibody were not sensitive enough and, had they used more sensitive tests, the antibody would have shown up in the normal range of six weeks to six months. If I could go back to the question of the median time between infection and demonstration of disease, that eight-year figure is perhaps the figure that was given for adults. That figure seems to be lower for children or infants infected and lower for individuals of the older age category that are in- fected; for instance, through blood transfusion. DR. LEE: One last question. Since everyone over here preempted me, I’m going to preempt Dr. Primn. On this drug abuse problem, I hope that your Behavioral Sciences Committee will be looking at that in depth. I spent an evening recently with some of you on this issue, and I don’t think fear is big on your list of targets. You indicated that one would think the fear of contracting AIDS through IV drug abuse would be a deterrent, but it isn’t. The question is, can we make it a deterrent? How successful can we be at getting that message across, and will it work? Cardinal O’Connor was hoping that you would not depend on fear as the main deterrent, perhaps because fear is not a great deterrent against drug abuse in general. I didn’t get the impression from talking to you that that was high on your list. DR. MILLER: Certainly the content of the message in the program is what we’re going to be focusing on, and the fear of contact may get dealt with, as I explained in assessing the content of the cue. 101 DR. LEE: Because you brought up, really, a terrific item which may be the key thing with this population, especially the youngest of them, which is peer pressure. What we -- at least what I -- have come to think on this Commission is that AIDS is a terrible and seemingly unending problem, but the real problem in this country is drug abuse, and when that is tied to a devastating disease like AIDS, you have a catastrophe. We have to change that drug abuse behavior. Some people believe we have to give up the present generation. Those people think you can’t do anything about people who have been deep into drugs for many years. In any case, we have to start anew, and we have to somehow create a climate in which peer pressure will be so strong that our children will not take drugs. I don’t think the medical profession has any success at all in dealing with drug abuse. Dr. Primm, I hope, will give me encouraging information on that, but I hope that the IOM report and you, Heather, will come up with very major recommendations on this drug abuse problem from a behavioral point of view. I might add one other thing. We always hear that IV drug abuse is the big problem with HIV infection, but it’s not just the IV drug abuse, because it’s the prostitution that occurs around drug addiction that is probably responsible for more of the heterosexual transmission of AIDS than the IV drugs, and I’d like to hear what Beny has to say about that. DR. MILLER: I’d like to say two things in response to your comments. The issue of changing normative behavior, which is changing the rules of how we all operate, the "shoulds" and the “oughts" of conducting behavior, has been thought to be a very important part of sustaining the change in the gay community and will likely be a part of sustaining any change in behaviors in groups over time. That fostering of support for new behaviors through peers is always important. Anybody who’s been on a diet that has a friend that’s dieting with them knows that kind of comradery. Businesses have thrived on that. The good news in terms of the intravenous drug use population, I think, comes from the studies in Newark that found that the introduction of information on how to sterilize works with bleach then led to an increase in demand for treatment shows us something about linking one health behavior to another; that, in fact, if you can get people to change a part of their behavior 102 that’s associated with risk, then perhaps you can sustain that and amplify it through other additional programs. So that I think that all is not lost in that. I think there are some good news indicators; however, we’re really going to have to look at those data very carefully. DR. WEISS: If I could add something to that and break my silence here. While no one would dispute the importance of preven- tion, there is, in fact, evidence in the medical literature that both alcohol and substance abuse treatment is sometimes effec- tive. What is controversial is exactly what kinds of treat- ment are most effective; but treatment versus no treatment does show successes, and I think that’s important to keep in mind as we advocate the expansion of treatment programs, for instance. DR. PRIMM: I have a comment on the Newark study. I think there were other variables there. I think the other variables were, indeed, that treatment was made available there were ex-addicts out on the street doing canvassing others. There was increase in terms of deaths of people in the peer group which probably influenced also, you know, wanting more treatment or going into treatment centers. So I think there are many variables that influence the conclusion that was drawn from that report, and I’d hate to think that just the fact of handing out bleach and maybe possibly a needle exchange program or whatever, or teaching people how to clean their works was the only factor that increased people’s going into treatment. DR. MILLER: As I said, we’re going to have to look at those data very carefully. CHAIRMAN WATKINS: Dr. Primn. DR. PRIMM: I had a few questions, and since Penny didn’t take any, I thought I would take her one and a half. Did you have one and a half? I have three and a half, then? CHAIRMAN WATKINS: Three and a half. DR. PRIMM: Okay. The first question I wanted to ask, to what extent, really, do you feel that the influence of cofactors play a role in the progression of sero-positivity to, indeed, disease, to AIDS itself? 103 I’m talking about the use of alcohol and, of course, cigarettes and other drugs including methadone. I know there are studies that talk about methadone, not influencing at all the immunological status. But if, indeed, heroin does and other opiates do, I don’t see why we should not have a study on that, and I think it would be good if something like that came out of the Academy rather than from the ranks of those who might be biased from the outset in looking at methadon as a immunosuppressant agent. That’s number one. The other question is I was interested, because when I got out to talk to people all over the country, they talk about the origin of this virus maybe being from the African green monkey, or the simian immunodeficiency virus, and that’s been pretty much dispelled here by Luc Montagnier in Naples recently with some African research that has indicated that the virus could not have necessarily come from the simian feces because pygmies actually eat this animal as a delicacy, and there’s a very low incidence of prevalence among that group, that tribe population in Africa, of AIDS or "slim disease." Then what do you feel about the feline immunodeficiency virus? Do you feel that it might have some origin in relation- ship to the human immunodeficiency virus, either 1 or 2, and what is that relationship? Is it a rectal virus, lymph virus, etc.? Then there is one question that really bothers me. I note with great joy that you talked about the expansion of methadone maintenance treatment programs and other drug treatment programs. But you also talked about the possibility of experi- mental or pilot programs in issuing needles and, of course, syringes. But somehow that bothers me. It bothers me because, you know, the cooker is also a very important part of it, and the little piece of cotton that they use is a very important part of it. It’s very misleading, I feel, for the Academy to recommend this unless we take into account that we’re talking about, really, teaching people how to safely use drugs. That’s what we’re saying in essence. I’m not so sure that this country is ready for that, and I’m sure I’m not ready for that, because if we are going to give them a needle and a syringe and a cooker and some sterile cotton and then give them some bleach so they can clean their 104 needle, then who’s going to give them whatever it is to put in that needle in order to take the shot? I think we’re going to possibly see crime increase, and I don’t think we can take the Dutch experience and extrapolate from that experience. It’s an entirely different culture, one that’s very permissive, and one that dispenses needles and, of course, syringes along with methadone. You can get them both, I guess, on the mobile vehicle that they use for this purpose. So I’m quite concerned about the Academy with its stature in this country maybe making a recommendation that because we have a crisis situation and not putting greater emphasis on the cessation of the use of all drugs, particularly intravenous drugs. So the last is the other half question that I had. You know, in the press it’s often reported that blacks after diagnosis with this disease live 19 weeks and the whites after diagnosis -- that’s full-blown AIDS once they get an opportunistic infection -- live two years. Now, that data is startling and terribly striking. This was reported in USA Today. It’s been reported in other papers and so forth. So I’m concerned about that and that when we look at those deaths, we should begin to think of why. The whys are terribly revealing, and the revelation that comes to me is probably the lack of access to good health care for certain people in this country, the lack of quality health care for certain people in this country, the lack of proper insurance, the lack of good physicians in the first instance when they’re in- fected with the problem and so forth. A delay and a denial and an unconcern that the Academy does not put a greater emphasis on those areas of concern -- and I would look to you to do so or have another look at that whole situation because it is a window of opportunity for us finally to bring some equality in health care in this nation. DR. WIDDUS: Let me try and run through these five and a half questions. [Laughter. } I agree with you completely that we need some very good studies on what might be or might not be cofactors for progres- sion of disease, what factors influence that. I think that this area, like many of the others that you mentioned, will be ad- dressed within the update of our report. In terms of the origin of the virus, when they are talking about the origin of what is commonly known as HIV-1, which is the predominant virus 105 in Central Africa, Europe and the United States, that, although it has been speculated that as monkey origin or transferred from the monkey population to the human, it’s also been speculated that it had origins in an iso- lated human population and for various reasons started spreading out of that isolated human population which had acclimated to it in the early ‘70s. There’s no evidence for either of those speculations because we have not found a virus similar to HIV-1 in an animal population. There’s no counterpart. With the HIV-2 virus, which is increasingly spreading in West Africa, which is another sort of subgroup within the whole category of human lentiretroviruses, there is an animal counterpart, a very closely related virus which affects monkeys in West Africa. But in terms of the origin of the virus that is the predominant cause of the epidemic, it is a mystery still and may well remain so. It’s very difficult, in fact very sensitive, to try and track down the origins. It is probably only something that will receive attention for a short while in the total history of this disease. No one speculates, for instance, where the hepatitis B virus originally came from geographically. Probably in the long run any relevance which can be gained will be avoided because in certain countries, the speculation of whether they were the origin of the virus causes distraction of effort away from actually preventing the further transmission of the disease. In regard to the feline immunodeficiency virus, I’d like to clarify. That is a lentivirus which is the virus in the same general category as the human immunodeficiency virus, but there is no reason to suspect that the feline immunodeficiency virus is in any way connected in origin to HIV. It has suffi- cient species specificity that it is almost impossible that it in any way derived from human viruses. They may have had a common ancestor millions of years ago, but that’s not to say that there’s any connection there. In terms of the last two issues that you mentioned, the various options which are available in tackling the spread of the virus within either drug users and the question of equity of access to health care and preventive diagnosis, et cetera, the report that we put out a year ago but which was done in about seven or eight months was intended to be a quick overview of the field. It was exhausting, but it was not intended to be exhaustive. 106 [Laughter. ] I think that there is reason to look further at the question of exactly, if one wanted to think about doing trials for reducing use of needles amongst drug users, there is now some information build up from the European studies which are not exactly extrapolatable, I agree, but there is some information there which can inform our choices. I think with a greater in depth look at exactly what are the practices you are trying to eliminate, exactly how is the virus transmitted, it is worth revisiting that area. I would still think that a possible intervention that should be considered is making needles more available, but it is well worth reconsidering it in the light of recent information. The same applies to paying more attention to the fact that the disease unfortunately looks as though it is unfortunately going to disproportionately affect minorities. I think strategies for tackling that problem need to be more carefully addressed in our update. DR. PRIMM: You didn’t speak about the cooker, and that is important. What is your feeling about the transmissibility of the virus through the cooker and, of course, through the cotton that is used to filter the solution of heroin and water, or cocaine and water in intravenous substance abuse? DR. WIDDUS: I’m not familiar with any evidence on the viral survival in that environment. I think those sorts of things should be taken into account whether the whole question of our experiment with syringes is worth promoting at this time. It needs to be looked at more carefully. DR. PRIMM: Particularly in programs like that, the one in New Jersey and the ADAPT program in New York that hand out bleach and so forth, I think something has to be done from this level, from your level. It lets people go off helter skelter and do whatever they think might be good, and what might be good might be promoting the bad. DR. WIDDUS: We have been approached by the National Institute for Drug Abuse to convene a workshop on questions sur- rounding reducing the spread of HIV in drug users and different approaches to treatment. I think that would be an excellent forum for continuing those discussions. DR. PRIMM: Just one more comment. I was just very, very impressed by your presentation and everybody’s presentation. I am just very proud to be a part of it here today, and hear you. It was excellent. 107 CHAIRMAN WATKINS: Before Dr. SerVaas, can I tag onto Dr. Primm? I think that Dr. Primm has made a terribly important point about the potential evils that can accrue when you recp,- mend something as medically proficient without putting it into context. I would think that if I were in your position or if I were a research scientist of any sort and people were constantly asking me what will stop this or what will stop that, I would tempted to give discrete answers and say, for example, "All right, you can help reduce IV transmission by distributing clean needles." But I think I would also have to say that you have asked me a purely medical question and I am giving you a purely medical answer. This is the National Academy of Sciences, and therefore I feel obliged to at least speculate on all of the social evils that could accrue with so simplistic an approach as that. DR. WIDDUS: Let me go back and say, as I said in my talk, the whole question of making needles more readily available as a method of preventing the further spread of the disease in the IV drug using community was one part, and in fact, was the last thing that I mentioned. We did have a hierarchy of activities that we sugges- ted. The first was getting people -- the obvious need to stop people using intravenous drugs. If you will go back and check the report, making treatment more readily available was the first of the things that we mentioned. We would then mention prevention of individuals enter- ing into drug use, and the third component was the suggesting that not in fact that we blanket the world or the drug using community with clean needles, but that carefully controlled ex- periments, monitoring the effect of making needles more readily available be conducted in particular locations and that one monitors both its impact upon IV drug use and its impact upon HIV spread. I think given that hierarchy, we did put the emphasis on those things which would be most effective and tried to formu- late our suggestion of doing something that could be useful in individuals that continued to inject in an experimental fashion, so that as we accumulated information about whether it was ef- fective or not effective, we could either move forward to broader availability, more forward from an experimental situation or broader availability, or we could rapidly curtail the experi- ment if it did seem to be not having an effect. CARDINAL O’CONNOR: Yes. I thought that you presented this in context very well. I thought we started to lose it here in the exchange with Dr. Primm, and that’s what concerned me. 108 CHAIRMAN WATKINS: What is the conclusion though, Dr. Weiss. Let’s assume you proved that clean needles, syringes, paraphernalia when used, do not transmit the virus. Can’t you predict that ahead of time? And if so, if the answer is yes -- the clean equipment does help for the IV drug abusers by eliminating virus transmission -- I don’t really see what conclusions that you draw from that other than the fact that clean equipment doesn’t transfer the virus through the drug injection. So, I don’t understand why can’t you predict that ahead of time and decide. You then shift to the Cardinal's concern, it seems to me, as the next issue: "Have you just done the right thing?" I don’t understand what this test would be. It just Says that clean equipment does not transmit the virus. It seems to me that you could come to that conclusion ahead of time, couldn’t you, in the laboratory? DR. WIDDUS: Clean equipment doesn’t transmit it in transmitting blood from one individual to another. There is the potential that what is put into the syringe that has been men- tioned, may contain the virus. What one is trying to do is, in the experiments that we were suggesting, is to determine which is the most significant factor in the spread from one IV drug user to another. Is it the fact that they are sharing equipment, or is it the fact that they are putting into syringes the product which comes out of the same cooker that was used to solubilize the drug. When one is trying to refine ones understanding of the exact mechanics of the process of transferring virus from one person to another, which is why you need an experimental situa- tion. Dr. Primm would like to expand on that. DR. PRIMM: No, I think you’ve done an excellent job. MRS. GEBBIE: It seems to me though that very quickly leads one to a whole other set of social questions, some of which are researchable and others of which are value judgments about whether it is appropriate to make what is basically an unhealthy and to all intents and purposes an illegal activity safer in order to save lives, or whether one puts the emphasis on some- thing entirely different letting those who don’t get off drugs continue to die of AIDS while working to get everybody off drugs or to stop their use. That’s a very complex value question, and we don’t really have a good vocabulary and context for that debate. 109 So, I think it becomes easier to sit around and debate about clean needles, clean works, clean cookers, because at least we can think about that in a little more organized fashion. DR. WEISS: Two other points. One, as you allude to, is that substance abuse has its own set of morbidities and mor- talities totally apart from AIDS. So, it is not a safe activity, a healthy activity, and it causes death for other reasons rather than AIDS. One other potential outcome that can be explored by a small project supplying sterile works would be to see what happens to the use of a drug within that population. Don Des Jarlais, at our annual meeting this year, presented some very voluminous evidence that given in the right context there was an increased demand for treatment on the part of the people who received the sterile works. That is an outcome that we need to study very carefully. DR. LEE: The problem is, as I understand it in Don Des Jarlais’ clinic is that these people are already 70 percent HIV positive by the time they get there. So, it’s great for drug addiction but not much for AIDS prevention, at least for those already infected. DR. WIDDUS: Let me emphasize that our Committee viewed a recommendation for a sort of experimental study of the effect of making needles more readily available as an interim measure at the best, while people really got to grips with the question of getting more people through treatment and getting more effective prevention programs in place. DR. LEE: Does the Institute of Medicine think of drug abuse as a major disease to be a threat? I/’11 tell you something, I looked up some financial figures on the cost of diseases for a talk I gave a week ago. These figures were projections for what would be the most ex- pensive illnesses in the United States in 1991. The most expensive disease was projected to be AIDS, which was going to cost a total of $8.1 billion. Cancer of the breast was listed at $3.7 billion. That’s the kind of thing you are talking about. Now, nowhere in there was there an estimate for the direct or indirect costs of drug abuse. What do you estimate the cost to this country of drug abuse is; $100 billion? DR. WEISS: If you include alcohol, which I think most people in the substance abuse field include alcohol and drugs as groups of substances. I don’t know the dollar figure but it’s quite enormous and has various ranges. 110 DR. LEE: Well you don’t want to take alcohol away; alcohol serves a good purpose. (Laughter. ] DR. WEISS: Actually, the pattern of substance abuse in recent years is such that there is more dual abuse than ever. The boundaries are overlapped more than ever. The Institute of Medicine has several very, very large projects in the area of substance abuse and alcoholism going on right now. I think the underlying presumption of most of the people involved in those studies is an acceptance of the disease modeled in some titration if there are genetic factors that it certainly is a social illness. But, it seems to me that in general there is a broad acceptance of some disease concept for substance abuse and alcoholism. DR. WIDDUS: Let me add something to that, that I think everyone that I’ve spoken to in the last year or two that have been looking at the epidemic in the broad sense thinks that the size of the AIDS epidemic in the broad population will be de- termined by how well we handle HIV infection in drug users, and the extent to which we can come to grips with HIV infection in drug users will be determined by how well we can tackle, or how much effort we put into, the overall drug problen. I think in that sense you have to get to grips with drug use as a broad societal problem and not just tinker on the edges with sort of HIV and drug use. DR. CRENSHAW: I would also like to add that you cannot separate drug use or abuse or alcohol use and abuse from sexual transmission, because one of the things that frequently gets overlooked is the judgment impairment and mind-altering impacts that cause people to alter their sexual behavior in very risky fashions. CHAIRMAN WATKINS: Dr. SerVaas, we have about eight minutes. DR. SERVAAS: Eight minutes. Dr. Widdus, what practi- cal and proved tests do you know about to further improve de- tecting the AIDS virus in blood donors? Specifically, is there an antigen test that is practical that might reveal the AIDS virus before the antibodies are developed. You’ve said the window is something, three to six months. Then I would like to know what you could tell us about whether or not you think we should be testing for the HTLV-1 lentivirus which I believe gives T-cell leukemia in 20 years, and 111 how soon do you think we will be testing for it in blood donors? I understand there is a practical test for that now and I wonder if that’s part of what the Commission should not be thinking about since it is such a slow virus in its HTLV-1. And then, what is your best estimate of the number of false positives you would find on confirmatory Western Blot per 100,000 tests; what would be your best guess or estimate on that? DR. WIDDUS: On antigen tests, I think that there is available for laboratory use, an antigen test for the virus. I don’t think that the companies that market that are promoting or have yet applied for its use as a sort of serologic test for the virus. I don’t think there is anything yet we that we could use as an antigen test on blood supplies or individuals. it would definitely be, if it was accurate and had some sort of con- firmatory test that could be done, it would be a very useful supplement to the current antibody test. If people have applied to make that a clinical test, I am not aware of the status of the approvals yet. The question of HTLV-1 testing, Dr. Potash sent a note that in fact, HTLV-1 infected individuals progress through leukemia in only about 1 percent of the cases of the infected individuals. I believe that a test is available. I’m not sure of how much it costs per test. I know that there are some dis- cussions going on amongst the Red Cross and the blood banks about whether to institute it routinely. I don’t know what the status of those is at the moment. Dr. Weiss will answer the question about false posi- tives. If you need sort of a referral to individuals who are exceptionally well versed in running testing programs and in sort of confirmatory tests, I would suggest that John Burke, who quality controls the military program may be the best individual to write to for some information. They have an exceptionally well quality controlled program. Quality controlled serologic testing is a very impor- tant issue. Robin? DR. WEISS: I mentioned at the lunch break that one small offer of technical assistance we could make would be to supply you with a person who could give a talk on the relation- ships among false positive, false negative, and the prevalence of a condition in a population being tested because it is an axiom of scientific testing that those things are related, and there- fore, you can’t just answer the question of the number of false positives without knowing the prevalence of the condition in the population being tested. I suggested, and it sounds like you’1ll probably be chairing a meeting that looks at some of those. 112 MRS. GEBBIE: I don’t think I’11 be chairing that meeting, but I think I am going to be working with the panel or at least with setting up the panel, because I am aware of that dynamic and how long an answer it takes to lay it out. DR. SERVAAS: That’s right. But once you get it, it’s very clear. MRS. GEBBIE: Yes, but you need -- DR. POTASH: I could supply you with some papers and some suggestions for real experts who could do a real pedagogi- cal discussion with you on that. DR. SERVAAS: I have a question for Dr. Weiss. You said that one of out 20 positive, HTLV-1 positives go onto to develop T-cell leukemia. If it takes 20 years, how do we know that it’s only one out of 20? DR. WEISS: I think it’s somewhat fewer than that. My idea was something on the order of a few percent, one percent. The virus, one can look back in terms of cell banks that are available to determine when a person may have been infected. The problem is with HTLV-1, it was widely spread before we knew that it caused disease at all. So, in fact, we have some history of who has been infected and the kinds of disease. But, it’s only been roughly about five years ago that we knew it caused disease at all. DR. LEE: Where does this 20 year figure come from; is that correct? DR. SERVAAS: The AABB, The American Association of Blood Banks last week in Orlando, said that what we know now about this fire is that it is unconscionable for us not to start testing right away. They had a show of hands that almost unani- mously said that yes, we are going to test. The Red Cross was there and all the private blood bankers were all there. They said 20 years, that it’s a lengthy virus and it takes 20 years for the T-cell leukemia to come from this virus and that we do have a practical test for it. I thought maybe you knew a lot more about it. DR. LEE: How can you come to that 20 year figure? I mean, we have a lot of children that get T-cell leukemia at age five, six, seven and eight. I mean, where does this 20 year figure come from? DR. POTASH: They may not be getting the T-cell leukemias that derive from HTLV-1, I don’t believe, although we 113 are not certain. As you well know, Dr. Lee, and you may know, Dr. SerVaas, there are several origins that inherit different sorts of T-cell leukemia. We could go into a long detail if you like, but not right now. This one is the one that permits an infectious T-cell leukemia. DR. SERVAAS: It is sexually transmitted they told her. DR. POTASH: It is transmitted by intimate contact. DR. PRIMM: Let me report to you one particular research project that is going on between a program in New Orleans, Louisiana and the desired project of the method of our maintenance treatment program and the National Institute of Health. There has been some blood samples to NIH for HIV-1 detection and they found no HIV-1 among these 250 samples. But, they found about 50 HTLV-1 positive in these samples. There is no evidence of leukemia among the spacious population nor in the New Orleans area. They are really be- ginning to look at that very, very closely. So, I think that it bears scrutiny, particularly among these "were addicts." DR. POTASH: I can’t help being interested because at least it has some of the same cells are infected by both viruses. One can’t help asking the question, is there any relation. They are not, as far as I know, all enormously distantly related viruses. They have a very different kind of biology. DR. PRIMM: I would like to ask something else -- not ask something but add something, since there are so many of you here that are investigating all of these different things. This is the incidence or prevalence of tuberculosis among intravenous drug users, and particularly areas like Harlem in New York, and the South Bronx where have a high incidence and prevalence of HIV-1 and certainly a great number of AIDS cases, and particu- larly among women. There ought to be some reports. I would love to have something come out of the Academy, the Institute of Medicine on that issue and other infectious diseases that are causing death among intravenous drug users long before they are diagnosed to have AIDS itself. That has prompted New York, as we know, to raise the numbers in terms of those that have died that are rep- resentative of intravenous drug users as opposed to people who are homosexual, bisexual cases of diagnosed AIDS cases -- death from diagnosed AIDS cases. 114 I think we need to really look at that very closely in other cities. The other thing is on the needle. I won’t go in and get back on that and beat a dead horse. That is, what is your thinking and maybe you want to think about this later on, that multiple injections whether the needle is clean or not could indeed in intravenous injections, trigger proliferation of the virus. I’ve heard that from certain researchers, so I don’t know how valid it is. DR. WIDDUS: I think that as I understand it generally on this last point, that any subsequent event after the initial infection which triggers the immune system is going to trigger another round of virus replication type reinfection of new T-cells. It may well be that individuals who are exposed to multiple antigen stimuli progress in the disease more rapidly than do others. In regard to the question about tuberculosis and the general question of interaction between HIV infection and other diseases, the World Health Organization will be convening a sym- posium in Nairobi in early December about such interaction. I will be pleased to feed back to you any information that comes out on that, which includes TB. CHAIRMAN WATKINS: Dr. Widdus, we are out of time. And I am going to ask of you the same thing I asked of Dr. Nelson this morning, that you allow us to submit further questions to you and the Institute of Medicine for your review and answer to us as our Commissioners deem appropriate. I would like to keep the hearings essentially open between us, so that we can continue the dialogue as our Com- mission unfolds here over the next few months. So, I would like not to terminate any discussion we have here with you, but to shift to a paperwork exchange if that’s satisfactory. We would like to then use those answers as appropriate when we aggregate the various pieces of information we think are necessary as we formulate our Final Report. We want to thank you and your team today. It has been enlightening for us. You obviously have a superb group, and as Dr. Lee, Dr. Primm, and the Cardinal said, we are very proud to be linked up in a common effort here with common objectives. Thank you very much for appearing today, and you will be hearing from us some more. This meeting is now adjourned. (Whereupon, at 4:06 p.m., the hearing adjourned. ] 115 APPENDIX Statement of the American Medical Association to the Presidential Commission on the Human Immunodeficiency Virus Epidemic Presented by Alan R. Nelson, M.D. RE: AMA Report on Prevention and Control of AIDS - An Interim Report November 24, 1987 American Medical Association §35 N. Dearborn Street Chicago, Illinois 60610 Department of Federal Legislation Division of Legislative Activities (312) 645-4775 STATEMENT of the AMERICAN MEDICAL ASSOCIATION to the Presidential Commission on the Human Immunodeficiency Virus Epidemic Presented by Alan R. Nelson, M.D. RE: AMA Report on Prevention and Control of AIDS - An Interim Report November 24, 1987 Mr. Chairman and Members of the Commission: My name is Alan R. Nelson, M.D., and I am physician in the practice of internal medicine in Salt Lake City, Utah. I am also Chairman of the Board of Trustees of the American Medical Association. The AMA appreciates this opportunity to appear before the Presidential Commission on the Human Immunodeficiency Virus Epidemic and to discuss the AMA's interim report on the prevention and control of AIDS. We would also like to apprise the Commission of other AMA initiatives which bear directly on the primary focus of the Commission. That is, to recommend measures that federal, state and local officials can take to: -2- o protect the public from contracting HIV infection; o assist in finding a cure for AIDS; and o care for those who already have the disease. As President Reagan stated before the American Foundation for AIDS Research, "The commission will help crystallize America's best ideas on how to deal with the AIDS crisis." A similar goal has been the aim of AMA's many activities on AIDS. The interim AMA report which we have been invited to discuss is keyed to this national objective, as identified in its title: "The Prevention and Control of AIDS." In developing the recommendations contained in our report, we have sought to balance two, separate, sometimes competing, concerns. First, the person who is afflicted with the disease needs compassionate treatment. Those who have the disease and those who have been infected with the virus should not be subjected to irrational discrimination based on fear, prejudice or stereotype. Second, and of critical importance, the uninfected must be protected. Those individuals who are not infected with the AIDS virus must have every opportunity to avoid transmission of the disease to them. In our opinion, while providing a judicious balance, the report provides protections for both populations based upon the current state of medical and scientific knowledge. Before I review the specific recommendations, I would like to discuss the fundamental requirement to which this Commission must address itself—the need for a national policy on AIDS. Given the growing dimensions of the crisis and given limited national resources, it is imperative that a national policy be developed jointly by the public and private sectors. Such a policy must seek, in a cost-effective way, to achieve fundamental national goals: prevention, treatment, and cure-—-and adequate research in all three areas. A coherent national approach to this modern killer is needed--a blueprint for a national response, not piecemeal solutions. Such a national policy must have certain characteristics: oO The policy must be comprehensive, proceeding simultaneously on the fronts of prevention, treatment, and research. The policy must be coordinated between public and private sectors and between the different levels of government. A national policy does not necessarily mean a federal policy: there are important roles at all levels of the health care system and at all levels of government. Nor does it necessarily mean uniformity: on certain issues different approaches should be tried to determine efficacy. The policy must be carefully balanced. For example, concern for the person with the disease must be balanced with concern for those who do not have the disease but who may become infected. Similarly, careful consideration must be given to directing scarce resources to increased prevention, even as increasingly large resources are necessarily devoted to research and treatment. The policy must be based on scientific information and medical judgments. Although policy choices must inevitably be made, they should be formed on the best available information and on the extensive public health experience in dealing both with AIDS and with other contagious diseases. The policy should be nonpartisan. Although it may be tempting to play on fears and prejudices, public figures and officials both inside and outside the health community should avoid exploiting the crisis for partisan political advantage. The policy should be capable of continuous review and modification as more and better information becomes available. Our nation is looking to this Commission to articulate a national policy such as I have just described; or in the President's words, to crystallize America's best ideas on how to deal with the AIDS crisis. I would now like to describe to you some of the recommended responses to the many difficult issues posed by the HIV epidemic which the AMA adopted as Association policy this past June. If you would like to discuss anything that appears in the AMA report, I would be happy to do so. For now, however, I intend to concentrate on the major recommendations which have the most bearing on the Commission's mission. Clearly, one of the most important subjects addressed in our report was that of testing for the HIV antibody. We concluded with recommendations that: o voluntary testing should be available to all; o testing should be mandatory for: - blood, organ and tissue donors, - immigrants to the U.S., - military personnel, and - prison inmates; o routine, but voluntary testing should be provided: - at sexually transmitted disease clinics, - at drug abuse clinics, . to pregnant women at high risk areas, early on, and . to certain individuals seeking family planning services; © essential to any testing program is appropriate counseling: - on ways to reduce the risk of infection, - on responsible behavior for those who are infected, » on strategies for coping with the infection, . on the necessity for notifying sexual partners and other contacts regarding possible infection. o informed consent should be knowingly and willfully given prior to testing. -5- We believe that our testing recommendations fit very nicely with the main purposes of testing: o to identify infected individuals for treatment and protection of third-parties; o to offer education and counseling aimed at modifying high risk behavior; o to obtain epidemiological information; and o to protect the nation's blood, organ and tissue supply. The question often arises as to why the AMA has not endorsed widespread mandatory testing. Mandatory testing has been proposed for those seeking marriage licenses or for hospital admissions, for example. We believe that health care resources would be better focused elsewhere in the battle against HIV. Mandatory testing of low incidence populations would divert finite testing and counseling resources from high risk individuals who volunteer for testing because they have reason to believe they are infected. There is also a chance that false positive results would be unacceptably frequent, with irreparable adverse results to innocent parties. Finally, the estimated cost for uncovering one valid case of infection within a very low incidence population would be extremely high. But will voluntary testing work? We believe that voluntary testing is working already. One indication is that in many areas, the capacity for testing and counseling cannot meet the demand. The greatest threat to the success of voluntary testing and counseling is that individuals will resist learning their serologic status if safeguards for maintaining confidentiality and protection against discrimination are not assured. It is for this reason that the AMA has made these recommendations: o Reporting of positive results of HIV testing to public health officials should be anonymous, or if carefully implemented with strict protections for confidentiality, with identifying information. o Laws must be adopted to encourage as much uniformity as possible in protecting the identity of HIV infected individuals, except where the public health requires otherwise. o Anti-discrimination laws must be clarified or amended to cover those who test positive for the antibodies to the AIDS virus. Discrimination inhibits the control of AIDS by discouraging voluntary testing. It also has the destructive effect of removing those who are otherwise productive members of society from the workforce or otherwise denying them involvement in fundamental aspects of normal life. The AMA has taken a strong stand on discrimination and we have backed this up in the courts. In three recent cases the AMA has filed amicus briefs supporting an interpretation of existing Constitutional, federal, and state law to encompass individuals with contagious disease in general and AIDS or HIV infection in particular. I am pleased to report that in all of these cases the courts reached the outcome we advocated. This includes a decision by the United States Supreme Court which acknowledged and adopted the AMA's suggested analysis for evaluating employment decisions involving individuals with contagious disease. Copies of these three amicus briefs have been made available to each member of the Commission, along with other AMA materials which I will describe in more detail later. Our efforts to ensure the fair treatment for individuals infected with HIV extend to treatment by the medical profession as well. The tradition of the AMA, since its organization in 1847, has been that "where an epidemic prevails, a physician must continue his [or her] labors without regard to the risk to his own health." The AMA Council on Ethical and Judicial Affairs has just recently addressed the question of the physician's ethical obligation towards individuals who are infected with HIV. The Council has now stated, ina clear pronouncement, that a physician may not ethically refuse to treat a patient whose condition is within the physician's current realm of competence solely because the patient is infected with HIV. Perhaps nowhere else is the judicious balance between the rights of infected individuals and the imperatives of public health more difficult to achieve than on the issue of contact tracing or partner notification. As a general rule, the AMA believes that unsuspecting contacts of a person who has been found to be infected with HIV should be informed of their risk. It will not be responsible, in every case, to rely on the infected individual to convey a suitable warning. Where intervention is indicated, public health officials should be able to act on mechanisms analogous to those used in the past by public health authorities to warn contacts concerning sexually transmitted disease. We believe specific statutes are needed that will, consistent with essential confidentiality and anti-discrimination protections: o provide a method for notifying unsuspecting partners; © protect physicians from liability for refraining to convey notification to a partner or contact; o establish clear standards for when a physician should notify public health authorities; and o provide clear guidelines for public health authorities to undertake partner notification or contact tracing. -8- Contact tracing provides a very specific, individual form of information on HIV infection. There also is an urgent and critical need for more scientifically sound data on the prevalence and spread of virus in the population as a whole. At the present time only those cases that meet the current CDC surveillance definition of AIDS are reported to that institution. Since AIDS is the terminal and fatal stage of HIV-infection, it represents only the tip of the iceberg. How large the base of that iceberg really is-—-that is, how many people are actually infected--can only be estimated from the number of reported AIDS cases. If economic and medical plans are to be made for the future, reliable projections must be available. How sufficient or exaggerated these plans may be depends upon the accuracy of current and future estimates of HIV-infected persons, particularly as to the extent of its spread into the low-risk heterosexual population. The CDC itself is unsure about the accuracy of its estimates. We believe that the CDC's estimates, however, are firmly based on scientific methodology, and only better and more extensive data will permit anyone to improve upon the CDC's work. Not only are accurate estimates of HIV-infected persons needed, but go too are reliable data on the rate conversion of asymptomatic seropositive persons to clinical illness, including AIDS, that requires increased medical care. This information is important for the formulation of plans to provide for the costly care of future patients. In order to obtain accurate information in HIV infected persons on the rate of conversion from asymptomatic to clinically severe illness, baseline data on their serologic status must be obtained as early as possible—not after clinically manifest disease is present. -~9- We believe that local health officials would benefit also from reports of HIV-seropositivity, for example, to determine if testing programs are reaching a significant infected population. Accordingly, the AMA recommends that individuals who are found to be seropositive to HIV should be reported to appropriate public health officials on an anonymous or confidential basis, with enough information to be epidemiologically significant. States may, in addressing their particular problems, require reporting by name. In any event, measures to provide confidentiality and protection against discrimination are essential to the success of any reporting program. Even with confidentiality and anti-discrimination safeguards in place, such reporting could deter some from seeking testing and counseling. The final recommendation that I will mention is the one on which I would expect the greatest consensus. This recommendation is: o Public funding must be provided in an amount sufficient (1) to promptly and efficiently counsel and test for AIDS, (2) to conduct the research necessary to find a cure and develop an effective vaccine, (3) to perform studies to evaluate the efficiency of counseling and education programs on changing behavior, and (4) to assist in the care of AIDS patients who cannot afford proper care or who cannot find appropriate facilities for treatment and care. Federal funding for FY88 to deal with AIDS may reach $1 billion. This amount is simply not sufficient to meet the challenge presented on the four fronts I have just identified. The federal government's role is especially crucial to meet the need for essential, basic scientific research. It may be that, on certain other issues, the deep divisions over the appropriate national policy may not be as easy to resolve as the need for resources. We suggest, however, that a clear message by this Commission regarding the need for adequate federal resources will be most constructive and widely supported. -10- We realize, of course, that the Commission is looking beyond the federal government. The formulation of a national policy is not limited to consideration of federal legislation. National policy embraces a role for states and local governments as well as for participation by the private sector. Measures taken at the’ state and local level have the particular benefit of an-awareness of the nature of local conditions. Our national policy on AIDS should preserve the flexibility needed to adopt measures that best suit local conditions. Conclusion The recommendations contained in our report are not merely abstract principles or debating points. The AMA has made every effort toward implementation. Where specific actions are recommended, such as organizing conferences or drafting legislation, these actions have been or are being carried out. Policy recommendations are guiding our active support of legislation on HIV testing, counseling, confidentiality, anti-discrimination, education, treatment and research, and in our amicus briefs in selected AIDS-related litigation. I hope that this presentation will leave the Commission with a clear picture of the AMA's resources and record of commitment to the public health challenge of AIDS. As this Commission combines the talents of its membership to develop its final product, we urge you to keep organized medicine in mind. We stand ready to integrate our efforts into the national effort and we look forward to participation with the Commission in this regard. 3291p/1-10 OTA @W- 1G BIdAL NATIONAL ACADEMY OF SCIENCES INSTITUTE OF MEDICINE Report of Committee on a National Strategy for AIDS Confronting AIDS, Directions for Public Health, Health Care, and Research SUMMARY OF RECOMMENDATIONS I. Status of the Epidemic The Committee believes: - fhe PHS estimates are reasonable and useful for planning purposes; (this does not obviate the need to acquire in- formation for better models); - Over the next 5-10 years, there will be substantially more heterosexual HIV cases, primarily among population groups at risk for other sexually transmitted diseases (STDs); II. Opportunities for Altering the Course of the Epidemic The Committee recommends: - A major educational campaign to reduce the spread of HIV; > coordinated and funded by federal government > target special population groups > message culturally tailored to minorities - Consideration of the establishment of a new office, possibly within Office of Assistant Secretary of Health, devoted exclusively to education for the prevention of HIV infection; ~ Increased educational and public awareness activities, supported by: > experts in advertising > government and foundations > information media > other private sector organizations - Legal and administrative barriers to the use of paid television for such educational purposes should be removed. ~ IV Drug Abuse: > more methadone and other treatment programs, testing and counseling services are needed > trials to provide easier access to sterile, disposable needles and syringes are warranted - Public health measures: > blood and plasma collection centers should develop administrative systems to further encourage self- deferral of donations of suspect blood while maintaining donor privacy > AIDS and ARC cases should be vigorously reported to local and state public health agencies with strict confidentiality > mandatory testing is not now recommended for population sub-groups, though arguments can be made for its use in the military > public health authorities should use the least restrictive measures commensurate with the goal of controlling the spread of HIV > children with HIV should be admitted to the same school classes they would attend if not infected, CDC guidelines are recommended for special circumstances - Funding for education and public health: > approximately $1 billion annually for education and public health by 1990 > a major portion must come from federal sources because only national agencies can launch and coordinate such large efforts - Discrimination: > workplace or housing discrimination due to potential health risk posed to others is not justified and should not be tolerated III. Care of Persons Infected With HIV -The Committee believes: > to be both comprehensive and cost effective, care must be carefully coordinated within the community with hospitalization only when necessary > for in-patient care, AIDS units or teams should be established in high incidence areas with a nursing and psychosocial support staff trained in AIDS care integrated with out-patient and community based staff > in high incidence areas, dedicated out-patient clinics should be considered - Health care costs: > to permit calculation of direct and indirect lifetime HIV health care costs, more information must be gathered on all aspects of care costs for HIV-related conditions > all demonstration projects should be designed to facilitate patients’ health outcomes, quality of life, effectiveness of care, and cost of provision - Health care financing: > all persons with HIV infection are entitled to adequate care > mechanisms equitable to both recipients and providers should be found for financing > solutions of financing problems must be found within framework that applies to existing health care financing, including possible national health insurance for catastrophic illness or state-based high-risk pools na \ from other health or research budgets. The federal governn she sear the responsibility for the $1 billion in research funding am also the only possible majority funding source for expenditures of the magnitude seen necessary for education and public health. Furthermore, to promote and integrate public and private sector efforts against HIV infection, a National Commission on AIDS should be created, Such a commission would advise on needed actions and report to the American pedple. Curbing the spread of HIV infection will entai! many actions, including the following: © Expand the availability of serologic testing, particularly among persons in high-risk groups. Encourage testing by keeping it voluntary and ensuring confidentiality. © Expand treatment and prevention programs against IV drug use. Experiment with making clean needles and syringes more freely available to reduce sharing of contaminated equipment. The care of HIV patients can be greatly improved by applying the results of health services research. In the meantime, the following actions should be taken: © Begin planning and training now for an increasing case Joad of patients with HIV infection. Emphasize care in the community, keeping hospitalization at a minimum. ® Find the best ways to collect demographic, health, and cost data on patients to identify cost-effective approaches to care. @ Devise methods of financing care that will provide appropriate and adequate funding. The recommended research efforts should include the following ac- ° ee tions: @ Enhance the knowledge needed for vaccine and drug development through basic research in virology, immunology, and viral protein structure. © Improve understanding of the natural history and pathogenesis of AIDS, and trace the spread of HIV infection by means of epidemiologic and clinical research. @ Study sexual behavior and IV drug use to find ways to reduce the risk of infection. @ Encourage participation of academic scientists in research against AIDS, in part by increasing the funding for investigator-initiated research proposals, ® Solicit participation of industry in collaboration with federal and academic research programs. @ Expand experimental animal resources, wor specially to con- serve chimpanzee stocks, and develop new uw models of LIV infection. Because AIDS and UEV infection are maior and mounting health problems worldwide: ® The United States should be a full participant in international efforts against the epidemic. ® United States involvement should include both support of World Health Organization programs and bilateral efforts. NOTE: Reference documentation for material in this summary is presented in th. respective chapters of the full report. olNAL Institute of Medicine National Academy of Sciences National Research Council Ongoing and Future AIDS-Related Activities (as of 22 October 1987) tle of Activit ONGOING AIDS Activities Oversight Committee Seminars to Disseminate Confronting AIDS to State Governments Collaboration in Drug Development Collaboration in Vaccine Development Modeling the Spread of HIV Infection and the Demographic Impact of AIDS AIDS Research and the Behavioral and Social Sciences FORTHCOMING (Initiation likely in less than Meeting Data Needs for Predicting the Impact of AIDS (OSTP request for workshop) Equitable Financing of AIDS Care (HCFA support for workshop) Preventing HIV Infection in Drug Users and Others (NIDA requested workshop) Unit Institute of Medicine/National Academy of Sciences Institute of Medicine/AIDS Activities Oversight Committee Institute of Medicine/Board on International Health Institute of Medicine/Board on International Health Institute of Medicine/Board on International Health Commission on Behavioral and Social Sciences and Education 3 months) Institute of Medicine/Commission on Behavioral and Social Sciences and Education Institute of Medicine/Division of Health Care Services Institute of Medicine/Division of Mental Health and Behavioral Medicine (continued) Inquiries relating to activities described here may be directed to Roy Widdus, Director, Division of International Health, IOM, NAS, 2101 Constitution Ave., N.W., Washington, D.C. (Phone 202-334-2453, Telex 248664 NASW UR), who will redirect them or respond as appropriate. Psychosocial Issues for AIDS Care Providers (anxiety and burnout) National Coordinating Board for AIDS Drug and Vaccine Development (self-initiated with industry and governmental support) Institute of Medicine/Division of Mental Health and Behavioral Medicine Institute of Medicine/National Acadeny of Sciences UNDER DEVELOPMENT (Initiation likely in less than 6 months) Mobilizing U.S. Resources and Pro- moting Collaborative Research in International Efforts Towards AIDS Prevention Psychosocial and Neuropsychiatric Aspects of Care of HIV Infected Persons Manpower Needs in Research, Health Care, and Public Health for AIDS Provision of Care and Financing for Pediatric AIDS Health Services Research and Demon- stration Projects Opportunities for Involving Women in AIDS Prevention Efforts AIDS in the Workplace Institute of Medicine/Board on International Health and Board on Science and Technology for International Development Institute of Medicine/Board on Mental Health and Behavioral Medicine Institute of Medicine/AIDS Activities Oversight Committee Institute of Medicine/Division of Health Promotion and Disease Prevention Institute of Medicine/Division of Health Care Services Institute of Medicine/Division of Health Promotion and Disease Prevention Institute of Medicine/Academy Industry Program