THE PRESIDENTIAL COMMISSION
on the
HUMAN IMMUNODEFICIENCY
VIRUS EPIDEMIC

HEARING ON tnnaswtes

April 18, 19 and 20, 1988

 
L August 24, 1988
\

TO OUR READERS:

The Presidential Commission on the HIV Epidemic held over 45
days of\ hearings and site visits in preparation for our final
report to the President submitted on June 27, 1988. On behalf
of the Commission, we hope you will find the contents of this
document as‘helpful in your endeavors as we found it valuable
in ours. We wish to thank the hundreds of witnesses and
special friends of the Commission who helped us successfully
complete these hearings. Many people generously devoted their
volunteer time in these efforts, particularly in setting up
our site visits, and we want to fully acknowledge their work.

The staff of the Presidential Commission worked around the
clock, Seven days a week to prepare and coordinate the hearings
and finally to edit the transcripts, all the while keeping up
with our demanding schedule as well as their other work. In
that regard, for this Hearing on the HIV Pandemic, we would
like to acknowledge the special work of Nancy Wolicki and
Adrienne Allison, in putting together the hearing, and Nancy
Wolicki, in editing the transcript so it is readable.

For the really devoted reader, further background information
on these hearings is available in the Commission files, as well
as the briefing books given to all Commissioners before each
hearing. These can be obtained from the National Archives and
Records Administration, Washington, D.C. 20408.

One last note--We were only able to print these hearings due
to the gracious and tremendous courtesies extended by Secretary
Bowen's Executive Office, especially Dolores Klopfer and her
staff, Reginald Andrews, Sandra Eubanks and Phyllis Noble.

Sincerely,

Polly Gault A leh ty law (oo Sait

Executivd Director Administrative Officer
 

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

RESPONSE TO THE PANDEMIC BY THE UNITED STATES
This Hearing was held at
THE PAN AMERICAN HEALTH ORGANIZATION
WASHINGTON, D.C.

Monday, April 18, 1988

COMMISSIONERS PRESENT:
COLLEEN CONWAY-WELCH, Ph.D.
THERESA L. CRENSHAW, M.D.
KRISTINE M. GEBBIE, R.N., M.N.
BURTON JAMES LEE, III, M.D.
FRANK LILLY, Ph.D.
BENY J. PRIMM, M.D.
CORY SerVAAS, M.D.
WILLIAM WALSH, M.D.

POLLY L. GAULT, EXECUTIVE DIRECTOR

COMMISSION MEMBERS NOT PRESENT:
JOHN J. CREEDON
RICHARD M. DEVOS
JOHN CARDINAL O'CONNOR
PENNY PULLEN

ADMIRAL JAMES D. WATKINS
I-N-D-E-X

WELCOME
POLLY L. GAULT, Executive Director

WILLIAM B. WALSH, M.D., Hearing Chair

ROBERT KNOUSE, M.D., Deputy Director
American Health Organization, World Health
Organization

PANEL ONE
MULTILATERAL RESPONSES: THE WORLD HEALTH
ORGANIZATION/GLOBAL PROGRAMME ON AIDS
Jonathan Mann, M.D., Director
Global Programme on AIDS World Health
Organization, Geneva

PANEL TWO
THE PANDEMIC IN AFRICA: DESCRIPTION, RESPONSES
AND IMPLICATIONS
Thomas C. Quinn, M.D., Associate Professor of
Medicine, School of Medicine, Johns Hopkins
University; Senior Investigator, Laboratory on
Immunoregulation, National Institutes of Health

John Bongaarts, Ph.D., Senior Associate
Center for Policy Studies, Population Council
New York

Mead Over, Ph.D., Economist
Population and Human Resources Department
World Bank

Peter Lamptey, M.B., Dr. P.H., Director
AIDSTECH, Family Health International
Research Triangle Park

Samuel Adeniyi-Jones, M.D.,Ph.D. National
Institute of Child Health Development, NIH

Peter L. Perine, M.D.,MPA, Director
Tropical Public Health and Medicine,
Uniformed Services of University Health Sciences

PANEL THREE
THE PANDEMIC IN THE AMERICAS: DESCRIPTION, RESPONSES AND
IMPLICATIONS
Alastair J. Clayton, M.B., Ch.B., F.R.C.P.(C),
Director General, Federal Centre for AIDS
Ottawa, Canada

PAGE

30

35

38

42

43

48

63
I-N-D-E-X (continued)

PANEL THREE(continued)
Ronald K. St. John, M.D., M.P.H., Coordinator,

Health Situation and Trend Assessment Progran,
Pan American Health Organization

Jamie Sepulveda, M.D., Director General of
Epidemiology, Ministry of Health,
Mexico D.F. Mexico

Jean William Pape, M.D., Department of
International Medicine, Cornell University
Medical College, New York, New York

PANEL FOUR
RESPONSE TO THE PANDEMIC: FRANCE
Alain Pompidou, Technical Counselor for Health,
Ministry of Health and the Family,
Paris, France

‘PANEL FIVE
THE PANDEMIC IN ASIA
Captain Michael Kilpatrick, M.C., U.S.N.,
Research Area Manager for Infectious Diseases
Naval Medical Research Development Command
Bethesda, Maryland

PANEL SIX
OTHER MULTILATERAL RESPONSES: THE WORLD BANK AND
THE UNITED NATIONS DEVELOPMENT PROGRAMME
Ann Hamilton, Director
Population and Human Resources Department
World Bank, Washington, D.C.

Timothy Rothermel, Director

Division for Global and Interregional Programmes,
United Nations Development Programme

New York, New York and

ALAN DOSS, Resident Representative, Zaire

PANEL SEVEN
THE FOOD AND DRUG ADMINISTRATION: RESPONSE TO
THE PANDEMIC
Frank Young, M.D., Commissioner
Food and Drug Administration,
Rockville, Maryland;
Member, Executive Board, World Health Organization

75

78

92

lll

121

124

128

142
THE HIV PANDEMIC

EXECUTIVE DIRECTOR GAULT: Good morning. Ladies and
gentlemen, distinguished witnesses, members of the President's
Commission. My name is Polly Gault. I am the designated federal
official here today. In that capacity, it is my pleasure to
declare this meeting opened. If everybody could take their
seats. Mr. Chairman.

CHAIRMAN WALSH: Good morning. I want to welcome all of you
to what I consider to be probably the most meaningful hearings
that this Commission will hold.

Up to now, we have concentrated primarily upon the
problems with which we are faced in the United States. Needless
to say, these are severe because we do have more cases of AIDS,
of HIV positivity, than anyone else in the world. However, we do
know that this is a pandemic, that cases have been reported from
more than 133 countries and we know, from our own experience,
that what seems like a small problem ten years in the past can
grow into a massive problem in relatively short order.

We have been privileged at this meeting to have been able to
get the participation of leading figures in the fight against
AIDS from many countries. I can't mention them all, but I
certainly do want to mention Jonathan Mann, whom you will
shortly meet and who is charged with the role of Commander in
Chief, as it were, of the global war on AIDS.

We have Alain Pompidou, who has joined us from France, who,
as the leader of the fight against AIDS in France, has assumed
really a leadership role in all of Europe and has done much in a
bilateral fashion in also bringing information and weapons
against this disease to Africa.

We have many others, over these three days, you will be
hearing not only from them, but also from representatives of our
own government who are involved in both multilateral and
bilateral assistance, from people in the academic arena but who
have devoted much of their time to international work. We will
be hearing from experts on the African continent and in our own
hemisphere.

We look forward to learning a great deal and also to
getting guidance on how to fulfill the charge given to us by the
president who has asked that, among other recommendations, we
recommend a position, a line of activity that the United States
should take in the global war against this dread disease.

Before finishing these brief remarks, I want to also
express the profound gratitude of the Commission to the Pan
American Health Organization for making these facilities
available for such a meeting. It not only gives importance to
the subject, but also indicates on the part of PAHO the concern
that they have in this international arena for participating in
this war, certainly in this hemisphere, and recognition that this
is indeed a global fight. Before getting into our specific
program, I want to introduce Dr. Bob Knouss, who is here on
behalf of Dr. Macedo, to say a few words about PAHO.

DR. KNOUSS: Thank you very much, Dr. Walsh.

Distinguished members of the Presidential Commission on the Human
Immunodeficiency Virus Epidemic and distinguished guests and
scientists and ladies and gentlemen, the Director of Pan American
Health Organization, Dr. -- Macedo, who is also the Regional
Director for the Americas of the World Health Organization, has
asked me personally to convey his greetings and to welcome you
all to our headquarters building for this important hearing on
the HIV pandemic.

He's also asked me to express his regrets at not being
present here personally with you today, but previous commitments
have precluded his participation. During the next several days,
the many important aspects of the international AIDS epidemic
will be covered extensively and it's not my purpose to try to
address any of these issues in these few remarks. But I do want,
however, to convey to you the fact that the Pan American Health
Organization shares with you the same sense of urgency and
concern for this epidemic.

Since 1983, we have been providing technical collaboration
to our member countries, first, in a limited fashion when the
disease began to spread in this region and subsequently, in an
intensive way during the last sixteen months since the World
Health Organization established the Global Program on AIDS thus
providing leadership essential for coordinating the world's
effort to combat this invariably deadly disease. Without such
leadership, we would not be able to assure ourselves that the
resources that are available will be used in the most efficient
and effective way possible.

WHO, as you said, is firmly committed to the objectives and
strategies of the global program and will act firmly and
decisively to implement them through our programs of technical
collaboration. In this light, ‘I want to particularly express
our appreciation to the United States of America, one of our
member countries, not only for your financial support to this
world-wide prevention and control effort, but also for the
significant contributions that have been made in both the public
and private sectors toward advancing our scientific and technical
knowledge about this disease, about its spread, about how to
treat those who are suffering from its consequences. This
hearing is yet another example of this commitment.
For these reasons, we are pleased to welcome you to PAHO and
WHO, as this is both, and I know that Dr. Macedo wishes you
every success and I want to join him in this wish. Welcome, Dr.
Walsh.

CHAIRMAN WALSH: Thank you, Bob.

CHAIRMAN WALSH: If Dr. Mann will join us and, Bob, if
you wish to sit at the table with Dr. Mann, please feel free to.
I'm going to make my introduction of Dr. Mann very brief because
I think the world already knows him for the thankless sacrifice
that he has made. I have never seen a man expend as much energy
and as much dedication in what seemed like an insurmountable task
as has been done by Dr. Mann. It's a privilege to have you here
with us, Jonathan, so please go ahead.

DR. MANN: Thank you very much, and thank you very much for
this opportunity to speak to you, which I've been personally
looking forward to for quite some time.

It's very humbling to us to realize that a decade ago there
was a world-wide epidemic of a virus, an epidemic that occurred
silently. We had no idea it was occurring, but it reached five
continents by 1980. The discovery of AIDS in the United States
in 1981 was a historical accident. It could have just as easily
been discovered on four other continents at that same time. In
fact, it's interesting to realize that, had AIDS been discovered
say in Africa where it was also existing in 1981, the disease
probably would have been thought of world-wide as a heterosexual
disease. It is the historical accident of its discovery in the
United States that has led some to consider this disease to be
more associated with homosexual rather than heterosexual
activity.

In 1982, cases of AIDS were discovered and recognized in
Europe, in parts of Latin America, and in Africans in Europe.
It was not until late 1983 that cases of AIDS in Africa itself
were recognized and it was then obvious and evident that Africa
had a major AIDS problem about which you'll be hearing more in
detail later this morning.

By early 1985, the discovery of a serological test and its
distribution allowed us for the first time to really assess the
global scope of this problem because, as you know, the cases of
AIDS come years after infection and cases of AIDS themselves do
not represent an accurate way to track the pace of a rapidly
spreading epidemic.

Now, in 1988, we estimate that there are between five and
ten million people in the world infected with HIV. As of April
of this year, there were almost 88,000, cases of AIDS officially
reported to the World Health Organization from 138 countries

4
around the world. Of these cases, seventy four percent, almost
three quarters, come from forty two countries in the Americas.
While the United States represents eighty eight percent of these
cases, Brazil, Canada, Mexico and Haiti each report more than
five hundred cases of AIDS.

Thirteen percent of the AIDS cases come from forty two
countries in Africa. Of the African AIDS cases that are
reported, ninety two percent are from eleven countries in
central, eastern and southern Africa.

Twelve percent of the AIDS cases in the world reported thus
far are from twenty seven countries in Europe. The countries
with the largest number of cases are France, the Federal Republic
of Germany, Italy and the United Kingdom. Eastern Europe,
involving eight countries and the Soviet Union, have thus far
reported a total of seventy two AIDS cases.

The remaining one percent of the AIDS cases in the world,
amounting to just over eleven hundred, have been reported from
twenty six countries in Asia and Oceana. While the majority of
those cases are from Australia, New Zealand and Japan and Qatar,
cases have also been reported from other countries including
India, Thailand, the Philippines, Hong Kong, Malasia, Singapore
and China. Because under the best of circumstances, not all
AIDS cases are actually reported, we estimate that the actual
number of AIDS cases having occurred during the current world-
wide epidemic is probably closer to 150,000. We also estimate
that, because of the wide spread infection that has already
occurred, there will be an additional 150,000 cases of the
disease AIDS world-wide during 1988. If we extrapolate a little
further into the future, we would estimate that by 1991 there
will have been a cumulative total of approximately one million
AIDS cases world-wide.

In addition to talking about numbers of cases and
infections, we're also very aware of what we call the third
epidemic. The first epidemic is the epidemic of HIV infection
itself. The second epidemic is the epidemic of AIDS and other
associated diseases that follow the epidemic of infection.

The third epidemic, which is just as much a part of the
pathology of this disease as the virus itself, is the epidemic of
social, cultural, political and economic impact and reaction to
the first two epidemics. AIDS has a tremendous impact on social
and economic development. Because it affects mainly people
between the ages of twenty and forty nine, it touches those that
are most productive in social and economic terms.

In terms of infant and childhood mortality, we see already
evidence from developing countries that, where five percent or
more of pregnant women are infected with HIV, the projected gains

5
through the child survival initiative in infant and child
survival may be tragically cancelled out by the effect of AIDS.
Therefore, in some developing countries, we expect to see a
decline in life expectancy over the next few years as a result of
AIDS.

In addition, we have seen a world-wide epidemic of fear,
ignorance and prejudice which threaten, at the international
level, the open communication, open travel and open commerce
which are at the heart of the modern world. Finally, we've seen
how AIDS unveils prejudices that already exist regarding race,
sex, national origin, and religion in countries throughout the
world.

In order to describe to you the current status of the
global fight against AIDS, it's important to realize how far
we've come in the last two years. Very briefly, I'd like to
describe to you the situation internationally in 1985.

First, in 1985, there were many countries that refused or
were reluctant to report about AIDS. They simply hid the fact
that they had AIDS. That's as bluntly and as clearly as I can
say it. They did this for a variety of reasons. One of the most
important reasons was the stigma that was felt to be attached to
the idea that you had AIDS in your country because, in many
societies in the world, male homosexuality is not accepted. In
those societies, even if AIDS cases were unrelated to male
homosexuality, in a prevailing international climate where AIDS
was equated with homosexuality, for countries to say "We have
AIDS" would be for countries to say "We have male homosexuality"
which, of course, is true, but nevertheless difficult for many
countries to discuss publicly.

This whole situation was exacerbated by various aspects of
media coverage which tended to dramatize, to point fingers and
to in other ways stigmatize areas of the world affected by AIDS.

Research itself was hampered during this period. Research
results were occasionally muzzled and not allowed to be
published. There was a tremendous sensitivity which obviously
comes from the fact that this virus is transmitted through sex,
through blood, through skin piercing practices and that these are
areas which are culturally sensitive in every country of the
world.

In addition, in 1985 we were all prey to wildly varying
estimates of the actual scope of infection. One could read in
the newspapers anything from hundreds of thousands to hundreds of
millions of people infected, all of which were estimates based on
preliminary data, small, unconfirmed reports and occasionally
studies done with laboratory techniques that were not in fact
acceptable.
In this context, those countries in the developing world
that realized they had an AIDS problem looked in many directions
trying to get help. I can give you examples where countries
would send a letter requesting help on AIDS to every development
organization and to, to every development assistance
organization in the world. The letter would say "We have an AIDS
problem please help". Now, that is a chaotic situation. That is
a situation which invites development agencies who are concerned
to send missions, to try to discover, to promise help and, in
some instances, the same help was promised by multiple countries
and multiple development agencies. It was accepted by the
recipient countries because they were not sure whether any of
those development agencies would actually deliver the goods.

So it was a chaotic situation from the viewpoint of the
countries who wished to get help and, from the viewpoint of
development agencies. They were ambivalent and understandably, a
bit confused. What should their role be in fighting
international AIDS? What should be done?

Initially -- in 1985 -- what was mostly done were the easy
things. In the international development environment it is easy
to buy equipment or supplies and to send it. Indeed, that can be
a contribution. But in the field of AIDS, it's more
complicated, and one can not simply parachute in some testing
equipment and walk away and feel that one has accomplished a
great deal. I remember vividly a call from a non-governmental
organization in 1986 informing WHO that they were planning to
send some laboratory supplies to an African country. The country
desperately needed those supplies but the organization involved
had not considered the fact that the supplies they were preparing
did not fit with the equipment that was already available in the
country. They had given no consideration to training. Indeed,
when they looked at the actual boxes they were preparing to
send, they noted that the supplies were outdated and should no
longer be used. That kind of chaos reigned two and a half years
ago.

The World Health Organization has a constitutional
responsibility to coordinate and direct international health
work. This was perhaps best illustrated in most people's minds
by the smallpox eradication program. WHO considered it essential
that some order be put into this environment because, if order
did not become evident and the chaos continued, the actual work
that needed to be done would not start effectively. —

So, we first created a global strategy in order to develop
and provide a conceptual framework for the struggle. The beauty
of a conceptual framework is that after it's in place and
everybody has read it and agreed to it, it seems obvious. But
that's the beauty of it because, in fact, it helps insure that

7
 

 

there is, in fact, consensus and consistency. What I'm about to
describe to you briefly as the Global Strategy for the prevention
and control of AIDS, I hope will seem to you to be self-

evident, but I assure you that world-wide, two years ago, it was
not self-evident.

The Global Strategy has on three objectives. First, to
prevent HIV infection. Secondly, to take care of all those who
are HIV infected, including those who are healthy and including,
of course, those who now have AIDS. Third, to unify national and
international efforts in fighting this disease.

Those objectives are linked to a set of principles, part of
the Global Strategy. First, that public health must be
protected. Secondly, that human rights must be respected and
discrimination must be prevented, and I will return to that
theme. Third, that through epidemiology, because we know how the
virus is spread, we know how to stop the spread of the virus even
without a vaccine and that stopping the spread will require
informed and responsible behavior. Therefore, education is the
key to AIDS prevention. It will require a sustained social and
political commitment because, as much as we would like this
problem to go away quickly, it will not. All countries in the
world, we believe, need a strong and comprehensive national AIDS
program, a program that is integrated with national health
systems linked in a global network.

Finally, we believe that systematic monitoring and
evaluation will be needed because, in this problem, we must learn
as we go. We must learn as we go how best to control this
disease.

Those are the objectives and that is the set of principles.
I would be shocked if you found any of that shocking because this
is the basis on which every country has been establishing its
national AIDS program. These principles help determine the
manner in which the objectives of AIDS control are actually
carried out in countries, regardless of their cultural context,
because we're dealing with cultures as absolutely widely
different as India and Qatar or Botswana and Brazil.

Specifically, for example, knowing the routes of HIV spread
and knowing that the focus of prevention must be behavior allows
us to realize that there are three things that are needed:
information and education, health and social services to support
the information and education, and a supportive social
environment that's based on understanding and tolerance.

Furthermore, because risk behaviors are private and often
hidden from society regardless of the culture, all people in
society must be educated. One does not know who may be at risk.
Yet, because risk is not equally distributed throughout the

8

 

 
 

 

entire society, it's important to target our efforts and it's
important to involve those who are to be targeted in the design

of our efforts.

In addition, because of the importance of health workers in
fighting AIDS, health workers at all levels must be well- informed
and educated and supported. Finally, because information and
education in some cultures is probably more powerful on an
individual level than on a mass level, counseling and other forms
of personal support have to be assured.

In addition to the information and education I've just
mentioned, it's clear that we need health and social services to
support long-term behavioral change. We say to ourselves, and
countries have said, how realistic is it to expect that a person,
for example, who is an IV drug user will no longer be an IV drug
user by themselves without external support? How likely is it
that a person who is infected with HIV will be able to lead the
responsible, constructive life that they may lead without access
to support and information over time? We have often asked
ourselves this question, if we, as individuals, were infected.

We ask people in many cultures to consider this situation of -
Who would you turn to when you needed information? It wouldn't
be just information once. It would be information for the rest
of your life. Information about a variety of issues. We believe
that, without the commitment to the health and social services
over time for the long run that is needed that the information
and education by itself can not be enough. Finally, we believe
that a supportive social environment is a necessity, not a
luxury.

I will turn again, to the issue of human rights which we
believe is fundamental, not an add-on to the entire question of
AIDS control. In addition to the question of a global strategy,
we have provided throughout the world a structured, systematic
approach to the planning and development of national AIDS
programs. After designing a blueprint which contains the
components of a national AIDS program, we have been providing
technical and financial support to countries around the world.
I'd briefly describe how that process is actually carried out.

First, a country contacts WHO and requests WHO support.
That's an important stepbecause, without the request, there may
not be the political commitment to see the work through. Once
the initial contact is made, a visit is performed by WHO staff
with consultant support to assess the epidemiological state and
the resource situation. What is the seriousness of the problem
and what is the current activity to fight the it?

We then provide urgent support. We provide urgent support
because in every country in which we've worked it's clear that
there is something that can be done immediately and that does not

9

 

 
 

 

require an extensive planning process in order to implement. As
one illustration, in some countries, materials have been prepared
for health workers but the resources are lacking to print them
and distribute them. So that's the kind of urgent support we can
provide without needing to go through an elaborate planning
process.

But then we focus quickly on the development of a plan.
WHO's role is not to go into a country and tell them what to do
or to go into a country and do it. What we do is go to a country
and say we would like to support you in the development of your
own national AIDS program in conformity with the Global AIDS
Strategy and its principles. Countries accept this willingly and
we, therefore, stand behind the country and help them develop a
comprehensive national plan.

That plan then serves as the instrument to focus assistance
from the International Development Assistance Agencies. Rather
than receiving a one page letter asking for help, Development
Assistance Agencies now receive a document that is a
comprehensive national plan. The document is used as the focal
point for a donor's meeting where all International Development
Agencies meet with the representatives of the country itself and
discuss how resources can now be made available to implement the
national plan.

As of the 11th of April, as of a week ago, and this has
basically occurred since February of '87, 139 countries around
the world have requested WHO collaboration. In the last 14
months, since the establishment of the AIDS programme in
February, 1987, visits have been completed to 117 countries. Of
these, 78 have completed written short term plans to cover a six
month to one year period; 22 have completed medium term (3-5
year) plans and eight countries have had donor's meetings and
received full financial support for the implementation of their
national AIDS program: Uganda, Tanzania, Ruwanda, Ethiopia,
Kenya, Zaire, Senegal and Zambia. By this work, the ideas of AIDS
prevention and control are being turned into a reality throughout
the world.

There is now an orderly process which has replaced the
chaos of only two years ago. The National AIDS Plan has become
the central document, not only for international funding, but for
national planning and for national support. Also, through the
document, we're able to insure that all parts of the National
AIDS Plan are covered. I'm sure you're well aware in this
country, because it's true in every country, that there are easy
things to do and there are hard things to do. It's important
that not only the easy things be done. It's very tempting when
one is wanting to support another country's activity to support
something which is visible, tangible and looks good. But there

10

 

 
 

 

are many things that aren't so visible, that aren't quite as
tangible and which are more complex which must be done if AIDS is
to be combated successfully. So, by taking the planning process,
we're able to insure that everything is looked at, not just the
popular things.

Let me be a little more precise about that to make sure
I've made that point. It's a lot easier to build a building ina
foreign country through development assistance, call it a blood
bank and say you built a blood bank. It's a lot more difficult
to train the people who will do the work, to insure that the
quality control will be done so that the test results are
meaningful, to insure that people go to the blood bank to give
blood and to insure that the blood that comes from the bank is
safe and to insure that that doesn't just happen this week or
during the time of a visit, but it happens over the long tern.

These are the serious, genuine, real problems of trying to
help any country with its national AIDS plan and therefore, the
planning process is critical. Through this process, a level of
cooperation among the development agencies that is unprecedented
has been assured. Everyone has realized the scarcity of
resources and this is not an area in which we want to see any
duplication or competition at the national level between
development assistance agencies of different countries.

Finally, the cultural context is respected. It is
extraordinarily difficulty to deal with sexual practices of one's
own society and one's own culture, least of all the sexual
practices of another society and of another culture. It would be
a tragic mistake if anyone attempted, from any ivory tower or any
location, to dictate to countries how the details of such as
education of school children should or should not be done. That
is a national decision. It must be respected as a national
decision, but we must provide the resources and the structure to
ensure that a full debate occurs, so that the issue is discussed.
Then if the country decides it wants to educate all its tenth
graders, we will provide the technical and financial support to
help them carry that through. Nor can we write the messages, not
only because of the language barriers, but because there are many
different ways in which sex is discussed around the world.

In addition to this way of helping countries specifically
develop their national AIDS programs, WHO has ensured a
commitment to the development of additional information. One of
the real dangers in this area is that people go off with small
pieces of information, extrapolate to continents and believe they
understand the situation. That's just as tragic as people
examining and interviewing a few sexually active people and from
that basis, drawing conclusions about the sexuality of a society,
a country, or even a continent or a region.

11

 

 
 

 

Therefore, the commitment to information is critical. WHO
supports countries by developing methods to determine the scope
of infection, to determine attitudes towards sexual practice and
sexual behavior. International comparisons become possible as
well as comparisons within the same country over time. This
activity is fundamental to AIDS control because, if we are to
learn what prevention activities work, we must know what people
do and we must know how people do or do not become infected. If
we don't have that information, I don't see how we'll be able to
judge the effectiveness of all our endeavors.

We're also able to open discussion on sensitive problems by
using the mechanisms available to WHO as a multi-lateral
organization with 166 member states. WHO is against AIDS but we
do not have a particular bias or any specific political
ambitions in that process. An example, is our early work with
African nations on AIDS. At a time when African governments
refused to talk about AIDS and, in general, refused to allow
studies of the problem, WHO held the first meeting on AIDS in
Africa in Bangui, Central African Republic in October 1985. This
was the first discussion of a technical, scientific nature about
AIDS in Africa. Then in November of 1986, WHO called a meeting
of forty countries in Africa and, for the first time -- a
historical turning point -- AIDS was discussed in Africa like any
other public health problem. The scientific discussion was open
- in front of the press - and with the question being asked, not
who to blame, but what to do and how to do it.

Similarly, in the Americas, in September of 1987, the first
Pan American Teleconference on AIDS may have been the largest
health meeting ever held. Its role in accelerating the
commitment to AIDS prevention and control action in the Americas
can not be underestimated.

Finally, in Asia and Oceania, meetings have been held; in
Kuwait for the countries of the middle east and north Africa; in
New Delhi for southeast Asia; and in Sydney, Australia for the
western Pacific and Oceana. Through these meetings, we achieve
momentum and through these meetings, we bring to each country the
obvious need to become involved in the global struggle.

In addition to collecting it is important to share the
information. As a multi-lateral neutral organization, we have
the capacity to move and share information. Although the sense
of stigma has diminished markedly, there is still a sense of
aifficulty or tension around the full disclosure of all
information and this remains a delicate issue. We stand behind
the countries and say all the information should be shared.

As part of WHO's coordinating and directing responsibility,
we have been mobilizing other institutions and organizations. We
have been challenging those organizations and saying you must

12

 

 
 

 

become involved in AIDS because AIDS is not "simply a health
issue". AIDS is an economic issue. It is a social issue. It's
a political issue. It's an educational issue. It's a cultural
issue. It's an issue, therefore, which requires that many
organizations play a role. This is not a one organization
campaign. Smallpox was eradicated by a one organization type of
campaign. AIDS can not be eradicated, can not be controlled, by
that kind of narrow focus. Therefore, working with governmental
organizations, with private organizations, with non-governmental
organizations, we have been able to help them overcome their
substantial initial reluctance to deal with AIDS. There is not
an institution, or an organization that has leapt into AIDS from
the beginning. Every organization goes through a certain
process. Every country goes through a certain process of coming
to terms with AIDS before it begins to grapple constructively
with the problems. Initially, there's always a desire to deny or
minimize a problem. Then finally, there comes the constructive
engagement that's so necessary.

In addition, in the United Nations system, we brought AIDS
to the floor of the United Nations General Assembly six months
ago today. Six months ago, we spoke and, for the first time on
the floor of the U.N. General Assembly, a disease was discussed.
The first time in history that a disease was discussed, it was
AIDS and the response was overwhelming and supportive. Asa
result of that response, other major U.N. organizations have
mobilized. Organizations such as the United Nations Development
Program -- which has a critical role to play in social and
economic development in countries throughout the world -- UNICEF,
the World Bank, the United Nations Population Fund, the
International Labor Office, and other parts of the U.N. systen.
These organizations are beginning increasingly to play an
important role.

Non-governmental organizations, including the International
Council of Nurses, Save the Children, AMFAR, the League of Red
Cross Red Crescent Societies, the National Council for
International Health, The World Council of Churches -- these
organizations and many others are all increasingly involved for
two very good reasons. First, because AIDS is a real problem.
Secondly, because the structure now exists, the strategy now
exists within which their activity makes more sense, within which
each organization, can understand its own role, its own piece, in
this overall picture. I contend that, without a view of the
overall picture, you can't understand your part in the picture.

There's a mobilization that has occurred and that
mobilization is increasing in its intensity. WHO also
facilitates research. AIDS research is now irrevocably
international. It can never again be strictly national research
and, therefore, in an area like vaccine field trials, WHO will
have an important role again as a multi-lateral neutral

13

 

 
organization because vaccine field trials will almost certainly
be international. Vaccines will probably be developed in
countries where the level of new infection is not sufficient to
efficiently test the vaccine. Vaccines developed, in the United
States or in western Europe, will almost certainly need to be
tested in other parts of the world, such as Africa. The stakes
are enormous for all of use in such international testing and
trials. They are enormous because, if the trial is done ina
way that is either scientifically or ethically not entirely
acceptable, the consequences fall upon all of us.

In addition, to be very specific, bilateral arrangements
suffer from the threat of perturbations of bilateral
relationships. For example, if the United States set up a
vaccine field trial bilaterally, with an African country -- what
would happen when the rulers change, the president changes, the
minister of health changes, or there is a break in diplomatic
relations? The history of bilateral relations between various
countries in the west and African countries, shows a considerable
threat to the integrity of vaccine trials that must go on over a
period of years. If the bilateral relationship suffers
politically, the science may suffer. Similarly, the science may
be held hostage to political relationships. Thus, WHO's
involvement in the organization of such field trials could be
very helpful in order to protect and stabilize international
science again perturbations of a bilateral and political nature.

There's also a need for pro-active exchange of information.
It's important that everybody have access to scientific
information. Let me give a specific example. There are now a
number of studies of the perinatal transmission of HIV taking
place in different parts of the world. At a consultation held
by WHO on breast feeding, and HIV, it was discovered that
preliminary data from one of the important perinatal studies had
not been shared with the researchers of another perinatal study.
A key factor in perinatal transmission was being discovered in
one study and another study wasn't even aware of the preliminary
data. The second group of researchers were therefore unable to
incorporate the new concept into their own study thereby
substantially weakening the study.

So, the need to bring people together effectively -
repeatedly - for the exchange of preliminary as well as final
information is essential in AIDS. We can not afford to wait
until research findings are published or until an international
meeting occurs.

Similarly, there's a need for common terminology. As a
neutral and international organization, WHO can remove these
questions from the specific national setting and place the
question in a global context. Therefore, we can bring the
‘leaders of international science together. They can agree and

14

 
 

 

it doesn't matter at that point whose idea it was. It goes out
under a WHO umbrella and therefore can be accepted by all.

The same thing is particularly true in the area of social
and behavioral research where the questions are more delicate and
difficult than some of the virology questions. In addition, by
developing guidelines and by helping to establish the technical
basis for national policy formulation, we make international
contributions to national AIDS efforts throughout the world. For
example, the consultation held by WHO on international travel and
AIDS (March 1987 Report of the Consultation on International
Travel and HIV Infection, Geneva, 2-3 March 1987,

WHO/SPA/GLO/ 87.1) played a major role in preventing a wave of
requests and discussions throughout the world of requirements for
tourists to hold certificates of freedom from HIV infection. In
late 1986 and early 1987, this issue was being discussed
throughout the world. The WHO technical consultation and
determined that such measures would be highly ineffective, highly
inappropriate, highly expensive and therefore should not at all
be recommended.

In that regard, we've had 165 successes and one failure.
The only country in the world that currently requires a
certificate for a tourist to enter the country is Iraq. Every
other country in the world has considered this issue and, at
least partially with the help of the WHO expert groups'
considerations, has agreed not to impose such an ineffective and
inefficient restriction.

WHO had an important consultation on the neuropsychiatric
impact of HIV infection (Report of the Consultation on the
Neuropsychiatric Aspects of HIV infection, Geneva, 14-17 March
1988, WHO/GPA/DIR/88.1). The meeting has major implication as it
focused on the issue: what are the neuropsychiatric effects of
HIV infection in people who are otherwise healthy? In other
words, healthy HIV-infected people. WHO brought together over
forty participants from about fifteen countries. The
consultation concluded that: At present, there is no evidence
that there are any clinically important neuropsychological
effects associated with HIV infection when a person is otherwise
healthy. This information was used almost immediately by
airline companies which had been considering questions such as
screening pilots.

Similarly, a meeting on AIDS in the work place to be held by
WHO in collaboration with the International Labor Office in June
will establish broad guidelines for the issue of AIDS in the work
place world-wide. We've had meetings on AIDS in prisons, on
strategies for preventing HIV infection among IV drug users, on
counseling, on breastfeeding, on childhood immunization and HIV.

15

 

 
I briefly mention the points about human rights, a global
issue which transcends national interests. You might ask why is
the World Health Organization, a health organization, so
involved and becoming increasingly involved with the human rights
aspects of AIDS?

The reason is very simple. The reason is that it is a
public health issue. It is a public health issue because where
and when the human rights of those who are HIV-infected are
violated, when and where discrimination is allowed to occur, the
capacity to fight the disease effectively is reduced. Where
exclusion and discrimination are applied against people who are
HIiv-infected, the capacity to effectively educate and support
people to deal effectively with the problem is reduced. In that
sense, discrimination threatens public health. Discrimination
itself becomes dangerous to the public health.

The only major barrier that we have seen in terms of
universal acceptance of this idea is that there are many
societies and many cultures which find it very difficult to deal
with reality. By reality, I mean that where there is
prostitution, one says there is prostitution and where there is
IV drug use, one says there is IV drug use. That's reality. But
there are many cultures which have difficulty admitting those
things and talking about those things publicly. In those
cultures, in those settings, it is sometimes tempting to look for
the easy solution. It is sometimes tempting to look for
solutions in which ideas of exclusion and discrimination
predominate, but that ignores the fundamental human realities of
HIV infection. We sometimes ask the decision makers in those
countries to consider what they would do if they were HIV-
infected themselves, to consider what they would do if the risk
of being known to be infected was loss of job, loss of status in
society and perhaps being moved to another place entirely. Most
people, when they ask this question honestly of themselves,
conclude that they would do everything within their power not to
be identified as HIV-infected including, if you carry this line
of reasoning further, for example, not using a condom if using a
condom raised the suspicion of why are you using a condom. In
other words, the very responsible behavior that we are trying to
promote can be undermined by a climate of fear and a climate of
discrimination.

I'm pleased to tell you that in virtually every country of
the world, the principle of respecting human rights has been
accepted. In summary, we have together forged and faced a
rapidly enlarging and new problem. We have been facing a new
global health priority. We have brought an unprecedented global
effort into reality. It's unprecedented because it has reached
more countries more rapidly than any other health program in
history. It is unprecedented because it is based on the concept
that we are not looking for a quick fix. We are looking to

16
develop the capacity to fight this problem over time. It's
unprecedented because we are insisting upon and receiving
agreement that cooperation is essential and that the issue is how
to provide the support to all countries of the world, rather than
how to provide speciai visibility to one donor country.

For example, we've reached an agreement on a new mechanism
for the evaluation of national AIDS programs by donor agencies.
Rather than each donor agency performing their own annual
evaluation of a country's program activity, (a large burden on
the country's resources if there are ten such agencies), there
has been an agreement among the donor agencies that we will forge
together a common evaluation and method system. Everyone will be
welcome to participate, in this evaluation but it will only
happen once. That's an example of the very practical but
creative approach that is allowing us to move as rapidly as we've
been able to move.

In a very rapid period of time we have replaced chaos with
order. We don't yet know all the answers, but we know that we
are in the process of setting up the system and setting up the
program that will help us learn what the answers are and then be
able to apply them. In 1988, and looking beyond, there are
several areas of concern which I'd like to briefly mention.
First, the AIDS problem is not going to disappear, but we
constantly see the desire of people to believe that it will go
away. The denial factor with AIDS is enormous. A piece of data
that shows why denial is inappropriate and incorrect comes from
Thailand. I was in Thailand recently when the new data on their
IV drug use problem was received. In Thailand in 1985 and 1986,
zero percent of the IV drug users tested were HIV infected. In
1987, one percent were infected. In the first three months of
1988, sixteen percent of the IV drug users tested in Bangkok are
infected. The number of IV drug users is estimated at 100,000 in
Bangkok alone. So, contrary to predictions rather than sex and
prostitution being the entry point for AIDS and the real point of
amplification in Thailand, the infection rate in IV drug users is
creating an urgent situation. There is now an urgent problen
where two years ago there was probably no problem at all.
Therefore, we believe that any form of self-congratulation or any
form of statement that the problem is essentially over is
premature, to say the least.

Secondly, we believe that chaos is a constant threat.
Chaos in the international scene could occur for a number of
reasons. It could occur if the resource commitment does not
continue to come from the resource rich countries towards the
resource poor countries. It could come by a failure to consider
the international implications of national efforts. I very much
appreciate and applaud the fact that during the next several days
you will be asking yourselves with each presentation, with each
program, in what way does this activity deal with the

17
 

 

international situation? In what way is it supportive’ of what
needs to occur in the international context?

Finally, chaos can occur if there is a focus on what is
easy to do. It's going to be difficult to change behaviors
world-wide. We already have evidence that it is being done, but
it's going to be difficult and we hope that patience will not run
out. We hope that countries will continue to provide the
necessary support and commitments that will be required over the
long tern.

There's a need for medium and long term planning. Unlike
smallpox, you cannot go into a country, do whatever is necessary
and then walk away and go to the next country. With AIDS, that's
impossible. With AIDS, we realize we will to be dealing with
AIDS for the rest of our lives and that, therefore, it's
important that we look to the medium and long term and not look
for the quick fix-for the good reason that quick fixes don't
work.

Finally, it is essential to ensure that the fruits of
international science be available to people around the world.
Will drugs and vaccines be affordable for all those who need such
drugs and vaccines or will the fruits of international science
be available only to the rich? That's a terribly important
problem for us to face as a global society in the future.

Therefore, Mr. Chairman, we live in a world which is
threatened by unlimited destructive force and yet, we have seen
that the work world-wide against AIDS over the last few years
represents a creative spirit, a spirit of harmony, a spirit of
bringing people together around an international problem that
affects not just the rich countries but the poor, affecting east,
west, north and south. We know that a world-wide effort will be
required to deal with this world-wide problem. This problen,
perhaps more than any other health problem in history, will
demonstrate and does demonstrate that the world is one.

On behalf of the World Health Organization, I would like to
thank you for your concern with how the United States can
support the international effort and I thank you for all the
technical, the resource and the moral support that the United
States has provided to the World Health Organization and to the
entire global effort. Thank you, Mr. Chairman.

CHAIRMAN WALSH: Thank you very much, Dr. Mann. I am sure
the rest of the Commissioners join me in a sense of
encouragement because certainly you have portrayed to us the
image of a leader who is dedicated, who is devoted, who is
knowledgeable, who is patient and above all, who will lead us
into finding a solution.

18

 

 
 

 

We are going to have a question period, which is our
custom, for you. My only comment from the United States
standpoint is I'm delighted we're a donor agency because I don't
think we would qualify for assistance since we don't have a plan.

DR. MANN: Is that a question, Mr. Chairman?

CHAIRMAN WALSH: And we would be in great trouble, I'm
afraid. But, at any rate, we hope this Commission will come up
with one. I'm going to start our questioning on the left side of
the table. Dr. SerVaas?

DR. SerVAAS: Thank you, Dr. Mann. It's certainly an
opportunity to have you come to join us here. My question is
about Ethiopia. How can we estimate the number of infected, or
even the number of deaths, from AIDS? I visited Blackline
Hospital in Addis Ababa in December of '84 and the refugee camps
outside the city, as well. There were machine guns in the hands
of teenagers, it looked like, to keep the emaciated refugees from
entering Addis Ababa and the hospital and the city limits. These
thin, undernourished people could also be dying from Slim
Disease, I thought, but I know of two U.S. health care workers
who contracted typhus in Ethiopia at that time. Our CDC told us
that they feared an epidemic then of typhus but they couldn't get
information from the Ethiopian government about typhus in '84 and
'85, Are we now getting into the Ethiopian refugee camps to know
if these people are dying from typhus or AIDS as well as
starvation and --

Since there is no vaccine for typhus, it seems that WHO
would alert medical missionaries to bring doxycycline, the magic
bullet to treat it. WHO, at that time, told me simply well, we
printed it our literature that Ethiopia has ninety percent of the
typhus in the world -- what's left of typhus. In Indiana, our
state board of health isn't kept abreast by WHO of the need to
take medicines for typhus. Are they told now? Is WHO telling
the people who leave to go overseas to work in Africa to take a
blood buddy, to avoid using this dangerous Ethiopian blood, if it
is dangerous? Does the WHO have lack of funds to notify state
board of health officers who do vaccinate our people before they
leave to go overseas to alert them of the dangers of working
there as missionaries or health workers?

DR. MANN: Thanks very much for your question. It opens up
a number of important issues. One is that it's important for me
to explain to you that the World Health Organization, by working
with governments, provides information to national governments.
Since I used to work as health officer in New Mexico, I know that
in the United States that information was provided through the
U.S. Public Health Service and usually particularly through the
Centers for Disease Control to me and I would then apply that to

19

 

 
 

people who were traveling to different parts of the world. In
the United States WHO doesn't generally reach to the state level.
It reaches the federal government level, which is where I would
feel that it would be most important to get guidance for U.S.
nationals planning to travel.

In terms of Ethiopia specifically, there are advantages and
disadvantages to being a multi-lateral organization. One of the
advantages is that we have sent missions to look at AIDS and to
begin to help governments working on AIDS. The countries have
included Ethiopia, Libya, Iran, Albania, and countries that are
closed to various bilateral missions. In Ethiopia specifically,
we have gone quite far in helping the Ethiopian government
develop their national AIDS plan. We have placed a WHO staff
member in Ethiopia to help work on that problem. Can we solve
all the Ethiopian problems? Absolutely not. Can we help them
deal effectively with AIDS? We think so. Will it work? I don't
know. Is it worth a try? Absolutely. I can't give you the
clear, final, ironclad answer I'd like to be able to give to your
question.

I don't know how many people are infected in Ethiopia. I
know that the level of infection has been increasing over the
last few years. Ethiopia is a very complex situation. We will
continue to help Ethiopia fight its AIDS problem and I hope that
a year from now I could give you a lot more information about
the facts about AIDS in Ethiopia. Right now, we have the
beginnings of a program. I hope in a year we'll have a lot more
to say.

DR. SerVAAS: I guess my concern is that even knowing when
the World Health Organization knew that ninety percent of our
typhus was in Ethiopia that people like myself and a nurse from
the Washington, D.C. area who, had gotten all the shots she
needed to go there ended up in Hadassa Hospital being treated for
resniovirus when indeed she became comatose with typhus and
untreated typhus is fatal. There is a magic bullet for it but
yet somehow the information isn't filtering from the WHO to
Indiana and to Washington, D.C. health people who give the
vaccines and send people overseas. There's no vaccine for
typhus but there's a good prevention. Now, that's what I'm
wondering. They said it was because we couldn't get information
from their government, but certainly the WHO did know. You said
it goes to national organizations and then it's our fault that it
isn't getting out to the state boards of health and the local
people who send our health workers overseas.

DR. MANN: If I may say, regarding AIDS, because that is my
area of expertise, we are making the point world-wide that AIDS
is a world-wide problem and no matter where you go, no matter
where you go in the world, you've got to be aware that AIDS
likely exists in the country you're going to. There are no safe

20

 

 
 

 

zones in the world for AIDS. That's another way of dealing with
the general problem of information is to tell people you should
behave when you travel to country X exactly the way you should
behave when you're in your own country and that way you'll avoid
becoming infected. In terms of AIDS, that's the way we approach
the overall question of informing people about international

travel.

DR. SerVAAS: Then should we be telling our missionaries to
bring blood buddies, no to use the local blood supply if they are
in an automobile accident? Are we doing that? Are we letting
our missionaries and health workers know that?

DR. MANN: I can't answer what is being done in the United
States regarding the education information to missionaries and
others who travel abroad. I know that from WHO's viewpoint,
we're doing a great deal to make those blood supplies safe in
terms of HIV infection, which is one issue. We're also doing a
lot to try to educate the traveler about the appropriate and
inappropriate things. For example, preventing the need for blood
transfusion in the first place. Most blood transfusions in
developing countries occur as a result of accidents and most of
those are automobile accidents. Many of those are preventible.
There's a whole line of thinking that has to go into the question
before you get to that final question of should you have a "blood
buddy" or not. Those are all very complex issues. I'd be happy
to give the Commission the text of our current policies and our
current statements on these questions.

CHAIRMAN WALSH: Dr. Primm, please?

DR. PRIMM: Dr. Mann, you spoke about the neuropsychiatric
effects during HIV infection. Would you elaborate on that a bit
more because we get constant reports and, of course, we Know that
there are many neuropsychiatric effects in people who have been
diagnosed to have full blown AIDS. Even during infection, we
talk about dementia and dementia is an indicator or marker for
diagnosis of AIDS now with the expanded CDC criteria for that
diagnosis.

The other question is in Thailand, I was rather shocked by
the increasing numbers, from zero in '85 in terms of
seroprevalence among IV drug users to sixteen percent now in
1988. To my knowledge, Thailand does have methadone maintenance
treatment programs and indeed have employed all kinds of
intervention methods to thwart this seroprevalence increase.

Have they used the syringe needle exchange in Thailand or are
they prepared to do that at this point? You and I have discussed
this about other problems. If you'd comment on those two issues.

21

 

 
DR. MANN: Thank you very much, Dr. Primm. In terms of the
neuropsychiatric aspects, perhaps I could just quote to you the
brief conclusion of the consultation and then I will be
delighted to provide to the Commission a copy of the consensus
statement that came from the meeting and, as soon as it is
available, I expect within a couple of weeks, the final report of
the meeting as well.

The consultation occurred in March and it involved forty
eight participants from seventeen countries including experts in
clinical psychology, epidemiology, ethics, health economics, law,
neurology, occupational health, psychiatry, public health. The
consultation reported, "At present, there is no evidence for an
increase of clinically significant neurological or
neuropsychological abnormalities in CDC Group II or Group III HIV
I seropositive individuals as compared to HIV I seronegative
controls. A parenthesis here, the Group II ana Group III refers
to people who are asymptomatic or who have persistent generalized
lymphadenopathy. Therefore, there is no justification for HIV-I
serological screening as a strategy for detecting such functional
impairments in asymptomatic persons."

Going back now to a text which we've prepared for another
purpose, "The most important outcome of the deliberations is that
governments, employers and the public can be assured that the
weight of currently available scientific evidence indicates that
otherwise healthy HIV infected individuals are no more likely to
be functionally impaired than uninfected persons." We will
be following this issue very carefully. We don't know what
ultimately will emerge from a continued study of HIV-infected but
asymptomatic people. The studies are underway and we have a
commitment to following through.

In terms of Thailand, we're very concerned. This is an
explosion of infection in a group of IV drug users. In the city
of Bangkok, approximately 42,000 people a year come for treatment
of IV drug use. The general policy applied in Bangkok is to use
methadone for detoxification but not for maintenance. They are
in the process of reconsidering that policy. In addition, WHO is
providing experts on IV drug use as consultants to the Thai
government to assist them to reassess their strategies and try to
determine what they should do. They are facing an urgent
problem. There is evidence of needle sharing and the increase
of infection is quite concerning. As IV drug use always does, it
links together other segments of the community. It links
together issues of perinatal transmission. It links together
issues of heterosexual transmission. Therefore, it is not just,
as you well know, an IV drug use problem. It's a problem for the
whole society.

22
There is no needle exchange at the present time in Bangkok.
They will be reassessing the use of needle exchange programs in
the context of the urgent situation they now face.

DR. PRIMM: I wanted to also personally commend you for such
a wonderful and complete presentation today. I think it's one of
the best we have ever heard and I just commend you highly for

that.
CHAIRMAN WALSH: Dr. Lee?

DR. LEE: My questions have to do with incidence and
prevalence, Dr. Mann, but they are so multi-faceted that I think
I'll defer my questions for now and hope that by the end of
today I'll be smarter. I'll have a chance at you tonight.

CHAIRMAN WALSH: Let's start on the end. Dr. Lilly.

DR. LILLY: A question for information. It's my
understanding that the United States has not paid its assessed
contribution to WHO and the AIDS program?

DR. MANN: On the one hand, the United States through the
USAID, has been one of the first and one of the most important
contributors to the Global AIDS Program of WHO. Their support -
technical, financial and moral has been critical to our success.

On the other hand it is a fact that the United States
government is in arrears regarding its assessed contribution for
the regular budget of the World Health Organization. This does
create a problem for the AIDS program insofar as we are funded by
sixteen countries who give extra resources beyond their normal
contribution to WHO in order to fund the AIDS activity. Of
those, the U.S. is the largest single contributor now to our
program of AIDS.

However, we require administrative support services from an
organization whose budget is not fully funded. It is true, sir,
that the assessed contribution is not fully paid at present. To
AIDS directly through USAID, the United States has been very
supportive and very generous.

DR. LILLY: Just one other question. Is the WHO in any way
involved at present in drug development for the treatment of
AIDS?

DR. MANN: We're involved in several areas around the issue
of drug development and we expect to be much more involved in the
future in several others. Briefly, for example, we just held a
technical meeting to examine the question of animal models, an
important issue around drug evaluation strategies.

23
 

 

In addition, within six to nine months WHO will be able to
play an important coordinating role in international studies of
drugs. In the same way, we will play an important role
regarding vaccines by providing an international forum and an
international umbrella, if you will, for the conduct of certain
studies. This will always and only be done at the express
request of the governments involved. If a government does not
want WHO to be involved, we will not be. We are nota
supranational organization but it is of great importance to us
all that field trials carried out internationally be done in
accordance with the highest scientific and ethical standards.
The issue is not that any one government or company or
institution does not understand those scientific standards, but
sometimes appearance is just as important as reality. If anyone,
anywhere, has the feeling that international science is using
people as guinea pigs, then we would all be the losers. It's in
that interest as well that WHO sees its role.

DR. LILLY: The guinea pig concept is one that bothers me a
great deal. I think it's something that has to be taken in
consideration there. Another is that while vaccines very often
turn out to be relatively cheap, drugs nowadays do not. There is
essentially no drug that is currently under development, either
for AIDS or for any other disease, that has any chance of being
even faintly as cheap as aspirin. For example, AZT is something
that's being used pretty widely in this country now. It's my
understanding that there's no underdeveloped country that can
afford AZT for anybody.

DR. MANN: Yes, sir, that's essentially true. AZT is
purchased and used for certain members of different societies.
In other words, people have different financial capacity in
developing countries. But it's certainly true that, at present,
there is no affordable drug that could be used widely in the
developing world. In addition, I have to add that the use of AZT
implies an infrastructure which includes the capacity to monitor
various clinical indicators such as hematologic status and these
facilities are not always present in developing countries. We
don't yet have the drug that we need. The question will clearly
be, once we have it, can we, the world, afford it?

I think there's an issue of fundamental equity at stake
here and I think it's a question we're going to have to face.
How do we make a drug that works and that can be used, for
example, to prevent the development of AIDS in HIV infected
people? How can we bring that drug to the people around the
world who need it? That seems to me to be a fundamental question
that we need to be asking ourselves. At the moment, we're not
much further than asking, but we are asking the question.

24

 

 
 

 

DR. LILLY: One last question. The United States is indeed
an extremely wealthy nation. We are doing an awful lot but we're
not doing it terribly efficiently at present. Many of the
countries that you deal with are not in the same ball park at
all with respect to economic situation. How can an extremely
poor country put together a program that has any chance to be
effective in preventing AIDS, in coping with the problem of
existing AIDS?

DR. MANN: I really appreciate your asking that question
because it's something that, of course, concerns us a good deal.
When you really look at what will be effective against AIDS, it's
not always as expensive as it might look in some ways. It
depends on what kind of an AIDS problem you have. When you have
an IV drug use AIDS problem, you've got, by definition, an
expensive problem on your hands. But, let's say that the basic
problem is like the problem in India today or in China or in the
Philippines. It's a problem of prevention. It's a problem of
education. It's a problem of social commitment and social
mobilization. Now, those are things in which no society
necessarily has an edge over another and where resources, money,
doesn't necessarily make all the difference. You do need a
certain amount of resource to conduct any activity, but I think
that we'll be seeing, over the next few years, true leadership,
in AIDS prevention coming from areas of the world that are
resource poor. They will be mobilizing the resources that they
already have, in the context of their culture and their society
in order to achieve the changes that are needed. After all,
that's what is required for a prevention.

No, they will not have large research programs. No, they
may not develop new drugs. That's excluded for most of the
world's population. They don't have the resources. Again, where
IV drug use is a problem, you have a particular issue that is
going to require a great deal of resources and time and
commitment. So, in many of the countries where the problem is
just beginning, they will be able to do a lot with very little.
In countries where the problem is well under way but not
overwhelming, I think we'll be impressed to see how much can be
done with a relatively small amount of money. But some of these
countries, sir, have no money at all really and therefore, it is
going to require international support through the international
networks, through the World Bank, through the bilateral
assistance agencies, through WHO. We will be required. We will
have to keep people in some of these countries to help them for
an indefinite period of time.

But that's not an insurmountable amount of money. We're not
talking, for that particular country, of hundreds of millions of
dollars. We're probably talking about several million dollars a
year. That's a budget that I think the world can afford.

25

 

 
CHAIRMAN WALSH: Dr. Crenshaw.

DR. CRENSHAW: I have particularly appreciated your writing
about phases which societies go through from denial,
minimization and constructive engagement. I think individuals do
that, too, but countries are confronting this problem relatively
inadequately still, and I think you would agree in many cases.

You mentioned that the estimate of cases by 1991 worldwide
of AIDS was a million. Could you give that estimate for that
same date for HIV positive?

DR. MANN: No, but I wish I could. The reason I can't is
that for the number of AIDS cases, the die is cast. That is to
say, unless we discover and use and deploy a drug that could
prevent the development of AIDS in HIV-infected people.
Otherwise, for the people already HIV-infected, the die is cast.
Now, the risk of developing AIDS is a finite risk and that we can
do nothing to prevent. But we have absolutely everything to say
and do about that other figure. In other words, that's where we
can act.

DR. CRENSHAW: That's where my question is going exactly.
What I would add is could you, from the point of view of
Gescribing for us the power and the potential of prevention -- if
you can't do it with HIV positives with the cases of AIDS -- a
worse case scenario and a best case scenario of five years after
1991 and five years again after that, 2001, giving what would
happen if we didn't improve and what we have the potential to do
by contrast? Best case and worst case.

DR. MANN: I can give you half an answer and maybe three
quarters of an answer. The best case is that the number of
infected people could essentially stabilize in the five to ten
million range. That's a best case, but that's a case, we have
to remember, that implies an ongoing number of AIDS cases and
burden of illness that would continue beyond 1991. —

The worst case I would put this way. We would guess -- it's
a guess -- that there are several hundred million people in the
world whose behavior puts them potentially at risk of infection
with HIV. Now, that is a guess. The studies aren't available
yet that would allow us to be any more precise. In other words
our best guess is that there are several hundred million people
who either practice self injecting behaviors or who have sexual
practices and a life style that would allow them to be HIV-
infected. The whole question becomes how common is infection
where they live and what's the likelihood that they have contact
with an infected person? I'm not saying that there could be
several hundred million people infected in five years.
Fortunately, I think that is not possible.

26
But, in terms of the ultimate potential of this epidemic --
realizing that if every infected person, infected two other
people over the course of their lifetime, they would increase the
epidemic ~in that context, we see the potential. From what has
been observed in IV drug using populations in Edinburgh, in New
York City, in Milan and now in Bangkok, in female prostitutes in
Nairobi, in male homosexuals in San Francisco and in parts of
Europe, we can say that HIV has the potential to create an
explosive epidemic in a population if the behaviors that spread
the virus are sufficiently intense. All we can do is say that
the potential for the involvement eventually of hundreds of
millions of people over a long period of time exists. That's the
best I can do in trying to estimate that answer.

DR. CRENSHAW: Thank you. And then you made some comments
about central nervous system involvement in asymptomatics. Could
you make some similar elaboration on comments of HIV infection in
the clinical stages and the impact of AIDS dementia and fine
motor coordination problems on pilots, etc., the concerns that
were raised?

DR. MANN: We basically have divided the issue into
otherwise asymptomatic people, CDC Group II and III, and people
who have ARC or AIDS. It's clear the people who already have the
disease AIDS will not be functioning, or are unlikely to
function, in a variety of particular occupational settings. The
problem of dementia in the people with AIDS is indeed a major
problem and it's a problem that's going to stress and strain the
health care capacity of a country like the United States
enormously. People have calculated the needs there will be for
psychiatric support and for surgeons to do brain biopsies to
determine etiology and so forth over the next five years. I've
seen the estimates. They're rather staggering in terms of the
current neurologic and psychiatric capacity in the United States
and what might be needed in five years to deal with an
increasing burden of AIDS dementia and neurological problems.
The WHO consultation concluded that the current weight of
evidence suggests that people who are otherwise asymptomatic, do
not have any increase in functional abnormality compared with
uninfected people. Once you are speaking of people with the
disease AIDS or with ARC, in functional terms one is dealing with
a different situation. There, clearly, AIDS dementia and other
neurological problems can play a very major role and will be a
major challenge to countries like the United States.

DR. LILLY: Do you have additional recommendations on how to
cope with that or does the World Health Organization? For the
sake of time, could you provide us with that document you
mentioned about the projections within the United States of the
burden to our psychiatric care system cost estimates? Do you
have some suggestions, just general common sense?

27
 

 

DR. MANN: Yes. Again, in the interest of time, if you
agree, I'll be happy to provide those to you in writing.
They're part of the report of the meeting that was held.
Regarding the projections for the psychiatric and neurologic
resources needed in the next few years, I will convey your
request to the author of that who is an American and ask if he
could possibly provide that to you because it's not my data.

DR. LILLY: Thank you.
CHAIRMAN WALSH: Ms. Gebbie?

MRS. GEBBIE: Two questions, at least a portion of which, I
think, is answerable in writing later on. I think it would be
very helpful for us to have a picture of exactly what resources
you have available to you. It at times sounds like you must have
a staff of five thousand with all kinds of support. I know
that's not true, but it's also bigger than just you. So some
outline of the staff directly assigned to your program, how
they're deployed and perhaps what you're able to draw on a short
term or interim basis from the member countries would help with
our perspective.

The question I'd like to have answered here may be one
that's awkward and difficult to answer but is very important to
us, given our charge. From your perspective, outside the United
States, what are the three things that this country should do in
the next year that would be most critical to your efforts world-
wide. I include in that either things we can do that are
contributions directly to your effort or things we could do in
total in our AIDS policy that would be a help to you in carrying
out your mission.

DR. MANN: Thank you very much. In terms of the first
question, we will be happy to provide you with that information.
Eighteen months ago, it was me and a secretary. We now have over
a hundred people working in the program. I would particularly
like to highlight the tremendous work that's been done here in
the Americas by the group based at PAHO under Dr. Ron St. John,
who you'll be hearing later, who exemplify what's true of
everyone working in this field which is to say we're
understaffed, overstressed, overworked, but we're doing a pretty
good job, all things considered. When you look back at the
adistance we've all come in just the last year or two, it gives us
some strength to proceed, not that more work isn't needed.

Three areas that come immediately to mind. A commitment by
the American research community to be fully supportive of
international research activities, to link, as much as possible,
American research with international research. A commitment to
the protection of human rights and to positions of anti~
discrimination regarding how people who are HIV-infected are

28

 

 
 

 

handled. The whole world looks at the United States. The whole
world watches and listens to your debates and your discussions.
For you to take the position that the protection of the human
right of people who are infected, which in no way diminishes
their responsibility to behave responsibly, the commitment to
anti-discrimination would be a beacon of light around the world.

The third thing would be ongoing and continued financial,
political and moral support for the world-wide effort. The world
can't do it without you. We need you to continue to play the
strong role that you have played in the beginnings of world-wide
AIDS control and to see that carried through.

So, a commitment to research being international and
functioning in the international context with international
cooperation, commitment to human rights in AIDS, and a commitment
to ongoing support. These would give people confidence that,
from the United States they see the ingredients for leadership
that will help lead the way for the future.

MRS. GEBBIE: Thank you. I would appreciate, with regard to
your first and third points, again as a followup in writing, if
you could elaborate a little more on how those might be carried
out or what you see as the gaps today that need to be filled. I
think that would be very helpful to us. Thank you.

DR. MANN: Of course.

CHAIRMAN WALSH: Dr. Mann, I want to thank you for being as
attentive in the replies to your questions as you have been. I
just want to make a very short comment. I shan't use the
prerogative of any questions to you at this time.

First of all, in regard to the United States' obligations to
the World Health Organization, I think it should be clarified
that the withholding of certain payments was a legislative action
taken by the Congress and was taken in the context of all United
Nations agencies with particular concern over the one agency
which has since, I think, clarified or rectified its problems.
Unfortunately, the World Health Organization was caught in the
concept of all of the affected agencies and there has been
general admission by the Congress in particular that of all of
the U.N. agencies that the World Health Organization has probably
been the most efficiently run, has squeezed out virtually all of
the fat and, as a result of that, a substantial payment to the
World Health Organization was made this year. I believe $68
million was given. Again, by law, they could only give eighty
percent of the assessment because that's part of what the
Congress has on the books. There's nothing you can do about it.
I personally am optimistic, however, that there is considerable
movement on the part of the administration and the state
department to move the rest of the funding so that I hope the

29

 

 
arrears problem will be settled. I don't think we should leave
that unclear for those who are paying attention to these
hearings.

I think the second aspect of it is that we're all concerned
about the cost of drugs and pharmaceutical development. I think
these problems have a way of getting solved but I don't like to
see it inhibit the research that's being done. If you try to
solve them before the research is completed, you'll do away with
the research. The normal way in which this has been done in the
past is that, vaccines, medications and the like are sold in the
developing world at a much lower rate than they are sold in our
own country and in western Europe. In fact, we pay, to some
extent, for the traffic that goes, in many instances, to the
Third World. I think out of fairness we can cite what is being
done in river blindness. This was a drug developed by an
American corporation that was used, actually in veterinary
medicine. Incidentally it was discovered that it was a potential
cure for river blindness which affects some forty million people
in the world. This was donated by the company to the World
Health Organization for distribution in the Third World. So, I
don't think we need to spare too much, too early. I think you
also Dr. Mann, who, in his own way, is a persistent and would be
an even more persistent adversary of anyone profiteering on
pharmaceuticals in the war against AIDS. I don't think this is
something that this Commission has to be concerned with at this
time.

Thank you very much, Dr. Mann.

CHAIRMAN WALSH: If the next panel would proceed to the
table, the next session is on the Pandemic in Africa:
Description, Responses and Implications. We have a half a dozen
people making presentations. As I think all of you know, we gave
Dr. Mann a considerable amount of time because he had a great
deal to say and gave us an overview of where we stand.

Therefore, I would ask that this panel try to keep to the
schedule, to allow use more time for questions and we would
welcome any additional statements, or remarks that you would like
to give to us to be presented in writing should you feel that
your views have not been fully presented.

The first representative of this panel will be Dr. Thomas Cc.
Quinn, Associate Professor of the School of Medicine of Johns
Hopkins University and a Senior Investigator at the Laboratory of
Immunoregulation of the National Institutes of Health. Dr.
Quinn.

DR. QUINN: Thank you, Mr. Chairman. Members of the
Commission, as indicated by Dr. Mann, within a relatively brief
period of time, AIDS has become a global pandemic with over
85,000 cases officially reported to the World Health Organization

30
 

 

from one hundred and thirty seven countries. Since many other
cases remain unrecognized and unreported, it is estimated that
over 150,000 cases of AIDS have probably occurred world-wide with
an additional 500,000 individuals with AIDS-related conditions
and an estimated five to ten million individuals infected with
the etiologic agent of AIDS, the human immunodeficiency virus.

Unfortunately, the vast majority of both asymptomatic and
symptomatic infected individuals reside in developing countries
where the economic and social impact of this disease will have
its greatest impact. + Because of limited financial resources in
these countries, the challenge to control this epidemic will be
greatest within those areas where traditional efforts to control
other infectious diseases with vaccines and other measures have
always waned behind more technologically advanced countries.

Five minutes is not enough time to sufficiently review the
current status of HIV infection in Africa, a problem which has
already claimed thousands of lives and where an estimated three
to five million people are already infected with this
potentially fatal virus.

Consequently, I've provided the Commission with several
recent reports which review in detail the present status of HIV
infection and AIDS within some African countries and I would now
like to review the salient points of these papers with specific
attention on the distinctive epidemiologic features of HIV
infection in Africa.

With your permission, I would like to show a few slides
while I present these remarks. If I could have the first slide,
please.

Presently thirty nine of forty four African countries have
reported over 10,943 cases of AIDS to the World Health
Organization. However, it is generally accepted that thousands
of additional cases remain unrecognized and unreported que to
inadequate resources for comprehensive surveillance.
Nevertheless, the impact of HIV infection can be readily
acknowledged by the extremely high seroprevalance rates of HIV in
selective populations throughout central Africa and neighboring
countries.

HIV infections range from five to fifteen percent among
healthy blood donors, two to eight percent among women attending
prenatal clinics, fifteen to twenty five percent among men
attending sexually transmitted disease clinics and twenty seven
to ninety percent among female prostitutes. In one city in
central Africa where surveillance rates have been in place for at
least three years, it is estimated that AIDS cases now two
hundred cases per hundred thousand population as of the end of
1987. Even with these disturbing numbers, it is probable that

31

 

 
 

 

these are minimal estimates, since the data reflect only
recognized and reported cases of AIDS in several hospitals within
that city.

Both AIDS surveillance and HIV serologic data can be
utilized to reflect some of the basic epidemiologic trends of
AIDS in Africa. As in developed countries, AIDS in Africa
primarily affect young and middle aged persons. However, in
contrast to the United States, AIDS cases in Africa are equally
distributed among both men and women with a sex ratio of
approximately 1 to 1.3. The sex and age distribution of HIV
infection in Africa as shown on this slide reflects patterns seen
with other sexually transmitted diseases in which the incidence
and morbidity rates are higher among younger women and slightly
older men. The seroprevalence status strongly suggests that HIV
infection is predominantly common in sexually active age groups
and that it is predominantly transmitted sexually since there is
insufficient evidence at the present time throughout Africa for
IV drug abuse and bisexuality to explain this distribution of
cases.

Longitudinal studies on HIV seroprevalence demonstrate the
annual incidence rates of HIV infection among selected
populations in Africa. Among female prostitutes in Nairobi,
Kenya, the rate of infection rose from four percent to eighty
percent over a six year period. Among men attending a sexually
transmitted disease clinic, the rate rose from one percent to
eighteen percent during that same time period. Similarly, among
the general population such as pregnant women attending a
prenatal clinic, the rate rose from less than one percent to
three percent in Nairobi and from two percent to eight percent in
Kinshasa, Zaire.

Rapidly increasing incidence rates in urban areas are
compared to the relatively stable rates in some rural areas as
recently documented in a remote village study in Zaire which
strongly suggests that rapid urbanization associated with both
economic and social changes have played a major role in the rapid
spread of HIV infection among certain populations.

Regardless of geographic region, HIV does appear to be
transmitted through three major routes: sexual, parenteral and
perinatal. There are important regional variations which exist
within each of these transmission categories. In contrast to
North America and Europe, where the predominant sexual mode of
transmission has been seen among homosexual men, heterosexual
transmission is far more common in central Africa. Numerous
studies have identified the following risk factors associated
with heterosexual transmission of HIV in Africa and, to a limited
extent, in the United States: the number of sexual partners, sex
with a prostitute; and being a prostitute or being a sexual
partner of an infected individual. Whereas anal receptive

32

 

 
 

intercourse is a prominent sexual behavior associated with HIV
infection among homosexuals in the U.S., this behavior does not
appear to play any specific role in HIV transmission in Africa.

Co-factors such as sexually transmitted diseases which
induce genital ulcerations are significantly associated with HIV
seropositivity. In nearly every study performed among
individuals attending STD clinics in Africa, HIV infection has
been independently associated with the presence of history of
genital ulcerations.: In one recent study, the rate of
seroconversion following sexual contact with an HIV infected
woman was eight percent for men with a recent history or clinical
evidence of genital ulceration.

With HIV seroprevalence rates of two to eight percent among
pregnant women in some central African areas, increased evidence
of perinatal transmission is being documented as shown on this
slide. Perinatal transmission of HIV may occur in utero,
through transplacental passage of HIV natally at the time of
delivery or postnatally possibly through breastfeeding or other
routes. Efficiency and the risk factors associated with
perinatal transmission remain unknown and prospective studies are
currently underway in several African countries. Preliminary
data from Kinshasa, Zaire and Nairobi, Kenya suggest that
approximately forty to fifty percent of children born to HIV
antibody positive mothers may be infected perinatally. In one
study, nearly a quarter of the children born to HIV seropositive
mothers have died by twelve months of age compared to only three
percent in a control group of children born to HIV seronegative
mothers. It is thus apparent that HIV infection is an important
cause of premature birth and perinatal death in Africa and that
transmission from mother to infant appears to be strongly
correlated with clinical stage and immunologic competence of the
mother.

The importance of blood transfusions in HIV transmission in
Africa is exemplified by the six to eighteen percent
seroprevalence rates documented among blood donors in Uganda,
Rwanda, Zambia and Zaire. The impact of this mode of HIV
transmission is substantial. For example, as shown on this
slide, approximately 8,900 blood transfusions were given to
children with malaria at one hospital in Kinshasa, Zaire in 1986.
Since the HIV seropositivity rate among blood donors is shown to
be six percent, one can estimate that 561 seropositive blood
donations were given the children with malaria in this hospital
setting alone. With assistance from international health
agencies, HIV screening by the development of a rapid blood test
has been utilized to prevent further transmission with HIV
positive blood.

33

 
Unfortunately, and this is where the tragedy continues to
persist, many other areas of Africa still do not have the
resources or assistance from other countries to implement such
basic preventative measures for HIV infection.

Exposure to unsterilized needles used for medicinal purposes
or rituals may also contribute to HIV transmission, but that
contribution in accelerating the HIV epidemic in this region has
been difficult to quantify. Additional studies are warranted to
delineate the attributable risk of HIV infection following
exposure to blood-contaminated needles and syringes. In review
of studies on household transmission and other epidemiologic
studies that have been performed in this area, it is evident
that there is no evidence for casual contact transmission or
transmission by insect vectors.

Finally, the AIDS situation in Africa has been compounded by
the appearance of another epidemic, HIV-II infection occurring in
the countries of west Africa. Identified in 1986, this related
human retrovirus appears to be associated with similar clinical
features ranging from asymptomatic infection to AIDS similar to
that described for HIV I, the predominant strain in the United
States. Seroprevalence rates for HIV II among residents of
western Africa, as shown on this slide, range from two percent to
a high of twenty five percent among female prostitutes.
Transmission patterns of HIV II appear to be essentially
identical to that described for HIV I. Recent studies have
identified evidence of HIV II infection, not only in Africa, but
now also, to a limited extent, in the Caribbean, Europe and, more
recently, a case in the United States. Intensive studies are
urgently needed to examine the natural history of this related
retrovirus and to determine its pathogenic role in causing AIDS,
not only in west Africa, but throughout the world.

In summary, it is evident that HIV infection and AIDS have
become a major health problem in Africa. In some urban
hospitals, such as in Kinshasa, Zaire, approximately thirty five
percent of hospitalized adults and twenty percent of hospitalized
children are known to be infected with HIV. With limited
financial resources in many of these areas, the efforts to
control this virus will require an unprecedented coordinated
international effort involving all countries.

The challenge to control HIV infection is great for all
countries, but perhaps it's even greater for Africa where a
greater proportion of the population may already be infected and
where the general social, political and economic context of
modern Africa may limit the effectiveness of some control
programs.

34
An intensive effort by the international health agencies,
scientific experts, politicians and the world population at large
will be required to combat this disease. This concludes my
formal remarks and I want to thank the Commission for the
opportunity to present before you.

EXECUTIVE DIRECTOR GAULT: Because of the logistical
Situation here, I think that the next two witnesses, as I
understand it, also have slides that they would like to show. I
think that the Commissioners should go into the audience so that
they can see the slides and not have to look backwards. Dr.
Quinn, if you could provide us for the record with hard copies of
your slides because I don't see them here in the testimony as

yet.
DR. QUINN: I'd be glad to.

EXECUTIVE DIRECTOR GAULT: If you all don't mind the
rudeness of maybe the Commissioners going to the back, it would
be easier for them then to understand your presentation. I don't
think that the last three witnesses have slides, do they? You do
have some slides. Okay. So Dr. Lamptey has some slides, also.

CHAIRMAN WALSH: We'll do the questioning of the whole
panel at the same time. Dr. Bongaarts, who is the Senior
Associate for the Center for Policy Studies at the Population
Council in New York, will be our next witness.

DR. BONGAARTS: Mr. Chairman, the AIDS epidemic in Africa
has raised a number of important demographic questions. In the
brief time available, I will deal with only one of those and that
is the issue of the potential impact of the epidemic on the
population growth rate. Some observers fear or claim that we
will see reductions in the size of populations in some African
populations. My analysis suggests that this will not happen.

Before explaining how I've reached that conclusion, I'd
like to show you what is expected to happen in the absence of the
epidemic. In the first slide, I've shown population projections
from the United Nations for the period 1980 to the year 2025 for
three major regions: the developed world, the developing world
and for Africa. As you can see, the developed world essentially
has reached stability and will go very little further. In
contrast, the developing world as a whole will approximately
double over the period considered here, so we'll see rapid growth
in this part of the world.

Within the developing world, however, there's a great deal
of heterogeneity. Continents such as Latin America and Asia
will grow slower than average while Africa will grow at a much
faster rate. In fact, Africa, at present, is by far the fastest
growing region in the world; it is expected to grow from less

35
 

 

than 500 million individuals in 1980 to 1.6 billion people in the
year 2025.

The reason for bringing this to your attention is that the
more rapid a population grows, the more difficult it is for an
epidemic, even a very large one such as AIDS, to stop its
growth.

The question before us then is whether: this population
growth curve which is projected in the absence of AIDS will be
marginally affected by the epidemic or whether it in effect will
decline, as some people believe. Answering this question
requires a complicated analysis because a large number of
behavioral, epidemiological and demographic variables are
involved. I've turned to the computer and developed a computer
model to attempt to answer this question.

The next slide presents the HIV prevalence curves estimated
in a projection of a severe epidemic such as we're seeing now in
central Africa. It's a projection for a twenty five year period
from about 1975 to the year 2000. Since the model keeps track
separately of different behavior groups, I have prevalence
projections for prostitutes and the male partners of prostitutes,
each group reaching very high prevalence levels. But I want to
draw your attention to the bottom curve. This is the
seroprevalence for all adults.

There are two points I would like to make. The first one is
the shape of the curve. Initially, seroprevalence grows
exponentially, then linearly and eventually it starts levels off.
I believe that this shape of the prevalence curve will be seen in
all countries in Africa, indeed everywhere in the world. We've
already seen it in the United States and there is evidence in one
city in Africa where perhaps seroprevalence is beginning to level
off as well.

The only question is at what level this will take place and
the timing. These factors will differ greatly from country to
country. The second point I'd like to make about this curve is
that this is an attempt to simulate the future course of a
severe epidemic. Assuming that this epidemic started in 1975, at
the moment 1987 would be at the mid point in the projection
interval and, according to the computer projection, have a
prevalence of about ten percent which is roughly what we see in
the hardest hit countries in Africa. So, the first part of this
curve is approximately corresponding to that type of an epidemic.

If the rest of the projection is correct, then we can

expect a leveling off by the year 2000 at a prevalence level of
around twenty to twenty five percent of all adults in countries

36

 

 
 

 

such as Uganda. I should emphasize that this is for the country
as a whole. For the urban areas, we'll see much higher
prevalence rates while the rural areas will be below that.

The final slide shows the effects of this epidemic on the
population growth rate again for the twenty five year period
from 1975 to the year 2000. At the beginning of the epidemic,
the growth rate is approximately three percent, which is typical
for central Africa. Over time, the population growth rate
declines very substantially to below two percent. However, the
growth rate is still very much positive so there will be
continued growth, even in the presence of this severe epidemic.

The cause of this decline in the growth rate is a rise in
the death rate as shown on this slide. I've plotted here both
the birth rate and the death rate. The growth rate equals the
G@ifference between them, so the five percent birth rate minus the
two percent death rate gives us the three percent growth rate
that we saw initially. Over time, the death rate will rise
substantially and reach about 2.6 percent, but this rise in the
death rate is not sufficient to close the gap between the death
rate and the birth rate and therefore, the growth rate will
remain positive.

My conclusion then, from this brief analysis, is that we'll
see very large increases in death rates in central Africa,
possibly doubling in some countries, but this will be
insufficient to reduce population growths to negative rates.
We'll see continued rapid population growth in these countries.

Two final points. The first one is that the simulation I've
shown here is for the most severe case, as seem in some Central
African countries. The remainder of Africa will probably be less
affected. It's unclear at the moment how much less severe this
will be because the epidemic will vary in size from country to
country and the timing of the epidemic will vary greatly.

The second point I'd like to make is that, as I already
said, these projections are made for countries as a whole. In
urban areas, seroprevalence will rise to much higher levels.
Some observers have wondered whether we could possibly see a
reduction in the population growth rate in the urban areas. The
answer again is no because, even if the death rate triples or
possibly even quadruples in the urban areas, the population
growth rates of the urban areas are so much higher than country
averages so that it has a strong offsetting effect, making it
very difficult to end up with a reduced size of the urban
population in Africa. Thank you very much.

CHAIRMAN WALSH: Thank you. Next we have Dr. Mead Over
from the World Bank. I think it is particularly significant
that Jonathan Mann has been working together with the World Bank

37

 

 
i

|

and with UNDP and other agencies to coordinate as well as he can
the joint efforts. Thank you, Dr. Over.

DR. OVER: Thank you, Mr. Chairman. The previous two
speakers, Dr. Quinn and Dr. Bongaarts, have described to you the
number of cases that we think there might be in Africa and other
developing countries and how that number of cases might evolve
over time.

I'm here today to talk about the economic impact of the HIV
virus on developing countries and I'm going to be talking
primarily in terms of the economic impact per case. One could
compute the total aggregate impact of the epidemic on individual
countries if one were to know the kinds of numerical answers that
have just been described and then multiply those numbers times
the cost per case.

As the Chairman has just mentioned, this work has been
supported by the WHO and the World Bank jointly. I will talk
today from a paper that's been made available to you and which
has been authored jointly by myself, two authors from the Global
Program on AIDS headed by Dr. Mann, and the National AIDS
Program Coordinators from the two cooperating countries which
were Tanzania and Zaire.

In these preliminary estimates we have not been able to
address all types of possible economic impact. In particular,
the effect that AIDS might have on the external demand either for
a country's hotel and tourism services or for its workers has
been omitted from the analysis. Also, it is too early to
predict how much countries will spend on prevention of HIV
infection using the national AIDS programs that we've heard
described this morning by Dr. Mann.

Furthermore, the possibility that large numbers of deaths
from AIDS in some countries might have an effect on the average
cost per death has not yet been addressed. The focus here is on
two categories of cost, the direct cost and the indirect cost.
By the direct cost of HIV infection, we mean the cost of health
care for ARC and AIDS patients. The indirect cost is the value
of the lost years of healthy life caused by the disease. I
believe you've already heard the estimates for the direct and
indirect cost of AIDS in the United States that have been
prepared by Ann Scitovsky and other researchers here in this
country.

Estimates of the direct cost of AIDS per patient in the
United States range from 28,000 to more than 50,000 dollars while
those for the indirect cost total approximately $200,000 per
patient. If these results are expressed in terms of the cost per
HIV infected person rather than in terms of the cost per AIDS
case and if the costs are discounted back to the time of the HIV

38

 
infection, which is that critical point in the history of the
disease that Dr. Mann was describing this morning, then in the
United States the present value of the direct treatment-related
costs would range from 10,000 to 18,000 dollars per infected
person and the indirect costs would equal about $73,000 per
infected person.

What are the comparable numbers for the developing
countries? This figure (Figure 4) displays our upper and lower
estimates for direct and indirect costs per case of HIV infection
in Tanzania and Zaire, the two countries which have been
cooperating with our study. The estimates for direct cost per
AIDS case vary between $100 and $1500, however, when expressed
as the direct cost per HIV infected person, rather than per AIDS
case, the range of these estimates drops to between $37 and $560.
The direct costs appear on this graph as the black portions of
the bars.

You can see also that the indirect costs per HIV infected
person ranges from $900 to more than $5,000 in these two
countries. The direct cost is clearly dominated entirely by the
much larger indirect costs.

Now let's look more closely at each of these two types of
costs. First, consider the direct cost. The estimates for
direct cost are calculated by estimating the typical cost of
treating each opportunistic illness in these developing countries
and then averaging these by weighing each illness according to
the estimated probability that it will strike an average AIDS
case again in these countries.

The direct cost estimate varies from individual to
individual and from country to country depending on both the
socioeconomic characteristics of the particular patient and on
the medical and institutional characteristics of the health care
options faced by that patient. These differences are visible in
Figure 1. It displays the direct cost per case on the vertical
axis of this chart, measured again in 1985 dollars, and on the
horizontal axis we've displayed the 1985 GNP per capita of Zaire
and Tanzania, where this work was performed, and of three other
countries. The range in GNP per capita is from $170 for Zaire up
to about $1700 for the United States.

You can see that the direct cost per case in Zaire and
Tanzania and in the other countries are related closely to the
GNP per capita. This is a very important finding. It's perhaps
not a surprising finding because we already know that health care
expenditures in general are closely related to GNP per capita.
Whether one looks across European countries, across developed
countries or whether one looks across all countries in the world,
as GNP changes, health expenditures change. This, we have found,
is also the case for AIDS.

39
Now consider indirect cost which we defined as the value of
the healthy life years lost due to the disease. First, we
estimate the total number of healthy years of life lost and
discount them to the date of infection. We've done this
calculation, not only for HIV infection which is represented by
the bar on the far left of the diagram, but also for thirteen
other diseases which are prominent causes of death and morbidity
in developing countries, especially in Africa. (See Figure 2)

The height of the bar represents the discounted number of
healthy life years lost per case of this disease. It also
represents the number of healthy life years that could be saved
by prevention of one case of each of these diseases. Notice that
HIV infection ranks about fifth on this diagram. It is dominated
by some other diseases whose principal victims are infants, but
it exceeds many other diseases which are known to be serious
health problems in Africa including malaria, for example. The
next step is to take these years of life that are lost due to a
case of each of these diseases and weight them by the
productivity of each of the years of life. We assign a weight of
one to the years between age fifteen and age fifty, a year zero
to the ages between zero and five and intermediate rates to
other age ranges. In this diagram, the hatched bars are a
reflection of the previous chart you just saw, the unweighted
healthy life years lost per case of each disease. (See Figure 3).
The solid bars represent the effect of weighing. Naturally,
because some of the healthy life years lost have been multiplied
by numbers smaller than one, the effect of this productivity
weighing is to reduce the number of years lost from a case of
each disease.

A major impact of this procedure, of course, has been to
greatly shrink the measured impact of the childhood diseases
relative to the adult diseases. Diseases like tetanus, birth
injury and sickle cell anemia are greatly reduced in their net
impact when the lost years of life in childhood are omitted from
the calculation.

The final step in calculating the indirect cost per case is
to attach a dollar amount to each productive healthy life year.
Low and high estimates of these values account for the
differences between low and high estimates of the values in the
first diagram that I showed you. (Figure 4).

Again let me point out that these indirect costs exceed
greatly in magnitude the direct costs, just as they do in the
United States and by approximately the same factor of
proportionality - between five and fifteen.

40
How large will be the total burden of HIV infection on a
developing country? Again, as I said at the beginning, the true
calculation of that amount is impossible right now because we
still do not have the final results of the quantitative
seroprevalence estimates that are being performed by
epidemiologists in these countries with the cooperation of WHO
and other international agencies. However, we can make some
hypothetical guesses. These hypothetical guesses will not apply
to either Tanzania or Zaire because we have no data that's
sufficiently complete for those countries to be able to make such
estimates.

But suppose that we have a country with a per capita income
of about $200, which is typical for this region of Africa, and
suppose that it has a population of about ten million people,
which is a nice round number, larger than some countries, smaller
than others in that area. Suppose that twenty percent of this
population lives in the urban area. Suppose, in addition, that
the average annual income of rural adults and urban adults are
about $250 and about $600 respectively. Finally, suppose that
the seroprevalence rate among rural adults is about one percent
and suppose that the seroprevalence rate among urban adults is
about six percent. Those figures are consistent with the
information we have on several severely affected countries. Then
the total number of HIV-infected adults in these two groups would
be 80,000 in the rural area and 120,000 respectively. If
approximately fifteen percent of these seropositives were
infected in the previous year, then about 12,000 rural and about
18,000 urban adults would have been infected during the previous
year.

What was the economic impact of those 30,000 people who
were infected in the last year? The results recorded here
suggest that the present value of the total direct cost of the
health care for these newly infected individuals over the future
course of their disease would be approximately between $150,000
and $1.5 million while the total indirect cost would be about $3
million for the rural adults who were infected and approximately
$11 million for the urban adults. Thus the total costs for this
African country would range between $14 and $15 million.

AS a percentage of GNP, this would represent about three
quarters of one percent. However, it might represent as much as
fifteen percent of total health expenditures in such a country.

Thank you, Mr. Chairman and ladies anda gentlemen.

CHAIRMAN WALSH: Our next presentation will come from Dr.

Peter Lamptey, who is the Director of AIDSTECH and Family Health
International at the Research Triangle Park in Durhan.

41
 

 

DR. LAMPTEY: Thank you, Mr. Chairman. I'm grateful and
privileged to be asked to testify to this Commission. I would
like to address the needs of the low prevalence countries,
especially those in Africa. As an African public physician, I'm
also grateful for the leadership the U.S. government has shown by
its support of the WHO Global Program on AIDS and other United
States agencies for international development assistance programs
such as the AIDSTECH and AIDSCOM projects.

Africa is the least developed of the developing world. It
has the worst health status and has the least financial and
human technical resources. It is also the area that is worst hit
by the AIDS pandemic. Of the over forty countries that have
reported AIDS cases in Africa, about only a quarter may be
described as high prevalence. Most of the publicity, some of it
adverse, has been focused on these countries. WHO and other
agencies have also concentrated their efforts on these high
prevalence countries. There's no doubt that countries with
relatively high prevalence of the disease must act now to stop
the transmission of AIDS.

There are equally compelling reasons why the low prevalence
countries must intervene just as quickly and forcefully. My
primary recommendation therefore -- low prevalence countries
deserve -- as much as the high prevalence countries. Even where
the rural prevalence is low, especially in West Africa where I
come from, some groups, such as commercial sex workers, have high
prevalence rates. AIDS can be compared, in this country, to a
forest fire. The fire has started in multiple places ina small
way and right now it is probably easier to control and extinguish
these fires by individuals using fire extinguishers. If we allow
the fire to grow to a raging inferno, it will be more difficult,
more costly both in terms of lives and money, to try and control
such an infection.

In some ways, AIDS in this country is a public health
opportunity. A small investment now in prevention will provide
substantial gains in slowing the spread of AIDS, especially in
countries who already have overstretched health resources.

AIDS is an international disaster. Lack of funding,
politics and ideology should not prevent assistance in AIDS
control. Low prevalence countries present an opportunity for a
better understanding of AIDS. Some of the gaps in our knowledge,
whether it's the epidemiology of the disease, the politics or the
cultural and social aspects, can be better studied in the low
prevalence countries than in the countries that have high
prevalence.

I would also like to make a special appeal to the U.S.
government to continue support for the global prevention of AIDS.
The current level of funding is inadequate. Here is the

42

 

 
 

 

rationale for this continued support. One, knowledge gained in
the epidemiology and control efforts in Africa will be useful for
control efforts in the U.S.

Second, the economies of developing countries can not
afford the cost of an AIDS program. In countries where the per
capita health budget for the year is less than a dollar, the
additional burden of an AIDS control program obviously can not be
afforded.

Three, AIDS is a global problem that is spread in part by
international travel. The virus recognizes no frontiers.
Lastly, for humanitarian reasons. The AIDS problem will only get
worse and we need the assistance of countries such as the U.S. to
continue providing such support. However, we must not divert
resources from other areas such as child survival programs. A
lot of progress has already been made in reducing morbidity and
mortality, especially in children. Diversion of resources from
these programs will only make the general health situation worse.

In conclusion, I'd like to make a special appeal to the
U.S. media. The media has helped raise awareness of the AIDS
problem and contributed immensely to the support that is being
provided by western countries.

At the same time, the media has also created much damage and
added to the AIDS problem by irresponsible reporting,
misinformation and sensationalism. These reports have
contributed partially to the delay of many African countries in
responding to the AIDS problem. Help us fight the global problem
of AIDS together by more responsible reporting. Thank you.

CHAIRMAN WALSH: Thank you very much, Dr. Lamptey. Our
next speaker is Samuel Adeniyi-Jones who is with the National
Institute of Child Health Development and whose national origin
is Nigeria, so we again have another first hand view of Africa.

DR. ADENIYI-JONES Thank you, Mr. Chairman and members of
the panel. I want to make it clear that I'm not speaking for
the NIH because I think this is something that needs to be
Clarified. My involvement with AIDS is a personal one and arose
from a personal desire on my part to help my colleagues in Africa
deal with the problem. There are two reasons.

One is that about two years ago when it became clear that
there was an epidemic raging in Africa, the political situation
immediately arose with the public health situation. I was very
worried that we would get into a situation where we would be busy
fighting the political situation and lose the battle of the
public health situation, which is actually what happened at the
very beginning. So I thought that I could play an important part.
in maintaining the focus on the public health situation.

43

 

 
Secondly, I thought I was also in a unique position, being a
scientist at the National Institute of Health. It seemed clear
to me that what was needed was international cooperation and that
I was in a unique position to bridge the gap for this sort of
international cooperation. I had colleagues here whom I had a
very good relationship with and I had colleagues in Nigeria.

That is why I embarked on this personal odyssey. Much to my
surprise, these things are much more easily said than done.

I have traveled to Africa several times in an attempt to
talk to health officials. I have been supported to a large part
by organizations here, the Africa Bureau of USAID was very

instrumental to my early programs. Through some of the agencies
that it supported, they have paid me as a consultant for some of
these trips.

I've also been a consultant for the World Bank, especially
in its attempt to help the Ugandan government deal with its
health problem in general and the AIDS problem in particular.

I think I have a sort of unique perspective because I have no
allegiance to any group or anybody and I have floated back and
forth.

What has become clear, and I think it's clear to everybody,
there are two major problems. One is that in some parts of
Africa, you have a raging epidemic. In the other parts, you have
the beginning of an epidemic. Dr. Lamptey has rightly stated
that both areas need equal attention for the reasons which he has
stated so I won't go into that.

The question we would ask ourselves is with the epidemic
raging in those parts of Africa, Uganda, Zaire, Tanzania, do we
have a program that would help control it? If you listen to
Jonathan Mann, you would think yes, we do have a program. But,
from the point of view of the African health officials who are
dealing with the program every single day, we don't have a
program. There are a few reasons for this.

One is that there are about four or five aspects of the
control program. One is sero- surveillance, and laboratory
diagnostic ability. Take a country like Uganda. This has been
well-established by the WHO and I think the WHO is best equipped
to deal with this sort of problem and coordinate it world-wide.
But we know that this is not the aspect of the program to control
the epidemic. This is just the assessment part. Of course, for
the beginning of the program it is important to assess and to
follow the program, to monitor where that program is effective.
It's also very essential.

44
But the control parts of a program are quite different.
They require massive education programs. They require somehow
dealing with the fact that patients have to be managed. A lot of
people are aware of the opinion that since we don't have the
facilities to manage these patients, they are not managed. But
in fact, they are in hospitals and anybody who has been to any of
these countries will tell you that in some hospitals you have
thirty percent of the AXDS patients in the adult medical wards,
for example.

The blood bank. ‘The numbers Tom Quinn gave, I think it's an
under estimate for places like Uganda. The estimates are
between fifteen, twenty and up to twenty five percent of blood
donors. This part is important because it's one of the few parts
of the AIDS program that we can actually do something about and
eliminate. There have been arguments put forward by some of the
WHO officials within Uganda that it wouldn't make a dent in the
system. But, if you talk to the doctors, there are no doctors in
any of the hospitals in Uganda, who do not want to stop this
means of transmission. They claim the patients come to them for
treatment and you have to do some basic minor surgery and you
have to do a blood transfusion and you give the patient one
chance out of four or five of getting a fatal disease. That, to
them, is a colossal disaster and I share their view.

It is one area where we can do something. Unfortunately,
the WHO program, as it stands today, and it is a WHO program, we
are told that they are a national AIDS program and, to some
extent, they are. But they're really programs that have been
developed by the WHO and in collaboration with these countries,
but many of the countries have had to just go along with it.
This is exactly what they have told me. One is that if they
don't go along with it totally, then it's difficult to get money
from the WHO to deal with the problem.

These are the areas that have to be dealt with. The
programs as they stand today are very heavy into these initial
assessments of epidemiology, which I said is okay. But the other
areas are not. I think probably the problem, and I went into it
in detail here, is that contrary to what we're told, in fact the
WHO is trying to control the programs within these countries. If
it stayed with coordinating the programs, especially this
assessment part of the programs that I mentioned, then we'll be
in a better position because there's a lot of resistance, which
is not voiced to the WHO, within these countries about having to
accept these programs that have been brought to then.

Secondly, I don't tnink that the WHO is equipped to deal
with the massive education program that is required. Actually,
it requires very aggressive and massive education. I don't think
it's equipped to deal with the medical clinical problem.

45
 

 

A lot of African officials are now thinking, in fact, that
the more important part of medical program management is in fact
not the medication but counseling. They are now crying out for
some sort of counseling. Counseling does many things. First of
all, it helps the patients themselves. It helps the families.
It helps the communities.

Secondly, it's also an important part of an AIDS prevention
program, especially when the counseling is extended beyond just
the patients and their immediate families and is taken, in fact,
to the community to people who are HIV positive. When the people
are educated then, I think they will have less tendency to
actually spread the disease.

The blood bank issue. The blood bank issue is not a simple
one of blood bank testing. This is where I also disagree with
Jonathan Mann. That you actually need a lot of money. In our
assessment of the Ugandan program, I'll give you a simple
example. You can not just take a testing kit to a hospital and
say we want to do HIV testing for blood banks. You'll find that
there's no electricity. You'll find that the refrigerators are
not working. So, it requires some sort of more comprehensive
approach. It requires infrastructure development and that's
where the money is needed. I was very happy with the assessment
made by the World Bank in Uganda. We're not dealing with an AIDS
issue. We're dealing with a health issue. It requires a
comprehensive health plan. They don't have the infrastructure to
Maintain any program. That is why some of the WHO officials are
correct. You put in too much money and it doesn't have anywhere
to go. But, if some of that money is actually channeled to
development of infrastructure, then I think we're starting the
business because, without it, I don't think we'll get anywhere.

That's why I think we should look seriously at those two
aspects of the program, assessment and control. So what can be
done for control? I think there are many agencies, like
education, UNICEF, USAID, that have had a lot of experience with
developing health education programs in these countries. The
health education units of these countries are the least
developed. That's where virtually no money goes. So it will
require development of those health education programs so that
they can do not only AIDS education, but they can do general
health education within which will be an aggressive AIDS
education program.

In reviewing the program in Uganda, it became clear that
this sort of health education program has to be controlled by the
Ministry and not by any external agency so that part of the
Ministry has to be developed and it has to give it the
direction, the spirited will, the sort of emotional drive that is
required to do this program because otherwise it won't work.

46

 

 
 

 

The blood bank issue should be broader and that is why the
Ministry of Health also should control the program because it
would require development. It would require developing a network
within different hospitals of blood banks and it would require
actually developing the blood banks because what we're talking
about is delivering safe blood to patients who require it when
they require it. The safety of the blood is not just HIV safety,
that is just one of the things, but I think it's part of the
larger picture.

The other important question is the one: what do we do with
patients? There are lots and lots of patients in this hospital.
I think it has the potential to paralyze the health care delivery
systems in this hospital with twenty, thirty patients within a
ward where you have about eighty patients. First of all, the
other patients know who the AIDS patients are and they're afraid.
I remember a case in Uganda, a young boy of fifteen refusing to
go to a ward because he said he saw AIDS patients being treated
there. So there has to be an aggressive policy towards what are
we going to do with all these patients that are going to come up
in these countries? The health care delivery system is paralyzed
and I'm sure the economic system will be paralyzed.

The time given me is very short but I hope I have somehow
tried to convey what is needed in order to actually deal with the
problems, especially in those areas where the epidemic is raging.
What is needed, of course, in the areas where the epidemic is not
raging is the same massive, aggressive education system which
should be instituted now, not later. If we don't do it now for
the reasons Dr. Lamptey just stated, we'll be in the same
position that these other countries were. If you look at some of
the graphs that they've drawn, you will find that the countries
that don't have a serious epidemic now are virtually in the same
position that Uganda and Zaire were about five years ago. Since
we don't have a program that can stop AIDS, in five years we'll
be exactly in the same position.

What can the United States do? I do not agree with
Jonathan Mann that they have money. To be very honest, when I
hear the officials saying they have money or too much money like
the official said in Uganda, I think that they're doing a
Qisservice to a lot of these African nations because what is
required requires a lot of resources, especially to develop the
sort of infrastructure that I'm talking about.

What I'm hoping is that the United States can give the sort
of leadership it has been able to give in some of these other
areas in AIDS control especially in Africa. A lot of money is
now being poured into AIDS control within the United States. I
think the real test for the United States is whether it can
broaden its approach to a more international approach to dealing

47

 

 
with the global problem and divert the necessary resources needed
to this program.

I want to make a final point which I don't think has come
out here. The WHO has insisted that all funds go to the WHO.
Some of us have insisted that it will not work. First of all,
some of these countries have had very good relationships with the
USA through UNICEF and some of these other organizations where
they've established good relations and can develop programs,
especially in the field of education. We've been fighting for
the last year and a half to have, and I think its important to
have multilateral relations to the umbrella of the World Health
Organization and that is working and it's nice, but I think it's
equally important that bilateral relations should be allowed to
occur.

I'm glad to see that the USAID has already come to that
conclusion, so I understand. I stand to be corrected. I hope
many of the other organizations will come to the same conclusion
because if they don't, we are in trouble. We need both
multilateral relations and bilateral relations. Thank you.

CHAIRMAN WALSH: Thank you very much, Doctor. Our next
presentation will come from Dr. Peter Perine who is the Director
of Tropical Public Health Medicine at the Uniformed Services
University of Health Science in Bethesda. Go ahead, Doctor.

DR. PERINE: Thank you very much, Mr. Chairman. I'm
speaking today with respect to a special situation of AIDS as it
affects one African country and that country is Zambia. I want
to first preface my remarks by saying that this represents the
work of several very remarkable, extremely professional and
highly dedicated Zambian physicians and health care workers.
They're facing a Herculean task, to say the least.

The first evidence of the presence of the Human
Immunodeficiency Virus in Zambia was in 1982 and it was a
presentation of patients with an atypical, aggressive form of
Kaposi's sarcoma that were being evaluated at the University
Teaching Hospital in Lusaka, which is the tertiary care referral
center for the country of Zambia. Over the next five years, the
numbers of AIDS cases has increased to a reported 754 with eighty
deaths which have disproportionately been members of the
professions and the educated. During this time, the number of
Zambians infected with HIV has also increased dramatically.

Medical care in Zambia is provided by the government to all
its citizens through seventy one hospitals in 845 urban and
rural health centers. It is organized as a primary health care
system extending to the level of the village health worker with a
referral mechanism up the pyramid from the district level to
health centers tq Provincial hospitals and, as I said, at the

48
 

 

national level to the University Teaching Hospital in Lusaka.

The total number of hospital beds in the country is 15,348.

There are an additional 6,320 beds available in its health
centers. Medical care for its 7.5 million people is therefore
provided by approximately 800 physicians, 6300 nurses, 1350
clinical medical officers, and 500 health assistants. That works
out to be approximately one physician for 100,000 population and
one health care worker for 10,000 people.

The HIV epidemic in Zambia is seriously taxing its health
care facilities. HIV-related disease currently accounts for
about ten percent of all general hospital admissions and up to
thirty percent of admissions to general medical wards. The
immediate problems this presents include a disproportionate
allocation of both diagnostic and therapeutic resources to AIDS
patients, repeated hospital admissions and treatment with
medications that are often in very short supply or nonexistent.

At the University Teaching Hospital, HIV cases currently
comprise 17 percent of all medical ward admissions and 42 percent
of these patients have active pulmonic or disseminated
tuberculosis. Tuberculosis is often the first manifestation of
HIV but diagnosis is difficult because chest x-rays may appear
normal or atypical. Although most patients respond to
antituberculosis therapy, expensive multiple drug regimens are
required and they're required for the remainder of the patient's
life time. Hospital stays are also prolonged. HIV infected
adults with active pulmonic tuberculosis are also sources of
exposure for young children sharing their households unless the
patients with tuberculosis are rendered noninfectious by
tuberculous chemotherapy.

With respect to pregnancy and congenital transmission, our
first study examined a large number of antenatal women that made
it to the labor wards of the University Teaching Hospital in
1985. 10.8 percent were confirmed seropositive and approximately
half their children appeared to be congenitally infected on
followup at one year. Significant risk factors for HIV infection
were the number of both life time sexual partners and the number
of episodes of sexually transmitted disease the mother had. Most
of the HIV infected mothers were asymptomatic and had term
pregnancies with no increase in miscarriage or abortion when
compared with age and parity-matched HIV negative pregnant women.
Of the 400 HIV seronegative mothers followed postpartum for
twelve months, only six or 1.5 percent converted to
seropositivity.

Infants born of HIV infected mothers do not differ in birth
weight or rate of neurological or social development from other
children. Those infected with HIV, however, usually become
symptomatic within the first year of life. They rapidly lose
weight from a combination of chronic diarrhea, cough and fever

49

 

 
requiring frequent and often prolonged hospitalization. We have
interestingly observed six sets of twins born to infected
mothers. Two of those twins were identical sets. In each
instance, one infant was infected and one infant was not
infected.

Virtually all Zambian infants are breast fed for the first
one or two years of their lives and most receive BCG, measles,
polio and DPT vaccinations during the first year. An ongoing
study shows no evidence that these attenuated vaccines, that is
BCG, polio and measles, act as opportunistic pathogens in HIV
infected children. We believe the measles vaccine also provides
solid protection against measles since no child immunized has

developed measles whereas several non-immunized HIV infected
children, aged eight to fifteen months, have been admitted to the
hospital with severe measles.

With respect to heterosexual transmission, there were
approximately 8,000 men and women evaluated at the Sexually
Transmitted Disease Clinic at the University Teaching Hospital
Since September, 1985. Approximately sixty percent of men were
seropositive for HIV-1. This is a referred population. Many of
these patients came to that clinic because their clinician or
health worker suspected they may have AIDS. The corresponding
figure for women attending the clinic was approximately fifty.
percent seroprevalence of HIV-1. The only sexual practice
acknowledged by both men and women, with few exceptions, is
heterosexual intercourse. Homosexuality and bisexuality are
denied by almost everyone except for, interestingly, the twenty
to thirty percent of male prison inmates. The infrequency of
rectal gonorrhea and of syphilis in STD clinics tends to
substantiate the rarity of anal intercourse in non-incarcerated
adults.

With respect to non-venereal transmission, there is a
potential for non-venereal transmission in Zambia from both rural
and urban settings because there is a widespread, almost
universal, problem with the presence of malaria. The households
of patients who have been diagnosed as having AIDS or ARC have
been evaluated extensively and we find no instance where a child
under the age of five years was HIV infected and whose mother was
not also infected.

We also looked at a large population of school children
living in a rural part of Zambia where malaria is constant
throughout the year. We had about 3300 children who were tested
for HIV and only sixteen of the boys, which is one percent of the
boys, and about one percent of the girls were seropositive. In
this population, almost all of them had malaria, either by blood
film examination or by test of antibody against one of the
Malaria antigens. None of the children we found to be

50
 

 

seropositive had any clinical manifestations of AIDS or ARC,
although about half had splenomegaly which we attributed to the
presence of malaria. Very few of these children had received
blood transfusions, but several had acknowledged sexual exposure.
We don't have any identified risk factor for HIV infections in
four of these children.

We've also looked at the households in this population of
approximately 100,000 in northeastern Zambia and found that
forty of about 300 households have one or more members infected
by HIV; approximately 1,000 people were tested. What was
interesting in this study is that there was a very highly
significant clustering of cases. In this population where there
were about 100 seropositives, about sixty percent of these
seropositive individuals belonged to one of seventeen households.
The adults were infected, both men and women, and usually
children under the age of five were likely to be found infected.

Significantly there was no child between the age of six and
thirteen that was infected. We think this represents one of two
things. These children had not been exposed to the virus,
despite they're very clearly being exposed to vectors on a daily
basis. They're also traditionally scarified on the skin for
decorative and traditional healing reasons on a very frequent
basis. In fact, one evidence of that is that we found, much to
our surprise, a dramatically high prevalence of hepatitis B virus
in this population. So we think all this evidence points out
that there is very little non-sexual, non-perinatal transmission
of HIV taking place in this population.

Admittedly, with this high prevalence of virus,
approximating ten to fifteen percent in the adults, there are a
large number of children who have been infected by being given
transfusions for malaria, since it is likely that at least one
in six or seven blood donors who will be infected with HIV.

Although it's premature to draw conclusions about the modes
of transmission in our study in the rural parts of Zambia, our
data indicate that heterosexual intercourse and congenital and
perinatal transmission are the principal modes. Despite
frequent exposure to unsterilized instruments such as razor
blades for scarification, there is little evidence that this
practice transmits HIV.

Finally, with respect to prevention and control, Zambia has
been rather progressive in developing a counseling service for
all patients who are found to be seropositive. This is true
throughout the country. They're told to bring their sexual
partners in for testing. Many of these patients are being
followed in cohort studies. They're encouraged to use condoms to
lessen heterosexual transmission. The usage rate of condoms in
Zambia over the past year has increased five fold.

51

 

 
 

 

Infected women are informed about the risks of congenital
transmission and the potential adverse effects of pregnancy on
themselves and their fetus. However, because children are so
cherished in Zambia, most women continue to become pregnant in
hopes that their child will be free from infection.

There has been a major emphasis put on educational
programs, particularly focused on pre~adolescent, pre-pubescent
children, that's been endorsed and widely publicized by President
Kuwanda of Zambia, as the current chairman of the Organization of
African Unity, who has indeed a personal and a rather tragic
experience with this disease. His oldest son died of AIDS, which

he has acknowledged and has used in talking to groups of people
to tell them about the human side and the dimensions of this
problem in Africa.

In summary, HIV is epidemic in Zambia among both urban and
rural populations. Transmission is predominately by
heterosexual intercourse and during pregnancy. Hospitals can not
now or soon will not be able to treat the large number of HIV
patients requiring care. The health care system faces critical
shortages in personnel, supplies and equipment and its facilities
are rapidly deteriorating because of a lack of maintenance
forcing families to assume a greater responsibility for patient
care at home.

Available epidemiologic data suggests that the slope of the
HIV epidemic in Zambia is falling, but the number of projected
AIDS cases among those already infected by the HIV may produce
catastrophic socioeconomic consequences for Zambia in the next
decade. Thank you very much.

CHAIRMAN WALSH: Thank you very much. We'll start the
questioning in a moment. Just a brief comment.

Dr. Jones, I think you'll be very happy to know that we're
spending most of tomorrow on potentials of bilateral assistance,
so a lot of your questions may be answered tomorrow. In fairness
to WHO, I think that Dr. Mann was not indicating that he was
against bilateral assistance or wanted all the funding to come to
WHO. Rather he indicated that there is a proper time for that
assistance when it would be most productive. What he was trying
to get at was some type of coordinating process so that the
bilateral assistance could be given efficiently. Maybe he was so
subtle in this expression that you may not have heard it. But I
think he was pretty clear on that, that he was encouraging
bilateral assistance.

52

 

 
 

 

DR. ADENIYI-JONES I wasn't referring to what he said. I
was referring to what is going on.

CHAIRMAN WALSH: Oh, yes, I understand. I was just
bringing out the fact that I think if he believes in that,
believe me, I know Dr. Mann, it will be stimulated if he believes
in it. I'm not going to question your statement but I know that
he believes in bilateral assistance. It's just the timing of
when it should be given. Dr. Colleen Conway-Welch.

DR. CONWAY-WELCH Dr. Jones, you mentioned counseling as
one of the most efficient ways to address the problem. Do you
have models of counseling? Do you use family members? The
shortness of health care professionals obviously means counseling
needs to be extended into the general population with resources
other than health care workers. How are you addressing that?

DR. ADENIYI-JONES I'm not addressing it in any detail
because it just came up. I was actually impressed when it was
brought up by officials in Uganda. When I went to Kenya, it was
brought up immediately that they're realizing now that they're
burdened with all these patients and some sort of counseling is
needed. One way it would help is to keep patients out of the
hospital. Like he was saying, they have to be treated outside
within the community.

I think what we're advocating is to be able to get some
money so that we start developing programs for counseling. They
have started having education for counselors in Uganda which is
the first thing to do. That has to be massive education for
counselors to integrate the counselor, education and functioning
into the health education system at all levels right up to the
community level. So I'm talking in broad terms because I don't
have a program but it came up and we have started discussing the
best way to approach it. The first thing to do is to train
counselors.

COMMISSIONER CONWAY-WELSH: Thank you.
CHAIRMAN WALSH: Dr. Lilly?

DR. LILLY: I have just one quick question. One figure that
was quoted this morning which I've heard quoted before, or
roughly the same thing, that the male to female ratio in many
parts of Africa is 1 to 1.3. This is, nevertheless, not a one to
one ratio. I'm wondering what this implies. I assume that the
risk for a woman to be HIV positive is somewhat detectably larger
than it is for a man. What does this mean for transmission?

DR. QUINN: Since I presented those figures, I'll respond to
that question. It does appear that there are more women than men
infected with the virus in some areas of Africa where’ studies

53

 

 
have been done. Some of these studies have involved female
prostitute populations and that may alter that data to some
degree. If one looks at AIDS statistics and people with AIDS in
the hospital, you still come away with this finding of slightly
more women than men, but it's fairly close to one to one. It may
be that male to female transmission may be slightly more
efficient. It may also reflect social cultural factors that may
be more common in Africa than in other areas of the world.

These issues need to be addressed and I don't believe that
sufficient studies have been conducted to answer that
satisfactorily.

CHAIRMAN WALSH: Dr. Crenshaw?

DR. CRENSHAW: Dr. Perine, following up on that same issue,
in your transcript backup material here, you make a very strong
statement that from your studies it appears that female to male
and male to female transmission is equally efficient. Could you
elaborate on that because the common perception is again what we
hear and what many in the United States believe, that men have
some kind of sex-linked immunity and the only reason it's
different in Africa is because of "co-factors". Would you bring
us up to date?

DR. PERINE: I made a general statement and I didn't intend
to say that the numbers of men infected in Zambia and the
numbers of women are proportional.

DR. CRENSHAW: I was referring to your spouse article.

DR. PERINE: When we looked at households of infected
patients where either the index case was a man or a woman, we
were surprised to find that in fact there were more spouses of
infected women who were infected as compared to fewer spouses of
infected men. I think part of the problem is that we now
recognize that the infectivity of a partner may change with the
duration of disease. This isn't clearly an accurate measurement
of that. What is, I think, happening, if you look at the broad
number of cases, in Zambia and elsewhere in Africa, the
proportionate number of cases indicate that the efficiency of
transmission is approximately the same for man to woman and from
woman to man.

DR. CRENSHAW: Did I understand you correctly that, of the
couples that you studied, there were more males infected, would
you repeat that one more time so I'm clear?

DR. PERINE: If the wife was infected, approximately sixty
nine percent of their male spouses were infected. If we looked
at the infected man and look at his wife, we found that a lower
percentage of the wives were infected of infected men than the
converse.

54
CHAIRMAN WALSH: Ms. Gebbie?

MRS. GEBBIE: I have a question that I'll direct to both
Dr. Bongaarts and Dr. Over with a request for some comment now
and then some written followup. In both of your cases, it would
be very helpful to me to see your methodologies in more detail to
really make sure I understood the points you were making. My
particular question, with regard to Dr. Bongaarts, is the fact
that you seem to be using total death rates rather than age
specific death rates. At least to a casual observer, if the age
specific death rate in those groups that are potential child
bearers shoots up dramatically, then, not in the short time frame
you illustrate but in the much longer time frame, I would expect
A more dramatic effect. So it may be you've accounted for that
and a more detailed look will help.

Dr. Over, with regard to yours, I'm used to looking at
productive years of life lost statistics in the United States
which discount years of life from sixty. Your totals seem to
come out with productive life lost below the age of eighteen and
then you discounted childhood years of life lost which I don't
always see. I'd appreciate some better understanding of the
rationale for the choices you made which appear different.

DR. BONGAARTS: Thank you.

To answer your question about the age specificity of the
death rate, the model is fully age specific. In fact, I
calculate death rates for each single age. So, if one has a
twenty five year projection, I would have to present twenty five
times eighty numbers which is too many. For the purpose of my
presentation, I have only summarized results with the overall
death rate. I'll be happy to provide you with the details of the
model. I do have a document that describes this.

MRS. GEBBIE: Thank you.

DR. OVER: Because not everyone agrees on exactly how
lost healthy life years should be valued, I did the calculation
in the steps that you saw, in several steps.

For many purposes, the first calculation I made would
be sufficient. For example, some decision makers may not care to
weight children's years of life differently than adult years, and
for those decision makers the first estimates I gave are,healthy
life years lost, discounted, but without any discounting for low
productivity of the childhood years would be the best.

However, if we want to move farther and try to think

about what the economic impact of the disease is on a country, we
do need to try to estimate that

55
impact. And, in order to do so, we need to differentiate between
productive years and unproductive ones, or less productive ones,
and that was the basis for the weighing that I performed. Is
that responsive?

MRS. GEBBIE: That's helpful. I'd like to see a more
detailed discussion of your methodology.

DR. OVER: Certainly.
MRS. GEBBIE: Thank you.
CHAIRMAN WALSH: Dr. SerVaas?

DR. SerVAAS: My question is to Dr. Perine. Are there
sufficient AIDS tests available in Zambia to know which children
should receive vaccines and which should not? Is that a
problem?

DR. PERINE: Thank you for the question. No, it's not
a problem. The vaccines are given starting at the first day of
life. That's when they receive BCG vaccine.

The children are immunized beginning at the third,
fourth and fifth month of life against polio and DPT, and receive
measles at eight months of age. And, you cannot test the infant
for antibody to the AIDS virus, because during this whole period
of time they are likely to have passively transferred antibody
from their mothers. So that, the testing procedure, including
even antigen tests for HIV, don't seem to be very efficient in
determining whether or not the infant is infected.

DR. SerVAAS: Then, do you go ahead and vaccinate the
children of HIV positive mothers?

DR. PERINE: Yes.
DR. SerVAAS: For measles, for everything.

DR. PERINE: Well, children who ultimately prove to be
HIV infected, they are vaccinated, that's correct.

DR. SerVAAS: And, is that a complication then?

DR. PERINE: It hasn't appeared to be, and, indeed, it
appears to also provide protection for the child.

CHAIRMAN WALSH: Dr. Primm?

DR. PRIMM: I had a considerable concern when Dr. Jones
spoke, and I did not hear the kind of concern that he expressed,
from any other member of the panel. And, that bothered ne,

56
because with most of our panels I've been able to glean a
concurrence or some similarities in what they expressed. And, I
was very shocked by that.

Dr. Perine presented statistics, of course, on Zambia,
that were startling to me, that certainly would question the
ability of the infrastructure to support the onslaught of
whatever this disease entity is going to bring to that nation.

Then Dr. Quinn did likewise, and I'm concerned that I
don't hear an orchestration of the problems of the
infrastructure in these countries that cannot handle the
situation at the present time, even if the WHO was in there, and
a refusal on the part of these countries to do something because
it's coming from an outside source and it's not from inside
itself. In other words, it would be much more successful if the
countries themselves, the Ministers of Health, as he expressed,
may receive some of these dollars, and much more effective if we
did something about the infrastructure of these nations,
particularly a health infrastructure, if we plan for them to
handle this problem, or if we intend to help then. Any
panel member could respond to that.

DR. PERINE: I'd like to respond to your question. I
should have pointed out very clearly, these are studies done by
Zambians. Our input has been very minimal. They've been given
money through a variety of sources, and they've utilized the
money, they've designed the studies, they've done the work.
This is Zambians doing the work; it's virtually no one else, or
people working in Zambia that are not nationals but under
contract to the government.

So that, the Zambian Ministry of Health is the person
or the group of people who have decided what their priorities are
and how they'll approach these problems, and I can't, again, say
enough about their professionalism and the way they've gone about
this.

They were one of the first countries, I might add,
that, perhaps, were a little bit reticent to take international
aid or assistance, because they felt that they had within
themselves the resources to do something about it.

Now that they know some of the dimensions of their
problem, they are clearly in a more receptive phase to further
develop the research they've initiated. And, there's no
question that they need all the help they can get, financial and
otherwise, to begin to cope with the burden of illness that HIV
is presenting to them now, and God only knows how they'll cope in
the future.

57
I might add also, and this is something that no one has
said about Africa, that the people, the family unit in Africa is
a remarkable supportive network. It's something we could learn a
lot from. Patients are never abandoned. They are taken care of.
Children are never abandoned. There are no orphanages in Zambia,
for example.

There is a coping mechanism in Africa that is
remarkable, and I wish there were some parts of it we could
integrate into our own health care system. They will cope, I
have no doubt about that, and they will suffer, but I think they
will ultimately persevere.

CHAIRMAN WALSH: Dr. Quinn?

DR. QUINN: I'd also like to respond. There is no
question that the situation of AIDS and HIV infection in Africa
is paramount to being a very serious medical problem that affects
all Africans, as it does to all Americans and other people
throughout the world.

Since 1983, we've been working in close collaboration
with the Ministry of Health in Zaire, the Ministry of Health of
Uganda, the Ministry of Health in Kenya, and the Ministry of
Health in Tanzania to try to assess the problem, and then to
implement preventive measures.

The first and easiest, which Dr. Jones has already
alluded to, is implementation of blood bank screening programs,
by bringing in types of programs that introduce rapid screening
tests for HIV. But, it can't stop there.

Any program that's to be successful on controlling HIV
in Africa has to rely on the health infrastructure of that
particular country. It has to be strengthened.

A very classic example, not just for Africa but for the
United States as well, is heterosexual transmission of HIV
appears to be related to genital ulcers and other sexually
transmitted diseases among heterosexuals. A control program that
would be successful in controlling those genital ulcers,
gonorrhea and syphilis and herpes and chancroid, would have an
indirect effect on helping control HIV among those
heterosexuals.

So, in our efforts to try to assist to control AIDS
worldwide, within Africa and in this country, I think we have to
broaden our perspectives, to not just AIDS, but the entire health
infrastructure within each country. That's a massive effort, but
it's one that we must do, and it will have secondary benefits.

58
The major benefit would obviously be helping to control AIDS,
which is killing thousands of people. The secondary benefit,
would be to provide health to millions of people. Thank you.

CHAIRMAN WALSH: Thank you. Dr. Lamptey?

DR. LAMPTEY: Yes. I'd like to comment. And, part of
what Dr. Jones has said is very true in terms of the absence or
inadequacy of infrastructure, and I'd like to illustrate one or

two examples.

One is the blood banking area. There are a lot of
countries in Africa where blood banks only exist in the urban
areas, or some of the bigger towns. And, the moment you go
beyond that, blood is almost sometimes transfused as soon as the
patient is bled.

In the absence of a blood bank, it becomes extremely
aifficult to try and screen adequately blood in these
circumstances. Therefore, one of the best things to do is to
either develop a blood bank or improve the system.

Dr. Jones was mentioning the absence of some of the
equipment that you need in a laboratory, it could be a
refrigerator or it could be other commodities that they need for
the optimal functioning of the laboratory. Improving the
infrastructure is therefore essential if we are to improve
services.

One other problem that we found in some of these
countries is lack of expertise in managing AIDS programs.
What has happened is that, a lot of physicians, such as
microbiologists have been put in charge of AIDS prevention
programs, people who have no expertise at all in handling a
public health situation or managing large health programs.
Adequate training in health care management for these program
managers is essential for the successful implementation of AIDS
programs.

We need to fill the gaps in our knowledge in terms of
epidemiology of AIDS and knowledge of sexual behavior. We have
already started trying to change sexual behavior when we least
understand it. Technical assistance is needed to study and
understand the AIDS problem in developing countries.

The needs of developing countries are both fiscal and
technical - we need funds to improve the infrastructure of the
health system, to provide equipment and commodities as well as
technical assistance to define the problem and manage the
intervention programs.

59
 

 

CHAIRMAN WALSH: Dr. Lee?

DR. LEE: One of the most important parts of our charge
is to tell the President what's going to happen, incidence and
prevalence continues to bother me, because the statistics
contradict each other. And, basically, this question will get
back to Dr. Bongaarts.

Now, if we look at some of the material that has been
presented by Dr. Mann and most of the rest of you, we're saying
that at least 10 percent of the blood donors in most of these
countries; around 2 to 18 percent of pregnant women, about 6 to
18 percent of the blood donors in various other countries, 10 to
15 percent of all the adults in Zambia, et cetera, et cetera.

Now, if we start looking at this and adding up the
figures, we were told by Dr. Mann that we've got 10 million
overall HIV infected in the world today. But, if we have 1.5 to
2 million in this country, and if 10 percent of Kenya is
infected, that's at least 2 million. That's two countries, and
we're up to 4 million. It seems to me that our exposure here
could be a great deal larger than we are giving it credit for.

We add to that the fact that if 10 percent of the women
that are delivering are positive, half of those babies will die.
It seems to me we've got to have an effect on population here
somewhere, according to the figures that you've given us.

Can you comment on that?

DR. BONGAARTS: Well, there are two parts to your
question. Let me start with the seroprevalence picture. You are
quite right, and several of the speakers have already indicated,
there are very high levels of seroprevalence in urban areas of
Central and East Africa, 10, 15, perhaps 20 percent in some
parts.

It is also important to remember that the majority of
Africans 80 percent or so, live in rural areas, and they, by and
large, are much less severely affected. I think there is
probably no rural area in which seroprevalence is over 10
percent, and most of them are far below that.

Secondly, large parts of Africa, North Africa or West
Africa, are much less severely affected by this epidemic than
Central Africa. The two largest populations in Africa, Nigeria
and Egypt, probably have a prevalence of less than 2 percent,
maybe only 1 percent.

DR. LEE: Nigeria, 2 percent?

60

 

 
 

 

DR. BONGAARTS: Well, there's a recent publication
that suggests 1 percent, .9 percent for Nigeria, a national
sample. Also very interesting is the low prevalence among
prostitutes. If an epidemic started in Nigeria, one would
expect to see seroprevalence rise first among prostitutes. The
prostitutes seroprevalence in Nigeria was estimated at less than
2 percent.

What I'm getting at is, that we're going to see a great
deal of variation in the sizes of epidemics in African countries.
It's possible that large parts of rural areas will never have a
serious epidemic. The reason for this is that, some parts of
Africa will not have what's called a self- ~sustaining epidemic.
One can introduce HIV, and a number of individuals, perhaps a
substantial number, will get infected and will eventually move on
to AIDS, but they will not have a self-sustaining epidemic like
we have among homosexuals and IV drug users in this country, or
as we have in the urban areas.

Now, how it all will develop is very unclear. At the
moment, the highest numbers are observed in urban areas in
Central Africa and in no rural area is seroprevalence over 10
percent.

Now, to the second part of your question, namely, the
demographic impact, a graph that I didn't show to you is one that
estimates what level of prevalence would be required to stop
population growth. In my simulation, it's approximately 50
percent, that 50 percent of the adults would have to be
seropositive before a population growth rate turns negative and
population size is reduced. That is the average.

Since the younger adults, between, say, 20 and 40, have
a higher seroprevalence than older ones, the prevalence among the
young would have to be 60-70 percent. It seems very implausible
that will happen, but I cannot rule it out. Theoretically, it's
possible, but it seems very unlikely. And, as I demonstrated,
the computer model suggests that this will not happen.

DR. LEE: Could I deduce from this then that in Africa,
just as in this country, this disease remains compartmentalized?

DR. BONGAARTS: No, I don't think that will happen.
What will happen, is that we'll get epidemics of very different
sizes in different countries.

We have the first and largest epidemics in some Central
African countries. It will undoubtedly spread to many other
countries, and we'll see increases in seroprevalence just about
everywhere in Africa and, perhaps, in the rest of the world.

61

 

 
The question is, what level of prevalence will we end
up with 10, 15 years from now? I think it is safe to say that
the rest of Africa will be below the 15 to 20 percent levels now
observed in some urban areas, of Central Africa.

DR. LEE: Any other comments on that?

DR. PERINE: Yes. I want to remind you that the
prevalence, about half of all Africa in this population are
children under the age of 15, and they are not sexually active,
and from our studies they are not infected, except if they are
infected at birth or they are unlikely to survive beyond the age
of five.

So that, you have to halve those prevalence figures and
apply them only to the sexually active population, somewhere
between the ages of 15 and 35 or 40. Beyond that, most people
seem to be at very low risk.

DR. LEE: I just have -- go ahead, do you want to --

DR. BONGAARTS: Perhaps, I should add one point that I
didn't make clear in my presentation, and, that is, that
projections I have made so far, all assume no behavioral change.
That is, the behavior that's analyzed in this epidemic will
continue as in the past.

I have no doubt that education campaigns will have an
impact, and they are crucial at this point in time to stop
whatever epidemic is coming and building momentum.

I believe that we already may be seeing the impact in
one country, in one city, Kinshasa, of such an epidemic. The
data are perhaps not conclusive, but they suggest a leveling off
of seroprevalence in Kinshasa. We'll need a few more years worth
of data before we can think this is definite, but there have
been strong education campaigns in Kinshasa, and it ‘appears to
have done some good.

CHAIRMAN WALSH: I have only one brief question, and,
that is, should we be concentrating, therefore, more effort on
the education and training of infrastructure if we're ever to win
this battle? It just seems to me that from what I have heard,
all that we may wish to be done cannot be done in Africa,
without a greater base of infrastructure. Is that an
overstatement?

DR. ADENIYI-JONES No. I think you are absolutely

correct. In the first place, that's the only thing that will
control it, the education type of program.

62
I was part of a group that went to assess the situation
in Uganda, the overall situation, and it was quite clear that if
you really want to do something, if you really want to
effectively do something, you have to develop those aspects of
the infrastructure that will --

CHAIRMAN WALSH: Because, this will help everything,
not just AIDS.

DR. ADENIYI-JONES And, it will help then.

CHAIRMAN WALSH: Any other comments on that? There is
general agreement on that, that more attention has to be paid to
training of infrastructure.

All right. Thank you very much. It's been a most
interesting panel, and I think we've all learned a lot. I think

you raised, perhaps, more questions than gave us answers, but
that's what we're here for.

And, we thank you very, very much.
THE PANDEMIC IN THE AMERICAS:
DESCRIPTION, RESPONSES AND IMPLICATIONS

CHAIRMAN WALSH: The next panel will bring us back to
this hemisphere, where we are going to learn something about the
pandemic in the Americas.

Now, our first presentation on this panel will be from
Dr. Alastair J. Clayton, who is the Director General of the
Federal Centre for AIDS in Ottawa, Canada.

Dr. Clayton?

DR. CLAYTON: Thank you, Mr. Chairman.

I think, if I may, I'll stand here and talk briefly.

As you, perhaps, know, I have to leave about 1:00
o'clock.

CHAIRMAN WALSH: Yes.

DR. CLAYTON: -- so thank you for allowing me to go
first.

CHAIRMAN WALSH: With your permission, if any of the
panel has questions, may they ask you before you leave?

DR. CLAYTON: Thank you, sir.

63
CHAIRMAN WALSH: Thank you.

DR. CLAYTON: I'd like then, very briefly, just to
talk to you about the Canadian situation, ladies and gentlemen.
I think the first thing to recognize is that while Canada is
somewhat north of the United States, and most of you have heard
of us, you don't know very much about us. I don't suggest that's
the case of this distinguished panel, but it is often the case.

But, one thing which is important is that Canada has
1/10 the population of the United States, 25 million distinct
from 250 million. And, that, of course, influences our
statistics dramatically.

The latest figures that we have, the material I sent to
you some month or so ago, have changed, and we have as of today,
some 1,700 cases in our country, of whom 900 or so have died.

The major difference between the U.S. and Canada is in the lack
of cases in intravenous drug users. We only have 11, which is
about .7 percent of the total, whereas, in the U.S. 17 or more
percent are intravenous drug users. I think there are reasons to
explain this, but I don't think I have time to go into this at
the moment.

The other major difference is, perhaps, children. We
have, again, less incidence in children, and most of those are
children of Haitian mothers, because there is a large Haitian
community in Montreal, which is predominantly French speaking.

Our National AIDS Program has developed over the past
seven or eight years, as has been the case in the United States.
Originally, we started off activities in the Laboratory Centre
for Disease Control, which is the Canadian equivalent of the
Centers for Disease Control in Atlanta.

And, as time moved along, and as the matter became more
serious and more, albeit, limited resources were added to us, so
did our activities become more comprehensive. Last year, we
created a Federal Centre for AIDS, which is now in the process
of being staffed with some 57 people, we have a limited budget at
the moment, but have requested the Canadian Government for
enhanced resources and funding, on which we have not yet had a
response.

The centre is designed to coordinate all governmental
activities we don't have an NIH, or a number of organizations
such as exist in the U.S. So, again, because of that 10 to 1
population differential, there is more concentration in our
activities. And so, our centre does virtually all of the things
that many of the central agencies in the U.S. are doing; this
includes the promotion of public education, liaison and promotion

64
of clinical trials, and development of new vaccines, liaison with
the manufacturers and the clinical investigators as well as the

regulatory agency.

Also we are involved in the coordination of preventive
social health activities, stimulation of epidemiological studies,
for example, a survey of health care workers who are exposed to
HIV infection. We've had nearly 200 people recruited into the
survey and nobody has seroconverted. This is encouraging.

Another epidemiological study involves multiply
sexually active women. We now have about 1,500 women recruited
from 6 cities across the country. There have been very few women
who have seroconverted.

We are responsible for maintaining, establishing and
improving surveillance within the country. The Centre conducts
most of the international liaison with WHO and other agencies
involved with AIDS control.

Also, within the center, we provide the National
Reference Service for Canadian laboratories. This involves the
more complex and definitive diagnostic testing, production of
reagents, quality control, culturing the virus and so forth.

We have an active international component in the
laboratory, acting as one of the WHO Reference and Collaborating
Centers. One of the major issues that we've had to deal with at
the moment, Mr. Chairman, is the matter of testing of immigrants
and others. We have a great deal of political pressure on our
government to institute testing for immigrants. This, of course,
has been conditioned very much by what has happened in the United
States.

The U.S. government recently produced a paper which
discusses the success of the "mechanism" of testing immigrants.
One can accept that this can be a successfully prosecuted
program, but how effective has it been? The information from the
U.S. has not to this time indicated to us that this has been an
effective program.

As Dr. Mann said earlier on, we know that testing of
large groups of relatively low risk people will not control the
spread of this disease. The political pressures of screening
immigrants are very high, but we are maintaining the existing
Canadian government policy, which is that testing should be done
only under conditions of informed consent with pre and post-test
counseling, in place.

65
How long we'll be able to resist these pressures, I
don't know. I hope we can continue with the present policy
because and I think this is probably the pattern developing in
the U.S., once you test one group of people, then it's kind of
"domino effect". Next, is testing of prisoners, which is
already happening in your country, then people going into
hospital, people who are going to get married and so forth. We
are trying to forestall this type of "chain reaction."

Our National Advisory Committee has produced a very
extensive document, which may have been given to you. It
discusses ever category of testing, whether it should be
mandatory or compulsory, distinct from voluntary. The Committee
has come out firmly on the side of non-mandatory testing. So,
we're very curious, as I think is the rest of the world, to see
what's going to happen in this country.

I would like to make a recommendation to you, but it's
probably not my business to do so.

Let me, therefore, just summarize or finalize, by
talking a little on our international activities. The Canadian

International Development Association, has provided $4 million
this year and $4 million last year to WHO/GPA. This makes us the
fourth highest contributor to WHO/GPA.

We have undertaken, with the Panamerican Health
Organization and our laboratory, a number of activities. These
involve training specifically a course to be held in August,
providing technology training for 50 scientists. One of the more
interesting things we're doing is providing reference services
for the Haitian Red Cross specifically, they have asked us to
undertake their Western Blot tests.

Finally, Mr. Chairman, let me express to you that the
Fifth International Conference on AIDS will be held in Montreal
next year, next June. This is the fifth in the series of
Conferences, previously held in Atlanta, Paris, Washington, and
Stockholm this year. Thank you.

CHAIRMAN WALSH: Thank you. I wonder if you are
willing, may we ask you some questions, so that you can leave,
and we'll save the rest for the others?

I think I'll start myself now, since we have a short
table. And, that is, in using the term "immigration," are you
using permanent immigration or are you using tourists as well,
because we see in our papers from time to time that because of
the high incidence of AIDS in the United States that you are
getting political pressure on that, and that's one question?

66
DR. CLAYTON: I think that's a very good question, sir.
I'd like to respond to it. As far as we are concerned, we are
talking about immigrants only. We have about 100,000 immigrants
who come to Canada each year. Now, those are legal immigrants.
We've, obviously, a number of illegal immigrants, as you do.
Also, there are a number of resident aliens, as you call them
who, of course, are part of that same picture. But, we are
talking about legal immigrants only.

I should say, to put this into context, that while we
have 100,000 legal immigrants a year coming into Canada, we have
68 million border crossings. I think the risk of acquiring
infection by a Canadian tourist to San Francisco or New York City
is probably more significant than detecting an infection in an
immigrant coming from Czechoslovakia or Iceland.

CHAIRMAN WALSH: Right. Well, I wondered, because I
know that in our own work in the foundation which I run, we are
now required in most of the countries in which we work to have
HIV testing done if our teachers are going to stay more than
three months. And, that seems to be a pattern that is
developing, and I wondered about that. But, as I say, with the
extensive exchange between our borders, the pressure has got to
be unbelievable.

DR. CLAYTON: It is quite difficult, and in some cases
you are sending people up to Montreal and Toronto to be tested
before you are letting them back in again.

CHAIRMAN WALSH: That's right.

DR. CLAYTON: This doesn't make it very easy for us
either.

CHAIRMAN WALSH: This is right. Okay. Dr. Lilly,
would you like to ask a question? .

DR. LILLY: I was interested in your analogy of sort of
the domino effect in testing, but, in particular, you seemed to
be on the verge of making a recommendation with respect to that,
and then you seemed to decide better of it. I was wondering if I
could convince you to give us your recommendation.

DR. CLAYTON: Well, it's a little difficult, Dr. Lilly.
It's probably not my business to do so. Canada, like ithe U.S.,
has provincial or state autonomy in health care delivery, and so,
if we are considering testing for people who are going to get
married or going to the hospital, that becomes a state or
provincial responsibility. If we are talking about prisoners or
people coming in from abroad then, that's a federal
responsibility.

67
 

 

I was going to make a recommendation, but instead I
would suggest that, perhaps, an illustration of what can happen
with respect to testing of certain groups, and what this can lead
to would be worthwhile deliberating upon in your reports. It is
the "domino effect" that's so important, and I'm concerned that
we'll eventually end up testing so many subgroups of people with
very low yield, and with so much expense involved. Particularly,
when you consider the number of false positives. For each
single positive test, there must be a follow-up regimen of
repeat and confirmed testing, and that costs money. And, I think
one has to recognize that the expense of testing to low-risk
groups is going to involve an expenditure which would be better
directed in other directions.

DR. LILLY: I couldn't agree more. To me, the cost
effectiveness of testing groups like that is simply non-
existent. The other question I wanted to ask you is, why do you
have so few AIDS cases among intravenous drug users in Canada?

DR. CLAYTON: It might be because it hasn't happened
yet. In other words, the virus hasn't penetrated into the drug
using society. I don't think that's quite the case, because
normally we've been about two years behind the U.S. in virtually
all of our epidemiological patterns, except for this one.

Certainly we have shooting galleries, but we don't
have them to the same extent. We don't have the problem and the
numbers that you have in New York City, for example. Most of our
drug users, are in our three major cities of Toronto, Vancouver
and Montreal, which are relatively small. But, I realize that
doesn't explain it either.

And, we've performed some serological surveys in
methadone clinics and detox centers, and we don't have more than
about a 4 percent seroconversion rate in those groups. So,
the infection is present, but still contained, and extensive
transmission hasn't happened yet. But, why this delay? I don't
know.

CHAIRMAN WALSH: Do you have a question?

MRS. GEBBIE: One quick question.

One of the major areas we've talked a lot about is the
care of those ill with AIDS or with symptomatic HIV disease of
all kinds. And, in many parts of this country it has been a

wrenching problem to provide that care. It's revealed flaws in
our system.

68

 

 
 

 

People comparing this country to Canada frequently
point out that you appear to lack some of those problems because
you have a more organized and comprehensive system of illness
treatment care than we have. You didn't really say much of
anything about that. Are you finding the illness treatment care
of these patients to be a problem? If so, could you just
briefly comment on that?

DR. CLAYTON: We do not have a problem yet. I think
that's likely because with a relatively few number of cases, 700
or so who are still alive, This hasn't had a big impact upon our

health care system.

I think at any given time, there are about 200,000
occupied acute care beds in Canada, and so, another 700 has
little impact as yet on the system. The other thing is, that we
have a Universal Health care System, which you do not have. So,
health care is accessible to everybody, including the indigent,
which many of the patients or people with AIDS especially become.

CHAIRMAN WALSH: All right. If there are no other
questions, we appreciate very much your coming down and talking
to us, and we're sorry that we're going to miss you the rest of

the day.

DR. CLAYTON: Thank you, sir. It's been a pleasure.

CHAIRMAN WALSH: Bye, bye. Thank you.

CHAIRMAN WALSH: All right. Dr. St. John is our next
witness, and he is the Coordinator of Health Situation and Trend
Assessment Programs at PAHO, and every time I call over here to
find anything out about AIDS, they tell me I've got to talk to
him. So, you must be their authority.

DR. ST. JOHN: Thank you, Dr. Walsh.

Mr. Chairman, distinguished members of the Commission,
very briefly this morning I'd like to do three things. First of
all, paint a brief backdrop of the health situation in the
Americas; second, review the AIDS situation; and third, talk to
you a little bit about the regional response to the AIDS
situation.

Just very briefly, the Region of the Americas is
composed of 46 countries and territories in different stages of
development, including two of the most developed countries in the
world, the United States and Canada.

Only one or two, perhaps, three of the countries in the
Americas can be counted among the poorest countries in the world.
Most nations are further along in the developmental spectrum, and

69

 

 
 

some may be classified as in transition between developing and
developed nations. .

In spite of its geographic diversity and extension, the
Region of the Americas has some unique, unifying characteristics.
Of the 655 million people of the Americas, 61 percent live in
Latin America, 260 million in Latin countries share one language,
Spanish, as their official language, and share a common 450-year
old cultural and historical Spanish-American heritage.

This influence reaches the southern borders of four
states of the United States, some of its larger metropolitan
areas and the Commonwealth of Puerto Rico. Portuguese is spoken
by 140 million people in Brazil, the largest county in Latin
America, which borders on all but two of the countries in South
America.

Besides the United States and most of Canada, English
is spoken by 6.5 million people distributed in 18-countries and
territories in the Caribbean Basin. A small proportion of the
total population of the Americas speaks other languages,
principally, French, Creole, Dutch and a host of American
languages.

The important point is that 99 percent of the
population can communicate with each other in just two languages,
a romance language, Portuguese or Spanish, which are quite well
understood between the two, or in English. The overall health
status of the population in the Americas is also marked by
geographical diversity resulting in an epidemiological mosaic of
health problems.

The peoples in Latin America are still affected by a
multitude of infectious diseases, including malaria, dengue,
Chage's Disease, diarrheal disease and multiple respiratory
infections which contribute to high morbidity and mortality in
certain population groups.

At the same time, the population is aging rapidly, and
most countries have surpassed WHO's global life expectancy goals
set for health for all by the year 2000. A consequence has been
the appearance of chronic diseases as major public health
problems.

Finally, massive urbanization has been occurring during
the last 20 years, bringing with it social and environmental
stresses, including severe atmospheric pollution, chemical
contamination of the environment, urban violence and general
breakdown changes of traditional family structure and social
mores.

70
The AIDS epidemic is superimposed on this disease
health profile. Given the ongoing economic crisis throughout
Latin America and the Caribbean, it is now clear that most
economies are not generating enough income to meet current
health needs. Over 700,00 children die each year in the Americas
from preventable illnesses or conditions.

PAHO estimates that approximately 130 million people do
not have regular access to routine health care, and cannot be
reached at the present time by the current moderately well-
developed health infrastructure. By the year 2000, 175 million
more people will be added to the total population. Health care
services will have to reach more than double the number of people
which they cannot reach now.

AIDS is one more economic burden added to the problems
of this Region. It is important to understand that the AIDS
epidemic in the. Americas takes place within this rather unique
social, cultural and economic context.

I'd like to show you a few slides that will illustrate
the epidemiology of AIDS. May I have the first slide, please?
The Panamerican Health Organization initiated region-wide AIDS
surveillance in 1983. Only officially reported cases of full-
blown AIDS have been tabulated.

Surveillance of HIV infection has not been carried out
in a systematic fashion as yet. As in all other regions of the
world, the number of AIDS cases grossly underestimates the
magnitude of the problem. PAHO estimates that between 2 and 2.5
million persons are infected in this region, and that
approximately 500,000 to 750,000 are located in Latin America and
the Caribbean.

This slide reveals that the Andean group of countries,
composed of Bolivia, Colombia, Ecuador, Peru and Venezuela, have
contributed a total of 334 accumulated cases as of February 16th.
The Southern Cone countries, composed of Argentina, Chile,
Paraguay and Uruguay, have contributed 206, while Brazil has
reported a total of 2,458 cases.

This slide reveals that the Central American countries
and Panama have reported a total of 191 cases, while Mexico, at
the time of this slide, had reached 779. The Mexican total, I
know, has surpassed 1,000 by now.

In this slide, the non-Latin Caribbean countries have
reported a total of 753 cases scattered among many different
countries. Some countries should be noted: Bahamas, with 176
cases; Trinidad and Tobago with 227 cases.

71
 

 

North America, composed of Bermuda, Canada and the
U.S.A. has contributed a total of 54,633 cases, with the greatest
majority, of course, coming from the United States. Thus, since
the beginning of surveillance in 1983, a total of 60,867 cases
and 33,209 deaths have been reported. The overall case fatality
rate is approximately 50 percent.

To give you some idea of trend, this slide compares
data from 1986 and '87, and reveals the percentage increase in
the number of reported cases. Although reported cases from North
America increased by just 13 percent, several other subregions
reported dramatic increases, such as: 207 percent from the
Southern Cone; 118 percent from the Central American Isthmus; 139
percent from the Latin Caribbean countries.

Five countries, the United States, Canada, Brazil,
Haiti, Mexico, contribute approximately 97 percent of all the
cases in the region. With the exception of Montserrat and the
British Virgin Islands, evidence of the spread of the AIDS virus
is found in all the countries and territories of the Americas.

Today the world has tracked this epidemic by
monitoring the total number of accumulated cases since 1981 when
the epidemic began. The total number of cases by country is not
particularly useful for making comparisons between countries
because the total does not consider the size of the population
which gives rise to the AIDS cases. Calculating the ratio of
reported cases for a given calendar year to the median
population estimates for that year provides a better method for
comparison. In this slide, we have taken the number of cases
reported for the year 1987 and divided by the mid-year population
estimates to give us cases per million population. This slide
reveals that the Caribbean Region, with 52.6 cases per million
population, is second only to the North America Subregion, which
has 66.6 cases per million population. Yet, even these averages
obscure significant differences between the countries.

These are the same calculations by individual country,
with more than ten reported cases per calendar year. In this
slide, you can see that there were 7.5 cases per million
population in Brazil, and Brazil is near the bottom of this list,
compared to places like the Bahamas, French Guiana and Bermuda,
where the ratios were in the range of 240-400 AIDS cases per
million population.

Indeed, the United States has moved down this list as
the epidemic has spread throughout other countries, and the vast
majority of countries in the first ten are Caribbean countries.

Initially, AIDS cases in Latin America were reported
among male homosexuals and bisexuals with a history of travel
outside Latin America and the Caribbean, mostly to the United

72

 

 
 

 

States. The first cases, many of which had already been
diagnosed in Europe and North America, were found in Mexico,
Colombia, Argentina, Brazil and other Latin American countries
from 1982 to 1985.

This pattern of predominant male sexual transmission
continues in North America and most countries in the southern
part of South America, as well as in the Andean countries. But,
an important difference between the countries in Latin America
and North America is the proportion of bisexual males, which
ranges from 15 to 25 percent of all AIDS cases. Many of them
are married or have stable female partners.

Seroprevalence studies to detect the presence of HIV
antibodies in some groups of homosexual and bisexual men, most of
them volunteers, have disclosed rates shown in this slide. They
range from 8.3 percent in the Dominican Republic, to 37.5
percent in Brazil.

Although this contrasts with the very high risk,
usually above 70 percent, of HIV infection among some homosexual
groups in some areas of the United States, the data may only
indicate a later introduction and dissemination of HIV infection
among homosexual men in Latin America and Caribbean countries.

Thus, HIV prevalence rates in some prospective studies
have gone from below 5 percent to the present rates of 10 to 20
percent in studies conducted in countries such as Argentina and
Uruguay.

The proportion of cases in which heterosexual
transmission of HIV is implicated is still below 10 percent of
all cases in most countries in Latin America. However, in the
Caribbean and parts of Central America, significant numbers of
AIDS cases and HIV infections in women are being detected.

During 1987, 24 cases of AIDS were diagnosed in
Jamaica, but ten of them were women. In 1984, in the Dominican
Republic, none of the cases were women; today, up to 40 percent
of the cases diagnosed are in women.

The prevalence of HIV infection in sexually
transmitted disease clinic patients has not been systematically
evaluated outside of the United States and Canada. Studies in
female prostitutes have shown HIV infection rates from 0 in some
studies in Mexico and Argentina, to a high of 49 percent in one
limited study of prostitutes in Haiti.

In some countries, between 5 and 10 percent of all

cases of AIDS are presumed to be secondary to blood transfusions,
mostly in Costa Rica, Brazil and Jamaica.

73

 

 
HIV antibody prevalence among blood donors is highly
variable, as shown in this slide, ranging from 0 percent in 4,000
donors in Argentina, 0.1 percent in 1,400 samples in Barbados, to
as high as 1.5 percent in the Dominican Republic, and 7.3
percent among some paid blood donors in high-risk areas of Mexico
City.

The contribution of contaminated needles and syringes
to the transmission of the AIDS virus among IV drug abusers
appears to be less significant in Latin America than in the
United States. Less than 1 percent of AIDS cases are believed to
be associated with IV drug abuse in Latin America, as opposed to
17 percent in the United States. May I have the lights,
please?

The cases associated with perinatal transmission in
Latin America and the Caribbean are still few. For example, less
than one fifth of cases in infants and children have been
associated with perinatal transmission in Brazil. In Mexico, 16
percent of cases are current infants of infected mothers.
However, limited studies in Haiti have found prevalences of HIV
infection of 3 to 8 percent in pregnant women.

The majority of cases in children have thus far been
associated with transfusion of blood and blood products, and, in
rare cases, with sexual abuse and child prostitution. In
contrast, more than 75 percent of pediatric cases in the United
States can be traced to a parent with HIV infection or engaged in
one of the high-risk behaviors, principally, IV drug abuse.

What has been the regional response to this
epidemiological situation? The Regional Offices of WHO are fully
participating components of the Global Program on AIDS. For
example, the Panamerican Health Organization, which is WHO's
Regional Office for the Americas, executes the Regional Program
on AIDS in the Americas. The PAHO/WHO program has mobilized a
total of $5.1 million since early 1987 from WHO's non-regular
funding sources for AIDS prevention and control activities in
this Region.

In countries where there has already been
epidemiological and political recognition of the HIV problem, the
PAHO/WHO Regional Program on AIDS provides technical assistance
and financial support for the formulation and execution of
national programs. This work will be strengthened and broadened
to assist other member states already engaged in confronting the
HIV epidemic. f

By June, 1988, all countries and territories in the

Americas will have initiated National AIDS Prevention and Control
Programs. We hope the United States will join as well.

74
An additional $5 million has been obtained for AIDS
research in Latin America and the Caribbean for a special
contract between PAHO and the U.S. National Institutes of Health,
National Institute of Allergy and Infectious Diseases. This
contract emphasizes perinatal and heterosexual transmission
research, as well as studies of the interaction of AIDS infection
with other endemic diseases.

PAHO has been very active in promoting AIDS education
throughout the Region. As Dr. Mann mentioned, PAHO organized
the first Panamerican Teleconference on AIDS, which was broadcast
to over 650 sites in all major countries and territories in the
Western Hemisphere.

For the first time in the history of PAHO and WHO,
approximately 45,000 rank and file health workers participated in
a PAHO/WHO technical scientific meeting by means of this
teleconference. PAHO is currently organizing and seeking funding
for the Second Panamerican AIDS Teleconference, which will take
place in Sao Paulo, Brazil, September 6th, 7th and 8th of this
year. With WHO's assistance, PAHO has established two AIDS
Information/Education Exchange Centers to act as resources in
support of national educational strategies, and we hope to
establish three more.

In this Region, the AIDS problem has been approached in
a manner which will permit the accomplishment of as much as
possible, as quickly as possible. Certain protocols and certain
procedures have been bypassed and eliminated. Given the urgency
of the HIV pandemic, PAHO believes that countries cannot follow
traditional "business as usual" approaches. PAHO and WHO have
made a commitment to its Member Countries in this Region and they
in turn are now committing themselves to confronting this
unprecedented epidemic. Thank you very much.

CHAIRMAN WALSH: Our next witness will be Dr. Jaime
Sepulveda, from Mexico. He is the Director General of
Epidemiology at the Ministry of Health. Doctor?

DR. SEPULVEDA: Thank you. Mr. Chairman,
distinguished members of the Presidential Commission. I shall
divide my presentation in two parts. First, referring to the
magnitude of the AIDS problem in Mexico, and second, referring to
the social and public organized response to the problem.

The first case of AIDS in Mexico was diagnosed in 1983
in a foreigner, who had onset of symptoms two years earlier.
That means, our epidemic is a young one, relatively. Since then,
1,233 cases have been reported to the Ministry of Health. The
incidence rate is exponential, with a doubling time of 7.5 months
from 1985 to the present. That means, the velocity of growth is
twice as large as in the U.S.A. almost.

75
 

 

Estimates of the number of AIDS cases indicate that
more than 20,000 new cases will occur in 1991 solely, with more
than 35,000 accumulated cases by that year. While the first
cases reported were associated with foreign contacts, since 1985
the spread can be attributed to endogenous transmission. Each of
Mexico's 32 States has reported at least two cases; most,
slightly over 50 percent of the cases, are concentrated in the
three largest metropolitan areas: Mexico City (37 percent),
Guadalajara (14 percent), and Monterrey (6 percent). Young
adults between 25 and 44 years of age account for 70 percent of
the cases. Of the 47 cases in children, ten are associated to
perinatal transmission. This proportion of pediatric cases is
three times the rate found in the United States. Eighty two
cases have occurred in women; thus, the male to female ratio is
14:1, essentially, similar as in this country. The risk groups
include homosexual and bisexual males (80 percent) ;
heterosexuals, (7 percent); recipients of blood transfusions (7
percent); hemophiliacs (3 percent); children through perinatal
transmission (1 percent); homosexuals who are also drug abusers
(1 percent); and, IV drug users only (0.4 percent). The
proportion of transfusion associated cases doubles that of the
United States. ‘

The trends observed have shown the largest growth in
cases associated with heterosexual and perinatal transmission.
At the present moment, AIDS cases are occurring in people from
every socio-economical stratum and are beginning to appear in
rural areas. The growth rate in women has increased
significantly in recent months.

Serological surveys conducted across this country in
different sub-population groups have yielded the following
results: homo and bisexual males with a prevalence between 1 and
33 percent, according to the geographical area; seroprevalence in
male prostitutes ranges between 2 and 16 percent; female
prostitutes show a low prevalence of 1 percent; hemophiliacs,
between 28 and 67 percent; prisoners, between 0.5 and 1 percent;
military recruits, 0.5 percent. Paid blood donors, when they
existed, had a high prevalence of 7 percent before the ban of
blood commerce, which occurred in Mexico last year, while
voluntary donors had only 0.1 percent.

The response. The Ministry of Health designed a
National Committee for the Prevention of AIDS (CONASIDA) that
started working in February, 1986, responsible for the
elaboration of national policies and programs. Epidemiological
surveillance in Mexico is now based, by Federal Law, in mandatory
notification of AIDS cases and HIV infected people. Sixty five
screening labs have been implemented, including~a National
Reference Laboratory for confirmation of positive results and
supervision of laboratory performance. Our national blood supply

76

 

 
is now considered to be safe, due to mandatory screening of this
tissue, since 1986. As mentioned above, following the discovery
of such high seroprevalence rates among paid blood donors, a law
was passed by Congress banning this trade.

There is a central, confidential registry of cases
which serves as data base for this monthly epidemiological
bulletin, published since early 1987. All seroepidemiological
surveys have been designed and conducted by CONASIDA, and I'm
sort of proud to announce that the first strictly representative
survey on a national scale will be completed very soon in Mexico
with over 80,000 sera collected and tested, and results will be
presented in Stockholm this coming June.

Surveys of knowledge, attitudes and practices about
AIDS have been undertaken in five different population sub-groups
in six large cities. The results show an increasing knowledge
about condoms as a preventive measure for AIDS. However, few
people incorporate knowledge into practice.

The educational campaign has been directed to groups
with high risk practices, health practices, and the general
public. Materials produced include flyers, posters,
audiovisuals, radio and television spots, one of which I hope I
will be able to present here soon. A National Information Center
was created in Mexico City, with others following in several
States. The main services provided by these centers are free
confidential testing, counselling, and a hotline that attends
several hundred calls a day.

A mass-media campaign for the prevention of HIV
transmission, with the participation of greater sectors of the
society, including actors, and that's the TV spot that I want to
present to you if that is technically feasible, and other well-
known personalities, was recently launched.

Finally, a Regional Documentation Center was created,
with support from WHO and PAHO, to concentrate, organize and
disseminate information regarding AIDS to serve Mexico and other
Spanish-speaking countries.

I want to gratefully acknowledge economic support for
our program from WHO, PAHO, USAID, the Population Council, NIH,
and above all, the Mexican Government. I wonder if we can
technically present this spot now. Otherwise, I will leave it as
part of my testimony. It seems like the latter will have to
occur.

CHAIRMAN WALSH: Well, why don't we, while they are
waiting, have they got it? Oh, good. All right. If they've got
it, we'll show it.

77
DR. SEPULVEDA: This is a very famous and popular
actress, number one in popularity in Mexico, and she's going to
give this contribution.

(Whereupon, TV spot shown.)
DR. SEPULVEDA: Could we have the lights back?

CHAIRMAN WALSH: We'll be able to look at it at another
time, okay, because we'd like to see it. I've seen a lot of them
from different countries, and many of the countries are well
ahead of us in this type of education, and it's important that we
learn from them.

CHAIRMAN WALSH: Our next speaker is Dr. Jean Pape,
from the Department of International Medicine, Cornell University
Medical School in New York.Dr. Pape?

DR. PAPE: Thank you. Mr. Chairman, distinguished
members of the Commission, as a native Haitian, and a staff
member of Cornell University Medical College, I've been working
in my home country for the past eight years. So, I hope to give
you first-hand information on what goes on there. I am also a
member of the National Commission on AIDS, and if the Commission
has not done as much as it should have, I'd be very happy to tell
you why.

If I could have the first slide, please. (Table 1).
The first case of AIDS was diagnosed in Haiti in June of 1979.
From June of 1979 to 1981, less than about one case a month was
diagnosed at the Cornell Medical Clinic in Port-Au-Prince. I
must tell you that this clinic, supported by NIH funds, sees
about 80 percent of all the AIDS cases diagnosed in Haiti, with a
staff of four physicians, including myself, we care for over
6,000 infected patients, AIDS patients, and their spouses and
children.

From 1982 to 1983, you can see already a dramatic
increase to about four cases a month, and for the last four
years, an eight-fold increase to 30 cases a month.

Now, one of the most significant changes that has
occurred is the change in residence in patients with AIDS. (Table
2). You can still see that the capital city of Port~-Au-Prince
has about 70 percent of all the cases diagnosed from 1984 to
1987. However, in the last three years, there has been a three-
fold increase in the number of cases diagnosed outside Port-Au-
Prince, from 11 percent to 30 percent.

However, the most significant change that has occurred
is a change in the sexual pattern of transmission. (Table 3).
I'd like to focus your attention on 1983. Remember that the

78

 
 

first case was diagnosed in 1979. In 1983, 50 percent of all the
AIDS cases were in homo and bisexuals. Actually, if you were to
do these factors according to-sex, 65 percent of all the male
AIDS cases would have been in that category. 23 percent of cases
had received a blood transfusion in the previous five years.
Intravenous drug abusers are few: about 1 percent.

The second point I'd like to focus your attention on is
that already in 1983, 26 percent of cases had either documented
heterosexual transmission or highly suspected heterosexual
transmission.

Now, from 1983 to the present, we've seen a change of
transmission patterns from those that are seen in the U.S. to
those that resemble what is found in Central Africa. Indeed, you
can see a rapid drop in the number of the percentage of patients
with homo or bisexual behaviors, from 50 percent in 1983, 27
percent in 1984, to 1 percent in 1987.

On the other hand, you can see a marked increase in the
percent of patients with either documented heterosexual
transmission from 5 percent to 15 percent, or highly suspected
heterosexual transmission from 21 percent to 73 percent.

Now, if one were to look at what had happened in Haiti,
one could have predicted what is happening now in many other
Caribbean countries. Look at Trinidad, for example. (Table 4).
The first case was diagnosed in 1983, and for the first two years
of the epidemic, 1983 and 1984, all cases were essentially in
homo and bisexual men. From 1985 on, there is a rapid shift in
sexual transmission pattern of the HIV infection. You can see
that the homo or bisexual group has decreased to 40 percent in
1987. On the other hand, patients with documented heterosexual
transmission have increased from 10 percent to 36 percent, and
those with probable heterosexual transmission from 2 to 22
percent, to the point that in 1987 heterosexual transmission is
really the major pattern of transmission of this disease in that
country.

As to be expected in Haiti, there has been doubling in
the number of women with the infection. (Table 5). Indeed, from
1979 to 1982, 15 percent of all cases were in women, 27 percent

in 1983-1985, and 30 percent in 1986-1987. So, we are not quite
yet in the same situation as Central Africa, but I think we are
getting there.

Similarly, in Trinidad and Tobago, in 1983 and 1984 all
the 27 cases diagnosed were in males, essentially, male homo or
bisexuals, and in the two years that followed, 1985 to 1987, 15
percent of all the cases occurred in women. (Table 6). In
summary, (Table 7} HIV infection and disease are of recent onset

79

 

 
in the Caribbean. Homo and bisexuality is no longer the major
risk factor for acquiring AIDS. Within a five-year period,
heterosexual transmission has become the major mode of HIV
spread. These findings have serious implications for countries
where other modes of transmission are still predominant. Thank

you.

DR. LEE: Nice to see you again. We'll wait for the
rest of the Commissioners to get up here. We can start with the
questions. Dr. Crenshaw?

DR. CRENSHAW: Dr. Pape, one of the things that I
thought was really compelling about your slides and your
conclusion is that you documented rather rapid progression into
the heterosexual community. But, interestingly, by contrast to
what people believe here, that it's mediated entirely through
drug abuse. The drug mediated heterosexual transmission seemed
relatively small. Am I interpreting your data correctly?

DR. PAPE: That's quite correct. Actually, except for
Bermuda, all countries in the Caribbeans have a very low
incidence of drug abuse as being a risk factor for acquiring
AIDS. For both Haiti and Trinidad and Tobago, it's about 1
percent of our patients who are intravenous drug abusers.
So, actually, the disease has shifted rapidly, but it is not due
to this group.

DR. CRENSHAW: Dr. Sepulveda, I wanted to compliment
you very, very emphatically on what you described having done in
Mexico, particularly, your seroprevalence study, which I think
you are to be commended for. And, I also want to say that given
the additional handicaps of a primarily Catholic society to have
gotten as far as you have in as brief a time. It really puts us
to shame in some ways here in the United States.

I just wanted to thank you. I didn't have any specific
questions, unless you'd like to comment on some of the things,
perhaps, the obstacles and the solutions to how you managed to
make this degree of progress. I'm not meaning to suggest your
problem is solved. I know it's not.

DR. SEPULVEDA: Thank you very much for your nice
comments. Perhaps, I should only say that indeed the Mexican
society, is a conservative one, and we are facing problems in our
public health campaign, particularly, relating to the advocacy of
condoms as a preventive barrier, a mechanical barrier for
preventing sexually transmitted diseases, such as AIDS. But, I
think slowly but steadily we'll get along.

80
DR. CRENSHAW: And then, my last question, which any or
all of you might wish to answer, is that I heard from most of you
that the pictures you are seeing are very limited by our focus on
the disease AIDS, and gives us, if you'll excuse my
interpretation of your words, backward look of, perhaps, five to
ten years when we are dealing with AIDS cases. And, this is the
common theme that we hear from many, many of our witnesses.

On the other hand, from many of those same witnesses,
we hear an enormous amount of reluctance to testing or moving
beyond AIDS to get a more accurate picture, perhaps, because of
the political issues and pressures. Could you comment on how we
can get out of this dilemma, learn more about a current picture
in various countries, in spite of the problems and obstacles in
the way?

And, if I may simplify it by saying, hypothetically, I
know the finances are a big issue, but if we could, for a moment,
hypothetically eliminate the cost factors, which I know isn't
practical. What would you do if it weren't for the money? What
would you like to see done?

DR. PAPE: Well, I must tell you that because of time I
did not go into seroprevalence studies, but we have tested over
30,000 healthy people throughout the country, and the
seroprevalence rate is between 0 and 10 percent for healthy
adults in Port-Au-Prince.

It varies according to age, obviously. It is higher in
the sexually active age group. According to socio-economic
status, from 2 percent for higher socio~economic groups, to 13
percent in the lower socio-economic groups.

It also varies according to sexual activity. Dr. St.
John mentioned 49 percent in our prostitutes, repeated studies in
1987 and 1988 showed 69 percent seropositivity in our
prostitutes. So, this is increasing tremendously in this
population group.

It also varies according to state of illness. Patients
with tuberculosis, for instance, in hospitals have had a
seropositivity rate of 40 percent to the point that we believe

that we do not really need an AIDS hospital in Haiti, because the
sanitoria that care for TB patients are already, whether they
want it or not, AIDS hospitals.

For the rural areas, the situation is much different,

and seroprevalence rates are much lower, and it varies from 1 to
3 percent.

81
DR. CRENSHAW: Thank you.
CHAIRMAN WALSH: Yes?

DR. ST. JOHN: I'd like to also respond, and it's
always a delight for an epidemiologist to be told that resources
are no constraint. There are lots of things we'd like to do if
resources were no constraint.

You might be interested to know that there is one
country in this Region that has opted for massive screening as
one of the cornerstones for their AIDS program, and that is Cuba.
Cuba has screened over 1.6 million of its total 10 million
population. They have screened -- they have effectively
screened, in the last two to two and a half years, 25 percent of
their sexually active population, for mixed reasons, which are
too long to go into here. We are not sure how much the cost has
been.

There are two aspects of massive screening that I think
are important to try to separate. One is the need for
epidemiological information. For epidemiologists, anonymous
screening of large segments of the population has a lot of
appeal.

There is another perspective, though, and that has to
do with what you are going to do with the information once you
get it? If you are capable of screening a large mass of a
population, what are you going to do with all those people that
you might find to be truly positive or falsely positive?

In Cuba, for a variety of reasons, including the extent
of their health care delivery system, they are taking -- they
have taken measures, they have activities planned for all the
ones that have been detected positive, and it adds to 174 people.
If we were to test 230 million people in this country, we'd have
quite a few more, and what would we do with them, and how much
would it cost?

Thus, when you move out the of purely epidemiological
realm into the cost benefit realm, and you throw in a few
economists to argue with you, it looks like, and I think WHO
feels this way as well, I do, that on the whole the balance is
against massive screening at the present time.

82
MRS. GEBBIE: We started to hear a little bit of an
answer to this, but I'd like some more discussion. While this
Hemisphere may be more developed than some of what we heard
about from Africa this morning, certainly I hear continually
about problems with the basic structure of providing health
services in many of the countries that we're discussing in this
panel now.

What is the potential impact of AIDS on that basic
provision of services to all citizens? What are the things that
are being struggled with in various countries, either as examples
or comprehensively, what needs to be done in that regard? I
address it to any of you.

DR. ST. JOHN: The potential impact throughout the
Americas, especially Latin America and the Caribbean, is also
large. The economic consequences of 500,000 to 750,000 infected
persons, and we ‘know, as Dr. Mann said, the stage is set for
what will happen there.

In Rio de Janeiro right now, it costs between to
$200.00 to $300.00 a day to take care of an AIDS patient, and the
average stay is between 12 and 30 days. So, it could conceivably
cost a patient at the maximum about $9,000.00 for each hospital
stay.

A secretary's salary in Rio is $200.00 a month. There
is no way that that's going to be able to be met by the system as
it is currently constructed. Large wrenching changes would have
to take place to accommodate the foreseen burden of AIDS.

I'd like to stress also that unlike the United States
situation, the endemic diseases that are prevalent in other
populations are different. In Brazil, and in many countries in
Latin America, tuberculosis is a common disease of children, so
that large proportions of the population are infected with
tuberculosis, held in check by their immune systems.

When you take that away, we find that, for example, in
Brazil about 17 percent of all the new cases of AIDS present as
tuberculosis. Well, that means you have a patient that now can
transmit two infectious diseases at the same time, AIDS and
tuberculosis. Hence, we think the impact on the really
significant progress made in tuberculosis control in Latin
America is really threatened by the AIDS situation.

So, the impacts are multiple. How far, how extensive

they will be will depend on what course the epidemic takes and
what we can do about it.

83
DR. SEPULVEDA: I agree completely with Dr. Ron St.
John. I want to say that even though economists say there is no
such a thing as new monies, it helps in part in Mexico.

So far, we have been able to get additional funding on
top of that originally assigned to the Ministry of Health,
dedicated to the combat against AIDS, but I do not know how far
we'll be able to sustain that.

MRS. GEBBIE: My other question is, really, the same
one I asked Dr. Mann this morning. From the point of view of
the Americas, what are the two or three things that this country
should do, either internally as a model, or as catching up with
the other countries in the Americas, about AIDS that we should
get on and do right now?

DR. ST. JOHN: I'd give a regional perspective, and
then I would ask Jaime to please give, and Jean, could give a
national perspective.

There is no question that the United States often sets
the tone and is the model. Unfortunately, in this Region at
least, we've had to say to countries time after time, don't look
at the United States model as a whole. There are individual
cities, there are individual states that have developed active
AIDS programs, and we frequently cite San Francisco, parts of the
Miami program, parts of the New York City program as models for
Latin American colleagues to look at and be aware of.

But, in developing their own National AIDS Programs, we
are often in a position of saying, no, don't look to the United
States for that model. You've got to strike out on your own, or
you've got to follow the WHO guidelines, but you are going to
have to develop your model because there is, in my opinion, a
lack of leadership in the AIDS situation in this country.

MRS. GEBBIE: So, straightening that out, in your view,
would be one of the most important things we could do. Thank
you.

DR. SEPULVEDA: Well, I really hesitate to give
recommendations to other countries. But, if that is the case,
and if you insist, I think most of the good things that need to
be done are being done in this country.

To me, the most efficient of all preventive measures,
in terms of cost benefit, is making the blood supply safe, and
that was done long ago in this country. So, that's the easiest
to achieve of all control measures.

84
I would like to see more research done, and as I see
the research agenda in this country, I do not see enough research
done in social issues and in sexual behavior, and I think that is
a must. If we are contending with a sexually transmitted
disease, a lot more sexual research needs to be done.
hat's one comment.

DR. PAPE: I certainly agree with what was said here.
I think Haiti confronts a particular problem in view of the fact
that you really have to understand that this country has been
traumatized by a number of things. The first thing that has
traumatized my country is the fact that the scientific world said
that Haiti was the origin of AIDS. We all know that this is not
correct, but this is not something that you can easily change.
It's still in the mind of: people, it is still in the mind of
health officials.

I've been a non-salaried health advisor to the Minister
of Health, and I can tell you at many points in time they were
very unhappy to report about AIDS cases, essentially, because
they felt that this was going to damage the country. They said,
well, other countries are not reporting about this.

The second thing, obviously, that has hurt us a lot, as
you know, is the tragic political situation we've lived in the
past two years. And, certainly, this had made the effort of the
National Commission very difficult.

However, there are some things that have been
accomplished. I think that the blood supply is now safe, and the
reason why it's safe, it is only because there is a limited
amount of blood donors. But, it is still safe, so that's one
important thing.

What I think that can be done mostly for us is really
this type of research that was just talked about, and also, some
kind of more generalized support for the National Commission.

As an example, we are kind of limited in what we can
do. For instance, we tell people they should use condoms, but
with the USAID aid that has been cut, as you know, there are no
condoms to be found in the country. So, everybody is striving
for condoms but they are no where to be found. So, how can we
have an ad on TV asking people to use condoms if they cannot find
it.

So, you see, it's a very complex problem that will be
resolved somenow when the generalized political situation is
improved. MRS. GEBBIE: Thank you.

CHAIRMAN WALSH: Dr. SerVaas?

85
er

DR. SerVAAS: I'm interested in what you have to say
about tuberculosis in Brazil and in Haiti, and could you, from
Mexico, tell us about how serious is the tuberculosis problem
there with AIDS?

DR. SEPULVEDA: I will be happy to do so.
Tuberculosis has been an endemic problem in Mexico for many
years. Now, AIDS is revealing, in some age groups, in urban
areas, an increased rate in TB, and we are finding that many of
those TB cases in young adults are associated with HIV infection.

And, that's one of the most common opportunistic
infections found in patients, TB.

DR. Se€rVAAS: Are drugs very effective with AIDS
patients, the traditional drugs for tuberculosis? Do they keep
it in check, or is it hard to control with --

DR. SEPULVEDA: It is possible to get over an acute
case of pulmonary TB, but it is, of course, much harder in the
long run to keep that person alive.

DR. ST. JOHN: If I could just add a comment there,
Dr. Walsh. I think that anybody with. AIDS who comes down with
acute pulmonary tuberculosis has got to-look at life-long
maintenance tuberculosis therapy. You don't cure TB unless
you have some help from the immune systen.

DR. SEPULVEDA: That's right.

DR. SerVAAS: Now, in Haiti, you use your sanitaria for
those patients?

DR. PAPE: Well, we use a number of facilities. I
must tell you that 50 percent of all the AIDS cases that we see
have associated tuberculosis.

In addition, 18 percent of people who are HIV infected,
but who do not have any other infection, also have tuberculosis.

We have been able to control tuberculosis somehow in
those patients with the drugs, but we have a tremendous burden of
putting on isoniazid prophylaxis all HIV infected individuals
which is a very large sector of our population.

CHAIRMAN WALSH: Dr. Primm?

DR. PRIMM: Dr. Pape, we see a number of young Haitian
males in New York who are positive for the virus, or who have
full-blown AIDS, or one episode or two of opportunistic
infection, and they completely deny homosexuality. They might

86
say that they might have had an experience, and that experience
is generally for survival rather than for the homosexual act

itself.

And, many Haitians do, indeed, deny that homosexuality
exists among their population. I'm wondering about the
interpretation of homosexual behavior when someone does it
primarily for survival. In other words, $10.00 for a sexual act
in Haiti is quite common, both for men and women, and yet, these
people are heterosexual in terms of their orientation.

Is that now still going on, and what is the incidence
and prevalence of homosexuality in Haiti now as you see it? I
noticed that you made no mention of what's happening in terms of
sexually transmitted diseases among that population. I'd like to
hear you comment on that.

The same with you, Dr. Sepulveda, in terms of Mexico.
DR. PAPE: Thank you for this question.

As you probably know, homosexuality is taboo in Haiti,
and when I got back there in 1980, I barely knew anybody who
would say that they were homosexual.

And, the reason is simple. Our patients are primarily
bisexual. When you ask them what is their sexual preference, |
they say it is for women, and one of the reasons why our women
got infected so early, we believe, is because actually those
bisexual men had many more contact with women and many more
contact with prostitutes than they actually did with men. Anda,
those are what we call commercial homosexuals, who do it for the
money, and very often their wife does not know anything about
this.

Now, in those people, we have found there is a very
significant percentage of sexually transmitted diseases, namely,
gonorrhea and syphilis. But, I must say to answer the last
point, is that percent of people who presently have AIDS and who
are bisexual have dropped tremendously.

DR. PRIMM: Well, has HIV infection, and, of course,
AIDS in Haiti caused a lessening of the kind of behavior that we
saw among the "beach boys" that led to what might have been the
spread into the heterosexual population.

DR. PAPE: Yes, I think that's quite correct.

DR. PRIMM: It has had an effect.

87
DR. PAPE: Yes.
DR. PRIMM: Significant?
DR. PAPE: I think so.

DR. SEPULVEDA: Well, you are asking about incidence and
prevalence of homosexuality, and I don't think myself or any
person can give you a good estimate of that in any country. But,
estimates vary from 5 to 15 percent of young adults, male young
adults.

What is a matter of concern to us is that there are,
particularly at the border, at the Rio Grande border, an
increasing number of male prostitutes. We see a lot of
Americans coming down and asking for male prostitution, and we
are seeing prevalence rates in male prostitutes are much, much
higher than in female prostitutes. In some places, they are as
high as 15 percent.

So, that is a matter of concern. I think it has to do
more with prostitution than with homosexuality prevalence.

DR. PRIMM: I just remarked knowing that none of your
data really reflected very much homosexual/bisexual contribution
to the numbers that you presented. And, I know that it exists.

Thank you very much.

CHAIRMAN WALSH: Dr. Lee?

DR. LEE: Dr. St. John, tell us what are the Cuban
results? Do you know what their incidence was in their 1.6
million people?

DR. ST. JOHN: Yes. They've detected a total 174
seropositive persons as of February. That includes asymptomatic
persons, people with ARC and people with AIDS. They have 27
cases of AIDS among those 174 people detected.

DR. LEEs 174 out of 1.6 million?

DR. ST. JOHN: Yes.

DR. LEE: I'm interested, in going back to some of the
population questions from the African panel, Dr. Bongaarts gave
us some very interesting curves and projections.

Now, in Dr. Mann's paper he talked about the pattern
one and pattern two, the U.S. versus the African.

88
Now, Dr. Pape shows us that we have some countries
that are going pattern two, that we're pattern one. In my
conversations with some of the African panel, they thought this
would not happen.

What do you think? Is pattern one a weigh station on
the way to pattern two, or are they going to remain separate?

DR. ST. JOHN: Well, in the Americas, fairly rapidly
the same kind of epidemiological mosaic applied to AIDS. It is
not a pure situation.

In North America, the pattern continues to be dominated
by homosexual/bisexual transmission and IV drug abuse.

In the far south of South America, in Argentina, Chile,
Uruguay, it remains a homosexual/bisexual male pattern.

But, throughout the Caribbean and now in parts of
Central America, we've seen the same rapid shift that Dr. Pape
has described in Haiti, and Trinidad and Tobago is occurring in a
variety of countries. So that, for the Caribbean as a whole,
the male/female ratio is less than 6 to 1.

And, in some countries in Central America, it is 2 to
1, and that's been a very rapid change over the last two to three

years.

I think that in some societies, for a host of reasons,
we are going to see the disease spread in that way, into the
heterosexual community.

DR. LEE: Dr. Bongaarts showed us a curve of leveling
off in Africa at 25 percent, do you have any ideas of where it
might level off in this hemisphere?

DR. ST. JOHN: No, I don't. It will level off. Not
everybody is susceptible, but it will level off at different
places in different countries for a whole host of variables, many
of which we don't understand.

We have avoided, up to now, making projections,
official projections for individual countries or for the region
as a whole.

In this region, because we don't think we know the
mathematical model that we could correctly apply, it is not right
to take the 50 to 100 multiplier effect used in this country and
apply it to other societies and cultures.

89
 

 

And, most mathematical models that have been developed
and published so far still do not have the basic information on
the critical variables, and people are still guessing at the
critical variables, and so, we have avoided creating an alarmist
environment, which often happens when you make unfounded
projections. I don't know where it will level off.

DR. LEE: You don't know where it will level off, but I
take it from this panel that you all think that pattern one is a
weigh station on the way to pattern two, and it will happen in
this country, in this hemisphere?

DR. ST. JOHN: In this hemisphere, yes, it already is
happening.

DR. SEPULVEDA: I will just add that, for instance, in
the very short span of one year, from March, 1987 to March, 1988,
the proportion of cases associated with homosexual men changed
from 72 percent to 57 percent. That's a very dramatic change in
such a short span. While, the heterosexual transmission changed
from 22.5 percent one year ago to 7.4 percent nowadays. So,
there is definitely a trend towards heterosexual transmission.

DR. LEE: Bill, can I just ask him one more? Do you
have any idea why we haven't seen it yet in this country?

DR. PAPE: Well, there may be a number of reasons.
The first one is why we are seeing it in the Caribbean. The
first one is that we are dealing mostly, as Dr. St. John
mentioned earlier, primarily with a bisexual population, many
more bisexuals than strictly homosexuals.

The second point will have to do with the fact that
prostitution is legal in a number of countries in those areas.
And, the third part is that free sex and polygamy is also
acceptable in many areas in the Caribbean Islands.

So, I think that those reasons may explain partly why
we are seeing more cases in the heterosexual population. In
addition, we have the fact that the blood system has not been
safe, particularly for women, since they were the one to get the
blood transfusions during obstetrical procedures. But,
on the other hand, you have a major problem here in this country
with IV drug abuse, which we do not have.

DR. ST. JOHN: When I talked to my colleagues at CDC, I
asked them that same question, and that's when I hear the smell
of burning rubber, their brains. I don't know that anyone
really knows why it hasn't happened. There are many, many things
you could speculate about, you know, based on everything from the
magnitude of the problem of poverty in different societies, the
level of education, sexual behaviors, there is just a host of

90

 

 
variables that we don't understand really. I've wondered it
myself.

DR. LEE: Thank you very much.
CHAIRMAN WALSH: Do you have a question, Dr. Lilly?

DR. LILLY: A small question. Is there a correlation
between the level of repression of open homosexuality within a
country, and the tendency for AIDS to become a heterosexual
disease in that country.

DR. ST. JOHN: It's clear to us that there are in
Latin American societies, which tend to be more conservative,
tremendous pressures on a males to conform to a heterosexual life

style.

And, I think many men who might in a different society
openly declare themselves as homosexual and pursue a homosexual
life style, that many of these men do marry under tremendous
social pressure and they do have children, and then their
behavior falls in a wide range, either as predominantly
homosexual with heterosexual intercourse with their wife for
purposes of procreation only, to the opposite, which is mostly
heterosexual behavior with an occasional homosexual encounter.

What is clear is that the bisexual male bridge is much,
much broader than it is in this country. As I mentioned in my
testimony, 20 to 25 percent of the male gay associated AIDS is
bisexual, and that is a major avenue for introduction, and
probably an even better avenue in terms of magnitude than IV drug
abuse for introducing the disease into the heterosexual
community.

If you then add to that social conditions, such as in
lower socio-economic classes where a free union marriage is more
common than a formal marriage, and for economic reasons these
unions tend to come and go. And so, there isn't maybe a lot of
promiscuity at one time, but there is serial polygamy, if you
will, going on. I mean there are many factors that would help to
foster heterosexual spread of AIDS.

DR. SEPULVEDA: I agree with that. The proportion of
the AIDS cases associated with bisexuality in Mexico has
remained rather constant, 20 to 25 percent over time.

We just completed a study, of those people attending
the National Information Center, one third who were infected with
HIV were married. So, bisexuality is a much more common practice
than pure homosexuality in Mexico.

91
CHAIRMAN WALSH: All right. Thank you very, very much.

We'll take a break, and we will reconvene at 2:15. We
are almost back on schedule.

(Whereupon, the hearing was recessed at 1:42 p.m., to
reconvene at 2:15 p.m., this same day.)

A-F-T-E-R-N-0~O-N S-E-S-S-I-O-N

CHAIRMAN WALSH: I think that we could agree that we
had a most interesting and informative morning, and I know,
speaking for the Commissioners, that we learned a great deal and
have got ample food for thought.

I believe, too, that this afternoon will provide us
with an equally interesting program.

RESPONSE TO THE PANDEMIC: FRANCE

CHAIRMAN WALSH: I have a special privilege really in
introducing our first speaker, whom I have come to know over the
past couple of years as a very good friend, as a man who is a
problem solver and a leader, and who does things just naturally
well. Alain Pompidou is the Technical Counselor for Health at
the Ministry of Health and the Family in France, and I have
participated with him in not only many meetings but also in many
other matters.

We touched just a little bit, for example, on bilateral
assistance this morning, and I was very impressed when I was last
in Paris to find how the government of France was already well to
the forefront of attempting to help many countries in the Third
World, while at the same time devoting attention to solving the
problems of AIDS in their own country, and actually. providing
leadership for a good part of Western Europe.

We all used to refer to Alain Pompidou in France as
"Mr. SIDA," which is really a compliment, and I know that I'm
looking forward to hearing what you have to say and want you to
share your thoughts with all of us. Thank you.

PROFESSOR POMPIDOU: Thank you, Mr. Chairman. Mr.
Chairman, distinguished members of the Commission, I must say
that it's a real pleasure and a great honor for me to testify in
front of the Presidential Commission for AIDS of the United
States. I hope that I will be helpful, and I am worthy to
answer as far as my responsibilities can allow me to all your
questions.

92
We have now, in France, 3,073 cases, and in a few weeks
we'll have 3,500 cases accumulated since '81. That means we have
about 2,500 AIDS patients already in care in the hospitals, which
breaks down to 55 per million inhabitants. France is, therefore,
the most severely affected by this new viral infection among
European countries.

The predictions are announcing 10,000 to 15,000 AIDS
cases at the end of '89; but, it is necessary to underline that
during the next four to five years, the tremendous increase of
AIDS cases will mask the decrease in the progression of
contamination which is already being observed.

This decrease is observed actually among the
homosexual community as has been observed on the West Coast of
the United States, and also, the contamination through
heterosexual contact is now stabilized in France, as is proven by
the stabilization of contamination of at-risk pregnant women in
France, and the stabilization of transmission through
heterosexual contact.

Nevertheless, the fact that AIDS is a real challenge
for the public health in France, engaged the French government
and especially Prime Minister, Mr. Jacques Chirac, and Michele
Barzach, Minister of Health and Family to settle a coordination
structure and a strong national program on AIDS as early as
January of '87. The coordinating organization represents two
major components.

First, a National Committee of Reflection, whose
function is to advise the Minister of the important decisions to
be taken in the fight against AIDS. Its members include
scientists, specialists in ethics, education, communication and
leisures as well as representatives of insurance companies and
the clergy.

On the other hand, reporting directly to the Minister
of Health, the National Coordinator is responsible for the
following:

- Ensuring the complimentarity of the work carried
out by the different Ministries with administerial
responsibility;

- Coordinating international research and
cooperation;

- Establishing ties with private associations and

organizations, like NGO's, foundations and industrial
groups;

93
The aim of the French National AIDS Program is based
upon two main assertions.

First, public health must be protected. Second,
patients and human beings must be respected. And, it seems to be
a kind of autonomy between these two aspects, an exclusivity
between these two aspects. But, the assessment of these two
major principles could not seem realistic regarding its
application to an infectious disease.

Nevertheless, this challenge is made possible by two
reasons. The first, and the more important one, is that AIDS is
an avoidable disease. AIDS is not plague, AIDS is not cholera,
AIDS is avoidable. And also, a cure is not impossible to find.

These two points induce the major components of the
AIDS program for France. Prevention, including information,
education and screening; research and care facilities; and,
international cooperation.

Prevention and research are the only means we have
today to limit the progression of this avoidable but deadly new
viral disease.

The National Prevention Campaign is composed of two
large measures. A National Information Program based upon
sensitization of the whole population using all media, videos and
leaflets. A program of educators formation (for face to face
information). And, the priority for AIDS will be the formation
of an outlet for information, so that you have a dialogue basis
information system.

Besides these two large measures, we have set up two
immediate measures. One is the authorization of advertising of
condoms and organization of quality control. We have observed
last November that 15 to 20 percent of the condoms were not
viable, and we have organized the control of quality for the
condom all over the country.

And, I must say that it was easy to do that since we
were not producing these materials. Second control measure is
the syringes sale in drug stores without prescription or identity
control.

The aim of these measures is to avoid contamination by
sexual contacts and contaminated blood from IV drug users. This
does not modify the determination of the French government to
struggle and to fight against IV drug users, but it is absolutely
necessary after this intoxication not to have contamination by
this virus by those people who are addicted and intoxicated.

94
The third measure, besides the first two large
measures, the two immediate measures, is that no mandatory
screening was organized in France. Of course, mandatory testing
is only performed for blood donors and organs, blood for tissue
donors or cell donors.

Why do we have no mandatory systematic screening? For
four different reasons: the first one is that it would have a
poor efficiency in areas which are limitedly involved by the
infection, and we know in France, because of the mandatory
declaration of AIDS cases, that 84 percent of the cases are
located in five provinces among 20 in France. That means,
essentially, Paris, and around Paris, and the south of France.

The second reason is the false security because
contamination can occur right after a screening test. The

third reason is that a mandatory systematic screening would be an
incitation to clandestinity for high-risk groups. And, we saw
that already for the testing for syphilis.

And, the last reason is that this measure would not be
an incitation to responsibility. The evaluation of this set of
measures is now the following, within one year ~ - Condom sales
have increased by 38 to 40 percent;

And, we know now from a new study, which has been polled in the
Paris area, that 12 percent of the 900 people who we asked the
question, which are sexually active people, use condoms, and that
is within the past six months. So, it's a new phenomenon, and we
went from 5 percent to 12 percent using condoms actually in the
Parisian area.

~ The second evaluation is that the syringe sales
have increased by three times in the more exposed
quarters of the largest towns.

~ The access to voluntary testing independently
from testing for blood donors was multiplied by three.
In '86, we have realized 800,000 voluntary tests, in
'87, 2,400,000 voluntary tests.

And, what is interesting also in terms of the epidemiological
data is that in Normandy, for instance, there was an exponential
increase in the demand for voluntary testing, but there was a
very low increase in seropositive patients.

- The fourth measure is large access to HIV
screening.

100 centers for free and anonymous screening are now set up, as
of the 18 of April, we have 100 centers, free and anonymous,

95
 

 

working all over the country, one for each department, and
sometimes two in large towns, two or three in large towns.

In these centers, prescriptions and positive results
are given only by physicians. And, the person tested does not
have to give his identity and has nothing to pay.

More than that, we have 300 counselors in hospitals all
over the country, who are able to take care of seropositive
people, people who want to know about their seropositivity.

All physicians, of course, are allowed to prescribe
screening tests, which is reimbursed by the Social Security
system, and the positive ELISA test is systematically controlled
by Western Blot, and two ELISA tests are systematically performed
in the laboratory before control by Western Blot.

The confidentiality of the testing is guaranteed by an
absolute respect of the medical secret. When to propose the HIV
testing? During key periods of life, and Mr. Barzach has
written a letter to the doctors all over the country, which is
being received now by all the physicians, which says that the
tests must be proposed but not prescribed. The differentiation
is that if it is proposed it can be avoided, it can be refused.
If it is refused, the physician has the opportunity to sensitize
a person who has refused, and to bring this person to acceptance,
but this person can still refuse it.

And, this must be proposed during key periods of life,
during prenuptial examination, during hospitalization for
patients in such departments as surgery, gynecology and
explorations. And, the testing must be proposed, as I said, and
all the results given to informed individuals.

It must be proposed during prenatal examination, but
not systematically. Testing must be proposed if any doubt
regarding contamination based upon questioning of the patient
exists.

Also, couples desiring to procreate must be proposed to
be tested as well if there is any doubt regarding contamination.
And, France is more faithful in a targeted and correctly
prescribed testing program, than in the blindly systematic
mandatory screening.

Following the recommendation of WHO and European
Council, systematic screening of foreigners has been refused by
all health and foreign office ministers of European communities.

And, an information campaign of international travelers
will begin within the next week, within the next few weeks, with
information leaflets, which are the same message as WHO has

96

 

 
proposed. This program is based upon sensitization and
responsibility. It will support public health in the respect of
patients and of human personality.

The prescription of HIV testing is something, the
consequence of which cannot be neglected. If the seropositivity
is not accepted by the tested person and by the population as
well, the responsibility will not occur leading to quarantines.

We must not speak anymore about groups at risk, but we
must speak about at-risk behavior, because everybody, whatever is
his own strengths, whatever is his own capacity to resist, may be
confronted by at-risk behavior, during which he must protect
himself. After testing, the only way to determine changes in
behavior from individuals and population is to organize medical
care, and research developments without forgetting the global
aspect of the pandemic.

Now, we speak about research and care facilities. Care
facilities are organized mostly within 22 pilot centers, 6 in
Paris, 14 all around the country, and 2 in Antilles and Guyana.
In these centers, patients are not quarantined but spread out in
all the different departments regarding their own
symptomatology. Out patients are monitored in day care units and
laboratory facilities are increased in immunology and in virology
units.

The pilot center is the main point of a network
including the regional hospitals. The pilot centers are
themselves coordinated with the other pilot centers all around
the country in order to evaluate, first, the costs, and also to
allow multicentric technical and theoretical studies.

Research is under the responsibility of the Minister
for Research and Universities. A specific program has been set
up for basic and clinical research, for treatment and vaccines,
as well as for the screening tests.

‘More than 50 different teams are working specifically
on AIDS, on socio-economical aspects as well as on laboratory
research, and 100 clinical departments are involved in hospitals.
In terms of international cooperation, it is a necessity to take
care of the global aspect of AIDS. As you know, a special
settlement has been signed between the Pasteur Institute and NIH
for research. A French-American Foundation has been created,
part of the money of which will help to promote the struggle in
the Third World.

An evaluation of the impact of the French National

Campaign will be held in collaboration with the United States of
America, and especially with Project Hope. An agreement has

97
 

 

been set up between France and Germany, as well as Great Britain,
for AIDS research.

France participated in the European Community Program
on AIDS, and is strongly supporting the WHO's Global Program on
AIDS. Yet again, as regards the fight against AIDS, we have
tried to plan for the future and to act. I would briefly remind
you of the measures which have been adopted.

1. Mandatory declaration of confirmed AIDS cases.

2. The launching of an information and sensitization
campaign aimed at the medical and auxiliary medical professions
and at the public as a whole.

3. The setting up of the 22 HIV centers for care with
improved means as regards personnel and equipment.

4. The National Reference Laboratory for HIV detection
reagents.

5. The authorization to market AZT, which, while not
curative, has proven to be efficient in the treatment of AIDS.

6. The authorization to advertise condoms and the
authorization, valid for one year, to sell syringes.

7. Organization of wide access to voluntary testing,
especially in 100 free and anonymous testing centers.

And finally, a large-scale training and information
program for social workers which has been started.

A total of more than 200 million U.S. dollars will be
spent in '88 on AIDS research, prevention and care.

In France, we have the firm intention of respecting a
certain number of fundamental principles.

Firstly, the desire to protect public health while
respecting the dignity of the patient and, in more general terms,
human beings. That is, for us, an invisible principle and the
honor of civilized societies which requires that they guarantee
it under all circumstances.

Secondly, that AIDS is a disease and not some nightmare
from the Dark Ages or a product of the subconscious. As with any
disease, it must be fought by strictly respecting medical
deontology and by protecting the link between the patient and his
doctor. Thirdly, that AIDS must on no account be used as a
political ploy. The fight against AIDS will demand both time and
continuity. To overcome it, we must act. A coherent overall

98

 

 
 

 

strategy is needed, but not sterile conflicts. Fourthly, the
absolute necessity to foresee, to plan for and to make reasoned
choices.

We must also begin now to plan for the material and
medical means which will be required to cope with the increase of
the number of infected people in the years to come. Our fifth
principle concerns the deliberate choice made by the French
authorities to inform people without creating a panic reaction,
to make them aware without being patronizing and especially to
encourage the individual to assume responsibility for his own
actions.

The results already obtained, such as the
modifications in the behavior of homosexuals and the increase of
the use of condoms, clearly demonstrates that the road taken,
though not the most spectacular, has been effective. This
French program is balanced, taking account not only of
prevention, health care and research, but also of socio-
economical and cultural aspects. Y

Confronting AIDS and at-risk behaviors is necessary to
remember that to be informed does not mean knowing, that to know
does not mean deciding, and that to decide does not mean to act.

Approaching such a problem, it is necessary to be fast
but not to hurry up too much in order to avoid irreversible or
inadequate decisions. It is necessary to take account of all of
the consequences of the decisions before they are adopted.

And to conclude, as said recently, Jonathan Mann,
Director of the Global Program on AIDS, "Confronting AIDS
necessitates to be stronger than fear and moreover to fear
quarantine or discrimination," in order that each country could
find the proper way to live with AIDS. Thank you.

CHAIRMAN WALSH: Thank you very much, Professor
Pompidou. We will start out questioning at this time on the
right with Dr. Conway-Welch.

DR. CONWAY-WELCH Thank you, Dr. Walsh.
Mr. Pompidou, in describing your voluntary testing measures,
could you speak for a moment on whether or not your country
requires people to sign a document saying that they have been
counseled? In our country, in some places, for medical/legal
protection, patients, while they can be confidentially and
anonymously tested, have to sign a piece of paper saying that
they have received counseling.

Now, some sign Mickey Mouse, or Donald Duck, or Santa
Claus to the piece of paper, but it's one of the vagaries that we
are encountering in my State of Tennessee, and I wondered if any

99

 

 
of the regions in your country had that legal problem. The
other question I wondered if you could talk about a bit would be
contact tracing, or need to know by the spouse or significant
other of the person who is identified as carrying the virus.

PROFESSOR POMPIDOU: Thank you very much. The first
thing is that the person who wants to be tested does not have to
sign a paper. There is different cases. If a person is going to
the free and anonymous center, he has a number, and there is
another question between this number and the results which will
be given from the blood sample. And, we know from these centers
how many have been tested, how many people are positive, but we
don't know the name of these people.

The second thing is that, what we plan to do, and what
is done in some hospitals, but not yet a proposal from the
Minister of Health, is that if somebody refused to be tested, he
has to fill out a form and sign why, and to say that he refused
to be tested. But, no, that is not a directive of the Ministry,
that is practiced by some hospitals or clinics. But, I mean,
it's not necessary.

But, what is absolutely necessary, is that nobody
should be tested without knowing it, and nobody should be tested
without being given the results of the test. But, of course,
there is no way to say that somebody has been tested, and because
he can show that, and say I've been tested, I'm negative, he can
be contaminated a few hours later. That's the first point.

In terms of tracing partners, is that your question?
In terms of tracing partners, I must tell you two things. The
first thing, I was in Japan three works ago, and I was impressed
by the proposal from the Liberal Party, which said,
approximately, the doctor should not say anything about
seropositivity to the family, to the employers and to the people
all around this person, but, to the police, which is very
interesting. This, though, has not been voted yet. That's the
first thing.

The second thing is that a physician in France has the
obligation to find the contact after syphilis contamination.
Prenuptial tests, syphilis tests, VD tests, and that is done
regularly.

But, when somebody has been contaminated by syphilis
and goes to the physician, the physician has to, this is a law,
has to find the contact and to treat the contact. And, this is
not anymore used since 30 years, and that is complex and
unsuccessful. And, that is one of the reasons why we decided not
to try to find contact, because this would not work. This
doesn't work for syphilis, this would not work more for HIV
infection.

100
DR. CONWAY-WELCH May I ask one quick question? What
would your rationale be for not requiring mandatory testing for
patients going into surgery?

PROFESSOR POMPIDOU: Because we have tested 20,000
pregnant women, and the rate to refuse for testing is less than 1
percent. So, we think that on the first approach, it's much more
necessary to have 99 percent of the people, of the women tested
in case of surgery, to accept the test.

DR. CONWAY-WELCH As voluntary.

PROFESSOR POMPIDOU: And, if they accept the test, they
will accept the training, and they will accept, perhaps, they
will more accept to change their behavior than others.

DR. CONWAY-WELCH Thank you.
CHAIRMAN WALSH: Dr. Lilly?

DR. LILLY: Just a couple more details on the question
of mandatory testing. We have mandatory testing in this country
in some areas, including in the field of immigration and in
federal prisons and in some state prisons, and I'm just
wondering why you do not have those in France.

PROFESSOR POMPIDOU: Yes. For immigration, we have no
testing -- no mandatory testing.

DR. LILLY: Yes.

PROFESSOR POMPIDOU: That is true if there is no
symptoms. If there is presence of symptoms, the program is
different, because at that time testing is proposed.

DR. LILLY: Yes.

PROFESSOR POMPIDOU: But, even if somebody is
seropositive and knows he's seropositive, he will not be rejected
from coming into the country, but he will have special
educational program which are now set up in universities, for
instance.

So, we have not quarantined, of course, and we have not
put out people from other countries which are seropositive.
That's the first point. Of course, for international travelers
there is no testing, but information. And then, what I must
tell you, which is very important, is that at the European level
there are more than 10,000 educators, among which 92 percent are
from European origin, so there are only eight percent from

101
 

foreign countries all over Europe. In terms of prisons, there
was a commission which was in charge, and I was working as a
professor as a coordinator.

So, the recommendation was at three levels. The first
level is that, 90 percent of the people found seropositive in
prison were seropositive before arriving in prison, and so were
not contaminated in prison, the first point.

And now there is three levels. First, any prisoner can
ask for testing on a voluntary basis, and this will be done, you
know, there are rapid turnovers in prison of prisoners, but
within three months this will be done.

The second thing is that if somebody is seropositive,
presents symptoms, it will be mandatory, not in the hospital, but
there will be blood -- some persons will go to the private
centers to be tested.

If a prisoner is ill, as soon as the prison infirmary
can take care of him, he will stay at the infirmary. The point
is to have not too much movement of the prisoner from the
hospital to the prison.

But, when he has some opportunistic infection, for
instance, he will be brought to the hospital. If he is close to
dying, I mean, some months to die, there will be opportunity to
ask presidential grace, presidential pardon if the person is a
prisoner asking, because some of the prisoners prefer to die in
the prison and not to have problem outside of the prison. So,
these are the three points, and there is special settlement
between Ministry of Justice and Ministry of Health to take care
of these patients in prison.

DR. LILLY: One further question. I think I
understood you to say that in France you have legalized the
buying and possession of needles and syringes, is that true, and
has it resulted in an increase in intravenous drug use?

PROFESSOR POMPIDOU: What we know is that, first, this
was done for one year, and this will be renewed next May, but the
evaluation we have is an increase in the consumption of syringes
in the registers of large towns. In the registers of towns less
than 100,000 inhabitants, the drug users were put out by the
people in the drug store. But, in drug store where --

DR. LILLY: I'm sorry, I didn't understand. What
happens?

PROFESSOR POMPIDOU: In towns less than 100,000
inhabitants --

102
DR. LILLY: Yes.

PROFESSOR POMPIDOU: -- when an IV drug user is asking
to buy syringe --

DR. LILLY: Yes.

PROFESSOR POMPIDOU: -- the pharmacist, doesn't want to
sell the syringes. In large towns, and in the districts more
exposed to the large towns, the pharmacists sell the syringes,
and there is a three-time increase in the sale of syringes.

We'll have more data next May, but to my knowledge
there is no increase in drug abuse in France, and also, people
who want to be detoxified will go to the detoxification system.
Less and less are contaminated.

DR. LILLY: Thank you.
CHAIRMAN WALSH: Dr. Crenshaw?

DR. CRENSHAW: You were mentioning the policies on
contact notification, and indicating that basically you didn't
feel that was effective or working. What is the law in France
pertaining to someone who is married? Is the husband or wife,
the spouse, informed if their partner is infected, and, in
particular, what if the patient doesn't wish to have the partner
notified, how do you handle that?

PROFESSOR POMPIDOU: Okay. In France, the medical
secret is absolute, and the only person who can authorize the
doctor not to be bound by the medical secret is the patient
himself. So, the program is inappropriate when the man or the
woman is contaminated.

So, the law is that the medical secret should be kept
and the physician should not turn to the person who is not
contaminated that the other one is contaminated. And, this can
go to court if the doctor says that.

Nevertheless, we think that it is the role of the
doctor to sensitize the contaminated person, or to allow the
doctor or physician to tell to the others, or to the sexual
partner, or to sensitize the contaminated person to tell the
sexual partner himself.

And, we always say that one part of the role of the
physician, besides diagnosis and treatment, is to sensitize and
care for the person, and to sensitize the person and to reassure
the anxious person. So, I think this is the role of the
physician, and it's a problem of case by case treatment.

103
DR. CRENSHAW: Thank you. Also here in the United
States, in some of our states, a physician is forbidden to tell
another physician that they are both treating a patient who is
infected without that patient's written consent. So, in some
cases, all the records go to another treating physician without
the blood tests. Is there a parallel in France, or is it
handled differently?

PROFESSOR POMPIDOU: No. In France, as I told you, the
medical secret is absolute, but all the physicians can share the
medical secret, And, for instance, the physician for the
insurance company can share this medical secret, but we have to
ask what we call the Order of the Physicians, the Order of the
Doctor, this is a special committee, you know, which is a
national committee, who is looking at the behavior of all the
doctors.

And so, Order of the Physicians has to remember the
physician of the insurance company, that it can share any kind of
diagnosis only with the patients or with other physicians, but
not with the company, of course.

DR. CRENSHAW: Thank you.
CHAIRMAN WALSH: Ms Gebbie?

MRS. GEBBIE: I thought I heard you indicate that all
of the counseling in your counseling sites was done by
physicians. If so, that's quite different from our pattern here,

in which a variety of trained counselors are used, depending on
the site. Would you clarify that for me?

PROFESSOR POMPIDOU: Thank you. We have different
levels of counseling. The more frequent counseling is when
somebody asks the physician to be tested, and when you go back to
the physician, and the physician counsels regarding positive test
results.

So, there are two attitudes. The physician must say
the diagnosis, but if the physician is not strong enough, is not
aware enough how to present the diagnosis of seropositivity, he
can say, he can ask the patient or the person to go to see
another physician who is trained to do that. That's the first
point.

The second point is that it is a free and anonymous
center, and if the result is negative, a non-physician, a medical
worker, or a worker, will speak about the problem, and with
concern because if somebody came to the center it is perhaps
because he is at risk or he has a chance to be contaminated. So,
there will be a discussion between a worker and this person.

104
If the diagnosis is seropositivity, so there is a
doctor who will take the time, at least half an hour, to explain
everything, and he will ask this patient to go and consult, get a
specialized consultation of the hospital, because, as you know,
during the first announcement of the diagnosis the patient is
there but is not listening to anything. So, you have to be twice
or three times trained about that.

And, the last aspect of counseling, we are
association, like for San Francisco, it's an association, we're
private and available association, which can do counseling for
people who want to have more information about AIDS and about
contamination and prevention and so on.

So, we have these three different counselings, the
doctor, the physician, the family physician, the doctor in the
center, free and anonymous, and workers, and we have now
information, 2,000 workers for this kind of counseling for
spreading out all facts. And, the last is the association, and
many of us, we can get counseling about information.

MRS. GEBBIE: Thank you very much.
CHAIRMAN WALSH: Dr. Lee?

DR. LEE: Monsieur Pompidou what happens, first of all,
if the doctor does tell the consort? Is the doctor liable for
criminal prosecution?

PROFESSOR POMPIDOU: Is the doctor what?

DR. LEE: If the doctor notifies the sexual contact, is
he criminally liable?

PROFESSOR POMPIDOU: Yes. You mean, if the doctor
notifies the sexual contact administration or to an enterprise?

DR. LEE: No, if X is positive --
PROFESSOR POMPIDOU: Yes.

DR. LEE: and the doctor tells X's wife, is the doctor
criminally liable for a crime in your country?

PROFESSOR POMPIDOU: It will not go to the courts, but
he will be erased from the list of doctors by the National Order
of the Doctors.

DR. LEE: Is that correct?

PROFESSOR POMPIDOU: That's absolutely true. The
Physician Order is very powerful. Every physician has to be

105
 

 

inscribed in the Physician Order, and if a doctor, without
authorization of the patient, tells the spouse, tells the
mistress, or tells somebody else that this person is
seropositive, he will be erased from the Order of the Doctors,
and he will not be allowed to practice anymore.

DR. LEE: Now, let me pose a question, a theoretical
question. The definition of assault would be abuse upon the body
of someone else. Now, isn't this assault, I mean, in this
country the lawyers are starting to think of this in terms of a
charge of aggravated assault.

PROFESSOR POMPIDOU: Yes.
DR. LEE: Now, in France, why is this not assault?

PROFESSOR POMPIDOU: You mean, if somebody is
contaminating somebody else knowing it?

DR. LEE: Yes.

PROFESSOR POMPIDOU: So, there is different aspect of
the thing. The first aspect is that it could be considered as
voluntary murder knowing it, and this has to be treated by the
courts.

Actually, the problem is that we decided not to have a
new law about that, but that a person which has been inserted,
whether or not it is contaminated, and, of course, if this person
has been contaminated, this person can appeal to the court. And,
the legislation now could be giving death, willing to give
death, but also we have old legislation which has been used for
toxemia, which has been used ten years ago which is based upon
poisoning, and perhaps, the lawyers are thinking about that now.

And, that's a more appropriate law to advocate the
poisoning law, because first you have to prove the poisoning, and
second, you have to be sure that the person was not willing to be
poisoned.

DR. LEE: That's very French, to put it in terms of
poisoning.

So, currently, it's not a criminal offense. Currently
it is not --

PROFESSOR POMPIDOU: Well, poisoning is a criminal
offense.

DR. LEE: So it is, if you knowingly transmit the
virus, it is a criminal offense in France.

106

 

 
 

 

PROFESSOR POMPIDOU: You have to prove it first. If
you prove that, there is no jurisprudence now. Nobody has
appeared before the court because they have contaminated, so I
cannot tell you what will be the jurisprudence.

I give you some feelings, it's not quite nice, really,
it's feelings, and it is close to giving deaths by wanting to
give it, or to poisoning, but that's all I can tell you. And,
all that will be taken into account only if there is a proof that
there was intent to contaminate, and there is contamination.

As you know, all sexual acts are not contaminating, but
only one is contaminating. Among hemophilidc, after six years of
regular sex for life without protection, oniy 40 persons are
contaminated.

So, it's not because one person had sex, one person
seropositive, have sex with a person seronegative, that this
person would be contaminated. And if this person goes to court
and this person is not contaminated, there is no proof. There is
only proof that there was sex, but no contamination.

DR. LEE: Thank you.

DR. PRIMM: Mr. Pompidou, you have a number of
narcotic addicts in your country, and, apparently, the modality
of treatment of narcotic addicts of methadone maintenance is not
employed on a large scale in France. What are you doing to
take care of those people who need and desire treatment who are
toxicomania in France?

PROFESSOR POMPIDOU: So, for those people, we have a
system which is an administerial commission which has been
created four years ago, which has a special project, and we are
about 15 different places all around France where these people
can be cared, not cured, but cared, in terms of drug abuse.

And, there is also a physician taking care of this
patient when these people are willing to be cared. And
now, there is discussion between the Minister of Justice and the
Minister of Health on how to organize a kind of mandatory care --

DR. PRIMM: Yes, Japonica Junction.

PROFESSOR POMPIDOU: And, also, among the 2,000 as
workers who are being trained for outlets for information. We
have are workers involved in the prevention and care of drug
addicts.

So, we are now reinforcing, what has been taken from
this administerial commission against toxicomania. $1 million

107

 

 
Franc has been given to reinforce the system of care for IV drug
users.

And also, we are setting up for prostitutes and for IV
drug users information -- specific information system with social
workers going to meet these people and to provide them with
special information, giving them the address of the center where
they can go, and giving them also the address of the association
where they can meet and where they can be sensitized to

detoxification.

DR. PRIMM: Community drug treatment centers are in
France?

PROFESSOR POMPIDOU: The evaluation is, we don't have
exact numbers, but the evaluation is about 150,000 drug addicts

in France.

DR. PRIMM: And, you have treatment for 150,000 in
place with those 20 some places that you have designated, and
these are --

PROFESSOR POMPIDOU: No. We have association, we can
speak with half of these people. As you know, half of these
people don't want to have any contact with this association or
with others. But, we have enough associations for half of these
people, and we have about 30,000 places in detoxification
centers.

DR. PRIMM: You had mentioned also that you had a
year's trial program with your needle and syringe exchange
through the pharmacist, and that that year will be up this May.

PROFESSOR POMPIDOU: Yes.

DR. PRIMM: One of the Commissioners had asked a
question, what was the result of that one-year's trial? Do you
have an increase drug abuse, or intravenous drug use, among
those persons? You said in towns over 100,000 people, for
example, the druggists continued to sell needles and syringes to
them, but in towns of under 100,000 people, they were sent away
from the drug stores or the pharmacies. What happens to
those people who are sent away? Do they go into treatment, or do
they just languish in the street?

PROFESSOR POMPIDOU: One year is not enough to builda
successful program. So, these people who have been put out of
the drug store, can go to the hospital, and can also buy syringes
from the hospital. These people also can have syringes from other
people, but what will be more difficult to break is the ritual of
exchanging and passing around the syringes from one to the
others. That is the first thing to do. And, we plan

108
now to have a program on how to bleach the syringes, but I think
it is much better to buy new syringes. They are not expensive.

DR. PRIMM: What is the seroprevalence rate among your
IV drug users? Apparently, you test IV drug users when they come
into the prison system. What has been the prevalence of HIV
infectivity among that group?

PROFESSOR POMPIDOU: That depends upon the area, but I
can tell you that in Marseilles, for instance, where there are
very many users, 80 percent of the drug users are contaminated.

DR. PRIMM: 8?

PROFESSOR POMPIDOU: 80 percent are contaminated. And,
the rate is between 40 and 80 percent contamination among IV drug
users.

DR. PRIMM: Thank you.
CHAIRMAN WALSH: Dr. SerVaas?

DR. SerVAAS: Mr. Pompidou, about counseling, how is
pre-test and post-test counseling done at the blood banks in
Paris? Before and after screening for AIDS, some of our states
have laws requiring pre and post-test counseling for all persons
tested for AIDS, but simultaneously permit no post-test
counseling for those who test negative, and let's the blood banks
contact their AIDS antibody positive persons by letter, by mail.

Do you have laws against letting blood banks notify
positives by letter, and are blood banks permitted not to counsel
their negatives at all in France? And then, I'd like to know
about your TB problem in France, is that also growing among your
AIDS patients?

I have a question on page 4 of your report here, where
you say, "Couples desiring to procreate must be proposed to be
tested if any doubt regarding contamination." What if they
propose not to accept and say, no. What do you do then? Is that
something that you make -- I didn't see anything or hear you say
that you have any pre-marriage license testing in France.

PROFESSOR POMPIDOU: We have no mandatory pre-marriage,
but this will be proposed to all couples who are going to be
married.

DR. SerVAAS: How do you propose that?

109
PROFESSOR POMPIDOU: When the couple is waiting to be
married, the physician must propose them to be tested and explain
to them why, because they are beginning a new life, because they
will be about to procreate and to raise a family, and so the
physician explains to them that it is in their own interest to
be tested altogether, male and the female. That is proposed.

But, if the couple doesn't accept the test, there is no
law which authorizes the physician to do it. But, he
has his own persuasion system. I mean, the pressure is not as
strong as during Mussolini time. But, of course, he may have
discretion, and he may have confidence between the physician and
the patient.

DR. ServVAAS: Do they always see a physician when they
get a marriage license? In our country, we just go to a cierk.
In France, they go to a physician?

PROFESSOR POMPIDOU: Yes. They go to a physician,
because we are doing mandatory testing for syphilis, so they must
go to the physician.

DR. SerVAAS: And then, the physician must propose an
AIDS test.

PROFESSOR POMPIDOU: Yes. The physician must prescribe
syphilis test and propose the HIV test.

DR. SerVAAS: What percent of the couples go along with
the AIDS test in France?

PROFESSOR POMPIDOU: Oh, I mean, this is a new measure,
so I cannot tell you. This is just being done now. So, after
one year I can tell you, but now I cannot.

DR. SerVAAS: TV?

PROFESSOR POMPIDOU: So, about TV, we have spots on TV,
you know, one saying that AIDS will not go through me, to show
responsibility, and then a few months later, AIDS will not go
through us, and this was a couple, and the wife, the young lady
was showing a condom to the young man. But, this TV spot was
well accepted.

DR. SerVAAS: Then the blood banks. What about the
blood banks and counseling?

PROFESSOR POMPIDOU: For the blood banks, we have not
done the testing of blood, but everybody who is giving blood has
to fill a form, and if there is any doubt about at-risk
comportment, the blood is discarded even if it is negative.

110
DR. SerVAAS: How do you notify the person who tests
positive at the blood bank? How are the blood banks going to
handle that?

PROFESSOR POMPIDOU: Yes. When somebody is positive,
he has concern not only that the blood bank should be the first
contact, but that it will be sent to one of the 300 counselors,
because it is necessary that these people see not exactly
specialists, because it is not a specialization, because it
should be the role of any physician, but to see physicians who
are all over in charge and trained, and are accustomed to take
care of seropositive people.

DR. SerVAAS: Thank you.
PROFESSOR POMPIDOU: You are welcome.

CHAIRMAN WALSH: Alain, as always, you have been most
stimulating, and I think that all of the Commissioners welcomed
your candor and your exchange.

Out of courtesy for our long-standing friendship, I
will defer my questions, and also in the interest of time,
because I know you and I will be seeing one another again.

And, I can't thank you enough for making the effort to
come to our country to share your experiences with us, and to
share your suggestions with us. And, we look forward to being in
touch with you in the future. Thank you very much.

PROFESSOR POMPIDOU: Thank you very much.
THE PANDEMIC IN ASIA

CHAIRMAN WALSH: Our next speaker is Captain Michael
Kilpatrick, Medical Corps, United States Navy, who is the
Research Area Manager for Infectious Diseases at the Naval
Medical Research Development Command in Bethesda. And, he is
going to discuss the Pandemic in Asia. Captain, go ahead.

CAPTAIN KILPATRICK: Thank you, Mr. Chairman,
distinguished members of the Commission. It is certainly my
pleasure to be here today as a spokesman for the pandemic of HIV
in Asia. I say "spokesman" because my normal function is to
serve aS a receiver, collector, organizer, interpreter, and then
transmitter of medical data on infectious diseases so that
appropriate medical policy treatment can be established within
the Navy.

Today, the focus is HIV, and the prevalence and
incidence of HIV in specific countries, as we've heard earlier

111
 

 

today several times, is an extremely sensitive area, both
politically, socially and economically. I would like to present
to you an overview of the HIV prevalence and incidence data in
Asia, limited though it is, along with further limitations in the
accuracy, completeness and interpretability of these data. As is
true of HIV data from all parts of the world, we only see small
parts of the population being sampled, and in general the
sampling or evaluation is done at a single point in time. The
disease with which we are concerned today, HIV, is not static in
the world. Terms are still being clarified, testing is

variable, fear continues to be a main adversary. Regional
coordination and cooperation is essential and must be developed.
Education remains our sole weapon.

The data in my report represent the dedication and
scientific excellence of hundreds of medical personnel in Asia
and around the world. The technology transfer, the laboratory
training, political awareness and honesty have really produced
this information database. The focus and future direction of
these efforts will be determined in large part by the conclusions
of this, the Presidential Commission on the Human
Immunodeficiency Virus Epidemic, and similar organizations
throughout the world.

The World Health Organization has taken a major step
forward in deciding to gather, summarize and publish all data on
HIV for member governments in the WHO Western Pacific Region, and
it's from their Virus Information Exchange Newsletter for
Southeast Asia and the Western Pacific that I have drawn the
majority of the data in this report.

Other information was obtained from the First
International Congress on AIDS in Asia and Other Sexually
Transmitted Diseases, which was held in Manila, Philippines in
November, 1987. That Congress was truly an open forum for
discussion and presentation of data.

As we've heard earlier today, the estimate for the
number of cases in the Asia area is 11,000, and I have a
breakdown from the Virus Exchange Newsletter showing cases as of
November of 1987. These cases totaled only 766 at that time.
Australia was the leader with 622, and going down the list,
China with 2, French Polynesia with 1, Hong Kong with 4, India
with 17, Japan with 50, Korea with 1, Macao and Malaysia with 1
each, New Zealand with 54, Philippines with 10, Singapore with 2
and Tonga with 1. You see the numbers are extremely small in all
these areas.

Laboratory confirmation of these cases of AIDS is
presumed on my part because it was not present in the information
published. For Australia and New Zealand, the data along with
this information indicated that the great majority of those who

112

 

 
were positive were male homosexuals or bisexuals. In Japan, the
majority of the AIDS cases were in hemophiliacs. Almost all
other cases reported, as has been present in so many areas of the
world, were said to have been in foreigners who were in the
country and became ill, or who were individuals from the country
who had acquired their disease outside of the home country and
had returned home knowing that they had AIDS.

The next portion of data I'd like to present is the HIV
antibody prevalence data for various countries in the Asian area.
One should not really attempt to compare these prevalence rates
between countries, because there is a wide variability in the
population groups which were sampled, and, perhaps, there was
even some bias in selecting individuals within the subgroups that

were sampled.

It's important to realize that the divisions that were
given or made, perhaps, artificially for the HIV seropositive
individuals fell into either blood donors, hemophiliacs,
homosexuals, bisexuals, female prostitutes and others. Anyone
who did not fit into any of those categories, obviously, would
have to fall into the others, and individuals who belong to more
than one category were not handled in a very clear manner.

I'd like to go through the numbers. Numbers are very
hard to try to present, but I'll try to distill it down to the
real rates and the limitations on the data. In Australia, there
were 17,741 individuals who were seropositive out of 362,000 who
were tested, for a prevalence rate of 48 per thousand. However,
there was no indication of the test that was done for HIV
seropositives, whether this was just an ELISA or whether this was
confirmed with Western Blot, and there was no definition of the
population which was sampled, whether these were hemophiliacs,
male homosexuals or just all comers. That rate of 48 per 1000 is
extremely high. The assumption is that this has to be a very
high-risk group that was sampled.

In Brunei, only two were positive out of nearly 4,000
that were sampled. In China, where the test was shown to be
Western Blot confirmation, only 4 of 6,500 were positive.

Again, in those last two, they didn't give a breakdown as to what
subgroups of people the positives were in, but they were very
small.

In French Polynesia, 29 of some 13,000 were positive,
but all 29 positives were from a group of 945 who were described
to be individuals at risk. In Guam, there were only 4 out of 543
positive, but again, no definition of the population group that
was surveyed.

In Hong Kong, there were 110 of 377,000 that were
seropositive, but 50 of those 110 were hemophiliacs, 55 were in

113
 

 

another group, and there were no prostitutes or homosexuals
sampled in that group. So, again, the data is skewed, and you
cannot compare the prevalence rate in these areas.
a
In India 120 were positive out of 40,000, for a
prevalence rate of 2.9 per thousand. Ninety percent of all those
positives were tn prostitutes.

DR. LEE: What country was that?

—_

CAPTAIN KILPATRICK: That was India.

~

DR. LEE: India.

CAPTAIN KILPATRICK: In Japan, there were 298
seropositives. There was no denominator given as to how many
were tested, and no definition of the population that was
surveyed.

Skipping to New Zealand, there were 256 seropositive,
but again, no denominator as to how many were tested or what
population they were from. In the Philippines, there were 52 who
were seropositive out of 65,000 who were tested. Fourty-seven of
the fifty-two were prostitutes, and no hemophiliacs were tested
in the country.

In the Republic of Korea, there were 11 positive of
some 216,000. Seven of the 11 were prostitutes, three were
identified as overseas workers, with no indication as to where
they had been working overseas.

Singapore, only 14 of 110,000 were positive, and in
Taiwan, 54 of some 77,000 were positive, but the ELISA test was
the confirmatory test. The Western Blot was not used. And, of
those 54, 17 that were positives were from a group of 775
homosexuals and 31 were from a group of 317 hemophiliacs. None
of the some 2,800 prostitutes who were sampled in Taiwan were
positive.

I think the essence of what I would like to put across
to the Commission is that, until there is a standardization of
defining the groups that are sampled, until there is a
determination of the standardization of testing that's done,
prevalence rates, in and of themselves, cannot be used for
comparing one area of the world with another, or even one country
in itself from one time to another.

The last data that I'd like to present to the
Commission are true incidence data of HIV positivity of
prostitutes in the Philippines. Ina project that involved the
Philippine Ministry of Health and the Navy Medical Research Unit
Number Two in Manila, some 3,271 female prostitutes who tested

114

 

 
 

 

negative for HIV in 1986 were tested again one year later Seven
of this group were found to be positive, which is an annual
incidence of 2.1 per 1,000. This is a highly-selective

population.

Education must remain as the principal objective in
dealing with HIV. The scientific community must continue to
become educated on how to perform HIV testing with standardized
methods and quality control. Population groups studied should be
completely categorized with standard descriptors. Incidence
studies must have standardized intervals and must evaluate
specific risk factors. Statistical evaluations need to be done
in a manner which is universally accepted. And again, the media
needs to be educated to understand the complexities inherent in
a seemingly simple statement about HIV rates.

The general population needs to be educated that what
is currently being measured in HIV studies is the humoral
response to the virus; we still don't know the variability of
interval between virus exposure or virus infection and the HIV
antibody production.

As I've listened through the morning, it's become even
more apparent that there are many basic questions that we don't
understand on HIV that need to be answered. Prevalence rates
certainly do give us a static retrospective picture of this
disease. Incidence rates put some motion to that picture but
they, too, are not focused in the present but in the near past.
It's essential that we have research programs which continue to
measure for transmission of this virus. International
cooperation is essential, since our world population is so
mobile. The HIV epidemic, I am certain, will continue to be a
medical, social and political challenge for the years to come.

I would like to state that recommendations from this
Commission will have a major impact on the way the world deals
with the HIV problem. A recommendation for a standard
nomenclature, which is internationally accepted, should be
adopted for describing the populations which are surveyed and any
testing that is done. We can only compare from one area to
another using a standard nomenclature because prevalence and
incidence rates are going to be variable depending upon the
subgroup that's tested. The denominator group is extremely
important.

Some of the currently used groupings that you read in
the literature and have heard described here today are
intravenous drug users, homosexuals, bisexuals, prostitutes,
hemophiliacs, overseas workers, blood donors, people attending
STD clinics. We need to work on making more precise what we mean
by these terms. Certainly, for example, as we heard discussed
earlier today, the definition of a homosexual or a homosexual act

115

 

 
may vary depending upon the cultural overlays that the individual
would have when being questioned for data to go along with the
test.

When we have workers overseas, we need to know which
geographic area they were in, and what were the risk factors
while they were in that geographic area. People who
belong to more than one risk group need to be precisely defined
in the denominator group when we are trying to prepare prevalence
and incidence data.

Without this standard internationally accepted
population subgroup identification system, no comparison can be
made from one region to another, or within any region over a
period of time. Another very critical element is the question of
the type of testing to be done. The technology is exploding in
the world of HIV testing. We are looking for easier to do, more
economical tests, and when seropositive tests are reported, it's
essential that along with that data go the information on the
kind of test that was done, so that comparisons can be made.

If an ELISA is the test for positive HIV results in one
country, and another country uses a Western Blot for its HIV
confirmatory test, those two data cannot be compared directly.
And, it's going to be important that all agencies who assist in
worldwide health care should subscribe to standardized testing
and reporting.

One additional factor here is the quality control that
must be done in all testing, that this should be done in as
internationally standardized a manner as possible, so that we can
be sure that when we are talking quality control, particularly
when we are looking at larger populations to be studied, that we
have good quality control and comparable results, regardless of
which area of the world the report is coming from. This
is all that I have from Asia at this time.

CHAIRMAN WALSH: Thank you. We'll start with you,
Cory.

DR. SerVAAS: Captain, do our civilian travelers or
military personnel have any problems in Asian countries? And, my
other question is, is HTLV-I testing done in Asian countries,
where HTLV-I is more prevalent?

CAPTAIN KILPATRICK: The first question, to date there
has not been any problem, but I just Friday saw a brief message
that the Philippines is going to start requiring HIV results of
people entering who are going to be staying longer than three
months.

116
This may continue to be a problem, and part of
responding to those kinds of questions is really educating about
what HIV tests like this mean. From a military standpoint,
people who are HIV positive do not leave the Continental United
States, so that this should not be a problem from a military
standpoint. I think the State Department is doing a similar kind
of program, since both our organizations have people overseas for
extended periods of time.

On the other question, the HTLV-I, there is no
reporting mechanism for HTLV-I. We know that prevalence rates
are much higher in certain areas of Asia, particularly Japan and
Okinawa. Testing to date has really been on a research,
epidemiological seroprevalence model, and until there are good
quality control standardized tests it's very difficult to say
that there should be testing done in any larger sort of numbers.
The big problem is that the commercially available tests are not
all that sensitive or all that specific.

DR. SerVAAS: You mentioned new things coming in
testing. Do you have any information on tests that are in the
works that we may be expecting soon?

CAPTAIN KILPATRICK: I don't directly. I'm working
with the Army Research and Development Command in the Infectious
Disease area. They are looking at comparing three or four
different kinds of tests, latex agglutination particles for
example, that would be cheaper to do. But, it's going to have to
be measured against our gold standard of the Western Blot.

These newer tests and newer procedures have to be
evaluated against the standard testing. And, that's being done,
not only within the military systems, but I'm sure within private
industry, trying to develop newer tests.

DR. ServVAAS: Thank you.
CHAIRMAN WALSH: Dr. Lee?

DR. LEE: Can we throw out all your statistics? I
can't come to grips with anything you said and think about it and
extrapolate it in any way. Would you agree with that?

CAPTAIN KILPATRICK: I think this is a problem that
we're dealing with, that these statistics have been gathered by |
small groups or organizations for example, a university sponsored
group going into an area, drawing a sampling of blood, giving
limited denominator information, and then reporting their data.

Until we have larger numbers reported through a system
such as the World Health Organization is trying to initiate in

117
 

 

the Asian area, in particular, the numbers are really
meaningless, because they are apples and oranges and no
comparison can be made.

I think when you look at it overall, and you see
prevalence rates of 1 or less per 1,000, it means the disease is
there, it is not in a major epidemic proportion, but you need to
know what the population group being studied is.

DR. LEE: Dr. Roy Widdus is sitting right here
listening to this, and I don't envy hin. They are trying to
make sense on a world basis about what the problem really is.
They estimate 10 million cases, but if you look just
superficially at your figures they could be off by a factor of 10
easily. Anyway, thank you, sir.

CHAIRMAN WALSH: All right. Dr. Welch?

DR. CONWAY-WELCH I wondered if you could expand on the
issue of the prostitutes who are HIV positive in the Philippines,
and the ways that we are responding to that problem?

CAPTAIN KILPATRICK: To date, there have been 44
prostitutes who have been identified as positive for HIV in the
Philippines. None of these individuals are symptomatic, and the
Philippine Ministry of Health has encouraged them to stop
professional prostitution and to look at another form of earning
money.

DR. CONWAY-WELCH Are we assuming responsibility,
though, for the fact that they are HIV positive, given the fact
that they are around our military bases?

CAPTAIN KILPATRICK: Okay. The 44 positives are
prostitutes and, indeed, have been identified near two large
military bases, Air Force and Navy, in the Philippines. There
has, to my best knowledge, been no determination of
responsibility.

DR. CONWAY-WELCH Is there a dichotomy between the
statement that you made about the military not allowing any
military personnel going overseas if they are HIV positive, and
the fact that there seems to be a direct relationship,
geographically at least, between the location of the bases and
the infection of the prostitutes. Would that have to do with
prior to the institution of this requirement?

CAPTAIN KILPATRICK: Obviously, the military testing
began once the epidemic, the disease, was identified as being
present. How many military people were overseas who were HIV
positive is data that I do not have. But, being able to
extrapolate from numbers that are positive and numbers that are

118

 

 
present overseas, that this would be a fairly small number of
individuals.

So, we can say today, having identified that there is
an infection, HIV, that the military is not in a position to be
sending individuals overseas who are positive. As we've heard
earlier today, the test is at one point in time, and an
individual may have been infected and be seronegative for
antibody, and this is one of the problems, one of the limitations
of testing.

The fact that we are not seeing much increase in the
numbers of HIV positive prostitutes in the Philippines, either
around the military bases or in metro Manila, where the major
testing continues to be done, means that, again, as I said
earlier in the testimony, we are looking back at seropositives
today, perhaps being infected as long ago as one or two or
several years ago. There is not hard evidence to say when they
were infected.

The military standpoint is that we are not, as best as
we can do with testing, sending anyone overseas who is
seropositive. For those 44 individuals, it is very difficult to
know for sure where they acquired the infection, because they,
too, are a mobile population.

DR. CONWAY-WELCH You also stated that the State
Department was, to the best of your knowledge, not sending anyone
overseas who was HIV positive. My understanding, which
certainly may be incorrect, was that at least last year that they
were trying to identify places that had access to tertiary
medical care, so that there were still some places abroad that
State Department personnel who were HIV positive could be
assigned. To your knowledge, has that policy changed now?

CAPTAIN KILPATRICK: On the State Department, I really
can't speak to that. When the policy began, whether they had to
modify that, I'm not certain.

DR. CONWAY-WELCH Thank you.
DR. LILLY: I pass.

DR. CRENSHAW: Having been in the Navy myself many
years ago, and treated many sailors, at least at that‘ time I
prescribed a lot of antibiotics for sexually transmitted
diseases, and they were good consumers of prostitutes in local
ports. When we think of the Orient, we think of sexual tourisn,
prostitution, and I have a two-part question relating to sexual
tourism.

119
 

 

One is the concern for the military men who followed
those who may or may not have infected prostitutes in the
Philippines or elsewhere, or military men overseas in the Orient
who frequent prostitutes and then bring home HIV infection that's
endemic to that prostitution population, regardless of how it got
there, to their families stateside.

Are there any studies going on to evaluate the flow of
infection from one direction to another, and what are the
thoughts? I'm sure there is some concern about it.

CAPTAIN KILPATRICK: Yes. There definitely is concern,
and that is why the military is going for the second round of all
force testing, as it is called, in that all military people will
be tested a second time, with the people who are overseas being
the primary focus. They will be tested first.

And, the database will continue to be kept. We'll
continue to monitor people who are at risk. Sexually transmitted
diseases qualify as putting a person at risk, which will be then
followed with a test for HIV.

The limitation, of course, is what is the window
between acquiring the virus and being positive on testing, and
that's what we're hoping to try to narrow down with the second
all force testing, to focus where continued testing needs to be
done, and what defines risk, and what are the risk behaviors
that need to be modified with education?

DR. CRENSHAW: Are equal rules being applied to
officers as well as enlisted personnel? When I was in the Navy,
if an enlisted man got an STD, he was grounded, and an officer
wasn't. I'm wondering if we have gotten more universal in our --

CAPTAIN KILPATRICK: The problem with the STDs policy
is that the action rest with the unit commander as to how to
handle that. From the medical standpoint, the policy is, that
grounding someone puts the symptoms under cover until the liberty
period is over. Medically we are recommending all treatment
should be given, and if an individual is infectious then,
certainly, they should not be allowed the opportunity to spread
that disease, whether it is strep throat or STD.

DR. CRENSHAW: This last question you may not be able
to answer, because it pertains to history and I'd really
appreciate your trying to refer me to someone if it isn't within
your field.

But, it's my understanding from several different areas
where I've heard it, that earlier in the 1900s China did one of

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the best jobs in the world of eradicating sexually transmitted
diseases. This was long before AIDS. Is my impression correct,
or do you know?

CAPTAIN KILPATRICK: Yes. I have heard that, that
sexually transmitted diseases were eliminated, and the
methodology of eliminating them was fairly severe. The people
who were found with sexually transmitted diseases were executed,

and --
DR. CRENSHAW: Forget I asked.

CAPTAIN KILPATRICK: -- that truly did eliminate
sexually transmitted disease.

DR. CRENSHAW: Okay. I don't need to know anymore
about that.

CHAIRMAN WALSH: Thank you very much for your
testimony. I have no questions. My only comment was, I also
served in the Navy, and it's contrary to policy for officers to
get VD.

OTHER MULTILATERAL RESPONSES: THE WORLD BANK AND
THE UNITED NATIONS DEVELOPMENT PROGRAMME

CHAIRMAN WALSH: Our next section of the program is
Other Multilateral Responses. You may recall this morning that
Jonathan Mann mentioned the cooperative relationship they are
attempting to establish with the World Bank and with the United
Nations Development Programme.

So, we are privileged to have representatives of both
of those organizations with us. We have Ann Hamilton, who is the
Director of Population and Human Resources Department, World
Bank, and I see we have a reprise from Dr. Mead Over, who is
here with her, and you are welcome back. And, we also have
Timothy Rothermel, the Director of the Division for Global and
Interregional Programmes, of the United Nations Development
Programme, and he is accompanied by Alan Doss, who is the
Resident Representative in Zaire. So, Ms. Hamilton, you are up
first.

MS. HAMILTON: Thank you very much, Mr. Chairman.
First, let me say a few words about what the World Bank is. It
was established in 1945. It's more formally known as the
International Bank for Reconstruction and Development, or the
IBRD. It is owned by its member governments, of which there are
now 151, with voting power linked through their capital
subscriptions to their relative economic strength. The Bank
obtains its funds by borrowing in the capital markets of Europe,

121

 

 
Japan, the United States and the Middle East. These funds are
then loaned to the governments of developing member countries
which request them, and which present acceptable proposals for
the use of the borrowed funds. In our fiscal year 1987, which
ended last June, the IBRD committed loans totaling $14.2 billion
to finance development projects in 78 member countries. IBRD
loans have a maturity of 15 to 20 years, including a grace period
of three to five years, and an interest rate which is currently
7.72 percent.

The Bank Group also has a "soft loan" window, called
the International Development Association (IDA). IDA is financed
by contributions from the wealthier countries, including the
United States, and lends to the world's poorest countries. The
cutoff point is countries with a per capita income below $790.00
a year. It is administered by the same staff as the IBRD and the
same criteria are used in project selection. In fiscal year
1987, some $3.5 billion were loaned on IDA terms, These terms
are very generous. They provide for a ten-year grace period, a
30-year maturity, and a service charge of 0.75 percent a year.

Most African countries, including those most affected
by AIDS, qualify for IDA terms. Some of the countries in Latin
America that are most affected by AIDS borrow from the World Bank
at IBRD rates.

Turning now to our lending activities, the Bank has
come increasingly to recognize that good health is itself both a
fundamental ingredient and a fundamental goal of the development
process. Investments in reducing the rate of population growth,
in improving nutritional status, and in reducing morbidity and
mortality across the board make a direct contribution to the
well-being of a population. Furthermore, it's apparent that the
prevention or cure of many diseases can release a country's
productive potential for the development process.

World Bank lending for the population, health and
nutrition (PHN) sectors has grown rapidly since it began which
was recently as 1980. Annual lending has more than doubled from
about $100 million a year in the early years of the decade to
about $220 million a year in the last three-year period, and our
projections for the next three-year period suggest that annual
lending will triple by the last years of the decade, to a total
of about $750 million a year. In the African countries south of
the Sahara Desert, which include the countries most affected by
AIDS, annual PHN lending has increased threefold since the early
years of the decade and will rise again threefold by the end of
the decade.

A similar growth has taken place in PHN lending as a
share of World Bank lending. From a very low level at the
beginning of the decade, it doubled during recent years to 1.4

122

 
percent of our total lending, and is projected to more than
double again, attaining over 3 percent in the next few years.
In Africa, PHN lending is already 3 percent of the total and is
projected to rise to almost 5 percent by the end of the decade.

Because the World Bank's goal is overall development,
most of our projects in the health sector are broad, aimed at
reinforcing a country's efforts to combat a wide range of its
disease problems. The World Bank has emphasized strengthening of
the national capability to extend basic preventive and curative
services to the general population of developing countries. At
the same time, in order to help promote the sustainability of
these investments, and reminiscent of some of what was said this
morning, the Bank places considerable emphasis on the
strengthening of the national institutions, which plan, manage,
and finance the health care systems.

Against this background of the Bank's mandate and its
activities in the health sector as a whole, I would like to
describe the place of AIDS control activities in our projects.
The role of World Bank-financed projects in the struggle against
AIDS is conditioned by three facts. First, our terms, even IDA
terms, are more costly than the grant financing which is
currently available from many other donors to finance AIDS
control programs. Second, the typical World Bank loan in the PHN
sectors is large, ranging from an average of $15 million in
Africa, to $35 million in Latin America, and about $55 million in
Asia. Third, because we appraise in depth and reach agreement
with the borrowing country government on virtually all aspects of
a project, including its economic, its financial, its technical,
its managerial and its institutional aspects, the preparation and
negotiation of a World Bank project is time-consuming. It
normally requires 12 to 24 months. Taken together, these facts
suggest that World Bank projects are better at addressing medium
and long-term issues raised by the struggle, against AIDS than at
mounting a fast emergency attack on the progran.

Countries which cannot obtain enough grant financing to
cover the entire cost of their AIDS control programs are the most
likely to request Bank Group financing for this purpose. But, in
these countries, as well as in those where AIDS programs are
fully funded by grants, World Bank projects are designed to
strengthen the total national health care system, within which
AIDS programs must function. Our continuing focus on management
and finance of the entire health system will support the AIDS
prevention programs while simultaneously protecting important
programs targeted at other diseases or population groups.

AIDS components in broader health projects are
currently under discussion in about 20 countries. In most of
these countries, these discussions are in their preliminary
stages. However, projects in two seriously affected countries,

123
Burundi and Brazil, have recently been approved. In Burundi, the
breakdown of financing between the AIDS component and the other
major components is telling. The AIDS component represents about
12 percent of the cost of the Bank-funded project, most of which
is devoted to maternal and child health and health education, and
about 42 percent of the total cost of Burundi's AIDS control
program. In the much larger Brazil project, a $9.3 million AIDS
component is 4 percent of the cost of the project and 8.5 percent
of the cost of Brazil's AIDS program.

Finally, I'd like to conclude by stressing that the
World Bank strongly supports WHO's leadership role in the global
struggle against AIDS, which Dr. Mann so eloquently described
this morning. Since the inception of WHO's program, the Bank
staff have cooperated actively to ensure the coordination of
Bank-financed operations with GPA-supported national AIDS plans.
The Bank has also supported GPA directly, by participating in its
analysis of the economic and demographic impact of AIDS, which
Dr. Over described this morning.

I'm hopeful that our budgetary situation, which is
currently under active discussion within the Bank, will permit us
to continue and expand our collaborative efforts with WHO.
Whatever our budgetary situation, however, we in the Bank who are
associated with the health sector remain committed to vigorous
collaboration with GPA, with UNDP, and with other donors,
including prominently the U.S. Agency for International
Development, in assisting the less developed countries in their
struggle against this new threat to their prospects for
development. Thank you very much.

CHAIRMAN WALSH: Thank you. Mr. Rothermel?

MR. ROTHERMEL: Thank you very much, Mr. Chairman, and
I thank you and the members of the Commission for giving my
colleague, Alan Doss, the United Nations Development Programme
Resident Representative in Zaire, and me the opportunity to
appear before you today.

Working as we do in an international development
institution, your attention to the international aspects of AIDS
in developing countries is especially welcomed.

Since the United Nations Development Programme, or
UNDP, may not be a well-known institution to all members of the
Commission, I'll briefly describe what we da. As the world's
largest voluntarily funded international grant technical
cooperation organization, now with a budget of over $1 billion
annually, UNDP operates in all developing countries and
territories. It has 112 field offices, headed by Resident
Representatives.

124
In the countries we serve, UNDP has the responsibility
of providing interdisciplinary assistance to governments in
planning and helping to achieve their overall development
priorities.

The implications of the global spread of AIDS have been
outlined by several other speakers today. It is clear that AIDS
is a social, economic and political issue, just as much as a
medical and scientific one. Its consequences already have become
a special concern for virtually all developing and developed
countries, and with the likelihood of five to ten-fold increases
in the number of AIDS cases in some countries within five years,
there are serious development implications.

We face the sobering prospect that in some of the
poorest developing countries, based on present HIV infection
levels, the death rate from AIDS among young or middle-aged
adults could equal or exceed the number of deaths from all other
causes by the early 1990s. And, excluding the increasing number
of children who will succumb to AIDS, the deaths of these men and
women will generally be in the 20 to 40-year old age group, thus
depriving countries already desperately lacking in human
resources of their most productive citizens. In all likelihood,
this group will include many of those who have the most to
contribute to their country's development.

Added to this is the yet undetermined but obviously
enormous future cost of health care for governments, which
already face severe health constraints. These costs will include
not only the provision of direct care to AIDS victims, but the
related costs of counseling, blood screening, medical supplies
and training. Taken together, these costs can be expected to
exceed by far current health expenditures in many countries,
resulting in an enormous drain of financial resources.

Finally, and on top of the diversion of human and
financial resources due to AIDS, the poorest in the world will
face indirect economic costs through lost years of production.
The result for developing countries can be a declining GNP, the
need to rethink development priorities, and the deferral or
elimination of vitally needed development programs.

The United Nations system has, in my judgment,
responded remarkably quickly with WHO leadership to meet the
challenge presented by AIDS, especially in developing countries.
The U.N. system is working together with bilateral and other
development organizations, including, particularly, the United
States Agency for International Development, to achieve two
overriding objectives for AIDS prevention and control.

125
They are, first, the development and implementation of
strong national AIDS prevention and control programs, since the
responsibility for national AIDS programs rests with governments.
The second objective is international leadership, coordination
and cooperation. The WHO Global Programme on AIDS is the lead
directing and coordinating organization in combatting AIDS.

In other parts of the United Nations system,
international organizations in their respective fields of
competence are complementing WHO's leadership role.

UNICEF is bringing its expertise to bear on the tragedy of AIDS
in mothers and children, and is undertaking several programs of
health education for AIDS, four of which are already underway in
Africa.

The U.N. Population Fund is involved with the
interaction between AIDS and family planning programs. And,
UNESCO is assisting in the design of AIDS education in formal and
non-formal educational systems.

Ms. Hamilton has just spoken about the important work
carried out by the World Bank. Less than three weeks ago, the
Director General of the World Health Organization and the
Administrator of UNDP formally announced a unique joint agreement
called the WHO-UNDP Alliance to Combat AIDS. Under this
agreement, UNDP's Resident Representatives, in the 112 field
offices I mentioned earlier, will bring together UNDP's
experience in multi-sectoral, socio-economic development, with
the health policy technical and scientific expertise of WHO to
support governments of developing countries in initiating,
implementing, monitoring and evaluating national AIDS prevention
and control plans.

UNDP will also be involved in seeking to ensure that
all inputs from the United Nations system are coordinated, and
that these AIDS plans are integrated into countries! overall
national development priorities. In developing countries, UNDP
and WHO officials have already begun to operate within this new
relationship with positive results, which Mr. Doss will be
describing.

I should add that UNDP at the country level is also
providing financing for a variety of AIDS-related activities,
amounting to several million dollars, covering education and
training activities, blood screening equipment and other forms of
technical assistance within the primary health care context.

At the international level, the UNDP Governing Council,

two months ago, approved a global program entitled, the Global
Blood Safety Initiative. The intent of this endeavor is to set

126
urgently in motion the steps required to make blood supplies safe
throughout the world in order to stem the spread of AIDS and

other diseases.

Specifically, UNDP is providing seed money,
$700,000.00 in this case, to establish a consortium of
organizations beginning with the World Health Organization, the
Red Cross and Red Crescent Societies, the International Society
of Blood Transfusion and UNDP, to be joined next month by an
expanded number of national and international organizations.

Working together with governments, this consortium will
seek to ensure that blood supply systems are fully sustainable,
and that comprehensive safe blood banks and transfusion
mechanisms are in place in every country.

If successful, in a few years the spread of diseases
through this mode of transmission, such as hepatitis-B and
malaria, as well as HIV, can be substantially reduced. The
Administrator of UNDP, Mr. William H. Draper, III, clearly, and
at an early stage, charged all of my colleagues to put our
financial, intellectual and managerial resources at the disposal
of developing countries in combatting AIDS. We firmly intend to
spare no effort to meet this challenge, and we welcome this
Commission's recommendations in this task. Thank you very much,
Mr. Chairman.

CHAIRMAN WALSH: Thank you very much. I personally
can't tell you, with sufficient eloquence, how delighted I am to
find your institutions really becoming involved in health.

For 30 years, we have felt at Project Hope that
economic development depended upon the health of the people.
And, if AIDS has highlighted this, and I know WHO shared the same
views during its lifetime, but if AIDs has highlighted the
necessity for the economic institutions to be able to persuade
their boards to take a greater interest in health, AIDS has
already done some good with all the tragedy it has brought.
And, I'm just so delighted, I just can't tell you. So,
we'll start with questions again --

DR. CONWAY-WELCH Mr. Doss --

CHAIRMAN WALSH: Oh, is Mr. Doss going to speak? Oh,
I'm sorry. I didn't know that.

MR. DOSS: I shall be brief, Mr. Chairman.
CHAIRMAN WALSH: No. Oh, go ahead. Go ahead.

MR. DOSS: I'll try to stick to --

127
CHAIRMAN WALSH: I just thought you were sitting like
he was.

MR. DOSS: I'm the sunny-sided partner from the field.
Thank you Mr. Chairman, members of the Commission.

The U.N. Development Programme (UNDP), and the World
Health Organization have already joined forces in Zaire to
support the government's national campaign against AIDS, and I
thought, perhaps, I could say a few words on how this is working,
as it might be of interest to the Commission members.

As the United Nations technical agency responsible for
health matters, WHO, obviously, has already played a leading role
in devising the national strategy for the prevention of AIDS in
Zaire. The implementation of this strategy calls for
substantial resources, about $15 million over five years, which
may be a conservative estimate. ,

Zaire, obviously, cannot raise all these funds from its
own budget in the present economic situation. External
assistance is, therefore, vital to the success of this campaign.

To mobilize these resources, the Zairian government
organized a donor conference in February, 1988. Eighteen
bilateral and multilateral donors attended the conference,
including ourselves, of course, WHO, the World Bank and USAID.
WHO provided technical support to the meeting, and called on UNDP
for guidance about financing mechanisms, and, particularly, donor
coordination.

In consultation with the Zaire Ministry of Health and
its AIDS Coordination Office, WHO and UNDP developed an approach
designed to secure maximum national and international support for
the AIDS campaign. Let me say a few words now about the main
elements of this approach, if I may. First and foremost, we
stressed the need to strengthen national coordination, national
coordination to ensure proper management of the AIDS campaign,
and we suggest that this could be done in the first instance in
two ways.

Firstly, by asking the Ministry of Planning to co-chair
the donor conference with the Ministry of Health. The Planning
Ministry in Zaire is designated, within the Zairian government
for external aid coordination, as well as for the preparation and
monitoring of the public investment program.

National financing for the campaign, especially for
recurrent costs -- I think that's very important to stress that
-- recurrent costs have to be properly planned and budgeted, and
the Ministry of Planning is an important and vital ally in that
process. The second point we stressed was to upgrade the status

128
of the National Committee for AIDS Prevention from a
departmental, i.e., a Ministry of Health Committee, to an
interdepartmental one, placing it under the authority of the
President or the Prime Minister's Office. This will help to
ensure, we believe, that the campaign gets full national support
and access to all relevant information and research results.

The second main element in our approach was to find a
suitable donor financing mechanism. Various alternatives were
looked at, taking into account the experience with similar fund
raising ventures for other multi-donor programs.

Administratively speaking, the simplest method was
simply to have created a kind of a trust fund, put all the money
into that pool and manage it collectively. But, for various
reason we recognized that most donors clearly preferred to keep
their contributions under their own direct control.

In the circumstances, we concluded that a consultive
approach was the best alternative. Essentially, this lets the
donors keep their contributions under their own direct control
and management, but they agree to direct them towards common
goals.

To make a consortium viable, however, it is vital for
the participants to agree on joint program objectives, agree also
to exchange information, and accept some common criteria for the
evaluation of the program. This can only be done with good
communication, and good communication in two ways. So, we
recommended that a permanent government donor mechanism
coordination and monitoring committee be established as a means
of ensuring this cohesion. This proposal, happily, was accepted
by the conference.

What are the next steps? A strategy is not a plan of
operation. While donors are certainly willing to finance the
Zaire AIDS campaign, the first year's funding is already
subscribed. We have indications that the full program will be
committed. Nevertheless, they still want a detailed action plan
that sets out program priorities and targets. We want cost
breakdowns, and some indication of who does what.

This last point is particularly important, because we
know that already they are at least ten donors are willing to
contribute to the Zaire campaign. So, a plan of operation is,
obviously, indispensable.

We want to prevent, in effect, a dispersion of effort
and resources, and avoid creating ten or more different AIDS
programs. We also want to make sure that AIDS activities are
fully integrated into the existing primary health care network.
I think it's vitally important that AIDS support, AIDS programs

129
 

 

not be seen as a diversion of resources from those primary health
care networks, because AIDS is but one of many problems that
confront African countries such as Zaire. It is an extremely
important program, but that doesn't mean to say resources should
be diverted from, as I say, the primary health care network,
which has been put in place over many years by many of the
donors who were present at that meeting.

UNDP, through WHO, would provide technical assistance
now to the National AIDS Coordination Office, so that it could
complete its plan of operations as soon as possible and provide
backup for its implementation. We will also help establish the
coordination and monitoring committee that will review the terms
of reference for the restructured national committee. We hope to
accomplish these tasks by October, 1988.

Mr. Chairman, my five minutes are up. I will conclude,
if I may, by saying that it's, obviously, too early to draw any
firm conclusions from this very preliminary experience. We are
embarked on a venture that will require many years of sustained
assistance, and I think, again, it's important to stress that

longer after the AIDS scare is over in the Western Press, the
African countries will still have to face up to the costs of this
program. So, we'll need follow-up.

We can say, I think at this point, that the UNDP-WHO
Alliance is operational, that it is helping to put in place the
institutional structure that's a prerequisite to the success,
eventual success, of the AIDS campaign in Zaire.

We think that it's a good start, and I must say that
we're encouraged, and continue to be encouraged by the openness
and cooperation shown by the Zairian authorities, who, after all,
must run the program. Thank you.

CHAIRMAN WALSH: Thank you very much. Now, I
don't want to make a mistake twice. Now, Mead, you don't have
another presentation?

DR. OVER: No.

CHAIRMAN WALSH: Okay, fine. Well then, Dr. Welch, do
you want to start?

DR. CONWAY-WELCH The background presentation that you
all have made is extremely helpful in seeing the cooperation
that's occurring.

I wonder, though, if you might be able to help us
identify very specific recommendations that we would make as a

130

 

 
 

 

Commission that would facilitate your programs. I'm having a
little trouble bringing it down to some very pragmatic, one-
sentence concerns that you have, and that you believe that we
could be helpful in facilitating. And, that's addressed to
anyone. If you could open the report, June 25th, what would you
like to see written in it?

MS. HAMILTON: I would find it hard to improve upon
Dr. Mann's response of this morning. The United States is, of
course, the most important donor to the World Bank, and to its
"soft loan" affiliate, IDA. In terms of our parochial
interests. In terms of our broader interests, I think Dr. Mann
stated extremely well in terms of research cooperation, the human
rights aspects and financial support. I really personally don't
have any particular claims to make except for such cooperation
and support.

DR. CONWAY-WELCH Does anyone else have any
suggestions?

MR. ROTHERMEL: I'd like to join Ann in recalling what
Dr. Mann said this morning. I think we have two points that
we're relating to the recommendations. It would be important to

include as one the importance attached to a national AIDS plan,
and not a plan in country X, with donor Y, and with donor A, B
and Cc. But, truly in a national AIDS plan.

The other point is one that Mr. Doss just made, and,
that is, it will be a long-term proposition, and it's not just
because AIDS happens to be in the news today, but even when it's
not in the news I suspect these problems will still be there.

DR. CONWAY-WELCH Thank you. Are there any other
comments? Mr. Doss, did you have --

MR. DOSS: If I might add one, simply a
recommendation. I would say that each country should have its
national plan produced by its own people, and that part of that
component should be some sort of mechanism for coordination
between the donors and the government authorities.

It would show that, with the very limited resources we
have, we don't disperse our efforts, and that we commit ourselves
over a lengthy period of time. Thank you.

DR. CONWAY-WELCH Thank you.

MRS. GEBBIE: We heard this morning some comments about
the effectiveness of the programs being performed under the
auspices of organizations such as your's, and the World Health

131

 

 
Organization. The allegation that while those were good
programs, and would probably do something about this epidemic,
they were often not the programs that those countries would have
written for themselves. This was by one speaker particularly,
that they were bullied into taking what the World Health
Organization wanted done, and that they felt that even if it
didn't match what they wanted, they had to take it because it was
the condition of the money.

I think it would be very helpful to hear from any of
you the extent to which you are aware of feelings such as that,
whether they are founded in reality or not, feelings such as that
in the countries which you are assisting, and what kinds of
things that might be done to improve upon that situation if, in
fact, it is being felt.

MR. DOSS: I was simply going to say, that comment
could be heard in any kind of aid program. It would apply to
Agriculture --

MRS. GEBBIE: I am not surprised about that, but I
think we need to hear some more discussion of it.

MR. DOSS: It is a constant preoccupation, but many
programs are perceived by recipients as donor imposed, priorities
are imposed by the donors. This is why I stressed earlier the
importance of not seeing AIDS totally outside of the context of
the primary health care system, because otherwise there is that
reaction that AIDS has affected America and Europe, therefore,
Africa must act. So, I think one has to counter that by
insisting that this is part of a package of assistance for
primary health care, that we're not excluding malaria control,
we're not excluding schistosomiasis, onchocerciasis or
diarrheal diseases. But, it is part of an integrated program,
and that the AIDS program, in fact, can help those other
programs, as my colleague from the World Bank mentioned earlier.

To avoid this perception of donor imposition, I think
the only solution, as in the other case, is a dialogue, is give
and take on both sides, and it does take time.

I can say in the case of Zaire, I haven't, in the AIDS
program, interestingly enough, run into that reaction in such an
overt fashion. There has been quite an open dialogue, and I
think it's because WHO, from the start, consulted, talked to
them. But, it is important. That programs, they feel
responsible for these programs from the very start, that these
are not donor imposed programs, but they have a say, that they do
really run these programs. Thank you.

CHAIRMAN WALSH: Ms. Hamilton?

132
MS. HAMILTON: I would like to emphasize something that
Mr. Doss said. I think that the solution to this problem, and
the only solution to the problem when you've got an
outsider/insider distinction, is time, time for discussion.

It's much easier, we find, in countries where we have a
continuing relationship in the health sector. Then discussion of
any component, an AIDS component, or a malaria component, or
anything else, fits nicely into established relationships and
into an increasingly shared view of the problems and the
solutions.

We learn from the countries and the countries learn
from us. It's a very mutual process. So, yes, it is a problem
at the beginning, but it gets to be less and less of a problem as
time goes on and the dialogue continues.

CHAIRMAN WALSH: I could even add to that from my own
experience, and even going back to the days of Point 4 and so on,
when we were just starting aid. It was tradition for a
countries' health ministers to say, well, what are you giving for
this year. And, whatever you are giving for, we need it, and
we'll abide by any rules you have because we are so desperate in
our need, which emphasizes what you have said. When the AIDS
program opens up,any assistance program opens up, it's the long-
term relationship that develops from it that makes it work.

And, I think anyone who has been in development, either
on the granting or receiving side, knows that. I mean, you are
sensitive to that, and they watch it. They do watch it.

DR. OVER: I have a comment.
CHAIRMAN WALSH: Mead?

DR. OVER: Could I just add more comment here? I
think it's important to remember that AIDS is new, and because it
is new it enters a situation where interest groups have been
established, both in the donor agencies and in the developing
countries.

All of a sudden, a new niche must be created. In the
creation of this niche some people will be hurt by a reallocation
of priorities. Some people who will be helped. In the donor
agencies, in the donor governments, and in all the affected
countries of the world it will take a while for that process to
work its way through.

Dr. Mann refers to this three-stage procedure of
denial, minimization and finally of constructive work with the
problem. And, I think we're talking about that process while we
are discussing this topic.

133
 

 

CHAIRMAN WALSH: Go ahead.

MRS. GEBBIE: Well, a somewhat related question. We
heard a little bit from Dr. Mann, this morning about the
attempts to coordinate evaluation of these programs to avoid
being burdensome.

What we didn't hear was the composition, perhaps, of
the evaluation team. We often encounter, those of us who grant
money within this country even, to ethnically diverse communities
allegations of bias in evaluation, because the team that comes in
may not include an adequate representation of the ethnic group
being served. And so, we've had in more recent years to learn a
great deal about inclusion of served populations on evaluation
teams in order to avoid bias.

To what extent is that an issue in evaluating programs
such as you support, and if it is an issue or it's, becoming an
issue, to what extent are you able to deal with it, and how?

MS. HAMILTON: Again, I'll take a quick stab.

That's valuable advice, and I think we should bear it
in mind and learn from that kind of experience in all of our
activities. In the case of evaluation of AIDS in particular,
it's an unusual type of issue because we are all so much on a
learning curve. It's not a grading episode. It's nota
judgmental process. We must make a special effort to see what
we can learn from different applications in different countries.

But, in my experience, the problem it doesn't come up
so much in AIDS ~-- specific matters, where we are all wide open
to learning whatever we can learn about what works, and don't
blame anybody for what doesn't work. That's part of the learning
process. But, it certainly is valuable advice for almost
everything else.

CHAIRMAN WALSH: Anything else, Commissioner Gebbie?
MRS. GEBBIE: No.
CHAIRMAN WALSH: Okay, next?

DR. PRIMM: Yes. I had a question concerning also Dr.
Jones' testimony earlier. Mr. Over, you were on that panel with
Dr. Jones, if you recall. And, what I think Ms. Gebbie was
trying to get at was the infrastructure of these nations that you
are helping, with your, "soft loan" window, what are you doing to
construct that infrastructure so that they can take whatever help
that they get and use it effectively? Because, the way I got it
this morning, from Dr. Jones, is that even the malaria, and the

134

 

 
 

 

sickle-cell anemia that oft times accompanies it, is not handled
properly. They don't have the wherewithal even to do that.

Injection equipment is used over and over again,
because they don't have the means for sterilization. He
said that oft times there is no electricity. What are we doping
to do something about the infrastructure of these nations so that
they can accept what the World Health Organization brings, what
you bring from your "soft loan" window to them to rebuild that,
so that their health system can have a structure that can be
built upon?

MS. HAMILTON: We're doing everything we know how.
But, of course it is an extremely slow, time-consuming and
difficult process. In the case of World Bank loans, almost every
single loan we make in this sector involves institution building.
Under the heading of institution building, we include technical
assistance in how to do these things, equipping offices,
providing vehicles to get around to the field stations, of
training of staff and training of trainers to train the future
staff. But these contributions are only drops ina bucket. It
is slow. It is time-consuming. It is really the building of
human capital.

As Mr. Doss pointed out there is also, an overwhelming
need for recurrent cost financing. Once you build the building,
or buy the vehicles, you then need the resources to put fuel in
the cars, to turn the electricity on.

We also, of course, in the World Bank, finance a lot of
infrastructure loans for, power, road, water supply and similar
investment, but there are difficult trade offs. We do what we
can, but it is slow and difficult!

DR. PRIMM: Well, it has been said to me that in
Uganda and other countries, that there is really no
infrastructure period, and that if you go in there to do anything
it's so very difficult.

And, I have seen some results of some of the World
Health Organization's work in Uganda at the London summit
conference, where I thought that they had produced some excellent
prevention and education materials. And, I was rather shocked
when I heard that they had really nothing to do anything with
there, and so disorganized that what will result from them being
hit by this epidemic is going to be catastrophic, and that if we
thought the Ethiopian famine was a serious occasion in Africa,
that was a picnic compared to what's going to happen in
countries like Uganda.

So, I'm concerned, and I'm happy that you all sort of
allay some of my concern, which means that Dr. Jones' testimony

135

 

 
this morning, I'm to assume that it was probably erroneous. Is
that the conclusion?

MS. HAMILTON: No, I wouldn't say that he was wrong.

DR. PRIMM: What should I assume? What should we take
away from here? He was adamant.

CHAIRMAN WALSH: Mr. Doss, do you want to take that?

MR. DOSS: Yes. I would like not to allay Dr. Primm's
fears. In fact, the truth is that, of course, the
infrastructure is deteriorating in all of these countries in
Central Africa. With the impact of the present economic
situation, we'll be hard pressed to stay where we are.

We are running to stand still, and we're really running
backwards. So, international assistance has to not only do AIDS,
but it has to do the things that will make AIDS programs
feasible. We have to somehow prevent this deterioration.

Even to do that will require a lot of resources, and I
don't think we can be too optimistic. I think we really are, as
they say in French, -- try to save what you can. I'm sorry to be
so pessimistic, but I think you have to be realistic also about
what we can do in the next few years.

DR. PRIMM: But, I think that is somewhat the attitude
toward Africa, and that's my concern, and not that that's a bad
one. I mean, you do the best you can with what you've got, I
understand that. But, I see that attitude as being pervasive,
and that we don't really do everything that we can. I think we
could do a hell of a lot more.

I've been told by African physicians, both infectious
disease physicians and pathologists from Zaire especially, that
unless they got disposable needles and syringes, and unless they
got just a simple ELISA test, and the Western Blot to test their
blood supply, that the problems would be devastating to the
population, and that we could, in the United States, just supply
that. That would be enough for them. I've heard that, directly
from then.

MR. DOSS: I wouldn't wish to get into a debate on
this, but I think it's not enough, frankly. Supply the doctors,
if you will, with their supplies, but if they don't get paid
properly, if they don't have gas for their cars, what are they
going to do with them?

DR. PRIMM: Exactly.

136
MR. DOSS: This is what I'm saying, that the AIDS
programs in Africa are very important. It's a vital program, but
you can't divorce it, as Dr. Hamilton was saying, you can't
divorce it from the overall deterioration of the health
infrastructure in these countries.

DR. PRIMM: So, what we need then is a social
earthquake in those nations to bring about a change that will
affect this problem, so that we can have a more positive outcome,
and that's what I gleaned from what you have said today.

MS. HAMILTON: If I may say so, Dr. Primm, you've
described the situation in Uganda very well. And in a very real
sense AIDS is the social earthquake. It's another one of those
cases that Dr. Walsh described, where there are some positive
benefits from this scourge. The collapse of the Ugandan health
infrastructure has been apparent to observers for a long time.
It is the overlay of the AIDS epidemic there that has finally
gotten enough attention paid to the problem that we are, in
effect, now discussing an AIDS project that involves no
investment in AIDS in Uganda. But ina sense, it is the ultimate
AIDS project, because it will begin to rebuild the health
infrastructure of the country.

DR. PRIMM: Thank you very much.
CHAIRMAN WALSH: Dr. Lee?

DR. LEE: Part of our success with our interim report
was that we tried to put a price tag on a lot of the things that
we did. Whether we were right or wrong remains to be seen. We
probably underestimated everything.

But, let me be educated by you bankers on a few facts
before I get to my final point. First of all, what really is the
mandate of the World Bank and who gave it to the World Bank?

MS. HAMILTON: The mandate was given at the Bretton
Woods Conference in 1945, by a group of finance ministers. It
started out post-war essentially, as the "R"-reconstruction-in
its name implied. Post-war reconstruction was the important
part, development was secondary.

DR. LEE: And, what did the Bretton Woods Conference
charge you with?

MS. HAMILTON: To finance, through loans, for projects,

essentially, the reconstruction of Europe and the development of
other countries.

137
DR. LEE: So, the UNDP and the World Bank have very
parallel purposes, is that correct?

MR. ROTHERMEL: In a sense, yes and no. Yes, we're
both interested in development. The UNDP is a creation of the
United Nations General Assembly, rather than the Bretton Woods

organizations. And, secondly, we are in the grant business
rather than lending.

DR. LEE: You are in the grant business.
MR. ROTHERMEL: Yes, sir.

DR. LEE: Well, that brings me into my second
question. The World Bank has lent some money to Burundi, $2
million for health care for mothers. In the history of the World
Bank, what percentage of those loans are paid back?

MS. HAMILTON: So far, virtually all.
DR. LEE: No kidding.

MS. HAMILTON: Yes. Now, I'm sorry to say, that
magnificent record is beginning to fray a little bit around the
edges with the debt crisis that is affecting so many countries.
But, up until now, the Bank really has been an effective
preferred creditor, even when a country defaulted on other loans,
it paid back the World Bank because of its influence --

DR. LEE: Prestige, yes.

MS. HAMILTON: -- in the international donor
community.

DR. LEE: Could I just ask one other question to get my
facts straight? How does USAID relate to the World Bank? You
have, again, very parallel purposes, don't you?

MS. HAMILTON: Yes.

DR. LEE: It's just funded a little differently.

MS. HAMILTON: It does involve different funding as a
bilateral agency. Virtually all developed countries have their
own bilateral aid agencies.

DR. LEE: Now, another thing that you said surprised me
very, very much. I thought the funds that the World Bank used
were donated by the various countries, but you said most of the
funds are borrowed.

MS. HAMILTON: Yes.

138
DR. LEE: Now, you are borrowing these funds from whom?

MS. HAMILTON: Capital markets. We issue bonds in
capital markets.

DR. LEE: All the capital markets.
MS. HAMILTON: Yes.

DR. LEE: And, you are paying more than 7.73 percent
for those funds, aren't you?

MS. HAMILTON: Yes.

DR. LEE: So, you just keep rolling over the
difference.

MS. HAMILTON: We have a large paid-in capital base,
dating from 1945. That goes a long way to reduce the average
cost of our funds. At the beginning, we got a large injection of
paid-in capital at zero cost.

DR. LEE: I see.

MS. HAMILTON: So that, if you average that together
with what we are borrowing at 7 and 8 percent, you --

DR. LEE: All right, but you are running down, aren't
you?

MS. HAMILTON: That will happen, yes.
DR. LEE: It is not happening now.

MS. HAMILTON: The interest rate goes both up and down.
It's fixed every six months. It is .5 percent above --

DR. LEE: But, I mean, your capital.

MS. HAMILTON: No, the interest rate that we charge
covers the full cost of our capital plus our operating cost.

DR. LEE: I know your interest rate varies, but have
you been able to maintain your capital?

MS. HAMILTON: Yes. Secretary Baker is testifying
regularly before the Congress and he is seeking a capital
increase now, a general capital increase. We have had two or
three capital increases in the life of the institution.

139
DR. LEE: Okay. Now, in USAID and the UNDP and the
World Bank, in the final analysis, what percentage of your money
comes directly from the United States taxpayer? Can that be
sorted out?

MS. HAMILTON: Well, USAID's all does.

DR. LEE: All.

MS. HAMILTON: Yes, by definition.

DR. LEE: And, UNDP, we'll let Mr. Rothermel --

MR. ROTHERMEL: About 10 percent of our income is from
the United States government.

DR. LEE: And, the other 90 percent?

MR. ROTHERMEL: Yes. It comes principaily from other
industrialized countries, although, almost all developing
countries make some token contribution.

DR. LEE: So, Nancy Kassebaum can't get at you. I
mean, it seems like it is a very fair distribution.

MR. ROTHERMEL: On a per capita basis, it is very
small, indeed, the contribution from the United States, in
comparison to, say, the Scandinavian countries.

DR. LEE: Well, that's very fair. Now, how about the
World Bank? In the final analysis, what is -- can you come up
with it?

MS. HAMILTON: IDA constitutes about 25 percent of our
total lending. Of that 25 percent, the U.S. contributes about 25
percent. We borrows the rest, the IBRD funds are borrowed in
the world capital markets.

DR. LEE: So, we can say your organizations really are
doing God's work here, and not depending on the United States
taxpayer for a hell of a lot of it. Okay. That's what I --

MS. HAMILTON: That's true.

DR. LEE: Thank you very much.

CHAIRMAN WALSH: Well, again, I thank this panel. You
were stimulating and informative, and I think also, again, from

my own standpoint, the increased importance and emphasis that you
are placing upon health warms my heart very much.

140
And, secondly, I think the realistic point of view that
you have taken on infrastructure, and I think that Dr. Primm's
concerns as he expressed them were, perhaps, maybe he was a
little bit misled by the intensity of Dr. Jones' testimony,
because I think to me it was apparent, and I think you should be
encouraged, Benny, that each of these institutions, and the World
Health Organization, have placed absolutely, to my mind,
predominant emphasis on the necessity for developing
infrastructure, and also for remembering that AIDS is only one
problen.

And, I have heard at many international meetings the
concerns of the Third World countries, which you both expressed
so well, that they hope AIDS and the interest in AIDS does not
submerge the rest of their health care systems to the exclusion
eof everything else.

And, I know that the World Health Organization is not
letting that happen, despite the fact that they have the
responsibility with AIDS, and I am so delighted to hear each of
you speak along the same line, because that's the only answer in
the long run, because we hope that AIDS will come and AIDS will
go, but the problems are going to stay unless we build that
infrastructure. And, I'm just delighted to hear your views on
that.

Thank you all very much, and we look forward to seeing
you all and hearing from you again. Please, don't hesitate to
write us any suggestions or ideas, because we have a charge to
recommend policy to the President, and we depend on those of you
who are involved in this to give us guidance and input so that
we give him good advice. So, thank you very much.

MR. ROTHERMEL: Thank you.

MR. DOSS: Thank you.

THE FOOD AND DRUG ADMINISTRATION:
RESPONSE TO THE PANDEMIC

CHAIRMAN WALSH: Our next speaker is an old friend, and has
appeared before this Commission before. Frank Young, the
Commissioner of the Food and Drug Administration, today is
appearing with a few friends, in his role, however, as a member
of the Executive Board of the World Health Organization. So, if
any of the Commissioners want to talk to him about treatment INDs
and so on, please, reserve that for a later time. If anyone
wants to discuss with him the price of pharmaceuticals, or the

141

 
 

 

cost of research, please defer that to another time, because we
already had that show in New York, Frank.

So, I hope that you will stress your role as a member
of the Executive Board of WHO, and how you feel this
international war on AIDS is going. Thank you very much for
taking the time to be with us again.

DR. YOUNG: Thank you very much. I'll introduce the
individuals that are with me. On my far right is Dr. Paul
Parkman, who coordinates FDA's activities in AIDS, and also since
Biologics was recently named as an international center, I've
asked him to come along. On my immediate right, is Dr. Stuart
Nightingale, who runs the Office of International Health for us,
and I thought that it would be helpful in the case if there were
international questions there. My Deputy, John Norris, has been
also active in the international activities that we have been
involved in, so I brought John.

I've learned that no good FDA Commissioner goes
anywhere without his general counsel, so Mr. Scarlett is there,
and finally, Paul Carpenter, because we have studied the
international evaluation of drugs ard how the United States
evaluation fits into that I've asked Paul Carpenter, who has done
these studies, to be available as a resource person, because I'd
like to describe how the approval and evaluation of drugs
internationally are important.

I think, actually, it's more than symbolic that we are
in a hall, in which sitting behind you are a number of flags from
the Americas, only one of which is the United States of America.
And, if I were to pick any theme that would be important for my
testimony, it is the crucial aspect of networking of information
as we deal with this. As you focused on the infrastructure in
the last testimony, the absolute need for it, I believe it was
Dr. Conway-Welch who asked, what are some specific
recommendations for the report, some things that you might like
to consider in regards to the international question. So, I
will, in my five minutes, assume that you've asked me that as
well.

If you look at what I would 1ike to say, in addition to
introducing my entire testimony, is that there are three themes
that I would like to interweave. First, I am particularly
pleased to have had the honor and privilege of representing the
United States on the Executive Committee of the World Health
Organization, and, therefore, on the Program Committee. And, as
some of you may know, I was particularly insistent to try to have
WHO raise this issue, and I was pleased than in the Program
committee it was brought forth, we were able to get it included
amongst infectious diseases. Jonathan Mann has done a stellar

142

 

 
 

 

job in developing and arguing for this program, and from that
time forward I've had the privilege of working with hin.

The United States has insisted that this topic be put
on the agenda of the World Health Organization, because in almost
a 50-year celebration of Orson Welles, War of the Worlds, this,
in a sense, is a war of the worlds between an infectious agent
and mankind.

In few instances have we had an organism that has been
so widespread throughout the world, and which has such a high
degree of mortality, and a high potential for disrupting social
patterns throughout the world.

The second theme that I would like to weave in is
networking in the diagnosis, the prevention and the cure of this
disease. Up to this time, a large amount of effort has been
expended, as Jonathan Mann rightfully focused, on the prevention
of the disease. He has, in his testimony, which I had the
opportunity to review, focused on the need to prevent additional
people from being infected, but he also recognized that those
people that are seen today with the disease were infected a long
time ago. And, we cannot abandon them or others along the way.

In my mind, this networking requires a number of
things, to try to answer Dr. Conway-Welch's question. The first
is the rapid spread of information throughout the world, and if I
were to answer your question, Dr. Conway-Welch, and add, what
could be done in addition, it would be the development of an
electronic bulletin board that would enable us to have rapid
access throughout the world. We are very pleased that we have
been able to use an electronic bulletin board in FDA and ITT
Dialcom, and just one nation to date has recently come on that.
We feel that an electronic network that would enable a rapid
access amongst nations would gain in a very substantially
hastened spread of information.

In addition to that, though there are biannual meetings
of the regulatory agencies around the world, and an annual
meeting of individuals dealing with AIDS research, there is no
dedicated meeting to bringing the nations of the world together,
those particular 11 nations which I will cite on Dr. Coppinger's
study, that would enable the regulatory agencies of the world to
look at this.

Let me give you an idea of what I mean. Dr. Coppinger
has studied, for the past 14 years, 11 developed nations, U.K.,
U.S., Switzerland, France, Germany, et cetera, and looked at how
drugs were introduced upon approval of one country into these.
The vast majority of these drugs stay within one or two
countries.

143,

 

 
 

 

Interesting, those drugs that are developed in the
United States, spread more than any other nation to the 11
nations that we studied.

It is also interesting to note that six and a half
months after the time of approval of AZT in the first nation in
the world, nine of the 11 nations had approved it, and about one
year after that 47 countries around the world. This is an
unparalleled penetration. But, resources are involved in the
approval of these drugs in the evaluation, and possibly with an
electronic bulletin board, and possibly with a way of getting
information spread amongst these regulatory agencies there might
be more harmonization.

We do not have all of the information on clinical
trials done in other nations. That also could be put, obviously,
respecting confidentiality, on such an electronic bulletin board.

I am not suggesting at this point in this information
network that a particular organization take the responsibility
for this. This is very sensitive. There is an organization at
WHO under Dr. Dunn, John Dunn, who coordinates the information on
regular drugs. I don't know whether this other information
should be under the coordination of one of the 11 nations that
are involved in drug evaluation, or whether it should be in WHO.
But, I think someone should take the lead as a repository of
information, and we at least, and I have asked Dr. Nightingale
to enlarge what we do on a quarterly basis of reporting to the 1l
nations, and to enlarge what we do with our tripartite, Canada,
the U.K. and ourselves, where we send things by fax around the
world, to do this to the other nations on AIDS.

But, there is a defect in that. We get nothing back
necessarily. There is not an organized system that has an
efficient loop, so while we can send information out, I think
this is something, Dr. Conway-Welch, that could be raised as an
additional thing to do.

I would also urge very strongly the focus on
infrastructure. This has been something in the building of a
national need, both in the countries in Africa and elsewhere,
that is absolutely key. Why do I say that? The United States,
through its ability to deal with licensure, investigational
drugs, including the treatment IND, and the export recently in
the Waxman-Hatch bill has capacities to exchange the use of drugs
and devices very rapidly. Example, the licensure is the
Classical way. The second, and very important, is the ability
through the investigational new drug, or the investigational new
device, to get devices and drugs and diagnostic kits spread
throughout the world.

So, you will see in my testimony that 50,000 test kits

144

 

 
 

were sent under an IND to Zaire.

To the best of my knowledge,

this is the largest IND that we have ever approved and approved
for a single country, but this test has the ability to be done
rapidly, and inexpensively, but it has not been evaluated yet

within the United States.

So, those aspects do exist.

We need to have a better information loop on this
infrastructure, though, as to how, when we send materials to

other nations, how that gets out.

It would be a shame to send

50,000 diagnostic kits out and have them used improperly, not get

to the right spot, or give misleading results.

One of the

concerns that we have in any test kit is the validation of these

results to know whether it will work.

back on that.

So, we need to have input

In the infrastructure area, as another suggestion to

the question Dr. Conway-Welch asked me, of course,

is the issue

of how to get unapproved drugs submitted out to other countries.
The Hatch-Waxman law that I cited provided the export to 21
countries in the developed world, thus, excluding all of Africa,

South America and most of Asia.

For your consideration would be a number of ways of

fixing that.

One might be a simple rider on a law that would

enable, for AIDS only, the export of unapproved drugs.

For devices, it's relatively easy.

The diagnostic

tests we made, Mr. Scarlett is looking at this, which is why I

have him with me, called Diagnostic Test Devices.

If we call

them Diagnostic Test Devices, then we are able, through the

Investigational Device Exemption, to ship those broadly.

We are

not sure legally whether we can do that.

But, certainly, save the IND route, we have no way to
deal with this in a widespread shipment to developing nations.
I would not personally like to advocate a widespread shipment of
unapproved drugs throughout the world to developing nations.
And, in my testimony before Congress, I urged that there be some

way of restricting that. But,

in the case of AIDS,

I would

submit that restriction may not be as sensible.

I would also, since we
this disease some day, if I were
designed, I'd put a sunset on it
that there is not a flooding and
countries by, as yet, unapproved

do hope to be able to conquer
asked how this should be

which could be renewable, so
exploitation of Third World
drugs. I would think, finally,

that we have only begun in the United States to fulfill our

international mission.

I'm delighted that Dr. Windom will be

speaking in general tomorrow on the PHS role, but we do stand one

flag among many.

Fortunately, I believe

that the research intense

145

 

 
companies that are within the United States and other multi-
nationals are going to be the hope for these medicinals that will
be forthcoming.

And, thus, the organization and coordination of this
research will require the three ingredients that I mentioned:
the networking, the harmonization of evaluation and approvals. I
did not emphasize as much as I should the concern of how we will
develop the trials, that's an important subnote, and I'll save
that for questions if you are interested.

And then, finally, the most critical issue of
infrastructure, and the way in which we can coordinate the rapid
dissemination of information and be sure that when drugs and
devices are brought forward to developing nations that they are
not squandered by the absence of an infrastructure, both in its
evaluation, its distribution and its utilization.

Dr. Walsh, I thank you for the privilege of coming
here today, and I'd be delighted to answer any questions that I
can, and I hope that the United States will fulfill its
commitment in an appropriate role in leadership in this, not only
supporting WHO, but also conducting its research and making
approved therapies and unapproved therapies appropriately
available as rapidly and expeditiously as possible. Thank you.

CHAIRMAN WALSH: Thank you, Frank. Dr. Young, and your

staff, we hope that the FDA is still functioning while you are
all here.

DR. YOUNG: We know that we are all biodegradable and
we have backups.

CHAIRMAN WALSH: Sure. But, we are delighted that you
are all here, because there is really nothing more important for
us than to be able to pick the brains of those of you who are
able to give it to us. So, we're going to start now with you,
Cory. It's your turn.

DR. SerVAAS: Well, thank you. I'11 ask the question
you proposed. How will you develop the trials?

DR. YOUNG: One of the things that we have been
working on very extensively is, under Dr. Windom's leadership to
determine whether or not there can be some systematic way that
we can interface with WHO on populations throughout the world,
both domestically and in other countries, that would enable us to
get the answers.

One of the critical factors that we have realized now
is that the trial has to be conducted in a very disciplined
fashion. We have had a little experience in the past, whereby

146
not following -- and I'm not talking about placebo control or
other types of control, but controls with questions in mind, we
can sometimes waste time. So, we would like to work either in

collaboration with WHO, which has been making countries available
as test sites, a way to function, or develop ways in which we can
coordinate them throughout the world.

Now, we have been locking at a number of these,
Zimbabwe is one, Zaire is an other. But, I would add one point
that I've been encouraged about. I'm detecting an increasing
interest in the countries that are looking to sponsor trials to
also give the country in which the trial is going on something
that country believes is important. It is not fair to
intellectually rape and pillage. In that sense, one of the
things that I've been pleased with is that as sponsoring
countries have been exploring this they've been asking, can we
make it possible, to have resources available for things such as
blood testing. There is a lot of concern about that. Where are
the countries going to get the resources for that?

Impact on infrastructure, I would foresee
collaborative experiences where the country that is having its
population donated in part for clinical trials, could also
receive some help in their priorities. I would focus, their
priorities. The one that I see the most that nations have talked
to me about is diagnostic testing and screening. There the
concern is, as in the United States, how do you know the tests
really are valid, and how do you know that it's done right? So,
that's the area that I would see added to. The infrastructure is
the other point.

DR. SerVAAS: Thank you.

DR. LEE: Dr. Young, a guy who sits with his lawyer
that close to him looks like a guilty man to me.

DR. YOUNG: It's a custom.
DR. LEE: It's a custom?

DR. YOUNG: It's a custom. I was told a few things
upon coming into FDA, really two. The first one was,
"Commissioner, we want you to know that no one in FDA ever got an
award for doing something. The only award was given for not
doing something." And, the second thing was, "Commissioner, we
want you to know that we trust you, we honor your judgment, but
you don't go anywhere without your lawyer, because the law is
something that is important in the Food, Drug and Cosmetic Act,
and it's a big arcane, and you might not understand it." They
are right on both counts.

147
DR. LEE: Well, we're safe. We have no lawyers on this
panel here at the moment. What hat are you wearing today? Are
you wearing the FDA hat or the WHO hat, or both?

DR. YOUNG: Since I am not cloned, and there is only
one copy, I would have to say that I'm here for you with my
WHO/international hat, but that's where FDA is involved
extensively. Since we have the responsibility for $570 billion
worth of commerce in the United States, and bilateral agreements
with other nations, I would be here in both the international and
the FDA hat, a single hat.

DR. LEE: Now, maybe the gentleman second from the
right is the man who is involved with international drug
development, what was that again?

DR. YOUNG: Paul Coppinger, on my far left, is the
person who did the study on the 11 nations, and the approval
rates there. On my immediate right is my associate Commissioner
for Health Affairs, who has the International Office.

DR. LEE: Could I get into a thing that bothers us
consistently?

DR. YOUNG: Of course.

DR. LEE: And, that is, drug trials and vaccine trials
in other countries. I tend to think America is being somewhat
arrogant when it takes the position that, if you are not doing it
up to our standards, you are making a mistake.

But, on the other hand, how does the World Health
Organization approach the ethics of this particular problem? The
vaccines are so hot, we have heard, that the companies here,
because of the tort process, don't want to get involved. They
ship them off to European companies. They transfer the problem
outside of the borders of this country, so they do not have the
liability that comes with it. But, how do you handle, on a world
basis now, the ethics of these various drug and vaccine trials
that liability-wise we don't seem to be able to do in this
country?

DR. YOUNG: Let me answer your question by answering
three points. First, the United States, with its, what is called
the NDA Rewrite, the new drug application rewrite of its
regulations, fully accepts all foreign data. And, in regards to
the human rights, we rely on the Helsinki Agreement that
describes, when there are not biosafety committees in other
parts of the world as there are in the United States, the basic
fundamental human rights and the informed consent that is
involved.

148

 
 

 

Now, we monitor that to be sure that, to the best of my
knowledge, the Helsinki Agreements are followed, but we don't
have the authority to reach in and deal directly. Now, in
regards to the ethical standards of countries, I have been
impressed with the novelty and ingenuity of the lawyers in our
country in dealing with other countries! citizens that were
adversely impacted.

DR. LEE: You mean to say, they're getting -- the
cancer is spreading?

DR. YOUNG: You noticed the large number of U.S.
lawyers that flew to India?

DR. LEE: Yes, ‘I did.

DR. YOUNG: That's right, I noticed very few flew
to Chernobyl.

DR. LEE: Yes.

DR. YOUNG: That might say something in regards to
societies. I watched that very carefully, and did not see any
New York lawyer go to the Soviet Union to deal with that
particular accident. But, I think our ingenuity in legal
aspects might see that happen. I'm very serious when I say that
I think the tort law, though not directly applicable, could be
seen, because the bell tolls around the world on this. I think
that there will be very little skulduggery permitted, because the
punitive risks are so high.

Now, in regards to the vaccine, though I know I've
taken some criticism by allowing FDA to approve testing for
safety of two vaccines without an animal model, those tests are
going on in the United States. It should also be said for the
record that in excess of 50 percent of the clinical trials occur
throughout the United States, and the rest, about 50 percent
around the world.

One of the problems in our doing clinical trials, in my
opinion, is from the time that you and I went to medical school
there has been an erosion of the great clinical trial centers in
the United States. There are very few centers, and, certainly,
very few deans, I can attest, that give tenure for doing
clinical trials. And, we have seen an erosion of the
capability. I think this and other events to, particularly,
biotechnology, will bring back some clinical trials into the
United States.

The cost is a factor. I do not think it is merely just
a human subject, and since now we can accept foreign data under
the Helsinki Agreement, I think we can guarantee human rights.

149

 

 
 

 

Now, I've given you a longer answer, but your question was so
important that I wanted to cover it.

DR. LEE: Does your staff agree with you, or do they
Gare disagree with you?

DR. YOUNG: They dare disagree with me on many
occasions. Stu, you deal with the institutional biosafety. Can
you comment on the Helsinki Agreement?

DR. NIGHTINGALE: I think, indeed, it's true in terms
of the ethical criteria that are used worldwide, the Declaration
of Helsinki is available. If something is done under an IND in
this country, it has to meet the standards to be acceptable to
us.

I think, again, Dr. Mann might be able to better
address this, but I believe that all studies that WHO is involved
in have to be reviewed by their own IRB institution or review
board. I think the infrastructure for the ethical issues is
there.

DR. YOUNG: Paul, would you like to comment, if you
could, on any of the 11 nations? Do they have comparable IRB
equivalents to our's that you know of?

DR. COPPINGER: No further information.

DR. LEE: But, as far as you are concerned then, this
Commission should not be particularly worried about these ethical
problems of testing these materials in other countries?

DR. YOUNG: If you were to relax, I would be worried.
I think that we have to focus on the ethical issues, but to the
best of my knowledge the systems are in place to address it.

But, I think under no circumstance can we slumber on
this, because there should not be, as I said earlier, the
experimental raping and pillaging of sub-populations. John,
did you want to add something?

MR. NORRIS: Yes. I might just add one more point to
that. We're concerned enough about the ethical issues to have
had just about five weeks ago Professor William Curran, who is
the Frances Lee Glesner, Professor of Law and Medicine from
Harvard University, come to FDA and talk to us about ethical
issues involved in clinical trials.

It's an issue that we are currently very concerned
about and looking at on an ongoing basis to make sure that we're
approaching it properly. One last comment also I would add is,
we don't want to mislead you at all. We are willing to receive

150

 

 
 

 

foreign data, and we're willing to give it its due weight,
whatever that might be. In some cases, the foreign data may be
perfectly acceptable in every way and helpful, and in other cases
it may be not terribly helpful.

DR. YOUNG: I would also add that Dr. Windom, in the
task force, has got the authority and is working together with
cpc, NIH and FDA to look at ways in which trials will be
conducted in other parts of the world, and you might like to also
ask him that question tomorrow. But, I've been very pleased that
he has been focusing on that issue.

DR. LEE: Thank you.

CHAIRMAN WALSH: Did Colleen leave? We lost our
flanker. She had to catch a plane, I'm afraid.

DR. YOUNG: Well, I'm glad I answered what I thought
she might ask --

CHAIRMAN WALSH: That's right.

DR. YOUNG: -~- listening to the last panel.
CHAIRMAN WALSH: Okay.

Dr. Lilly?

DR. LILLY: She actually left the question with me to
ask you.

DR. YOUNG: Wonderful.

DR. LILLY: I'm going to postpone it, because I think
it fits a little bit later in some of the questions that I wanted
to ask. My first is a very fundamental question. What is the
philosophy behind our willingness to export drugs to other
countries that we wouldn't use?

DR. YOUNG: There are a number of drugs that are being
developed primarily for tropical’and infectious diseases, and
others that are not applicable in the United States. The best
example is one that was given away by Merck, Ivamectin, for
river blindness. To the best of my knowledge, we have no river
blindness in the United States, other than those people that
would come in with that disease. And, for them to go through the
evaluation, approval and development for the use of this drug,
which was then given away subsequently, would be inappropriate.

Right now, we are working on a malaria vaccine. The
malaria vaccine, through biotechnology, and one for
schistosomiasis, will, if effective, be very important for parts

151

 

 
 

 

of the world, but that's not going to be important for the United
States.

And, in view of the laborious task of bringing this
through that was thought to be important. Now, the second
big bucket on this is the drug that might be requested while it
is under development in another nation, and yet to be --

DR. LILLY: Requested by whom?

DR. YOUNG: By the authority, the regulatory authority
in the other developed nations. So, the way the bill works is,
if a regulatory agency in another nation requests it, we would
evaluate that request and determine, based on our information of
that drug, whether it is appropriate to ship it elsewhere. So
that, it respects the other regulatory agencies and their
capability in dealing with it.

MR. NORRIS: I would only add one more point, and, that
is, also, as in the case with the IND where we authorized a
shipment of some 50,000 tests to Zaire, the question of
infrastructure comes up again. What would be helpful, very
helpful, and those tests apparently have -- there is an
indication that they have been helpful -- because of the lack of
infrastructure, tests that would work well in the United States
aren't really usable in a country like Zaire. On the other hand,
because of the high infrastructure in the United States, the
tests that were shipped wouldn't necessarily be very helpful to
the United States. So, you have to look at the market, you have
to look at the infrastructure that's there, the ability to
actually use something and make a difference in that country.

CHAIRMAN WALSH: I think Frank, in Ivamectin, too, I
think WHO field tested Ivamectin for about three or four years --

DR. YOUNG: I believe so.

CHAIRMAN WALSH: -- and, did toxicity studies and so
on, before the gift was made.

DR. YOUNG: That's right, and it's also been approved
for a long time for heartworms for dogs.

CHAIRMAN WALSH: Exactly.
DR. YOUNG: But all the experimental evaluation was

there, and clinical trials were done. It was just not sought for
approval in the United States.

MRS. GEBBIE: This is a factual question to clarify
something before you go on this. You talked about this
relationship being dependent on your work with the regulatory

152

 

 
 

 

body in other countries. Do all other countries universally have
a body to deal with drugs, or are there, in fact, some countries
where that question becomes irrelevant, the drugs can just be
dumped or marketed?

DR. YOUNG: Yes. That's the way the law was written,
so that 21 that were selected are countries that are analogous to
the U.S. in their regulatory schemata. They are not the
countries which would not have regulatory organizations, and
they were specifically chosen by Congress to take those nations
that are equivalent to the United States.

That's a very important question. It would be bad if
that were not the case. Excuse me, if I could, Mrs. Gebbie,
that's why I asked that you might want to consider an exemption
in AIDS for other countries that might want to request a drug for
treatment that is not yet approved in the United States.
Because, as it exists now, we could ship to the 21 and it would
be illegal for trans-shipment to go from here to Africa. That's
against the law, and thus, we are barred, if we had a drug that
was coming down, and under an evaluation, for example, of a
treatment IND, though we might subsume it under the IND and have
to go through the request of an IND, and the evaluation of the
physicians and such which we could use as a loophole, save that,
we could not ship a drug just prior to approval in the United
States to any of the developing countries, and that's something
that I wanted to point out for Dr. Conway-Welch.

CHAIRMAN WALSH: Frank?

DR. LILLY: Yes. Then her question goes on from that.
Given the fact that there is a mechanism for exporting AIDS-
related drugs to other countries prior to full FDA approval, she
wants to know is there a mechanism for the United States to
receive similar, not yet approved AIDS drugs for use in our
citizens with AIDS?

DR. YOUNG: No. There is not such a mechanism in that
way at all. One of the problems that we have in our law is that
we must, by our law, state that the drug is not only safe, but
also effective. So that, in that case we could ask for it to he
sent out, but we couldn't receive it, with a few caveats. At
the time that HPA-23, as a crisis arose, we were able to get some
of the interaction between the Institute of Pasteur and bring it
in as an investigational new drug, and as you know, as soon as it
was studied for any significant period of time, it was found out
that in that particular country, and in the countries that had
studied it before, there was not any toxicity data done, and it
was found to be a hepatotoxic drug of a significant magnitude,
and thus, there are not too many active studies on HPA-23 today.

153

 

 
As a footnote to her question, probably for better or
worse, the United States Congress has made laws that are more
stringent than any other part of the world, and thus, we could
bring it on investigational new drug, but the drugs that are not
approved in the United States would be mis-branded.

We have, though, taken a course that I've advocated, I
know I've been criticized in some quarters for it, that
individuals who wanted to bring in a drug from another country
for their own use, or went to another country and obtained the
drug for their own use, would not in any way be influenced by
FDA.

However, once it gets commercialized in the country or
is sent in a commercialized fashion without approval, then we
would deal with the company, not the individuals. So, we've
tried to adjust that way. It is not a complete solution, but
I've seen so many individuals involved with drugs that have not
been completely evaluated, that it's a knife-edge call, and we're
stuck with our law at this time.

DR. LILLY: Under what circumstances would you
consider research data obtained outside the United States?

DR. YOUNG: In all situations, we would evaluate this
data with the same intensity of scrutiny that we do in the U.S.,
and if it was good data, we would fully accept it, and there have
been a few drugs that have been approved on almost completely
foreign data.

There were some situations before the NDA Rewrite,
where at least one study had to be conducted in the U.S. That is
no longer applicable at this time, and I think that's a good
change, and I was glad to bring that one on board.

DR. LILLY: Okay. Let's see, I had one more
question. Relevant to the question of international standards
for evaluating drugs, are there internationally accepted
standards? Would it be useful to develop them?

DR. YOUNG: No, there are not. I do not see them
being useful at this point, because the cultures are so
different. For example, in West Germany, the company is bonded
against severe penalties in the information that they have. So
that, the company is trusted and then in the event that they did
something dishonorable there would be legal sanctions. That is
not the culture in the United States.

DR. LILLY: But, if there were a set of international
standards that company were bonded to.

154
DR. YOUNG: The United States, I think, as I see it
today would not necessarily want to be bonded to international
standards, and I know the E.C. now struggling trying to get
international standards by 1992 in pharmaceuticals, and they are
having a particularly difficult time.

We see even in the United States at this point, some
states looking to unbond themselves on standards, and I think
that it would be very hard to hold this at this particular
moment. Do you want to add a point, John?

MR. NORRIS: Just along the lines that Dr. Young
started off his testimony about, establishing a collaborative
network for information sharing with loops in it, so that we get
feedback on what is working and what's not working. So, you get
the best of both worlds that way. You don't have to establish
"international standards" or methods. You get the experience of
other countries in this country, and learn from that what really
will work. I want to make one other comment while I've got the
floor.

DR. LILLY: Well, with that, I wonder could I ask, what
are the barriers to getting that information into --

MR. NORRIS: Right now, there is not a successful on-
line, real time way of sharing information. We need to use --
and we've begun to use already, electronic media for sharing
information. We need to get feedback from other countries. We
need the same kinds of information we send them, we need to have
sent back to us.

DR. LILLY: And, why don't you get it?

MR. NORRIS: Well, we need to establish that
infrastructure, as the term you've used, the network.

DR. YOUNG: Dr. Lilly, I think I can add some points on
this that may be helpful. In the case of the three nations,
Canada, U.S. and U.K., we have agreement on a tripartite basis,
that we have that information.

Part of the problem has been resources in other nations as
well. One of the reasons that I raised this as a potential issue
is that, one nation does have to take the lead, or WHO has to
take the lead, and this is going to cost some degree of funds in
dealing with that.

Now, I'm not trying to advocate resource expenditures
here, but you're saying that one of the problems that WHO has had
in its international drug information system is there has just
not been the resources to make it really move internationally as
fast as possible.

155
And, I, for one, am very interested in seeing this
information started, and would be even if it were acceptable
internationally take the lead in that. But, I do think there is
some sensitivities that other nations might be concerned with.

DR. LILLY: This information that you're hoping to get,
is this information that you are hoping to be able to plug into
your evaluation of a drug?

DR. YOUNG: Yes. These are the kinds of things that I
would like to know. I would like to know, just as we put out
monthly our list of drugs that are under investigation, I would
love to know drugs in other nations that are under investigation.

We don't receive this in a formal fashion. We get some
of this, but it is only catch as catch can. I would like to see
adverse reactions, specifically, for AIDS drugs, as early as we
can. Sweden has an adverse reaction system, but it has fallen,
in regards to many, to disrepute. And, actually, at the last
Executive Board Committee, they were trying to evaluate and did
put a study forward to see whether the adverse reaction
reporting system is really meeting its needs. I'd like to see
that type of a situation, because we have the case, as I cited,
HPA=23 counted as an important drug, only to find out that there
had not been any substantial studies that dealt with toxicity.

I'd like to have a network on what animal studies have
been done on toxicity, so we would know, and not make the wheel
turn around each time. We would to, and Stuart has the
responsibility in our organization of communicating with the
other nations, but one of the things that I've asked him to do
now is to develop a method, if we can't use electronic, what can
we do by fax to send information out? But, I think we also ought
to have some information coming in, and I would like to see those
adverse reports.

Finally, I'd like to see if there were any major
concerns on research, any of the compounds that were looked at to
be of high interest in other countries. We do get some of this
information through NIH and Tony Faucci, as a good network. But,
the regulatory agencies, I think other than a research network,
need to have a network of what's going on in regards to other
countries, so that we can see what is likely to be a good lead as
early as possible. I will just recount one of these. When A.L.
721 first came out, it came out from, a European source, it took
a while to get the information on what that was based. I mean,
what were the definitive studies? How much was known? It's
these kinds of things that I would like to have a routine sharing
in some way, so that we can electronically get this around the
world as fast as we can.

156
DR. LILLY: Are these difficulties to any extent
proprietary? Are the barriers to transmittal of this
information in proprietary?

DR. YOUNG: Some of it would be proprietary, and each
nation has a different law, but the dominant issue is not
proprietary. The dominant issue is an exchange of just what's
going on there. You do have to protect proprietary, but the
regulators are used to doing that.

MR. NORRIS: It's really organizational and leadership
kinds of issues, and dollars kinds of issues. But, we have a
primitive information sharing network now established with some
WHO member countries to share post-marketing surveillance
information that's just coming on line now.

But, the system now can produce information in six
months that would have taken a year before, let's say. We need
to get that eventually geared up to a system that can give you
real-time feedback of drug experience, post-marketing experience,
and also pre-marketing experience with drugs. Information from
around the world would be helpful in our deliberations, and vice
versa.

CHAIRMAN WALSH: Thank you. How about you, Theresa, do
you have something?

DR. CRENSHAW: Yes. This seems like another and very
good example of how our concern about AIDS has become an impetus
to establish systems that will help us in many other diseases and
many other health care issues.

One of the questions that I'd like to ask that may be a
little naive, is that in relation to exporting drugs not yet
approved here, if they get an exclusion and they could go to
countries that didn't have our systems, could this not create a
black market for drugs? I'm particularly sensitive to that
because of being in San Diego and close to the Tiajuana border,
and I see what's happening already, where the net effect could be
that people with HIV infection in the United States could be
paying black market prices for drugs that have gone a very
indirect route back to them as their emissaries or others
transport them back and forth across the border. And, I know for
a fact, and I personally disapprove of this that the border
guards kind of wink at the HIV-related medications and allow --

DR. YOUNG: I'm responsible for that one way or
another.

DR. CRENSHAW: I know, you answered part of my
question a moment ago. But, could you comment on this?

157

 
 

DR. YOUNG: Surely. In regards to the black market
concern of drugs, that is a great one. The law says that there
cannot be trans-shipment, but you would have to catch the
violator to show that trans-shipment has not occurred to the
other developing countries.

I think it is a finite problem. The one thing that
will help us the most is to get good information out as to how
good or how poor a drug would be.

I was encouraged by the information that we cited in
your testimony for you, that if the drug is good, like AZT, nine
of the 11 countries, developed countries, have approved it in six
and a half months, and 47 countries in a year. The
biggest thing that we can do in the United States is get out
information on drugs that are useful.

The difficulty that I see in the United’States, if the
Chairman will permit me to take a slight tangent, is the fact
that we now are moving to public action on one study. 1'11 give
you two non-AIDS examples. A number of ladies in the United
States are using Retin A to take care of wrinkles, and Retin A
was done in a study of 30 people in a placebo. I have said on
television that no long-term carcinogenicity study or
teratogenicity study has ever been done on that drug, and that
drug is similar in makeup to Acutane, which we know gives
congenital defects.

So, the danger of now using that "willy-nilly" is high.
The same is true with aspirin, when you saw with a published
study on 44-year old to 84-year old men, that individuals were
switching to aspirin, and I had one person say, "Well, I really
love my husband so much, if one aspirin is good, couldn't I have
him take five?" You know, what risk is that per day?

And so, people are moving on therapies without them
being studied, and I worry about that in AIDS, but again, we've
got to get information out worldwide, and that's why I'd like to
have a network of regulators that can really spread information
back and forth on what is the validity of some of the claims in
the first studies.

DR. CRENSHAW: If there were bonding of some form in
place to neutralize your concern about liability within the
United States, would you support or favor making unapproved
drugs available in humanitarian studies? I know certain
humanitarian studies are already being done, but I mean on a
larger basis within the United States itself, or are there
problems I haven't thought of associated with that?

DR. YOUNG: I would personally not favor them until we
had some shreds of evidence of efficacy, for two reasons. The

158
first is, people are likely to chase, because of the desperately
ill nature of the disease, I can identify with this, I've shared
in another audience, I haven't shared before this Commission, but
last fall I had a melanoma that was removed. Fortunately, it was
a superficial melanoma. It's probability of a seven-year cure,
my odds are very good, 96 percent seven-year cure. Do TI feel
behind my ear where this was located? Yes. Do I worry about it?
Yes. Now, what if a person, instead of this prognosis, has
something where they've got a good chance of dying?

DR. CRENSHAW: Sure.

DR. YOUNG: By gosh, the temptation to try anything is
high. And thus, in that circumstance, I would not like to see
personally a deviation away from what the treatment IND has done.

Now, we have not had a large number of drugs come
forward yet on the treatment IND. I think that's a moment in
time. I think we will have more. And, since the time that I
believe I testified with you, we've looked back into the number
of INDs, and 61 percent of the 124 INDs that are active now are
in phase two, and 6 percent are in phase 3. So, we think we're
going to see some substantial treatment INDs. I think we have
the mechanism in place that will deal with that.

But, your question is one that's been an age-old one,
should anyone that's afflicted with a disease have access to any
drug, whether it be approved or not? I think that even if the
liability standpoints were taken care of, that there would be
such a temptation to use drugs that may be harmful, that some
sort of a collation of information might be important. John,
did you want to add to that?

MR. NORRIS: I just wanted to add that just a month ago
in Kansas City, we held a National Conference on Health Fraud,
and the temptation, the pressures to exploit these people are
very great, and we've got to be very concerned about them.

Fortunately, so far, the exploitation of the AIDS
patient has not been as great as we feared it would be. We've
taken a number of steps to help prevent that, but the potential
is very great. These people are desperately ill, and the
purveyor of health fraud, who successfully purveys billions of
dollars worth of fraud each year to cancer victims, and people
who are suffering from other ailments, can readily exploit this
population if we let them loose.

So, we've got to balance both the right of the
individual and the need of the individual to access to anything
that has real promise, with the protection of the individual from
true exploitation when they are so desperately ill.

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DR. CRENSHAW: Well, I think it's a really difficult
balance to achieve, and I don't envy you your task.
Thank you.

DR. YOUNG: This is a very great burden, there is no
question.

CHAIRMAN WALSH: Ms. Gebbie?

MRS. GEBBIE: First, I can't help but remark with
regard to your idea about an electronic network, which is an
admirable goal. One, I'm a little skeptical about achieving on a
worldwide basis in the short term, remembering how long it took
the FDA to get onto our nationwide network connecting us to
health departments, just an example, and we have a phone system
that generally works. It's admirable, but I have some questions.

DR. YOUNG: It's a hard issue, but I'd like to -- I've
got to get real-time sharing or fax sharing, or something.

MRS. GEBBIE: The two questions I have are a shift of
gears from the drug piece, and things that I think would be nice
to receive in writing, partly because of the time. We are
already running late and so on.

I think we need to hear a little more about the United
States agenda as a member of the Executive Committee of the World
Health Organization. We are a nation that tends to run after
quick fixes and shiny things, and I am concerned that AIDS can be
one of those, and would like some sense of how our agenda, as a
voting country, reflects those points about infrastructure that
you made at the beginning, either in the form of proposals we
have made, are making, or directions we are going, things we are
sustaining that build that, because I do see that as critical.

DR. YOUNG: I will supply for you for the record a
number of speeches that I have given, one in particular, I
believe you have it, an international meeting where I focused on
infrastructure.

Second, in regards to the program, at least as long as
I'm there on the WHO seat, you can rest assured that I will be
very vigorous, both in talking with the Secretariat, in speaking
with Dr. Mann, and I believe that he is still --

MRS. GEBBIE: He went into hiding, I think.

DR. YOUNG: -- here. He went into hiding. You can
ask him whether or not I have been vigorous on pounding on the
international scene there, and demanding, in the best way that I
can, that the United States meet its full commitments in regards
to AIDS. I think that this cannot be let go.

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MRS. GEBBIE: Well, I see it as much easier for us to
meet our full commitments on AIDS, but slither off on
commitments on that infrastructure more broadly stated, and
that's the piece I want some backup on.

DR. YOUNG: Yes. I think that there's a recognition,
and I will also have Stuart send you some information that we've
been working with in PAHO, to try to develop experimental
networks to build infrastructure. And, the one that I'm working
on now actually is, we've been asked by the Chinese government,
People's Republic of China, to develop their infrastructure in
regards to the Food and Drug Administration, and we'll be going
over there, I believe, in the fall, this September, and we are
working with them on questionnaires. We have also been asked to
do this in Pakistan. We have not completed that yet. We are
working with Jamaica and Costa Rica in this now, and we'll send
you that information.

MRS. GEBBIE: The other area that I'd like some
follow-up on is really a version of the question I've asked a
couple of witnesses earlier today. We are charged with making
recommendations for this country. It is clear from the
testimony we've had that what happens in this country has an
impact other places.

DR. YOUNG: Obviously.

MRS. GEBBIE: Wearing the hat, your hat as a voting
member of the WHO Executive Committee, what are the two or three
things that we could recommend this country do that would make
your seat on that body more comfortable, more expedient, more
useful, easier -- however you would label that? What are the two
or three things, from that point of view, that are most critical
for us to do?

DR. YOUNG: The first is a prompt and full payment of
our assessment. We are accused continuously of abrogating
unilaterally treaty agreements. And, I must say that in the two
years, the last two years, I have been deeply embarrassed. I
would say further that failure to meet our payments has resulted
in other nations being successfully able to take the leadership,
even though we still pay 20 percent, and other nations pay far
less than that, because all of the nations in the world say that
the United States has unilaterally abrogated its treaty. What is
our defense?

Our defense is that we are already paying 25 percent,
that we needed some reforms, and they were appropriate reforms,
and I support that. The only problem is, after the reforms cane,
the money didn't, and that's a difficulty.

161
The second thing that would be very important, and I
think would help me immensely and my successors in that post, is
to have some continuity. I guess that I'm one of the few people
that have served out the WHO Executive Committee term for the
three years that the person sits on it.

Sir John Reed served 17 consecutive years in the
Executive Board. The Soviet delegate serves many consecutive
years. Most of the nations in the world serve many years
consecutively on the Executive Board. The United States
reinvents its Executive Board membership about every year and a
half, and thus, the person coming over there does not have an
institutional history.

I have learned through this that you do need to build
up a degree of trust. You have to be consistent. You have to be
forthright and honest. In the absence of that, the first year or
two that you are at the Executive Board, you are not going to be
listened to, and then that changes.

The third area that I would see that's very important
for the United States is for the United States to have a stronger
network with other nations in a working relationship in its
international health. And, in here, the role of the Surgeon
General has been very helpful. He has spoken strongly about
international health, and in his visibility in AIDS, that's true.

But, the United States, because of the three areas that
I mentioned, has not had, in my opinion, the leadership that it
should. I believe that personally we've been able to garner some
good inter-relationships, but it is likely, following past
pattern, that after serving a three-year term, yet again, someone
else will start another three-year term, and will serve about a
year and a half of it, and the next person will fill the next
year and a half. I think you combine that with a lack of
payments, and you have an erosion of leadership, and that's an
irony for a country as great as this one is. .

MRS. GEBBIE: Thank you.

DR. YOUNG: I've tried to be possibly too blunt on
that.

MRS. GEBBIE: I don't mind people being blunt.

CHAIRMAN WALSH: We'll take it out of the record,
Frank.

DR. YOUNG: I may have to --

MRS. GEBBIE: Leave it in.

162
DR. YOUNG: -=- comment for the record further on that.
I was more candid.

CHAIRMAN WALSH: Well, we thank you again for your
candor, which you always demonstrate when you testify before us,
and I want the Commission to join me in congratulating you for
the award you are going to receive tonight for the work that
you've done in the "orphan drug" area. It's a well-deserved
recognition, and we congratulate you for it. And, with that, you
and your team are excused.

DR. YOUNG: Thank you very much.
CHAIRMAN WALSH: 9:00 o'clock tomorrow morning.

(Whereupon, the meeting was adjourned at 5:52 p.m.)

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