SPEAKERS CONTENTS INSERTS
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51–957 CC
1998
THE SPREAD OF AIDS IN THE DEVELOPING WORLD
HEARING
BEFORE THE
COMMITTEE ON
INTERNATIONAL RELATIONS
HOUSE OF REPRESENTATIVES
ONE HUNDRED FIFTH CONGRESS
SECOND SESSION
SEPTEMBER 16, 1998
Printed for the use of the Committee on International Relations
COMMITTEE ON INTERNATIONAL RELATIONS
BENJAMIN A. GILMAN, New York, Chairman
WILLIAM GOODLING, Pennsylvania
JAMES A. LEACH, Iowa
HENRY J. HYDE, Illinois
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DOUG BEREUTER, Nebraska
CHRISTOPHER SMITH, New Jersey
DAN BURTON, Indiana
ELTON GALLEGLY, California
ILEANA ROS-LEHTINEN, Florida
CASS BALLENGER, North Carolina
DANA ROHRABACHER, California
DONALD A. MANZULLO, Illinois
EDWARD R. ROYCE, California
PETER T. KING, New York
JAY KIM, California
STEVEN J. CHABOT, Ohio
MARSHALL ''MARK'' SANFORD, South Carolina
MATT SALMON, Arizona
AMO HOUGHTON, New York
TOM CAMPBELL, California
JON FOX, Pennsylvania
JOHN McHUGH, New York
LINDSEY GRAHAM, South Carolina
ROY BLUNT, Missouri
KEVIN BRADY, Texas
RICHARD BURR, North Carolina
LEE HAMILTON, Indiana
SAM GEJDENSON, Connecticut
TOM LANTOS, California
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HOWARD BERMAN, California
GARY ACKERMAN, New York
ENI F.H. FALEOMAVAEGA, American Samoa
MATTHEW G. MARTINEZ, California
DONALD M. PAYNE, New Jersey
ROBERT ANDREWS, New Jersey
ROBERT MENENDEZ, New Jersey
SHERROD BROWN, Ohio
CYNTHIA A. McKINNEY, Georgia
ALCEE L. HASTINGS, Florida
PAT DANNER, Missouri
EARL HILLIARD, Alabama
BRAD SHERMAN, California
ROBERT WEXLER, Florida
STEVE ROTHMAN, New Jersey
BOB CLEMENT, Tennessee
BILL LUTHER, Minnesota
JIM DAVIS, Florida
LOIS CAPPS, California
RICHARD J. GARON, Chief of Staff
MICHAEL H. VAN DUSEN, Democratic Chief of Staff
MARK S. KIRK, Counsel
ALLISON K. KIERNAN, Staff Associate
C O N T E N T S
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WITNESSES
Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases
Colonel Deborah Birx, M.D., Director, U.S. Military HIV Rsearch Program
Dr. Paul De Lay, Chief of HIV/AIDS Division, U.S. Agency for International Development
Dr. Peter Piot, Executive Director, UNAIDS
Dr. Nils Daulaire, M.D., President and CEO, National Council for International Health/Global Health Council
Mr. Peter Young, Vice President, HIV and Opportunistic Infections Therapeutic Development and Product Strategy, Glaxo Wellcome Research and Development
Dr. Michael Merson, Dean of Public Health and Professor and Chairman of the Department of Epidemiology and Public Health, Yale University School of Medicine
APPENDIX
Prepared statements:
The Honorable Benjamin A. Gilman, a Representative in Congress from New York, and Chairman, Committee on International Relations
The Honorable Nancy Pelosi, a Representative in Congress from California plus attachment
Colonel Deborah Birx, M.D.
Dr. Paul De Lay
Dr. Peter Piot
Dr. Nils Daulaire
Mr. Peter Young
Dr. Michael Merson
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The Honorable J. Brian Atwood, Administrator, U.S. Agency for International Development
Additional material submitted for the record:
Letter from The World Bank dated September 11, 1998, with ''Information Brief'' attachment
Letter from Senator Patrick Leahy dated September 16, 1998
Letter and background information regarding AIDS from the General Accounting Office dated September 15, 1998
Statement of Benjamin Nelson, Director, International Relations and Trade Issues, GAO
THE SPREAD OF AIDS IN THE DEVELOPING WORLD
WEDNESDAY, SEPTEMBER 16, 1998
House of Representatives,
Committee on International Relations,
Washington, DC.
The Committee met, pursuant to notice, at 10:20 a.m. in room 2172, Rayburn House Office Building, Hon. Benjamin A. Gilman (chairman of the Committee) presiding.
Chairman GILMAN. The hearing will come to order and I apologize. The Republican Conference is still in session. Some of our Members may be unduly delayed. Today the International Relations Committee meets to hear testimony on the spread of the HIV/AIDS virus. We are fortunate to have the opportunity to hear from the topmost experts in the field. They are all here in this room today. This is truly an extraordinary gathering and we are pleased to see all of you here in our hearing room.
Before proceeding further, I would like to take note of one person who is not able to be here today: Dr. Jonathan Mann and his wife, Mary Lou Clements, who were on the Swissair flight that went down over Nova Scotia. It was Dr. Mann's intellect and sheer force of personality that helped to move our Nation to the leadership position that it holds today in the fight against AIDS. We are holding a picture here of Dr. Mann and I ask for a moment of silence in memory of Dr. Jonathan Mann and his wife, who did so much for this important cause.
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Thank you.
Since its discovery, the HIV/AIDS virus has become the No. 1 killer of people who are aged 16 to 45 in most of the world's nations. Over 30 million people have HIV/AIDS. Five million people are newly infected each and every year. Eight million children have been orphaned because of AIDS. One thousand people will be infected with the virus during this hearing alone. Up to half of the adult population in some African countries have the disease.
The late Princess Diana dispelled many false conceptions about HIV/AIDS. There are still people who think that the average person with AIDS is a young person living in New York City who contracted the disease via intravenous drug use or unsafe sex with another person. Nothing could be further from the truth. As we will learn, in the next decade the average person with HIV will be a young Asian woman who contracted the disease from her husband.
There is another emerging misconception, and while mixtures of antiviral drugs like AZT offer hope for Americans with HIV to survive, people in the developing world cannot afford this option. Treatment which costs up to $15,000 per year cannot be sustained in the developing world where the entire annual health budget averages $10 per capita. The only hope is a change in behavior and a vaccine.
I would like our witnesses to address two major policy changes that the Congress should consider when viewing ways to strengthen our fight against AIDS. First is a suggestion by the Gay Men's Health Crisis that the drug AZT be provided to pregnant women with the virus as a way of preventing its transmission to their babies. They advise me that for $150 million, the international community could prevent 680,000 babies from being infected by their mothers. I think that is worthy of consideration.
Second, we should review the organization and progress of the U.N. anti-AIDS program, also known as UNAIDS. The GAO recently highlighted the excellent work of our own U.S. agency for International Development in this field and they also pointed to some concerns with regard to UNAIDS. It appears UNAIDS has been given an enormous mission with very few resources. We should consider ways to bolster UNAIDS by making it part of the World Health Organization or the World Bank, where most funding for the fight against AIDS is now being spent.
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Dr. Martha MacGuffie of the Nyack Hospital, a constituent of mine and winner of the 1998 Lions International Humanitarian Award, met with me just this last weekend and highlighted the three C's in our fight against AIDS: Challenge, Change, and Courage. Dr. MacGuffie, I might note, has been a missionary. She is a plastic surgeon and has visited many of the African nations in her quest for providing better health throughout the world.
We must recognize the huge challenge that AIDS poses, bring the change in attitudes required, and finally muster the courage to fight this plague of our times. Dr. MacGuffie runs programs, as I have noted, in Africa, and has already witnessed the coming devastation caused by AIDS.
Before introducing our first panel of witnesses, I would like to recognize our Ranking Minority Member, Mr. Hamilton, for any opening remarks he may have. Mr. Hamilton.
Mr. HAMILTON. Mr. Chairman, we thank you for calling the hearing. I want to join you in welcoming our very distinguished witnesses, not just for their appearance this morning but for their dedication to dealing with this problem of the spread of AIDS.
And I yield to Mr. Gejdenson for comments.
Mr. GEJDENSON. Thank you, Mr. Chairman. I would just say what we have before us is a challenge in an economic sense as well as simply in a medical sense in that the poorest of the poor out there have the greatest challenges in getting the information about how to prevent AIDS and clearly the medical necessities to fight AIDS once it has been contracted. Jared Diamond in a book entitled ''Guns, Germs and Steel,'' as he looked at the development of man, said that the most dangerous illnesses were not those that killed as quickly but those that lingered on in the host able to infect for years to come. AIDS untreated can last almost a decade in an individual and we can see the effect globally, clearly in sub-Saharan Africa where almost half of the daily 16,000 HIV infections occur. We need to make sure that our program out of USAID and the U.N. programs all work together and that we provide the funding. This is a case where it is not simply humanitarian. It is also economic. The economic devastation of AIDS will bring ruin upon the economies of sub-Saharan Africa and other communities in the world and will have an economic impact on the United States as well.
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So for both humanitarian and economic reasons it is, I think, critical that we move forward as quickly as possible, and I commend the Chairman for holding this hearing.
Chairman GILMAN. Mr. Lantos.
Mr. LANTOS. Thank you, Mr. Chairman. I would like to commend you for convening this hearing. At the outset I want to thank publicly my staff person, Serena Lin, for the outstanding work she has done in this field.
Mr. Chairman, over 90 percent of the 30 million people living with AIDS reside in the developing world. Only by working from an integrated and coordinated global perspective can we successfully combat this disease and lessen its debilitating effects upon our own country. We are all present at this hearing because we recognize how serious the AIDS epidemic is to be taken, and during this hearing we will learn a great deal about the resources we have available to address this disease as well as the resources still needed in order to stand this horrendous plight.
I am very pleased we will have the opportunity to look into the recent GAO report on USAID and the U.N. response to the epidemic in the developing world. Even beyond the scope of the recent GAO report, the questions we would like to answer are very difficult ones. What is the economic impact of the dramatic spread of the AIDS virus in such places as South Africa, South and Southeast Asia, Latin America and Eastern Europe? When might we obtain an AIDS vaccine? How can we best prioritize our resources needed to combat the virus?
I am particularly pleased, Mr. Chairman, that today we are privileged to hear from one of the most distinguished authorities in the world on this subject. One of them, though, is not testifying and I would like to take this opportunity to recognize Dr. Tom Coates from my own district in San Francisco, who is here with us today. Dr. Coates is the renowned executive director of the AIDS Policy Research Center at the University of California in San Francisco, one of the crown jewels of my congressional district. JCSF is committed to international HIV/AIDS research and operates the largest AIDS research effort in this country outside of the NIH.
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Dr. Coates has brought to my attention some astonishing numbers, Mr. Chairman, in regards to our international AIDS effort. The fund for Centers for Disease Control is $650 million in the fight against HIV/AIDS domestically, and I strongly support that. We fund USAID with $120 million and contribute only $16 million to the UNAIDS program, which is about 60 percent of the paltry budget of some $60 million with which to fight against HIV/AIDS transmissions in the rest of the world.
How can we hope to have success in eradicating this epidemic with some modest resources? According to Dr. Coates, USAID and UNAIDS have worked successfully with the University of California, San Francisco AIDS Center, and each of these organizations is a key factor in the success of the others. This is truly a symbiotic relationship.
I would like to highlight the extraordinary contribution of the United States in fighting the AIDS epidemic. We are the largest single support of HIV/AIDS prevention in the developing world. We must continue this commitment and in my judgment must increase it dramatically. We cannot be hindered by political squabbles, primitive approaches to this important and serious disease.
I would like, Mr. Chairman, to welcome Dr. Peter Piot, the Executive Director of the UNAIDS program, a renowned scientist who discovered E-bola virus and is a leader in the AIDS field. He is here to address the concerns of the recent GAO report in regards to the UNAIDS program as well as to tell us how the United States might best continue to support and improve this essential operation.
I want to thank you again for calling this hearing, and I look forward to our witnesses.
Chairman GILMAN. Thank you, Mr. Lantos. We are pleased to have with us this morning Congressman John Porter of Illinois. Mr. Porter founded the U.S. Government program against international AIDS in 1986 and has worked closely with the late Dr. Mann. We welcome Congressman Porter. Congressman Porter also serves as a chairman of the Labor-HHS Subcommittee of the Appropriations Committee and is one of the most influential Members of Congress on all HIV/AIDS issues, including a search for a vaccine. Congressman Porter, if you would like to make your statement, please proceed.
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Mr. PORTER. Mr. Chairman, let me thank you very much for including me in this very, very important hearing. I did first get involved with the issue of AIDS on the international scene in 1986, when Dr. Jonathan Mann came to me as a Member of the Foreign Operations Subcommittee requesting assistance for funding for the World Health Organization's effort, and we did provide an initial amount of $30 million. Obviously the problem has become much worse since that time, although there is also some ray of hope for improvement.
Mr. Chairman, I welcome the witnesses and I am very anxious to hear their testimony. Some of them come before my subcommittee, Labor, Health and Human Resources and Education, a subcommittee of the Appropriations Committee, and I particularly want to welcome Dr. Fauci, who has provided such tremendous leadership not only for our country but throughout the world as Director of the International Institute of Allergy and Infectious Diseases and under whose guidance a great deal of progress has been recently made in the area of AIDS research.
So, Mr. Chairman, thank you so much for including me today. I am very anxious to hear what our witnesses have to tell us.
Chairman GILMAN. Thank you, Congressman Porter. I would also like to recognize the following distinguished people in the audience who have been playing a key role in their fight against AIDS. If they would kindly please stand as we introduce you.
Paul Boneberg, Director of Global AIDS Action Network. Mr. Boneberg, thank you for being here.
Ambassador Sally Cowal, Director of UNAIDS Department of External Relations. Welcome, Madam Ambassador.
Ronald Johnson, Managing Director for Public Policy, Communications, Community Relations at the Gay Men's Health Crisis in New York City, also serves as a member of the President's Advisory Council on HIV/AIDS. Thank you for joining us.
Patsy Fleming, former Director of the White House Office on National AIDS Policy. Thank you for being with us.
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Ron Macinnis, Director of Global Health Council Global AIDS Program. Welcome, Mr. Macinnis.
Jairo Pedraza, UNAIDS Program Coordinating Board, North American Delegate and Community Chair of the HIV Planning Council. Thank you.
Lt. Colonel John McNeil, Chief of HIV/AIDS Development, Walter Reed Army Hospital. Colonel, thank you for joining us.
Jacob Gayle, UNAIDS Liaison to World Bank. Thank you, Jacob.
Tom Coates, Director of UCSF AIDS Research Institute, University of California, San Francisco. Is Tom Coates here? Tom, thank you for joining us.
Helen Miramontes, Presidential Advisory Council on AIDS, University of California, San Francisco. Thank you, Helen.
Jane Silver, AMFAR, Director of Public Policy. Jane, thank you. And Chuck Einloth, Director of HIV/AIDS Workplace Education Project. AFL–CIO. Thank you, Mr. Einloth.
Our first panel features Dr. Fauci, who has been appropriately described as a national hero. Among the one million scientists throughout the world who published during 1981 through 1994, Dr. Fauci was the fifth most cited. As an author, coauthor or editor, he has published more than 900 scientific publications and holds 17 honorary doctorates. That wall must be pretty heavily adorned. Since 1968, he has served the National Institutes of Health and is the current Director of Allergy and Infectious Diseases.
Dr. Fauci, we welcome you to the International Relations Committee. You may submit your prepared statement for the record or summarize, whatever you deem appropriate. Welcome, Dr. Fauci. You may proceed.
STATEMENT OF DR. ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
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Dr. FAUCI. Mr. Chairman, with your permission, I would like to use some visual aids.
Chairman GILMAN. By all means. Keep the mike handy over there if you would.
Dr. FAUCI. What I would like to do in the few minutes I have is summarize for you some of the activities that we have undertaken at the National Institutes of Health and our sister agencies with regard to combating the HIV/AIDS epidemic. I show this first poster to emphasize that HIV/AIDS is one of any of a number of emerging microbes that have evolved literally from the beginning of time, some of which have caused devastating public health effects. This is just a partial list. We had a scare this past winter with the bird flu, H5N1, in Hong Kong. We have antimicrobial resistance of microorganisms and then we have the subject of the discussion this morning, HIV/AIDS.
As you heard in the opening statements of some of the Members, there are more than 30 million people living with HIV worldwide, and there is no end in sight to this devastating epidemic. The projection is that these numbers will skyrocket over the next several years. Importantly, the vast majority of these infections have occurred in developing countries, particularly, as you see here, in sub-Saharan Africa, with some statistics that are really quite staggering. One in every 100 adults worldwide between the ages of 15 and 49 is HIV positive, with, as we have heard this morning, approximately 16,000 new infections each day; 11.7 million HIV-related deaths occurred through December 1997 and approximately 80 percent of adult infections are due to heterosexual transmission, predominantly in the developing world.
This slide is good news, but it is good news only for developed countries. This graph shows the AIDS deaths in the United States. From January 1985 through June 1997 and, as you can see, over the past couple of years, there has been approximately a 40 to 50 percent decrease in the death rates, almost certainly due to the introduction of highly effective antiretroviral therapy in addition to other factors such as successful preventive measures. But with this good news comes some sobering news. This next poster indicates the drugs that have been approved for HIV, making up what is commonly known as the antiretroviral cocktail or triple combination of drugs including a protease inhibitor. You see the cluster of approvals from 1996 through 1997, and at least two and likely three new drugs are currently pending FDA approval.
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But if you look at the annual cost of these drugs; up to $15,000 to $20,000 per year per patient to adequately treat an HIV-infected individual. Such therapy is not yet totally available to citizens within this country and is completely out of the reach of individuals in developing countries, where the per capita allotment to health care is measured in a few dollars per year, literally not enough to treat an individual for a week or two, leaving us to the approaches to HIV prevention, which are many, culminating in one that I would like to spend a moment on. I refer to the interruption of vertical transmission, which you just alluded to, which could occur with treatment with AZT of individuals who are pregnant during their latter weeks of pregnancy. Education and behavioral modification, topical microbicides, condoms and clean syringes, treatment of sexually transmitted diseases and finally, and most importantly, for the developing world, vaccination. This is a schematic diagram showing the increase in funding for AIDS vaccine research at NIH from 1995 to 1999. And with the generosity of the committee that Mr. Porter chairs, we now are up to over $180 million, which is a marked increase over the past few years, with the selective concentration on the development of a safe and effective vaccine.
Now, the pursuit of these preventive measures, particularly internationally, requires a strong degree of collaboration, and this slide schematically diagrams some of the collaborating organizations with which we in the Public Health Service and at the NIH interact, from our own sister government agents, to nongovernmental, philanthropic organizations, to industry, academia, foreign nations and also UNAIDS, which is the subject of some of the discussion this morning.
Let me close by giving you some of the examples of successful NIH-UNAIDS collaborations, ranging from the ethical issues in preventive HIV clinical trials where they serve as an honest broker between developed countries and developing host countries; interrupting maternal-fetal transmission by collaborating with us on these clinical trials; feasibility studies for vaccine trials, as well as obtaining reagents such as viral strains from developing countries.
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So in summary, the effort on HIV is one which spans a number of disciplines. I have addressed the research component of this; however, I want to close by emphasizing the importance of international collaboration if we are to successfully contain this terrible epidemic. I would be happy to answer any questions.
[The information referred to appears in the appendix.]
Chairman GILMAN. Thank you, Dr. Fauci, for your very poignant presentation and emphasizing some of the important aspects of our work. What is your best estimate on when a workable HIV/AIDS vaccine may be available, Doctor?
Dr. FAUCI. Unfortunately, Mr. Chairman, it is impossible to give anything resembling an accurate estimate. I can give you some very brief facts that might help us understand what will happen over the next few years. It is very likely that there will not be a safe and effective vaccine available for the next several years. There are a number of candidate vaccines that are in various stages of clinical trials, which are already looking at efficacy both here in the United States and soon in countries such as Thailand, as well as many candidates that are in phase one and phase two trials. So we do have a number of candidates in the pipeline, which won't be available for several years, which emphasizes the importance of today engaging in other preventive measures as we accelerate our vaccine efforts.
Chairman GILMAN. Some of the preventive medications that are out there are quite costly. Can you tell us what the average cost is of those that slowed down the whole process?
Dr. FAUCI. The medications referred to are for treating people who are already infected with HIV. If you look at a typical triple combination, including the protease inhibitor, it ranges anywhere from $12,000 to $18,000 up to sometimes $20,000 per year per patient. The mean is somewhere around $18,000.
Chairman GILMAN. Do any of the medical plans take care of that medication?
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Dr. FAUCI. In the United States, a number of the health care delivery and payment plans do take into account and are able to provide the resources for this, but this is not universal. There are still some communities that do not have the resources to provide the full triple combination therapy to their constituents.
Chairman GILMAN. And Dr. Fauci, do you think we should support a program, as it has been suggested, to provide antiviral medicine to mothers in the developing world to prevent the transmission of HIV to their children?
Dr. FAUCI. Well, certainly that is an approach that would have a substantial impact. It was shown in our original study that was done in collaboration with our European colleagues that if you treat pregnant HIV-infected mothers for many weeks during pregnancy, from the 13th week on, you can have a dramatic decrease in the transmissibility to the fetus. Recent trials have shown that just a few weeks during the latter part of pregnancy can decrease the transmissibility by 50 percent or more. So given those facts, it certainly makes sense that, if at all possible, providing this drug to people in developing countries would have a major impact on perinatal transmissibility.
Chairman GILMAN. Dr. Fauci, what are the prospects for less expensive diagnostic kits that could be affordable to the developing world to measure the spread of the HIV virus?
Dr. FAUCI. As we get better and better technically, there is an excellent prospect for inexpensive kits. Some of them are already in the process of far advanced development and others are still in the pipeline. I foresee in the next few years that we will have kits available that could easily make the diagnosis of HIV by a standard antibody test but in a very rapid, inexpensive way.
Chairman GILMAN. Dr. Fauci, one last question. How does NIH coordinate its research priorities in design with organizations that work on the ground with these people and what can we do to improve collaboration?
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Dr. FAUCI. Well, over the past several years, collaboration really has been excellent. In the beginning of the epidemic, at a time when many agencies were going in somewhat different directions, this was somewhat problematic. However, over the last several years, the collaboration not only among U.S. Government agencies but among international agencies has been excellent. So I really look forward to continuation of this collaboration.
Chairman GILMAN. Thank you, Dr. Fauci. We commend you and hope you will continue your good work.
Mr. Hamilton. Thank you.
Mr. HAMILTON. Thank you, Mr. Chairman. Dr. Fauci, I am not sure you are the person to answer this. Perhaps you know. How much does the U.S. Government spend on AIDS? In all aspects.
Dr. FAUCI. In the research endeavor, for example, at the NIH it is $1.7 billion on research per year. If you add AIDS in the other agencies, including the health care costs for drugs, you are talking about several billions of dollars.
Mr. HAMILTON. That includes treatment through the Medicaid program?
Dr. FAUCI. Precisely.
Mr. HAMILTON. So it is a very expensive business. I know very little about this field but I am impressed by the large number of statistics and that raises a question. I also have some experience with the developing world. How good are these statistics? You threw around an awful lot of statistics in the testimony before us today. I know how difficult it is, or have some idea how difficult it is, to collect information in developing countries. Are you operating from a pretty good data base, do you think, in these figures that are thrown around here?
Dr. FAUCI. Mr. Hamilton, I believe that we have data that are as good as we can get. When you do sentinel studies where you take representative samples from different developing countries and develop a mathematical model to project what the infections are, the number that we gave and that my colleagues will talk about, for example, 30 million individuals living with HIV infection, is, if anything, somewhat of an underestimate.
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Mr. HAMILTON. You think those figures are conservative then?
Dr. FAUCI. I think they are relatively conservative. Recent data that came from WHO and UNAIDS over the past several months, just about the time of the international conference in Geneva, gave some rather startling examples. For example, in sub-Saharan Africa two countries, Botswana and Zimbabwe, approximately 25 percent of the adult population is infected with HIV, which is absolutely devastating.
Mr. HAMILTON. You mentioned that the 30 million figure of people in the world who now test positively was going to—I am not sure of your word—explode or increase dramatically. Do you know what that figure might top out to be? Is there going to be a cap on it at some point?
Dr. FAUCI. I can't say, but it will depend upon the efficacy and efficiency of preventive measures. I will give you a very brief example. Right now about 20 million of the 30 million HIV-infected individuals are in sub-Saharan Africa. The most recent report is that there are about 5 or 6 million people infected in India. If India explodes with HIV infection, which everyone is predicting that it will if we don't do something dramatic with regard to preventive measures, then we are talking about 40 million people infected by the end of this century and up to 100 million as we enter the early part of the 21st century. Again, those are projections, but if we look at what the projection was in Africa and what actually happened in Africa, there is every reason to believe that unless something dramatic happens in the realm of prevention, we will see this and even worse in some of the Asian countries.
Mr. HAMILTON. Can you spell out for me how the explosion of this disease in the developing world will impact Americans here in this country?
Dr. FAUCI. Well, that is something that is very complex, but very real. If you look, for example, at something like the economics of it, we have interactions and relationships with nations whose economic and even political stability is severely threatened by the disease burden that is currently present and that might actually evolve over the next few years. So there are political, economic, and of course humanitarian interests with regard to the American public. So in several arenas, I think this is of considerable importance to those of us in the United States.
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Mr. HAMILTON. The well-being of Americans will be greatly impacted by the progress of this disease in the developing world; is that a fair statement?
Dr. FAUCI. I think so. I think there are people on the Committee who know more about this than I do. We often use the phraseology, which is true, that we now live in a global community and we need to take international health very seriously because it will have a real impact on America. Since HIV is such a devastating epidemic, I think that it is a very good prototype of how an international disease can ultimately have impact on the United States notwithstanding people in this country who are infected.
Mr. HAMILTON. One final question, Mr. Chairman, if I may, you used a phrase a moment ago that this rapid increase in the number of people that are positive would occur unless there were dramatic steps, I think I am quoting you about right, dramatic steps to prevent it.
Dr. FAUCI. Right.
Mr. HAMILTON. Put aside the money factor for a moment. What other kinds of dramatic steps would you envision if we really wanted to get serious about preventing the spread of this disease? Forget the economics of it, obviously very important, but what kinds of things should we be doing?
Dr. FAUCI. The first and foremost is something that is not going to be the solution this year or next, and that is the development of a vaccine, as I alluded to in the presentation. But prior to and even subsequent to the development of a vaccine, intensification of education and behavioral modification. We have good examples of countries in which the infection rate was horrific, absolutely astronomical. Because of the seriousness of the leaders of those countries and international organizations such as WHO and UNAIDS and others who have helped, the turnaround of transmissibility has been dramatic. Two countries that come to mind are Thailand, for one, which among military conscripts had a double-figures infection rate per year approaching 20 percent. This rate has gone down dramatically because of education and behavioral modification, and the same is true even in developing countries such as Uganda, which has shown a significant turnaround. And I think if we use those two countries as models, we may be able to have a positive impact not only in sub-Saharan Africa and South America but also in the next wave of the epidemic in Asia.
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Mr. HAMILTON. The political leadership has to get very strong.
Dr. FAUCI. Absolutely. In fact, political leadership was one of the major factors that turned things around in Uganda.
Mr. HAMILTON. Thank you.
Chairman GILMAN. Thank you, Mr. Hamilton. Mr. Porter.
Mr. PORTER. Thank you, Mr. Chairman. Dr. Fauci, if you look, let's say, alone at the African continent and if you said that the world wasn't going to do anything regarding HIV infection on that continent and you looked at current population trends and death rates from HIV, what would you see 20 years out?
Dr. FAUCI. If there were no improvements at all, as you mentioned, Mr. Porter, I would see absolute devastation of populations. We are really on the brink of that when you look at, for example, Botswana and Zimbabwe. When you have 25 percent of the adult population infected, if you just take those 25 percent alone, that is actually much worse than a devastating war. The fact that there is such a high volume of infected people in the country means that transmissibility will be that much easier because if you have a low prevalence of infection, then that would be an important factor toward a low incidence; whereas, if you have a very high prevalence of infection, then new infections very rapidly occur. So you can talk about real devastations of whole populations and nations.
Mr. PORTER. Let me try and summarize. The treatment cocktail that has been developed is obviously hugely expensive and really from a practical standpoint will not be available any time soon to people in Africa. The vaccine is some years away from development and will take some time to become available worldwide when it is developed. The diagnostic tests are not relevant if you don't have the means of treating the disease or preventing it. So what we are left with is looking at—maybe you can put your list back up there—is prevention. That is a place where international dollars can do some good. And I am correct in saying that the money spent in preventing an individual from getting the disease is very cost effective compared to treating someone who has already become HIV-infected, and we should continue to put dollars into vaccine development through NIH and through your institute, which is obviously in the best interest directly of the American people. What can we do in terms of putting dollars into UNAIDS that will result in public education programs that really will prevent the disease? In other words, with limited dollars, what should we be doing in Congress to target in a way that is most effective the dollars that we spend to prevent people from getting this infection?
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Dr. FAUCI. Mr. Porter, I think, as alluded to when you asked to put that up, it is really on there. There are several things that are already ongoing in our collaborations. For example, with UNAIDS, and support of that collaboration directly and indirectly I think would hit upon several of the areas that I have on that poster. For example, the interruption of vertical transmission and collaborations in the clinical trials that would affect these areas. A very, very important component of education and behavioral modification.
Mr. PORTER. Isn't that very expensive compared to spending money on public education, let's say?
Dr. FAUCI. Which one?
Mr. PORTER. The interruption of vertical transmission.
Dr. FAUCI. Well, the answer is yes, but if you look at the data that now shows that if you treat women for the last few weeks of pregnancy, you can have up to and greater than a 50 percent decrease in transmissibility. So for a few hundred dollars or less, if the drug is made available at that low amount, you can prevent the infection of an individual. If you were going to treat that individual would be measured in thousands and thousands and tens of thousands of dollars, which wouldn't even be feasible because in developing countries they are not going to get treated anyway. But what is important is that an individual who is not infected who otherwise would be infected results in a decrease in the total burden of infection in the country.
Mr. PORTER. Recognizing that Africa is a very diverse continent with a lot of different countries and a lot of different medical care systems, is that a practical alternative in many places where you actually can get pregnant women who are HIV positive into a medical service place for treatment? Is this possible to do?
Dr. FAUCI. To say that it would be possible to the extent that you would see it in a developed country, the answer to your question is no. Would it be possible enough to have a significant impact? I think yes. Obviously the infrastructure in many of these countries is such that the health care delivery system would not even allow you to have access to a significant proportion of individuals who are pregnant and HIV-infected. But we feel you need to start somewhere and that is why infrastructure building in these countries and the kinds of work that USAID and UNAIDS is doing is going to be very important.
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Mr. PORTER. What I am really trying to get at is where can we best spend our money because funds are limited and where will the expenditure of money do the most to prevent the most number of people from becoming HIV-infected?
Dr. FAUCI. I think two places. One is one that would take time, and that is vaccine because as in any disease like HIV, vaccination could possibly put an end to the epidemic.
Mr. PORTER. We are going to do that in any case.
Dr. FAUCI. Exactly.
Mr. PORTER. Beyond vaccine.
Dr. FAUCI. Beyond that I think things like interruption of vertical transmission and a reconcentration on our international collaborations that are involved in education and behavioral modification. You have the Uganda model. It works. You have the Thailand model. It works. We as a nation should collaborate and help our sister nations, both developed countries and developing countries, in trying to use those mechanisms to interrupt the epidemic in developing countries. So I think concentration on education and behavioral modification is important. We are doing research on topical microbicides. If we get safe and effective topical microbicide, that could have an enormous impact on those societies where it is very difficult socially for women to demand the use of a condom, which is another reason why we are emphasizing topical microbicides in our research effort.
Mr. PORTER. Thank you, Dr. Fauci. Thank you, Mr. Chairman.
Chairman GILMAN. Mr. Gejdenson.
Mr. GEJDENSON. Thank you, Mr. Chairman. The Chairman in his opening statement expressed some concern about the UNAIDS program whether or not it should be moved into the world health organization. You in your opening statement seem to indicate that UNAIDS was helpful in accessing data and information and countries might not be as ready to simply hand it over to an American agency or USAID. Could you expand a little bit on your view? Apparently an earlier GAO report argued there were some shortcomings, people involved in the program say that well, you know, we just started. It was a few months. To pull the rug out from under us now and starting a whole new bureaucracy will just create additional trouble. Do you have any opinion on that?
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Dr. FAUCI. Well, I can only speak from the interaction that I have and my agency has as a scientific organization doing basic and clinical research and we most interact with UNAIDS in our clinical research endeavors on the international front. I can tell you quite clearly that our interactions have been very favorable with them. I cannot address the problems that were specifically alluded to in the GAO report, because I don't see that coming into the arena in which I interact.
Mr. GEJDENSON. Agencies operated with a level of expertise and responsibility, care, quality that you think is a very good working relationship for it?
Dr. FAUCI. Without a doubt. There is no question about that.
Mr. GEJDENSON. Thank you very much.
Chairman GILMAN. Mr. Burr.
Mr. BURR. Thank you, Mr. Chairman. Welcome, Dr. Fauci.
Dr. FAUCI. Good to be here.
Mr. BURR. Usually we see each other in Commerce, so it is a little different setting. I have had the opportunity to spend some time with you at NIH and to see the work and I commend you in front of this Committee for the work that you have had underway for some time there and for your expertise and compassion in this issue. Let me move right to the heart of things. I think John Porter tried to find out from you, maybe not from an international standpoint, from a domestic standpoint, what have we done here that has been the most effective? Given the fact that we have developed new drugs to treat individuals, what have we done that got us to those that were infected? What policy, what initiative have we done that got us into the population of those infected with HIV?
Dr. FAUCI. It has been embracing from a public health standpoint, the HIV-infected community so that one builds up a trust with them so that we have access to their communities. In the very early years of the epidemic because of the extraordinary organization and competency of the organized gay populations, that was relatively easy because they were working very hard, as hard as we were, and we developed a good relationship to have access into that community. Most recently, with the shift of the epidemic from a demographic standpoint, inner cities, minorities, individuals of low economic status, women, HIV drug users, we have had to work much harder to embrace the leaders of those communities so we could have access into them. I think that is reflected very nicely in the demography of our clinical trials effort, which very early on in the epidemic had less than a couple of percent of individuals who were inner city minorities or women. Now they occupy up to 30 percent or more of the trials. So it really is a consistent effort each year to try to engage the individual communities so that we can have access to them.
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Mr. BURR. You mentioned the public health effort. In fact, we are talking about HIV infection in countries that have yet to even discover what a public health organization is in many cases. What challenge does that present USAID or UNAIDS or any group that is going to try——
Dr. FAUCI. It is a very daunting challenge which is the reason that those of us in the public health community here in the United States are very, very hesitant to criticize efforts because we know the extraordinary obstacles that organizations such as UNAIDS and USAID face in going into countries where the infrastructure is very prohibitive for their efforts. And despite that, there has been headway made, which is the reason why those of us who have the luxury of operating in the structure in the United States are very encouraging toward our colleagues because under the circumstances they are doing a very fine job.
Mr. BURR. If you remember the polio effort, in fact the health community internationally could not complete that process. It took a private organization, Rotary International, to cross the political challenges that exist across the country. Do you see that in this case as well? You face many of the same hurdles.
Dr. FAUCI. Mr. Burr, I think you are right on the money there. If we, and I believe we will, develop a safe and effective vaccine, I think we are going to have to see the same sort of international collaborative effort that we saw with polio and with small pox to help eradicate, if not eradicate, at least substantially suppress and curtail this epidemic. That is when you have a product, a vaccine that works. So you can imagine when you are trying to effect a change on pure public health issues by prevention and behavioral modification, how much more difficult that is when you don't have good access because there isn't a good health care delivery system. So it is a very daunting challenge.
Mr. BURR. Two very quick questions. You alluded to the fact that you were hopeful that in the very near future we would have an easy and accurate test for HIV. Do you perceive that possibly being a home testing kit?
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Dr. FAUCI. Well, certainly there are home testing kits that have already been developed and they didn't go anywhere because there was not, at least in this country, a substantial market for them. There was somewhat of a miscalculation of what the need or the desire of it would be, and that is probably because as the home test kit evolved, it became very easy to get confidential testing at any of a number of community organizations so that there wasn't the need for a home test kit. But from a technical standpoint, kits are readily available and the situation will be even better as kits become less expensive and easier to use.
Mr. BURR. The last question, you said we are not in just a domestic health world. We are in an international health world. Should our domestic and international policy on health be one and the same?
Dr. FAUCI. Well, I don't think it should be identical, but I think we should make international health part of our public policy, in fact even perhaps our foreign policy, because of the enormity of the problem of health in developing nations that are of importance to us both politically and economically. So as a scientist who doesn't have political expertise, I see from a public health standpoint that we must pay attention to international health because it is becoming more and more of a problem that impacts Americans each and every day and it will be more so as we enter the 21st century.
Mr. BURR. I thank you, Dr. Fauci. I yield back the remainder of my time, Mr. Chairman.
Chairman GILMAN. Thank you, Mr. Burr.
Mr. Payne.
Mr. PAYNE. Thank you very much. Good to see you, Dr. Fauci. First I just want to comment for a moment. I was very happy to hear your relationship with the UNAIDS has been very positive. I haven't had an opportunity to read the GAO report but I did see a cover letter sent to the chairman of the Committee that talks about four reasons that they thought that the program was not moving along well, and I think that the program has been in existence for such a short time, with such a complicated problem, I am not surprised that there would be difficulties in starting up and coordinating between six different U.N. organizations. So I totally feel that this GAO report might be a little bit premature and that we ought to try to do a GAO report to see how we could get more support and aid from the U.S. Government and USAID toward this project, because I think when you have a group focus, primarily coordinating with the other U.N. agency, it would certainly end up being more effective. And so I am glad GAO did the report but I think we could have saved some money if we had waited a little while to let the agency get started.
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Let me ask a couple of very quick questions. There was, as you know, a decade or so ago, a push for breast feeding. What is the position now and is HIV transmitted through—we know it is supposed to be transmitted through breast milk. What is the position in those developing countries?
Dr. FAUCI. The position has certainly evolved. You can recall, Mr. Payne, that early on when it was clear that HIV could be transmitted by breast milk, that there was the feeling that since there are a number of other diseases that would occur and the health of the child in the developing world would probably suffer more if you recommended not to breast feed, then it was best to say go ahead and breast feed. But we are seeing now that there is a substantial proportion of infections in infants that are occurring after birth and as a result of breast feeding. So now the international community is rethinking this recommendation about whether or not we should, where possible, recommend the use of formula. You recall years ago there was somewhat of a catastrophe when formula was recommended and the water wasn't clean and we did more harm than we did good. But right now we have to readdress that question because too many infants and young children are getting infected through breast feeding. So that needs and is getting a very hard, fresh look.
Mr. PAYNE. Thank you. What about the question of cesarean births. Does that reduce the possibility? I know it is not available in many, many places, but does that tend to cut down the possibility of HIV transmission?
Dr. FAUCI. The answer is yes, Mr. Payne. Early on there were some anecdotal reports that cesarean section, all other things being equal with regard to any infection and the placenta, would decrease the transmissibility since the vast majority of transmissi-bilities occur at or around the time of birth. There are now studies that I have looked at reasonably carefully and the data looked reasonably good. The difficulty, as you alluded to yourself, is that it is just not a feasible approach, certainly not in a developing country where it would be totally impractical to perform these operations on individuals.
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Mr. PAYNE. Going along with the chart, I see that Botswana and Zimbabwe, within sub-Saharan Africa, are two countries which have the highest incidence, which is kind of surprising because Botswana probably has about the highest per capita of sub-Saharan Africa and Zimbabwe probably has an educational system maybe even comparable on the primary and secondary school to U.S. schools. And so two countries where you have a high level of—comparative to the rest of the continent, where there is a higher standard of living and a higher per capita and a higher literacy, is there any rationale for what we see?
Dr. FAUCI. There are several points to be made. One, there are migrations that have contributed to the problem, but that doesn't explain at all the inherent problem in the country. And I think it has a lot to do with the lack of realization of the potential for the spread of this epidemic and there may even have been a little bit of complacency when one has a reasonably good health care delivery system. But if you are not paying attention to preventive measures, it doesn't make a difference what kind of health care delivery system you have.
We recall with great sadness and horror what happened in our cities with the gay population early on in the epidemic, where we have a wonderful system that those individuals had access to, but because of the lack of realization of what was going on, it devastated that community. So it is not too difficult to understand.
Mr. PAYNE. Another quick question as I conclude. We talked about the Uganda example and as you know at one point, especially during the conflict and there is a correlation, I think, of civil strife and conflict in countries where you have large militaries and the transmissal of the virus. But Uganda had one of the highest rates a decade ago and the President, who did not want to hear anything at all because I had about two or three meetings with him, one on one, about the use of condoms, he just said abstinence was the way to go and that was it. Well, I think with the concentration on President Museveni and finally seeing there had to be something else done and the fact that they create local groups that go out to villages, implement the use of drama and music—I visited several of them—has been very effective.
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One of the charges I would say that for the UNAIDS group would be to really spend a good deal of time trying to chronicle and make a prototype, as you have indicated, of the Uganda model. Of course, once again, it takes the Head of State to decide that he is going to put all of his Cabinet people, so to speak, in the fight and I don't know whether they are all as enlightened as President Museveni is, but I would suggest that any thoughts you have with the UNAIDS people that they look at this model carefully.
Dr. FAUCI. They are very aware of it and are actually using models like that to help other countries who are trying to look for the most effective means of prevention and they have done a very good job at that.
Mr. PAYNE. Just finally, could you explain the tremendous increase in Russia, Belarus for example, where there has been a tremendous increase in the last 2 or 3 years—it doesn't have anything to do with democracy, does it?
Dr. FAUCI. No, I don't think democracy did it, Mr. Payne. I think it was an example of a disaster waiting to happen. With the destabilization of many of these countries there is an extraordinary amount of intravenous drug use which really sparked the epidemic, and now it is spilling over into the heterosexual population. There is increase in prostitution and an increase in intravenous drug use. Those are the same factors that fueled epidemics in other countries. It is no surprise that it is happening in the former Soviet Union.
Mr. PAYNE. Thank you very much.
Chairman GILMAN. Thank you, Mr. Payne. Mrs. Capps.
Mrs. CAPPS. Thank you, Mr. Chairman. I want to commend you and your office for holding these hearings. This topic is of vital interest to all of us in the International Relations Committee but also within our Congress and I am sorry, Dr. Fauci, I wasn't able to hear your presentation. As a public health nurse who spent my career with teenagers and in a school district in my community, this topic is of vital interest to me and my constituents. In a world perspective, it is also very important to our country.
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I know you touched many of the issues. I just want to—maybe for a summary, I think I am the last questioner. I am talking now about research at the NIH and how we can help make that go further. Within the next 5 years, do you see other areas besides the vaccination area that you are hoping to see progress on?
Dr. FAUCI. We hope to see progress in a couple of areas. In the area of therapeutics, we know we have some excellent drugs now. Unfortunately, the initial euphoria of the great effectiveness of these drugs is leading to a sober reality that there are a substantial proportion of people who either do not respond initially to the antiretrovirals or cannot tolerate them.
Either lack of compliance because it is difficult to take so many pills, or the toxic side effects that we have seen and heard about most recently, make it very difficult for people to take the drugs.
In addition, there is the emergence of multiple drug resistant HIV. We need newer drugs against newer targets, and we need drugs that are more user-friendly, in the sense that they do not need to be taken 4 or 6 times a day, but can perhaps be taken one time in the morning so that there would be a greater level of adherence by the individual. So therapeutics need to be developed.
I alluded earlier to topical microbicides. It is important to find ways that we can empower women to take into their own hands their ability to avoid and prevent HIV transmission, because in many cultures even in this country it is very difficult for a woman to negotiate successfully the use of a condom by her partner.
And then finally the vaccine, as I alluded to. We are now selectively accelerating our resources and efforts in the area of vaccines. Those are three areas.
Mrs. CAPPS. One further question with two parts to it: In the area of the collaboration within this country, collaboration among sexually transmitted diseases within NIH or other public health arenas, that there be a concerted effort. They often are not solitary. And also then how you see that kind of collaboration extending to Third World countries.
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Dr. FAUCI. Right. Well, again it is right there next to the last one.
Mrs. CAPPS. Yes, it is.
Dr. FAUCI. There have been very good studies that have shown that HIV transmissibility is markedly enhanced in the presence of other sexually transmitted diseases, particularly those that cause genital ulcers. Also, some studies have proven that if you treat individuals under certain circumstances, with sexually transmitted diseases, you can decrease the rate of transmission of HIV.
We know what is successful here in the United States and in some developing countries. So a marriage of disciplines of sexually transmitted disease studies, both from medical, therapeutic, and sociological standpoint, is extremely important in combating HIV. And that is something that I believe we have been successfully doing over the past few years.
Mrs. CAPPS. And is that able to be implemented in other countries, as well?
Dr. FAUCI. Well, absolutely. Some examples of treating sexually transmitted diseases and having an impact on HIV have actually been shown in some developing countries. There is one study that actually contradicted it, but there are other studies that showed that if you treat whole villages, for example, for sexually transmitted diseases, you can have an impact on the rate of transmissibility of HIV.
Mrs. CAPPS. Thank you very much.
Dr. FAUCI. You are welcome.
Chairman GILMAN. Thank you, Mrs. Capps.
Dr. Fauci, we truly appreciate your spending the time with us. We want to commend you for your good work, and we wish you success in your future endeavors.
Dr. FAUCI. Thank you, Mr. Chairman.
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Chairman GILMAN. Thank you for taking the time to be with us.
Dr. FAUCI. Thank you, Mr. Chairman.
Chairman GILMAN. I would like to submit, by unanimous consent, the following documents. I ask unanimous consent to include copies of the GAO report and their letter updating their findings in the record. The report is dated September 15th, 1998.
I also ask unanimous consent that a letter from our executive director to the World Bank, an attachment detailing the World Bank's cooperation with UNAIDS, be included in the record, and that is dated September 11th, 1998.
I would also ask unanimous consent to include a letter to the Committee from the No. 1 supporter of the program in the Senate, Senator Patrick Leahy of Vermont, dated September 16th, 1998. Without objection.
[The information referred to appears in the appendix.]
Chairman GILMAN. We now call our second panel, if they would be kind enough to come to the witness table: Colonel Debra Birx, Director, U.S. Military HIV Research Program; Dr. Paul De Lay, Chief of HIV/AIDS Division in the U.S. Agency for International Development; and Dr. Peter Piot, Executive Director of UNAIDS.
The second panel features these three witnesses who represent our military, USAID and UNAIDS, three organizations that our government has given lead roles to in fighting AIDS.
Colonel Birx has served the Army Medical Corps for some 18 years, subspecializing in immunology at Walter Reed Army Medical Center, currently serves as Director of Retrovirology and is in charge of the U.S. Military HIV Research Program.
Dr. Paul De Lay is Chief of the USAID Global Bureau, HIV/AIDS Division. Dr. De Lay worked under Dr. Mann in the global program on AIDS and took over USAID's program from Dr. Daulaire in February 1997.
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Dr. Peter Piot is the Executive Director of the Joint U.N. Programme on HIV/AIDS, UNAIDS, taking over from Dr. Merson, who followed Dr. Mann.
Doctors, you may submit your prepared testimony for the record or you may summarize your own statement, whichever you may deem appropriate. And Colonel Birx, you may begin.
STATEMENT OF COLONEL DEBORAH BIRX, M.D., DIRECTOR, U.S. MILITARY HIV RESEARCH PROGRAM
Colonel BIRX. Chairman Gilman, Members of the Committee. Thank you for this opportunity to speak to you today about the HIV/AIDS epidemic and the work that the U.S. Military HIV Research Program is doing to combat this global public health issue. I will just summarize my written statement.
The Human Immunodeficiency Virus, or HIV, is the virus that causes AIDS, is a serious threat to the U.S. military forces. In response to this threat, a research program was initiated in 1986 to minimize the impact of HIV on U.S. military readiness by monitoring the spread of HIV infection in our military forces and developing specific methods to combat these infections.
The U.S. Military HIV Research Program is a highly targeted program specifically addressing the military concerns of HIV. This includes international surveillance and national surveillance of infection rates and HIV subtypes around the world; development of effective global HIV-1 vaccines and unique education strategies to prevent infection, and clinical studies to slow progression and prevent immune deficiency in our already infected active forces.
Research on HIV infection is necessary to safeguard our military forces. New data clearly demonstrates that a number of our active duty personnel are acquiring HIV during overseas deployments. In addition, there is continuous discovery by our scientists that new genetic variants with unpredicted biologic qualities and epidemic potentials continue to emerge internationally.
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We also know that HIV/AIDS has emerged as a pandemic over the last 20 years, destabilizing some national governments and infecting a large number of our international military forces to which we are co-deployed. Infection in our active duty troops acquired during overseas deployments is caused by HIV strains not normally found within the United States. These foreign viral strains may have different transmission characteristics or even be unresponsive to the currently well-described therapies outlined by Dr. Fauci.
As you know, there is currently no cure or approved vaccine to prevent HIV infection. The Military HIV Research Program has as its primary goal the prevention of HIV infection in our fighting force; therefore the development of a protective vaccine that is effective against all strains of HIV is a cornerstone of this mission.
The military HIV program, focusing on the development of a vaccine that protects against all strains of HIV, is highly leveraged through cooperative development initiatives with private industry and vaccine companies. In addition, coordination with U.S. Federal agencies, including the NIH and the CDC, and international agencies such as UNAIDS, as well as strategic alliance with the Royal Thai Government, has resulted in an excellent opportunity for the U.S. military to conduct advanced development of protective vaccines focusing on non-U.S. strains.
These collaborative efforts are an integral force in the battle against the HIV/AIDS epidemic. The Military HIV Research Program has strong relationships with many U.S. Government and intermatched organizations, and without their support our mission would be made much more difficult to accomplish.
Evidence of this support can be found in our relationship with UNAIDS. We look to UNAIDS as an international voice, a voice of fairness and reason when dealing very specifically with developing countries. The relationships that UNAIDS has developed around the world have greatly benefited our program in numerous and specific ways.
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Our program has utilized UNAIDS to review protocols for vaccine development, and to assist with the implementation of these global clinical vaccine protocols in other nations. We look to UNAIDS for its sound ethical and scientific review of our work and as an ally in assisting us in the fight of the HIV/AIDS epidemic around the world.
For the past decade, the Military HIV Research Program has been in the forefront of the global battle against HIV, focusing on the aspects of the epidemic that pose a very specific threat to U.S. military readiness. We thank the Committee and I thank you specifically for inviting me to testify today about the military research program, and I would be happy to answer any questions that are deemed appropriate.
[The prepared statement of Colonel Birx appears in the appendix.]
Chairman GILMAN. Thank you Colonel Birx.
Dr. De Lay.
STATEMENT OF DR. PAUL DE LAY, CHIEF OF HIV/AIDS DIVISION, U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT
Dr. DE LAY. Thank you. I, too, on behalf of USAID, would like to thank the Committee for affording us the opportunity to address this issue which is going to continue to haunt us well into the next century, and is going to be a legacy that our children's children are going to have to deal with.
I would like to make a couple of comments, for the purpose of brevity, on the GAO audit. And it is important for us to note that we were very gratified that USAID was noted for two major accomplishments: We are, and, continue to be, the major donor in the battle against the international epidemic, and have contributed over $1 billion since 1986. Our current budget of $121 million is $34 million more than the World Bank health sector loans, which is the second major donor. We provide 25 percent of the annual budget of UNAIDS, and it is a testament and tribute to you on this Committee and other key Members of Congress that we have been able to withstand all of the storms as far as overseas funding and been able to maintain this amount.
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The second achievement, that we think is more noteworthy, is that UNAIDS was recognized as being one of the prime developers of the essential interventions that have led to success in the developing world, particularly regarding prevention. We validated these interventions and are now sharing them globally.
We have been working in over 70 countries, and have offered intensive personal counseling and education to over 22 million persons for sexual behavior change. Our programs mainly focus on community groups and NGO's; in fact, 70 percent of our funding goes to those groups. We also are the major supporter of actual implementation of activities. And these two key points make us very different from what UNAIDS does, and I would like to return to the role of UNAIDS at the close of this.
I would like to focus on three key lessons that we have learned in the last 10 years and hopefully emphasize that we need to keep these in mind, particularly in regard to the questions that you have raised earlier.
The first and foremost one is that we do have the tools today to help stem this epidemic, even in the absence of a vaccine. We have got several examples that have already been mentioned—Uganda, Dominican Republic, Thailand—of reversing the very severe epidemics.
However, there is another cluster of countries that we should also point to where we feel we have stemmed the development of the epidemics through early, comprehensive, very aggressive programs. These include Senegal, the Philippines and, we hope, Indonesia. So this is working now much sooner than I think any of us really thought that it would.
The other thing we should remember, particularly in regards to a vaccine, is that it is very unlikely that we will get, early on, 100 percent effective vaccine. And unless this is clearly explained to those who receive the vaccine, we may see disregarding of safer sexual behavior and we could wind up doing more damage than good. We also know from experience that vaccine programs directed at adults in the developing world are very difficult to pull off in a short order of time.
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The second basic truth that I think that we have learned about this epidemic, and it really drives our success, is that we are able to change a very basic primal behavior, sexual behavior, in a sustainable way. And the ways that we have learned to do this have focused very much on early involvement of community groups, early involvement of community groups and targeting of our interventions so that they really address those most vulnerable and most at risk of transmitting the infection.
The third lesson I would like to point to is that we need to start doing selected aspects of care. Care is not defined for us as antiretrovirals; instead, it is very simple palliative therapies. It is focused on the major killer of people who have AIDS in the developing world, which is tuberculosis. And it is the secondary epidemic, the explosion of this secondary epidemic that we need to be very concerned about in this country, in addition to that of HIV.
I want to close by just making a couple of comments about UNAIDS. The U.S. Government was one of the first supporters of the special program on AIDS and supported GPA through 1995. We also were part of the designers of the UNAIDS. As was pointed out, I used to work for GPA. I spent 3 years in Malawi in East Africa, one of the most severely affected countries, and I know what our strengths were and what our weaknesses were.
And one of the things we could never do working under the WHO was to bring and convene the six U.N. cosponsors together in a room. We just did not have that credibility. And this is clearly one of the mandates that UNAIDS has. It is a unique organization. It is very complementary to what we are doing as far as provision of services, and if it didn't exist, we would have to turn around and create it.
Thank you.
[The prepared statement of Dr. De Lay appears in the appendix.]
Chairman GILMAN. Thank you, Dr. De Lay.
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Dr. Piot.
STATEMENT OF DR. PETER PIOT, EXECUTIVE DIRECTOR, UNAIDS
Dr. PIOT. Thank you, Mr. Chairman, Members of the Committee. It is an honor to address this important hearing on the global AIDS crisis. And I would like to summarize my written statement in four main points, but before that let me join you in paying tribute to Jonathan Mann and Mary Lou Clements, who were both on their way to UNAIDS in Geneva when they tragically died.
The first point I would like to make is that the AIDS epidemic is far from being over, as mentioned by all previous speakers, and I won't elaborate on that.
My second point is that prevention works. And I am often asked what the bottom line is with regard to bringing the global HIV epidemic under control, and there are two bottom lines: one for today and one for the future.
The bottom line for the future is that we desperately need an effective vaccine. You have just heard from Drs. Fauci and Birx how the United States is showing leadership here. And we are very proud of UNAIDS, that we are playing a modest but vital role in this endeavor, particularly when it comes to the development of an HIV vaccine in and for the developing world.
The bottom line for the present is that we must act now, with the knowledge and tools we have in hand, with the kind of approaches as just mentioned by Dr. De Lay. This doesn't require new breakthroughs in technology, but rather new breakthroughs in political will.
The third point is that only a worldwide effort can stop the HIV epidemic, and is even necessary to bring HIV sustainably under control in the richer countries. Over the past 15 years we have learned that such a response requires solid partnerships working in a synergistic fashion.
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But of course it is not enough to simply have more partners mobilized. Such partnerships require common objectives, a cohesive strategy and effective leadership, and that effort requires an effective platform. And I believe that if the U.N. system did not exist before the epidemic, we would have had to invent it for this purpose.
This brings me to my fourth and main point. The U.N. system under the umbrella of UNAIDS has made significant progress to a more effective response to the epidemic.
Mr. Chairman, in organizational terms, UNAIDS is a different type of animal within the U.N. system. It was deliberately decided by the member states of the United Nations, led by the United States, Canada and Sweden, not to make UNAIDS a separate organization, as experience has shown that no single organization, be it WHO or the World Bank, has all the expertise or resources to effectively address the politics and the programmatic aspects of the response to the AIDS epidemic.
Instead, UNAIDS is a multiagency effort with a small secretariat, and the six partners in this program, which previously operated separately, as was just mentioned by Dr. De Lay, and often were advocating different policies, now increasingly work together in a common forum. And let's not forget that many of their country programs are now addressing AIDS for the first time ever.
Let me also mention that this is also the first U.N. program to extend broad membership to peoples organizations. UNAIDS is standing to act as a global advocate.
At the global level, the multilateral platform has enabled UNAIDS to serve an effective brokering role for both ideas and commodities. Recent examples include negotiating economy-of-scale prices for antiretroviral drugs, for HIV test kits, and a public sector price for the female condom.
Last year alone, we supported over 50 countries to develop their own strategies and priorities for fighting HIV. And providing practical tools and technical advice to countries is one of our highest priorities, and it is increasingly supported by a popular collection of over 160 best practice documents.
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And to end, I would say that 2 1/2 years after our creation, I am convinced that the basic concept works, and for me that basic concept is called the power of partnership, the power of leverage.
And let me cite you just a few countries before ending. In the largest country in the world, China, the efforts of the UNAIDS, the Theme Groups on AIDS and UNAIDS, and the government resulted in a major policy change on AIDS, a changing of gear in response to the epidemic. I summarized this in the joint UNAIDS-Government of China policy report.
In India, the country with the largest number of infected individuals, UNAIDS has forged a major expansion of the international partnership and supported the Government of India around a new major bank loan, a loan from the World Bank, and with USAID as a major partner.
And I could give you far more examples, like in Eastern Europe where we are supporting community advocates to challenge political leaders to address the skyrocketing HIV problem, particularly among HIV drug users.
In closing, Mr. Chairman, as one who has seen this epidemic from the time we first recognized it as a public health problem, I believe that we are selectively still seriously underestimating the impact of the epidemic. And perhaps, tragically, we are also underestimating what we can do now to slow it down. If we only join forces and dedicate the massive resources we need to use the tools we have today and to find more tools for tomorrow, I am convinced that we can turn this epidemic around. And with your commitment and leadership, we are more likely to succeed.
Thank you very much for your support.
[The prepared statement of Dr. Piot appears in the appendix.]
Chairman GILMAN. Thank you, Dr. Piot.
I want to welcome our colleague, Congresswoman Nancy Pelosi of California. Ms. Pelosi serves as a Ranking Democratic Member of the Foreign Operations Subcommittee of the Appropriations Committee. She is a No. 1 supporter of the program to fight AIDS in our Subcommittee, according to her chairman, Sonny Callahan, who advised me that he simply follows Nancy's guidance on these issues.
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Thank you, Congresswoman Pelosi, for coming, and if you would like to make an opening statement, please proceed.
Ms. PELOSI. Thank you very much, Mr. Chairman. With the business on the floor and all the rest, I am sorry that I could not be here for the full hearing. First of all I want to thank you for your leadership in having this hearing today. I thank you and I thank our distinguished Ranking Member, Mr. Hamilton, for being present also at this hearing to demonstrate your personal commitment to this very, very important issue. I thank you both for your leadership on so many issues.
Yes, this is a priority for us on the Appropriations Committee and our chairman, Sonny Callahan, has been cooperative. I just wish the constraints of our budget allocation were not so tight, so that we could even do more, but it is a very high priority in our bill.
This, I understand, is only the second time that the Congress has ever had a hearing on the global AIDS pandemic, and I am so pleased to see the level of participation that we have here.
Mr. Chairman, I do want to acknowledge the terrible loss of Jonathan Mann and Mary Lou Clements-Mann. It was stunning news to us. We all know what important warriors Jonathan and Mary Lou were in this fight, and their work and their lives, as well as their sad deaths, should always be an inspiration to us in this fight.
You know the horrifying statistics about the worldwide AIDS epidemic, so I would just like to make two specific points about the GAO report. First, it is gratifying to see that the principal conclusion of the GAO report reflects the success of our investment in the USAID global AIDS program. Second, we must have a multilateral, multiagency approach to the international epidemic. UNAIDS is responsible for coordinating the work of many international agencies. They have already implemented steps to address some of the shortcomings identified by the GAO report.
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I am disappointed that the GAO reports that the support given to UNAIDS by other U.N. agencies appears to be less than promised, so hopefully the focus on this issue now will change that. There are many other issues: perinatal transmission, the promise of biomedical answers to prevention, AZT, the new drugs, et cetera, all point to our best hope being a vaccine.
I know that that issue has already been addressed in this meeting, so I won't go into it. This is a primary issue for our office. In my district we have lost about 15,000 people to AIDS. I know the statistics are staggering throughout the world, but the spread of AIDS into the heterosexual community and among children highlights the importance of this issue.
I am so pleased to see the very, very distinguished panel that you have before you, and I know everyone came to hear them and not me, so I will submit the rest of my statement for the record. But I do, in closing, want once again to commend you and Mr. Hamilton and the Members of the Committee for your personal and official attention to this issue.
We have tried for a long time to get the worldwide AIDS issue onto the agenda of the G–7, because the devastation that AIDS is presenting to countries will have economic impact, but most importantly it has a personal impact. I know that Dr. Piot has had some level of success in that direction, but I think we need to have more, and a hearing of this kind will serve to elevate this issue to that level.
Thank you, Mr. Chairman, for your leadership, and for affording me the opportunity to make some comments at this important hearing.
Chairman GILMAN. Thank you, Congresswoman Pelosi, for coming, and for your leadership in your Appropriations Committee which is so important.
I am being called to the floor, and I am going to ask Congressman Burr to chair the meeting. Before I leave, though, I want to thank NCIH and Ms. Carol Miller for all of the assistance that she has provided to the Committee in arranging for the hearing.
Mr. Burr.
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Mr. BURR. [Presiding.] I thank the Chairman. And the Chair would recognize himself for 5 minutes.
Colonel, let me just ask, is the education on HIV within the military different for those troops who go to areas of the world that we know have a high concentration of HIV infection, or is it consistent throughout the force?
Colonel BIRX. That is a very insightful question. And it wasn't until about 5 years ago that we realized that we were teaching vanilla education techniques to soldiers and sailors and airmen that were at differential risk during deployment. We did not have different techniques for evaluating troops prior to deployment.
I think that is an important thing, and over the last 3 years we have designed programs that are currently undergoing testing and evaluation during shipboard deployments. The sailors are a very captive audience during their original transition in the ocean, and we are able to provide intensive, 20, 25 hours of very intensive behavioral/scenario education about potential risks during deployments. I think this is absolutely critical, and we are now deploying this technique to our Marine guards that are stationed throughout Africa because they have the same risk.
We are also trying to reach specific actual deployment groups prior to deployment, and there are very good education techniques going on in the Bosnia sector now. I think that is a very important point.
Mr. BURR. What is the department's testing policy for troops? Do we have one HIV testing policy?
Colonel BIRX. It varies by service. The Army tests all active duty troops every other year. The Navy is testing every year. And the Air Force is testing approximately every 5 years. There is also a requirement for testing within 6 months of any international deployments.
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Mr. BURR. Is there any effort within our military to standardize that within the branches?
Colonel BIRX. There is. And I think each of the branches is very sensitive to the unique risk that each of their services are under. And they know, they are tracking their infections and have a good idea now of which are occurring during deployments, and I think post-deployment screening is beginning. And so I think they are becoming very aware of the need for standardization.
Mr. BURR. Dr. De Lay, if we had a vaccine today that was 100 percent effective, how long would it take us internationally, from your estimate, to get this infection under control?
Dr. DE LAY. I think the response to that would be based on what resources we had available; how aggressive, how massive the response could be. When we look at vaccine programs in particular, and the resources that we have had over the last 30 years, and realize how difficult they are to pull off, particularly the ones that are focused on pediatric infections where you are more likely to see that child and mother access the health infrastructure, that has taken an incredible amount of time.
And we are only now seeing the impact of those immunization programs 30 years later, where we have had fairly sufficient—or not sufficient, but at least adequate resources. I wouldn't postulate the amount of time it would take. We would probably go in and target youth as the first population and then go into the higher risk areas and do a targeted phaseout of the vaccine.
Mr. BURR. Aren't we talking about international countries where we are still having a difficult time educating some people about the bacterial effects of the water that we ask them not to drink?
Dr. DE LAY. Yes.
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Mr. BURR. So the challenge is huge?
Dr. DE LAY. The cultural considerations. I think this was one of the most daunting aspects of the behavior change interventions, our different culture, different social norms, different levels of awareness, different understandings of biomedical models, the whole concept of organisms causing disease, the concept of viruses, the concept of incubation periods, the concept of infectiousness.
Mr. BURR. Do you believe, Dr. De Lay, that we have a structure set up currently, whether it is USAID or whether it is UNAIDS or any of the interrelated agencies that are involved from an international standpoint, that has identified yet all of the challenges we will be faced with, political and economic?
Dr. DE LAY. No, I think we are still struggling with both the response and with the impact, and we are learning every day. We are far more sophisticated than we were 10 years ago. Ten years ago we would look at every country equally and state if there was evidence of unsafe behavior going on, either injecting drug use or sexual behavior, and if you threw HIV into that mix, you would inevitably get the same explosive epidemic from country to country.
We are way beyond that. We have a much better understanding of the quantitative aspects of behavior and how to intervene. As far as the impact, political stability, social stability, impacts on specific health sectors, labor sectors, 40 percent of the health providers in East Africa are infected. Forty percent of the teachers, primary and secondary school, are infected. That is going to have a devastating impact. We can't retrain these people fast enough.
So it has a devastating impact on all aspects of society. We originally looked at macroeconomic indicators, GNP, GDP, per capita, and failed to find impressive changes. Now we are getting much more subtle and realizing that the changes are happening at the household level. Households are being decimated by this, as they struggle with their last resources to care for the sick and then pay for the funerals.
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Mr. BURR. I thank you, Doctor.
The Chair's time is expired. The Chair would recognize Mr. Hamilton for 5 minutes.
Mr. HAMILTON. Thank you. And I want to thank the members of the panel for their contribution.
Colonel, how many military people are infected with the HIV virus?
Colonel BIRX. The numbers continue to change, of course, as the epidemic has moved on, and many of our military personnel have retired secondary to immunodeficiency. But the estimates in all three services range between 7,000 and 10,000.
Mr. HAMILTON. And is that figure moving up sharply? What is the trend line, going down or staying pretty steady?
Colonel BIRX. It has been very stable over the last 5 years. It is no longer decreasing.
Mr. HAMILTON. OK. To the panel in general, what countries—we have had several references to sub-Saharan Africa, but what countries worry you the most? What two or three countries cause you the greatest concern?
Dr. DE LAY. In Asia, undoubtedly Cambodia is probably the lead country. It is a small country, but 4 percent of the general adult population is infected, and that is twice what we saw in Thailand, which we used to think was the worst affected. But clearly the impact on India and on China, because of the sheer population size, they have a prevalence of less than 1 percent but that means 5 million people infected. That can double so quickly.
But with that size of vulnerable population, India is a population that is twice the size of sub-Saharan Africa, so we can get much lower seroprevalence rates but still have massive numbers of people.
As far as Latin America, Haiti, 12 percent of the population is infected in Haiti.
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Dr. PIOT. Mr. Chairman, I think that we should not neglect what is going on in Eastern Europe at the moment. Even if in absolute terms only a few hundreds of thousands of people are infected, what we are seeing is an explosive situation against the background of a social decay, of a disruption of the fabric of society, and with an emerging epidemic of injecting drug use as well. So we are very concerned about that, and the current economic and social crisis, of course, will undoubtedly contribute to the spread of HIV.
Mr. HAMILTON. Do you include Russia as well?
Dr. PIOT. Yes, Russia. Ukraine is the most affected country at the moment, but even some of the Central Asian republics are becoming seriously affected by HIV, primarily through injecting drug use.
Mr. HAMILTON. And in Africa, what two or three countries are the worst there?
Dr. PIOT. I Include at the moment Botswana and Zimbabwe and all the countries of southern Africa. I would say that it is South Africa that in absolute terms is now leading this macabre competition. Last year alone 700,000 South Africans became infected with HIV. We are now totaling about 3 million South Africans that are infected. That is really where the major impact of the epidemic will be seen, and we will see economic devastation as a result of AIDS.
Mr. HAMILTON. Now if you were to point to a success story, what would be the best example of a success story, of a country that has come to grips with the AIDS virus, launched an effective program on it, and made some real progress in decreasing the incidence of the disease? Would that be Uganda?
Dr. PIOT. I would say, Mr. Hamilton, Uganda is certainly a prime example of a successful response. We have also been able to measure and document very well what is going on: A decline by about 40 percent of the prevalence of the rate of infection among urban women over a 5-year period, and that is associated with a dramatic change in sexual behavior; delayed onset of first sexual intercourse, with an average of 2 years delay, which is spectacular over 3 or 4 years; less sex partners, higher condom use.
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And I think it is due to two key factors, or three: First, political leadership, as mentioned before by Representative Payne. And then, second, a community-based response. And, third, a very focused assistance by the international community, with USAID being in a leadership position there.
And I think that making HIV visible and openness about the epidemic has been a real key factor, which implies now that there is far less discrimination about HIV in a country like Uganda than in the other African countries we just mentioned.
Mr. HAMILTON. Is it fair to say that key among the factors you mentioned is political leadership at the top of the government, I presume; is that right? They really have to get focused on this problem and then energize the entire country?
Dr. PIOT. That is true, Mr. Hamilton. I will say up to the top, but also leadership at community level. We are working, for example, very much now with religious leaders because they are very influential in their communities. And, for example, in several African countries we work together with Islamic and Christian religious leaders, because we have seen that that is a very important part of a sustainable response to the epidemic.
Mr. BURR. The gentleman's time has expired.
The Chair at this time would recognize our colleague, Jim McDermott, from Washington. Dr. McDermott is one of the most experienced Members on the subject of international AIDS and was a co-requester of the GAO report. The Chair would certainly extend to Jim the opportunity to make any type of statement that he would like to if he feels so moved.
We thank our colleague for joining us.
At this time the Chair would recognize Mr. Gejdenson.
Mr. GEJDENSON. Thank you, Mr. Chairman.
Dr. Piot, let me just ask you the main proposition that Chairman Gilman put forth, apparently responding to the GAO report. His suggestion was that you should be blended in with the World Health Organization. What is your response to that?
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Dr. PIOT. Thank you for that question. I have no problem with that question because we are already part of WHO and also of the World Bank, because we are not a specialized or separate agency, as I said in my statement, but we are really a cosponsored program. This was decided based on the lessons of the last 10 years of international action on HIV, and where it was clearly demonstrated that no agency can do this alone because there is no single approach that will make it.
And also AIDS has now become a true development problem, even if it is a crisis. This is not like an epidemic outbreak which will come and go in a few years, this is about generations. And that is why it is absolutely vital that each agency in terms of the U.N. system addresses HIV in its programs, in its mainstream and in its core programs.
When I think of UNICEF, I think of the 500,000 babies that are born every year with HIV, and where AIDS has now become the No. 1 cause of mortality, and asking UNICEF not to deal with that would be absurd.
Mr. GEJDENSON. Let me interrupt you. Additionally, it seems to me that if there was a criticism of your agency, it was that you took too long to get started, whether that is reasonable, or get organized to the level they were looking for. So it seems to me if we were now to try to create a new organization, either in the World Bank or in the World Health Organization, we would have to go through the same growing pains once again and lose again valuable time. Any prevention that occurs today, any slowdown of the increase obviously is a victory of sorts.
Dr. PIOT. I would agree with that. First, reform takes time and is painful. We have seen that. And we are really part of a more efficient and effective approach in the international arena and of the U.N. system. And I would say also that we have now reached a momentum, where HIV/AIDS is now one of the top priorities of the new WHO as declared by Dr. Brundtland.
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Second, at the board meeting of UNICEF last week it was stated that HIV will now be one of the priorities of UNICEF, particularly in Africa. And also at the World Bank there are a number of very important loans on HIV that are in the pipeline. So we are here in the momentum that I think would be really too bad to break at this time.
Mr. GEJDENSON. Thank you very much.
Dr. PIOT. Thank you.
Mr. BURR. The gentleman's time has expired.
The Chair would recognize Ms. Pelosi.
Ms. PELOSI. Mr. Chairman, if I might yield to the gentleman from Washington state.
Chairman GILMAN. The gentlewoman may yield. The Chair would recognize Mr. McDermott.
Mr. MCDERMOTT. I want to raise the question, and really why I requested the GAO report in the first place, has the structure of the program shifted at all from a medically-oriented focus to one that deals with a broader issue? For a long time the approach to the epidemic has been controlled mostly by physicians and medical people, rather than seeing it as a much broader issue. And that is really what this GAO report was aimed at, is trying to figure out if there is the broader application, and I would like to hear your response to that.
Dr. PIOT. Thank you, Mr. McDermott. I fully agree, as I also said in my statement, this is a problem—we can never make a difference if we use only a medical approach, and that is why one of our top priorities is what we call political mobilization. Without this political commitment, it will not work.
Since this will be with us for generations, since this in the developing world, particularly in Africa, is primarily becoming one of the major obstacles to development and that poverty and development problems are really driving this epidemic, we need multiple approaches in that. And that is why it is so vital to have nonmedical approaches. And in our staff only I would say—well, over half of our professional staff are not medically qualified people.
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Mr. MCDERMOTT. Having lived and worked in Africa, and lived in Kinshasa and traveled all over southern Africa, health ministries in their relationship to the United Nations were sometimes not ultimately very helpful in trying to deal with the epidemic. Is that more or less true today as it was 5 years ago?
Dr. PIOT. Well, I certainly share your analysis, Mr. McDermott. And what is happening today is that when I take several African countries, the body that is charged with coordination of AIDS activity in a number of countries is now in the President's or Vice President's office. I am just back from Zimbabwe, for example, where after a 2-year lobbying from our side, it was finally decided now that the AIDS program will be elevated to the status of an office in the President's office. And I think that will be very important to make sure that all relevant ministries will be involved. And the same thing is going on in Ethiopia, and we think also in Zambia, but that is not sure yet.
Mr. MCDERMOTT. I had the experience in India a few years ago, where the USAID was trying to give money directly to an NGO in Tamil Nadu, India, and we could never get the money out of the bureaucracy in Delhi until I talked to Manmohan Singh, who was the Minister of Finance. I had to go to the highest level before the money could get directly to the NGO, and it seems to be that that is one of the major problems that we are facing in dealing with this epidemic internationally.
Dr. PIOT. We agree. That is one of the added values of the UNAIDS program. We have multiple points of entry in the government, but we are also working through our cosponsors directly with some NGO's. And, for example, in India we have now reached agreement through this new upcoming World Bank loan that there will be direct communication and transfer of funds with the states at the state level, avoiding already one level of bureaucracy, not eliminating it altogether. But that is one step forward.
Mr. MCDERMOTT. Thank you, Mr. Chairman.
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Ms. PELOSI. Mr. Chairman, I think there are 30 seconds left. I would like to reclaim my time.
Mr. BURR. The gentlelady can be recognized for her own time now if she would prefer.
Ms. PELOSI. I don't want to do that because our colleague, Mr. Sherman, has come in, and he has been a champion on this issue, and I know his schedule is busy.
But I just did want to say, following up on Dr. McDermott's questions, and also I should have said when I yielded to him that while many of us are engaged in this issue and we have traveled to see how the issue of AIDS is treated in many countries, no one has been more places than Dr. McDermott. He brings to those visits his own experience as a health professional and his experience living in Africa and serving in Africa, so we are blessed to have him as a resource on this issue.
Just in closing I want to say, Dr. McDermott, I had mentioned that in our Committee we have been trying for years to get this issue on the G–7 agenda in a very serious way, because while we saw it as a domestic issue originally here, certainly it has been an international challenge. AIDS has tremendous impact on the economies and the social and economic lives of families throughout the world.
So I think we still have to push for AIDS to be on the G–7 agenda and I look forward to working with you to demonstrate why that would be very, very important, because it has to be a political decision to assist in all of the on-the-ground and community-based solutions that are there.
Did you have something you want to say to that, Dr. Piot? You had some mention and some results from before?
Dr. PIOT. Yes. In terms of political commitment, I think it is very crucial that HIV is now also part of the foreign policy dialog of major countries and certainly of the United States, and not only at the G–7 but also in interactions with heads of state in affected countries or in vulnerable countries. And that has been very helpful, just as the U.S. Administration has been very helpful in bringing the cosponsors together and putting HIV much higher on their agenda, and this has been a concerted effort between different parts of the Administration. So I really would like to thank the United States for its support to UNAIDS, not only in financial terms but also politically.
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And for me, ultimately, it is the political pressure and dialog that is going to make the difference. That will open the doors for doing all the things that Dr. De Lay alluded to, and Dr. Fauci, and that is the way we approach it.
Ms. PELOSI. Thank you. I thank the distinguished panel and the distinguished chairman.
Mr. BURR. The gentlelady's time has expired. The Chairman would recognize the gentleman from California for any questions that he might have.
Mr. SHERMAN. Just a brief statement. I think it is wise that we are holding these hearings. I notice that the incidence of AIDS worldwide is still skyrocketing. American expenditure on HIV in our international program seems to have stabilized at $120 million. I know the people with the power of the money are sitting right behind me. And I would hope that we would respond to this growing problem not only with additional international efforts, but also with additional scientific efforts to find vaccines and cures.
I think you folks have clearly brought to our attention that no matter what else we achieve in terms of Third World development, market liberalization, even democracy, that all of that is at risk and it can be canceled out by this one virus. I thank you for coming before us.
Dr. PIOT. Thank you.
Dr. DE LAY. Thank you.
Chairman GILMAN. The gentleman's time has expired.
The Chair would recognize himself for some followup questions.
Dr. Piot, you talked about these regions of concern, Eastern Europe, Russia. Let me ask you, if you will, what is the major method of transmission of HIV and, if you will, break it out into the three predominant regions where you show the greatest concern.
Dr. PIOT. Overall on the worldwide scale, Mr. Chairman, it is heterosexual transmission from men to women and women to men. That is the main mode of transmission, and that is certainly the case in Africa, sub-Saharan Africa, and in much of Asia, certainly India, for example.
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The second mode of transmission is injecting drug use. I would say that in Eastern Europe that is by far today the No. 1 mode of transmission. But we know from experience that it won't be limited to transmission through sharing of needles, and that we are seeing also more and more heterosexual transmission in that part of the world.
There is, in contrast to what many people may think, also an injecting drug problem in many developing countries, particularly in Asia. For example, in India, in some of the northeastern provinces next to the border with Burma, next to the Golden Triangle, injecting drug use is a major mode of transmission; also in Myanmar, Burma; it is part of Thailand; Vietnam, for example; southern China.
So this is a problem that is extremely difficult to address. But if we want to really act or intervene very early to make a difference, we have to address it.
And the third mode of transmission in terms of importance is transmission from mother to child. About 600,000 babies last year were born with HIV infection because their mother was infected with HIV, and half a million of them are living in Africa. And this is a mode of transmission we can prevent. We have the drugs, but we need to put in place programs, and that is something that we are starting to do now with UNICEF and WHO in about 10 countries in Africa today.
Mr. BURR. If I understand you correctly, illegal drug use is a major contributor?
Dr. PIOT. It is definitely the case, Mr. Chairman.
Mr. BURR. Dr. De Lay, quickly, you mentioned that 40 percent of health care workers in Africa are infected with HIV. Was that accurate?
Dr. DE LAY. In eastern and southern Africa.
Mr. BURR. From the standpoint of this Committee, who could believe that even those who we have chosen as the most educated, we have a difficult time conveying to them a degree of education that keeps them from HIV infection? Is that in performing their job or is that in another method of transmission?
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Dr. DE LAY. Most of that is from sexual transmission. They are higher up in society. They have more finances. They are more likely to have additional sexual encounters.
Unfortunately, it is almost impossible for us to tease out how much of that transmission could be occurring in the health care setting, because you don't have cohort populations that you can track that don't also engage in sexual behavior. We feel that that is probably less. But clearly there is a danger, when you have 60 percent of your beds filled with HIV-positive people, both in your pediatric and in your adult wards, and the lack of access to gloves and goggles and aprons and reasonable use of needles. There is considerable risk in that health care setting.
That clearly would not be the case, though, for the teachers where there would be essentially a sexual transmission.
Mr. BURR. Dr. Piot, let me go back to you and just allow you to address anything that you feel needs to be addressed that you haven't so far in your opening statement or in your answers, that would be comments toward the conclusions reached by the GAO.
Dr. PIOT. I think that I made the main points in my statement. I firmly believe that the basic concept of UNAIDS works. We shouldn't expect miracles. When you work in 120 countries, you can't expect that every single country performs equally well. But we have sufficient what I will call success stories, countries where we have made a difference, where the response has been expanded outside and beyond the medical approach, where there is more political commitment, where there are more resources.
Because I think we not only should look at this in terms of international resources, but this is a problem of the countries themselves in the first place, a development problem. That is why the countries themselves have to invest in HIV prevention and in care to the same extent as they invest in other development issues. And that is one of our major goals, so that they are not dependent on external funding.
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And I think that the question of the structure of UNAIDS, where we are, should not be reexamined at this time, first of all because experience has shown that a joint effort is one that has a much better chance to succeed, and also because we are reaching a momentum that should not be broken at the moment.
I would say that, as I said before, that with both the political and the technical and financial support from the United States, I believe that over the next years we will see a difference in terms of the spread of the epidemic in many countries.
Thank you.
Mr. BURR. I thank you, Dr. Piot, and I thank Dr. De Lay and Colonel Birx. Let me just say in the conclusion of this panel, it is certainly much easier in this country for us to see the human face of hunger, the human face of war, than it is to see the human face of medical conditions that exist internationally. We certainly have a tremendous challenge, not only in the international arena to complete the task that each of you and your organizations are headed for, but to also convince the American people that there still exists a real threat, a threat that is not just limited to our domestic thoughts but to our international vision.
And we thank you for your testimony. At this time we would recess the second panel and call up the third panel.
Joining us on the third panel is Dr. Daulaire, President of the National Council for International Health; Mr. Peter Young, the Vice President of HIV and Opportunistic Infections Research and Development, Glaxo Wellcome, Inc.; and Dr. Michael Merson, Dean of Public Health, Yale University School of Medicine.
Gentlemen, we welcome you here today.
Dr. Daulaire, at this time we would recognize you for your opening statement.
STATEMENT OF DR. NILS DAULAIRE, PRESIDENT, NATIONAL COUNCIL FOR INTERNATIONAL HEALTH
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Dr. DAULAIRE. Thank you very much. I would like to summarize my prepared statement which has been submitted for the record.
I would first of all like to congratulate this Committee and its chairman for holding this hearing. It is in our view an extremely important event to have this issue of global AIDS brought before the U.S. Congress in this kind of a forum, and I think that the rest of the panelists here have done a remarkable job of laying forth some of the global issues that are posed by this epidemic.
My organization, the National Council for International Health, is a membership organization, and our members are thousands of individuals and organizations working in the trenches in more than 75 countries around the world. We have been actively involved in many of these things highlighted in the GAO report and by earlier speakers, recognizing that the role of nongovernmental organizations and private voluntary organizations working with individuals in their communities has been key to the kinds of behavior change that have been proven to have an effect on the dynamics of this epidemic.
Our entire community mourned the loss of Jonathan Mann and Mary Lou Clements-Mann, and we very much appreciate the testimonial given to them at the beginning of this hearing. I am very pleased to announce today that the National Council for International Health, in conjunction with a leading human rights organization, Human Rights Watch, is instituting the Jonathan Mann Award for Global Health and Human Rights, which will be given each year to a prominent practitioner who has extended the boundaries of this very important interface.
And I am also pleased to announce that several of our former panel members today have agreed to serve on a blue ribbon panel to select the designee for this award for the first year. Dr. Tony Fauci has agreed to do that, as has Dr. Peter Piot. In addition, Mr. Kenneth Roth, who is the Executive Director of Human Rights Watch, Senator Patrick Leahy, Dr. Barry Bloom, the incoming dean of Harvard School of Public Death, and Dr. Helene Gayle, the head of the CDC Center for HIV/AIDS, TB and Sexually Transmitted Diseases, will play a prominent role in this process.
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We think that what Jonathan Mann and Mary Lou Clements-Mann stood for is at the heart of what we are discussing today with respect to the global AIDS epidemic. Jonathan, in particular, highlighted both the risks that the world faced and the strategies that we would have to pursue in order to have a real impact. Those risks, when he first talked about them in the 1980's, seemed overblown and outrageous. He talked about tens of millions of people infected with HIV, and very few people put much credence in that. We now know that 30 million people are infected.
We also know, as was commented earlier, that within the next decade, unless we see a very major change in the dynamics of the epidemic, over 100 million people will become infected. And in the first quarter of the 21st century more people will die of HIV/AIDS than died in all of the wars in the 20th century put together. So this is a cataclysm of staggering proportions and certainly calls for the kind of attention and resources that have been called for here.
Now, we do have some extraordinarily positive signs and those have been talked about today. We look very much forward to the development of an effective vaccine. But as was stated, and thank you, Mr. Burr, for your clear perception here, the development of the vaccine is only the first step in a very long and difficult process.
We have had an excellent vaccine against polio since the 1950's, an excellent vaccine against measles since the 1960's, and the world still faces those diseases, hopefully not much longer with polio but certainly with measles. So this will be the beginning of a major fight, again, which will have to be waged in the villages and the slums around the world, and will have to be carried out by a partnership of private organizations, nongovernmental groups and governments.
And this is, I think, the highlight of the GAO report from our standpoint. It has cited, and we strongly concur with the assessment, the success of U.S. Agency for International Development in its AIDS efforts, largely because of that focus on supporting and promoting the nongovernmental sector as a very active partner in this process.
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We would note that, while USAID has been very successful, we have always faced and we continue to face the issue raised earlier in this hearing, which is the issue of resources. We know that the Congress has to deal with many competing demands on resources; and one thing that I would like to be very clear about is that we do not call simply for an increase in resources devoted to the global HIV/AIDS epidemic. As important as that is—because we heard today how important also the social network, the economic opportunities, and the entire fabric of society are for preventing and for dealing with the issue of HIV/AIDS. The Council calls once again, as we have for the last 5 years, calls on Congress to reverse the downward spiral in international development assistance which we believe has very negative consequences in spite of maintaining levels of funding specifically for HIV and AIDS.
Now, we were asked two questions at the beginning of this hearing. One was about the organization and progress of UNAIDS. Let me say categorically that the National Council for International Health and our thousands of members very strongly support the existence and the work of UNAIDS. As highlighted earlier, UNAIDS has for the first time in the context of this kind of an international effort highlighted and worked very closely with nongovernmental organizations. It has gone beyond the boundaries of government, and we see this as very key.
There have been issues of startup, but we think the very worst thing in the world at this point would be to try to start over or to recreate something which is now up and running, and, in our opinion, is showing a great deal of promise. I think regarding the GAO report, since it left off—obviously, there is always a lag time on these things—several months back, we have seen a great deal of progress even in those months. UNAIDS is a very young organization and we very strongly support the things that it has done.
Let me mention, however, that the issue raised in the GAO report relating to active participation of the cosponsors is one that we think is very important, and we certainly hope that the Committee will continue to pay attention to this and continue to urge the various cosponsoring agencies who are, after all, the implementers—UNAIDS is not the implementing agency, it is simply the coordinating agent—to continue to expand their dedication to HIV/AIDS issues.
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The second question raised was the question of mother-to-child transmission. And this is, I think, one of the great conundrums facing HIV/AIDS at this point. We have now, as Dr. Fauci said, indication that there is a reasonably effective intervention to deal with mother-to-child transmission, but I will take some issue with some of the earlier statements in raising the question of whether this would make a big difference in the overall dynamics of the epidemic.
It would make a huge difference in the lives of up to 500,000 newborns a year, and that is, without doubt, a very important end result in itself. But let's recognize that those infants who are contracting the AIDS virus from their mothers, first of all, are not the ones who are passing on the AIDS virus to the next recipient and the next recipient. Devoting resources to that and as a consequence withdrawing them from areas of prevention of transmission on this ongoing chain could have some very negative consequences. It could leave the world incapable of reducing this 100-million figure that I was talking about in terms of stopping that chain of transmission before it goes much further.
So while we endorse careful and thoughtful efforts to deal with mother-to-child transmission and recognize the value of the tool that we now have before us, we would not recommend and would not be supportive of a major shift of resources away from the prevention and the education aspects that have been highlighted here.
Let me note also that the most critical issue with respect to children is their parents and, particularly, their mothers. The treatment of women with AZT during pregnancy does nothing to prevent the progression of the disease and the ultimate deaths of these women. We know from long experience in the developing world that the death of a mother is most often either a death sentence for her child or a sentence of life on the street, exploitation and eventually recruitment into the pool of the next generation of HIV carriers.
The fact that there will be 40 million orphans around the world within the next 20 years is one that should disturb and concern all of us. These AIDS orphans are the children of the 21st century's ragtag armies; they are the seeds of social decay and chaos, and they should be of as much concern to a committee concerned with international security as any particular disease.
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I thank the Chairman again for the opportunity to speak today. I think what you are doing here is of great importance, and I appreciate the opportunity you have given me.
Mr. BURR. Thank you, Doctor.
[The prepared statement of Dr. Daulaire appears in the appendix.]
Mr. BURR. The Chair would recognize Mr. Young.
STATEMENT OF PETER YOUNG, VICE PRESIDENT OF HIV AND OPPORTUNISTIC INFECTIONS RESEARCH AND DEVELOPMENT, GLAXO WELLCOME, INC.
Mr. YOUNG. Mr. Chairman, Dr. McDermott, I will summarize my written comments and thank you for the privilege of addressing you, in such distinguished company, on one of the most challenging public health priorities facing the world today, responding to the global HIV epidemic in the developing world. I am here to offer a private-sector perspective that reinforces a fundamental point articulated by most of the other witnesses before you today.
The challenge posed by HIV in the developing world is too complex, too extensive and ultimately too devastating to be addressed by any single agency, authority or organization. Progress against this disease, whether via prevention or treatment, ultimately requires our best combined, collaborative efforts across all societal sectors. As one of the private sector's leading researchers and suppliers of medicines for HIV, Glaxo Wellcome is in many ways uniquely qualified to make this observation.
As a company whose basic purpose is the creation of medical advances for people who need them, we have, from the moment our medicines began to show promise, taken very seriously the fact that 90 percent of the world's HIV population lives in an environment where limited public health infrastructure and medical capability and resource constrain access to HIV treatments.
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We also realistically recognize that the availability and cost of medicines are only one element in the constellation of interdependent factors which influence the response to the epidemic and care for HIV-positive people in the developing world. Hence, this is not an issue we can respond to by ourselves.
Much of the possible progress depends on an effective alignment of multilateral goals and constructive public-sector and private-sector partnerships. Our most prominent example of this is in the area of HIV mother-to-child transmission where the use of AZT or Retrovir dramatically reduces the rate of infection in newborns. As you have heard, this is a problem now largely addressed in the United States, but it is an increasing route of transmission for a conservatively estimated million and a half infants in developing countries every year.
We agreed quickly and early with UNAIDS about the importance of assuring successful access to this important means of preventing infection in newborns as soon as practical dosing regimens for the developing world proved effective. When this was demonstrated by the Thai/CDC results earlier this year, we announced a commitment to preferential prices for poor countries, as much as 75 percent lower than the cost of a comparable regimen in the United States.
If all HIV-positive pregnant women in the developing world received AZT, this would represent lost revenue of potentially hundreds of millions of dollars; but of course, the point of this pricing is aimed at enabling AZT use at developing countries' standards of cost effectiveness to begin where it might not otherwise be used at all.
Furthermore, since pricing is not by any means the solitary obstacle to effective use of AZT, we are also actively engaged with UNAIDS and UNICEF in a collaborative effort to establish an international pilot program which will address additional issues of infrastructure, education and counseling, packaging and distribution; and which also includes a commitment for initial startup supplies at no cost to facilitate the earliest possible implementation.
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A second example of constructive public-sector private-sector partnership is provided by the UNAIDS treatment access initiative, a program in which we have been a catalyst. Shortly after UNAIDS' inception, we contacted them to explore ways of moving forward on the difficult question of improving access to the dramatically rising benefits of treatment for people with HIV in developing countries, recognizing that the challenges of chronic therapy with demanding combinations of multiple antiviral medicines made this both problematic and controversial. We encountered an immediately receptive, energetic and open-minded attitude, simultaneously committed to exploring new possibilities and to providing a realistic, systematic approach to treatment that desperate countries and HIV-positive individuals in the developing world will inevitably seek in however poor or inappropriate a form.
Neither this nor HIV mother-to-child transmission are problems that can be addressed in a sustainable fashion by charity or donating drugs. A sustainable model must align public-sector and private-sector objectives and capabilities and build a platform that can support progress across a broad front. The UNAIDS access encourages a comprehensive appraisal of what HIV treatment can realistically accomplish and the prerequisites to realize this at a national level and facilitates negotiations with suppliers of the desired antivirals, opportunistic infection medicines and diagnostics to make use of their products more economic and feasible in a developing country framework.
While the expectations of increased treatment necessarily remain modest in the scope of the overall epidemic, the model establishes a new paradigm that can both stimulate and build on the coevolution of medical treatments and developing country care capabilities and on the mutually reinforcing interrelationship of treatment, care and prevention.
Finally, I would like to mention two additional areas of company activity in which we have benefited from effective multilateral partnership in the HIV field. One is positive action, an umbrella for a variety of nongovernmental organizations, community-based care and development programs that the company supports and sponsors, many of which have been so successfully targeted at developing countries that it has acquired an independent reputation in its own right. UNAIDS has participated in these programs on several occasions.
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In addition, Glaxo Wellcome and UNAIDS are founding copartners for the HIV Global Business Council, an effort to establish a broader base for private-sector employer engagement in the global epidemic as an important force of progress in both the industrialized and developing world. This ambitious but important initiative is chaired by Sir Richard Sykes, chairman of Glaxo Wellcome, while the Honorable Nelson Mandela, President of South Africa, serves as honorary President.
Mr. Chairman, in closing, I hope I have amply illustrated our commitment to the difficult challenges of the HIV global epidemic and to the public-sector, private-sector partnerships we feel are indispensable to progress against the disease. UNAIDS has provided a unique focal point for this that would be conspicuous now by its absence. Our experience with UNAIDS in many ways exemplifies what we feel we can all ultimately accomplish together.
On behalf of my company, I thank you again for the opportunity to speak before the Committee today.
Chairman GILMAN. The Committee thanks Mr. Young.
[The prepared statement of Mr. Young appears in the appendix.]
Chairman GILMAN. At this time we would recognize Dr. Merson.
STATEMENT OF MICHAEL H. MERSON, M.D., DEAN OF PUBLIC HEALTH, YALE UNIVERSITY SCHOOL OF MEDICINE
Dr. MERSON. Thank you, Mr. Chairman, for inviting me here today. I had the privilege of serving as the director of the World Health Organization's Global Program on AIDS (GPA) from April 1990 to March 1995. I succeeded Dr. Jonathan Mann as director of that program, so the past 2 weeks have been very difficult for me.
During the 5-year period as director of GPA I visited some 120 countries and witnessed the devastating impact that the epidemic is having.
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Unfortunately, I watched the epidemic expand to countries in Southern Africa, Asia, Latin America, and Central and Eastern Europe. But we learned some important lessons. We found that it required a multisectorial response to enable our prevention interventions to work effectively. We saw that we needed to use multiple approaches and channels to deliver our prevention messages. Governments, community-based organizations, the private sector all had to play their role. But above all else, we observed that the most important prerequisite for successful prevention was political commitment, commitment that would view AIDS first and foremost as a public health crisis that demanded bold decisions about sensitive matters.
I spent much of my last 2 years as Director of GPA working to establish UNAIDS with my colleagues from UNICEF, UNDP, UNFPA, UNESCO and the World Bank. We did this in partnership with a number of donor governments who believed strongly in the idea of a joint program, particularly Sweden, Canada, and the United States.
As Dr. De Lay said earlier, the rationale behind the program was clear. The expanding AIDS epidemic required a coordinated response from the U.N. system to ensure multisectorial action at the country level, and that all countries receive consistent technical and policy advice on the myriad of issues they faced. This would, it was assumed, bring about the best use of available resources for AIDS prevention and care by the U.N. system and donor and recipient countries.
Furthermore, such a joint and cosponsored program, I want to emphasize the first of its kind in the United Nations, would allow each of the participatory U.N. agencies to contribute its respective strengths and resources at country and global levels to combat the epidemic. It was believed that if the U.N. system could not work together and coordinate its efforts in this way to confront the AIDS epidemic, it could never be successful in dealing with the many other complex political and economic problems it faces. The program was to be owned equally by all the participating agencies and thus was not located within any of them.
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The process of establishing the program was not without its disagreements over content and structure. But in the end, all six agencies signed on and pledged their full commitment to the program. It was a brave commitment but one that the epidemic demanded.
Mr. Chairman, I have carefully studied the GAO audit. On the one hand, I do not believe it was fair to evaluate UNAIDS so soon after its establishment and, moreover, to compare it to USAID's efforts, which existed for more than a decade. On the other hand, I agree with many of the report's findings about UNAIDS, but I draw a somewhat different conclusion and that is that the program has made real and significant progress in a very short period of time.
Within a mere 2 years, four of the six cosponsoring agencies increased their AIDS funding; remarkable progress, as we just heard, has been made involving the pharmaceutical sector in the program; U.N. coordination had improved in almost a third of the countries; and a number of innovative grass-root projects have began.
If we could just step back a bit from the details, I regard it as an enormous achievement that six large agencies of the U.N. system have, for the most part, worked harmoniously to deal with one of the world's greatest health, social and economic problems.
One concern I have is the current level of funding for UNAIDS. It is clearly not sufficient for UNAIDS to do all it needs to do, and this is not what the U.N. agencies expected. I find it unacceptable, frankly, given the great political support given to the creation of UNAIDS by donor governments and the ever-expanding epidemic and its consequences. In my opinion, in India, China, and Russia the epidemic is ready to explode, and they represent more than half the world's population. I would urge the U.S. Congress to increase its funding to UNAIDS to the same level it provided the Global Program on AIDS between 1993 and 1995 and to challenge its donor partners to do likewise. UNAIDS must be given the opportunity to reach its full potential.
I cannot understand the GAO's report with regard to its finding on the World Bank's lack of commitment to UNAIDS. When I was director of GPA, I found in country after country that it was the World Bank that provided, through its loans, the greatest amount of support to AIDS prevention because of its concern about the epidemic's impact on economic development. In providing the support, it often looked to other partners for advice and assistance. I can only suggest that this finding be looked into further to be sure of its validity, for the World Bank's full commitment to UNAIDS is vital for its success.
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With regard to USAID's response, I concur with the observations made on AIDSCAP's achievements. I commend the earlier decision made by the Administrator to merge AIDSCOM and AIDSTECH when creating AIDSCAP, and hope that the new structure of USAID support, which will depend on a real commitment of the field missions, will be as successful. But let us remember that much of what AIDSCAP achieved was built on the global, technical and policy framework for AIDS prevention developed by WHO and the rest of the U.N. system.
The lesson is clear, the bilateral and multilateral systems reinforce and must continue to reinforce each other and both must be fully supportive.
We all know that Jonathan Mann was the world's greatest crusader for health and human rights. If he were here, I am sure he would have told us that it is the right of every individual on our planet to have the full knowledge and means to protect him or herself from the deadly AIDS virus. I call on our government to provide through the U.N. system and its bilateral program the support needed to obtain this noble goal.
Thank you, Mr. Chairman.
Mr. BURR. [Presiding.] Thank you, Dr. Merson.
[The prepared statement of Dr. Merson appears in the appendix.]
Mr. BURR. At this time the Chair would recognize Mr. McDermott for questions.
Dr. MCDERMOTT. Thank you, Mr. Chairman. I neglected to say earlier that I commend you for holding this hearing. I think this is an issue that does not get the kind of attention that it really deserves in terms of what the international impact of the HIV/AIDS pandemic will be in the future.
Dr. Daulaire, you suggest that we have to be careful about moving money from one aspect of the AIDS approach to another from prevention to treatment and so forth. How do you suggest we do that? We have got to be careful not to wipe out the prevention efforts so that we can put more money into treatment. Dr. Merson suggests we simply need more money. I think it would be useful for the Committee to hear your thoughts—let's say there is more money for the U.S. Congress to invest in international HIV/AIDS programs. Where should the money go?
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Should it all be put into USAID programs because that is totally controlled by the United States and we can direct it exactly where we want it; or is it more efficiently used through the United Nations? And if we do provide more money, into what areas should we pay close attention?
I would like to hear your best thoughts on this issue.
Dr. DAULAIRE. Dr. McDermott, I would love to be able to give a simple answer to that, but I have been struggling with these questions for years now, and I have come to the conclusion that there is none. The reality is, as we have seen in the——
Dr. MCDERMOTT. Patrick Moynihan once said over in the Senate, there are a lot of simple answers in the world; what we need is a great complexifier. So feel free.
Dr. DAULAIRE. The issue that has been laid out before us in the testimony and in the GAO report is that you can't do just one thing against AIDS. It requires a whole range of interventions at the behavioral level, at the political and social level, in the area of research, in the areas of both prevention and of care. It is clear that the amount of resources going into HIV/AIDS prevention and control worldwide is grossly insufficient. There is enormously more absorptive capacity, and far more resources could be used well than are currently available, and I fully agree with Dr. Merson in that regard.
I would not, personally, put all of that money into USAID; I would not put all of that money into UNAIDS; I would not put all of it into the National Institutes of Health. I think the issue here is developing a balanced program where we can learn as we move forward. First of all, we don't know what the answer yet is to the AIDS epidemic. We know many pieces of the answer, but we don't know the answer.
If we are very fortunate—I think it is very unlikely, but if we are very fortunate—there will be an answer, a highly effective vaccine that can be readily delivered, stable and so forth, or some other answer; and then we can really devote all of our resources to that, as we are doing at this point with polio eradication. Until that time, we have to pursue a multi-pronged strategy just as we would pursue a stock portfolio where you don't want to put all your money in one high-flying, high-tech firm—with your district in mind, sir.
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Clearly, the way to go is to invest in a number of areas—not wildly, but in areas that are starting to show promise or that have the basis for delivering results; and then to make sure that we have a strong investment in a program for evaluating the effects, for looking at the impact, and for ensuring the long-range sustainability of these kinds of efforts. And I don't think any one agency can do that by itself and any one approach can do it by itself.
So I apologize for my lack of clarity in an answer, but I don't think there is one there.
Dr. MCDERMOTT. Let me ask, just before Dr. Merson answers, you mentioned the high-tech companies in my district. Mr. Gates has recently given $1.5 million to the IAVI, the International AIDS Vaccine Initiative, which is an international attempt to get a vaccine effort going. Is that an area where the Congress should begin to participate in a more direct way?
Dr. DAULAIRE. Congress should certainly be looking at that. The partnership between the NIH programs and the private-sector programs would benefit from further strengthening. I think there has been a great deal of work that has taken place over the last year with the President's statement of a commitment to a crash program to develop a vaccine, but I think it is a very important interface.
Dr. MERSON. Thank you. Four quick responses.
Congressman McDermott, you know that I came up on this Hill many times as the Director of GPA, and you know if it wasn't for people like you and others that have been here today, we wouldn't have the level of funding we have. We got up to, I believe, $125 million, and that was a struggle. It was inadequate, but given the realities, it was a struggle.
I certainly would like to see at least the overall level maintained that we had in the past. The thought of a decrease in funding, which I have heard coming into this hearing, is remarkable to me, given the state of the epidemic. I understand there are other competing priorities, but I can't imagine any justification for decreasing the funding level.
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I think the distribution the U.S. Government has had over the years of GPA (1990–1995) between the U.N. system and USAID has been, in general, a good one, and I would seek to maintain that distribution.
I will confess that my bias, my second point, is toward giving more funds for prevention when it comes to the developing world. I think that is where we are going to get the most for our buck. There have been a lot of reviews done which indicate what can be achieved through prevention. Certainly, intensive education programs directed at high-risk populations, social marketing of condoms, sex education in schools, voluntary testing and counseling, treatment of sexually transmitted diseases—none of these are outrageously expensive, and all of them are highly effective in reducing transmission, if we can mount the political commitment to do them.
The issue has always been for the past 5 years not what to do, but whether we have the courage to do it and not simply the resources.
Dr. MCDERMOTT. What is it that takes courage? In what form is our lack of courage? Is it taking on other foreign governments, or taking on the religious institutions, or taking on the responsibility?
Dr. MERSON. All of the above. Promotion of condoms, sex education in schools, harm reduction for injecting drug users, with all due respect, we have had difficulties in our own country dealing with these issues at a political level; and yet I think the lessons are clear that those countries that have had the most success are those where the political leadership or the religious leadership or the nongovernmental-sector leadership or the private-sector leadership had been willing to talk frankly and openly about this disease and treat this epidemic as a public health crisis rather than a moral crisis. And I understand the difficulties in doing this, but where it has been done, it has been effective.
If I may finish, on the treatment side, I think the challenge for the developing world is to reduce the cost of treatment. And the way to reduce the cost of treatment, as has been done with the beautiful work done by UNAIDS, is on finding ways of achieving successful treatment with less drugs or shorter periods of treatment or other approaches of that nature.
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Reduction of perinatal transmission might turn out to be quite inexpensive in the developing world once the final results from the studies are in. I hope treatment of AIDS as a disease for adults could be made less expensive by developing drug regimens that require less amount of drug and therefore will be less expensive. This may be difficult to do for the pharmaceutical sector, but the more they can work together, the more I believe we are likely to reduce the cost of treatment. As long as the cost of treatment remains $15,000 to $20,000 a year, it is going to be very hard for developing countries to support it. Certainly, we have some countries, like Brazil and Thailand, where the government has invested that kind of money, but these efforts are going to be difficult for the U.S. Government and other governments to support in a big way.
My final comment is with regard to vaccines. I greatly admire the work done by the National Institutes of Health and others on vaccine development, but I think we have to be realistic about one critical fact.
Dr. Fauci said today we will have a vaccine in several years. Let's say we had a vaccine in several years, and let's say it took several years to develop—to get out that vaccine. Well, several years plus several years, let's say that is about 15 to 20 years. If we haven't stopped this epidemic in Eastern and Central Europe, in Russia, in China, in India by then, no vaccine is going to do much for us.
I would emphasize that the next 5 years in many countries of the developing world that are not yet heavily infected are the critical 5 years. And if I were legislating resources for HIV prevention, I would think that what I did in the next 5 years could be the most important decisions I could make.
Dr. MCDERMOTT. There is obviously some tension around the issue of ethics in this whole area, both in the treatment that has been developed around the perinatal period for women and also the whole question of testing vaccines and so forth. Where do you see the issue of ethics today? Where is the United States in terms of including the developing world in the process of making decisions about various testing of trials? Is it simply the United States coming in with money and saying to the developing world, this is what you are going to get and this is how you use it?
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Dr. DAULAIRE. Again, UNAIDS has played a critical role here in putting forward the structures for active engagement of nationals from countries where these research programs are carried out and for engaging the private and nongovernmental sectors.
I know that the ethics issue has gotten a fair amount of play. I have to say my personal view, as someone who has spent a lifetime working in the developing world, that some of these arguments are based, I think, on a misperception that if we are offering any sort of research regimen, it has to be at the same level as the best standard of care available in the United States.
We saw earlier what the best standard of care in the United States costs, and that's a hollow promise for the tens of millions of people at risk in the developing world. What we have to do is to look at this as a whole separate set of research questions, which I think is the way many of these research programs have been conducted, looking at what is reasonable, what is feasible, what can be effective in the context of developing countries; and I think that there has been a fair amount of naivete in some of the issues that have been put forward, which I think have no place in trying to improve the lives of people around the world.
Dr. MERSON. Briefly, no doubt we can always do better, but I think your question is a very relevant one since it has been highlighted a lot in the past year. I would say I think that the charges that have been levied in the medical literature and in the lay press about the trials have, in my opinion—for the most part, been unfounded.
I think the trials that have been done have been ethical. I think, however, that the debate has been a healthy one; and I believe, as Dr. Daulaire said, that UNAIDS has taken steps to be sure that—as WHO had done in the past, that the upmost ethical principles are applied in vaccine or any kind of clinical trials that are done in the developing world. Without doubt, no drug or any other products should be tested without the full understanding of those receiving the drug or vaccine, including informed consent, and appropriate ethical clearances by the institutes and governments where the drugs are being tested in institutes.
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Dr. MCDERMOTT. Thank you, Mr. Chairman. I just want to close by saying a kind word about Glaxo Wellcome. I think your company is to be commended. I don't often say nice things about pharmaceutical companies, but I think your efforts should be acknowledged and commended in trying to deal with some of these issues. So thank you very much.
Mr. YOUNG. Thank you.
Mr. MCDERMOTT. Thank you, Mr. Chairman.
Mr. BURR. I thank the gentleman for his comment on that good North Carolina company, Glaxo Wellcome.
The Chair would recognize himself, and let me say to all three of you at the beginning, you are all right. And for the sake of understanding better what it is we are faced with, I will take the opportunity to challenge you in a couple of areas with the understanding up front, you are right.
Dr. Merson, you made a statement, treatment internationally needs to be less expensive. I don't think that anybody would disagree with that statement. My question would be, you are not suggesting that price alone would solve our ability to treat internationally those people infected with HIV?
Dr. MERSON. Perhaps I did not articulate this clearly. We saw with perinatal transmission that the way in which this was being prevented was with a particular drug regimen that was given during pregnancy, the entire period or most of the pregnancy, say 6 to 8 or 9 months. WHO, and then UNAIDS, has supported studies that show, as we have heard, that in fact you can almost get the same results with the same drug, but by only giving it for a few weeks during the end of pregnancy or maybe only at delivery. In other words, you can, with the same drug, use it in a different way to cut down the cost of treatment.
Mr. BURR. Let me go to Mr. Young, because his company certainly manufactures AZT. And let me go to the cocktail or the combination treatment.
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We know domestically the consistency that is needed and the discipline that is needed by patients in taking that drug, don't we?
Mr. YOUNG. Yes, sir.
Mr. BURR. Now, do you see in the international market without a tremendous amount of education that we could even, with access, go in and have the same type of discipline from patients infected by HIV in those countries?
Mr. YOUNG. Stated as simply as that, it is extremely challenging, if not impossible. It is difficult enough in this country. However, as Dr. Merson articulated and as Dr. Fauci showed earlier in the day, the history of treatment in this epidemic has moved light years in a very short period of time, and as much progress as has been made to date, we continue to make progress.
There is a significant pipeline of new medicines that will be introduced over the next 5 years. Treatments will get simpler, more effective, easier to tolerate and I think will become generally more applicable on a global basis. That is really our job in the private sector; that is what we are trying to focus on. That will have benefits simultaneously in the industrialized West, as well as developing countries.
But one of the reasons we have taken the approach we have, working specifically with UNAIDS on this issue, is that we do completely believe that price alone is not the solitary key that will unlock this problem. It is multifactorial. You need public health infrastructure, medical capability on a broad front to be able to make progress on this. If we do that, if we make those collaborative commitments, I believe you can make progress incrementally over time as the medicine itself evolves.
And it has been shown, I think quite clearly, over time in the history of this epidemic that the capability you build around care and that would ultimately include treatment, is relevant and indeed highly beneficial for the primary goal of prevention as well, which we would not dispute is ultimately the most cost-effective intervention of all, anywhere.
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Mr. BURR. Let me turn to both doctors. Do you believe that the full cooperation of those supporting agencies has existed in this first 2 1/2 years? I am not suggesting that any agency didn't play some degree of participation in it, but do you believe that the type of commitment was made by all those supporting agencies that could have been made and that was really designed to have been made?
Dr. DAULAIRE. This glass is decidedly half full, Mr. Chairman. We think, though, that the glass is filling. We see increasing signs of more active and more energetic cooperation on the part of the agencies.
I have worked nowhere near as long as Dr. Merson, of course, but I worked with the U.N. agencies; and it takes a long time to get away from the mindset of ''we are doing our thing and leave us alone.'' What the UNAIDS program is all about is breaking down the barriers between a whole set of agencies that have done their own thing for several decades.
That doesn't happen overnight. I see evidence that it is taking place, and that is a very positive sign; but we are not there yet, and it is an ongoing process.
Dr. MERSON. Mr. Chairman, I would add only one thing. I had the privilege of sitting at the table with the heads of these six agencies and the then-Secretary General Boutros-Ghali where they agreed, all of them, one by one, to be a full partner. As Dr. Daulaire has said, at that time each agency had its own program, and just because the person at the top says this is the way it is going to be, it doesn't happen that way overnight. But in general, I must say I have been impressed with how fast it has happened, and I would appeal that we give the program, based on what Dr. Piot has said, the time to demonstrate what it is going to achieve.
Mr. BURR. I have always learned over my business life that the only way to enter into a partnership is to have the word ''general'' in front of your part so that you can trump everybody else in the partnership, because in fact, joining in a partnership, you learn a lot about the partners.
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And let me take this opportunity to say that I think I share your views on the report. I disagree with some of the conclusions that GAO came to. I think it is too early for any type of an assessment like that to be made.
And I think, if you look at the report as a blueprint of what our effort needs to incorporate, where they saw deficiencies, and we show the discipline to ask, are these deficiencies real, and if they are, what do we need to do, what do we need to change to actually get back on the track of the initial instructions of the general, then I think it is a useful tool; and I think we need to look at it that way.
Let me ask you quickly, Dr. Merson, you have got a tremendous international first-hand experience. How concerned should we be on the International Relations Committee about the potential explosion of HIV infection in Russia?
Dr. MERSON. As you know, I am now at a university and have left my U.N. life, but I have maintained an interest in AIDS, and the one country in which I am working is Russia. I don't think you knew that when you asked the question. I have been there recently and, in fact, I am going again in 2 weeks' time, and I am alarmed. I cannot understate this.
As Dr. Piot mentioned, there is a raging problem with injecting drugs. Drug use is very high. It is mostly in young people. The drugs are coming from various sources into the country. There is easy access to them, and they are drugs that are quite potent, not only in terms of their effect on the brain, but also on the liver and the kidney.
As you also heard today, there is a great deal of openness about sex and a lot more prostitution, so it is inevitable we will have heterosexual transmission; and I think, given the latest developments in that country, that we are going to have many more people that are vulnerable and looking anywhere to make money, such as through prostitution or through selling drugs.
So I can only say, sir, that I would hope your Committee would, in general, be very concerned about that country, but certainly generally with regard to HIV/AIDS and other health problems.
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Mr. BURR. I would assure you we are very concerned about that country. We just need to know whether we should be as concerned from a health standpoint.
Dr. MERSON. One other point. It has a very serious tuberculosis epidemic with drug-resistant strains we have never seen elsewhere, just to add to their problems.
Mr. BURR. Peter, let me follow up on something that the good doctor to your left said.
He suggested that there shouldn't exist a shift of funds for the transmission of pregnant women from areas that they are currently in, that would not be limited to that. From a standpoint of the company.
I would also allow the good doctor to make comments on it—from the standpoint of your company, the pharmaceutical world and the power of this partnership with UNAIDS, how important is it in all the countries that we enter into to get some type of program started? You know, if we went straight for the cocktail treatment, we would begin to compound our challenges because of that discipline we talked about.
We have heard testimony that for a much shorter period of time, though, we can go in and gain the confidence and the trust of an affected population, specifically those who are pregnant, who understand the possibilities that exist in transmission from mother to child.
Do you agree with his comment that we shouldn't shift there? Do you disagree with him? If so, why is the effort that we are making specifically toward pregnant women so important?
Mr. YOUNG. I think generally I would agree. I think it would be a shame to rob Peter to pay Paul and take funds away from other extremely important priorities, as we have heard most of the morning, that are pivotal to a comprehensive approach to the epidemic.
We have also heard eloquently this morning the reality that even in the most significant success stories in the history of medicine globally, polio, smallpox and so forth, that the progress—and this is true in most of the history of medicine—has been made, has been one of mostly incremental steps and one which you build around a small capability and that, in turn, allows gradual expansion of that capability over time.
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And I certainly feel, and I think my company feels that mother-to-child transmission represents such an example, something that we can start with and build on, rather than take a view that says, this problem is so overwhelming that we can do nothing but sit back and wait for its inevitable long-term consequences. That, I think, is not an acceptable approach.
And so we are quite enthusiastic about joining these sorts of partnerships and try to chip away where progress can be made.
Mr. BURR. Dr. Daulaire.
Dr. DAULAIRE. Let me clarify what I said earlier because, in fact, I do not believe what was stated by the Chair a few moments ago—that we should not shift at all.
I think that what we have learned, if anything, over the past 15 years is that dealing with the global AIDS pandemic in a static, menu-driven way, ''this is the way we do it,'' is a terrible mistake. I am very strongly supportive of careful, well-assessed and well-moderated efforts to treat pregnant women, and prevent transmission to their children as much for what we can learn about the dynamics and ways of influencing behavior and so forth.
We have learned, for instance, as Dr. Paul De Lay said a few years ago—we shouldn't be involved in care at all, and we have learned that being involved in some way in care actually has a very strong effect on prevention of disease. And I think Mr. Young and I are in complete agreement: It needs to be done carefully and thoughtfully. But we certainly should not say no, absolutely not.
Mr. BURR. You know, the great thing to me about the GAO report? We are doing something. I mean, that is a great first start. We may have some disagreements about the structure. We may see some deficiencies in the blueprint that was set up. I have some gripes about what I perceive to be the administrative costs versus the actual treatment in the field. But I am willing to let those concerns go to a period where we can judge the structure better and understand the startup costs in a little different way.
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Peter, your company has made a huge investment in this, and we thank you. We thank Glaxo Wellcome.
Let me go to really the question of a vaccine, not necessarily a question on what Glaxo is doing. My question would be, does our health policy in this country support at the right level our movement toward an HIV vaccine?
Mr. YOUNG. I can only answer within the rather strict confines of my competence on this subject. But it won't surprise you if, in so doing, I will sound like a proponent for a free-market model, not one that is exclusive of public-sector interaction and partnership, because I think that is indispensable, particularly in the vaccine field.
But I would encourage an approach that continues to build on the kind of natural, private-sector dynamics that have been reasonably successful to date on the treatment side. I think those can and historically actually have been reasonably successful in other areas of vaccine application. So I would encourage and approach the trials to continue to cultivate that and build on it.
Mr. BURR. Any comments relative to our current effort?
Dr. MERSON. I can only concur. I think most successful vaccines in this country have been primarily developed by the private sector. There is no question that the contributions to basic science from the NIH are essential to this. I think, therefore, we need to encourage the private sector, as well as NIH to pursue vaccine development.
Most private companies have stayed away from the development of an AIDS vaccine. They have been worried about the development costs and about the ability of countries to purchase it once a vaccine became available. That is why the IAVI initiative, which Congressman McDermott referred to, is an important contribution because it is trying to bridge this gap and to encourage more American companies to get into the area of AIDS vaccine. That would be what my hope would be too.
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Dr. DAULAIRE. I would add one additional thing to that, and that is concerns about liability which I think have kept many companies out of the area of vaccine development. I think that is one that Congress should perhaps be looking at.
Mr. BURR. Certainly, the Congress is well aware of the liability issue, even some of us more than others. And it is a challenge for us, and I hope that in the not-too-distant future, we will solve that one.
Given the fact that I am the last Member here, it would be very appropriate for me to say to this panel and to the other panels, the lack of participation today is not a lack of interest. It is an indication of how hectic this schedule is this week having come back from the August break and the challenges that currently are in front of us in Washington.
This Committee, as well as the Commerce, Health Subcommittee, takes the issue of our efforts, our policy and our initiatives, as it relates to HIV infection, very seriously. We understand the significant impact that it has not only on this country both in a financial way, but a human way.
We also understand that the United States has a huge responsibility in our global leadership on this initiative.
I hope that each one of you doctors and I hope, Mr. Young, that Glaxo and other pharmaceutical companies will work with us on our commitment to the global effort in the future to help us remain focused.
And I will assure you, Dr. Merson, that I do not believe that the elimination of funding is even a question in the Congress of the United States.
I thank each of you. This hearing is now adjourned.
[Whereupon, at 1:17 p.m., the Committee was adjourned.]
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