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88–790 PDF 2004

S. HRG. 108–294

SOLUTIONS TO THE PROBLEM OF HEALTH CARE

TRANSMISSION OF HIV/AIDS IN AFRICA

HEARING

BEFORE THE

COMMITTEE ON HEALTH, EDUCATION,

LABOR, AND PENSIONS

UNITED STATES SENATE

ONE HUNDRED EIGHTH CONGRESS

FIRST SESSION

ON

EXAMINING SOLUTIONS TO THE PROBLEM OF HEALTH CARE TRANSMISSION OF HIV/AIDS IN AFRICA, FOCUSING ON INJECTION SAFETY,

BLOOD SAFETY, SAFE OBSTETRICAL DELIVERY PRACTICES, AND

QUALITY ASSURANCE IN MEDICAL CARE

JULY 31, 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, JULY 31, 2003

Page

Alexander, Hon. Lamar, a U.S. Senator from the State of Tennessee ................ 1

Peterson, E. Anne, M.D., Assistant Administrator For the Bureau of Global

Health, U.S. Agency For International Development: and Yvan Hutin, M.D.,

Medical Officer, Department of Blood Safety, World Health Organization .... 3

Ssemakula, John Kiwanuka, M.D., Medilinks: Holly Burkhalter, Physicians

for Human Rights; and John Stover, Vice President, The Futures Group

International, Glastonbury, CT ........................................................................... 19

ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:

E. Anne Peterson, M.D. .................................................................................... 40

Yvan Hutin, M.D. ............................................................................................. 47

John Kiwanuka Ssemakula, M.D. ................................................................... 50

Holly Burkhalter .............................................................................................. 60

John Stover ....................................................................................................... 64

(III)

(1)

SOLUTIONS TO THE PROBLEM OF HEALTH

CARE TRANSMISSION OF HIV/AIDS IN AFRICA

THURSDAY, JULY 31, 2003

U.S. SENATE,

COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS,

Washington, DC.

The committee met, pursuant to notice, at 10:35 a.m., in room

SD–430, Dirksen Senate Office Building, Senator Sessions presiding.

Present: Senators Sessions and Alexander.

OPENING STATEMENT OF SENATOR ALEXANDER

Senator ALEXANDER [presiding]. The hearing will come to order.

Our chairman, Senator Sessions, is in the midst of a press conference. Rather than keep you waiting, he asked me to go ahead

and begin the hearing, which I am happy to do.

This is a very important topic in which Senator Sessions has

taken a lot of interest. All of us in the Senate are focusing more

of our attention on HIV/AIDS. Senator Sessions has looked especially at how AIDS is transmitted. Today, we are talking about the

medical transmission of AIDS, what are some of the solutions for

medical transmission and what policy makers should know and understand as we go about making decisions.

This all occurs against a backdrop where President Bush has announced with virtually unanimous bipartisan support in the Senate—the only disagreement is over who can support it the most, I

think is the idea—our moral commitment as a country to working

on helping to deal with the terrible problem of HIV/AIDS, especially in Africa, and that is what we are talking about today, one

piece of the problem.

We have two panels of witnesses. I will introduce the first panel

and ask them to go ahead and then Senator Sessions will be here

and we will both have questions of both panels as time comes

along.

Dr. Anne Peterson is our first witness. She is well known to us,

Assistant Administrator for the Bureau of Global Health for the

U.S. AID. It is the principal government agency providing economic

and humanitarian assistance to transitioning and developing nations. Within U.S. AID, the Bureau for Global Health provides

technical and program support to field interventions in areas such

as HIV/AIDS, infectious disease control, and child and maternal

health. Dr. Peterson knows what she is talking about. She has
2

lived and worked in Africa in different countries and we are delighted that she is here today. Dr. Peterson?

Before we begin I have a statement from Senator Kennedy.

[The prepared statement of Senator Kennedy follows:]

PREPARED STATEMENT OF SENATOR KENNEDY

I commend Senator Sessions for calling this hearing to highlight

the AIDS crisis in Africa and the profound effects of this worldwide

epidemic. We are now in the third decade of the epidemic, and

every nation has an obligation to do more to end it. Almost 22 million lives have been lost to AIDS, and there is an urgent need to

develop more effective means of prevention and treatment.

AIDS imposes its heaviest toll on developing countries. Of the 42

million people who are infected today, the overwhelming majority

are in the poorest nations of the world. Sub-Saharan Africa is the

region that has been hardest hit. The overwhelming majority of the

thirteen million children who have been orphaned by AIDS live in

that region. The United States has been far too silent while that

enormous suffering goes on.

AIDS robs poor countries of hope. It robs them of workers needed

to develop their economies teachers needed to combat illiteracy and

train men and women for jobs and farmers needed to sustain their

communities and feed their people. Year after year, because of

AIDS, poor nations sink deeper into even more desperate poverty.

We know that challenges like these are not insurmountable, and

that other governments can make the difference in battling AIDS

in Africa. Thirteen years ago, we demonstrated our commitment to

the care and treatment of Americans living with AIDS by passing

the Ryan White Care Act. Since then, community-based care has

become much more widely available. Public health campaigns have

increased awareness of the disease, and the new awareness has

made prevention a major part of our effort. That kind of model can

be applied in other nations too, even in parts of the world that are

reeling from the AIDS crisis.

In America, we have already made large gains in helping those

infected by the virus to lead long and productive lives because of

the miracle of prescription drugs. Drug treatments are available

that nearly double the life expectancy of HIV-positive individuals.

Tragically, these advances are readily available only in wealthy

nations. We have an obligation to continue fighting this disease at

home, but we also need to share these enormous scientific advances

with other nations. We must do all we can to provide access for everyone to today’s life-saving therapies.

We must also take the lead on providing resources to developing

nations. When governments obtain the necessary resources, infection rates have dropped by as much as 80 percent. They use these

resources to carry out educational campaigns and improve the distribution of information to schools and health professionals. Mass

media campaigns are needed to educate all sectors of society about

the spread of AIDS and what each person can do to protect themselves against infection. Above all, poor nations need help in paying

for necessary drug treatments and developing the local infrastructure to provide health care and get drugs to victims.
3

There is no silver bullet to solve the AIDS crisis. The solution

must be wide-ranging and include steps to prevent unsafe sex practices, prevent transmission of the disease from mother to child, and

prevent infections from contaminated blood and unsafe injections.

President Bush deserves great credit for his recently enacted $15

billion initiative over the next five years to combat the global AIDS

epidemic. Lets be sure that these resources are delivered quickly

and are available to prevent all methods of transmission with a

particular focus on sexual transmission, which is widely recognized

by all major national and international public health agencies as

the most widespread type of transmission in both industrial nations and developing nations.

Dollars and common sense also mean that the use of the funds

should not be based ideology. We have so little time to act, and we

can’t waste this opportunity. Working together, we can lead the

world community in defeating one of the greatest threats of our

time.

Again, I commend our Chairman for calling this hearing, and I

look forward to the testimony of our witnesses.

STATEMENTS OF E. ANNE PETERSON, M.D., M.P.H., ASSISTANT

ADMINISTRATOR FOR THE BUREAU OF GLOBAL HEALTH,

U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT; AND

YVAN HUTIN, M.D., PH.D., MEDICAL OFFICER, DEPARTMENT

OF BLOOD SAFETY, WORLD HEALTH ORGANIZATION

Dr. PETERSON. Thank you. I very much appreciate the chance to

be here today to speak on this important topic. The U.S. Government does acknowledge that there is medical transmission of HIV/

AIDS and that this is an area that we need to take very seriously.

I am not today going to try and talk about the epidemiology and

how big the problem is, but more what kinds of things are we

doing, where are we working in ways that can begin already to address the medical transmission of HIV/AIDS.

I was also asked specifically just to touch on the general epidemiology, how big is the epidemic and what is different in different

parts of Africa. In your handout, you can see the slide that shows

that Africa has a very high prevalence. Obviously, that is why we

are here. But there is a difference in the epidemic from West Africa, East Africa, and Southern Africa. We don’t completely know

why there are those differences. It probably has to do with strains

of HIV, response to the epidemic, maybe even things like male circumcision, a very interesting and new strongly supported area.

My experience is that medical transmission probably isn’t the explanation for the differences between West Africa’s slow growth

and Southern Africa’s very rapid growth, but I know that——

Senator ALEXANDER. Growth in AIDS, you mean.

Dr. PETERSON. For AIDS.

Senator ALEXANDER. HIV.

Dr. PETERSON. Yes. But that CDC/HHS is doing a study looking

at what do we know about medical transmission and the epidemiology of that. So I expect in the new few months we will know more.

We will be able to say which areas we can make the most difference.
4

Within HIV/AIDS, there are a host of strategies that we could be

involved in. On the slide under ‘‘Comprehensive Approach,’’ you

will see that very many of them are in a medical and clinical setting, not all, but in each one of those areas, like ensuring blood

safety, injection safety, postexposure prophylaxis, treating of STDs,

even voluntary counseling and testing. Those are interventions in

our AIDS program that happen in medical settings. Some of them

are places where there can be medical transmission of HIV/AIDS

and, therefore, they are areas where we want to reduce any potential transmission to the greatest possible extent.

In the next slide, we have a modeling that John Stover has done

that—and I know he will be presenting to you later, and the most

important point is that we truly have many and complementary

strategies. Do you want me to—— Senator ALEXANDER. Please go ahead.

Dr. PETERSON. Thank you.

Senator SESSIONS [presiding]. Dr. Peterson, thank you for your

testimony and I apologize for being late. We just had a big brouhaha and my good friend, the Attorney General of Alabama, and

we find his nomination to be filibustered, so we got caught up in

that. I am sorry. It was an important matter, but this is very important also and we are delighted to have you here.

Dr. PETERSON. Thank you very much.

Senator SESSIONS. Please continue.

Dr. PETERSON. And we have just started. The real point is that

we have many and complementary strategies to address transmission of HIV/AIDS, especially within the medical setting, and

prevention of medical transmission happens within our AIDS programming, the things like blood safety, postexposure prophylaxis,

our mother-to-child transmission programs, but a lot of what is already happening that could address medical transmission of HIV/

AIDS is being done through our general health programs, our injection safety programs, our immunization programs, our maternity

care and delivery programs, the White Ribbon campaign, new protocols for delivery, malaria prevention—I will talk a little bit more

about that, as well as the research that we do, the health systems

training and quality assurance.

All of those things that are currently being done are predominately funded out of our child health and maternal health program

funding, and as you can see, that is about 25 percent of our overall

funding for U.S. AID’s health programs. I am on the second page

of the handout.

Injection safety is, I think, what really brought this issue to everyone’s attention, and there is a lot already happening addressing

injection safety. I sit on the board of the Global Alliance for Vaccines and Immunizations. Like the Global Fund, it is a public-private partnership that has had a lot of money put in, a lot of emphasis on immunization, both new and routine, and a portion of the

funds that gets distributed to the countries is specifically for immunization system strengthening.

The U.S. contribution is $58 million in this year. It is a total of

$160 million. And specifically, immunization services support has

received $332 million through various of the countries and $77 million specifically for injection safety in the last 3 years.
5

U.S. AID has also been very involved in the technology development, the development of the auto-destruct syringe, so the singleuse syringe, and the newest one, the Unijet, which is a small, very

small—I should have brought it—syringe that can only be used

once. It looks like a little bubble from bubble wrap. Part of what

we are doing now is finding more and more of the immunizations

and other kinds of injections that can be used using that modality.

We had more than 400 million of the auto-disabled syringes that

have been supplied to 40 countries and 22.6 million Unijet devices

that have gone out worldwide since 1998. We are also working in blood safety. In Kenya, we have $3.3 million to equip and construct a national and four regional blood

transfusion centers to work with model transfusion projects and

operational guidelines. In Nigeria, there is a newly-designed program, and in many places, we are working with countries to change

their protocols for when do you transfuse.

That leads us really to both the maternal care and malaria

issues. Maternity and delivery care is important for HIV medical

transmission because postpartum hemorrhage is a major reason for

anemia that leads to transfusion. There is the mother-to-child

transmission, as well. Addressing the quality of maternity care protects the baby in mother-to-child, it protects the mother from receiving transmission, and it protects the health care workers, as

well. If you can reduce the high-risk deliveries and you can reduce

blood exposures, you are protecting all three of those populations

in a medical setting.

So we have worked enormously there, both with changing protocols for delivery, working with improved postpartum and PAC care,

working with getting Oxytocin, which is the drug that reduces

bleeding into the Unijet, so again, it can be administered safety.

We have done regional training in best practices, and again, dealing with when do you transfuse in those kinds of situations. All of

this reduces HIV transmission in medical settings.

Similarly, malaria, which you know is a huge problem in sub-Saharan Africa, is a major contributor to the need of transfusion. Our

malaria expert told me this morning he had just come back from

Congo and 80 percent of the beds had to do—for young children—

were there because of severe malaria and 80 percent of the transfusions were because of probably inappropriate transfusion of these

children who were severely anemic. So we are working in our malaria programs, one, to reduce malaria. The primary prevention

program is scaling up to national scale——

Senator SESSIONS. Dr. Peterson, you said 80 percent of what was

caused by the transfusions?

Dr. PETERSON. Eighty percent of the children in the hospital had

severe malaria, and 80 percent of those children were having inappropriate—well, a mix of appropriate and inappropriate transfusions. But he was very concerned and that was his ‘‘just returned’’ example. That is probably an exceptional case for the place

that he had just visited, but it is an overall problem, that severe

anemia is a common result of malaria and, in general, it has in the

past been treated with transfusions. If we change the protocols for

when you transfuse and if we can reduce the malaria burden for

infants and children, we reduce, again, that risk of transfusion.
6

Malawi is fascinating in that a program to address the treatment

protocol for malaria, get the right drugs to people who are sick

with malaria, resulted in a 30 percent difference compared to other

countries in the mortality for infants and children. It will equivalently change the amount of severe anemia. So primary prevention,

correct treatment of malaria, and again, the changing of protocol

for transfusions.

We also work in the science and technology. I mentioned the

technical innovations like the auto-destruct syringe. But we also

work in biomedical research, rapid diagnostic tests that let you

know what you are dealing with so you can respond very quickly.

And since we are an implementing agency, one of the most important things we do is operations research. How do you know that

what you are doing is being done well and is having the effects that

it should have? And so things like are they doing their STD treatment properly, integrating family planning with PMCT, acceptance

of medical waste protocols as we deal with immunization and medical waste and the potential transmission that you have in that kind

of setting, and how do you get best practices in the medical setting

for medical waste.

We have quality assurance projects that look at the protocols for

doing treatment. This will be very important for the President’s initiative in doing ARV treatment, but it will also be important for

the mother-to-child transmission, for maternity care. In each one of

these areas, having the right protocols and having people trained

and following them correctly and the quality assurance and the

oversight and management of that can make a real difference in

medical transmission. We have seen that in the U.S. We certainly

are seeing it also in international settings.

In the set of slides, I gave one example where in South Africa,

and it would be wonderful if Senator Alexander got to see this

project, in the Eastern Cape, which is the area of South Africa with

the worst health indicators, very significant HIV, we worked in a

management oversight information system type of program. We

took $7 million of our U.S. AID money and we helped do technical

assistance and management oversight and leveraged, really, the

$420 million the South African provincial government was putting

into their provincial health system and worked with them to recognize what they were doing and if there were problems to respond

back.

If you walk through the slides, you can see that these were really

poor settings. They didn’t all have water and electricity. And over

the course of 3 years, all of the process indicators improved. They

did more counseling for HIV than they had previously. They got

their TB drugs better into the clinics. They got their immunization

drugs better into the clinics. They followed proper TB protocols.

They followed proper management of STD protocols. And within 3

years, we saw a spectacular decline in syphilis and other disease

outcomes and the beginning of the leveling off of HIV in the youngest age group in this whole province, and again, one of the poorest

provinces in South Africa.

So this is a management oversight quality assurance program

that we were doing to the provincial government that was having

a profound impact on how the clinical care was being done and the
7

disease transmission and treatment and therapies within those settings. So the policy issues can make a huge difference.

There are still challenges. We need better data and surveillance

to know where the greatest amount of medical transmission of HIV

is happening. That is likely to change over time as we continue to

implement programs and impacts. So we will have to continue to

keep track of it.

Informal sector does contribute to ‘‘medical transmission’’ of HIV.

There are many places in sub-Saharan Africa where you have nonmedical providers doing injections and other therapies and that

will be a hard sector to reach.

We also need to look at a major thrust of the President’s initiative, the scale-up of anti-retroviral therapy, and recognize that we

have a great potential and a caution, and that is as we do the

scale-up for treatment of HIV/AIDS, we will necessarily have to

work on the health systems. We can, as we plan it, either choose

to be very narrowly focused and just make sure we have got the

delivery systems and the protocols for ART, and like polio, perhaps

get some diversion of attention. Polio has diverted in some places

attention from routine immunization. Or we have the opportunity

as we scale up and address health systems issues for the antiretroviral treatment. We can make sure that it improves the health

systems broadly for all of the different parts of medical transmission potential.

So it is a place to pay attention to as we go forward and make

sure that the health systems work that we do specifically for the

AIDS treatment does the best possible for all possible transmissions of HIV.

In the future, these are the things that I see going forward. Our

health programs will certainly continue to pay attention to how can

we deal with injection safety, delivery care, those kinds of things.

The GAVI Board has just, really at our instigation, initiated a

study looking at the immunization strengthening support dollars,

the hundreds of millions of dollars that they are doing in ISS, to

make sure that it is having a good impact and to make recommendations on that.

The Global Fund will similarly be scaling up their AIDS, TB, and

malaria programs. They have the same opportunity that we do

within our Presidential initiative to broadly assist in health systems strengthening and to address medical transmission of HIV/

AIDS.

And as we have anti-retrovirals available, we will have more opportunities for introducing protocols that aren’t done a lot currently

in Africa, like postexposure prophylaxis. If you have the ARVs

available, that will then be much more easily accessible to the

health care workers and others on occasional exposure.

Senator SESSIONS. If you can wrap up——

Dr. PETERSON. Sure. And that is really it. If we can go forward,

I think there is great scope for us to begin to make even more difference than in the past on medical transmission. Thank you.

Senator SESSIONS. Thank you.

[The prepared statement of Dr. Peterson may be found in additional.]
8

Senator SESSIONS. Dr. Yvan Hutin works for the Department of

Blood Safety and Clinical Technology of the World Health Organization in Geneva, Switzerland. He attended medical school at the

University of Nancy in France before going on to complete his Master of Science in clinical and tropical medicine at the University of

London, a diploma of specialized studies in hepatology and gastroenterology in Paris, and a Ph.D. in epidemiology at the Swiss

Troppen Institute.

Dr. Hutin has extensive experience in epidemiology and injection

safety. He has spent over 10 years studying the epidemiology of infectious diseases, including a number of years specifically focused

on the assessment of African nations. His service in epidemiology

includes acting as a medical epidemiologist specializing in hepatitis

B prevention with the CDC, as well as his present position at the

World Health Organization. He is presently the project leader of

the Safe Injection Global Network of WHO, which acts to assist

member states in assessing, planning, implementing, and evaluating policies for the safe and appropriate use of injections.

Dr. Hutin, we thank you, and thanks to WHO for allowing you

to take time out of your busy schedule to share with us. We are,

for both of you, we are going to be spending a tremendous amount

of additional funds. As I know both of you agree, it is a moral imperative that we apply those funds as wisely as possible to get the

greatest possible reduction of this terrible disease in Africa. Dr.

Hutin?

Dr. HUTIN. Thank you. Mr. Chairman, distinguished members of

the committee, the World Health Organization appreciates the opportunity to brief the committee on the prevention of HIV through

health care practices in Africa and appreciates the interest of the

committee in this important public health issue.

Senator Sessions, members of the committee, I am Dr. Yvan

Hutin from the World Health Organization in Geneva, Switzerland.

WHO is an international organization, the technical specialized

agency for health of the United Nations system, which currently

has 192 member states. The United States has been a member of

the WHO since it was founded in 1948.

As a clinician, I have experience in the care of individuals with

HIV infection and viral hepatitis both in Europe and in Africa. As

an epidemiology, I served in the Epidemic Intelligence Service of

the United States Centers for Disease Control and Prevention. As

you mentioned, I am now project leader for the Safe Injection Global Network.

In addition to my statement, I have provided the committee copies of two reports entitled, ‘‘The Cost Effectiveness of National Policy for the Safe and Appropriate Use of Injections,’’ and ‘‘Progress

Towards the Safe and Appropriate Use of Injections Worldwide

2000-2001,’’ and I would request that these two reports be made

part of the record.

A number of health care procedures may lead to the transmission

of HIV. These include transfusion of infected blood, unsafe injections, and other skin-piercing procedures that would be conducted

in the absence of universal precautions. Thus, health care services

should offer to their users selection and testing of blood donors,

and when applicable, viral inactivation of human material for
9

therapeutic use, safe and appropriate use of injections, and procedures that are conducted according to the universal precautions.

In Africa, for a population of 0.6 billion, which is about ten percent of the world, only 2.4 million blood units are collected annually. That is against an estimated annual need of six million units.

About one-third of the blood is donated by family replacement or

paid donors that we consider to be a high risk for HIV transmission

when we look at the incidence of prevalence of HIV in Africa. In

addition, 50 percent of collected blood is not tested, either for HIV,

hepatitis B, hepatitis C, or syphilis. The high efficiency of the

transmission of HIV through the transfusion of infected blood,

which is about more than 90 percent, leads to a substantial burden

of infection among the patients who receive blood transfusions.

Senator SESSIONS. Does that mean if you are transfused with infected blood, you have a 90 percent chance of——

Dr. HUTIN. Yes. If you receive an infected blood transfusion, your

risk of becoming infected yourself is 90 percent. The risk is much

smaller for unsafe injections. However, unsafe injections are a more

common procedure than blood transfusion, so this is how the difference plays out.

For the remainder of the statement, I will focus primarily on the

issue of unsafe health care injections, which I have been asked by

the committee to address.

WHO estimates that in developing and transitional countries, 16

billion health care injections are administered each year, an average of 3.4 injections per person per year. This high figure, along

with evaluation reports indicating inappropriate use of injections,

suggests that injections are overused to administer medications.

The causes of this overuse may include a preference for injection

among patients. However, the key cause is a desire from the health

care provider to satisfy what they believe is a preference for injection among the clients, and in fact, research suggests that most patients are very open to oral medications when you explain to them

that they are just as effective as injections.

In addition to being overused, injections may also be administered by unsafe procedures and cause infections. A safe injection

should not harm the patient, the health care worker, or the community at large. However, an injection may harm the patient when

injection devices are reused in the absence of sterilization. Injections may harm the health care workers when dirty needles are

collected in the absence of safety boxes. And injections may harm

the community at large when health care facilities are surrounded

by sharps, health care waste, mostly dirty syringes and needles.

Reuse of injection devices in the absence of sterilization is a problem of greatest concern that we have to address as it leads to the

largest burden of disease. A mathematical model developed by

WHO suggests that in 2000, in developing and transitional countries, reuse of injection devices accounted for an estimated 22 million new cases of hepatitis B infection, which is about a third of

the total, two million cases of infection with the hepatitis C virus,

which is about 40 percent of the total, and about a quarter-million

of HIV infection, which is about five percent of the total for the

whole world. These infections acquired in 2000 alone are expected
10

to lead to an estimated nine million years of life lost, and this is

adjusted for disability, between the year 2000 and the year 2030.

As the committee is certainly aware, there has been a recent controversy over the role that unsafe health care injections play in the

transmission of HIV infection in sub-Saharan Africa. While WHO

estimates that, worldwide, about five percent of all HIV infections

are transmitted through unsafe health care injections, this estimate is only 2.5 percent for sub-Saharan Africa. Although there is

uncertainty around these figures, WHO and our sister program, the

U.N. AIDS, believe that these are in the right order of magnitude

and that the vast majority of HIV infections in sub-Saharan Africa

are transmitted via unsafe sexual practices.

The public health issue of unsafe injection may appear daunting.

Yet, evidence indicates that the death and disability associated

with unsafe injections is highly preventable. First, interventions

conducted to improve communication between patients and health

care workers and intervention to improve the rationality of the prescription of the prescribers are effective in decreasing injection

overuse.

Second, interventions to ensure the injection device security, and

what we mean by that is to make sure that single-use syringes are

available reliably in every health care facility, are effective in preventing reuse of injection devices. Some of the poorest countries in

the world, Burkina Faso, for instance, have actually achieved substantial progress through ensuring that all injectable medications

are made available with sufficient quantities of single-use syringes

and needles.

In addition to being highly effective, policies and plans for the

safe and appropriate use of injections are a very sound investment

in health. In the scientific paper that I presented to the committee

as part of my statement, WHO has estimated that interventions

implemented in 2000 for the safe and appropriate use of injection

would have cost about $102 for each year of life saved, and that

is also adjusted for disability. This cost is under the threshold of

1 year of average per capita income, which is considered by the

WHO Commission on Macroeconomics and Health to be the threshold to consider health intervention as highly cost-effective health

intervention.

Thus, implementation of safe and appropriate use of injections as

part of HIV prevention and care programs is highly desirable and

can be accomplished with only a modest shift in the assignment of

resources for two reasons. First, injection safety is not that of a

costly intervention. The scientific paper on the cost effectiveness

that I submitted to the committee as part of my statement includes

an estimate of what it could cost to ensure injection safety in each

of the world regions, and so you can check the figures. Second, the

large majority of HIV infections worldwide are caused by unsafe

sexual practices. Thus, the emphasis of HIV prevention programs

must remain on preventing sexual transmission.

Among prevention opportunities, single-use injection devices with

reuse-prevention features deserve a specific mention. These have

been also referred as auto-disable or auto-destruct syringes. These

syringes inactive themselves after one use through either plunger

breaking or plunger blocking or needle retraction and are now the
11

norm for immunization services and they are becoming also the

norm for other programs that are supported by international donors or lenders.

I just thought it would be useful for you to see how these devices

work. This is an example of a device that works through plunger

breaking, so if I give an injection once, then I can’t pull back the

plunger because it has been blocked by a metal clip.

The second type of device that I have here would work through

a plunger breaking, and here, I can give one injection and once I

have given it, if I try to give a second injection, the plunger has

been broken off.

The third type of device that we can use is based on a system

by which the needle retracts after the injection, so here I am giving

one injection, and if I want to give another one, the needle has disappeared. I will clean my toys afterwards, I promise. [Laughter.]

So in addition, we have new single-use syringes with reuse-prevention features that have now been developed for general curative

health care services and not only sort of donor and lender funded

programs. These devices that are very promising require field evaluation so that we can define the exact future role that they will

have in public health.

Since the establish of SIGN at WHO in 1999, great progress has

been made toward the safe and appropriate use of injection. In the

progress report that I have attached as part of my statement, you

will see that actually the Government of the United States has

supported very strongly WHO’s effort in this area through the Division of Viral Hepatitis of the Centers for Disease Control and Prevention, the United States Agency of International Development,

and the United States National Vaccine Program Office. Additional

support will be needed in the future to prevent death and disability

through key interventions at a country level.

Four key interventions are needed for injection safety. These include increasing the awareness of the population so they can know

that when they are exposed to a dirty syringe, they can get HIV;

making sure there is enough quantities of single-use injection devices and safety boxes in every health care facility where injections

are administered; ensuring that all donors and lenders who support

the supply of injectable substances in developing and transitional

countries also support the provision of injection devices with reuseprevention features and safety boxes—we don’t believe it is ethical

to send to a country injectable substances if you don’t have the syringes that go with it; and finally, manage the waste associated

with dirty syringes and needles in a safe and appropriate way.

The four key interventions for blood transfusion safety are the

national blood transfusion service; the collection of blood from voluntary, nonremunerated blood donors from low-risk populations;

the testing of all donated blood; and the reduction of unnecessary

transfusion.

WHO appreciates the opportunity to brief the committee on this

important issue and I would like to thank you for your attention

and will be happy to answer any questions that you may have on

the subject.

Senator SESSIONS. Thank you, Dr. Hutin.
12

[The prepared statement of Dr. Hutin may be found in additional

material.]

Senator SESSIONS. Thanks to you and thank you, Dr. Peterson.

Those were very worthwhile comments that you made and I would

like to raise a few questions.

First, I think we ought to deal with the question of injections, Dr.

Hutin, and where we stand on that. Have you had the occasion to

study Dr. Gisselquist’s study of the transmissions by injection? I

know he has numbers extraordinarily higher than the two percent

or 2.5 percent WHO has come up with.

Let me ask you this. When WHO has a number like 2.5 percent

transmitted by dirty needles, injections, does that figure include— that only includes that transmission. It does not include the possibility that the person unknowingly infected may infect other people, is that right?

Dr. HUTIN. Yes. I think that would be very difficult to take into

account. I am familiar with Dr. David Gisselquist’s work and I

think his work has been useful to bring light to this important public health issue. We have done the math and done a mathematical

model that suggests that there is a certain amount of uncertainty

about the proportion of HIV that comes from unsafe injections, but

that it would be about five percent globally and 2.5 percent only

in Africa.

As I say, there is a certain amount of uncertainty around that

and our number may be slightly on the lower side, but it is very

clear from a WHO point of view that the very large majority of HIV

transmission in sub-Saharan Africa is caused by sexual transmission. However, I would like to add that we do not believe it is

a question of fighting for percent, and I agree with your comments.

There is all this issue of secondary transmission that is difficult to

address. It is not like we can cut a pie with a proportion that we

can definitely assign to a mode of transmission.

We have now consensus at WHO to say that whatever the mode

of transmission of HIV, all modes of transmission should be prevented. Sexual transmission should be prevented. Health care

transmission should be prevented. And because, as I have said in

my statement, because injection safety is not that expensive and

because the major issue is sexual transmission, we do not believe

that the shift of resources should be of a major magnitude. However, it is clear that injection safety is a low-hanging fruit that

really needs to be taken care of.

Senator SESSIONS. Thank you. I would agree with that. I would

just say, WHO’s leadership on SARS was extraordinary. I think

you moved decisively, courageously. You moved based on sound

science and apparently have curtailed this dangerous disease. I

would like to see all of us do a better job of being that decisive,

that courageous, and that effective on AIDS, which is an even more

deadly disease.

In your report, I notice that WHO was insisting on its lower figure earlier this year in reference to Dr. Gisselquist’s report, but in

your report for the WHO, the global burden of disease attributable

to contaminated injections given in health care settings, you concluded that in AFR E, is that Africa—— Dr. HUTIN. Yes.
13

Senator SESSIONS. Africa East?

Dr. HUTIN. It is one of our acronyms for a subregion in Africa.

Senator SESSIONS. That subregion, at least, you reported that

where prospective studies are available, the lowest attributable

fraction calculated on the basis of the data provided by the authors

was eight percent. In looking at your footnotes, you note that three

other studies came in, in addition to the eight, 15, 41, and 45 percent. What could you tell us about those numbers and what implications they may have for us?

Dr. HUTIN. What I have done is we have done a mathematical

model which has suggested that the proportion of HIV that comes

from the unsafe injections is about 2.5 percent. We have compared

this figure with epidemiological studies that have been conducted

in the field, and when we look at these epidemiological studies,

they give figures of a slightly higher order of magnitude.

So the conclusion that I have made is that probably our number

is slightly on the lower side. However, as I have said earlier in my

statement, we do not believe that the medical transmission—the

injection-associated transmission of HIV could be of an order of

magnitude of more than ten percent. The vast majority is sexual

transmission. So we may be on the lower side with 2.5 percent, but

that remains our best estimate, together with the margin of uncertainty that is mentioned in this report, and clearly, the majority of

HIV is transmitted by sex.

Senator SESSIONS. It is just strange to me that you did report

and your conclusion was that the 2.5 percent was probably conservative, I believe were your words, so that would indicate it is more

than that. As I understand it, 2.5 percent translates into 50 or

100,000 infections per year in the continent, would that be correct?

Dr. HUTIN. I want to make sure I have the right figure. I know

it is a quarter-million worldwide. I don’t have the exact figure right

here.

Senator SESSIONS. I believe that was the figure from one of the

WHO numbers.

Dr. HUTIN. Right.

Senator SESSIONS. I guess what I am saying is, if it were to be

ten percent, even, and Gisselquist has it higher than that, that

would be four times as many, and so we would be talking about

in, I believe, in Africa, 400,000 maybe infections a year.

Dr. Peterson, you raised and shared with us your concern about

transfusions in particular because your studies deal only with injections, that that may be even higher. I believe you relied on WHO

numbers that suggested that five to ten percent of the infections

in Africa came from transfusions. Would you share any comments

you might have about that?

Dr. PETERSON. Sure. I am really looking forward to where the

study that I know has commissioned goes on this. The data that

they have always is looking retrospectively, and on something like

blood supply and safe transfusion, we get samples. So again, very

similar to what you have heard on injection safety, you have your

best estimate and you have an area of uncertainty around it. The

most often quoted is five percent. Five to ten percent is probably

blood safety or blood transfusion related.
14

But that is the working number for a number of years, and part

of what has happened in the last two or 3 years which would not

yet be reflected in any of the data we have in hand is we are trying

to address that, both in the protocols and all of our other programs,

to reduce that amount—— Senator SESSIONS. Yes.

Dr. PETERSON. —both dealing with the blood banking issue itself,

but also dealing with how often you transfuse and the need for

transfusion. So we have got several years of intervention where we

have known that the blood has not been safe and people have been

responding to that.

I will give a personal example. My third child was born in

Kenya. I had a c-section, and what I did, given the very known

unsafety of the blood supply in Kenya, was made sure I had a

blood donor of my blood type available should I need a transfusion.

Those are the kinds of things that people have been doing in response.

So what we need now is more up-to-date data on how much is

actually—how much transmission is actually happening. We have

better ideas of how much of the blood is unsafe, but how much

transmission is actually happening is something we need to find

out, address, and keep track of, and continue to address very

strongly.

Senator SESSIONS. We did place in the global AIDS authorization

bill a requirement that HHS conduct a study, but from what I am

hearing from you, we may need to do more than study studies. We

may need to develop a very intense study and move on it, and I

would just share this thought, that this is a life-and-death matter.

I still shudder every time I think of a German study that came

out in May that found that there were 670,000 children in South

Africa, 670,000 from age two to 14, infected with AIDS, and most

likely the majority of that would have come from either transfusions or injections, from what we understand. It is just a stunning, stunning number. To me, we need to move on this rapidly.

It is just so important.

So studies don’t need to be a two- or three-year study. They need

to be absolutely prompt and get the best data we have got and we

are going to have to act without absolute clarity in some of these

issues, it seems to me.

Senator Lamar Alexander, we appreciate you starting this meeting off. As a university president, reviewer and hirer of scientists,

we would be delighted to have your insights at this time.

Senator ALEXANDER. Thank you, Mr. Chairman. University presidents work for the scientists. That is the way it really works.

[Laughter.]

What interests me especially, Dr. Hutin, is this huge number of

injections—16 billion health care injections in developing and transitional countries, an average of 3.4 injections per person per year

in all the countries that you are talking about. Now, in a country

like the United States, what would be the average injection per

person per year?

Dr. HUTIN. That is a very good question. Unfortunately, I am unable to answer it. We think that it is probably much lower, but unfortunately, we don’t have very accurate data.
15

Senator ALEXANDER. As I understand your testimony, injections

are by far the largest part of the health care transmission of HIV/

AIDS, is that right?

Dr. HUTIN. We have done the global burden of disease exercise

for the injections. We have not completed it for the blood transfusion. We are in the process of doing this.

Senator ALEXANDER. OK.

Dr. HUTIN. So I can’t release any official number, but the order

of magnitude is about the same. In other words, we are talking

under ten percent and—— Senator ALEXANDER. You mean about as much transmission of

HIV/AIDS from blood transfusions as from injections?

Dr. HUTIN. Injections, about the same order of magnitude.

Senator ALEXANDER. OK. Sixteen billion injections, and while it

might be a relatively small percentage of the transmission of HIV/

AIDS, according to your figures, it is a large percentage of the

transmission of hepatitis B and C, a huge, disturbing percentage.

Dr. HUTIN. Absolutely.

Senator ALEXANDER. So rather than Safe Injection Global Network, maybe we need a ‘‘Less Injections Global Network.’’ Is there

a major effort to try to discourage the use of injections as a way

of administering medicines in transitional and developing countries?

Dr. HUTIN. You are absolutely right and this is why, in fact, you

will see throughout this statement that I use the phrase ‘‘safe and

appropriate use of injection.’’ If you have a look at this paper, we

have actually estimated the cost of intervention to reduce injection

overuse and the cost of intervention to make injections safe, and

the cost of the combined interventions.

Senator ALEXANDER. Which is the cheapest? I guess, less injections?

Dr. HUTIN. What we think is that both should be done, because

if you reduce injection overuse, then you use less injections, it is

actually less expensive to make them safe, so—— Senator ALEXANDER. Many people prefer the injection to taking

a pill orally, is that what you are saying?

Dr. HUTIN. Not exactly. What I am saying is that most doctors

imagine that this is what is in the patient’s head and, therefore,

they give injections to the patient while, in fact, the patient would

be pretty happy with a pill.

Senator ALEXANDER. Do you have a rough estimate of how many

of the 16 billion health care injections administered each year in

developing and transitional countries may only be done by injection?

Dr. HUTIN. You mean the proportion that would be necessary?

Senator ALEXANDER. Would it be half? How much of that medicine could be taken in some other form?

Dr. HUTIN. I can’t back this up with very good scientific numbers, but if you want a ballpark estimate, I would say about a half

or 75 percent are unnecessary.

Senator ALEXANDER. So for maybe a half or more, half to 75 percent of the injections, instead of an injection, you could take a pill.

Dr. HUTIN. Actually, if you will allow me, I will give you an anecdote that will make it extremely clear.
16

Senator ALEXANDER. That would be helpful.

Dr. HUTIN. I visited a place in South Asia that people refer to

as ‘‘Doctor’s Bazaar,’’ where you have an informal lay health care

provider who has no formal qualification and they have a line of

patients who are there and they come and they say, ‘‘Doctor, I have

generalized body pain,’’ and the provider will take a syringe, will

make a mixture between three different multidose vials, take the

syringe from his ear—I actually have a photo where the provider

put the syringe on his ear—he prepares the injection, give it to the

patient. The interaction between the patient and the provider lasts

less than 1.5 minutes, and then he recaps the syringe, puts it back

on his ear for the next patient. I have seen that with my own eyes

and it is very common in South Asia.

Senator ALEXANDER. And the reason for that? [Laughter.]

I mean, are doctors selling things? Is that an attractive way to

do things?

Dr. HUTIN. These informal lay health care providers that I am

referring to are very often in the private sector and there is a financial incentive for them to make the patient happy through the

prescription of these injections that are not justified.

Senator ALEXANDER. Dr. Peterson, do you have any comment on

this?

Dr. PETERSON. I have seen very similar. In Zaire, there were informal providers that were injecting gasoline into people and they

would come to the clinic then with huge ulcerative lesions. The

problem is, this informal sector is much harder for us to intervene

in and either cut out completely, because they are doing it for profit, or improve their practices if that were possible. So the informal

sector is a large part of these unsafe injections and it was part of

the reason I said the challenges we will be addressing in this informal sector.

In the formal sector, the public sector hospitals, the charity and

faith-based hospitals and proper protocols, we have got ways to address that. The informal sector is harder to do the training. We

have got some programs that try and address that, as well.

Senator ALEXANDER. Thank you. Thank you, Mr. Chairman.

Senator SESSIONS. We are going to have testimony in our next

panel, Dr. Peterson, from a doctor and he will present dramatic evidence that we are reusing needles right now in Africa and other

places in the world, as you have testified is occurring.

I just note that in a news article in the French press in March

of this year, a Botswana nurse injected 170 school children with

the same needle during an immunization campaign. They then said

that should any of the children test positive, we will follow up with

HIV-negative children and retest them to determine their status.

It has caused a scare in the country. Then the article notes that

at least 330,000 of the country’s 1.6 million people are infected

with HIV or have full-blown AIDS, which is 20 percent, while

65,000 children have been orphaned by the disease. So it is really

a stunning thing.

We were discussing the number of 2.5 percent. The best data

that I have, Dr. Hutin, I think this is WHO numbers, is that there

are 3.5 million new cases a year in Africa, 3.5 million people given

a death sentence. At 2.5 percent of those being injections, that is
17

88,000 a year. If that number is conservative and is considerably

higher, we are talking about probably 100,000, 200,000, 300,000,

maybe even more. It could be even greater.

Doctor, I will just ask you this. You know, I am not in the medical profession. I haven’t lived with these difficulties like you have.

I don’t believe you always have to do things perfectly and get everything in control and run a perfect program. What if we were to

make a consensus decision with the world leadership and the African leadership, the United States money that we are putting up,

and say we are going to supply nonreusable needles for every clinic

in Africa and we are going to do it within 6 months and we are

going to tell people with clarity that they should never have an excuse to reuse a needle again.

Is that the low-hanging fruit we are talking about? Could we

make a dramatic difference? Sure, we could train and have all

kinds of other things to go even further, but couldn’t we do that

on a fairly short basis?

Dr. HUTIN. Absolutely. In fact, in the paper that I have submitted as part of my statement, what we are trying to say is that it

is not an issue about 2.5 percent or five percent or one percent. We

have actually done a sort of worst-case scenario and we have said

in this paper, let us say we have overestimated the 2.5 percent and

let us say, in fact, we need even more needles than what we have

estimated and we have actually underestimated the cost.

Even under the sort of worst-case scenario in our approach, safe

and appropriate use of injections remains a very highly cost-effective health intervention. We remain, in terms of cost per deadly

averted, under the threshold of one-year per capita income. So we

are talking of an extraordinarily simple thing.

At a moment when we are talking about other sophisticated

health care intervention, here we are talking of making sure that

in a dispensary in Africa, when you have a vial of penicillin, well,

next to the vial of penicillin there is also a syringe that is being

provided, and if possible, a syringe with a reuse-prevention device.

It is extraordinarily simple. You have the cost figures in this paper.

It is not high——

Senator SESSIONS. Could you share with us your ranges?

Dr. HUTIN. The cost figures? Yes, absolutely. For Africa, for the

combined safe and appropriate use of injection policy would be, for

the reduction of unsafe use—I am sorry, the combined safe and appropriate use of injection policy, which includes reduction of overuse and safety, it would be $22 million. And for AFRE, $22 million

also. So you are talking $44 million——

Senator SESSIONS. For the nonreusable safe needles, or for the

whole program?

Dr. HUTIN. Forty-four million dollars in total in Africa to reduce

injection overuse and to make these injections safe.

Senator SESSIONS. Overuse——

Dr. HUTIN. And make them safe.

Senator SESSIONS. I have been told that for every injection in Africa bought in bulk, the safe nonreusable needles could be supplied

for $100 million a year. When you consider that we will probably

be spending $2 to $3 billion a year over the next 5 years, that may
18

just in itself—but you are saying that if we really knock down the

unnecessary injections, you could get an even bigger saving.

Dr. HUTIN. Exactly.

Senator SESSIONS. Obviously.

Dr. HUTIN. And as I say, the cost, as you see, is not that high.

So it wouldn’t call for a major shift in resources and the emphasis

can remain on the prevention of sexual transmission of HIV.

Senator SESSIONS. Would you comment on the urgency of that,

and Dr. Peterson, should we line up, get serious, have a generalized conference on this issue and urge every leader in every African

Nation to institute dramatic change?

Dr. PETERSON. I would say we are already pretty serious about

it. The GAVI Board has been working, getting immunization out at

a much better level, and all of those vaccines are provided in autodestruct. So a lot of the gear-up of immunization practices in the

last couple of years has already said this is really important. We

need to be dealing with injection safety.

Similarly, I mentioned the Unijet. One of the places we are doing

research is to find not just the vaccines, but other drugs that can

be used in the Unijets. We are looking at the contraceptives, the

Depo-Provera that women get every 3 months, that it would be

available in these little Unijets that can only be used once.

So we are very actively looking for as many different places to

do injections much more safely than in the past. Our quality assurance programs, when we work in hospitals and clinics on what are

their protocols, proper use of medical equipment, we are working

on sharps and appropriate auto-destruct syringes availability.

Senator SESSIONS. And one more thing. Likewise, I assume, it

would not be cost prohibitive to develop a much, much more effective program in dealing with transfusions, to make sure that all

blood is tested. It may be difficult managerially, but it would not

be a huge cost in terms of the overall cost of fighting AIDS, would

it?

Dr. PETERSON. I would have to go and get that data for you. This

is something that CDC/HHS does even more than we do. One of

the issues is not just how much does it cost to make sure that the

blood supply is safe, but do you have enough blood donors, as well,

and there are some trade-offs there.

But we are, frankly, working both on improving the blood supply,

and again, similar to the injections, reducing unnecessary transfusions or even—it would be good to have a transfusion, but the

risks are higher of having a transfusion than not having one and

setting those protocols in ways that reduce medical transmission

through blood, as well.

Senator SESSIONS. Well, thank you, both of you, for your service

to the world. Your commitment is extraordinary and total. At

times, I know you are having to deal with difficult choices and limited resources.

This chart on the wall, though, has sort of hit me very hard. It

says, ‘‘Fast Track to Global Disaster,’’ the San Francisco Chronicle,

and the subheading there is, ‘‘For decades, researchers warned that

contaminated syringes could transmit deadly viruses with cruel efficiency, but efforts to defuse the crisis failed and today it has be-
19

come an insidious global epidemic, destroying millions of lives

every year.’’ What I would note that is most dramatic about that article is

that it is dated October 27, 1998, and we are not there yet. I think

those of us in public policy have got to get you the resources, create

some public and world interest, and it has got to be intensive. I

have no doubt that the leadership in the African countries are

more and more attuned to the crisis that is facing them, and if we

give them good sound science and a good sound plan that will

work, such as providing on an immediate basis nonreusable needles, I think we could save a lot of lives.

Do either of you have any comment on that before we go to the

next panel, or any thoughts?

Dr. HUTIN. Actually, I just wanted to mention about blood transfusion safety because I am in the Department of Blood Safety and

Clinical Technology at WHO. WHO conducted a systematic review

of the cost effectiveness of all the various interventions in the field

of HIV that was published by Dr. Andrew Creese in the Lancet recently, and blood transfusion safety was actually one of the most

cost effective of the various interventions against HIV. So it is a

small—it is exactly like injection safety. You are a small piece of

HIV burden, but it is actually an inexpensive one that you can fix

pretty rapidly.

Senator SESSIONS. Well, I thank you for that. That is where we

need to be heading, it is pretty obvious to me. Thank you so much.

We will go to the next panel. We will have Dr. John Ssemakula

of Medilinks, Holly Burkhalter of Physicians for Human Rights,

and John Stover of The Futures Group International.

Dr. John Ssemakula is the founder of Medilinks, an online source

of health information for Africa. He is also a public health consultant with the Africa-America Institute, where he serves as program

manager and adviser on the AAI HIV/AIDS Initiative. Dr.

Ssemakula trained at Ibadan University Medical School in Nigeria

and Makerere University in Uganda, where he received his M.D.

He subsequently received an M.P.H. degree at Dundee University

Medical School in Scotland, where his master’s thesis was entitled,

‘‘HIV/AIDS and the Health Care System in Uganda.’’

Dr. Ssemakula has extensive on-the-ground experience as a practicing physician in Uganda and was able to witness firsthand the

impact on HIV on his home country. He has published multiple articles on HIV/AIDS, including a March 2003 article on the role of

unsafe medical care in continuing spread of HIV in Africa.

I will start with you, Dr. Ssemakula.

STATEMENTS OF JOHN KIWANUKA SSEMAKULA, M.D., M.P.H.,

MEDILINKS; HOLLY BURKHALTER, PHYSICIANS FOR HUMAN

RIGHTS; AND JOHN STOVER, VICE PRESIDENT, THE FUTURES GROUP INTERNATIONAL, GLASTONBURY, CT

Dr. SSEMAKULA. Thank you very much. Senators, thank you for

affording me the honor and privilege to address this Senate hearing committee on the very important subject of safe health care in

Africa.

Senator SESSIONS. Dr. Ssemakula, I will note that we will try to

keep our statements to five minutes. We can go over a little if need
20

be, but we would like to do that so everybody will have a chance

to speak.

Dr. SSEMAKULA. I have had a professional personal relationship

with HIV and AIDS throughout my tertiary education, as you said,

both in medical school and then my on-the-ground experiences as

a young physician, first undertaking medical internship as a medical officer in the early 1990s during the peak period of the HIV/

AIDS crisis in Uganda.

My interest in HIV and AIDS, though, is not just professional.

It is also on an intensely personal level. I have lost several cousins

who were like brothers and sisters to me over the years.

I have been following the issue of unsafe health care and its role

in the spread of HIV and AIDS in Africa for a year now, from the

time David Gisselquist sent me a draft of his groundbreaking paper

almost a year ago and the controversy that ensued when it was

published in the International Journal of STD and AIDS. But as

far as I was concerned, people who are discussing the issue in

terms of controversy were missing the point completely, for there

wasn’t a controversy. It was not about the percent of HIV and

AIDS that was transmitted by unsafe needles, be it 2.5 percent, ten

percent, or 40 percent. It was really simply about health care, the

first and most basic thing as a doctor one should provide.

I have since learned that there are relatively cheap technologies,

such as auto-disable syringes made by BD or companies like Starr,

or such as retractable syringes as you saw Dr. Hutin demonstrating.

I have just come back from Uganda—in fact, I came back on

Monday this week—where I have been talking to people about the

issue of unsafe health and the possibility of getting AIDS through

needles. None of the people I talked to saw any hint of a controversy. No one jumped to the conclusion that providing safe

health care would lead to more unsafe sex. They had equal concerns about safe health care and safe sex, saying we need both.

While in Uganda, I also attended the Uganda Bishop’s Council,

where they were taking landmark decisions on adolescent youth

sexual and reproductive health. They were very excited to hear

that I could be testifying before the Senate. They all agreed that

the issue of reuse of needles was very important, just as important

as safe sex. They told me, ‘‘We are sending you as our emissary to

the USA and we are trusting you to tell the Senators about this.

Tell the Senators we are also working very hard. We appreciate

any and all help you can give us in our fight against HIV and

AIDS.’’

I also visited health centers in Uganda, first in Rakai District,

where AIDS was first seen in Uganda. That is my mother’s and my

cousin’s home district, and then in Luwero District. While in Rakai

District, I was taken around to one of the health centers by Sister

Namperwa of Kakuto Health Center and she told me, ‘‘We don’t

reuse needles here. But,’’ she said, ‘‘if you have these auto-disable

syringes and you can bring them to Uganda, it would be good. Doctors are worn out fighting AIDS day in, day out, and it will help

all those doctors at those clinics further up-country because they

are just stuck.’’
21

While at Luwero Health Center, I was also taken around by another doctor and sister, a Sister Margaret Serunjoji, the ‘‘in charge’’ of the maternity wing. I asked her, among other things, if they had

a problem with the reuse of needles. She said in immunization

there was no problem because of the provision of the UNEPI program and auto-disable syringes, except if they were running low on

supplies, they may have a few difficulties. But, she said, they have

nothing similar for curative services.

When I told her about the existence of auto-disable syringes that

may be made available and the moves to make them available in

Africa for curative services, she became excited. Sister Serunjoji

told me, ‘‘This is just what we need. Even though we don’t reuse

needles here at the clinic because supply is generally good, sometimes we run out. When that happens, patients are forced to buy

syringes. But the problem is, even at 300 shillings,’’ which is equivalent to 15 cents, ‘‘it is still too expensive for most villagers. So

when a patient comes with their own syringe, they will tell the doctor,’’ and I will use this in my language, [spoken in Ugandan],

which means, ‘‘Doctor, give me back my needle so I can go and boil

it again so I can reuse it.’’ They don’t want to buy a syringe every

time because it costs too much.

I remarked, isn’t this particularly dangerous, especially with the

danger of AIDS in Uganda? Isn’t there a possibility of it being

spread this way? The doctor who was also taking me around replied, ‘‘This is a very real problem. It is even more urgent if one

realizes that when a patient buys a needle, sometimes they share

it among the family. It is a common practice, using it over and over

again, or being good neighbors, they may even share it with their

neighbors. Auto-disable syringes that are cheap enough and supplied in enough quantities would help prevent this by using technology as a control. This is not just an issue of health, but it is also

an issue of poverty.’’ On my visit, every single doctor and nurse I met in the past few

weeks were concerned about HIV transmission in health care settings, because as health care workers today, they are still living

many of the same experiences that I lived through as a practicing

doctor in Uganda. As a medical student, a junior house officer, and

a medical officer, I witnessed the reuse of needles in the late 1980s

and 1990s. I witnessed the reuse of needles constantly. Thankfully,

that is not the case today, which shows how much Uganda has

done.

But back then, sometimes the needles were so blunt they could

actually cause trauma to the patient and blood would flow, and

many of my colleagues still recall some of the stories. And at that

time, so concerned were we as junior doctors, doing most of the

work and on the front line, we went on a work to rule demanding

equipment such as disposable needles and gloves that would allow

us to do our jobs in a safe environment, both for the protection of

ourselves and our patients.

I remember one time a colleague and I decided just to do an informal survey, because at the time, we didn’t have the means to

do testing on everybody. We just decided to do an informal survey

to see how many of our patients were HIV-positive. We were

shocked to discover that up to 50 percent of our patients were HIV-
22

positive. In fact, at the time, people felt it was so unsafe practicing

as a doctor, even my aunts, cousins begged me to go into other

lines, branches of medicine that would expose me less to any of

these hazards.

Also, it is also at this time while I was working in pediatrics, I

and a colleague, Dr. Madewo, started noticing children that were

presenting as HIV-positive when the mother was not, and some of

these children were quite old. This is going back 10 years and this

was not in the data that WHO was giving out. So we tried to theorize what was happening and we thought perhaps they were being

infected through immunizations, either injections or unsafe blood,

and the reason we thought this was because for a lot of patients

who came, and if you asked them a question, they would always

tell you they are being given an injection by a doctor.

Now, a ‘‘doctor’’ is a quotation. The word is [in Ugandan] in my

language. It could be anybody from a lay health worker, traditional

birth attendant, or whatever it is. An injection is given as a means

of treatment, and it may or may not contain any medicine at all.

Unfortunately, at that time, for various reasons, we were unable to

investigate further, but I believe this was a missed opportunity to

investigate the possibility of HIV being spread in a medical setting.

I will say there is no denying that unsafe sex is probably the

major route for transmission of AIDS, but other routes, such as the

reuse of needles and other unsafe health care practices, are just as

significant. The message of safe sex and behavioral changes to safeguard people is of paramount importance because this is something

the individual has control over, but they have no control over what

happens in a hospital or clinic. In this, they put their trust in I as

a doctor or the nurse or the clinical officer to provide the safest

health care.

Knowing this and the danger of AIDS and other bloodborne diseases, should we then not be striving to achieve the safest health

care? I say again, as I have said to people, how in all honesty can

I stand in front of people in rural areas in the rural health clinics

and villages to address them on practicing safe sex when I know

that I am not giving them the highest possible standard of health

care. How can I just say that you should not have this as a basic

choice?

It is not really a case of choice between safe sex or safe health

care. It is quite simply, and this came out of my visit to Uganda,

the health care workers, that the people who have been and continue to be on the front line of the fight against HIV and AIDS,

who despite battling huge difficulties and odds have succeeded in

doing tremendous work, and they are simply asking for tools that

will help them in the fight. It is about the fight for the future. In

this and this, there is no controversy.

Whatever help can be given should be provided, and can anyone

in all honesty give a reason in this case why such equipment and

help or assistance should not be rendered? I say, if you can’t, if so,

let them come to these health clinics that I visited, look at these

health workers and their patients, and look and say why they can’t

get these things. Thank you very much.
23

Senator SESSIONS. Thank you, Dr. Ssemakula, for those eloquent

comments from the heart and from your scientific experience. We

appreciate that.

[The prepared statement of Dr. Saemakula may be found in additional material.]

Senator SESSIONS. Dr. Burkhalter, let me introduce you. I

haven’t done that yet. Dr. Burkhalter is the U.S. Policy Director of

Physicians for Human Rights, a Boston-based human rights organization specializing in medical, scientific, and forensic investigations

of violations of internationally recognized human rights. Her group

has evaluated the problem of health care transmission of HIV in

Africa, the very subject we are talking about, and has developed a

comprehensive plan with associated cost projections to address the

issue.

Ms. Burkhalter graduated Phi Beta Kappa from Iowa State University in 1978 and subsequently worked for 4 years on the staff

of then-Senator Tom Harkin—I guess Representative Tom Harkin

then. She subsequently staffed the House Foreign Affairs Subcommittee on Human Rights and International Organizations before going on to work for 14 years as the Advocacy Director and

Washington Office Director of Human Rights Watch. She has published extensively on human rights and human rights law, as well

as on the problem of HIV/AIDS in the regions she has studied. I

suppose, Ms. Burkhalter, that it is an important human right in

that a young person getting an inoculation or a person going in for

a shot not be unnecessarily subjected to a deadly disease.

Ms. BURKHALTER. Yes, indeed it is, Senator Sessions. Thank you

very much for having me. I am not a doctor, actually, but thank

you for the promotion. I work for a lot of doctors, though. [Laughter.]

And I am privileged to say that Physicians for Human Rights,

over the course of the last several years, has put together an advisory committee of the preeminent HIV/AIDS experts in the United

States, most of whom are engaged in overseas activities involving

prevention, care, and treatment of the disease. They advise us and

I try as best I can to speak for them.

I am the chair of an informal network of nongovernmental

groups that has joined together—Dr. John is one of our members—

to promote safe health care, particularly in the context of HIV/

AIDS and other infectious disease transmissions. We are privileged

to be here and thank you very much for your kind attention to this

long-neglected issue.

I will be very brief. I have an extensive and detailed testimony

that I would appreciate having included in the record, and I thank

my research assistant, Eric Friedman, for his wonderful assistance

in producing it.

Senator SESSIONS. We will make that a part of the record.

Ms. BURKHALTER. Thank you, sir. I would note that even though

you have brought this issue to our attention in these times, it has

been on the agenda for some time, and the U.N. Declaration on

AIDS 2 years ago committed governments to having universal precautions available by the year 2003 and blood safety and injection

safety by 2005, but we are very far from achieving those goals, nowhere close to meeting it, upwards of half-a-million AIDS infec-
24

tions, at a minimum, from unsafe blood and unsafe injections, 20

million-plus hepatitis infections in health care settings. Only 13 of

some 46 countries in Africa with safe blood policies, 25 to 50 percent of blood units in Africa not screened for AIDS. You could go

on. Yvan Hutin is the expert and his recitation of what is left to

do was absolutely chilling.

Experts disagree on the numbers of transmissions, as you have

heard and as we know. But I think all agree that this is a form

of AIDS transmission that is completely preventable. It is not tolerated in rich countries. It is not tolerated in the West and I wonder

why it is tolerated in poor countries. Asian and African life are not

cheap, and 500,000, at a minimum, preventable transmissions

worldwide is not trivial. It is not a rounding error. It is not trivial.

It is not a write-off. Therefore, it is somewhat of a mystery to me

why there has been some opposition to engagement on this within

the international health establishment.

One of the possible explanations is fear that leaders and publics

in AIDS-burdened countries cannot address two issues simultaneously, the notion being somehow if the issue of safe health care

and ending unsafe injections and cleaning up the blood supply are

raised up in a very prominent way, that someone people will immediately begin to neglect safe sexual practices. I don’t see any reason

whatsoever why African governments and others can’t do exactly

what our government and Western governments have done, which

is, of course, both.

And you look at cases of some of the poorest countries in Africa,

such as Burkina Faso, where they have under their own leadership, for example, made nonreusable injection technology part of

their essential medicines list and reduced by a huge percentage,

from 50 percent unsafe injections to four percent. They did not neglect their safe sexual prevention programs in the context of doing

that. Nor did Senegal, for example, which has a very comprehensive blood safety and injection safety program. They did so without

neglecting other needed aspects of prevention. It should be promoted among all of the countries of high risk.

I have a number of recommendations to the U.S. Government

and I am not going to go through them now. They are all in the

testimony. But I would say that a lot of what the United States can

do is political. We can urge, for example, that when countries are

putting together their national strategies to apply for global AIDS

Fund funding, each one should include a safe health care provision.

Countries vary in terms of what they have. Some have safe

blood. Some have good education. But all countries should have a

plan and a request for technical assistance if they need it, as well

as supplies, in this area.

We can raise up this issue internationally. A good opportunity to

do so will be at the Bangkok AIDS meeting a year from now, in

July of 2004.

We can promote assessments in every country. It is cheap as can

be, $20,000 to do an assessment of safe or unsafe health care, to

allow governments, to encourage them to make these assessments,

to pay for them if we need to to identify the problems and craft solutions to them.
25

Encourage countries to include safe health care in their national

AIDS strategies. Promote education. Provide supplies and logistics.

I have a back-of-the-envelope costing for it if you would like to hear

from that.

I would just conclude by saying that 20 years into the AIDS pandemic, it is a disgrace that the world is so far behind the curve on

safe health care. I give you again as an example, Uganda has only

just recently called in experts, such as Dr. John, to help them develop a national safe blood and injection safety program. Uganda

is a model of national leadership on AIDS prevention. They have

long been held up as a model, quite rightly so. But many, many

years after they had developed the best practices with regard to

safe sex, they are only now developing national strategies to deal

with safe blood.

The rest of the world is far behind. It is proposed that India, for

example, one-quarter of the new infections from AIDS will be attributable to unsafe needles. The fact that this is still going on and

it is entirely preventable is just vital.

Let me just add one quick thing, though I know I am out of time.

It is really—and this should have been the focus of my remarks as

a human rights activist—it is really vital that universal precautions and safety of health care workers and doctors, no many

how many transmissions occur in health care settings, be held up

as a real goal, because much of the discrimination against people

with AIDS, including in the health professions, comes from people’s

fear of unwitting infection.

We recently carried out a very extensive survey of doctors and

nurses in Nigeria and asked them their attitudes about people with

AIDS, where there is much discrimination within the medical profession against people with AIDS. And much of their reluctance to

treat people with AIDS or to deal with them in a kind and humane

way, as they would any other patient, comes from their fear of

them and their fear of unwitting transmission.

When you are in health care settings where midwives are delivering ten babies a day and don’t have enough gloves, or you are

in a situation where doctors are hoarding their supplies, their injection equipment or their gloves or the protective gear, they are

hoarding it and only using it with people they think might have

AIDS, thus identifying them to people around them, this contributes to stigma and discrimination and it just should not be.

I would conclude to say that there are many ways that the world

falls short of affording the right to health that all people deserve,

but surely the most important among the right to health should be

people’s right to enter a health care setting and not come away

with a deadly disease from health care providers who are doing

their best in an environment of scarcity.

These are, as Yvan Hutin mentioned in the previous remarks,

among the most cost-effective interventions one can make to shore

up a beleaguered medical establishment that is fighting the worst

pandemic in human history and I am very pleased at the leadership you have provided that will put the United States in a leadership role. Thank you.
26

Senator SESSIONS. Thank you very much. I guess that great oath,

the first part of it is, first, do no harm. That is an important concept.

[The prepared statement of Ms. Burkhalter may be found in additional material.]

Senator SESSIONS. John Stover is the Vice President of Futures

Group, International, as well as a Director of the Group’s Connecticut office. In this capacity, he is responsible for computer applications and modeling and directs the Group’s efforts in the area of

HIV/AIDS.

Mr. Stover has substantial experience in developing and applying

population-related models in developing nations. He has published

articles on topics ranging from population and family planning to

AIDS modeling, intervention analysis, and demographic impact

analysis. In this field, he is noted for having developed an AIDS

impact model used to evaluate the effectiveness of AIDS interventions.

Mr. Stover, it is a delight to have you with us and to hear from

you at this time.

Mr. STOVER. Thank you very much for the opportunity to be here

today. Much of the work that I have been doing with colleagues at

U.N. AIDS, WHO, and other research institutions in the past couple years has focused on estimating what needs to be done now to

achieve the goals that we have all set for ourselves. The Declaration of Commitment of the U.N. General Assembly Special Session

on AIDS called for a 25 percent reduction in infection levels among

young people in the next few years. WHO has set a goal of having

three million people on ARV therapy by 2005. And the President’s

emergency plan for AIDS relief aims to prevent seven million new

infections, treat two million infected people, and care for ten million people and orphans in 14 priority countries.

So our work is focused on what is required to achieve those goals.

What do we need to do? And we have some good ideas of what we

need to do in the areas of care and treatment, in terms of expanding access to health care, providing more training for health care

providers, and expanding supplies of drugs, and changes in policies

and regulations.

We also have some ideas of what needs to be done to prevent

new infections. It is clear to us that no single intervention will be

enough, but that a comprehensive approach that reaches people

with different risks and with a variety of information and services

can be effective.

So we have looked—we have done an analysis, a country-bycountry analysis of 135 low- and middle-income countries to look at

the prospects for the future. Our analysis indicates that if current

trends continue, there will be about 45 million new infections between now and the year 2010, and that is what you see here on

this bar on the left part of the chart labeled ‘‘Baseline.’’ The majority of these new infections will be in sub-Saharan Africa, where

HIV prevalence levels are the highest, and also in South and

Southeast Asia, where populations are large and the epidemic is

growing rapidly.

But this somber projection is not inevitable. Our estimates indicate that the implementation of a comprehensive package of pre-
27

vention programs in these countries by 2005 would reduce the

number of new infections by 29 million, in other words, averting

about two-thirds of the infections that would otherwise occur.

This is shown in the second bar here, labeled ‘‘Expanded Response.’’ The benefits will be large in sub-Saharan Africa, where almost 60 percent of projected infections could be averted, and the

gains could be even larger in Asia, where early action can be especially effective.

Well, what do we need to do to achieve these results? In order

to achieve these, we need to expand the coverage of a variety of

HIV/AIDS services and information. We need to—our estimates assume that we can achieve relatively full coverage of some services,

such as mass media, AIDS education, treatment of sexually-transmitted diseases, voluntary counseling and testing, and coverage for

maybe two-thirds of the population for such services as condoms,

workplace interventions, programs for out-of-school youth, prevention of mother-to-child transmission.

Achieving these results will be a big effort, however, because

today, globally, perhaps only one in five people have access to these

important services, and in Africa, it is even less. Perhaps one percent have access to anti-retroviral therapy and programs to prevent

mother-to-child transmission. Only maybe about five percent have

access to voluntary counseling and testing, and 70 percent of infected people in sub-Saharan Africa don’t have access to even the

basic level of care as defined by the World Health Organization.

But we believe that we can achieve this and the next chart looks

at estimates of what it will require in terms of costs, financial resources, to achieve these goals. This represents resources from all

sources, so it is national governments, it is international and bilateral donors, it is also individuals and households. And from the

chart—I don’t know whether you can read that there, but you can

see the range of different services that we included in this analysis.

Total resources required will go from about $6 billion today to

$10 billion by 2005 and $15 billion or so by 2007. For Africa, the

resources will more than double, from about $2.5 billion today to

$5.5 billion by 2007. And for the 14 countries of the Presidential

initiative, requirements would double, from about $2 million today

to about—$2 billion today, sorry, to $4 billion by 2007.

The largest amount, as you may be able to see from this chart,

would be required for anti-retroviral therapy and treatment of opportunistic infections because these are relatively expensive. Support for orphans and vulnerable children also requires significant

funding. And in the area of prevention, the greatest needs are for

programs for youth, voluntary counseling and testing, condom programs, workplace programs.

The red line here is blood safety, and from the red line upwards,

you can see blood safety and safe injection, universal precautions,

and postexposure prophylaxis, which together in this estimate account for about four to five percent of total spending. I should mention that these figures look at countries with prevalence above one

percent. So countries with lower levels of prevalence would have

additional needs for safe injection and universal precautions that

are not shown here.
28

About half of the required resources are for prevention and half

are for care. Globally, this level of spending would provide prevention services for over 270 million people in low- and middle-income

countries and would provide needed care and treatment for an additional 13 million.

Senator SESSIONS. Mr. Stover, this crazy Senate is so frustrating.

Today has been one of the worst days of the year. But I have got

to do something that will take me 15 minutes. With great apologies, I would sincerely ask if you could suspend now. We will be

back in 15 minutes, and I have some questions I would like to ask

this panel also and allow you to elaborate in any way you would

like on the points you have made. It is very, very frustrating for

me to have to ask you to do this, but it is just one of those unavoidable things and I will try to be right back. Thank you.

We are adjourned for 15 minutes.

[Recess.]

Senator SESSIONS. I am just terribly, terribly sorry. You know,

the problem in the Senate is you never have time to think. You are

always being jerked around here or there. You are causing us to

think about policy and the billions of dollars that we will—new billions that we will be spending, in addition to the amounts of money

that people all over the world are spending on AIDS and we have

got to get it right. Lives are at stake.

Mr. Stover, I am so sorry to have interrupted you, but I shall be

pleased if you would complete your remarks.

Mr. STOVER. Thank you. I was actually just coming to the end,

so I will just say a couple of words.

One, on the issue of injection safety and blood safety, from the

figures that we have estimated here, if we look just at sub-Saharan

Africa, our estimates would be that the total requirement for injection safety and blood safety would be somewhere in the order of

maybe $130 million today, increasing to $250 million or so in the

next few years. That would be the total requirement. It wouldn’t

be the U.S. share of it. We would hope that lots of donors would

contribute to that.

But speaking of the total funding of $6 to $10 billion over the

next few years or increasing to $15 billion beyond that, we have

also tried to take a little bit of a look at what might be the fair

share of the U.S. to contribute to that total figure, because the total

figure includes national spending by national governments as well

as individuals and other donors. It all depends on the assumptions

that you make about how much national governments should be

paying for themselves and how you would allocate the international

share, whether using some formula based on the U.N. or WHO allocations or whatever. But generally, the figures come in around $2

to $3 billion today as the U.S. fair share and increasing to somewhere between $3.5 and 5.5 billion over the next 5 years.

So just to conclude, we recognize that the full implementation of

this expanded response presents many challenges. U.N. capacity to

deliver the required interventions needs to be scaled up greatly and

improved infrastructure will need to be developed to meet the demands of expanded services. Meeting these challenges will require

both financial and political commitment.
29

The costs of scaling up are great. However, without this effort,

we will not achieve our goals, and the costs of doing nothing are

even higher. So thank you very much for your attention.

Senator SESSIONS. Thank you very much.

[The prepared statement of Mr. Stover may be found in additional material.]

Senator SESSIONS. The President said—I was with him yesterday

in a private conversation and he made clear his commitment to go

beyond just prevention and that we are going to put money out for

treatment, life preserving, extending treatment, which is very, very

expensive.

Of course, as a doctor, Dr. Ssemakula, nothing good happens if

you contract that virus. The best thing is to prevent it if possible,

is it not?

Dr. SSEMAKULA. I quite agree, and one of the things that people

tend to forget, they are looking at providing these safe needles as

a curative thing. It is actually preventive in the sense that you are

preventing the person from getting an infection so they can infect

some other people. Sometimes also giving treatment, if it cures a

person, is also part of prevention. If a person has TB, you can prevent a person from getting TB by immunizing them, but if they actually contract the disease, you give them treatment and they don’t

go and infect another person.

In the case of anti-retrovirals, it is not a cure. It is the person

will always be infected for the rest of their lives, and until we get

some kind of cure, we will have to rely on methods that can prevent people from getting infected. One of these, of course, is behavioral sex, but the other is just a simple thing, safe needles. I mean,

that is such a simple thing that already exists. Unlike antiretrovirals, 16 billion injections already exist in existence. So you

can just provide this technology and change it to safe practices.

Senator SESSIONS. Does anybody else want to comment on that

subject? Ms. Burkhalter, why hasn’t more been done to address the

issues of blood safety and injections? What are your observations

as one involved but somewhat on the outside of the official program? I know you are not wanting to be critical, but let us be frank

about what is happening and what we can do.

Ms. BURKHALTER. Obviously, some of the best—the leading work

on this issue is done by the WHO in the form of Yvan Hutin, and

at the same time, the International AIDS Establishment from the

same institution, I think has been less in the forefront, and U.N.

AIDS perhaps has been less in the forefront. You don’t see, for example, in the kind of protocols of best prevention practices. This is

kind of the orphan stepchild.

I wouldn’t want to speculate, nor would I want to impugn either

medical professionalism or ethics of the principal actors. I do think

that there is such a well-meant concern about the principal mode

of transmission that there is a concern that if the message is to— and indeed, you can find quotations from WHO leadership saying

that if this message about safe sex is diluted, is diverted or diluted.

If attention is somehow turned to something else, that then there

will be careless with regard to safe sexual practices.

And I appreciate the attention to the very important means of

both behavior change and provision of supplies, particularly to
30

those most vulnerable to sexual transmission, as well, I might add,

to a neglected area of sexual transmission, which is violence, rape,

and trafficking. I appreciate it very much. But I think that this just

so obviously needs to be a part of what is considered to be bets

practice and it needs to be promoted as such and lifted up very actively, particularly among the health establishment that deals with

international AIDS.

You see, for example, that the immunization community has

really embraced this and led the safe needle, safe health care initiatives, but the AIDS community seems to think that this is a diversion or a red herring. I just think we need to take a look at

what Africans themselves are doing and what they are asking for

and then provide the kind of leadership in technical assistance and

procurement and supplies that will allow them to have what we

take for granted, which is safe health care.

Senator SESSIONS. I thank you for that. I guess you would agree,

and I am not one to claim that everything bad that happens in the

world is a human right, but when 170 kids go down to be given

an inoculation with the same needle, that is a right of humanity,

I think, to assume that those people giving those inoculations understand the dangers that are being risked and would not take

them. Those children come in entrusting their lives and their

health to a health care giver, and that is important.

You indicated, Ms. Burkhalter, that you had some, I think, backof-the-envelope numbers about what you thought it would take to

make some immediate inroads into this problem. Could you just

share with us your thoughts?

Ms. BURKHALTER. Well, this is just kind of—of course, they are

all based on Yvan’s work, so you should really get him up here, and

again—— Senator SESSIONS. Well, maybe we should. Maybe he should

come back up.

Ms. BURKHALTER. When I make a mistake, I will depend upon

him to correct me.

Senator SESSIONS. As a matter of fact—— Ms. BURKHALTER. John is really more expert than I, as well,

and——

Senator SESSIONS. Dr. Hutin, why don’t you pull up a chair, if

you will.

Ms. BURKHALTER. I will just start you off, sir, and then I can be

corrected when I make an error.

Senator SESSIONS. You can defend yourself, since they are talking about you.

Ms. BURKHALTER. We should take Mr. Stover’s advice, however,

and understand that there are multiple providers of foreign assistance and that governments themselves will want to and need to

take a leadership role. There are a whole bunch of these interventions that are virtually free—law, regulation, putting nonreusable

injection technology on essential medicines list. This is not costly

at all and it requires political leadership, and let us not overlook

that.

But just looking at what you asked for, which is what actually

is the cost for Africa, you can extrapolate a little bit from some of

what was already said today. I noted that Dr. Peterson described
31

the cost of putting together a safe blood program for Kenya was

$3.3 million. WHO has not yet released its own studies on what the

price tag for safe blood for Africa, though Yvan might want to give

us some under-the-table estimates.

But if you just extrapolate from what it cost for Kenya, $3.3 million, and I believe the EU provided safe blood—now, this is just one

component of the overall safe health care price tag, but we noted

in our testimony that the EU supported a Ugandan safe blood program that was $1.5 million. I don’t know. You can’t expect every

country’s cost to be the same, but it looks to me like a ballpark for a blood safety program might be somewhere from $2 to $3 million.

There are 14 countries identified on the President’s list, and you

can do the mathematics.

WHO has estimated that the price tag for the African region for

injection safety, which I had always assumed would be a very big

price tag, is actually very affordable, coming in at about $45 million. Dr. Hutin can give you the detail about what that includes,

but it does include provision of supplies as well as education and

training.

Senator SESSIONS. If you did those two things, if those two plans

would occur, I will ask you and Dr. Ssemakula and Dr. Hutin,

couldn’t we expect rather significant reductions in medical transmissions just by those two steps, even though there may be other

things that——

Ms. BURKHALTER. It seems important to me, we are neglecting— and don’t neglect universal precautions, which has a much bigger

price tag, and Yvan can explain where some of those costs come

from. But the injection safety and the blood safety will help you

keep your health providers safe. But we need to make sure we have

waste management, sharps disposal, gloves, and all the other protection for health care workers that is an added cost.

I will let Yvan take over from here, or—— Senator SESSIONS. Dr. Ssemakula?

Dr. SSEMAKULA. Yes. The introduction of that technology would

have tremendous effects. I take what Ms. Burkhalter said about

waste disposal and the management, and these were all the questions when I went to Uganda. All the health workers asked me,

how do we dispose of this? But at the same time, their concern was

having safe health care. That was the first and paramount thing.

They said, we will find a way of how to dispose of these things.

But we have this risk. Partly because they don’t have the opportunities like I have to tell people, the outside world about this, they

said, if you can tell people that we need this, it will have a tremendous effect.

I mean, for instance, the story I told you about people sharing

needles, I mean, that is just frightening. All it needs is one infected

person to share it, infect the entire family, infect the neighborhood.

I mean, that is all it needs. Just one auto-disable syringe can prevent that, and this will have a tremendous effect.

If you think about the number of people that have died in Africa

of HIV and AIDS over the past—let us not just talk—over the past

5 years, it is almost 15 million, and you just do an extrapolation

of how many could have been saved. And this is not just their lives,

their families and the orphans that have come as a result. This is
32

such a small cost and it is something that you don’t even have to

think about. The effect would be so much greater than just the

amount that is spent.

Senator SESSIONS. Let me congratulate Uganda for the good

work they have done. I had an occasion to meet with the first lady

of Uganda and get a briefing on what you have accomplished. It

is terrific and I am glad to see you step up to the plate on medical

transmissions.

Let me ask you. Do you think there are other areas in Africa

that are not as up-to-date as Uganda is today on medical transmissions and do you think many of them are operating as you were

years ago when you were operating there still?

Dr. SSEMAKULA. Oh, certainly. I lived in Nigeria for 5 years, and

that is where I first started my medical school. Nigeria is a much

larger country. It has much wider disparity and much more poverty

and their health care system is almost nonexistent in the rural

areas.

I know my friends who are doctors, we all know the same thing.

These are people I am talking to. And they said, yes, these practices go on. They go on there. And part of the problem is that they

are still very far behind Uganda in terms of opening up in HIV and

AIDS. So people are still operating in a complete environment of

ignorance, still practicing unsafe health care, unsafe practices, be

it behavioral or such.

There was a similar thing in Kenya, which should be more advanced than Uganda, but they still have the same problems, and

even in Tanzania, where I visited a couple of years ago. They still

had similar problems.

So I would say, taking Uganda as a model, then you take that

back to all the other African countries. You must realize that there

is a problem and we need to do something about it.

Senator SESSIONS. Dr. Hutin, would you like to make any general comments on what we have heard so far?

Dr. HUTIN. Two quick comments, the first one about what is currently the situation in Africa. In our paper, you have our estimates

of about 18 percent of injections being reused in the absence of

sterilization for sub-Saharan Africa. I just want to make a brief

comment about the reliability of this number.

This is based on ten systematic injection safety assessments that

we, WHO, coordinated in ten countries of the region. This is a

standardized WHO methodology where you go in a country, you

visit 80 health care facilities selected at random. You send an investigator there. You have health care workers who know they are

not supposed to be reusing injection equipment, and here, under

the eyes of the investigator, you will see that 18 percent of injections will be administered with reused injection equipment. That is

the history behind this number.

Senator SESSIONS. So you would say that is a conservative number?

Dr. HUTIN. That, I think, providing that we are using a methodology where it is direct observation of the health care worker

during an investigation, I am confident in saying that the reuse of

injection equipment is probably on the conservative side, because

you send an investigator where people are supposed to know they
33

should not reuse injection equipment, and here during an assessment they will do that in 18 percent of the cases. That, as I say,

is based on basically 80 health care facilities in each country times

ten. So we visited 800 health care facilities in Africa to come up

with that number in randomized fashion.

And I think that we are not talking about whether it is 2.5 percent or one percent or ten percent. I think that 20 years into the

HIV epidemic, knowing that roughly one injection out of five in Africa is given with a reused needle, is unacceptable. Nobody would

question these numbers would want to go in an African dispensary

and say, oh, the risk is small and I will take an injection with a

reused syringe because it is only one percent.

Senator SESSIONS. Wouldn’t it also be important to note that

when you talk about a country that may have a 30 percent infection rate, that reusing needles is even more dramatically risky

than in a country where the infection rate is much lower than

that?

Dr. HUTIN. Yes, of course, although what we have seen is that

because precisely the bulk of the transmission is caused by sex and

not by injection, sometimes the country with the highest prevalence

of HIV, such as the Southern cone of Africa, will not have the worst

practices. So the worst practices and the worst prevalence rate will

not necessarily match because the driver is elsewhere.

Senator SESSIONS. Ms. Burkhalter?

Ms. BURKHALTER. Could I just say something that hasn’t been

talked about very much, but it is a cheap intervention that I think

could actually have disproportionate value, and that is public education about unnecessary injections. Some of the data we looked at

showed that 70 to 90 percent of injections are unnecessary. Some

of these are given in the nonformal sector. You cannot drive people

out of these doctor bazaars, drive them out of the nonformal sector

by saying it is unsafe unless the formal sector is itself safe.

It is very important, the way that consumer demand for a clean

needle, a clean syringe being taken out of a sealed package can

itself drive the market. At the same time, you don’t want to create

a demand for something that literally doesn’t exist, but demand

creation can itself help take care of this problem.

I noted in something that Yvan has put together that is not even

released yet, but I was speaking with the WHO about this, there

is 100 percent awareness that dirty needles can cause HIV/AIDS

in the country of Romania. Why? Because of the terrible epidemic

of pediatric AIDS that occurred in that country because of this totally wacky medical practice that is completely unsupported by

modern medical literature of injecting sickly orphanage babies and

children with plasma and other vitamins and antibiotics and all

kinds of crazy stuff, but with blood during the Ceaucescu years

when Romania was completely cut off from international medical

discourse and all other kinds of, you know, sort of the modern

world.

Romania ended up with this extraordinary and totally anomalous

pediatric AIDS epidemic from children who were infected through

needles and blood in their orphanages. I know the medical doctor

at Baylor University who now manages a caseload over there of

800 kids who are on anti-retrovirals, and doing brilliantly, I might
34

add. But because of this terrible tragedy of medical transmission

in these hundreds and hundreds of children, everybody in Romania

knows about this and nobody in Romania would ever consent to

getting a shot from anything but a needle that came out of a package.

Accordingly, a very cheap intervention and one that AID knows

how to do, as well as a whole host of NGOs, is create this demand

for clean health care on the part of consumers. And I just think it

would help develop health infrastructure and help put the power

of safe health care into the hands of health consumers, which is

where it belongs.

Senator SESSIONS. Dr. Ssemakula, let me ask this. We heard Dr.

Hutin mention that there are markets in Southeast Asia where

people come in and just get shots as they go by and they are not

really official medical places. They don’t use medical standards and

they are not part of the government health care system. Do you

have those in Africa and is that likewise a difficult group to control?

Dr. SSEMAKULA. They do exist. It is not as organized, but in Africa, they do exist. As I said, in a lot of the patients who come to

see me in the hospital, I would ask them, have you received any

treatment, and they would say, ‘‘I have had an injection from a doctor.’’ Now, that doctor could be anybody. A lot of people just call

themselves a doctor. They will get a white coat from the hospital.

It could just be someone in the village and that is what they do

for a living, they give injections.

It could be water, it could be all sorts of substances. In some

cases, the children would come in poisoned. A lot of the injections

were for children because they frequently suffered malaria and

vomiting so they couldn’t swallow pills, or they had pneumonia.

But this practice exists, and they are a difficult group.

But the introduction of this technology, I mean, we tend to think,

because if you are really educated, you tend to think the people in

the village don’t have common sense. They do. They know what the

best drug is in the hospital, what the best practices are. They see

that you are using auto-disabled syringes, then they will have a

market. They will go to these people and say, look, I want the best

syringe, and they will force them to create that. It may drive the

price up, obviously, being a market, but it will introduce a better

practice even within these unsafe people, because if they want to

keep their market, they will have to use auto-disabled syringes.

Senator SESSIONS. Let me ask you this. I am a free market person, but what would happen if every country was provided a sufficient supply of needles for all the reasonably necessary injections

in the country, so that every clinic had an abundant supply of reusable needles. What incentive would there be for any health care

worker not to use a clean needle every time?

Dr. SSEMAKULA. There would be none. There is no excuse. It is

a simple thing. If the supply—that is what they say. If the supply

is there, they will use it. There will be no excuse at all. And, in

fact, it is criminal if they are doing otherwise.

Senator SESSIONS. In fact, the health clinic leaders and health

department leaders could impose discipline if people failed under

those circumstances.
35

Dr. SSEMAKULA. Yes.

Senator SESSIONS. And if they made that a clear message, in

your opinion, if the health care system and the governmental leaders and the WHO and all made this clear that these are standards

that cannot ever be violated, you always must use safe injections,

don’t you think that we could achieve pretty dramatic results with

this problem?

Dr. SSEMAKULA. I certainly think so. I mean, as I said, it is one

thing that a patient does not have control over, is what happens

to them in a clinic. That is incumbent on the doctor or the health

care provider and they must be providing the best health care. If

they don’t do that, then they are liable, and it must be made clear,

if the technology exists, it becomes part of policy, that if you fall

short of those standards, you must expect to be tried by the law,

whatever it is, be it in court or in the health care setting. But I

think that would have a tremendous effect.

Senator SESSIONS. Dr. Hutin, do you see any significant impediments to an immediate decisive action by governmental leaders to

strive to take the injection transmission mode down to zero and

spending the money and would it be a good use of their money?

Dr. HUTIN. As I said, a good use of the money, there is no question. The cost-effectiveness analyses support that. But even more

important, it is extraordinarily effective.

My colleague has just raised the issue of Romania, which in 10

years has wiped out the HIV transmission in the medical setting

because of a very strong consumer demand that came out of the big

scandal.

I would just like to share with a little bit more detail the story

of Burkina Faso. In 1995, there was an injection safety assessment

done by WHO and Burkina Faso that showed a high proportion of

reuse of injection equipment. In 2000, we redid it and we saw almost no reuse of injection equipment, much to our surprise, much

to the surprise of the people in Burkina Faso.

We tried to understand why, so we sent a consultant to try to

understand what had happened. What we found is the difference

between 1995 and 2000, in the meantime, the essential drug program had decided that in every health care facility, there would be

a community-based pharmacy and that the community-based pharmacy would make syringes available at low cost and only make the

syringes available in a country like Burkina Faso, which is one of

the poorest countries in the world, wiped out the reuse of syringes

and needles in the course of 5 years in such an easy and effective

way, if I may say so, that nobody was even aware that the problem

had been fixed before we did the assessment.

It was done as an essential drug common sense intervention, not

even to improve injection safety, because somebody in the Ministry

of Health said, we can’t send the penicillin to the dispensary without the syringes, and they fixed the problem in the course of 5

years. As I said, I am talking with one of the poorest countries on

the planet. So I think it can be done extremely easily.

Senator SESSIONS. Mr. Stover, you have really given us some insight into the complexity and the things that we need to do around

the world that could make a big difference in the AIDS fight. Do

you think we could come in with a targeted program less expensive
36

than yours focusing on the immediate low-hanging fruit situation

and make a big difference, and shouldn’t we act there even if we

are not able to do everything that needs to be done?

Mr. STOVER. I definitely do think that a program to promote injection safety and blood safety would be something worth doing and

it would make a large contribution. I think that perhaps the reason—one of the reasons that it hasn’t been done in the past is if

it is done as part of an AIDS program, in the past, AIDS programs

have been very under-funded. There has not been enough money

for anything. So it is not so much that people were against the idea

of injection safety. It is just that with so limited funds, you have

to decide, well, where will we put these limited funds, and the decision was not always to give the highest priority to injection safety.

I think that could also be true going forward in the future. But

the amazing thing that has happened in the last couple years is

that the total resources available for HIV/AIDS have expanded dramatically and the President’s initiative is a good example of that,

in which resources are not going to be the major limitation. If that

is true, I don’t think you will find any opposition to programs to

provide injection safety throughout the world. Everybody is going

to support that because it is an important component.

The fact that there will also be money for all the other things

that need to be done to address the AIDS pandemic makes it much

easier, but I don’t think there would be any objection from anybody

to pressing forward with that program, and it would have many

benefits, not only for HIV/AIDS, but also for other disease transmission and for—— Senator SESSIONS. Yes. We aren’t talking about hepatitis and—— Mr. STOVER. Absolutely. Absolutely.

Senator SESSIONS. Would either one of you like to comment on

the debilitation caused by hepatitis and the extent of that? I assume we have the same transmission rate numbers from needles

and blood transfusions, or relative numbers.

Ms. BURKHALTER. Much higher. Much higher for hepatitis. Dramatically higher——

Senator SESSIONS. Why would that be?

Ms. BURKHALTER. Some 20 million cases or something like that.

Senator SESSIONS. You have more cases, and therefore you would

be more likely when injected with a reused needle to be infected?

Is it transmitted as easily?

Dr. HUTIN. With respect to HIV, as I have said before, there is

a certain amount of uncertainty about the proportion of HIV that

comes from unsafe injections. That is why there has been this controversy.

With respect to hepatitis B and C, there is much less uncertainty, and I can say with a lot of confidence that for about a third

of hepatitis B in the world in developing countries comes from unsafe injections, about 40 percent of hepatitis C. In addition——

Senator SESSIONS. Those are stunning numbers.

Dr. HUTIN. Yes, and in addition—— Senator SESSIONS. Precautions for HIV would be just as effective

in reducing the hepatitis.

Dr. HUTIN. Yes. And in addition, we have solid evidence to say

that in countries where hepatitis C has become a huge problem,
37

like Egypt, for instance, this transmission has been very largely

driven by medical injections. Even industrialized countries that are

industrialized today that have had a lot of hepatitis C transmission

in the past, such as Italy and Japan, these outbreaks have been

driven by health care injections.

So the link between viral hepatitis and unsafe injections is even

clearer than for HIV, and this is actually the reason why this

whole injection safety initiative was initially spearheaded by the

Division of Viral Hepatitis of the Centers for Disease Control,

where I used to work before I came to WHO.

Senator SESSIONS. Very important numbers. I remember one

anecdote that was told, that in Russia, a group of people had been

infected with HIV and an investigation was conducted to find out

what happened, and they found 250 people infected from one dirty

needle transmission. Is that possible? Could the numbers be that

high? Dr. Hutin?

Dr. HUTIN. Yes. The capacity of hepatitis B to be transmitted

through unsafe injection is 100 times higher than the capacity of

HIV. In other words, if you have a patient who was infected with

hepatitis B, you use a syringe on this patient and then use it on

a second patient, the second patient has 30 percent probability of

getting hepatitis B, whereas for HIV we are talking 0.3 percent. So

hepatitis B and hepatitis C are viruses that are almost engineered

to be transmitted through syringes.

Senator SESSIONS. Dr. Ssemakula?

Dr. SSEMAKULA. I was going to say, yes, hepatitis B is a problem.

I mean, the focus, obviously, the overwhelming number of patients

we would see in Uganda were HIV and AIDS, but we used to see

a lot of people who were in the end stages of liver disease.

Senator SESSIONS. Tell me about the progression of hepatitis for

the patients you saw in Africa, what their life was like and how

it affected their quality of life.

Dr. SSEMAKULA. I mean, it was actually pathetic because there

was nothing we could do for them. We would see people in the end

stages of liver failure, because hepatitis, it is a disease that progresses much like HIV and AIDS. You can have it for many years

and then it manifests itself. It is a systemic disease. Your body begins to break down. And they would die much like AIDS patients.

There was nothing we could do for them. They would come in jaundiced, with fever, unable to look after them, and it was a similar

thing. We would just try and treat them and then they will die. It

is a problem, you know.

But, you see, we have been focusing on HIV and AIDS because

that has been the more immediate issue, but again, I say, if we can

protect people from any disease, then let us do it. This is what we

should be doing. We don’t want people to get infected in a health

care setting.

Senator SESSIONS. This has been a most fascinating discussion.

I have had occasion to talk with senior administration officials to

just share this general information that we are learning and met

with Mr. Tobias this morning and Dr. O’Neill at the White House

yesterday.

I believe that we need to, as the United States, be aggressive on

this issue, and I think if we can reach an accord with WHO and
38

the nations in Africa, if we work it correctly, we can have an impact on the number of people that are infected with AIDS and hepatitis. I don’t think there is any doubt about that, and it is a moral

imperative. The numbers we are hearing, Dr. Burkhalter, if you

take WHO numbers on needles and your numbers, $44 million I

guess U.S. AID came up, or that was WHO, on blood transfusion,

you are not looking at much over $100 million a year for doing

what would be the largest part, would you say, Dr. Hutin, dealing

with the largest part of the problem?

Dr. HUTIN. With respect to health care transmission of HIV, I

think it is fair to say that the bulk is caused by injection and transfusion. If we were to fix these two, we would fix the majority. Universal precaution, as was said, would cost more money for a smaller benefit in terms of HIV, but actually a huge benefit also for

other diseases, such as SARS, for instance. We have seen with

SARS how hospitals can actually be disease amplifiers. With the

implementation of universal precautions, you could actually address that, too, but maybe that is the purpose of another hearing.

Senator SESSIONS. There are a lot of factors. Am I incorrect, Dr.

Ssemakula, that I think you indicated that people who come into

the clinics are even more likely to be AIDS patients than the normal person who would be more healthy. So because they are ill,

they are more likely to come in, so you have a higher likelihood

that when you are reusing a needle, that you are taking it from a

person who may be infected than in the population as a whole.

Dr. SSEMAKULA. That is absolutely correct. And in that sense, I

heard this term ‘‘super-spreaders’’ from SARS, about how one person can infect a lot of people, and you have just mentioned—Dr.

Hutin has just mentioned that the health care setting can become

that. Because you have such a large number of HIV-positive people,

the likelihood—I mean, those studies done in Kenya a long time

ago about people who were getting infected from hospitals and the

likelihood was that much greater, the risk is that much amplified

because of the nature of the environment.

Ms. BURKHALTER. I don’t want you to—I don’t want any of us to

skip over the universal precautions because even if the immediate

impact on AIDS transmission is not as great as the bang for the

buck with the two identifiable, blood and injection safety, which I

strongly, strongly support directing funds toward, I do think it is

worth mentioning that the continent of Africa is losing its doctors

and nurses in very large numbers. They cannot graduate enough

new health professionals to even account for the brain drain that

is occurring because we are taking their health professionals to

work in our clinics and hospitals.

Those that are there, a dwindling number who themselves get

sick from a variety of means, but some of them get sick from needle-stick injuries, are just beleaguered. All their patients are dying.

They can only provide actual treatment to keep them alive for a

handful that can afford the ARVs. They are just psychologically

traumatized all the time and they are working way too hard and

they are scared of their patients and they are at risk. They don’t

have enough gloves to even deliver babies safely.

I just think that even though it is the more expensive piece, that

the public health model alone of maximum bang for the buck, we
39

need to also be aware of just the human costs on these front-line

activists who are trying to save their people from the worst epidemic in human history should not be avoided. Let us get better

cost estimates for what it would cost to work with med schools and

hospitals and clinics in Africa, work with suppliers, provide those

technical and systems management services like Anne Peterson

was providing in the East Cape to include distribution and dissemination and education of gloves and masks so we don’t have such

a terrible burden on these heroes.

Senator SESSIONS. Thank you very much. We certainly have not

focused on all the problems in dealing with the transmission of

AIDS in Africa. This is an issue I raised with Chairman Judd

Gregg and he urged me to have these hearings and pursue it and

see what we would discover. I think we have been affirmed in the

idea that we can do better and that it would save hundreds of

thousands of lives. I believe it is our responsibility to do so.

I thank all of you on the panel for your commitment to that.

Thank you, Ms. Burkhalter, for preparing a thoughtful paper,

which we will be looking at, on some of your ideas on a more comprehensive program. We shall continue to work on it. If you have

any suggestions, I would be pleased to receive them.

Ms. BURKHALTER. Thank you.

Senator SESSIONS. If there is nothing else, we are adjourned.

[Additional material follows.]
40

ADDITIONAL MATERIAL

PREPARED STATEMENT OF E. ANNE PETERSON, M.D.

SOLUTIONS TO THE HEALTH CARE TRANSMISSION OF HIV/AIDS IN AFRICA

Good morning. Thank you for inviting me to testify on the important topic of the

transmission of HIV/AIDS during medical care.

USAID recognizes that HIV and other infections do occur in medical settings.

Clearly, potential transmission is greatest in countries that have a high burden of

disease and poor quality of medical services. The higher the general HIV prevalence,

the greater the risk of transmission through all modalities will be. Risks of transmission by medical procedure will depend on local practices and implementation and

is widely variable. Utility and cost-effectiveness of any intervention depends on not

just the direct costs but system needs and how common the problem is.

Injection safety and medical best practices can play an important role in preventing unintentional spread of certain blood-borne diseases, including HIV, during medical care. I welcome the attention this committee is giving to this mode of HIV

transmission.

Not every contaminated injection transmits HIV. In the U.S. the post-exposure

transmission rate is 3 in 1,000 needle stick injuries for health care workers. Hepatitis is much more infectious. The extent of HIV transmission through other routes

in a medical setting in Africa are not nearly as well documented. I am sure later

testimony will give more detail, and we all look forward to the Centers for Disease

Control study on the relative contribution of medical setting transmission.

Proper safety procedures can reduce HIV transmission through transfusion of

blood products and contaminated needles. However, addressing healthcare safety in

much of the developing world is a complex endeavor that requires much more than

simply providing supplies. It includes behavior change among providers and patients, careful supply chain management, addressing poor distribution systems, poor

forecasting of supplies, inappropriate use of supplies by providers, and poor waste

management practices.

USAID is the implementation arm of the U.S. Government in foreign aid and development. I would like to describe USAID’s work in the areas of injection safety,

blood safety, safe delivery practices, and quality assurance.

USAID has a long history of strengthening health systems and improving the

quality and safety of health care in developing countries. USAID’s programs in child

survival, maternal health, infectious diseases, and HIV/AIDS have improved the

safety of medical practices through technological innovations, clinical training, policy guidance in best practices and appropriate protocols, and strengthened management and logistics systems. Most of these interventions are currently funded out of

our non-AIDS child survival budget but contribute to the prevention of HIV in medical settings.

Injection Safety

Over 16 billion injections are given every year in developing countries for immunizations, therapeutic purposes, transfusion of blood and blood products, and

injectable contraceptives. These injections, if contaminated with infected blood, can

transmit hepatitis B, hepatitis C, and HIV.

While there is significant variation between countries, WHO estimates that in

sub-Saharan Africa approximately 18 percent of injections are given with reused syringes or needles that have not been sterilized. However, unsafe medical injections

are believed to occur most frequently in South Asia, the Eastern Mediterranean,

and the Western Pacific Regions. Together, these account for 88 percent of all injections administered with reused unsterilized equipment.

USAID has been a global leader in support of immunization safety as part of comprehensive routine immunization programs in developing countries since the early

1980s and remains committed to injection safety. Raising the focus on immunization

safety is a top priority for USAID global health programs. USAID has provided leadership to change country policies and procedures to improve medical practices; promote behavior change by recognizing the role of unsafe medical practices; create a

research agenda to identify risk factors in poorly covered areas; reduce unnecessary

injections; and further work in technical development.

USAID has worked with its partners to document the extent of the unsafe injection practices and the cost-effectiveness of interventions to improve the safety of injections in the developing world. USAID’s efforts in this area led to the development

of the World Health Organization’s Safe Injection Global Network (SIGN). USAID

has provided technical assistance to SIGN to establish injection standards that are
41

not only scientifically sound, but which also are designed to change the behavior of

health care providers.

In addition, USAID through the Program for Appropriate Technologies for Health

(PATH), has developed and introduced single-use injection devices, and is currently

developing and introducing systems for safely disposing of contaminated needles.

Uniject, a new smaller single-use device, will reduce costs, medical waste, and the

risk of unintentional needle sticks. USAID is supporting research to expand the

number of injections that can be given with Uniject. USAID currently ‘‘bundles’’

Depo-Provera with a single use syringe and a safety box to improve the safety of

disposal.

Finally, USAID has been a lead partner in the effort which resulted in the Global

Alliance for Vaccine and Immunizations (GAVI). Five-year commitments to immunize children in the world’s poorest countries through the GAVI and The Vaccine

Fund topped $1 billion in July, bringing to 71 the total number of countries receiving support for health infrastructure, vaccines and supplies from The Vaccine Fund.

The U.S. contribution to The Vaccine Fund, GAVI’s financing arm, has increased annually, from $48 million in fiscal year 2001 to $53 million in fiscal year 2002 and

$58 million in 2003—resulting in a total U.S. contribution over the past three years

of nearly $160 million. GAVI is providing safe injection supplies to all of its participating countries as well as supporting the development of waste management plans.

GAVI has estimated commitments for support of $332 million for immunization

services support over 5 years and $77 million for injection safety over three years.

USAID was the instigator at the last GAVI meeting for insisting on a review of how

ISS funds are being used.

Blood safety

Each year, countless lives are saved through necessary blood transfusions, but

various limitations in how the blood is collected and tested put many people at risk

of infection with HIV. Interventions to make the blood supply safer have led to a

significant reduction in HIV transmission by blood transfusion in industrialized

countries, and USAID is working to extend these practices to the developing world.

In Kenya, USAID played a leadership role by helping the national blood safety

program address challenges to the blood supply, including problems of limited training and experience with blood transfusion science among health care personnel and

the need for quality monitoring. HIV transmission through unsafe blood transfusions was reduced through the system put in place by USAID/Kenya following the

1998 Nairobi bombing. The new system, made up of 5 regional blood transfusion

centers, trained staff, new equipment, policy guidelines, and donor recruitment activities, met its primary objective, preparedness for future disasters, by providing

safe blood to the victims of the Thanksgiving Day terrorist attack in Mombasa.

USAID continues to support the government of Kenya in developing its blood safety

program and blood transfusion services.

Through the new Safe Blood for Africa project, USAID will help develop a blood

collection and distribution center in Abuja, Nigeria to help combat the crisis of HIV

transmission through blood transfusion in Nigeria. USAID will provide funding for

staff, equipment, and review of operating systems and organizational structures. In

Abuja, blood services are severely understaffed, underfunded and are far from meeting standards for blood collection and distribution set out by the WHO. Not only

does the substantial probability exist for HIV infection from blood transfusion, but

also, adequate stocks of blood for routine medical requirements are not available.

USAID anticipates that this new project will significantly reduce the transmission

of HIV through blood transfusion in the area and increase the safe blood supply in

the Abuja Region. USAID support for this initiative will contribute to the long range

goal of implementing a National Blood Policy and establishing a Nigerian National

Blood Transfusion Service.

Major reasons for transfusion include severe anemia, malaria, or bleeding after

childbirth. A little recognized contribution to reducing HIV transmission is some

major changes in the rate of giving transfusions. We can substantially reduce the

number of transfusions through changing transfusion criteria, reducing the need for

transfusions by addressing delivery care and through our extensive malaria prevention and treatment programs.

Safe Delivery Practices

USAID supports two levels of HIV prevention during delivery care. The first level

is focused interventions for prevention of mother-to-child transmission, and the second is protecting medical workers from exposure by implementing proper sharps

disposal and universal precautions.
42

The USAID-funded Maternal and Neonatal Health Program works in 10 countries

in Africa on infection prevention practices for safe motherhood and newborn health.

We work at the national level on policies and standards which are then reflected

in curricula for pre-service and in-service training of health care workers, preparation of training sites, the development of job aids and supportive supervision systems. The program focuses on the prevention of mother-to-child transmission of HIV

(P–MTCT) and safe motherhood service delivery. In addition, we emphasize several

key infection prevention behaviors: injection safety, universal precautions, handwashing, clean, safe delivery, avoiding of unnecessary medical procedures, proper

sterilization of instruments, proper disposal of hazardous waste, and newborn umbilical cord care.

USAID funded the Program for Appropriate Technology in Health to test the feasibility of putting the drug oxytocin in Uniject pre-filled, auto-disposable injection

devices. Oxytocin effectively reduces bleeding following birth, the biggest cause of

maternal deaths. The use of the Uniject device to deliver oxytocin would make this

life-saving intervention even safer for patients and providers.

USAID is also a partner in the White Ribbon Alliance, an international coalition

that increases public awareness about the need to make pregnancy and childbirth

safe for all women and newborns. The Alliance disseminates technical information

on safe delivery practices, mobilizes communities, and calls attention to the needs

of HIV positive mothers.

USAID has also supported the development of protocols for postpartum hemorrhage and delivery by caesarian section.

QUALITY ASSURANCE IN MEDICAL CARE

Quality assurance can be defined as the development and promotion of cost-effective methods to strengthen health care services and systems. Examples of activities

include accreditation of facilities, supervision of health workers, or other efforts to

improve the performance of health workers and the quality of health services. Applying the principles of quality assurance to our work in the health care sector is

critical to ensuring that our programs are effective and do not cause risks to health

care workers or their patients.

USAID supports programs to introduce modern quality assurance practices into

the health systems of developing countries. In Zambia, we developed a hospital accreditation program, which included criteria for blood transfusion, infection control,

quality assurance activities, and incident reporting and analysis.

In Tanzania, our program supported a quality improvement collaboration in which

Tanzanian hospitals learn from one another’s experience in infection prevention and

the use of universal precautions during procedures.

USAID has supported studies of how the stigma of HIV/AIDS affects health provider behavior in Rwanda. As a result, we have made recommendations for the use

of post-exposure prophylaxis, protective equipment and other preventive measures.

In addition, USAID has supported infection prevention training programs in several countries around the world, including Malawi, Ghana, Kenya, Honduras, Guatemala, Nepal, Indonesia, Haiti, Senegal, Uganda, Guinea, Bolivia, Mali, Burkina

Faso, the Philippines, and the Ukraine. These courses include basics on disease

transmission, hygiene, processing instruments, safe injection practices, gloves and

other items (decontamination, cleaning, high-level disinfection, sterilization), and

waste disposal (a universal precautions approach to protect both healthcare workers

and clients/patients). The training on safe injection practices includes teaching

about how to dispose of needles and syringes safely using locally available resources.

The Development of the HIV/AIDS Epidemic in Africa

In addition to discussing medical transmission of HIV, I was also asked to address

the question of why the AIDS pandemic has affected Africa more severely than

other regions, and why are there such disparities between regions in Africa.We can

track the trends that differ between the regions but why the epidemic has followed

such different patterns is much less clear.

Most West African countries continue to have relatively low prevalence levels.

Meanwhile, in the newer epidemics of southern Africa, the prevalence has exploded

to nearly 40 percent in many countries. The highest prevalence countries are all located in southern Africa.

Although studies show a high rate of knowledge about HIV in Africa, there is a

very low rate of knowledge on how to protect oneself from acquiring HIV infection.

There is low prevalence of male circumcision in these countries. New, very strong

evidence shows an association of increased risk of HIV with not being circumcised.

Circumcision varies geographically and by tribal group in Africa and is a possible

contributing factor to the differences in the growth of the epidemic. Western Africa
43

has very high rates of male circumcision and southern Africa variable but generally

low rates of circumcision. Differing sexual practices may also contribute or strains

of HIV may be contributing factors.

Certainly, behavior change response to the epidemic (the ABCs: Abstinence, Behavior change, and correct and consistent Condom use) varies by country. Decreasing number of partners (being faithful) is beginning to look like the most important

factor in turning around the epidemic. USAID will soon be publishing a baseline

ABC study in six countries showing some of the contrasting behaviors.

Conclusion

In conclusion, I would like to emphasize that USAID is committed to HIV/AIDS

prevention. We will continue to ensure that risky medical practices, risky sexual behaviors, and mother to child transmission are all addressed as part of the overall

response to the HIV/AIDS pandemic. We look forward to being a key partner in implementing the President’s Emergency Plan for AIDS Relief and continuing to

achieve results in HIV/AIDS prevention, care, treatment, and support.

I believe very firmly that it will be impossible to do the prevention of mother-tochild transmission and treatment envisioned in the President’s initiative without

systems strengthening that will improve delivery care, drug and commodity logistics, and clinical protocols. All these improvements will directly impact and reduce

HIV transmission in medical settings.Thank you again for inviting me to speak on

this important topic.
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PREPARED STATEMENT OF YVAN HUTIN, M.D.

Mr Chairman, distinguished Members of the Committee, the World Health Organization (WHO) appreciates the opportunity to brief the Committee on the prevention of HIV through safe health care practices in Africa and appreciates the interest

of the Committee in this important public health issue.

Senator Sessions and Members of the Committee, the World Health Organization

in Geneva, Switzerland. WHO is an international organization—the technical specialized agency for health of the United Nations system—which currently has 192

Member States. The United States has been a member of WHO since it was founded

in 1948. As a clinician, I have experience in the care of individuals with HIV infection and viral hepatitis. As an epidemiologist, I served in the Epidemic Intelligence

Service of the United States Centers for Disease Control and Prevention. I am now

Project Leader of the WHO-based Safe Injection Global Network (SIGN) which is

an international coalition of stakeholders working together to make injections safe.

In addition to my statement, I have provided the Committee copies of two reports
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entitled ‘‘The cost effectiveness of national policies for the safe and appropriate use

of injections’’ and ‘‘Progress towards the safe and appropriate use of injections

worldwide, 2000-2001’’ and I request that these two reports be made a part of the

record.

A number of health care procedures may lead to the transmission of HIV. These

include (1) transfusion of infected blood, (2) unsafe injections and (3) other skinpiercing procedures performed in the absence of universal precautions. Thus, safe

health care services should offer to their users (1) selection and testing of blood donors, and when applicable, viral inactivation of human material for therapeutic use,

(2) safe and appropriate use of injections and (3) procedures conducted according to

universal precautions.

In Africa, for a population of 0.6 billion (10% of the world), only 2.4 million blood

units are collected annually against an estimated need of six million units. About

one-third of blood is donated by family replacement or paid donors considered at

high risk for HIV transmission, considering the incidence and prevalence of HIV in

Africa. In addition, 50% of collected blood is not tested either for HIV, HBV, HCV

or syphilis. The high efficiency of transmission of HIV through transfusion of infected blood (>90%) leads to a substantial burden of infection among transfused patients. For the remainder of this statement, I will focus primarily on the issue of

unsafe health care injections which I have been asked by the Committee to address.

WHO estimates that in developing and transitional countries, 16 billion health

care injections are administered each year (an average of 3.4 injections per person,

per year). This high figure, along with evaluation reports indicating inappropriate

use of injections, suggests that injections are overused to administer medications.

Causes of this overuse may include a preference for injections among patients. However, the most important cause is a desire by health care providers to satisfy what

is believed to be a preference for injections among clients. In fact, research suggests

that most patients are open to use of oral medications.

In addition to being overused, injections may also be administered by unsafe procedures and cause infections. A safe injection should not harm the patient, the

health care worker or the community. However, injections may harm the patient

when injection devices are reused in the absence of sterilization. Injections may

harm the health care workers when dirty needles are not collected in safety boxes.

Injections may harm the community at large when health care facilities are surrounded by sharp health care waste—mostly dirty syringes and needles. Reuse of

injection devices in the absence of sterilization is the problem of greatest concern

that we have to address as to leads to the largest burden of disease. A mathematical

model developed by WHO suggests that in 2000, in developing and transitional

countries, reuse of injection devices accounted for an estimated 22 million new infections with the hepatitis B virus (a third of the total), two million new infections with

the hepatitis C virus (40% of the total) and 260 000 new HIV infections (5% of the

total). These infections acquired in 2000 alone are expected to lead to an estimated

nine million years of life lost (adjusted for disability) between 2000 and 2030.

There has been a recent controversy over the role that unsafe health care injections play in the transmission of HIV infection in sub-Saharan Africa. While WHO

estimates that, worldwide, about 5% of all HIV infections are transmitted through

unsafe health care injections, this estimate is only 2—5% for sub-Saharan Africa.

Although there is uncertainty around these figures, WHO and our sister program,

UNAIDS, believe that they are in the right order of magnitude and that the vast

majority of HIV infections in sub-Saharan Africa are transmitted via unsafe sexual

practices.

This public health issue may appear daunting. Yet, evidence indicates that the

death and disability associated with unsafe injections are highly preventable. First,

interventions conducted to improve communication between patients and doctors

and interventions to improve prescriptions through monitoring of providers have

proven effective in decreasing injection overuse. Second, interventions to ensure injection device security (i.e., make single-use syringes available reliably in each

health care facility) are effective in preventing reuse of injection devices. Some of

the poorest countries in the world have actually achieved substantial progress

through ensuring that all injectable medications are made available with sufficient

quantities of single-use syringes and needles.

In addition to being highly effective, policies and plans for the safe and appropriate use of injections are a sound investment in Health: In the scientific paper

that I presented to the Committee as part of my statement, WHO has estimated

that interventions implemented in 2000 for the safe andappropriate use of injections

would have cost $102 per year of life saved (adjusted for disability). This cost is

under the threshold of one year of average per capita income in developing countries

used by the WHO Commission on Macroeconomics and Health as a criterion for an
49

intervention to be considered very cost-effective. Thus, implementation of safe and

appropriate use of injections as part of HIV prevention and care programmes is

highly desirable and can be accomplished with only a modest shift in the assignment of resources for two reasons:

(1) Injection safety is not a costly intervention. The scientific paper on the cost

effectiveness that I submitted to the committed as part of my statement includes

estimates of what it would cost to ensure injection safety in each of the world’s regions;

(2) The large majority of HIV infections worldwide are caused by unsafe sexual

practices, thus the emphasis of HIV prevention programmes must remain on preventing sexual transmission.

Among prevention opportunities, single-use injection devices with reuse-prevention features deserve a special mention. These have been also referred to as autodisable or auto-destruct syringes. These syringes that inactivate themselves after

one use through plunger blocking, plunger breaking or needle retraction are now the

norm in immunization services and are becoming the norm in other international

donor and lender-supported services (e.g., family planning and tuberculosis treatment). In addition, promising new single-use syringes with reuse-prevention features have now been developed for general curative services. These devices now require field evaluation to define their future role in public health.

Since the establishment of the Safe Injection Global Network (SIGN) at WHO in

1999, great progress has been made towards the safe and appropriate use of injection worldwide. In the progress report that I have attached as part of my statement,

you will see that the government of the United States has supported WHO’s effort

in this area through the Centers for Disease Control and Prevention (CDC), the

United States Agency of International Development (USAID) and the United States

National Vaccine Program Office (NVPO). Additional support will be needed in the

future to prevent death and disability through key interventions at country level.

Four key interventions are needed for injection safety:

(1) Increasing the awareness of the population regarding the risk of HIV and

other infections associated with unsafe injections;

(2) Making sure there are sufficient quantities of single-use injection devices and

safety boxes in every health care facility where injections are administered;

(3) Ensuring that all donors and lenders who support the supply of injectable substances in developing and transitional countries also support the provision of injection devices with reuse-prevention features and safety boxes;

(4) Managing the waste associated with dirty syringes and needles in a safe and

appropriate way.

Four key interventions are needed for blood transfusion safety:

(1) Establishment of a nationally-coordinated blood transfusion service;

(2) Collection of blood only from voluntary non-remunerated blood donors from

low-risk populations;

(3) Testing of all donated blood, including screening for transfusion-transmissible

infections, blood grouping and compatibility testing;

(4) Reduction in unnecessary transfusions through the effective clinical use of

blood, including the use of simple alternatives to transfusion.WHO appreciates the

opportunity to brief the Committee on this important issue. I thank you for your

attention and I will be happy to answer questions you may have on this subject.
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1See Declaration of Commitment on HIV/AIDS, United Nations General Assembly Special

Session on HIV/AIDS (UNGASS), adopted June 27, 2001, at para. 51-52. Available at: http://

www.un.org/ga/aids/coverage/FinalDeclarationHIVAIDS.html. 2See Anja M. Hauri, Gregory L. Armstrong & Yvan J. F. Hutin, ‘‘Contaminated injections in

health care settings.’’ In M. Ezzati et al. (editors) Comparative quantification of health risks:

global and regional burden of disease attributable to selected major risk factors (Geneva: World

Health Organization, 2003) (attributing 260,000 HIV infections in 2000 to unsafe medical injections); World Health Organization, Department of Blood Safety and Clinical Technology, Blood

Safety Clinical Technology Progress 2000-2001, 2002, at 1. Available at: http://www.who.int/bct/

Main—areas—of—work/Resource—Centre/General—docs/BCT%20Progress%20Report.pdf (estimating that 5-10% of new HIV infections are caused by unsafe blood transfusions). In 2002,

there were 5 million new HIV infections. See UNAIDS, Estimated number of adults and children newly infected with HIV during 2002, Dec. 1, 2002. Available at: http://www.unaids.org/

worldaidsday/2002/press/EpiCoreSlides2002/EPIcore—en/Slide5.GIF. Since 5% of 5 million

equals 250,000, unsafe blood transfusions cause at least 250,000 new HIV infections every year.

Therefore, at least half a million new HIV infections from unsafe blood transfusions (250,000)

and unsafe medical injections (260,000) occur every year. 3See A. Kane et al., ‘‘Transmission of Hepatitis B, Hepatitis C and Human Immunodeficiency

Viruses through Unsafe Injections in the Developing World: Model-Based Regional Estimates.’’ Bulletin of the World Health Organization (1999) 77(10): 801-807, at 803 (estimating 8-16 million hepatitis B and 2.3-4.7 million hepatitis C infections every year from unsafe medical injections); Anja M. Hauri, Gregory L. Armstrong & Yvan J. F. Hutin, ‘‘The Global Burden of Disease

Attributable to Contaminated Injections Given in Health Care Settings.’’ International Journal

of STD & AIDS (2003) (in press) (estimating 20.6 million hepatitis B and 2.0 million hepatitis

C infections every year from unsafe medical injections). 4See J.B. Tapko, Workshop of the Directors of National Blood Transfusion Services, May 2-

5, 2000, Harare, Zimbabwe, at 1. Available at: http://www.afro.who.int/bls/pdf/blsworkshop1.pdf.

PREPARED STATEMENT OF HOLLY BURKHALTER

Thank you, Mr. Chairman, for holding this important hearing. I am honored to

be here. My name is Holly Burkhalter, and I am the Director of U.S. Policy for Physicians for Human Rights, a Boston-based human rights organization. Since forming

our ‘‘Health Action AIDS’’ campaign two years ago, Physicians for Human Rights

has engaged in extensive activities to mobilize the medical, nursing, and public

health communities in the United States to confront the global HIV/AIDS pandemic.

Our Health Action AIDS advisory board includes this country’s leading specialists

in HIV/AIDS prevention, care, and treatment, many of whom are engaged in overseas programs.

A particular focus of our work on the global HIV/AIDS pandemic is to promote

‘‘best practices’’ to prevent the transmission of the disease, as well as the right to

care and treatment. Best medical practices in preventing transmission of AIDS include providing access to education, counseling, testing, and prevention supplies, especially for those in high-risk groups. It also includes protecting women and girls

from violent transmission of AIDS through rape and sexual violence and enhancing

their right to education, health care, and legal equality.

The topic of today’s hearing—assuring that the disease is not transmitted in

health care settings—is a ‘‘best practice’’ in preventing HIV/AIDS and other disease

transmission that has been, for the most part, overlooked by the international AIDS

establishment, by governments of AIDS-burdened countries, and by wealthy donor

nations. Thanks to your interest, Chairman Sessions, and the pioneering work of

such leaders as Yvan Hutin, who is with us at today’s hearing, the issue is now

being given the prominence that it deserves. It is our hope that these hearings will

contribute to the United States becoming a leader in promoting safe health care and

integrating injection safety, universal precautions, and a safe blood supply in all

health programs.

It is important to note that the issue of preventing HIV/AIDS infections in health

care settings has been identified by the United Nations. The June 2001 U.N. General Assembly Special Session on HIV/AIDS final document, the Declaration of Commitment on HIV/AIDS, called upon all countries to implement universal precautions

in health-care settings to prevent transmission of HIV infection by 2003 and to implement a wide range of prevention programs by 2005, including sterile injecting

equipment and safe blood supply. 1 Yet it is now the year 2003 and this year—and

every year—at least half a million people will become infected with HIV/AIDS

through unsafe medical injections and blood transfusions, 2 and approximately 8.0-

20.6 million people will become infected with hepatitis B and 2.0-4.7 million with

hepatitis C because of unsafe medical injections. 3 A report cited at a 2000 World

Health Organization (WHO) meeting of directors of national blood transfusion services in Africa stated that only 13 of 46 countries in the WHO African Region had

implemented national blood safety policies. 4 The financial, political, and technical
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5See Anja M. Hauri, Gregory L. Armstrong & Yvan J. F. Hutin, ‘‘The Global Burden of Disease Attributable to Contaminated Injections Given in Health Care Settings.’’ International

Journal of STD & AIDS (2003) (in press). 6See L. Simonsen et al., ‘‘Unsafe Injections in the Developing World and Transmission of

Bloodborne Pathogens: A Review.’’ Bulletin of the World Health Organization (1999) 77(10): 789-

800, at 792. Available at: http://www.who.int/bulletin/pdf/issue10/simonsen.pdf. 7See World Health Organization Regional Committee for Africa press release, Ensuring blood

transfusion Safety in Africa, Aug. 27-Sept. 1, 2001. Available at: http://www.afro.who.int/press/

2001/regionalcommittee/rc51004.html.

support required for the development of safe health care in the developing world has

not begun to keep pace with the commitments reflected in the UNGASS document.

Some AIDS experts have expressed reluctance at acknowledging the importance

of unsafe injections, in particular, for fear that attention to this widespread problem

in Africa and Asia will divert attention from safe sex education and condom promotion and dissemination. Interestingly, no WHO or UNAIDS official ever admonished rich countries for addressing the problem of iatrogenic HIV/AIDS transmission

in health care settings, where even one such infection is cause for serious investigation and correction of the problem. This is the attitude that should be assumed towards iatrogenic HIV/AIDS infections in poor countries. Each case of an HIV infection in a young child whose mother is HIV negative, or in sero-discordant,

monogamous couples should be the cause of concern and immediate investigation,

and national governments, donors, and international development agencies should

make the wholly preventable transmission of HIV/AIDS and other infectious disease

through unsafe needles and blood and occupational injuries a top priority.

WHO’s latest estimates indicate that 17-19% of injections in Africa are unsafe, 5

though other studies estimate higher levels of unsafe injections. 6 WHO’s Regional

Office for Africa reported in 2001 that about 25% of blood units transfused in subSaharan Africa are not screened for HIV, more than half of the units are not being

screened for hepatitis B, and 81% are not being screened for hepatitis C. 7 Yet because of a lack of emphasis on the importance of assuring injection and universal

precautions, it may well be the case that many poor governments are not aware that

they have a problem. A review of nearly all of the proposals of the 90-plus countries

that have received funding from the newly-formed Global Fund to Fight AIDS, Tuberculosis and Malaria, found only one—Ethiopia—requested funding for implementing universal precautions.

Poor countries, like their Western counterparts, are fully capable of absorbing a

variety of prevention best practices and virtually eliminating iatrogenic transmission without diverting attention and resources from prevention of sexual transmission. In Burkina Faso, for example, single-use syringes were included on the

country’s essential medicines list and within five years, the proportion of non-sterile

injections in health care settings plunged from 50% to 4%. In Senegal, experts were

invited to develop a comprehensive safe injection system, and have done so without

neglecting other aspects of HIV/AIDS prevention, including safe sex education and

programs.

Addressing health care transmissions of HIV, besides preventing new infections,

will help counter something nearly as deadly—discrimination against people living

with HIV/AIDS. Doctors, nurses, and midwives who are at risk of needlestick injuries or who are delivering babies without gloves are afraid of patients with HIV/

AIDS and sometimes refuse them health care. Alternatively, health care workers

whose supply of gloves, masks, sterile needles, and other equipment is limited sometimes adhere to universal precautions only for those suspected of having HIV/AIDS

or segregating them. Such measures, in the context of a disease that carries with

it immense social stigma, contributes to discrimination against people with HIV/

AIDS.

The United States can play a vital role in helping eradicate medical transmissions

and discrimination in health care settings. This testimony includes detailed recommendations on many aspects of safe health care, including specific activities and

infrastructure to fund. One of the most important things the U.S. Government can

do, however, will be to raise the issue of safe health care within international agencies and insist that ‘‘best practices’’ to eliminate disease transmission to and from

health care workers in the workplace, to assure injection safety and a clean blood

supply, and promote public education to discourage unnecessary injections be included in prevention strategies and programs.

DISEASE TRANSMISSION IN HEALTH CARE SETTINGS

In countries with common unsterile conditions in health care, public and professional education and selected items and logistical support are required to establish
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8See World Health Organization, Managing an Injection Safety Policy (2003), at 7.

9See World Health Organization, Online documents on Health-care waste management, http:/

/www.healthcarewaste.org/htmlpages/onlineDoc.html. Accessed July 27, 2003. 10See Ethiopia Country Coordinating Mechanism, The Global Fund proposal to reduce HIV/

AIDS and malaria in Ethiopia, July 2002, at 30. Available at http://www.globalfundatm.org/proposals/round2/files/ethiopiahivuk.doc.

new standards of safety that will decisively stop transmission of HIV and other

blood-borne pathogens in health care settings. The components of a comprehensive

program are well understood and include infection control ensuring safe injections

and other health care procedures, universal precautions to protect healthcare workers and their patients, and safe blood. Injection safety and blood safety are among

the most cost-effective HIV prevention interventions.

The high proportion of unsafe and unnecessary injections in many developing

countries, where as many as 70%-90% of injections are unnecessary, means that

public education and health care worker training to ensure that injections are both

safe and appropriate are crucial. A safe injection strategy should also ensure adequate supplies of new syringes through health facilities and pharmacies, and should

include sharps waste management. A complete program for infection control requires attention to other health care procedures such as dental care and minor operations, where sterilization is crucial.

Universal precautions, simple infection control measures to protect health care

workers and their patients, require both a consistent and sufficient supply of protective gear and adequate training.

Blood safety, which has already been achieved in at least several low-income

countries, requires a national transfusion service, a system to recruit voluntary, unpaid donors, blood screening, and the appropriate use of blood transfusions.

Using the best available estimate from WHO, the annual global cost of a global

injection safety program is $905 million ($45 million in WHO’s African Region), decreasing significantly over time as fewer inappropriate injections are administered.

Ministries of public health will contribute, and particularly in the private and informal sectors, some of the cost of increased injection safety will be borne by consumers

aware of the importance of sterile care. Donors also have an important role to play,

both because of the resources they can direct at the problem and through their leadership and technical expertise. Based on UNAIDS estimates, the incremental global

cost of blood safety is about $200 million per year, and the incremental cost of implementing universal precautions in countries that have an HIV prevalence of more

than 1% is about $600 million in 2004, increasing to about $1.1 billion in 2007.

ASSESSMENT AND PLANS FOR INJECTION SAFETY AND OTHER INFECTION CONTROL

A first step for any country where sterile health care practices may be spreading

HIV and other blood-borne pathogens is to assess its own situation with respect to

injection safety. The World Health Organization (WHO) has developed several survey guides—or tools—to assess injection safety. Perhaps the more important of the

two generates nationally representative quantitative information on injection practices in health care facilities, and can be completed in about 3 weeks at a cost of

$20,000. The other tool, which costs about $10,000 to use, provides a more qualitative analysis. 8 A health care waste management rapid assessment tool also exists. 9

WHO does not have an equivalent tool for universal precautions and other aspects

of infection control, though at least one country, Egypt, has developed several assessment tools. A proper assessment is important for developing sound policy. By

highlighting the very fact that a problem exists, an assessment may also be crucial

in generating political will to address the problem. Ethiopia, for example, has pioneered using the Global Fund to Fight AIDS, Tuberculosis and Malaria to support

the implementation of universal precautions. Ethiopia drafted national guidelines on

universal precautions and sought funding from the Global Fund to begin to implement the guidelines because a rapid assessment of injection practices found that

30% of injections were unsafe. 10

While injection equipment security, health care provider training, and public education are all elements of a safe injection strategy, different countries have varying

capacities in these areas, and therefore have different needs. There is no single ideal

distribution of funds between these areas; a flexible approach is required. Countries

should develop injection safety strategies and strategies to minimize other health

care exposures to HIV and other blood-borne pathogens. WHO, through the Safe Injection Global Network (SIGN), has an excellent guide to helping countries formulate national injection safety strategies, including budgeting, in their booklet ‘‘Man-
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11WHO, Managing an Injection Safety Policy (2003). 12See World Health Organization, Online documents on Health-care waste management,

http://www.healthcarewaste.org/htmlpages/onlineDoc.html. Accessed July 27, 2003. 13 Ethiopia, the only country that we are aware of to have included injection safety in a proposal to the Global Fund to Fight AIDS, Tuberculosis and Malaria, had conducted an injection

safety assessment in 2000. The assessment revealed a 30% syringe re-use rate, a likely

motivator for policymakers to include universal precautions, including injection safety, in the

country’s second round application to the Global Fund. 14See Safe Injection Global Network (SIGN), Annual Meeting Report, 30-31 August 2002,

2001, of HIV with not being circumcised. Circumcision varies geographically and by tribal group

in Africa and is a possible contributing factor to the differences in the growth of the epidemic.

Western Africa has very high rates of male circumcision and southern Africa variable but generally low rates of circumcision. Differing sexual practices may also contribute or strains of HIV

may be contributing factors.

aging an Injection Safety Policy.’’ 11 WHO has also developed draft guidelines on developing a national action plan on health care waste management. 12

To help ensure that national policies on blood safety, universal precautions, and

injection safety are implemented, countries should guarantee blood safety, universal

precautions, and injection safety through their legal systems, whether through legislation or regulation. It is critical that sufficient resources be allocated to these areas

if the legislation or regulation is to be successful. For example, Amit Sen Gupta,

an Indian doctor, told us that India’s rigorous blood safety legislation can have a

negative impact of making blood unavailable in some areas. Clinics in many rural

areas, without the resources to ensure safe blood as required by Indian law, often

have no blood available for transfusions. To be successful, a blood policy must be

designed so as to meet a country’s need for blood transfusions—while minimizing

that need through rational clinical use of blood transfusions—while ensuring that

all blood that is transfused is screened for HIV and other blood-borne pathogens.

And the policy must receive the resources required to succeed.

Recommended U.S. action: The United States should encourage countries to assess their injection safety situation, as well as that of other aspects of universal precautions. In advising countries on developing HIV/AIDS strategies, for example,

U.S. agencies can encourage countries to conduct an injection safety assessment

and, based on findings, to develop a safe injection strategy. If needed, the United

States can provide funding for these assessments. Along with the value of assessments in forming policy, by revealing a lack of injection safety, they can motivate

countries to address injection safety. 13 The United States, whether through its own

initiative or as part of a World Health Organization (WHO) or other multilateral

initiative, should develop, or help develop, an inexpensive and rapid assessment tool

that countries can use to evaluate their situation with respect to universal precautions not addressed by the injection safety assessment guides. The Egyptian instruments could be a useful starting point. This tool should be made widely available.

The United States government can also provide technical assistance in helping

countries develop laws and adequately budget programs on blood safety, universal

precautions, and injection safety. A related and inexpensive undertaking that the

United States could take through field offices of USAID, the CDC, and other relevant agencies that could ease national efforts to develop legislation and regulation

on blood safety, universal precautions, and injection safety, as well as on numerous

other AIDS-related legislation and regulations, would be to develop a database for

these and other AIDS-related laws and regulations. No such central database now

exists. Such a database, which should be easily accessible to the public, would be

very useful in national efforts to develop critical legal tools to ensure sound and effective HIV/AIDS policy.

INJECTION EQUIPMENT SECURITY

Ensuring that sufficient quantities of safe injection equipment, including new single-use syringes, new needles, and safety disposal boxes, are consistently available

at all points of injection is central to an injection safety strategy. In Burkina Faso,

WHO attributes a rapid fall in the proportion of unsafe injections through the late

1990s—50% of injections were unsafe in 1995, down to 4% in 2000—primarily to increased availability of single-use syringes because they were included in Burkina

Faso’s essential drugs program. 14

Certainly, behavior change response to the epidemic (the ABCs: Abstinence, Behavior change, and correct and consistent Condom use) varies by country. Decreasing number of partners (being faithful) is beginning to look like the most important

factor in turning around the epidemic. USAID will soon be publishing a baseline

ABC study in six countries showing some of the contrasting behaviors.
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Conclusion

In conclusion, I would like to emphasize that USAID is committed to HIV/AIDS

prevention. We will continue to ensure that risky medical practices, risky sexual behaviors, and mother to child transmission are all addressed as part of the overall

response to the HIV/AIDS pandemic. We look forward to being a key partner in implementing the President’s Emergency Plan for AIDS Relief and continuing to

achieve results in HIV/AIDS prevention, care, treatment, and support.

I believe very firmly that it will be impossible to do the prevention of mother-tochild transmission and treatment envisioned in the President’s initiative without

systems strengthening that will improve delivery care, drug and commodity logistics, and clinical protocols. All these improvements will directly impact and reduce

HIV transmission in medical settings.Thank you again for inviting me to speak on

this important topic.

PREPARED STATEMENT OF JOHN STOVER

Thank you for the opportunity to be here today to address the important issue

of confronting the global HIV/AIDS epidemic. I will focus my remarks on the goals

we have set for ourselves, what needs to be done to achieve those goals, and the

cost of implementing these programs.

Goals

Much of the work that my colleagues and I have done in the past couple of years

has focused on estimating what needs to be done to achieve the goals we all have

set for ourselves. The Declaration of Commitment of the UN General Assembly Special Session on AIDS calls for a 25 percent reduction in infection levels among young

people in the next few years. WHO has set a goal of having 3 million HIV-infected

people on ARV (anti-retroviral therapy) by 2005. The President’s Emergency Plan

for AIDS Relief aims to prevent 7 million new infections, treat 2 million HIV-infected people and care for 10 million infected people and orphans in 14 priority

countries.

How Will We Achieve These Goals? What Needs To Be Done now and how

Much Will it Cost?

We do have a good idea of what needs to be done to achieve the care and treatment goals. We need to expand access to health care, provide more training for

health care providers and expand supplies of drugs and equipment.

We also have a good idea of what needs to be done to prevent new infections. It

is clear that no single intervention will be enough, but a comprehensive approach

that reaches people with different risks with a variety of information and services

can be effective. A comprehensive approach includes mobilization of communities

and civil society, behavior change interventions, service delivery (such as treatment

for sexually transmitted infections, condoms and voluntary counseling and testing),

medical precautions, care and treatment, and mitigation of the impact of AIDS on

orphans and other vulnerable children.

We have done a country-by-country analysis for 135 low and middle-income countries to look at the prospects for the future. Our analysis indicates that if current

trends continue there will be about 45 million new HIV infections between 2002 and

2010. You can see that figure in the first bar of the chart, labeled ‘‘Baseline.’’ The

majority of these new infections will be in sub-Saharan Africa, where HIV prevalence levels are the highest, and in South and South-East Asia, where populations

are large and the epidemic is growing rapidly.

But these projections are not inevitable. Our estimates indicate that the implementation of a comprehensive prevention package in these countries by 2005 would

reduce the total number of new infections by 29 million, averting about 2⁄3 of the

infections that would otherwise occur. As shown in the second bar in the chart, labeled ‘‘Expanded Response,’’ the benefits will be large in sub-Saharan Africa where

almost 60 percent of projected new infections can be averted. Note that the gains

could be even larger in Asia, where early action will be especially effective.

Effects of delay

It is important to expand our prevention efforts as rapidly as possible. Delayed

implementation will lead to large reductions in the benefits. Just a 3-year delay in

achieving full implementation of this program would reduce the total number of new

infections averted by 2010 by 50 percent.

What Do We Need To Do To Achieve This Result?

These results can be achieved by expanding the coverage of HIV/AIDS services.

In our estimates we assumed that full coverage would be achieved in high preva-
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lence countries for programs such as mass media, AIDS education, treatment of sexually transmitted infections, voluntary counseling and testing, safe blood and safe

injections. Coverage of 50–60 percent was assumed for services such as condoms,

workplace interventions, out-of-school youth and prevention of mother-to-child

transmission of HIV.

Achieving this result will require a large effort. Currently the coverage of key

services is very low in most countries. We estimate that fewer than 20 percent have

access to basic prevention services. In Africa the figures are even lower:

• Only 1 percent have access to anti-retroviral therapy.

• Only 1 percent have access to ‘‘Prevention of mother to child transmission’’ programs.

• Only 6 percent have access to voluntary counseling and testing.

• 70 percent do not receive even the basic level of care as defined by the World

Health Organization.

What Will It Cost?

The second chart shows you our estimate of the total resource required to achieve

these goals between now and 2007 by year and by program. This represents resources from all sources: national governments, individuals and households, bi-lateral and multi-lateral donors, foundations and the Global Fund.

From the chart you can see the range of programs considered and the relative

funding required by each.

The resources required will increase from about $6 billion today to $10 billion by

2005 and $15 billion by 2007. For Africa the resources required will double from

$2.6 billion today to $5.5 billion by 2007. For the 14 countries of the Presidential

Initiative, requirements will double from just under $2 billion in 2003 to $4 billion

by 2007.

The largest amount will be required for anti-retroviral therapy and treatment of

opportunistic infections. Support for orphans and vulnerable children will also require significant funding. In prevention, the greatest funding needs are for programs for youth, voluntary counseling and testing, condoms and workplace programs. About 4 percent is required for safe injections and universal precautions.

Through 2005 about half of the resources are needed for prevention and half for

care and treatment. After that, the share required for treatment increases as more

people are maintained on ARVs. Eventually the share for care and treatment will

decrease as the prevention efforts reduce the number of new infections.

Globally, this level of spending by 2005 would provide prevention services for over

270 million people in low- and middle-income countries and would provide needed

care and treatment for an additional 13 million.

How Much Is Currently Available?

We do not know exactly how much funding is currently available for HIV/AIDS

programs in these countries. But our best estimate is that of the $6 billion needed

today, about $4 billion is actually available. This includes about $2.6 billion from

bi-lateral and multi-lateral international donors, $0.5 billion from national governments and nearly $1 billion from household and employer-financed spending. Thus

there is currently a gap of nearly $2 billion dollars that will only grow larger in

the next few years unless we can mobilize significant new resources.

How Much Funding Should the U.S. Provide?

Various estimates of the ‘‘fair share’’ the United States should contribute to the

global need can be developed depending on assumptions about how much developing

countries can and should pay themselves and how the international contribution is

allocated. Our calculations suggest that the U.S. share should range somewhere between 25–35 percent of the total. This translates into $2.0–2.8 billion today and

$3.7–5.2 billion in 2005.

The Cost of Doing Nothing

We recognize that the full implementation of this expanded response presents

many challenges. Human capacity to deliver the required interventions needs to be

scaled up greatly and improved infrastructure will need to be developed to meet the

demand of expanded services. Meeting these challenges will require both financial

and political commitment.

The costs of scaling up programs as indicated here are large. However, without

this effort we will not achieve our goals of rolling back the AIDS pandemic. The

costs of doing nothing are even higher.

Thank you for you attention.
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[Whereupon, at 1:19 p.m., the committee was adjourned.]

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