[Senate Hearing 108-294]
[From the U.S. Government Publishing Office]



                                                        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


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

                  JUDD GREGG, New Hampshire, Chairman

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

                  Sharon R. Soderstrom, Staff Director

      J. Michael Myers, Minority Staff Director and Chief Counsel

                                  (ii)




                            C O N T E N T S

                               __________

                               STATEMENTS

                        THURSDAY, 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)

  

 
  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 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.
    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.
    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.
    U.S. AID has also been very involved in the technology 
development, the development of the auto-destruct syringe, so 
the single-use 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.
    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 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 anti-retroviral 
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.]
    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 
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 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 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 reuse-
prevention 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.
    [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.
    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.
    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.
    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.
    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 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 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 auto-destruct. 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 become 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 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.''
    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-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.
    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 infections, 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.
    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.
    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-by-
country 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 
prevention 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.
    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.
    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 anti-retrovirals, 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 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, 
back-of-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 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 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 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 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.
    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 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, 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 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 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.]

                          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 
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.
    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, hand-washing, 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 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-to-child 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 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 
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 skin-piercing 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 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 auto-disable 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.





















                 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 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.
---------------------------------------------------------------------------
    \1\ See 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.
    \2\ See 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.
    \3\ See 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).
    \4\ See 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.
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    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 sub-Saharan 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.
---------------------------------------------------------------------------
    \5\ See 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).
    \6\ See 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.
    \7\ See 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.
---------------------------------------------------------------------------
    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 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\
---------------------------------------------------------------------------
    \8\ See World Health Organization, Managing an Injection Safety 
Policy (2003), at 7.
    \9\ See World Health Organization, Online documents on Health-care 
waste management, http://www.healthcarewaste.org/htmlpages/
onlineDoc.html. Accessed July 27, 2003.
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    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\
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    \10\ See 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.
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    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 ``Managing an 
Injection Safety Policy.'' \11\ WHO has also developed draft guidelines 
on developing a national action plan on health care waste management. 
\12\
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    \11\ WHO, Managing an Injection Safety Policy (2003).
    \12\ See World Health Organization, Online documents on Health-care 
waste management, http://www.healthcarewaste.org/htmlpages/
onlineDoc.html. Accessed July 27, 2003.
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    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.
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    \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.
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    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\
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    \14\ See 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.
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    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-to-child 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 prevalence 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.

    
    
    
    
    [Whereupon, at 1:19 p.m., the committee was adjourned.]

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