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86–273 PDF 2003

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

(
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

JUDD GREGG, New Hampshire, Chairman

BILL FRIST, Tennessee

MICHAEL B. ENZI, Wyoming

LAMAR ALEXANDER, Tennessee

CHRISTOPHER S. BOND, Missouri

MIKE DEWINE, Ohio

PAT ROBERTS, Kansas

JEFF SESSIONS, Alabama

JOHN ENSIGN, Nevada

LINDSEY O. GRAHAM, South Carolina

JOHN W. WARNER, Virginia

EDWARD M. KENNEDY, Massachusetts

CHRISTOPHER J. DODD, Connecticut

TOM HARKIN, Iowa

BARBARA A. MIKULSKI, Maryland

JAMES M. JEFFORDS (I), Vermont

JEFF BINGAMAN, New Mexico

PATTY MURRAY, Washington

JACK REED, Rhode Island

JOHN EDWARDS, North Carolina

HILLARY RODHAM CLINTON, New York

SHARON R. SODERSTROM, Staff Director

J. MICHAEL MYERS, Minority Staff Director and Chief Counsel

(II)
CONTENTS

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)

(1)

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
2

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 un-
3

safe 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,
4

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 re-
5

constitute 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-tochild 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 muchneeded 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-tochild transmission initiative is part of our overall global AIDS pro-
6

gram 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.
7

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
8

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 indepth 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 nee-
9

dle 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 govern-
10

ment 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
11

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
12

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 trans-
13

mission 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
14

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
15

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
16

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 HIVpositive 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
17

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 motherto-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,
18

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 hepatitisB 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
19

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
20

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
21

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.
22

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
23

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 lowlevel 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.
24

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
25

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 inpatient 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 HIVpositive 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?
26

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
27

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 microtransfusions 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, how-
28

ever 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
29

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.]
30

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 onethird 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.
31

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 universitybased, 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 incountry 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.
32

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 hostcountry 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 antiretrovirals, 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
33

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
34

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
35

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, ShortCourse—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
36

1 Chin J, Sato PA, Mann JM. Projections of HIV infections and AIDS cases to the year 2000.

WHO Bull 1990; 68: 1-11. 2Gisselquist 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. 3Gisselquist 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. 4Karon 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: (RR13): 1-31.

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.

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.

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.

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
37

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

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. 9Weiss HA, Quigley MA, Hayes RJ. Male circumcision and the risk of HIV infection in subSaharan Africa: a systematic review and meta-analysis. AIDS 2000; 14: 2361-2370. 10Wald 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. 11 Buve A, Bishikwabo-Nsarhaza K, Mutangadura G. The spread and effect of HIV-1 infection

in subSaharan Africa. Lancet 2002; 359: 2011-2017. 12Gisselquist D, Potterat JJ. Heterosexual transmission of HIV in Africa: an empiric estimate.

Int J STD AIDS. 14: 162-173.

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.

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

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.

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.

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.’’

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
38

13Gisselquist D. Unanswered questions about sexual transmission of HIV in Mwanza, Tanzania. J Acquir Immune Defic Syndr 2003; 32: 349-351. 14Gisselquist D, Potterat JJ. Heterosexual transmission of HIV in Africa: an empiric estimate.

Int J STD AIDS. 14: 162-173. 15Gisselquist 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. 16Gisselquist 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. 17Gisselquist 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.

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 spouseto-spouse transmission explains roughly 10-14% of total incident (or new) infections

that would be required to explain even a slow-growing epidemic.

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 HIVnegative, 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

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.

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.

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.

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
39

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. 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. 20Shisana 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. 21Sidley P. HIV infection rate among South African children found to be 5.6%. BMJ 2002;

325: 1380. 22Simonsen 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. 23Mukumbira R. 200 kids, one syringe. News 24. 6 March 2003. <www.news24.com/News24/

South—Africa/AIDS—Focus/0,6119,2-7-659—1329560,00.html>

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

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.

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.
40

24Kamali 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. 25Wawer 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. 27Gisselquist 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. 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. 30Priotto G. Injection use in the population of Mbarara District, Uganda. WHO, 2001 (unpublished).

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

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.

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.

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
41

31WHO. 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.

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

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
42

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.
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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 Godgiven 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
63

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.
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1http://www-nehc.med.navy.mil/downloads/hp/990806.pdf

It is my hope that the discussions that have begun on this issue will lead to reinvigorate 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.

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
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2Min 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 3Gisselquist, 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 4 ActionAid comment in the International Journal of STDs and AIDS March, 2003.

5Gender and the HIV Epidemic, UNDP, 1999.

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

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.

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
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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.
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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).
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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 injectionassociated 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.
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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 underreport 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.
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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
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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 lifesaving 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
72

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.
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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
74

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.]

Æ