[Senate Hearing 108-34]
[From the U.S. Government Publishing Office]



                                                         S. Hrg. 108-34

            AIDS CRISIS IN AFRICA: HEALTH CARE TRANSMISSIONS

=======================================================================

                                HEARING

                               BEFORE THE

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS
                          UNITED STATES SENATE

                      ONE HUNDRED EIGHTH CONGRESS

                             FIRST SESSION

                                   ON

  EXAMINING THE FEDERAL ROLE IN COMBATING THE GLOBAL TRANSMISSION OF 
 AIDS, IN AFRICA, FOCUSING ON ISSUES RELATING TO RESEARCH, PREVENTION, 
CARE AND TREATMENT, HIV TRANSMISSION THROUGH UNSAFE MEDICAL PRACTICES, 
             AND GLOBAL CONTROL OF TUBERCULOSIS AND MALARIA

                               __________

                             MARCH 27, 2003

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions


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                            WASHINGTON : 2003
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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  JUDD GREGG, New Hampshire, Chairman

BILL FRIST, Tennessee                EDWARD M. KENNEDY, Massachusetts
MICHAEL B. ENZI, Wyoming             CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee           TOM HARKIN, Iowa
CHRISTOPHER S. BOND, Missouri        BARBARA A. MIKULSKI, Maryland
MIKE DeWINE, Ohio                    JAMES M. JEFFORDS (I), Vermont
PAT ROBERTS, Kansas                  JEFF BINGAMAN, New Mexico
JEFF SESSIONS, Alabama               PATTY MURRAY, Washington
JOHN ENSIGN, Nevada                  JACK REED, Rhode Island
LINDSEY O. GRAHAM, South Carolina    JOHN EDWARDS, North Carolina
JOHN W. WARNER, Virginia             HILLARY RODHAM CLINTON, New York

                  Sharon R. Soderstrom, Staff Director

      J. Michael Myers, Minority Staff Director and Chief Counsel

                                  (ii)

  




                            C O N T E N T S

                               __________

                               STATEMENTS

                        Thursday, March 27, 2003

                                                                   Page
Sessions, Hon. Jeff, a U.S. Senator from the State of Alabama....     1
Enzi, Hon. Michael, a U.S. Senator from the State of Wyoming.....     2
Allen, Claude A., Deputy Secretary, Department of Health and 
  Human Services, Washington, DC.................................     5
Gisselquist, David and Maria Wawer, M.D..........................    14

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Claude Allen.................................................    30
    David Gisselquist............................................    35
    Milton B. Amayun, M.D........................................    62
    Lillie C. Thomas.............................................    64
    Marie J. Wawer, M.D..........................................    66
    World Health Organization....................................    69

                                 (iii)

  

 
            AIDS CRISIS IN AFRICA: HEALTH CARE TRANSMISSIONS

                              ----------                              


                        THURSDAY, MARCH 27, 2003

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:03 a.m., in 
room SD-430, Dirksen Senate Office Building, Senator Sessions, 
presiding.
    Present: Senators Sessions, Enzi, and Alexander.

                 Opening Statement of Senator Sessions

    Senator Sessions. Good morning. Today's hearing will focus 
on the AIDS crisis in Africa and the role of medical 
transmissions in the spread of this epidemic. This is a 
critically important issue. The idea of a young person or any 
person, for that matter, going into a clinic to have an 
immunization or a shot for an infection and departing after 
having been inadvertently infected by a deadly disease like 
AIDS is too horrible to contemplate. If health care procedures 
account for a significant percentage of the cases of HIV 
infections in Africa then we must immediately and radically 
change our prevention procedures.
    The good news is that with an intensive effort, immediate 
changes for the better could occur. Even if the proportion of 
cases from injections is much lower than that by heterosexual 
transmission, it is an important component of the problem and 
we must act quickly. It would be the height of immorality to 
allow this horror to continue if it is preventable.
    We know there is a dispute over the issue. The World Health 
Organization says that the Gisselquist study, which we will 
hear from today, is not correct. They may be right. What we are 
here today to do is to air this issue. We have years of study 
and much research into the epidemiology of AIDS and we have 
experts who have analyzed this data to give us their judgment 
as to the causes of this epidemic and the most effective 
solutions. We have three experts here today and we are eager to 
hear from you.
    The specific question for the committee today is what is 
the role of health care, particularly injections, in the spread 
of this disease? This has been a subject of much discussion 
over the last several weeks, largely due to a series of 
articles published by Dr. Gisselquist and others in the Journal 
of STD and AIDS. Their research, based on an analysis of 
existing studies, indicates that medical transmissions from 
dirty needles, tainted blood, play a much larger role than 
previously thought.
    I am approaching this data with a naturally critical eye. 
We want to know the truth and I will be asking the witnesses 
today two questions. Based on all available data, what is the 
role of the health care setting in the African AIDS epidemic? 
And two, what should Congress do to address this problem? We 
are not looking for hyperbole or generalizations; we do not 
have time for that. Lives are at stake and we have had over a 
decade to look at this problem. I want to hear the facts. What 
are the statistics? Have they been properly evaluated over the 
years? What do those statistics tell us? And based on that 
information, what can we do to address these problems and save 
lives?
    Our first panelist will be Claude Allen, deputy secretary 
of Health and Human Services. Mr. Allen has previously served 
as secretary of Health and Human Services for the Commonwealth 
of Virginia. Before that he was counsel to the Virginia 
Attorney General.
    The second panel will consist of two witnesses, both of 
whom have impressive credentials and experience in these 
matters. The first is Dr. David Gisselquist. Dr. Gisselquist is 
the co-author of a series of article in the International 
Journal of STD and AIDS, a publication of the Royal Society of 
Medicine.
    Dr. Maria Wawer is a professor of clinical population and 
family health. Dr. Wawer has an impressive record of experience 
in the area of AIDS and particularly in Africa and has written 
extensively on this important issue.
    I thank each of you for being here and we look forward to 
your testimony.
    I am glad to see my colleague, Senator Mike Enzi, here. 
Senator Enzi, do you have any comments before we get started?

                   Opening Statement of Senator Enzi

    Senator Enzi. Thank you, Mr. Chairman. I have a few words I 
would like to say. I want to thank you for convening this 
hearing. I know that you have been investigating and exploring 
and interested in this for some time and I thank you for the 
panel members that you have assembled who will be sharing their 
time, their expertise and their experience with us today.
    It is important for us to determine whether sexual behavior 
or unsanitary medical procedures are more to blame for the AIDS 
crisis. However, it is also important that we provide treatment 
and care to the millions of Africans afflicted with HIV and 
AIDS. Risky sexual behavior is usually cited as the main cause 
for HIV transmission in Africa. However, in October 2002 a team 
of researchers and independent consultants led by David 
Gisselquist published a series of articles that challenged the 
conventional hypothesis that sexual transmission is the primary 
driver of the HIV and AIDS pandemic. I am pleased that Dr. 
Gisselquist is here today to discuss his conclusions in detail.
    The World Health Organization and UNAIDS have reviewed Dr. 
Gisselquist's findings but they disagree with his conclusions. 
They have reiterated their current view that unsafe sex is the 
primary mode of transmission of HIV in Africa and they estimate 
that unsafe injection practices account for only about 2.5 
percent of the HIV infections in Sub-Saharan Africa. I believe 
that Dr. Wawer shares this view and I look forward to hearing 
her assessment of the data.
    The debate over the primary modes of HIV transmission 
suggests that we may need a closer examination of the data. If 
we need further research, the results of such studies should 
certainly be factored into our global prevention strategies. 
However, we should not let this debate slow our efforts to 
provide treatment and hope for the millions of African men, 
women and children afflicted with the disease.
    We are holding this hearing at a very propitious time. 
During this year's State of the Union Address President Bush 
announced his emergency plan for AIDS relief in Africa and the 
Caribbean. I understand that Mr. Allen from our Department of 
Health and Human Services will outline the proposal in some 
detail in his testimony. This five-year plan would escalate our 
commitment to fighting AIDS across the globe by focusing our 
resources on the 14 nations that account for 50 percent of all 
HIV infections. The plan will focus both on treating the 
currently infected and on preventing future infections through 
the employment of proven education and intervention programs. 
As a member of this committee and the Foreign Relations 
Committee, I am working with my fellow committee members to 
help bring the president's proposal to fruition.
    Without question, AIDS is one of the main contributors to 
the deterioration of families and the instability of societies 
in Africa. If we can reverse the course of this tragedy, we 
will provide the people of Africa with a better future. In the 
highly interconnected world in which we live, more security for 
the people of one region also means security for people all 
over the globe.
    I thank Senator Sessions for calling and chairing this 
hearing and I look forward to the testimony of our witnesses.
    Senator Sessions. Thank you, Senator Enzi. I know Senator 
Kennedy planned to be here but there is a very significant 
Judiciary Committee hearing going on at this moment and perhaps 
he will be able to join us later.
    [The prepared statement of Senator Kennedy follows:]

                 Prepared Statement of Senator Kennedy

    I commend Senator Sessions for calling this hearing on the 
AIDS crisis in Africa. We are now in the third decade of this 
worldwide epidemic, and every nation, including our own, has an 
obligation to do more to end it. Almost 22 million lives have 
been lost because of AIDS, and the need is urgent to develop 
more effective measures for its prevention and treatment, and 
for the care of those who suffer from it.
    We already know how to help those infected by the virus to 
lead long and productive lives through the miracle of 
prescription drugs.
    Thirteen years ago, we demonstrated our commitment to the 
care and treatment of our citizens living with AIDS by passing 
the Ryan White Care Act. Since then, community-based care has 
become more widely available. Drug treatments have been 
developed that nearly double the life expectancy of HIV-
positive individuals. Public campaigns have increased awareness 
of the disease. Tragically, advances such as these remain 
largely available only in wealthy nations. We have an 
obligation to continue to combat this disease at home, but we 
should also share what we have learned, so that we can help 
other countries deal with this life-and-death battle. We must 
do all we can to provide new resources to help those who cannot 
afford today's therapies.
    AIDS imposes a heavy toll on developing countries. Of the 
42 million people who have HIV/AIDS today, the overwhelming 
majority are in the poorest countries. Sub Saharan Africa is 
the most affected region. Nearly all of the thirteen million 
children who have been orphaned by AIDS live in those nations.
    AIDS robs poor countries of the workers they need to 
develop their economies. They lose teachers needed to combat 
illiteracy and train workers for modern challenges. Africa has 
lost seven million farmers needed to meet the food requirement 
of their nations. AIDS plunges poor nations into steadily 
deeper, more desperate poverty.
    The challenges are great, but not insurmountable.
    Governments can make the difference in battling scourges 
such as AIDS. Where these governments obtain the resources, 
their infection rates have dropped by 80 percent. But they 
cannot do it on their own. These governments deserve the 
technical assistance and resources to carry out educational 
campaigns. They deserve financial help to pay for needed drugs, 
and drug companies must do their part to make their products 
more accessible to the poor. These countries also need 
assistance to develop the infrastructure to provide health care 
and deliver the drugs to the patients who need them.
    Solving the AIDS crisis in Africa and in other parts of the 
world requires a broad approach that takes into account all the 
aspects of the transmission of this disease, including steps to 
prevent unsafe sex practices, mother-to-child transmission of 
the disease, and infection from contaminated blood and unsafe 
injections.
    We know that AIDS ends lives, destroys families, undermines 
whole nations, and threatens their stability and progress. 
President Bush deserves great credit for proposing $15 billion 
over the next 5 years to combat the global AIDS epidemic. 
Together with legislation that Congress should pass soon, we 
can lead the world community in defeating one of the greatest 
public health threats of our time.
    Senator Sessions. Senator Enzi, I thank you for those 
comments.
    I do support and I believe this Congress will support the 
president's plan to triple the amount of money that we spend on 
fighting AIDS globally. It is a scourge of unprecedented 
proportions. It is something that I believe in and support. We 
had Sir Elton John testify before our committee and he also 
challenged us to use that money wisely and he pointed out the 
difficulties of making sure that our money is applied in a most 
effective way to have the greatest possible impact on 
eliminating this disease. So that is where we come from today.
    It is good to see Mr. Allen. We had some difficulty with 
rural health clinics in Alabama and I called him and asked for 
his help and not only did he help; he came down. He spent 2 
days traveling the State, visiting poverty, rural health 
clinics, and helped us reconstitute them in an effective way. 
Mr. Allen, it is a pleasure to have you before us and we would 
be delighted to hear your comments at this time.

 STATEMENT OF CLAUDE A. ALLEN, DEPUTY SECRETARY, DEPARTMENT OF 
           HEALTH AND HUMAN SERVICES, WASHINGTON, DC.

    Mr. Allen. Thank you, Mr. Chairman.
    Senator Sessions. By the way, I understand you have taken a 
real personal interest in this issue and we thank you for that.
    Mr. Allen. Thank you, Senator. Indeed, Mr. Chairman, 
Senator Enzi, members of the committee, it is a privilege to be 
here before you on behalf of the Department of Health and Human 
Services, to have an opportunity to talk with you this morning 
about our global response to the HIV/AIDS pandemic. Senator, as 
you pointed out, it is not only a subject that is very personal 
to the president, to Secretary Thompson, but to all of us in 
the Department of Health and Human Services.
    The United States is a blessed Nation and the president has 
called upon us to provide hope to millions upon millions of 
people around the world who are suffering from HIV/AIDS, 
tuberculosis and malaria. When the president announced his 
emergency plan for AIDS relief at the end of January, he said 
it is ``a step toward showing the world the great compassion of 
a great country'' and ``a work of mercy.'' Indeed, the 
president's $15 billion plan will prevent 7 million new HIV 
infections, treat 2 million HIV-infected people with anti-
retroviral drugs, and care for 10 million HIV-infected 
individuals and AIDS orphans. This initiative will virtually 
triple our commitment to international HIV/AIDS assistance in 
14 countries in Africa and the Caribbean, two area of the world 
that are being devastated by this disease right now.
    Since the impact of HIV/AIDS in the world is so severe, we 
need to be flexible with this program. As an example, we have 
decided that while our projected figure for anti-retroviral 
treatment is 2 million people, all persons who receive HIV 
diagnostic testing through the president's plan and who meet 
the medical criteria for anti-retroviral therapy will receive 
it.
    The president wants to make sure that the taxpayers' 
dollars are making the maximum difference for the maximum 
number of people. Ensuring that people are in treatment will 
allow families to stay intact longer and reduce the horrific 
number of AIDS orphans that is on the horizon.
    The president's plan follows on the heels of his new 
mother-to-child transmission prevention effort, which he 
announced last year. The mother-to-child initiative is a strong 
model of good government and demonstrates how quickly the 
United States can get much-needed resources out the door 
through our bilateral mechanisms.
    HHS, the State Department, and the United States Agency for 
International Development have all worked cooperatively with 
the White House Office on National AIDS Policy to ensure that 
the mother-to-child program pools all of the resources of the 
U.S. government that we have to offer to countries desperate to 
prevent children from coming into this world HIV-positive. The 
mother-to-child transmission initiative is part of our overall 
global AIDS program or what we call GAP program at HHS. We work 
directly with 25 countries in Africa, Asia and Latin America 
and the Caribbean to prevent new infections, provide care and 
treatment to those already infected, and develop the capacity 
and infrastructure needed to support these programs.
    The president's emergency plan for AIDS relief includes 
both a pledge of support for a dramatic increase in our 
bilateral assistance and a multiyear commitment to the global 
fund to fight HIV/AIDS, tuberculosis and malaria.
    Mr. Chairman, as you know, Secretary Thompson is now the 
chairman of the global fund. The secretary and I hope the 
president's commitment to HIV/AIDS will encourage other donors, 
countries and the private sector, to partner with us by 
increasing their bilateral assistance in countries where they 
are present, in addition to making contributions to the global 
fund.
    We must never forget how important a component research is 
to fight HIV/AIDS throughout the world, tuberculosis and 
malaria. In fiscal year 2003 the National Institutes of Health 
will devote $251 million for AIDS-related international 
research. We are working here in the United States and around 
the world to develop laboratory capacity, train scientists, and 
help nations develop prevention and treatment research agendas 
to deal with these diseases. We are working aggressively also 
to develop clinical research and trials for HIV/AIDS vaccines. 
And while we have made tremendous progress in this area, we are 
still years away from a vaccine. That is why we have to focus 
our attention on prevention, care, and treatment.
    Finally, I want to mention recent reports that unsafe 
medical practices, including unsafe injections, are responsible 
for a more significant percentage of HIV infection in Africa 
than previously thought. We believe certainly that unsafe 
injections and medical practices do contribute to the spread of 
HIV/AIDS and do require further scientific evaluation. 
Estimates vary as to what percentage of HIV infections are due 
to unsafe practices, but we know one fact with complete 
certainty--even one is too many. This is one reason why the 
president's plan has a component to cut such transmission. 
Prevention activities will be directed at all modes of 
transmission, including improving safe blood supplies, and we 
will have the flexibility to adjust resource allocation based 
on scientific data as it becomes available.
    As we discuss international programs for prevention, it is 
important that we as Americans do not export our own ideas but 
rather, allow the countries we aid develop prevention methods 
and treatment programs that are sensitive to their own culture. 
Uganda is a shining example of a country that has turned around 
the HIV pandemic successfully within its own borders. Uganda is 
the only Nation in Africa with an increasing life expectancy. 
They did this by reaching back into their own culture and 
employing what they call the ABCs of prevention. A is for 
abstinence in young people, B is for being faithful within a 
relationship, and C is for condom use in high-risk populations 
with the knowledge that condoms are not as effective in 
preventing all sexually transmitted diseases as they are with 
HIV/AIDS.
    Uganda has shown us a proven method of prevention that can 
be measured in real lives. As we develop domestic and 
international models for prevention, we need to look at their 
success.
    Mr. Chairman and members of the committee, we have a real 
opportunity to effect change in the world with the president's 
new initiative. The administration is ready to work with you to 
put together a bill that we can all be proud of and Secretary 
Thompson and I look forward to working to make sure that it 
becomes a reality.
    I want to again thank you for allowing me to be with you 
this morning and I am happy to answer any questions that you 
may have at this time.
    Senator Sessions. Well, thank you very, very much. I think 
it is important to highlight some of the successes that have 
occurred in Africa, particularly in Uganda, and there are other 
things that show real potential and we need to be supportive of 
that.
    You know, the first question I ask is a question that 
Senator Kennedy had and it is one that is really my first 
question to you, also. The question is this, Mr. Allen. What 
impact will the recent studies by Dr. Gisselquist and other 
authors about the significance of health care practices on the 
transmission of HIV/AIDS have on your department? Is it causing 
you to reevaluate and are you taking any action since you have 
learned of these studies?
    Mr. Allen. Mr. Chairman, we have looked at the Gisselquist 
study, along with the UNAIDS and WHO in reviewing that, and 
while we believe that the primary mode of transmission of HIV 
continues to be sexual, we do believe that as we have stated 
already, any transmission mode will be looked at and 
investigated. We believe that in terms of unsafe medical 
practices, the president's proposal actually provides a 
tremendous opportunity to focus prevention activities in 
targeting at ending unsafe practices.
    If I may just briefly address that, in terms of not so much 
in a research agenda but actually in the treatment, prevention 
and care agenda, we will focus our activities. The president's 
proposal calls for us to partner with countries, right now the 
14 countries that we have identified, and using what we call a 
network model. The network model consists of working with 
countries that will work with their primary institutions, 
medical institutions, which typically are in their major 
cities, and going out from there so that we will be not only 
focussing on testing but we will also focus on unsafe medical 
practices, blood safety practices, education and research, and 
then from those urban areas reach outward into primary clinics 
that would be in more remote areas, ultimately reaching rural 
areas where we believe much of the issue in terms of unsafe 
medical practices exists, and that is in the case of 
traditional healing practices, and that is what we need to 
reach.
    Senator Sessions. You know, when we visited clinics in 
Alabama, as you do all over the country, is it not a 
particularly horrible thought that a young person or an adult 
goes to that clinic for medical treatment and could come home 
infected by AIDS? And do you think the department has seriously 
examined this study and report at this time?
    Mr. Allen. I think yes, we have examined the report and 
study and that is why we are not allowing the study or the 
report to be pushed aside. We would not suggest pushing it 
aside because it does add value. At the very least, what the 
study has done is that it has caused the research community to 
go back and reevaluate their data, to reevaluate the modes of 
transmission.
    So there is value of the study, but I want to make sure 
that as we look at the study we will be employing and 
continuing to look at moving safe medical practices into the 
more remote areas.
    Senator, as you know, as we have traveled throughout the 
country and particularly in Alabama, in many ways my travels 
throughout Africa and rural Africa mimicked in many ways very 
much what we see in rural areas in this country, with this 
exception. In this country in rural areas you still can get 
access to medical care and that medical care oftentimes uses 
the very modern methods of safe medical practices--blood 
safety, handling of needles and blood products.
    In rural areas, much of the health provision is not 
provided by the formal sector, it is provided by the informal 
sector, and that is where you go to a traditional healer and 
that healer will use traditional methods but also giving 
injections for vitamins or even for immunizations, and that is 
where we need to tackle and the way we tackle it is twofold--
one, by moving the formal setting farther out under the 
president's proposed plan, but also by education and training 
and providing safe needles for the use by those who are 
providing health care in those settings.
    Senator Sessions. Mr. Allen, I know that your department 
adheres to the view that the majority of the transmission are 
by heterosexual sex and sexual relations and that may be true. 
The question is is it 35 to 30 or is it what WHO is 
maintaining, that for adults, 90 percent of the transmissions 
are sexual transmissions? Are you prepared to defend that 90 
percent figure?
    Mr. Allen. Yes, we would be prepared to defend the 90 
percent figure but----
    Senator Sessions. Let me ask you this.
    Mr. Allen. Sure.
    Senator Sessions. Do you know if the department has done a 
peer-reviewed study of all the peer-reviewed studies of AIDS in 
Africa to reach that conclusion, focussing particularly on the 
potential for transmission of HIV/AIDS by medical injections? 
Has your department specifically studied all those studies and 
done an in-depth mathematical analysis of it to determine 
whether or not that position of WHO is correct?
    Mr. Allen. Senator, we have gone back and looked at the 
studies that have been done in Africa. I cannot say that we 
have concluded a peer-reviewed study of all the studies that 
are being done. What I can say is happening is that those 
primary researchers who have done those studies are actually 
going back and looking at that data themselves.
    What I can point you to is one case as an example of why we 
believe that the rate of transmission for children is not as 
high as 30 to 35 percent is just one example in countries such 
as Uganda, as I pointed out earlier. In Uganda when you look at 
the curve of the disease, progression of the disease, and you 
look at that population of zero to 15, we find that the primary 
mode of transmission has been mother-to-child. In those cases 
if there were unsafe needle practices, you would expect to see 
more cases in the zero to 15 population once you have excluded 
the mother-to-child transmission and the studies that we have 
looked at show that that is a very low transmission rate.
    Again in terms of unsafe needle practices, a study in South 
Africa that looked at these issues once again looked at other 
anecdotal data, looked at transmission of hepatitis-C virus, 
for example, which is a much easier disease to transmit via 
needle than would be HIV/AIDS, and in that study in South 
Africa there was about a 201 percent difference between HIV 
transmission as compared to hepatitis-C transmission.
    So we are very confident that the primary mode of 
transmission in Africa is heterosexual sex. We do know also 
that there are issues of blood supply, we do know that there 
are issues of unsafe needle practices, so I do not want to 
minimize the significance of that because again, if there is 
one child that is getting HIV/AIDS because of an unclean needle 
or unsafe medical practices, that is unacceptable. So we will 
continue to look at those issues but we think the research is 
very sound in the area that we have been discussing.
    Senator Sessions. We will talk more about that as Dr. 
Gisselquist has, in fact, studied rigorously all the tests and 
reached a different conclusion. It will be interesting.
    Senator Enzi?
    Senator Enzi. Thank you, Mr. Chairman.
    I do appreciate the president's effort in this. I think 
that he has placed the United States as a leader in getting not 
only the United States more involved in this issue but in 
encouraging other nations to participate.
    I am one of the two congressional delegates to the United 
Nations and I have met with the Geneva group, which is the 
group that contributes about 80 percent of all the revenues to 
the United Nations, and those are the people that we will be 
encouraging, as well, to give their proportion to this 
particular effort.
    I do know from meetings with that group, though, that there 
is quite a concern with a number of agencies, and UNAIDS has to 
be included in that, with the amount of overhead that actually 
keeps the money from getting to the customer, the person that 
has AIDS or that we need to prevent from having AIDS. So I hope 
that the administration will continue to both lead and 
encourage other countries and to see if we cannot cut down on 
the amount of overhead and that amount that is wasted money.
    In another capacity I am the subcommittee chairman for 
Employment, Safety, and Training and we have just finished 
legislation to address needle stick problems in hospitals, both 
of the nurses who might accidently get stuck or the employees 
who, when they are taking care of refuse, might get stuck and 
then not know for 6 months or so what might have happened to 
them. I have seen the kind of tension that that generates.
    One of the things that we know is that there are now 
needles that after use, retract and cannot be used again. Are 
there some barriers to wider use of these retractable needles 
in Africa?
    Mr. Allen. There are some barriers and some of the ones I 
have cited but on the positive side of it, I can certainly say 
that what we are doing as a department and what we are doing as 
a government in terms of our supplying needles for use is that 
we are using the auto-disabled syringes that self-destruct 
after use, that are single-use needles.
    The barriers that exist in terms of getting those needles 
in wider places are in the very remote and rural areas where 
you have traditional medical practices taking place. In those 
areas what we do is that we have begun with our vaccination 
programs through the Global Alliance for Vaccination and 
Immunization initiative is a public/private partnership that is 
working throughout the world in terms of immunizations. Within 
those programs, for example, all the needles that are being 
utilized are the auto-disable type of needles, but they only 
account for about 25 percent of the needles that would be 
utilized in immunizations.
    So one of the key steps that we need to take is as the 
United States continues to encourage childhood immunizations, 
adult immunizations, that we would more and more begin to 
utilize the newer technology, the auto-disabled needles or 
auto-destructing needles, so that there can be one-time use.
    What we need to also do is we need to reach into those 
informal sectors where health care is often delivered in 
Africa, and that is the traditional healers, and we are 
reaching out to them, as well. As we are doing education and 
training, we are reaching into those pockets where there are 
traditional healers who are practicing, but the challenge again 
is the vast number of needles that are already in the 
marketplace and how do we get those back and, at the same time, 
get safer needles in their hands that will encourage safe 
medical practices but also decrease the unnecessary use of 
needles, anyway?
    Senator Enzi. For my help and for the record, can you 
explain in a little more depth what traditional healers are?
    Mr. Allen. Yes. Traditional healers very much practice in 
many cases alternative medicine using herbs, using roots, using 
in some terms potions that are derived within the community. 
These are individuals who are often looked to for health care 
practices. In many of these countries they are very informally 
organized. In many places, in villages, rural villages, this is 
the person you go to who would concoct some medication for you. 
And one of the areas that oftentimes traditional healers will 
recommend is they will recommend vitamin shots for children. 
They will recommend medication in terms of antibiotics that are 
administered by needle that oftentimes is unnecessary.
    They are a large population throughout Africa, indeed 
throughout the world, where you have traditional practices 
taking place.
    Senator Enzi. Thank you. And you mentioned the Uganda 
prevention model, the ABC model. Are there more statistics that 
have been gathered on how effective that has been? It sounds 
like something that ought to be more extensively used in the 
United States. What are some of the barriers for doing more of 
that here?
    Mr. Allen. Senator, we would very much agree with you that 
it is a model that has worked effectively and it is a model 
that really deals with age-appropriate massaging and situation-
appropriate massaging.
    In Uganda the data is very significant that comes out on 
Uganda and other countries that are applying the ABC approach. 
What that data shows, for example, in Uganda is that they were 
able to turn around the pandemic in Uganda because of three 
things. First of all, with the youth they focus on a strong 
message of abstinence until marriage and what they were able to 
do in that country was be able to increase the age of sexual 
debut, the age of first sexual experience for young women, by 
as much as 2 years. Because they were able to do that, that 
reduced the infection rate by somewhere around 50 percent is 
what some studies have shown.
    The second thing they did is they reached back to their 
culture and they challenged adults to be faithful in their 
relationships. They used a concept called zero grazing, which 
basically meant that you should not go outside of the bonds of 
the unit to which you were married in. What that did in 
particular regions of Uganda is that it reduced the number of 
partners that men had drastically, very significantly, and that 
by itself also had a direct impact on the spread of the 
disease.
    Then the last thing they did is they focussed on those 
high-risk populations, the commercial sex workers, itinerant 
workers, the military, and urged the use of condoms 
consistently and correctly and that is what drove the disease 
down.
    I would agree with you. We need to be looking at that as a 
model here in this country. We need to have a strong message to 
young people in the United States about preserving themselves 
until marriage. That is the safest way to prevent transmission 
of not only HIV/AIDS but the contraction of other sexually 
transmitted diseases. We also need to emphasize fidelity in 
relationships, with mutually monogamous relationships with 
uninfected partners. And in those circumstances where there is 
high risk that takes place in sexual relationships, that 
condoms are an appropriate means of preventing the transmission 
of the disease. So we think that that would be a good model and 
one that we support here both domestically and internationally.
    Senator Enzi. It seems like success stories might have an 
effect all over the world but even in the United States.
    Mr. Allen. Here, here.
    Senator Enzi. Thank you, Mr. Chairman.
    Senator Sessions. Well said, Senator Enzi. We are really 
impressed with the success of the Ugandan model and this 
hearing is not in any way intended to denigrate that but I 
worry a little bit when I read the study that is intensively 
done, a number of scientists concurring on it, having published 
it, and the establishment basically saying that we cannot be 
wrong; we still think it is 90 percent sexual and only 2 
percent health care transmission.
    Do you think it could be an error? Are you open to the fact 
that there may be an error there?
    Mr. Allen. Absolutely we are open to that fact but I will 
go back and say that we could be wrong but the point being that 
even if we were wrong as to the percentage, that does not 
change our commitment to ending that method of transmission as 
a vector for transmitting HIV/AIDS.
    Senator Sessions. Well, yes. The percentages that people 
agree on today, everybody agrees on, is 50,000 to 100,000 
infections per year, which is a stunning number in itself. And 
if it is 10 percent or 20 percent, you know, those figures 
would be stunningly higher, also. So I think you are correct to 
proceed with that.
    Let me ask you this, Mr. Allen. Would you and would the 
department support a new study, and I assume one could be 
crafted, that could help answer this question?
    Mr. Allen. One of the challenges--the short answer to that, 
Mr. Chairman, would be yes, but I would have to quality it. One 
of the challenges with a directly observed study is that we 
would have to be in settings where actually unsafe practices 
would be taking place and that would be unethical and immoral 
to allow to take place, so we would----
    Senator Sessions. What do you mean it would be unethical to 
be in a place where people are using dirty needles?
    Mr. Allen. Meaning that if we were in that place we would 
seek to ensure that dirty needles would not be used at all. So 
to be in a place, for example, in a setting where unsafe 
medical practices were taking place, we would not simply 
observe that. We would seek to intervene at that point because 
the most important thing is the health of that individual.
    So medical ethics would dictate that we would not be put in 
a setting where we would allow for unsafe medical practices to 
take place.
    Senator Sessions. Well, let us assume there might be 
another way to skin that cat and come at that issue from 
another way. Would you support that?
    Mr. Allen. We would support additional research in this 
area, yes. In fact, what is already happening, as I pointed out 
earlier, the one thing that the Gisselquist study has done is 
that it has challenged the scientific community to look back at 
their own data and to determine what is actually happening. But 
it also has put us on notice to focus in on unsafe medical 
practices as we are going forward. So I think that it has 
already had an effect not only on research but on practice.
    Senator Sessions. Well, I am a lawyer and you are a lawyer, 
so I am sure we are probably not the best in the world equipped 
to design a study that could define for us the real situation 
and I hope that you would look at that. I think there are some 
ideas that I have heard floated that could give us a good 
indication.
    I do not think any broad-based study has been conducted to 
my knowledge specifically designed to deal with this and if 
they have, they have had some flaws to them. Dr. Gisselquist, I 
think, would point that out.
    One more question. Let me ask you this. We will be changing 
how the United States conducts this effort. It may not all be 
in your department. But if we were to study the health care 
transmissions of AIDS would your department be the one in 
charge of that? And have you taken any steps to create a 
committee or a section that would focus explicitly on that?
    Mr. Allen. We have, through the Centers for Disease Control 
and through the National Institutes of Health, we have two 
networks that focus in terms of vaccine and what would be 
needle--programs that include immunizations and vaccinations. 
One is the HIV prevention vaccine trial network that looks at--
it has an intake function where we are trying to discern the 
modes of transmission of HIV/AIDS. And in that program we would 
be evaluating, whether it was through needle usage, whether it 
would be through scarring, which is traditional, or tattooing, 
very common methods of transmission of not only HIV but 
hepatitis-C, hepatitis-B, other forms of infectious diseases, 
we already are looking at that.
    We also partner with an international organization, the 
United States Help, set up through the World Health 
Organization, called the Safe Injection Global Network, which 
is housed within the World Health Organization, and the Centers 
for Disease Control contributes about $200,000 a year to this 
organization and they promote safe needle practices in terms of 
the health care setting.
    The last piece I would suggest to you for that is in terms 
of the president's emergency relief program, about a third of 
the funding from that program is targeted toward prevention and 
in that prevention mode we spending money specifically targeted 
at blood safety, at safe medical practices, at education and 
training of health professionals, again beginning using the 
network model in urban settings and moving out from there to 
build the capacity to address it.
    So yes, we will be working very aggressively in that 
through Department of HHS but also with our partners through 
the State Department and through the United States Agency for 
International Development.
    Senator Sessions. Well, I thank you for that. I do think we 
need to proceed with this and I suppose you would not disagree 
that if health care transmission turns out to be more 
significant than we have thought, that it provides an 
opportunity for maybe more rapid prevention activity than other 
transmission forms.
    Mr. Allen. We would certainly respond to that. If we find 
that health care practices are contributing more and more to 
the spread of the disease, we will go after that method of 
transmission aggressively and collaboratively to end that as a 
mode of transmission.
    It is important because what is important about this 
disease and ending this disease, particularly in countries like 
Africa, is that we want to have a generation that comes into 
this world and is able to grow up in this world disease-free. 
That is the key. And the key to doing that is not only in terms 
of reaching the mother, preventing transmission from mother to 
child, but it would be unsafe medical practices that would put 
those kids at risk in their later life. So we would work very 
aggressively with you in that, as well.
    Senator Sessions. Thank you.
    Senator Enzi?
    Senator Enzi. Just one final quick question. The San 
Francisco Chronicle pointed out that there was a study under 
way with Ethiopia and Cameroon where they are intercepting 
needles after use to test them for viruses. Is Health and Human 
Services involved in that in any way?
    Mr. Allen. I was recently in Ethiopia back in December and 
saw much of what they were doing there. We would be 
tangentially involved through our multilateral partnerships, 
through the WHO, very likely through working with the Ministry 
of Health in Ethiopia. We are very interested in partnering 
with countries, both bilaterally and multilaterally, in their 
efforts to try to determine the methods of transmission and to 
reduce the risks associated with them, so that would be one 
example that we would very likely be working with.
    Senator Enzi. Thank you very much, Mr. Chairman.
    Senator Sessions. All right, thank you very much, Mr. 
Allen. We appreciate your response and I have enjoyed working 
with you. Thank you for your leadership for America.
    Mr. Allen. Thank you. It was a pleasure to be here with 
you. Thank you, Senator.
    [The prepared statement of Mr. Allen may be found in 
additional material.]
    Senator Sessions. Our next panel will be Dr. David 
Gisselquist, Ph.D. He is from Pennsylvania. He has over 20 
years of experience in international economics, rural 
development and health. He lived and worked in Bangladesh for 
10 years and in Thailand for 2 years and has worked short-term 
in many African, Asian, East Asian and Central European 
countries. He has worked for the World Health Organization as a 
consultant, the World Bank, the Food and Agricultural 
Organization, USAID, GTZ, the German AID, and many other 
organizations.
    For the last several years he has worked with an informal 
team of medical experts to review the transmission of HIV/AIDS 
in Africa and his publications have been the basis of this 
hearing.
    Maria Wawer is an M.D. M.H., professor of clinical and 
population and family health at the School of Public Health, 
Columbia University. Her expertise is AIDS in Africa and Asia. 
She is one of the key researchers in a five-year joint study in 
Uganda funded by the National Institutes of Health, the 
Rockefeller Foundation and World Bank on whether intensive 
control of sexually transmitted diseases will reduce HIV 
transmission. She is a member of the Working Group on 
Population Conception Usage in Subsaharan Africa, the National 
Academy on Committee on Population, and in the study section 
Division of AIDS NIAID. She also a director of the 
International Operations Research Program at Columbia.
    We are delighted that you are here and appreciate this 
exchange. In my view, I am a believer in science, not much of a 
scientist myself, but I do believe that science can put us on 
the right track and those of us in policy positions need to 
have our best hands on the best science that we can get as we 
decide the policies that will affect the direction of our 
country and our policies.
    Dr. Gisselquist, if you are ready we would be delighted to 
hear from you at this time.

STATEMENTS OF DAVID GISSELQUIST, PH.D., AND MARIA WAWER, M.D., 
                              MHSc

    Mr. Gisselquist. Mr. Chairman, Senators, thank you for the 
opportunity to address this committee.
    Based on 20 years of evidence about HIV in Africa, a strong 
case can be made that the driving force for the epidemic, what 
allows it to grow rather than to die out, has been unsafe 
health care. In this testimony I first summarize some of this 
evidence and then consider implications for HIV prevention.
    After some early debates about health care and sexual 
transmission in Africa's AIDS epidemic, most experts reached a 
consensus no later than 1988 to focus on sex. In that year the 
World Health Organization circulated estimates showing over 90 
percent of HIV in African adults from heterosexual transmission 
and less than 2 percent from unsafe medical injections. We 
found no paper that shows how these estimates were derived from 
evidence.
    So in order to find the facts behind these estimates, we 
looked for studies of risk factors for HIV in Africa with field 
work that had been completed through 1988 and we found 13 
studies that had tested and questioned a total of more than 
25,000 adults from the general population. Across all studies 
that had asked about injections, an average of 48 percent of 
HIV infections were associated with injections. In contrast, 
only 16 percent of HIV infections were associated with having 
more than one sexual partner.
    Now the measure of association that we are using here is 
the crude population attributable fraction, which is a standard 
measure for epidemiological research, and for various reasons 
it may somewhat overestimate or underestimate causation, so 
that it is an approximate figure. But even so, from the 
beginning the estimate that over 90 percent of HIV in African 
adults is from heterosexual transmission and less than 2 
percent from medical injections disagreed with available 
evidence.
    Nevertheless, the estimate has been widely accepted and 
most experts believe that sex drives Africa's HIV epidemic. For 
this to be true, heterosexual transmission would have to be 
much, much faster in Africa than in the U.S. or Europe. It is 
not clear how this could be so, since there have been many 
studies of sexual behavior that show Africans, on average, to 
have no more sexual partners than Americans or Europeans and 
the impact of other factors, such as lack of circumcision and 
presence of other sexually transmitted diseases, appears to be 
too small to explain this supposed much faster sexual 
transmission in Africa.
    In a recent article we assembled evidence from African 
studies through 2002, as late as we could get, to make the 
first empiric estimate of the proportion of HIV in African 
adults from sexual transmission and what we found from the 
evidence is that sexual transmission accounts for about 25 to 
35 percent only, which is far less than the 90 percent that has 
been supposed and repeated since 1990.
    Now if we assume that most of the HIV in Africa that is not 
from sex is from health care, then we can estimate that health 
care accounts for 60 to 70 percent of HIV. Now this is an 
indirect estimate. An alternate and a preferred approach would 
be to build up estimates of health care transmission from 
studies that look at specific categories of health care. With 
this direct approach, injections are the biggest risk. From 16 
large studies through 2002, an average of 28 percent of HIV 
infections is associated with medical injections.
    There is also some information on HIV associated with blood 
transmissions, around 5 percent maybe, and from ritual 
scarification, but we know very little about dental care, about 
drawing blood for tests, about traditional operations, and 
other blood exposures.
    Overall, the available evidence suggests very roughly about 
a third from sex and a third from injections, but that leaves 
large areas of ignorance and there are large margins of error 
around the estimates that we do have.
    Other evidence for health care transmission of HIV includes 
many reports of children with HIV who have HIV-negative 
mothers, and just one example. In Kinshasa in 1985 39 percent 
of HIV-positive children had HIV-negative mothers, and there 
are many other examples that are in the literature throughout 
the years, and I have circulated some statistical information 
and you can find some of those in Table 4 starting on page 9.
    In addition, a number of studies report more HIV in 
children five to 14 years old than can be explained by mother-
to-child transmission. Last year, for example, a South African 
national survey in December 2002 reported 5.6 percent HIV 
prevalence in children two to 14 years old and only a quarter 
of this total could be explained by mother-to-child 
transmissions, which would leave roughly 500,000 unexplained 
infections, and on-going studies are now trying to figure out 
what is really happening there--is the data right and what is 
happening?
    It is also well known among health experts familiar with 
Africa that health care is very often unsafe. Several recent 
studies by the World Health Organization report hundreds of 
millions of unsafe injections in Africa each year and these 
come from formal, as well as informal, providers, including 
pharmacists, untrained injection doctors, and neighbors.
    These findings have implications for HIV prevention. In 
much of Africa and Asia, HIV epidemics have continued, despite 
aggressive promotion of behavior change in condoms. But even if 
we are only partly correct about the contribution of health 
care transmission to Africa's AIDS epidemic, we can expect much 
better success with programs that address both health care and 
sexual risks.
    However, HIV prevention is not only a social and a 
government goal but it is also a personal challenge. UNAIDS, 
for example, publishes its book on AIDS and HIV prevention and 
in this--this is for distribution to U.N. employees--and in 
this book they advise U.N. employees to carry their own 
syringes for personal use. Similarly, a young African couple 
that is trying to raise a family in a community with 20 percent 
HIV prevalence faces a variety of risks. When the wife is 
pregnant they have to decide if she will go to the public 
antenatal clinic. When someone has a toothache they face risks 
in dental care. In Harari, for example, people are advised to 
go to the dentist early because it is cleaner, and this is in a 
country where there is about 25 percent HIV prevalence, so if 
you are the fourth one in the chair, the chances are better 
than 50/50 that somebody before you had HIV.
    Since Africans are on the front lines against HIV, we can 
be more effective in stopping HIV to the extent that we help 
them get the information and the life skills that they need to 
live safely in the midst of the epidemic. The current focus on 
condoms and sexual behavior simply does not speak to all of 
their concerns. It speaks to some of them but not all of them, 
and it does not meet all their needs.
    This review of the evidence and issues in prevention leads 
me to three recommendations. First, the research agenda needs a 
major overhaul. We know too little about injections and other 
health care and blood exposures as risk for HIV.
    Second, efforts to educate people about sexual risk for HIV 
and options to reduce those risks, such as condoms and 
abstinence, should continue. Everything we have said, if it is 
25 to 35 percent or 90 percent, you still have to worry about 
sexual transmission, so we are not challenging those programs.
    And third, both to control the epidemic and to help 
individuals control their personal risk, it is crucial to ramp 
up programs promoting health care safety. This is at the same 
time a human rights issue. The most important and low-cost task 
in this effort is public education so that health care 
consumers are aware of the risks and they know the importance 
of sterile care and they are ready to demand it and pay for it 
if they have to. Other components, such as provision of auto-
disabled syringes and single-dose vials and cleaning up the 
blood supply, will take more money.
    The low priority that has been accorded to health care risk 
for HIV over the last 15 years means that we have a major job 
ahead--to redesign HIV prevention programs.
    Senator Sessions. Thank you very much, Dr. Gisselquist. You 
certainly challenge the established numbers on this subject.
    [The prepared statement of Mr. Gisselquist may be found in 
additional material.]
    Senator Sessions. Dr. Wawer, we are delighted to have you 
and I think you tend to favor the established numbers, so we 
would be delighted to hear your comments.
    Dr. Wawer. Mr. Chairman, members of the committee, thank 
you very much for this opportunity to testify regarding HIV 
transmission in Africa. Since 1988 I have worked on HIV 
epidemiological, behavioral and preventive research in 
international settings and have been the principal investigator 
or co-investigator on more than 20 HIV-related studies, most of 
them carried out in Uganda and funded by NIH.
    Mr. Chairman, available data indicate that sexual and 
mother-to-child transmission are the major causes of HIV in 
Africa. Although HIV can be spread by unsafe injections and 
blood transfusions, such transmissions contribute only a minor 
proportion of new infections in the region. The patterns of HIV 
infection in infants and young children provide evidence of 
route of infection. Infection in infants and young children 
results predominantly from mother-to-child transmission. In the 
absence of preventive therapy, approximately 25 percent of 
mothers will transmit HIV to their infant before or during 
delivery or through breast milk. Many infants and young 
children are exposed to multiple injections for therapies, etc. 
However, if their mothers are not infected, very few contract 
HIV. I will give just a few examples out of many studies.
    In a study in Kampala, Uganda conducted in 1992, 98 percent 
of HIV-infected children had an HIV-positive mother. 
Transfusions and injections were the probable causes of 
infection in the 2 percent of HIV-positive children whose 
mother was HIV-negative. Studies conducted in the late 1990s in 
Cote d'Ivoire, Tanzania, Kenya and other countries observed no 
HIV infection to children born to HIV-negative mothers. Of 
almost 4,000 initially HIV-negative children aged zero to 12 
followed in rural Masaka District, Uganda in the mid-1990s, 
only one child became HIV infected over the subsequent year and 
this is a region in which health care is not very well 
developed in the sense that access to truly safe services would 
be less ideal than one would like.
    Dr. Gisselquist quotes data on infant and childhood 
infections from the mid-1980s and arrives at high rates of HIV 
infection in children born to HIV-negative mothers in that 
period. At that time, however, HIV testing in African 
populations was unfortunately less reliable than today, 
resulting in some false positive results. That is, not all of 
the positive kids are likely to actually have been positive and 
actually infected. Also, HIV transmission via breast milk had 
not yet been recognized. Thus, the earlier data need to be 
examined with great caution.
    More recent data collected in the past decade show low 
rates of HIV infection, generally below 1 percent, in children 
aged five to 14 in most African countries with available data. 
Children in this age range are not exposed to mother-to-child 
transmission; nor do they have frequent sexual risk.
    However, after childhood, the rates of HIV infection 
increase, often dramatically, during adolescence and young 
adulthood, reflecting the onset of sexual activity. The 
increase is usually more rapid among females, reflecting the 
fact that in many African settings girls become sexually active 
before boys and are also more likely to have older partners who 
are themselves already infected. Similar patterns in age curves 
are observed for other STDs, such as HSV-2, the virus that 
causes genital herpes. In addition, rates of new infection of 
HIV decline after age 40 or 50, commensurate with decreased 
number of partners and decreased coital frequency in older 
individuals. In the great majority of HIV studies, rates of 
infection are closely associated with reported sexual activity, 
including numbers of partners.
    With respect to unsafe injection, there can be no doubt 
that such injections represent a public health problem. For 
example, they have been implicated as major routes of 
transmission for hepatitis-B and hepatitis-C. However, the 
epidemiological evidence does not support the hypothesis that 
unsafe injections result in substantial HIV transmission in 
Africa.
    Based on data previously collected by other researchers, 
Dr. Gisselquist indicates that HIV-infected persons report more 
injections. That is entirely to be expected. Persons with HIV 
are more likely to seek health care because of HIV-related 
symptoms. One needs to assess whether the injections preceded 
HIV infection in order to avoid a classical case of 
epidemiological confounding--in this case, the possibility that 
the higher use of injections is the result of, rather than the 
cause of the HIV infection.
    In our own studies in Rakai, Uganda we conduct long-term 
HIV surveillance in over 50 villages and also ask questions 
about multiple risk factors, including injections. We recently 
reexamined our Rakai data and found no association between 
reported injections and the acquisition of new HIV infection.
    In addition, any analysis of injection risk must consider 
the procedure being carried out and the type of equipment being 
used for the procedure. Transfusion of blood from an HIV-
infected person represents a very high risk of transmission, 
but transfusions are much less common than injections. Also, 
needles used for intravenous injections or blood sample 
collection can retain blood. However, the most common 
injections--subcutaneous and intramuscular--are given in a way 
as to minimize drawing up blood.
    Using highly sensitive tests, researchers have examined 
syringes which have been used to actually provide subcutaneous 
or intramuscular injections to HIV-infected persons. Less than 
4 percent of these syringes contained HIV viral particles. Most 
injections provided in health care facilities in Africa are IM 
or subcutaneous and not intravenous. In developing his 
estimates, Dr. Gisselquist did not differentiate between types 
of procedures and the types of equipment used to the degree 
that would have been desirable.
    The World Health Organization, as was indicated, estimates 
that approximately 2 to 3 percent of new cases of HIV are 
transmitted annually in Africa through unsafe injections. These 
risks, of course, may differ somewhat between countries 
depending on background HIV rates and injection practices but 
overall, the data from children, the data from infants, the 
data on older adults support that these estimates are in a 
correct range.
    We do thank Dr. Gisselquist for pointing out important 
areas and all researchers in the health care establishment 
should be looking at these issues. However, his analyses do 
suffer from selective use of data, particularly older data, 
confounding in that the injection, the timing of injection 
versus the timing of HIV acquisition have not been assessed.
    Dr. Gisselquist, among others, has quoted our data, data of 
other of our colleagues, and in some instances it is very 
difficult to understand how these data, which we know very well 
have been interpreted since our own conclusions looking at 
these data with very detailed analyses, with epidemiologists, 
biostatisticians, modelers, lab people, behavioral people, do 
not provide us with the same conclusions.
    In conclusion, transmission of HIV via unsafe injections 
does occur in Africa but the contribution of this route of 
infection to the overall epidemic is modest. However, since any 
HIV transmission via health care is unacceptable, efforts to 
reduce unsafe injections should be encouraged and in this we 
absolutely agree with Dr. Gisselquist and his colleagues.
    HIV researchers should obviously and objectively assess 
existing empirical data for potential injection-associated 
transmission and for the circumstances under which such 
transmission may occur in order to develop and target 
preventive programs. Whenever possible, HIV studies should 
include questions on injection and transfusion practices, again 
to help dissect how much may be due to such practices and to 
target exactly where prevention should go. Efforts to provide 
an adequate and long-term supply of clean injection equipment, 
coupled with educational programs to promote needle safety and 
reduce unnecessary injections, would be of great public health 
benefit. However, an operative term here is long-term provision 
of safe equipment because in resource-poor settings, if 
individuals do not trust that the equipment will be available 
for the long run, then hoarding of supplies and so on does 
occur, and it is in those kinds of circumstances that re-use of 
injection equipment can also occur. Obviously, single-use 
injection equipment is also highly desirable. And again in this 
we absolutely agree with Dr. Gisselquist.
    However, the data to date indicate that sexual transmission 
and mother-to-child transmission represent the most common 
routes of HIV in Africa and continued efforts to prevent such 
spread are crucial. If we reduce resources to prevent sex 
spread we will, in effect, wind up with more HIV infected 
adults, more HIV-infected children through mother-to-child 
transmission, and this would be a tremendous tragedy. Thank 
you.
    Senator Sessions. Thank you very much.
    [The prepared statement of Dr. Wawer may be found in 
additional material.]
    Senator Sessions. The mother-to-child transmission, I do 
not think we stated, is so preventable. We have such a capacity 
if we act promptly in advance of the birth to avoid that 
tragedy, that we certainly do not need to overlook that.
    Dr. Gisselquist, in terms of your study would you give us 
some of the background of the people who participated with you 
in the analysis of this data and where you had it published and 
was it peer-reviewed?
    Mr. Gisselquist. There have been a number of co-authors 
involved in the various studies. I have worked quite a bit with 
John Potterat, who has been an epidemiologist specializing in 
STDs and HIV and published extensively for 25 years and has 
worked in Colorado particularly tracing STDs.
    Another co-author that has been involved is Dr. Rothenberg, 
who teaches at Emory and is the editor of one of the foremost 
journals on epidemiology in the world, Annals of Epidemiology.
    Dr. Drucker is at Albert Einstein Institute of Medicine and 
Dr. Vachon is a doctor in France who has had experience in 
Africa and was involved in some of these dates, making the same 
points in the mid-1980s. So we come from various places.
    Senator Sessions. Well, I noticed the World Health 
Organization, before you completed your presentation, had 
restated their position publicly in a press release or press 
statement. Mr. Allen still maintains that 90 percent of adults 
infected in Africa are through sexual relations. Dr. Wawer 
disagrees. Why should we believe your study? What would you 
summarize for us?
    Mr. Gisselquist. Well, what we have done with this is we 
make the claim that we are making the first empiric estimates 
and we have put them into the journals and we are asking for 
people to review them and come back at them. Some of the 
charges are----
    Senator Sessions. When you say first, do you mean this is 
the first time anybody has analyzed all the studies for this 
particular method of transmission? Is that pretty undisputed, 
that no one else has looked at all the studies focussing solely 
on health care transmissions?
    Mr. Gisselquist. The study that we have done in assembling 
the estimates for injections, yes, is the first time, and this 
was actually also repeated by CDC and UNAIDS and they have a 
paper that is circulated but it does not seem that it is 
getting to see the light of day. It basically confirms what we 
have done. It is also the first estimate that is tied into 
epidemiology data that is estimating the proportion from sexual 
transmission.
    So we have put these things out in excruciating detail and 
we are waiting for responses. The charge that we selected the 
data--we looked for what we could find and we used what we 
could find. The questions about whether the tests were good so 
many years ago and whatever, these are the kinds of questions 
that we need to thrash out in the refereed medical journals.
    Senator Sessions. Dr. Wawer, you know, these numbers in his 
study are a pretty dramatic challenge to the establishment 
view. The establishment view is around 2 percent transmitted 
through health care. Would it be a shocking thing to you if the 
figure were 8 percent or 10 percent? Is that possible? Do you 
have enough data to say it is not at least that high?
    I guess my question is could we design some studies that 
could give us a more accurate picture of the conditions?
    Dr. Wawer. Mr. Chairman, these are very important 
questions. Certainly at this time when we look at primary data 
that is not a compilation of analyses based on secondary data 
but primary data, the proportions of transmissions we see in 
children whose mothers are not HIV-positive, the low rates of 
HIV in children who are not sexually exposed, the overall 
researchers, both in Africa and in Europe and the U.S. are very 
comfortable that the rates of HIV transmission through the 
health care system or through injections in Africa is not up to 
8 percent.
    Again these are estimates, but estimates around 2 to 3 
percent, we believe, are quite accurate, given particularly the 
patterns of disease we see in those individuals who are not 
sexually active, less sexually active compared to individuals 
who are more sexually active.
    It is very difficult to take data from a number of studies, 
many of them designed for different purposes, group them 
together and try to arrive at estimates, the kind of global 
estimates that Dr. Gisselquist and his colleagues have tried to 
do. It is a formidable effort that they did. It poses a 
challenge to us all. But the way the data have been analyzed 
really does present us with some problems.
    Again we have empirical data that specifically track 
individuals--I mean not only in Rakai project in Uganda where I 
work but in Masaka District in Uganda--in other studies that 
have actually tracked children, know which mothers are HIV-
positive, know which mothers are HIV-negative. The early data 
from Uganda where they went into hospitals and looked at of the 
children who were actually HIV-positive, what proportion had a 
negative mother, and that was only 2 percent.
    So again we would all agree that 1, 2 or 3 percent of 
transmission through health care systems is unacceptable but 
what we would argue is that to reduce the relative importance 
of sexual and mother-to-child transmission could be very 
deleterious, both from the resource level but also we do not 
want to--certainly my colleagues in Uganda would not want to 
give their counterparts in Uganda the false hope that if they 
can just avoid unsafe injections, other things are not as huge 
a risk factor as has been considered.
    Uganda has made its efforts because they have been 
extremely open on the issue of sexual transmission. President 
Museveni came out back in the 1980s discussing how important it 
is to have safe sex.
    Senator Sessions. Senator Alexander, we are delighted you 
can join us.
    Senator Alexander. Thank you, Mr. Chairman and thanks to 
the witnesses for coming today.
    I congratulate Senator Sessions for putting the spotlight 
on this discussion. One of the difficulties in with dealing 
with the AIDS crisis has been poor information sometimes, and 
political leaders not recognizing the truth and telling people 
within their countries that one thing is right when another 
thing is wrong.
    So, it is tremendously important that we know what the 
truth is here as we make policy and as we go forward with 
President Bush's effort and the effort of many senators on both 
sides of the aisle, especially in Africa, to try to combat this 
terrible crisis. This is a good first step to help those of us 
who are lay people to try to evaluate the work that is done 
here and decide what we think is correct.
    I wanted to discuss this situation with the two of you, 
since you are respected academicians. It is not so unusual in 
the academic world to have an established view and then have a 
paper or a set of researchers who challenge the established 
view. In fact, it is common. Usually you have a set of 
established procedures for going about how you evaluate whether 
the established view still is right or whether the challenge is 
more correct and you come to a conclusion about that.
    What could this committee do to take the work that has been 
done here and create a fairly prompt independent evaluation of 
who is right and who is wrong so that those of us who are in a 
policy position can make intelligent decisions? I wonder, for 
example, could we ask a respected medical school or an 
institution? Should we go to a school of government and ask 
them to assemble a group of statisticians and epidemiologists 
and review the work and review the competing claims and give us 
a report? What in the ordinary course of business would be a 
way to evaluate the conflicting information we have heard 
today? I would like to ask each of you for your suggestion.
    Dr. Wawer. Senator Alexander, certainly having a panel that 
would review, an independent panel composed of epidemiologists, 
clinicians, behavioral scientists, etc, who would review the 
existing literature would make a lot of sense.
    Senator Alexander. Who would be a sponsor of such an 
independent review? Who would put that together?
    Dr. Wawer. The IOM, for instance, would be an excellent 
sponsor for that. The Institute of Medicine.
    The other thing that can be done, and I agree entirely with 
Mr. Allen that one could not do a trial of safe versus unsafe 
injection--we are completely all in agreement on that--but what 
could be done is that researchers could be encouraged within 
different countries to go to clinic settings, for instance, and 
test children who are both of positive mothers and of negative 
mothers, to do that in a systematic way in a number of 
countries, in a number of different kinds of health care 
settings--big city hospitals, small urban clinics, rural 
villages--to see what proportion of children who have a 
negative mother, for instance, are HIV-positive.
    That is an excellent indicator. It is like a canary in the 
coal mine, in effect, that if children who have negative 
mothers are getting HIV, that would be an indication of HIV 
transmission. Current data from the studies that do exist 
suggest that is not happening, but a systematic effort to do 
these kinds of studies would be relatively quick, relatively 
low-cost, and a very good indicator.
    Children get a lot of injections, not only immunizations. 
And I should stress that most immunizations given in the world 
these days are given through programs such as the EPI, the 
Expanded Program for Immunization, and those programs use very 
safe needles. But children are exposed to an awful lot of 
injection from low-level health workers for vitamins, to give 
antibiotics, and also traditional healers.
    Senator Alexander. Is not the first question, though, that 
you raise, a challenge his statistical methods? Before I came 
here, I was, I hasten to add, a professor of practice at the 
Harvard School of Government. I attended on a weekly basis 
meetings where researchers, like Dr. Gisselquist, would present 
their findings in a preliminary way and other faculty members 
would work them over pretty hard if there was anything about 
their method that they needed to rethink.
    Now would that not be the first thing to do, to have a 
panel that would look at the methods and see if there are 
suggestions that would either discredit or cause Dr. 
Gisselquist to take another look or that would suggest to you 
to take another look? Then maybe we should go out in the field 
and do things. That might be step two, it would seem to me.
    Dr. Wawer. I do not disagree. I think that is an excellent 
idea.
    Senator Alexander. Well, let me ask Dr. Gisselquist, how 
would you suggest that we persuade ourselves that you right 
rather than wrong by some independent review? Or how are you 
looking forward to testing your own findings?
    Mr. Gisselquist. Yes, your suggestions about the procedures 
of academic review and scientific review, I think we have 
started that in some circles by getting these publications into 
the refereed medical literature and we need some reactions.
    Senator Alexander. So by publishing your work you are 
inviting reaction, which you are getting.
    Mr. Gisselquist. Exactly. I am looking for all the hard 
questions anyone can think up because I want this debate to 
find out what is going on. And if panels can be assembled, 
including some people who are neutral, who have not made a 
career out of saying one thing and now they are being 
challenged, we need some people who are willing to go one way 
or the other.
    Senator Alexander. Where would you find such people? Where 
would we if we wanted to encourage such a panel?
    Mr. Gisselquist. Well, we are raising questions about how 
the epidemiology was done and so just good epidemiologists that 
can deal with the questions we are raising about the techniques 
that were used in the research.
    Senator Alexander. Epidemiologists? I assume statisticians 
would be people who understand methods and statistics of 
research to verify what you have done and the way you have gone 
about it?
    Mr. Gisselquist. And then people who have worked at solving 
other diseases, figuring out where they are coming from and how 
to attack them.
    Senator Alexander. What sort of institution would you 
suggest would be the right sort of institution to organize such 
a panel?
    Mr. Gisselquist. Well, there are a lot of them that could 
do it. I guess----
    Senator Alexander. Would a medical center be one? Would a 
school of government be one? Would you think of other 
institutions if you had to think of three or four types of 
institutions? You do not have to name one but just a type of 
institution.
    Mr. Gisselquist. me of the academic societies could 
nominate a team or take part in nominating people on a team.
    Senator Alexander. Like an academic society of 
epidemiologists could nominate a team?
    Mr. Gisselquist. Yes.
    Senator Alexander. And they could organize such a thing and 
give a report to a Senate committee.
    Mr. Gisselquist. Yes.
    Senator Alexander. Dr. Wawer, do you agree with that? Does 
that sound like a reasonable approach?
    Dr. Wawer. I certainly agree, yes.
    Senator Alexander. Well, Senator Sessions, I think you have 
done a service here. I want to congratulate the witnesses and I 
have a suggestion to make. There will be a process that 
naturally occurs over the next several years as researchers in 
this area consider Dr. Gisselquist's comments and 
recommendations and he himself, if he is a superior researcher, 
which I am sure he is, welcomes that, invites that, and he is 
looking forward to being challenged to see what he can learn 
further about the area that he is interested in. Then the other 
side will say if we are wrong, we need to know it, too, or if 
we have overlooked something, we would like to know about that.
    Now that will take a while. I would suggest that this 
committee consider working with either a medical center or the 
appropriate medical society, and since we have a majority 
leader who is a physician and is also very interested in this 
subject, we might ask his advice and ask one of those societies 
to organize an independent panel to look at this research and 
give us a preliminary review of what they think about this 
while this other natural process is occurring.
    For example, if there are significant flaws in statistical 
method or in use of statistics, that might help us know that. 
If there are not, we ought to know that, too, as we go about 
making policy.
    Senator Sessions. Well said. I thank you for those very 
wise comments. At 2 percent we cannot go wrong in improving 
that number, reducing that number, and if it is higher than 
that, it is even more intensively important that we act. And 
frankly, since it is a life and death matter, I do not think we 
need to delay.
    Senator Alexander. Also, we are getting ready to spend a 
lot of money and go to a lot of effort and we need to make sure 
that our money and our effort is directed in the most precise 
way at a massive problem.
    Senator Sessions. Dr. Gisselquist, Dr. Wawer mentioned the 
children being infected and some numbers that she thinks 
supports the current figures. You have some numbers of child 
studies. Could you share those with us and share what you think 
those numbers imply?
    Mr. Gisselquist. Yes, the situation is that if you look 
around, you can find populations where it is very low and you 
can find populations where there is more. Particularly in 
Uganda, where there has been a very aggressive effort from the 
late 1980s of public education about health care risks, the 
explanation and our understanding of why HIV actually declined 
in Uganda may have overlooked some of these changes in health 
care. But let me give some other data, for example.
    Around 1990-1991 there was a four-city study that looked at 
in-patient children in four African cities in Rwanda, in 
Tanzania, Uganda and Zambia. They studied over 5,500 children 
and their mother and they found from these 5,500 children, 
including positive and negative children, the in-patient 
children, 1.1 percent of the children were HIV-positive with 
HIV-negative mothers. That was 61 kids. They did not report how 
many children were HIV-positive with HIV-positive mothers so we 
do not know the percentage, but I would say it is probably 
around 7 percent. This is in four cities. These children were 
only six to 59 months old, so they had had a lot of time for a 
lot of health care transmission, but that is the most likely 
explanation for this.
    The WHO remarkably said after this that it looks like 
health care transmission is not a serious risk and basically 
closed the book on this issue. You can imagine what would have 
happened if that had occurred in Chicago or Brussels, if 1.1 
percent of the in-patient kids had HIV that we cannot explain.
    Senator Sessions. So this is 1.1 percent of the in-patient 
children had AIDS when their mothers did not?
    Mr. Gisselquist. Yes, sir.
    Senator Sessions. So there is very little explanation of 
that infection except a health care situation; is that correct?
    Mr. Gisselquist. Exactly. Exactly.
    Then there are other studies. For example, in Cote d'Ivoire 
a study around 1994 reports 21 percent of HIV-plus children had 
HIV-negative mothers. This was a small study.
    In Uganda in 1989 to 1994 26 children with HIV and Kaposi's 
sarcoma at the Uganda Cancer Research Center, they were able to 
test their mothers and five of the mothers were HIV-negative, 
so that means 19 percent of these children that had HIV had it 
from some other source. Then there are other studies that have 
reported rates of 3, 4, 5 percent of children five to 14 with 
HIV and it is pretty hard to explain much of that from their 
mothers.
    Senator Sessions. Dr. Gisselquist, is there research that 
shows the relative transmission rates from utilizing a dirty 
needle, as opposed to heterosexual sex? What kind of likelihood 
or chance would the transmission occur from sex, as opposed to 
HIV-infected needles?
    Mr. Gisselquist. Yes, sir. The best estimate we have for 
transmission per coital act is about one in a thousand, and 
that has also been found in an excellent study in Uganda that 
Dr. Wawer was associated with, as well. So it is about one in a 
thousand per coital acts for transmission between sero-
discordant partners.
    For transmission through an unsafe injection, the number 
that has often been used is three in a thousand. What this 
comes from is needle stick accidents, from health care workers. 
And 97 percent of the needle stick accidents do not pierce the 
skin. If you look at only the deep needle stick accidents--that 
is, where the needle goes in enough so that you could 
actually--the needle goes through the skin--the average risk 
would be about 2.3 percent, so significantly higher.
    That is really not entirely satisfactory evidence. What we 
would like to do is look at an iatrogenic outbreak where we 
have actually seen a lot of children get HIV through the 
medical system and there are a number of cases like that. Just 
one of them, for example, in Russia in 1988 doctors found one 
child with HIV that had an HIV-negative mother and said 
something is wrong here, so they tested tens of thousands of 
kids throughout a huge part of Russia and they identified 250 
kids that had gotten HIV from medical care and were able to 
trace it all back to one index case. They did the sequencing of 
the virus, so they knew exactly where it came from and it came 
from this one case.
    And in two hospitals in Elista it had gone from one case, 
one child, to 90 inside of 11 months. That is an amazingly fast 
expansion. That is doubling every 2 months. You did not even 
get that kind of expansion in San Francisco bathhouses in the 
early 1980s. So it can go extremely efficiently through the 
health care system.
    Senator Sessions. And in Africa I saw some of the studies 
that talked about children or people who had had 40 injections 
or 30 injections. In the health care systems in Africa are 
people regularly given inoculations and shots, as we do here in 
the United States? What is their rate of injections compared to 
the United States?
    Mr. Gisselquist. The estimates that WHO has compiled is 
around two per capita. You find some studies where it is 
higher. For example, it might be 10 per year in children and 
five per year in adults in some populations.
    Senator Sessions. That is two per capita per year?
    Mr. Gisselquist. Yes, yes, that's the best estimate that we 
have.
    Senator Sessions. So at age 10 a person could have had as 
many as 20 injections.
    Mr. Gisselquist. Yes.
    Senator Sessions. And do you have any scientific study that 
could give us any indication about how often bad health care 
practices occur and needles are being reused? Do we have any 
indication at this point of what that number might be?
    Mr. Gisselquist. The numbers that are compiled by WHO, they 
estimate I think around 20 percent, but those estimates are 
based on a protocol to look at safety where they go to the 
ministry of health and they select 80 health care centers 
around the country and then they go out to those health care 
centers, they interview the director, they interview the nurse, 
and then they watch the nurse give two injections and then they 
say whether it is safe or not.
    So in a situation like that, when you have notified people 
that you are going to watch them and then you are watching them 
and you are still having 20 percent, you can be pretty 
concerned about what kinds of percentages you would have when 
you are not watching.
    Even so, we are still not looking at what the pharmacists 
are doing, what the injection doctors are doing, what is going 
on in the traditional medicine. So we can be pretty sure that 
it is higher than 20 percent.
    Senator Sessions. Dr. Wawer, do you agree with that number, 
that the numbers are as much as 20 percent of needles are not 
cleaned or are being reused?
    Dr. Wawer. That will be very site-specific, Mr. Chairman. 
It will depend on whether you are looking at large facilities, 
small facilities, and the country. Countries like South Africa, 
for instance, have made a major effort to provide clean needles 
throughout the country. Other resource-poor places will have 
much lower use of clean needles and much higher use of unsafe 
injections.
    Again the bottom line is we all agree that unsafe 
injections should be stopped, must be stopped, but the numbers 
that Dr. Gisselquist was just quoting, 1 percent of children in 
the four-city study being HIV-infected, children who had an 
HIV-negative mother, are very much in keeping with the numbers 
that we were discussing earlier. It is a problem. It is not the 
single predominant problem for HIV transmission either in 
children or in adults in Africa.
    Also, it is very difficult to interpret numbers if one does 
not know with very small numbers of children or children where 
one is only looking at the children who are HIV-positive with a 
negative mother without knowing what the full denominator, what 
the whole population at risk is, and also knowing what the 
proportion of HIV infection is in those kids who have positive 
mothers. That is the way that one can really assess the 
proportion of overall HIV infection that is being contributed 
by unsafe injections in all likelihood versus maternal-to-
child.
    Senator Sessions. And we do not have that data to rely on 
at this moment but we could obtain that?
    Dr. Wawer. We have those data in some places. We do not 
have them in many places.
    The other quick point I would like to make, Mr. Chairman, 
if you permit, is that basically there is no doubt that 
transfusions are a much more effective way of transmitting HIV 
than even injections and a lot of the horrific epidemics that 
we have seen in children, whether it is in Rumania or in 
Russia, were as a result of micro-transfusions to children, 
that a single infected blood donor, that blood would then be 
made into small transfusions, in effect, that were given to 
children who had anemia or whatever. There you are actually not 
just using dirty needles; you are actually putting in infected 
blood into the child, so one would expect extremely high rates 
of infection.
    It is a tragedy. It should not occur. We must do everything 
to keep it from happening. But those kinds of micro-epidemics, 
however awful, one has to carefully assess exactly how they 
were caused.
    So again this is not to take away from the importance of 
having clean injections, but we have to keep it in proportion, 
how it is playing into the overall terrible epidemic of HIV in 
Africa and the world.
    Senator Sessions. Well, with this number of 20 percent 
being unclean needles, and I think Dr. Wawer indicated that 
people who have AIDS may not know it and that they go to the 
doctor more often, which could skew the numbers somewhat, and 
by the time a person is 20 they have had 40 shots, is that what 
you are talking about? I believe you used the phrase--you said 
it was a driving force here, a factor that seems to be at play 
in Africa that is not in play somewhere else. The numbers in 
Africa are so dramatically higher than in other areas.
    Is that what you are getting at, Dr. Gisselquist? Do you 
think this may be an unknown accelerating factor?
    Mr. Gisselquist. Yes, exactly. And the injections are 
particularly dangerous in particular settings. For example, if 
someone has an STD and goes to an STD clinic there are high 
rates of infection in the other people where you are sharing 
the needles.
    And, for example, if a woman is going to an antenatal 
clinic there is also high infection in the clinic and it is 
dangerous for another reason, because they are going back 
several times. So they will go once, they will give a blood 
test to test for syphilis and they might get an injection of 
tetanus because they get a series of tetanus immunizations so 
the child does not have neonatal tetanus. Then they come back 
another month later before birth and maybe they have a primary 
infection and they have hyperemia before the antibodies kick 
in, so they are very dangerous for transmitting it again.
    So it is the settings where you have high background 
prevalence and then you have repeat visits that can be 
extremely dangerous, and that is where you are getting an 
intersection between sex and injections. And because people 
have not been looking at information about injections and 
health care, this has all been attributed to sex. We need to do 
the studies the right way to figure out what is going on here.
    Senator Sessions. And I believe you indicated to Senator 
Alexander that some studies could be designed that would give 
us a pretty clear picture of the situation. I know that it has 
been said--Mr. Allen said it--that somehow you are violating 
privacy or medical ethics to go in and allow unclean needles to 
be used in your presence but surely there is a different way we 
could analyze this. Could we establish a clinic in a 
substantial area and make absolutely sure that no needles were 
reused and then compare that to an area where we may not know 
what the behavior pattern is or have a suggestion that may not 
be as good? Would that not give us some indication of what the 
situation is?
    Mr. Gisselquist. Yes, there are ways to do it without 
watching somebody give a bad injection. Another way to do it 
would be to go around to clinics and use the secret shopper 
technique where you hire somebody to pose, like a truck driver, 
and he says, ``I need an injection; I have an STD.'' So they 
will say this is the guy you go to to get it. So in that way 
you find out the informal providers, as well. Then when they 
are ready to give you an injection you say, ``Thank you; please 
give me the needle; please give me the multidose vial. Here are 
new needles, new vials; this is a study; it is all 
confidential.'' We could do those kinds of things.
    You could also go to antenatal clinics and just collect 
whatever is available to be used and collect the multidose 
vials, give them replacements, take them back and test them.
    So we could do some of these studies. I mean there really 
should be almost regular monitoring to find out whether things 
are safe. Remarkably, these have not been done. I have not seen 
anybody that has tested a multidose vial in Africa to find out 
if there is any bacteria or any pathogens in it.
    Senator Sessions. Well, perhaps, like all of us in any area 
of business, we had businesses transmitting asbestos and being 
blind, deliberately blind to the problems, just refusing to 
acknowledge it and infecting people throughout this country. It 
just seems to me that maybe if we do have a larger problem than 
we think and if we make that public and make a clear commitment 
to not allow it to continue, you could probably have a 
significant improvement in conditions overnight. Now you do not 
want to scare people if it is not true.
    So I think we are moving forward in a historic acceleration 
of our efforts against AIDS. This Congress is going to be 
increasing funding to a dramatic degree. We want to see it 
wisely used. So I think we have a right to expect our 
governmental agencies that will be expending this money to 
examine the situation carefully.
    Do either of you have any final comments before we adjourn?
    Dr. Wawer. Thank you very much for this opportunity.
    Senator Sessions. Thank you.
    Mr. Gisselquist. Thank you.
    Senator Sessions. Dr. Gisselquist, we thank you. When you 
challenge the establishment it is always an interesting 
experience. We thank you for coming forward here and sharing 
your information.
    This is a life and death matter. This very day even at the 
low numbers we are looking at, some child is being infected by 
a health care injection and will die as a result of it. If we 
can stop that, we should do so. Thank you very much. Additional 
statements will be made part of the record.
    Senator Sessions. The hearing is adjourned.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

                 Prepared Statement of Claude A. Allen
    Mr. Chairman and Members of the Committee. I am Claude A. Allen, 
Deputy Secretary of the U.S. Department of Health and Human Services. I 
am pleased to be here today to provide an overview of the Department of 
Health and Human Services' activities to combat the global spread of 
HIV-AIDS, Tuberculosis (TB), and Malaria. I bring greetings from 
Secretary Thompson, and his thanks as well, for your tireless efforts 
to address these worldwide pandemics.
    At the outset, I would like to acknowledge that we, at HHS, are in 
your debt, Mr. Chairman, and in the debt of your colleagues on this 
Committee, and others in this Chamber, for your support of prevention, 
care, and treatment of these diseases. The leadership of this Committee 
has been crucial to the U.S. Government's response to these devastating 
diseases, and will continue to be, as Congress and the Administration 
work together to support the Global Fund for AIDS, TB and Malaria, 
implement the President's Emergency Plan for AIDS Relief, announced in 
the State of the Union address in January, and implement his 
international Mother and Child HIV Prevention Initiative, announced 
last summer. The broad bipartisan support that these initiatives 
enjoy--as well as the strong public support--speaks to their vital 
importance. I look forward to continuing to work with each of you to 
make them reality.
    The United States has a long history of assisting other countries 
in need. And I am pleased to report that the Department of Health and 
Human Services is continuing that humanitarian tradition in a variety 
of ways, but most particularly in helping developing countries address 
the devastation caused by AIDS, TB and malaria.
    From Tanzania to Vietnam to Haiti, HHS employees are on the ground, 
working with Ministries of Health, nongovernmental organizations (NGO), 
faith-based groups, and--equally important--with other U.S. government 
entities, such as the Department of State and the U.S. Agency for 
International Development (USAID), to develop country-specific 
solutions to the ravages of AIDS. Together with USAID, we are working 
with 16 countries and with international organizations such as the 
World Health Organization (WHO) to address TB--which infects nearly 
eight million persons per year. Worldwide. TB kills two million people 
each year and is the leading cause of death for one-third of persons 
infected with HIV, causing fully one-third of all AIDS deaths. Further, 
we work with the WHO and other partners to address malaria, which kills 
an estimated one million children in the developing world each year.
    Today, I will provide you with an overview of HHS activities and, I 
hope, reinforce your longstanding, demonstrated commitment to U.S. 
support in this essential endeavor.
    Three HHS operating divisions are most actively involved in 
fighting AIDS, TB, and malaria worldwide. The National Institutes of 
Health (NIH) has a strong portfolio of basic research in the areas of 
HIV and TB, including vital efforts to develop a vaccine to prevent HIV 
infection and new treatment technologies and strategies. NIH also 
trains U.S. and foreign scientists as a critical part of its mission. 
The Centers for Disease Control and Prevention (CDC) has engaged in 
international applied AIDS research and programmatic efforts since the 
beginning of the pandemic and supports bilateral and multilateral 
efforts to address TB and malaria. And the Health Resources and 
Services Administration (HRSA), through a cooperative agreement with 
CDC, works to train health care workers internationally to care for 
people living with HIV and AIDS.
    While there is not time today to go over all that we do to address 
HIV, TB and malaria, permit me to briefly illustrate how, at HHS, the 
pieces fit together into a strategic plan to combat AIDS around the 
globe.

                            RESEARCH ON AIDS

    Guiding principles for the National Institutes of Health's global 
research are to: 1. Target research efforts to develop prevention and 
therapeutic strategies adapted for the unique needs of developing 
countries;2. Develop multidisciplinary research programs on AIDS, TB, 
and malaria; 3. Build and sustain research capacity in developing 
countries; 4. Stimulate scientific collaboration and global, multi-
sectorial partnerships; and 5. Work with scientists in countries 
hardest hit to develop training, communication, and outreach programs.
    The United States has been the world's leader in research and 
practical assistance to battle HIV AIDS, and NIH's budget confirms that 
commitment. In fiscal year 2003, NIH will devote over $2.7 billion to 
AIDS research, with over S250 million to be spent on AIDS research and 
training efforts abroad.
    To conduct clinical research on vaccines for HIV AIDS, the NIH 
supports the HIV Vaccine Trials Network--or HVTN--a network of 16 
domestic and 13 international sites. Directly and through 
collaborations with investigators, mostly university-based, the HVTN 
also supports laboratory research worldwide to ensure that vaccines are 
efficacious against a variety of HIV strains found in different parts 
of the world. The HVTN currently is conducting a phase II clinical 
trial in Haiti, Brazil, and Trinidad/Tobago. NIH is working with the 
CDC in several countries to identify cohorts of populations at risk for 
HIV infection and build the infrastructure necessary to conduct large-
scale efficacy trials of potential vaccine candidates worldwide when 
they become available.
    NIH supports a growing portfolio of university-based biomedical and 
behavioral research for the discovery, development, preclinical 
testing, and clinical evaluation of interventions to prevent HIV 
transmission, slow disease progression, and limit disease mortality. 
NIH-sponsored programs target studies in Africa, Asia, Latin America 
and the Caribbean on factors related to HIV transmission and the 
mechanisms associated with HIV disease progression. The HIV Prevention 
Trials Network--or HPTN--is a worldwide collaborative network designed 
to conduct research in 16 international and nine domestic sites on 
promising and innovative biomedical, behavioral strategies for the 
prevention or reduction of HIV transmission among at risk adult and 
infant populations.
    A critical element of NIH's research portfolio is efforts to 
strengthen--or create--the research infrastructure of developing 
countries as well as the capacity of in-country investigators to 
conduct clinical trials of therapeutic and preventive therapies. These 
therapies include treatment for opportunistic infections, such as TB, 
which kills a third of those infected with HIV, AIDS vaccines, 
microbicides, and interventions to prevent mother-to-child 
transmission.
    Capacity-building for international research is a critical issue in 
all the countries where NIH funds research activities. NIH focuses its 
efforts in three essential areas:
    Training Research Scientists--It is critical to the success of 
international studies that foreign scientists be full and equal 
partners in the design and conduct of collaborative studies. To help 
build capacity in developing countries, NIH, through the Fogarty 
International Center, funds the AIDS International Training and 
Research Program (AITRP). The AITRP provides research training to 
foreign scientists through grants to U.S. universities. The program has 
provided training in the U.S. for scientists from developing countries 
in Africa, Asia, Latin America and the Caribbean, 85 percent of whom 
return home, and training courses have been conducted in 60 countries. 
Over 200 senior investigators and health officials in Africa have been 
trained through the AITRP, and thousands at more junior levels. With 
85% of trainees returning home, the AITRP is a model of capacity 
building. It is no wonder that Dr. Salim Abdool-Karim, Deputy Vice 
Chancellor for Research and Development at the University of Natal in 
South Africa, and Principal Investigator of a highly successful Fogarty 
AITRP grant has described this program as the pre-eminent model of 
capacity-building, for developing countries.
    Laboratory Capacity--NIH-supported HIV-related research helps to 
build laboratory capacity in developing countries, where the research 
is conducted, through purchase of laboratory equipment and transfer of 
research technology.
    Comprehensive International Program of Research on AIDS (CIPRA)--
has launched CIPRA to provide long-term support to developing countries 
to plan and implement a comprehensive HIV AIDS prevention and treatment 
research agenda relevant to their populations, and to enhance the 
infrastructure necessary to conduct such research. Through this 
initiative, funding will be provided directly to foreign institutions 
for HIV research that is relevant to the host country.
    A safe and effective HIV preventive vaccine is essential to 
controlling, the AIDS pandemic. But, while we have made tremendous 
progress in vaccine development, the deployment of a vaccine is likely 
years away. Other biomedical interventions, such as microbicides, are 
likewise not yet proven or ready for widespread use.
    In the interim, the world's best--and only--hope for controlling 
the epidemic is through sound prevention programs. And care and 
treatment programs are essential to helping the millions already 
infected to diminish the likelihood of infecting their partners, 
furthering the aims of prevention and helping to keep productive 
workers and citizens alive.
    I will now discuss some of the prevention, care, and treatment work 
HHS staff are performing in countries hardest hit by this terrible 
disease. HHS scientists, public health experts, and specialists in AIDS 
care and treatment form a critical component of the U.S. Government's 
interagency response to the international HIV AIDS pandemic.

                     PREVENTION, CARE AND TREATMENT

    Through the HHS Global AIDS Program, CDC works directly with 25 
countries in Africa, Asia, Latin America, and the Caribbean to prevent 
new infections, provide care and treatment to those already infected 
and develop the capacity and infrastructure needed to support these 
programs. We calculate that these 25 countries account for more than 90 
percent of the world's AIDS burden, based on prevalence estimates 
released at the end of last year by the WHO and UNAIDS. Targeting our 
resources to those countries most in need makes sense, and allows us to 
achieve the greatest results for our modest investment. For this fiscal 
year, the budget for the Global AIDS Program is $143 million, plus $40 
million directed by Congress to the President's international Mother 
and Child HIV Prevention Initiative, jointly implemented by HHS and 
USAID. In addition, CDC supports approximately $11 million in applied 
prevention research to support these programs.
    CDC's highly trained physicians, epidemiologists--who have special 
training in the causes, distribution and control of disease in 
populations--virologists and other laboratory scientists, and public 
health advisors--who are experts in the science and practice of 
protecting and improving the health of a community through a variety of 
measures, including preventive medicine, health education, disease 
control, refugee health, and sanitation, for example--are providing 
technical assistance to host-country governments and others working to 
prevent and control HIV AIDS.
    CDC staff is often located directly in host-country ministries of 
Health or their affiliated National AIDS Control Programs. Working in 
close proximity with public health and medical colleagues for both 
government and non-governmental organizations allows CDC experts to 
enhance their services to host-country programs. They are also co-
located with USAID colleagues, promoting complementary programming 
between the two agencies.
    In addition to CDC employees, the HHS Global AIDS Program currently 
has nearly 400 locally employed staff, who serve in a range of 
capacities, from research scientists, laboratory technicians, nurses, 
and midwives to computer specialists, statisticians, sociologists, and 
support staff. One of the primary goals of the HHS Global AIDS Program 
is to develop in-country capacity to address HIV AIDS. Local staff are 
employed to form a national cadre of trained professionals who can 
share their knowledge with others, developing an ever-growing cadre of 
trained personnel.
    The Global AIDS Program was first funded in fiscal year 2000. It 
builds on HHS's long and successful history of global initiatives to 
promote health, in areas such as immunization. For example, in 
Thailand, CDC staff worked with the Thai government to develop a 
national mother-to-child HIV prevention program, the first of its kind 
in the developing world. As a result of this effort, testing has been 
implemented in all public hospitals and it is estimated that perinatal 
transmission has been reduced to less than 10 percent preventing more 
than 1,000 HIV infections in children each year.
    All of this work now forms the foundation for HHS support for and 
involvement in the President's Emergency Plan, which is focused on 14 
of the hardest-hit nations, accounting for 50 percent of all HIV 
infections. This five-year plan is expected to prevent seven million 
new infections--60 percent of the projected new infections in the 
targeted countries. Two million HIV-infected people will be treated 
with anti-retrovirals, and care will be provided to 10 million HIV-
infected individuals and AIDS orphans. Implementation will be based on 
a ``network model'' being employed in countries such as Uganda: a 
layered network of central medical centers that support satellite 
centers and mobile units, with varying levels of medical expertise as 
treatment moves from urban areas to rural communities. The model will 
employ uniform prevention, care, and treatment protocols and prepared 
medication packs for ease of drug administration. It will build 
directly on clinics, sites, and programs established through USAID, 
HHS, non-governmental organizations, faith-based groups, and willing 
host governments.
    Let me emphasize that all persons who receive HIV diagnostic 
testing through the President's Emergency Plan for AIDS Relief and who 
meet the medical criteria for anti-retroviral therapy will receive it.
    Now, let me explain how we derived that goal of putting two million 
people on anti-retrovirals, which some people have tried to claim is 
too small, given the more than 20 million people estimated to be HIV-
positive in our 14 target countries. First, let us remember that the 
World Health Organization endorsed a world-wide target to put three 
million people on anti-retrovirals by 2005.
    Second, our goal is based on field experience and research. The 
President's Plan projects that 50 percent of patients who are HIV-
infected in the 14 countries will enter voluntary counseling and 
testing programs during the five years of the program, an optimistic 
projection, but one supported by data from Brazil and here in the U.S. 
So, approximately 10 million of the 20 million HIV-infected persons in 
our 14 target countries will be diagnosed with HIV-infection and 
receive counseling. All of these persons will receive appropriate 
medical care through the Emergency Plan.
    Most important, according to medical criteria and international 
guidelines, an estimated 20 percent of HIV-infected persons in 
resource-limited settings at any one time require antiretroviral 
therapy. Twenty percent of 20 million infected would be four million, 
but remember that we estimate that only half of the infected population 
will come in to receive testing to find out their status and receive 
medical attention. Therefore, approximately two million of the 10 
million persons who are diagnosed with HIV infection in our 14 
countries will require antiretroviral therapy during the five years of 
the program.
    Because those with advanced disease who are very sick are most 
likely to come in for care through the plan. it is possible our 
partners in the Plan will treat more than two million people with anti-
retroviral therapy: if more than two million people require such 
therapy, the Emergency Plan will provide it. If this scenario were to 
occur, economies of scale should allow for a reduction in the price of 
anti-retroviral medications and certain laboratory tests to keep the 
Plan within the budget the President has requested.
    Although the President's Emergency Relief Plan will not begin until 
next fiscal year, the first stage of this unprecedented effort is his 
Mother and Child HIV Prevention Initiative, which has already begun in 
the same 14 countries and is jointly implemented by HHS and USAID. HHS 
and USAID staff have worked with host governments and NGO's to develop 
preliminary country-specific plans of action that will target one 
million HIV-infected women annually within 5 years or less, provide 
them with HIV counseling and voluntary testing, essential prenatal care 
and support services and--most importantly--with the life-saving drugs 
that will help their babies be born free of HIV infection. We expect 
that this initiative will reduce mother-to-child HIV transmission by 40 
percent among the women treated. A second goal of the initiative is to 
improve health care systems to provide care and treatment not only to 
mothers and babies, but to fathers, other children, and the broader 
community as well. Strengthening health care systems is essential to 
the success of the President's broader Emergency Relief Plan.
    HRSA is lending its strength to this initiative through the 
training of health care providers and the facilitation of partnerships 
between U.S. hospitals and clinics and their counterparts in the 14 
countries (``twinning''). HRSA also supports broader HIS/AIDS 
international training initiatives through a cooperative agreement with 
CDC.
    The President's Emergency Plan also increased our pledge to the 
Global Fund to Fight AIDS, Tuberculosis and Malaria to $1.65 billion, 
50 percent of the total $3.36 billion pledged to date. Our fiscal rear 
2003 commitment alone accounts for 45 percent of all resources 
available to the Fund this year ($350 million of a total $780 million 
pledged or in the bank), and the U.S. is responsible for 37 percent of 
the Fund's cash on hand. With the exception of Germany and Ireland, 
major donor countries have not increased their initial pledges, which 
in most cases extend over several years. Secretary Thompson, who was 
elected to serve a one year term as Board Chair during the last Global 
Fund Board meeting in January, is committed to mobilizing additional 
resources from both donor nations and the private sector. The U.S. 
supported strongly the creation of the Global Fund and continues to 
support its efforts through technical assistance to partnerships as 
they develop proposals for the Fund and helping to implement and 
monitor Global Fund financed programs.
    For too long, people in the developing world have seen a diagnosis 
of HIV infection as a death sentence. And it has been. But with the 
promise of care and treatment, for the first time, learning your HIV 
status can be seen as a stepping stone to needed care. An HIV test will 
be the gateway to services. For those who are infected, they will be 
able to receive treatment--and essential prevention and support 
services to keep from transmitting the virus to others. For those who 
are not infected, they can receive vital prevention services to learn 
how to remain HIV-free, emphasizing the ABCs of HIV prevention. ``A'' 
is for abstinence in young people. ``B'' is for being faithful within a 
relationship, and ``C'' for condom use in high risk populations with 
the knowledge that condoms are not as effective in preventing all 
sexually transmitted diseases as they are with HIV. I have traveled to 
Uganda, and I have seen that ABC is working. Uganda is the only country 
in Africa with an increasing life expectancy. The ABC prevention 
concept is something that we should seriously examine in our own 
country.
    All this is possible because of the hope of care and treatment. We 
at HHS, in partnership with USAID and other organizations, are making 
good on this promise. We are providing the essential training, 
technical assistance and financial support to governments and 
scientific institutions around the globe to help them help their 
people. None of this would be possible without the continued support of 
members of this Committee and your colleagues in the House and Senate.

           HIV TRANSMISSION THROUGH UNSAFE MEDICAL PRACTICES

    As the focus of today's hearing, I will now briefly speak about 
recent reports that unsafe medical practices, including unsafe 
injections, are responsible for a more significant percentage of HIV 
infection in Africa than previously thought.
    A clear understanding of the modes of HIV transmission will 
contribute to achieving our goal of turning the tide of this epidemic. 
We at HHS are committed to exploring all avenues of inquiry that may 
hasten the achievement of that goal. We acknowledge, and have 
acknowledged publicly, the contribution of unsafe medical practices to 
HIV in resource-limited settings. HHS, through CDC, has been a major 
proponent of the need for safe blood practices and provides technical 
assistance in this regard throughout the world. However, it is 
important to acknowledge that the contribution of such practices to HIV 
infection in resource-limited settings is unknown. There are a few key 
points regarding the recent publication in this regard.
    First, the publication was not a study, it did not perform primary 
research and did not perform actual surveillance. Rather, the authors 
reviewed previously published data and came to conclusions different 
from the authors of those studies, and of the global scientific 
community in general.
    Second, I should note that the vast majority of scientists, and we 
at HHS, accept the premise that the contribution of unsafe injection 
and medical practices discussed in the paper does require further 
evaluation. However, the preponderance of experts reviewing the same 
data have concluded that the author's estimate that medical practices 
are responsible for 20 to 40 percent of infections in Africa is likely 
a significant overestimate.
    Finally, however high the percentage of infections in Africa 
contributed by unsafe injections and medical practices really is, I 
want to assure you that the President's Emergency Plan for AIDS Relief 
in Africa and the Caribbean has a component to reduce transmission from 
unsafe injections and medical practices. Each and every infection with 
a dirty needle is whooly presentable and should be presented. Under the 
President's initiative, prevention activities will be directed at all 
modes of transmission, including improving safe blood supplies, and the 
Emergency Plan will have the flexibility to adjust resource allocation 
based on scientific data as it becomes available.
    In addition, the Emergency Plan will enhance the medical capacity 
and infrastructure in the countries participating in the program: these 
activities in and of themselves should have a ``spillover'' effect to 
promote safer medical practices. Finally, it is important to note that 
the Emergency Plan is committed to providing medical care and 
treatment, including anti-retroviral therapy, for those who are 
infected with HIV regardless of hogs they acquired the virus. However a 
person obtained HIV, the President's bold and compassionate Plan will 
provide the necessary care and treatment.
    An important target of HHS HIV prevention activities is to present 
the infection of children. Although the contribution of unsafe medical 
practices to the infection of children has not been fully quantified, 
there is no question that transmission of HIV from mothers to their 
infants is the most significant cause of infection among children. For 
this reason, the Congress has supported the President's Initiative to 
prevent vertical transmission of HIV. As noted above, this Initiative 
hopes to present 40% of HIV infections from mothers to their infants. 
However, one of the most effective ways to present a mother from 
infecting her infant, and to protect the child from becoming an orphan, 
is to present the mother from becoming infected in the first place. The 
President's Emergency Plan provides broad prevention activities that 
have had great success in reducing infections of mothers in Uganda, 
Senegal, Brazil, and Thailand. It is important that we continue to 
support these proven strategies.

                    GLOBAL CONTROL OF TB AND MALARIA

    Thus far, I have focused on HIV and AIDS in this testimony. Let me 
now make a few comments regarding HHS's contributions to the global 
control of tuberculosis and malaria. HHS's approaches to both TB and 
malaria are similar to that of HIV AIDS, but are more limited in terms 
of scope and resources.
    Both NIH and CDC work to address TB. TB is a global emergency and a 
leading infectious killer of young adults worldwide. Approximately one-
third of the world's population is infected with the bacterium that 
causes TB and 80 percent of active TB cases originate in 22 high-burden 
countries. As I noted earlier, TB accounts for one-third of deaths 
among persons with AIDS. Basic research on TB, including research on a 
vaccine, is conducted at NIH. CDC supports applied research, including 
operational research to improve programs and clinical research to 
evaluate new drugs and diagnostics, and program implementation.
    In addition to addressing HIV and TB coinfection through the Global 
AIDS Program, CDC works closely with USAID, international 
organizations, and 16 countries around the globe to control TB. 
International partners include the WHO and the International Union 
Against TB and Lung Diseases (IUATLD). Collaborative efforts include 
the Stop TB Partnership, technical support to USAID, and technical 
assistance to specific countries. Technical assistance is focused on 
countries that contribute most to U.S. cases, are high burden 
countries, have High rates of multi-drug resistant TB (MDR-TB), are of 
strategic importance (e.g. countries participating in the HHS Global 
AIDS Program), or provide opportunities to improve diagnosis and 
treatment of TB, MDR-TB, and HIV-associated TB.
    Spearheaded by the WHO and its international partners, including 
HHS, a proven effective national case management strategy has been 
applied increasingly in developing nations. This strategy is termed 
DOTS--Directly Observed Therapy, Short-Course--which emphasizes 
consistent drug supply, microscopic based diagnosis, and direct 
observation of each dose of life saving medication. The World Bank has 
ranked DOTS as one of the most cost-effective of all health 
interventions. CDC works with WHO and other partners to expand the 
current DOTS strategy so that people with TB have access to effective 
diagnosis and treatment, and to adapt this strategy to meet the 
challenges of HIV and multi-drug resistance.
    CDC and NIH are also involved actively in research on global 
malaria prevention and control. NIH is engaged in research both 
domestically and globally with a focus on malaria vaccine development 
and optimal use of the information on newly characterized malaria 
genome and the mosquito vector genome. CDC continues to work on U.S. 
domestic prevention and monitoring and on global collaborations with 
Ministries of Health, U.S. universities and schools of public health, 
and non-governmental and faith-based organizations in the prevention 
and control of malaria in malaria-endemic settings--mostly in sub-
Saharan Africa. In fact, much of the HHS global work on malaria is in 
the same setting where HIV prevention work is underway.
    The HHS effort in malaria is widely collaborative with the 
Department of State, USAID and the Department of Defense. The U.S. 
leadership in the Global Fund to Fight AIDS, TB, and Malaria has been 
especially well-received in the malaria community.
    Currently available control strategies for malaria have proven to 
be highly effective in saying lives. Effective antimalarial treatment 
exists that cures infection and disease. Effective prevention exists, 
as evidenced by the 20 percent reduction in child mortality with the 
use of insecticide-treated bed nets in Africa. Use of insecticide 
treated bed nets and preventive treatment can alter the impact of 
malaria dramatically in pregnant women and their newborns, improving 
newborn birth weight and reducing anemia in the mother and the newborn, 
and saying lives.
    Finally, as a with TB, malaria must also be seen in the context of 
HIV and AIDS prevention and control. Recent studies have shown that 
malaria and HIV interact broadly. Malaria causes anemia and the needed 
blood transfusions can be a source of HIV transmission. HIV-infected 
pregnant women contract the disease disproportionately and exhibit more 
severe complications, conferring a greater risk to the developing fetus 
and the newborn. Most recently, studies suggest that malaria is more 
severe in HIV-infected adults and that malaria may stimulate HIV viral 
replication, with potentially greater increased risk for HIV 
transmission. The widespread coexistence of malaria and HIV in Africa 
likely means that each is making the other worse and that addressing 
both is a good police.
    I thank you again, and welcome any questions you have for me.

                Prepared Statement by David Gisselquist

    It is a privilege and a challenge to address this committee on a 
matter so important to the health of people in Africa and by extension 
in Haiti and much of Asia as well. With a better understanding of the 
HIV epidemic in Africa, the new resources that President
    Bush has asked for could make an enormous difference to almost 
immediately stop and even reverse epidemic growth in developing 
countries.
    If we consider all of the evidence about HIV in Africa, from the 
time A1DS was first recognized on the continent 20 years ago to the 
present, this evidence suggests that the driving force for the 
epidemic--what allows the epidemic to grow rather than to die out--has 
been and continues to be unsafe health care. This view of the epidemic 
challenges the conventional wisdom that over 90% of HIV in African 
adults is from heterosexual transmission. In this testimony, I first 
summarize the evidence showing that health care rather that 
heterosexual transmission drives Africa's epidemic, and I then consider 
implications for HIV prevention.
    Evidence for HIV from health care and heterosexual transmission 
through 1988 After early debates about the relative importance of 
unsterile health care and heterosexual transmission in Africa's AIDS 
epidemic, most AIDS experts reached a consensus no later than 1988 to 
focus on heterosexual transmission. In that year, WHO circulated 
estimates that 80% of African HIV came from heterosexual transmission, 
just over 10% from mother-to-child transmission, 6% from blood 
transfusions, and less than 2% from unsafe medical injections. \1\ We 
have been unable to find an explanation of how WHO experts or anyone 
else derived these estimates from evidence.
---------------------------------------------------------------------------
    \1\ Chin J, Sato PA, Mann JM. Projections of HIV infections and 
AIDS cases to the year 2000. WHO Bull 1990; 68: 1-11.
---------------------------------------------------------------------------
    To determine the facts behind these estimates, we looked at all of 
the studies of risk factors for HIV in Africa with field work completed 
through 1988. We found 13 studies that tested and questioned a total of 
more than 25,000 adults from the general population. \2\ In these 
studies, people who reported medical injections in previous years were 
more likely to have HIV infections; across all studies that asked about 
injections, an average of 48% of HIV infections were associated with 
injections. Similarly, 5% of HIV infections were associated with blond 
transfusions and some with scarification, so that health care exposures 
were associated with over 50% of infections. In contrast, across all 
studies that asked about numbers of sexual partners, only 16% of HIV 
infections were associated with having more than one sexual partner. 
The measure of association that we have used is the crude population 
attributable fraction, which for various reasons may overestimate or 
underestimate the causative association.
---------------------------------------------------------------------------
    \2\ Gisselquist D, Potterat JJ, Brody S, Vachon F. Let it be 
sexual: how health care transmission of AIDS in Africa was ignored. Int 
J STD AIDS 2003; 14: 148-161.
---------------------------------------------------------------------------
    Another dozen studies during 1984-88 looked at HIV in African 
prostitutes, and characteristically found high HIV prevalence. However, 
prostitutes get a lot of injections for sexually transmitted disease 
(STD), so they have at least two important risks--health care and sex. 
No study of African prostitutes through 1988--or later--has collected 
and reported enough information on medical exposures to sort out how 
much HIV is coming from sex versus health care.
    Despite high HIV prey hence in prostitutes, most HIV in Africa in 
the 1980s was in men and women in the general population with very 
normal and even conservative sex lives--with 0-1 sexual partners in the 
last six months, last year, or even lifetime. \3\ And in the general 
population, more HIV was associated with medical than with sexual 
exposures. Hence, WHO's 1988 estimates that over 90% of HIV in African 
adults was from sexual transmission and less than 2% from medical 
injections disagreed with available evidence. From the beginning, this 
estimate has floated above the facts.
---------------------------------------------------------------------------
    \3\ Gisselquist D, Potterat JJ, Brody S, Vachon F. Let it be 
sexual: how health care transmission of AIDS in Africa was ignored. Int 
J STD AIDS 2003; 14: 148-161.
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      EVIDENCE FOR HIV FROM HETEROSEXUAL TRANSMISSION THROUGH 2003

    Nevertheless, the estimate was widely accepted, and the dominant 
view from the late 198Os has been that HIV in--African adults is spread 
primarily by heterosexual contact. For this to be true, heterosexual 
transmission would have to be much faster in Africa than in the US and 
Europe. Rough calculations can show how big this difference would have 
to be. In the US, there are about 800,000 men and women with HIV, and 
of this total, about 400,000 are heterosexually active, including men 
and women infected from injection drug use or heterosexual partners and 
bisexual men infected by male lovers. Whatever the source of their HIV 
infections, these 400,000 men and women are a threat for heterosexual 
transmission. According to recent estimates, there are in the US about 
40,000 new HIV infections each year of which roughly a quarter--
10,000--are from heterosexual contact. From this, we can estimate that 
400,000 heterosexually active men and women with HIV infect 10,000 
through heterosexual contact in a year, or on average 40 people infect 
I in a year. \4\ \5\ Hence, in the US, HIV would not even survive as an 
epidemic through heterosexual transmission alone. Without treatment, 
people with HIV live on average about 10 years, while they would have 
to live 40 years on average to infect another person through 
heterosexual contact. It is noteworthy as well that many of the 
heterosexuals with HIV in the US, including prostitutes and drug users, 
are not low risk and conservative in their sexual behavior.
---------------------------------------------------------------------------
    \4\ Karon JM, Fleming PK, Steketee RW, De Cock KM. HIV in the 
United States at the turn of the century: an epidemic in transition. Am 
J Public Health 2001; 91: 1060-1068.
    \5\ Centers for Disease Control and Prevention. CDC guidelines for 
national human immunodeficiency virus case surveillance, including 
monitoring for human immunodeficiency virus infection and acquired 
immune deficiency syndrome. MMWR Morb Mortal Wkly Rep 1999; 48: (RR-
13): 1-31.
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    We can compare this US experience with what has been supposed about 
sexual transmission in Africa. In Africa, the HIV epidemic has often 
been observed to double in as little as 1-3 years in low risk 
populations such as antenatal women in Botswana and South Africa in the 
early 1990s. For heterosexual transmission to explain such rapid 
growth, on average each man or women with HIV would have, to infect 
another in 1-3 years, or roughly 15-30 times faster than average 
heterosexual transmission in the US. Hence, there is much to explain.
    Initially, AIDS experts supposed that faster heterosexual 
transmission in Africa than in the US could be explained by greater 
promiscuity among Africans. However, studies of sexual behavior in 12 
African countries in 1989-93 derailed this hypothesis, showing Africans 
to have on average no more partners than Americans or Europeans. \6\ A 
1995 WHO publication noted that ``These results are totally 
incompatible with the view, prevalent only a few years ago, that the 
HIV pandemic in Africa was fuelled by extreme promiscuity'' (page 211). 
\7\
---------------------------------------------------------------------------
    \6\ Carael M, Cleland J, Deheneffe JC, Ferry B, Ingham R. Sexual 
behaviour in developing countries: implications for HIV control. AIDS 
1995; 9: 1171-1175.
    \7\ 
---------------------------------------------------------------------------
    7 Cleland J, Ferry B, Carael M. Summary and conclusions. In: 
Cleland J, Ferry B, editors. Sexual behavior and AIDS in the developing 
world. Geneva: WHO, 1995.
    Another proposed explanation for much faster heterosexual 
transmission in Africa is that more Africans are infected with STD such 
as gonorrhea and.syphilis, which are cofactors that increase the rate 
of HIV transmission. However, the size of the impact is the issue. In 
many African studies, different levels of STD prevalence across 
communities or time do not correlate with and hence cannot explain 
differences in HIV prevalence or incidence. For example, a major study 
in 1997-98 tested and questioned roughly 1,000 men, 1,000 women, and 
300 prostitutes in four African cities--two with high and two with low 
HIV prevalence. The study reported that high rate of partner change, 
sex with prostitutes, concurrent partnerships, gonorrhea, chlamydia, 
syphilis, and lack of condom use were \8\ ``not more common in the two 
high prevalence cities.'' Notably, Yaounde in Cameroon, one of the two 
cities with low HIV prevalence, had the highest rates of gonorrhea and 
chlamydia.
---------------------------------------------------------------------------
    \8\ Buve A, Carael M, Haves RJ, et al. The multicentre study on 
factors determining the differential spread of HIV in four African 
cities: summary and conclusions. AIDS 2001; (suppl 4): S127-S131.
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    Other factors that have been proposed to explain Africa's 
heterosexual epidemic include lack of male circumcision and genital 
herpes. Lack of circumcision appears to increase risks for males by a 
factor of about two. \9\ Similarly, a recent review of research on 
genital herpes suggests that it, too, increases risks to contract HIV 
by a factor of about two. \10\ These co-factor effects are too small to 
explain the supposed differences in sexual transmission between Africa 
and developed countries. Furthermore, genital herpes and uncircumcised 
males are common in the US and/or Europe.
---------------------------------------------------------------------------
    \9\ Weiss HA, Quigley MA, Hayes RJ. Male circumcision and the risk 
of HIV infection in sub-Saharan Africa: a systematic review and meta-
analysis. AIDS 2000; 14: 2361-2370.
    \10\ Wald A, Link K. Risk of human immunodeficiency virus infection 
in herpes simplex virus type 2seropositive persons: a meta-analysis. J 
Infect Dis 2001; 185: 45-52.
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    From 1988 through 2003 repeated efforts to explain Africa's 
supposed much faster heterosexual transmission have foundered on the 
facts. Nevertheless, AIDS experts have not abandoned the vision. An 
important 2002 article in Lancet asserts that a \11\ ``complex 
interplay of behavioral factors and factors that effect the 
transmission of HIV-1 during sexual intercourse'' explains HIV 
epidemics in Africa. Translated into plain English, what this means is 
that ``We think it's a sexual epidemic, but we can't explain how.''
---------------------------------------------------------------------------
    \11\ Buve A, Bishikwabo-Nsarhaza K, Mutangadura G. The spread and 
effect of HIV-1 infection in subSaharan Africa. Lancet 2002; 359: 2011-
2017.
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    In the years since 1988, research in Africa has produced an 
increasing body of evidence measuring the association between HIV and 
various sexual exposures. We have used this evidence to make the first 
empiric estimates of the proportion of HIV in African adults from 
heterosexual transmission. \12\ One important category of evidence 
comes from five studies that show the annual rate of HIV transmission 
between serodiscordant partners in Africa who continue unprotected sex. 
In these studies, either the husband or wife is HIV-positive while the 
other is HIV-negative, most did not know their own or spouse's HIV 
status, and condom use was rare. Across these five studies the average 
annual rate of incidence in HIV-negative men was 7.1%, and in women, 
10%. These rates are somewhat higher but comparable to what has been 
found in similar studies in the US and Europe. From this and other 
empiric information on HIV in married partners, we can calculate that 
spouse-to-spouse transmission explains roughly 10-14% of total incident 
(or new) infections that would be required to explain even a slow-
growing epidemic.
---------------------------------------------------------------------------
    \12\ Gisselquist D, Potterat JJ. Heterosexual transmission of HIV 
in Africa: an empiric estimate. Int J STD AIDS. 14: 162-173.
---------------------------------------------------------------------------
    The other important category of evidence that we use is the 
proportion of new HIV infections in African adults associated with 
having multiple sexual partners. For this, we use data from studies 
that followed people who initially tested HIV-negative, and then re-
tested and questioned them later to identify risks for those that 
seroconverted before follow-up tests. We found 10 such studies. From 
these, we calculated an (unweighted) average of 15% of new HIV 
infections associated with having more than one sexual partner. \13\
---------------------------------------------------------------------------
    \13\ Gisselquist D. Unanswered questions about sexual transmission 
of HIV in Mwanza, Tanzania. J Acquir Immune Defic Syndr 2003; 32: 349-
351.
---------------------------------------------------------------------------
    To estimate all HIV infections associated with sexual transmission, 
we add 10-14% from spouse-to-spouse transmission and 15% from multiple 
partners, and we add some infections that unmarried people contract 
from their first or only partner in a year. From these calculations, 
which we report in detail in a recent paper, our best point estimates 
(we do not estimate confidence intervals) are that heterosexual 
transmission is responsible for 25-35% of HIV in African adults. \14\ 
Since these are the first evidence-based estimates of the proportion of 
HIV in African adults from sexual transmission, we recognize that there 
will be questions about data and analyses, and we invite revisions and 
refinements.
---------------------------------------------------------------------------
    \14\ Gisselquist D, Potterat JJ. Heterosexual transmission of HIV 
in Africa: an empiric estimate. Int J STD AIDS. 14: 162-173.
---------------------------------------------------------------------------
             EVIDENCE FOR HIV FROM HEALTH CARE THROUGH 2003

    If we assume that most of the HIV in Africa that is not from sexual 
transmission is from health care, we can estimate that health care is 
responsible for 60-70% of HIV. This indirect approach gives us no 
information about specific health care risks--The direct approach is to 
build up estimates of health care transmission from studies that 
associate HIV with injections, blood transfusions, dental care, and so 
on.
    Taking the direct approach, health care injections appear to be the 
biggest single risk. From the 16 available large studies in Africa with 
sufficient data on injections, an average of 28% of HIV infections is 
associated with medical injections. \15\ Some studies associate HIV 
with blood transfusions and/or scarification, but we know little about 
dental care, drawing blood for tests, traditional operations, and other 
blood exposures.
---------------------------------------------------------------------------
    \15\ Gisselquist D. Proportion of HIV in African adults associated 
with medical injections and multiple partners (unpublished paper 
distributed at a meeting on Unsafe injection practices and HIV 
infection, Geneva, WHO, 14 March 2003). See also: Gisselquist D, 
Rothenberg R, Potterat J, Drucker EM. H TV infections in sub-Saharan 
Africa not explained by sexual or vertical transmission. Int J STD AIDS 
2002; 13: 657-666.
---------------------------------------------------------------------------
    Even so, there is other evidence for health care transmission. For 
example, a number of studies show unexplained high HIV incidence in 
African women from first antenatal visit to delivery and for the first 
year postpartum. \16\ In 1990 in Malawi, for example, HIV-negative 
antenatal and postpartum women were observed to contract HIV at the 
rate of 21% per year. This is, notably, double the rate that one would 
expect if all their husbands were HIV-positive. No one tested the 
husbands, but we can estimate how many would be HIV-positive and how 
many new infections would be due to spouse-to-spouse transmission, and 
we are left with unexplained incidence of 19% per year. Another similar 
study in Zimbabwe in 1990-94 shows unexplained incidence of 14% per 
year in antenatal women and 10% per year during 0-6 months postpartum. 
This evidence suggests possible HIV transmission through blood tests, 
vaginal exams, tetanus vaccinations, and/or other pregnancy-related 
health care. If so, this could explain an--important proportion of HIV 
in young women in many African countries.
---------------------------------------------------------------------------
    \16\ Gisselquist D, Rothenberg R, Potterat J, Drucker EM. HIV 
infections in sub-Saharan Africa not explained by sexual or vertical 
transmission. Int J STD AIDS 2002; 13: 657-666.
---------------------------------------------------------------------------
    Many studies have reported HIV-infected children with HIV-negative 
mothers. \17\ In Kinshasa in 1985, for example, 17 of 44 HIV-positive 
inpatient and outpatient children had HIV-negative mothers. In Kigali 
in 1984-86, 15 of 76 children with AIDS or AIDS symptoms had HIV-
negative mothers. In Uganda in 1989-94, 19% of 26 children with 
Kaposi's sarcoma and HIV had HIV-negative mothers. And in a large study 
of inpatient children and mothers in four African cities ca. 1990-91, 
61 (1.1 %) of 5,593 children were HIV-positive with HIV-negative 
mothers (the study did not report total HIV-positive children, so we 
don't know the proportion with HIV-negative mothers). \18\
---------------------------------------------------------------------------
    \17\ Gisselquist D, Rothenberg R, Potterat J, Drucker EM. HIV 
infections in sub-Saharan Africa not explained by sexual or vertical 
transmission. Int J STD AIDS 2002; 13: 657-666.
    \18\ Hitimana D, Luo-Mutti C, Madraa B, Mwaikambo E, Malek A, 
Nkowane B. A multicentre matched case control study of possible 
nosocomial HIV-1 transmission in developing countries. In: Abstracts of 
the IXth International Conference on AIDS: 6-11 June 1993, Berlin, 
Germany. Abstract WS-C13-02, p 94.
---------------------------------------------------------------------------
    In addition, a number of studies have reported levels of HIV 
prevalence in children too high to be explained by mother-to-child 
transmission. In a random sample survey in Rwanda in 1986, for example, 
4.2% of urban children 6-15 were HIV-positive. Most of these infections 
would be from health care, since these children were born when HIV 
prevalence in mothers was low, and most of the children infected from 
their mothers would have died before reaching 6 years old. \19\ In 
2002, a national random sample survey in South Africa reported 5.6% HIV 
prevalence in children 2-14 years old. \20\ One quarter of this total 
can be explained by what we know about mother-to-child transmission and 
child survival with HIV, leaving roughly 500,000 unexplained 
infections. A comment in the British Medical Journal proposes that 
child abuse might be a factor, \21\ however, child abuse would have to 
be a thousand times more common than reported to account for the 
infections. In other words if the data is correct, health care is 
suspect.
---------------------------------------------------------------------------
    \19\ Rwandan HIV Seroprevalence Study Group. Nationwide community-
based serological survey of HIV-1 and other human retrovirus infections 
in a central African country. Lancet 1989; is 941-943.
    \20\ Shisana O, Simbayi L, Bezuidenhout F, et al. Nelson Mandela/
HSRC Study of HIV/AIDS: South African national HIV prevalence, 
behavioral risks and mass media: household survey 2002. Cape Town: 
Human Sciences Research Council, 2002.
    \21\ Sidley P. HIV infection rate among South African children 
found to be 5.6%. BMJ 2002; 325: 1380.
---------------------------------------------------------------------------
    Some evidence suggests that large scale HIV transmission through 
health care in Africa is plausible. At least three large iatrogenic HIV 
outbreaks have been documented outside Africa. In Russia in 1988, 
doctors who found one child with HIV set in motion an investigation 
that identified 250 children infected through health care. During this 
outbreak, the number of infections in two hospitals in Elista increased 
from one to 90 in 11 months, doubling on average in less than two 
months, which is faster than HIV spread among gay men attending 
bathhouses in San Francisco in the early 1980s. Other comparable 
iatrogenic outbreaks have been uncovered in Romania in 1989 with over 
1,000 infected children and in Libya in 1998, with almost 400 infected 
children.
    What has happened in Russia, Romania, and Libya has no doubt 
happened in a number of African countries. As already noted, from the 
mid-1980s, many studies have reported HIV-infected African children 
with HIV-negative mothers, but there have been no follow-on 
investigations to find the numbers infected and clinics and procedures 
involved, allowing informed action to stop transmission. One wonders 
what would have happened in Russia or Libya, for example, if doctors 
had not sounded the alarm after finding one unexplained infection, and 
if outbreaks had been allowed to continue, doubling every several 
months. From this perspective, it is possible that hundreds of 
thousands of African children have HIV infections from health care, 
which could explain the 5.6% prevalence in children 2-14 years old in 
South Africa's 2002 household census.
    Several recent WHO studies report hundreds of millions of unsafe 
injections in Africa each year. \22\ These occur in formal as well as 
informal settings. For example, in early March 2003, a nurse in 
Botswana was observed reusing the same needle without sterilization on 
170 children. \23\ What may be remarkable about this incident is that 
teachers objected and someone reported it to the newspaper, but it is 
also noteworthy that teachers allowed the injections to continue. 
Hospitals and clinics often operate without running water. Doctors and 
nurses may reuse gloves with many patients, if they have gloves at all. 
Since formal systems are often not able to meet the demand for health 
care, people go to a variety of informal providers, including 
pharmacists, untrained injection doctors, and neighbors. The situation 
is certainly much worse on average than in Russia, Romania, and Libya, 
where hundreds to thousands of iatrogenic infections have been found.
---------------------------------------------------------------------------
    \22\ Simonsen L, Kane A, Lloyd J, Zaffran M, Kane M. Unsafe 
injections in the developing world and transmission of bloodborne 
pathogens: a review. WHO Bull 1999, 77: 789-800.
    \23\ Mukumbira R. 200 kids, one syringe. News 24. 6 March 2003. 

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               IMPLICATIONS FOR COMMUNITY HIV PREVENTION

    If the arguments and estimates that we present about the 
proportions of HIV from sex and health care are even partially correct, 
we can expect much more success in slowing the HIV epidemic with a 
combined program that addresses both sets of--risks. From 1988, efforts 
for HIV prevention among Africa youth and adults have focused almost 
exclusively on sexual risks, promoting behavior change--fewer partners 
and more condom use--and improved STD treatment. A variety of evidence 
suggests that these and other interventions targeted at sexual 
transmission can be expected to have only modest impact on the spread 
of HIV in a community. For example, studies of sexual behavior in 12 
African countries in 1989-93 showed little or no correlation between 
average numbers of sexual partners in a country and level of HIV 
prevalence. Similarly, the 1997-98 four-city found no correlation 
between most measures of sexual exposure and HIV prevalence. And a 
recent large trial of behavior change interventions on HIV incidence in 
Masaka, Uganda, reported that increased condom use with last casual 
partner had no significant impact on HIV incidence. \24\
---------------------------------------------------------------------------
    \24\ Kamali A, Quigley M. Nakiyingi J, et al. Syndromic management 
of sexually-transmitted infections and behavior change interventions on 
transmission of HIV-1 in rural Uganda: a community randomized trial. 
Lancet 2003; 361: 645-652.
---------------------------------------------------------------------------
    From 1991, three large trials in Tanzania and Uganda tested the 
impact of improved STD treatment on community HIV incidence. In two of 
these trials, in Rakai \25\ and Masaka \26\ in Uganda, STD treatment 
reduced STD prevalence but had no significant impact on HIV incidence. 
In a third trial in Mwanza, Tanzania, which was the first to report in 
1995, improved STD treatment had little impact on STD prevalence, but 
HIV incidence was much lower in intervention than in control 
communities. \27\ These results are a puzzle, since it is not possible 
from the data to explain lower MV incidence on the basis of modest and 
questionable reductions in STD prevalence. However, the Mwanza trial 
coincided with an injection safety initiative, which might well be the 
missing factor that explains it's apparent success.
---------------------------------------------------------------------------
    \25\ Wawer MJ, Sewarikambo NK, Serwadda D, et al. Control of 
sexually transmitted diseases for AIDS prevention in Uganda: a 
randomized community trial. Lancet 1999; 353: 525-535.
    \26\ 26 Kamali A, Quigley M, Nakiyingi J, et al. Syndromic 
management of sexually-transmitted infections and behavior change 
interventions on transmission of HIV-1 in rural Uganda: a community 
randomized trial. Lancet 2003; 361: 645-652.
    \27\ Gisselquist D, Potterat JJ. Confound it: latent lessons from 
the Mwanza trial of STD treatment to reduce HIV transmission. Int J STD 
AIDS 2003; 14: 179-184.
---------------------------------------------------------------------------
    Among the many developing countries with generalized HIV epidemics, 
Uganda is one of the few to show falling HIV prevalence, which appears 
to have peaked around 1990 and then declined. \28\ Experts debate the 
relative importance of less extramarital sex (abstinence and 
faithfulness) versus condom use to explain this success. However, this 
debate ignores big improvements in health care safety. From the late 
1980s, the government of Uganda, as part of its response to HIV, 
arranged special training for health care workers in infection control. 
In addition, both government campaigns and private radio have educated 
the public about risks from unsterile health care. When Ugandans go for 
injections, they often bring their own syringes. A 1998 study reported 
that Ugandans taking relatives to the hospital bring saucepans and 
cookers to sterilize instruments every night at the foot of the bed, 
not trusting hospital sterilization. \29\ A 2001 WHO-funded study 
reports that \30\ ``Private medical practices are very popular . . . in 
Uganda where public facilities are often mistrusted and held 
responsible for the spread of the AIDS epidemic.'' Hence, attempts to 
explain the observed fall in HIV prevalence in Uganda are incomplete 
without attention to changes in health care practices. The same goes 
for Thailand, another country where success against HIV has been 
claimed for interventions targeting sexual transmission (particularly 
the 10090 condom program for prostitutes), and where large improvements 
in health care practices are plausible and ignored.
---------------------------------------------------------------------------
    \28\ Hogle J, Green E, Nantulya V, Stoneburner R. Stover J. What 
happened in Uganda? Declining HIV prevalence, behavior, and the 
national response. Washington DC: USAID, 2002.
    \29\ Birungi H. Injections and self-help: risk and trust in Ugandan 
health care. Soc Sci Med 1998; 47: 14551461.
    \30\ Priotto G. Injection use in the population of Mbarara 
District, Uganda. WHO, 2001 (unpublished).
---------------------------------------------------------------------------
    Overall, repeated findings of weak or absent correlations between 
levels of HIV infections and community levels of sexual behavior, 
condom use, and STD prevalence suggest that even aggressive and 
successful efforts aimed at sexual risks may have little impact on the 
trajectory of epidemic expansion in countries with generalized 
epidemics. This makes sense if health care rather than sex drives HIV 
growth. The consequences of continuing failure to control emerging and 
ongoing generalized epidemics can be measured in tens of millions of 
new infections over the next decade, many of which can be expected in 
populous Asian countries such as India, Pakistan, and Indonesia. Even 
if we are only partially correct about the role of health care 
transmission in generalized AIDS epidemics, we can expect much better 
success with programs that address both health care and sexual risks.

       IMPLICATIONS FOR HELPING INDIVIDUALS REDUCE PERSONAL RISK

    People living and raising families in communities where 1%-30% or 
more of adults are HIV-positive face a variety of risks. UNAIDS, for 
example, advises UN employees going to many developing countries to 
bring their own syringes arid to ask about sterilization when seeking 
health care. Similarly, a young African couple trying to raise a family 
safely has to consider whether or not to send the wife to the public 
antenatal clinic, where nurses take tetanus vaccine out of multidose 
vials, and specula may be reused without sterilization. When children 
are young, the couple has to balance risks from measles and other 
diseases against risks with immunization. Even if they buy and bring 
their own disposable syringe, they don't know what other needles have 
gone into multidose vaccine vials, and single-dose vials may not be 
available. When someone has a toothache, they face risks in dental 
care. In Harare, for example, people are advised to go to the dentist 
early because it's cleaner, with about 30% adult HIV prevalence, if one 
is the fourth person in the chair, chances are better than 50% that one 
of the previous patients was HIV-positive.
    In addition to these health care risks, people need information 
about sexual risks, including their own and their partner's HIV status 
and options to reduce sexual risks. When someone is looking for a 
spouse or a young couple is planning to have a child, for example, they 
need access to HIV tests to make informed life decisions. However, in 
most African countries, test kits are strictly controlled through 
public trade, which means that tests are not conveniently available. In 
2001, for example, only two sites in Cote d'Ivoire offered HIV tests, 
and only 16 sites in Zimbabwe. \31\ Testing sites are often far away, 
and two visits may be required to draw blood and to receive one's 
results. Without a major relaxation of controls on HIV tests, over 90% 
of Africans with HIV will continue to live and die without they or 
their partner ever knowing they are HIV positive. This situation 
undermines all efforts to control sexual transmission. Hence, big 
changes are required in regulation of HIV testing to enable people to 
see and control their sexual risks. Rapid tests are available for less 
than $2. \32\
---------------------------------------------------------------------------
    \31\ WHO. The health sector response to HIV/AIDS: coverage of 
selected services in 2001. Geneva: WHO, 2002.
    \32\ Branson BM. Rapid tests for HIV antibody. AIDS Revue 2000; 2: 
76-83.
---------------------------------------------------------------------------
    Once people are tested and know their status, if both partners are 
HIV-negative they can throw away condoms and save money as long as they 
stay with current partners. If one partner is HIV-positive, they will 
presumably be attentive to advice about condoms and other options.
    The WHO Constitution affirms that ``Informed opinion and active 
cooperation on the part of the public are of utmost importance in the 
improvement of the health of the people.'' Since Africans are on the 
front lines facing multiple risks from HIV, we can be more effective 
against HIV to the extent that we help them get the information and 
life skills that they need to live safely in the midst of a terrible 
epidemic. Considering all the risks that they face, the current focus 
on condoms and sexual behavior simply does not speak to all their 
concerns and does not meet all their needs.

                            RECOMMENDATIONS

    This review of evidence and issues in prevention leads to four 
recommendations.
    1. The research agenda needs a major overhaul. Over the last 10 
years--after some good early research--we have learned very little 
about HIV transmission through health care and other blood exposures. 
Changes in personnel and structure of agencies directing HIV research 
may be considered to strengthen research management in NIH, CDC, and 
WHO. It is unreasonable, for example, to expect the vice squad to solve 
the Enron scandal; we need some accountants. In the same vein, if we 
want new research to give us better information about health care 
risks, it may be useful to bring in infection control experts, 
anthropologists, and some new epidemiologists interested and committed 
to explore health care risks.
    2. To give people in developing countries the information they need 
to plan their lives and to protect themselves and their loved ones, 
controls that currently limit import and sale of HIV test kits should 
be relaxed to allow uncontrolled private import and sale of kits 
approved by WHO, or if that is too radical to allow private import and 
sale to all nurses, doctors, and clergymen, so that people can either 
buy kits to test themselves or can go to people in their community for 
tests.
    3. Efforts to educate people about sexual risks for HIV and options 
to reduce those risks--such as condoms and abstinence--should continue. 
When more people are able to get themselves and their partners tested 
for HIV, we can expect increased interest in these options.
    4. Both to control the epidemic and to help individuals control 
their risks, it is crucial to ramp up programs promoting health care 
safety. This is at the same time a human rights issue. The most 
important--and relatively low-cost--component of such programs is 
public education, so that health care consumers know the importance of 
safe care and will demand and pay for it if necessary. There are, 
however, other components that will take more money, including 
provision of autodisable syringes and single-dose vials, cleaning up 
the blood supply, in-service training for a wide range of health care 
personnel including dentists, and provision of autoclaves and spare 
parts to sterilize reusable medical equipment (such as scissors and 
specula). The low priority accorded to health care risks for HIV over 
the last 15 years means that we have a major job ahead over the next 
year or two to design effective programs for HIV prevention and to 
decide how best to proceed.







































              Prepared Statement of Milton B. Amayun, M.D.

                  WORLD VISION INTERNATIONAL IN AFRICA

    World Vision International (WVI) is a large faith-based non-
governmental organization working in nearly 100 countries around the 
globe. Twenty-five national offices are located in Africa: all of them 
are engaged in relief and development work, including the delivery of 
services at the grassroots, or intensive support to different health 
efforts at the periphery of the health system. Many of them have been 
engaged in AIDS prevention and care of orphans in the last two decades.
    All of WVIs activities are intended to enable the young child to 
reach her/his God-given potential as an individual precious in God's 
sight. To achieve this, we aim to eliminate the root causes of poverty 
in and together with communities. In 2002, over 2.1 million children 
were assisted through World Vision sponsors worldwide.

        MY INVOLVEMENT AS A HEALTH SPECIALIST FOR WVI IN AFRICA

    I am currently working for WVI as the Senior Technical Advisor for 
the Hope Initiative, our global response to HIV/AIDS. I travel the 
globe developing programs, evaluating projects, and writing proposals.
    As a family physician whose career has focused on public health 
problems around the world. I am very familiar with the state of health 
services in many countries of Africa, and where it intersects the HIV/
AIDS pandemic. During the period 1981-2001, it was my privilege to be 
involved in the delivery of essential health services in different 
locations of Africa, under various conditions and levels of 
responsibility:
    In 1981-82, I directed a health service program in a large refugee 
camp in northern Somalia.
    In 1985-86, I led a relief team to provide food and basic health 
services to an isolated district of northern Ethiopia, where a civil 
war was in progress.
    Between 1986 and 1989, I managed a large USAID-funded regional 
child survival project in Senegal, where my team and I vaccinated tens 
of thousands of young children against six childhood killer diseases. 
Many mothers received the UNICEF-recommended five tetanus toxoid shots 
to prevent neonatal tetanus. At one point when Chad reported cases of 
meningitis, we gave meningitis vaccinations to the whole population of 
nearly half a million.
    Between 1989 and 1998, as the Director of International Health 
Programs at World Vision ]United States. I supervised and frequently 
visited child survival projects in Senegal, Mali, Mauritania, Niger, 
Uganda, Kenya, Mozambique, Malawi and Zimbabwe. The main components of 
these projects were childhood immunizations, oral rehydration therapy 
for diarrhea, nutrition promotion and control of endemic diseases.
    It was during the above period that HIV/AIDS emerged as a major 
global problem and WVI was at the forefront of prevention efforts. I 
wrote the first USAID-funded HIV/AIDS prevention for Africa projects 
for World Vision in Senegal, Kenya, Tanzania and Zimbabwe. I was also 
involved in the development and implementation of the first World Bank-
funded project to assist AIDS orphans in Uganda in 1991-1995. I 
testified before the Select Committee on Hunger of the US House of 
Representatives in 1991 to warn Congress of my observation that HIV/
AIDS was eroding our gains in child survival and maternal health in 
sub-Saharan Africa.

      OBSERVATIONS ON HEALTH CARE DELIVERY, IN SUB-SAHARAN AFRICA

    Many remote locations of sub-Saharan Africa have no access to basic 
health services. The reasons are many and here are a few: inadequate 
transportation, especially during the rainy season, to enable mothers 
to consult at the antenatal clinic or to bring their children for 
immunizations at a health post: lack of trained personnel who can 
provide safe deliveries and emergency, care for the sick; poor supply 
of life-saving medicines for malaria, TB and AIDS; lack of 
infrastructure, e.g., electricity to run sterilizers, refrigerators and 
laboratory equipment; and inadequate resources to develop systems, 
maintain equipment, and compensate health professionals.
    The projects I led or supervised had the backing of a large non-
governmental organization, and in most locations, they were well funded 
over several years. We had the resources for immunizations. We ensured 
our needles were used only once, and we emphasized proper disposal 
practices. We had gloves when handling blood or treating wounds. We had 
refrigerators to keep vaccines and reagents fresh. To the best of our 
ability, we practiced proper protocols to prevent blood-borne 
infections, such as hepatitis and HIV/AIDS, for our own and our 
patients' protection.
    The practice of such protocols in those Ministry of Health 
locations where health service delivery was led by a midwife, a dresser 
or volunteer health worker was often different. Asepsis and proper 
disposal of used supplies were not major preoccupations. I saw needles, 
blades and catgut re-used, with little concern for sterile techniques. 
Very often, re-use of supplies was necessary to ensure injections were 
given or simple surgeries done. In many cases, there was neither 
electricity--to boil the items being re-used nor solutions to soak them 
in.

                      EXPECTED AND ACTUAL OUTCOMES

    My experiences in rural Africa showed me that the situation 
described above was neither rare nor infrequent. It was and still is 
common to many remote corners of most countries mentioned above. Health 
systems that were not in crisis were the exception, and these were the 
health systems that were struggling with war, economic dislocation or 
disasters. It was against such a background during the last two decades 
that HIV/AIDS emerged as another public health crisis. I saw it first 
publicly recognized in Uganda and Tanzania, whose adjacent border 
districts constituted the epicenter of a growing pandemic in its early 
days.
    I have followed the trends of the pandemic as well as those of the 
health systems in WVI's portfolio over the years. As a public health 
professional. I think it is safe to say the following:
    1. The problems of supplies, sterilization, inadequate training and 
poorly staffed health systems have not changed much in the last decade, 
and they persist today. One can assume that if HIV/AIDS transmission 
has predominantly had an iatrogenic transmission, the HIV prevalence 
rates among rural populations of subSaharan countries would be 
uniformly high today. Injections are commonly given, and immunization 
rates among mothers and children are high. These alone would have been 
enough to be the virus' entry point to infect the majorities of 
populations of all ages. Thankfully, we have not seen any evidence in 
the communities that WV serves that this has happened.
    2. If the predominant mode of HIV transmission were iatrogenic, 
persistently high prevalence (old and new cases at a given point in 
time) and incidence rates (new cases per year) would have been observed 
over several years. This also has not happened. Of the countries that I 
mentioned above, three trends could actually be observed. Uganda's HIV 
prevalence rate has gone down from a peak of 19-20% among pregnant 
mothers visiting antenatal clinics in 1991 to about 6-7% in 2001. 
Senegal's never took off and it remains low today. On the other hand, 
Kenya's and Zimbabwe's have soared, in spite of efforts at prevention.
    3. If HIV/AIDS transmission were predominantly iatrogenic, the two 
countries with the greatest potential to address the specific 
weaknesses of their health systems would have been South Africa and 
Botswana. These two countries have the highest proportions of HIV 
prevalence today.
    4. Most countries in sub-Saharan Africa have achieved full 
immunization rates of eligible children at 70-80%. If HIV/AIDS 
transmission were predominantly iatrogenic, we would have across Africa 
a cohort of young adults 15-20 years with an unusually high HIV 
prevalence rate. This has not happened anywhere.

                              CONCLUSIONS

    Knowing the modes of transmission of the HIV virus as well as the 
status of health service delivery systems in Africa, we can be certain 
that there have been cases of HIV/AIDS transmission through improperly 
sterilized needles, poor surgical protocols and other weaknesses of 
inadequately funded health systems. However, from my observations, I 
believe that the predominant mode of HIV transmission is not 
iatrogenic.
    Having said that, I must emphasis that I do not know for certain 
what proportion of HIV/AIDS cases have been due to services delivered 
by the health system. It probably varies from country to country, and 
some countries are more vulnerable than others. This should be a 
priority theme for further studies.
    Finally, I am thankful that this issue has been raised as a major 
concern. I have been involved in child survival in Africa at a time 
when HIV/AIDS was emerging. I have seen my fears in my 1991 testimony 
to the Select Committee on Hunger happen over the last twelve years. I 
would like to see the many national immunization programs strengthened 
and given more resources so that needles do not have to be re-used and 
that adequate supplies are available at any time that a young child or 
her/his mother needs to be immunized. If the safety of national 
immunization programs is compromised, we would see the eventual 
diminution of parents' confidence in having their infants and young 
children immunized. If such a scenario happens, such programs would 
eventually die, opening the door to the re-emergence of the childhood 
diseases they were meant to conquer.
    It is my hope that the discussions that have begun on this issue 
will lead to re-invigorate attention to child survival programs, and 
increased protection of infants, young children and their mothers from 
HIV/AIDS.

         Statement of Lillie C. Thomas--LMR International Inc.

    I read with interest the announcement of the hearing you will chair 
of the Senate Health Committee on March 27, 2003 regarding Dr. David 
Gisselquist's study concerning the source of the AIDS pandemic in 
Africa being related to needles rather than sexual transmission.
    HIV/AIDS has multiple modes of transmission, some involving medical 
practices, some involving high risk behaviors (i.e. IV drug use) and 
some involving sexual transmission. It is first important to note that 
HIV/AIDS is a disease that takes time to develop, and in some 
individuals they may remain symptom free for long periods of time. 
Given that Dr. Gisselquist's study is not a study per se, (he did not 
study human populations) but is really a review of studies that have 
been conducted, from a statistical viewpoint, it is important to 
examine his methodology because it could have a significant impact on 
his conclusions. Further, he makes assumptions about methodology and 
during the twenty year period he studied, there have been advances in 
how studies of this nature are conducted. His conclusions, then, could 
be biased because of the nature of his data. His two main thrusts, the 
rate of disease progression and the speed it can spread through 
heterosexual contact does not withstand analysis. The HIV disease 
progression that Dr. Gisselquist discusses has a fundamental assumption 
that all STDs (including HIV) are the same. They are not. He also 
assumes that the spread through heterosexual contact cannot be as fast 
as the rise in cases indicates. This is not supported by the data. 
Figures from the U.S. (where medical precautions are strictly enforced) 
do not support his conclusion. The number of women infected via 
heterosexual sex has doubled to 45% of all new cases in just ? years. 
The pandemic in Africa has been a fact of life for more than ten years. 
If the assumptions that Dr. Gisselquist makes are not correct, then the 
consequences for those who suffer the risk of exposure to HIV/AIDS in 
Africa (and logically other areas of the world that could experience 
equal of more severe rates of infection like China and India) could be 
devastating.
    In the Associated press article I read concerning the hearing your 
committee will be conducting, Dr. Gisselquist was quoted as saying 
``The AIDS industry to date is giving signals they want the whole thing 
focused on sex and treatment. We need to fight to get the message in 
there to look at prevention.'' There are several parts of this 
statement that concern me. First, there is no ``AIDS industry''. There 
are many government organizations, non-profit organizations and faith 
based organizations that are working to change long held attitudes and 
cultural mores for the purpose of improving conditions and limiting the 
spread of disease. There are companies that support this process. The 
agencies are driven. not as an industry, but as a humanitarian project 
for the prevention of HIV/AIDS. Dr. Gisselquist's assertion that it is 
all about condoms and not prevention is contrary to the humanitarian 
efforts underway in Africa today. For all of the condoms that USAID has 
given away since the programs began, the yearly total only reflects an 
average of 4 condoms per sexually active male per year. John Hopkins 
estimated that condom use should increase from 6 to 9 billion to over 
24 billion annually to prevent disease. \1\ In cultures where multiple 
partners and multiple wives are generally accepted, the Western concept 
of monogamy is not an applicable prevention tool. Multiple sex partners 
have been proven to be a significant risk factor for the transmission 
of HIV/AIDS.
---------------------------------------------------------------------------
    \1\ http://www-nehc.med.navy.mil/downloads/hp/990806.pdf
---------------------------------------------------------------------------
    Condoms become a significant prevention tool because HIV 
transmission is more likely to occur in the receptive partner. Condoms 
are protective of that partner. The U.S. Public Health Service 
concluded in 1995 that 90% of the sexually transmitted infections are 
passed from men to women. The Department of Health and Human Services 
said in 1996 that 66% of all persons with HIV/AIDS contracted the 
disease during sexual activity with an infected partner. Using 
statistics available regarding the American population, one of the most 
highly educated and one with the best access to healthcare, and a 
system that observes Universal Precautions. 80% of the infected 
population do not know they are infected with HIV/AIDS according to a 
UNAIDS report in 1997. The rates of sexually transmitted diseases are 
significantly higher in the United States that anywhere else in the 
industrialized world. If it were, as Dr. Gisselquist suggests, merely a 
matter of better public health control, the U.S. would see very little 
disease. This is not the case.
    In Africa, it is true that healthcare is more like to reuse 
devices, even the ones designed for single use. In Africa, needles are 
less likely to be treated as a biological waste and destroyed after 
single use. However, I would contend that it is not the medical 
situation, where medical staff knows the consequences for medical 
needle reuse, but the IV drug user who takes the needles after they are 
properly used, but improperly disposed. These individuals have a higher 
risk of transmission, not only because of their drug use, but because 
they will engage in unprotected sexual activity at times to get the 
funds necessary to support their habits or while they are under the 
influence of drugs. Data from Birmingham, AL reports this happens in 
the U.S. Dr. Wang indicated that non-injecting cocaine users were at an 
increased risk for HIV/AIDS due to increased numbers of partners, less 
condom use, and use of drugs during sexual activity. Dr. Wang found 
that drug use is associated with more risky sexual behaviors increasing 
significantly the risk of HIV transmission. \2\ Dr. Gisselquist, in an 
article in 2002 concluded that the researchers ``did not know the 
direction of the causation''. This is a telling admission. If the 
individual was already infected through sexual activity, the injections 
just furthered the spread, but they did not start it. If, on the other 
hand, the injections started the infection, then risky sexual behavior 
only furthered the progress of the disease. Either way, the causation 
could not be positively established. \3\
---------------------------------------------------------------------------
    \2\ Min Qi Wang, et al., ``Drug, Use and HIV Risk Behaviors: A 
Street Outreach Study of Black Adults'' Feb., 2000, Southern Medical 
Journal, 93(2):186-190
    \3\ Gisselquist, D., et al. ``HIV infection in sub-Saharan Africa 
not explained by sexual or vertical transmission'' International 
Journal of STD and AIDS, Oct., 2002, 13910:657-66
---------------------------------------------------------------------------
    Dr. Gisselquist has stated that HIV disease progression has not 
followed the patterns of STD progression. The assumption that the two 
would be the same would be expected if the latent period for the 
diseases were the same. They are not. For many sexually transmitted 
diseases, the latent period (time from exposure to active disease) is 
shorter for the common STI like syphilis and gonorrhea than it is for 
HIV. Thus, an attempt to compare the two rates of infection is not 
meaningful because of the latent period of HIV. Further, as HIV does 
have several modes of transmission and it is common for more than one 
risk factor to be present in any discrete case of HIV/AIDS, the fact 
the two rates would not match is further explained.
    Dr Gisselquist has stated that the infection rate could not have 
been as fast via heterosexual sex. In many cultures in Africa, body 
piercings, cultural exchanges of blood products, and other tribal 
behaviors between men could provide a mode of transmission that could 
allow a rapid entry into heterosexual activity. Using the U.S. 
experience, HIV/AIDS started as a male to male transmission, and has 
now become a primarily heterosexual transmission in the last 5 years, 
with the rates of infection in women increasing dramatically, until 460 
of all new cases for HIV/AIDS are women who only engage in heterosexual 
sex. In Africa, because of the patriarchal societies, women may not be 
able to ascertain their partner's HIV/AID risk, and even if they could, 
not be able to anything other than use a condom to protect themselves.
    It is important to understand that Dr. Gisselquist worked with 
studies, not people as the medical researcher he studied had. The 
statements Dr. Gisselquist made are not supported by those who work 
with the suffering populations in Africa. Dr. Chris Ouma ActionAid 
Kenya said that medical procedures have been largely made safe in 
Kenya, yet infections rates continue to rise. \4\ This is not to say 
all injections are safe. According to UNAIDS/WHO release March 14th 
concerning the Gisselquist study, potentially 30% of the 16 billion 
injections worldwide are unsafe because of needle reuse. For those 
populations that already have significant risk, reuse may increase 
transmission, but did not necessary provide the sole source of 
transmission. In many impoverished areas, women are forced into 
prostitution to support their children and this amplifies the spread of 
AIDS. However, the majority of women who become infected in Africa do 
so with one partner. \5\ In populations like Africa where medical care 
is an occasional experience, to assume that it can transmit at the same 
rate as sexual activity, a much more frequent occurrence, is not 
logical.
---------------------------------------------------------------------------
    \4\ ActionAid comment in the International Journal of STDs and AIDS 
March, 2003.
    \5\ Gender and the HIV Epidemic, UNDP, 1999.
---------------------------------------------------------------------------
    As an Alabama manufacturing company actively involved in the public 
health mission of USAID, we know that increased condom use is a 
significant factor in the decline of HIV/AIDS. Condoms, however, are 
only part of an overall education and prevention program required to 
eliminate HIV/AIDS. We also believe that the necessary AIDS drugs are 
important to assure that those in Africa with AIDS are able to maintain 
a good quality of life. To the extent that programs are successful in 
preserving the lives of those with AIDS, it becomes even more important 
to assure that adequate condom supplies are available to prevent the 
spread of the disease further. It is essential that the number of 
condoms increase significantly on a per sexually active adult basis. 
Longer lives could mean more opportunities for infecting those who are 
negative, not from intentional actions, but because education is needed 
to cure misconceptions about disease. We do believe that there is a 
need for more condoms in Africa and in new emerging areas of HIV 
infections in China and India, and the education programs to support 
safe behaviors and medical service provision.
    Thank you for considering our information as part of your fact 
finding process.
               Prepared Statement of Maria J. Wawer, M.D.

   THE ROLES OF SEXUAL TRANSMISSION AND UNSAFE INJECTIONS IN THE HIV 
                     EPIDEMIC IN SUB-SAHARAN AFRICA

    Mr. Chairman, Members of the Committee, thank you for this 
opportunity to testify regarding the very important topic of HIV/AIDS 
prevention in Africa. Given the AIDS crisis on the African continent, 
every effort must be made to determine optimal approaches to 
prevention.

                       CREDENTIALS AND EXPERIENCE

    I am Maria Wawer, Professor of Clinical Public Health, Mailman 
School of Public Health, Columbia University, and Adjunct Professor of 
Public Health, Johns Hopkins Bloomberg School of Public Health. I a in 
also a Principal Investigator on the Rakai Project, one of the largest 
HIV/AIDS research collaborations in Sub-Saharan Africa.
    I received my MD degree in 1977, from McMaster University, 
Hamilton, Ontario, Canada; an MHSc in 1980, from the University of 
Toronto, Toronto, Canada; and have been a Fellow, of the Royal College 
of Physicians and Surgeons of Canada [FRCP(C)] since 1984. The latter 
is equivalent to Board Certification in preventive medicine in the US.
    Since 1988, I have worked in the area of HIV/AIDS epidemiological, 
behavioral and preventive research in international settings. During 
this period, I have been the Principal Investigator on 11 HIV 
scientific studies, and a senior co-investigator on more than 10 other 
HIV related studies. Most of this research has been supported by the 
National Institutes of Health. I have authored and co-authored over 60 
peer reviewed papers and 6 book chapters on HIV/AIDS, and have 
delivered or contributed to over 120 presentations at international 
HIV/AIDS/STD meetings.
    My primary HIV-related research for the past 15 years has been 
conducted in Rakai District, Uganda. With my colleagues at Makerere 
University, the Uganda Virus Research Institute/Uganda Ministry of 
Health, Columbia University and Johns Hopkins, we have conducted 
detailed examinations of risk factors for HIV acquisition and 
transmission, in order to develop and test HIV prevention and care 
strategies. We have also worked closely and exchanged data with other 
HIV/AIDS researchers in Uganda and throughout Africa, as members of 
international research networks and collaborations, and through 
international meetings and consultancies.

       WHAT DO THE DATA TELL US ABOUT HIV TRANSMISSION IN AFRICA?

1. The HIV epidemic represents a crisis in the Sub-Saharan region of 
        Africa.
    WHO estimates that there are 29.4 million HIV infected persons 
living in Africa, and that approximately 3.5 million new infections 
occurred in 2002 (WHO, 2002) This represents a severe humanitarian, 
social and economic burden.
    Although the epidemic has stabilized and abated somewhat in Uganda, 
we still observe HIV rates of over 10% among adults in towns and 
cities. Among the 300 Ugandan researchers and health staff who work 
with me in Rakai, every one has lost family members to the epidemic. We 
thus urge that every effort be made to curb the spread of HIV.

2. What are the major routes of HIV spread in Africa?
    HIV can be spread via unsafe injection practices and blood 
transfusion. Efforts to reduce such transmission by provision of single 
use syringes and needles, appropriate sterilization equipment, 
facilities for the disposal of contaminated injection materials, and 
high quality HIV screening of potential blood donors, are all highly 
desirable.
    However, data from Africa do not support the hypothesis that unsafe 
injections represent a common route of HIV transmission in the Sub-
Saharan region. Available evidence from abroad range of sources points 
to heterosexual transmission, followed by mother-to-child transmission, 
as the major routes of HIV spread on the continent.

        EVIDENCE REGARDING ROUTES OF HIV TRANSMISSION IN AFRICA

    To assess the main routes of HIV transmission, we must first 
examine the epidemiological pattems of infection by age, gender and 
reported behaviors, and assess which modes of transmission (unsafe 
injections, heterosexual and/or mother-to-child) are most plausible.
Age and gender patterns of HIV infection
    Table 1 (attached) summarizes data from a number of African 
countries, showing the proportions of persons infected with HIV by age 
group and gender. The countries are illustrative of general patterns 
observed in the region. The data can be summarized as follows:
    Rates of HIV infection are low (below 1%) in children aged 5-14, 
and age at which mother-to child transmission does not occur and when 
sexual exposure is unlikely (Table 1).
    Rates of HIV infection increase, often dramatically, during 
adolescence and young adulthood, reflecting the onset of sexual 
activity (Table 1). The increase is usually more rapid among females. 
Our data and those of others show that girls in many African settings 
become sexually active at younger ages than boys, and sexual debut 
frequently occurs with men who are some years older. this places 
adolescent girls at higher risk than adolescent boys. We reviewed our 
most recent data on HIV acquisition in Rakai, and again found these 
patterns: only 1% of new infections occurred among persons aged 15-16, 
while over 90% occurred in persons aged 17-49, the age range of peak 
sexual exposure. In women in particular, the rate of new infections 
dropped to very low levels above age 50.
    In the great majority of HIV risk studies, rates of infection are 
closely associated with reported sexual activity, including numbers of 
partners. Similar patterns are observed with other STDs, such as HSV-2 
(genital herpes).
    The age and gender distribution of HIV in Africa does not follow 
the pattern of receipt of injections (for vaccination and treatment in 
young children; for treatment in older persons).
HIV acquisition in infants and young children
    Although most infants and young children are exposed to multiple 
injections (for example, for immunization) the great majority of HIV-
positive children in Africa acquire HIV from their infected mothers. In 
the absence of preventive therapy, approximately 15-20% of HIV infected 
mothers transmit the virus to the infant in utero or at time of birth, 
and 10-15% transmit through breast milk.
    Early in the recognized epidemic in Kinshasa, Zaire (currently 
Congo), Mann et al. reported that over a third of early childhood HIV 
infection was associated with blood transfusion and injections. 
However, it should be noted that infant testing was still under 
development in the mid 1980s, and such high rates of non-vertical 
transmission have not been reported by other researchers or in more 
recent years. In a study in Kampala, Uganda, 98% of HIV-infected 
children had an HIV-positive mother (Muller and Moser, 1992). The 
probable causes of infection in the 2% of HIV+children who had 
uninfected mother were transfusion and injections. Researchers in Cote 
d'Ivoire, Tanzania and Kenya followed a total of over 660 children born 
to HIV-negative mothers for two years on average, and observed no HIV 
infections in these children (Sherry et al., Karlsson et al., Ekipni et 
al.). In a separate study in rural Masaka, Uganda, over 2,500 children 
aged 5-12 were tested for HIV and only 10 (0.4%) were found to be 
infected: one of these 10 infections was attributed to transfusion and 
one to unsafe injections (Kengeya-Kayondo et al). When 3,941 initially 
HIV-negative children aged 0-12 were followed in the same district, 
only one child became HIV-infected over the subsequent year, probably 
through breast milk (the mother was HIV-positive). The authors 
concluded that, in this setting, no infections had arisen as a result 
of injections (Mulder et al).

Biological evidence for modes of transmission
    Studies have shown that transmission from an HIV-infected person to 
a sexual partner is strongly associated with the infected person's HIV 
viral load (the amount of HIV in the blood). (Gray et al, Wawer et al, 
2003), and with the presence of genital ulcer.
    Comparison of HIV rates with rates of hepatitis C, an infection 
which is readily spread by injections, shows no common patterns 
throughout Africa. For example, South Africa has very high HIV rates 
but relatively low hepatitis C seroprevalence, whereas the opposite 
situation occurs in Tanzania (Madhava et al, WHO). However, HIV rates 
generally mirror those of HSV-2 (genital herpes) which is transmitted 
sexually, but not through unsafe injections (Wawer et al, 2001).

Unsafe injections
    There can be no doubt that unsafe injections represent a public 
health problem. For example, they have been implicated as major routes 
of transmission for hepatitis B and hepatitis C (Simonsen et al).; 
Also, many injections given world wide are unnecessary.
    Hollow gauge needles, especially those used for intravenous 
injections or sample collection, can retain blood. HIV has been 
recovered from such needles for up to up to several weeks (Abdala et 
al). It is less clear whether syringes used for non-intravenous 
injection (i.e., subcutaneous or intramuscular injections, the types 
generally administered for immunization and therapy) pose a severe risk 
of HIV transmission. When syringes used to provide subcutaneous or 
intramuscular injections to HIV-infected clinic patients were 
subsequently tested for HIV content using highly sensitive HIV tests, 
only a small number (<4%) revealed the presence of potentially 
infectious material (Rich et al.). There is thus likely to be 
variability in the risk posed by unclean needles, depending on their 
type, use, and whether blood is left in the needle or syringe.
    Although in some studies persons with established HIV infection 
report receiving more injections and uninfected persons, this may 
reflect receipt of injections for treatment of HIV-related illness. We 
recently re-examined our Rakai data and found no association between 
reported injections and the acquisition of new HIV infection: persons 
who did not acquire HIV actually reported slightly more injections from 
all sources (government clinics, medicine shops, traditional healers) 
than persons who acquired HIV during follow up.
    The World Health Organization estimates that approximately 1.4-2.9% 
(or about 50,000-100,000) cases of HIV are spread annually in Africa 
through unsafe injections (WHO 2002). However, the risk may be spread 
unevenly between countries and regions, depending on background HIV 
rates and injection practices. Clearly, improving injection safety and 
reducing the number of unnecessary injections would be of public health 
benefit.

3. Conclusions
    The data indicate that sexual transmssion, and in infants, mother-
to-child transmission, represent the most common routes of HIV 
infection in Africa.
    However, there are also data that transmission via unsafe 
injections does occur in Africa, although it is not a main cause of the 
infection. Given the diversity of the African continent, great 
differences in medical resources and practices, and in the background 
rate of HIV infection, it is not possible to arrive at a meaningful 
summary estimate of the proportion of infections contributed by unsafe 
injections. The data, however, suggest that it is low and probably 
below 3% in the great majority of settings.
    This should not be a reason for complacency. HIV researchers should 
reassess existing data to provide greater precision regarding the 
extent of potential injection-associated transmission, and of the 
circumstances under which it occurs. Wherever possible, HIV studies 
should include questions on injection and transfusion practices. 
Efforts to provide an adequate and long term supply of clean injection 
equipment, coupled with educational programs to promote needle safety 
and reduce unnecessary injections, would be of public health benefit.
    From the viewpoint of HIV prevention, however, the data argue for 
continued, concerted efforts to reduce risks of HIV transmission 
associated with unsafe sex and to improve prevention of mother-to-child 
HIV transmission.



               Statement of the World Health Organization

                                SUMMARY

    Sexual transmission of HIV is the predominant mode of transmission 
globally and in sub-Saharan Africa.
    Adults account for an estimated 80% of new HIV infections in sub-
Saharan Africa, of which 909 is due to sexual transmission. At least 
90% of new HIV infections among children under 15 is attributable to 
mother-to-child transmission.
    Measuring sexual behaviour is complex, especially as individuals 
tend to under-report behaviours perceived to be socially undesirable, 
but there is a large body of evidence on the drivers of sexual 
transmission of HIV in sub-Saharan Africa.
    Around 2.5% of HIV infections in sub-Saharan Africa are caused by 
unsafe injections. Improving the safety of injections and other medical 
procedures globally is an important health issue. WHO is taking an 
active lead in improving the global safety of injections.
    The weight of scientific evidence does not support speculation that 
unsafe injections are responsible for a far higher proportion of HIV 
infections in sub-Saharan Africa than hitherto assumed.
    In sub-Saharan Africa there is no association between rates of 
infection with HIV and the Hepatitis C virus (spread mainly through 
blood, in injecting drug use or in medical settings), thereby strongly 
supporting the view that sexual transmission accounts for the vast 
majority of HIV infections in this region.

                               BACKGROUND

    1. Globally, the major mode of HIV transmission is sexual, with 
additional transmission peri-natally (from mother to child), or in 
blood-borne transmission via medical procedures (e.g. transfusion or 
unsafe injection) or injecting drug use. Other modes of transmission. 
for example from mosquito to human, have been widely scientifically 
discounted.
    There has been recent controversy concerning the extent to which 
unsafe injections may account for a larger proportion of HIV infections 
in sub-Saharan Africa than hitherto accepted. In particular, a recent 
series of articles by a number of independently-based authors and 
consultants, including Gisselquist and others, speculate that unsafe 
injections may account for more HIV infections than sexual 
transmission.

    3. This position paper presents current evidence and conclusions of 
the World Health Organization (WHO) and the Joint United Nations 
Programme on HIV/AIDS (UNAIDS) in relation to HIV transmission, 
especially in sub-Saharan Africa.

            MODES OF HIV TRANSMISSION IN SUB-SAHARAN AFRICA

    4. WHO and UNAIDS estimate that there were 3.5 million new HIV 
infections in sub-Saharan Africa in 2002 (UNAIDS and WHO 2002). Eighty 
per cent of new HIV infections in sub-Saharan Africa occur among 
adults. Twenty per cent of new infections occur among children aged 0-
14 years (720,000 infections among children in 2002).

    5. Of the adult infections, 90% are attributable to sexual 
transmission. Other modes of transmission include blood transfusion, 
other medical procedures including unsafe injection, and injecting drug 
use.

    6. Of the infections among children, at least 90% are attributable 
to transmission from mother-to-child. The remaining infections are 
attributable to medical procedures and to sexual transmission.

            SEXUAL TRANSMISSION OF HIV IN SUB-SAHARAN AFRICA

    In 1988, WHO estimated that heterosexual transmission accounted for 
80% of all HIV infections in Africa (Chin et al., 1990).

    8. Measuring sexual behaviour is complex, and patterns of sexual 
mixing are important for the spread of HIV and other sexually 
transmitted infections. Therefore, the emphasis in survey data 
collection has shifted to obtaining better data on sexual partnerships. 
In the early 1990s a series of national surveys by WHO showed an 
average of 28% of men in sub-Saharan Africa reported sex with a non-
regular partner in the last 12 months (country results ranged from 5% 
to 50%). Forewomen the average was 8%.

    9. Behavioural factors affecting the sexual spread of HIV include 
the lifetime number of sexual partners, the rate of sexual partner 
change, the extent of sex with non-regular partners (e.g. in commercial 
sex), age at first sexual intercourse, and condom use (Plot and Bartos 
2002). The presence of sexually transmitted infections appears to be a 
strong co-factor in transmission. Other factors which may have some 
impact on HIV transmission include male circumcision and genetic 
variation in different strains of HIV, although the extent of their 
contribution remains controversial.

    10. Relatively high prevalences of sexually transmitted infections 
in sub-Saharan Africa may be a particular factor in fuelling the 
epidemic. For example, population estimates have suggested the 
proportion of HIV infections associated with a sexually transmitted 
infection are be considerably higher for sub-Saharan Africa (44-69%) 
than for the United States (7-18%) (Fleming 1999).

    11. HIV is found in semen, vaginal/cervical secretions, blood in 
the genital tract, and secretions associated with sexually transmitted 
infections, Higher viral load (i.e., the amount of virus present, 
commonly measured in the blood), has been associated with greater 
likelihood of HIV transmission (Quinn 2000).

               AGE AND SEX DISTRIBUTION OF HIV INFECTION

    12. One of the most consistent features of the distribution of HIV 
in sub-Saharan Africa is its distribution by age and sex. Female 
prevalence climbs during the teens and early twenties and peaks in the 
late twenties or early thirties. Male prevalence follows a similar 
pattern at some five to ten years older. This age gap is very similar 
to the age gap between spouses.

    13. Urban areas and rural trading areas, where sexual mixing is 
more extensive, have 17 higher HIV rates, as do divorced or separated 
men and women--typical of the pattern in sexually transmitted 
infections.

    14. While HIV may be present in those who report never having had 
sex, this is likely to be due to underreporting of sexual activity. For 
example in one study from Africa, 23 of 980 women aged 15 to 24 who 
reported never having had sex were infected with HIV, but 15 women who 
reported never having had sex were in fact pregnant (Gregson 2002).

                       HIV INFECTION IN CHILDREN

    15. HIV prevalence among children under five years of age is 
dominated by infections transmitted from the mother to the child prior 
to or during delivery, or through breastfeeding. Survival of most of 
these infants is poor, although a proportion of children infected 
through mother to child transmission survive beyond the age of 5 years.

    16. In studies of infants of HIV-negative mothers (i.e where 
transmission would be attributed to a mode other than mother-to-child), 
zero or very small rates of HIV infections have been found:
    o In an Abidjan, Cote d'Ivoire, study no infections occurred over 
48 months in children born to HIV-negative mothers.
    o In Kinshasa. Democratic Republic Congo, 1 of 287 children born to 
HIV-negative mothers seroconverted during 1003 person years.

    17. Although data are limited, there is consistent evidence that 
HIV prevalence (and incidence) is love in children 5-14 years.
    In Masaka (Uganda), 10 (0.44) of children 5-12 years of age were 
infected vs. 84 of adults (Kengeya-Kayondo et al., 1995). Of the 10 
children. 6 had a mother who was HIV+ or who had died of AIDS, one had 
received a blood transfusion, one was thought to have been infected by 
injections and the route of infection of the remaining two was unknown.
    In Ethiopia no infections occurred in 6-13 year-olds, while 
infection began at age 14 and reached an adult peak prevalence in the 
25-29 year-old age band of 13.94 (Fontanet et al., 1998).
    In South Africa, one figure from a recently released study reported 
5.4% of children aged 2-14 years were infected, however this is more 
likely to be due to data quality problems than to unexpected modes of 
transmission.

    18. Population-based studies find very little infection among 15 
year olds, suggesting very low incidence in the preceding years (Auvert 
2001).

                           UNSAFE INJECTIONS

    19. The issue of unsafe injections is a serious one for global 
health. An estimated 16.7 billion injections were given annually in 
recent years throughout the world. an average of 3.4 injections per 
person per year in developing countries and countries in transition 
(Hutin 2000). In Africa, the average is between 2 and 2.2 injections 
per person per year. Injections are commonly given to children, as part 
of immunization programmes during the first two years of life and as 
part of treatment for infectious diseases throughout childhood, so 
injections safety is clearly an issue for this population.

    20. WHO estimates that Globally nearly 409 of injections are given 
with syringe or needles reused in the absence of sterilization, with 
the highest rates in South Asia, the Eastern Mediterranean and the 
Western Pacific. In Africa, systematic WHO surveys of injection 
practices in 10 countries found between 179 and 1990 of injections were 
given with reused equipment, and average of 0.38 per person per year. 
There is considerable country by country variation in the proportion of 
unsafe injections, e.g. South Africa and Zimbabwe are thought to have 
extremely safe injection practices.

    21. WHO has estimated that, globally, reuse of injection equipment 
led in 2000 to 21 million new cases of hepatitis B, two million cases 
of hepatitis C and 260,000 cases of HIV.

    22. Injections are vital for immunization programmes and for the 
provision of life-saving treatment. Injections should be used only when 
medically necessary, and should be given using single use equipment 
which is then disposed of safely. In the past several years, major 
efforts and resources have been devoted to enhancing injection safety 
in the healthcare setting through better planning of services including 
immunization, training of care providers and vaccinators, provision of 
single-use injection equipment and proper 'sharps' disposal. More needs 
to be done to eliminate unsafe injection practices throughout the 
world. To further this work, WHO has recently issued a framework to 
assist countries with all aspects of the provision of safe injections, 
entitled ``Managing an Injection Safety Policy''.

          RATES OF HIV TRANSMISSION THROUGH UNSAFE INJECTIONS

    23. It has long been accepted that unsafe injections are 
responsible for some proportion of HIV infections. In the 1980s, WHO 
estimated that unsafe injections and the use of other adequately 
sterilized skin-piercing instruments caused 1.6% of HIV infections in 
Africa. In 1999, a WHO model estimated 1.4-2.9% of total HIV infections 
in sub-Saharan Africa were caused annually by unsafe injections. WHO 
subsequently sponsored a systematic review of the studies that examined 
the association of unsafe injection practices and HIV transmission 
(Segury nd) as part of a global initiative to achieve the safe and 
appropriate use of safe injections and as a result refined its model to 
estimate that 2.5% of HIV infections in sub-Saharan Africa are caused 
by unsafe injections.

    24. The possibility of HIV transmission by means of an unsafe 
injection depends on whether the source needle or syringe was 
previously used on an HIV-positive person. and if so, whether there is 
sufficient virus in the needle to be capable of transmission (e.g. it 
may have been washed or otherwise disinfected).

    25. A study of unsafe injections in 39 health care facilities in 
Tanzania in the early 1990s (Hoelscher 1994) showed nearly 60% of 
needles were not sterile but only 12.6% contained enough blood to be 
capable of transmitting HIV, and none had an appreciable volume of 
blood (>0.09 ul). This study concluded that in a population with HIV 
prevalence of 3090 and where 2.11 million injections are given 
annually. <0.490 of the estimated 4,500-8,500 annual HIV infections 
were caused by unsafe injections.

    26. Many of the at least 23 studies which have examined the 
association of injections with prevalent HIV infection have found an 
association, with odds ratios ranging from 1.16-2.96 (Seguy nd). 
However in cross sectional studies it is not possible to attribute 
causality, viz. it is likely that people who are HIV infected will have 
been sick and have had a higher number of injections than the rest of 
the population. Even in longitudinal (prospective) studies it is 
possible that an individual will be given injections due to illness in 
the interval between their contracting HIV and their study recording 
their sero-conversion.

    27. There are four published longitudinal studies with number of 
injections as one of the variables examined. Two, from Kinshasa, DR 
Congo and Rakai, Uganda, found no association of injections and HIV 
infection, while a third, from Rwanda, found no association after 
adjustment for other variables. The fourth study, from Masaka, Uganda, 
found an association but questions were asked. on average, a year after 
seroconversion (Quigley 2000).

      INFECTION RATES OF HIV AND HEPATITIS C VIRUS DO NOT COINCIDE

    28. Hepatitis C virus (HCV) is efficiently spread by blood, either 
in injection drug use or in medial procedures. It is not efficiently 
spread otherwise (e.g. sexually). The risk to a health care worker 
following percutaneous exposure to an HCV-positive source is 1.890, six 
times the rate for HIV transmission (CDC 2001).

    29. If HIV were substantially transmitted via unsafe injections, 
one would expect to generally find similar trends in HCV and HIV 
infection within populations. The epidemiology of HCV infection in sub 
Saharan Africa has recently been reviewed (Madhava 2002). Although 
prevalence of HCV varied considerably among countries. a trend with 
increasing age suggested that cases may be spread by unsafe medical 
practices.

    30. Comparing prevalences of HCV with those of HIV shows little 
correlation, suggesting that while unsafe injection may be a 
significant mode of transmission for HCV in sub-Saharan Africa, it is 
not so for HIV.



    31. In the countries with arguably the most highly developed safe 
injection programmes, i.e., Zimbabwe and South Africa, while having low 
HCV prevalences (consistent with safe injection practices) have 
extremely high rates of HIV, suggesting the main mode of transmission 
of the two diseases is different.

                   THE ARGUMENTS OF GISSELQUIST ET AL

    32. A recent series of publications by Gisselquist et al. have 
speculated that unsafe injections may be the main mode of HIV 
transmission in sub-Saharan Africa, with relatively less significance 
of sexual transmission. If this were so, it might suggest 17 some 
reorientation of programming priorities in responding to HIV was 
required. It may also constitute a significant deterrent to valuable 
health interventions, for example childhood immunization, in sub-
Saharan Africa.

    33. WHO and UNAIDS welcome continued attention to the need to 
promote injections safety as the cause of a relatively small but 
nevertheless appreciable number of HIV infections in sub-Saharan Africa 
and globally. However, WHO and UNAIDS disagree with the analysis of 
Gisselquist et al that the proportion of infections attributable to 
unsafe injections is greatly higher than hitherto estimated, on the 
following grounds:

    34 Gisselquist and colleagues claim there are lower rates of HIV 
prevalence in Northern industrialized countries compared to sub-Saharan 
Africa despite similar sexual
    behaviours. However the proportion of married or cohabiting men in 
Northern industrialized countries who report two or more sexual 
partners in the past year is around 5% while in studies in Africa, the 
typical value is closer to 20% (Carael 1995) (see paragraph 8 above).

    35. If injections are a common mode of transmission, one would 
expect to find HIV infection to be common among children before the age 
of sexual debut (see paragraphs 15-18 above).

    36. Gisselquist et al. (2003) re-analyze data from a series of 
cross-sectional studies in the 1980s using self-reported sexual 
behaviour which may under-estimate exposure. They neglect limitations 
in self-report data on sexual behaviour (see paragraphs 8 and 14 above)

    37. Gisselquist et al. make extensive use of population 
attributable fractions (PAF) which estimate the fraction of all disease 
cases in the population attributable to a particular risk factor. 
However PAFs establish association not causality, they often add up to 
more than 100% because there is overlap of risk factors, they are 
subject to reporting bias (e.g. individuals may under-report sexual 
activity because it is more socially acceptable to do so, but over-
report recent medical procedures) and they depend on accurate 
measurement of exposure and the rate at which exposure will lead to 
infection.

    38. The reinterpretation by Gisselquist et al relies on an estimate 
that the transmission probability from unsafe injection is 2.3%, 
whereas estimates based on needlestick injuries place it at 0.3% (c.f. 
Gerberding CDC studies). In modeling WHO's estimate of HIV infections 
due to unsafe injection, transmission efficiency of 1.3% was assumed. 
WHO believe its estimate is generously high. given evidence from 
needlestick injury, from tests of the amount of HIV in exposed needles 
(Rich), given that in practice in Africa individuals with HIV will have 
lower viral loads than those in patients in hospital studies from which 
needlestick transmission rates are derived. and the common practice of 
washing syringes between use (not considered in the models of 
Gisselquist et al.)

    39. Gisselquist and colleagues claim that a sexual route cannot 
explain the wide spread of HIV (Gisselquist, 2003) but underestimate 
sexual transmission risk, and estimate risk on the basis of a snapshot 
of late-stage epidemics, when the epidemic has already moved from those 
with many partners to those with very few, thus underestimating the 
dynamics of spread in an early rapidly-growing epidemic.

    40. Gisselquist et al neglect the extent to which sexually 
transmitted infections are an important co-factor in the spread of HIV 
in sub-Saharan Africa (see paragraph 10 above).

    41. The case of South Africa presents an important counterfactual 
to the speculation that unsafe injection is responsible for a high 
proportion of HIV infections. According to
    the South African Ministry of Heath, HIV prevalence among women in 
antenatal care clinics reached 24.8% in 2001, but at the same time, 
South Africa has the most highly developed health care system in sub 
Saharan Africa with routinely good injection safety.

    42. Gisselquist and colleagues have argued that a recent population 
survey finding of 5.69c HIV prevalence in 2-14 year old children in 
South Africa is evidence of widespread transmission from medical 
practices, but there is no evidence for this. Higher rates for boys 
than girls in this study, and rates that do not increase with age, 
suggest it is unlikely unsafe injection is the cause. The hypothesis of 
unsafe injections as a major cause HIV infection in South African 
children is also not supported by the ethnic differences in the study, 
where white children were found to have higher rates than African 
children, while they could be expected to be more likely to receive 
injections in contexts of higher safety. This suggests that data 
quality issues (e.g. mixing of test results, and high non-response 
rates) are important in explaining the results. In fact, quality 
control measures were limited in this study, and the survey's authors 
have themselves suggested further investigation is required to 
understand their unexpected finding. Inyany event, if the 5.6% HIV 
prevalence figure among children were correct and was caused by unsafe 
injections, then South African children would have had to have received 
at least 30 unsafe injections every year from 0 to 10 years of age.
    [Whereupon, at 11:41 a.m., the committee was adjourned.]

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