[Senate Hearing 110-803]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 110-803
 
          MEETING THE GLOBAL CHALLENGE OF AIDS, TB AND MALARIA

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


                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                                   ON

EXAMINING THE GLOBAL CHALLENGE OF HIV/AIDS, TUBERCULOSIS, AND MALARIA, 
  FOCUSING ON THE PRESIDENT'S EMERGENCY PLAN FOR AIDS RELIEF (PEPFAR)

                               __________

                           DECEMBER 11, 2007

                               __________

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


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                                 senate



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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

               EDWARD M. KENNEDY, Massachusetts, Chairman

CHRISTOPHER J. DODD, Connecticut     MICHAEL B. ENZI, Wyoming,
TOM HARKIN, Iowa                     JUDD GREGG, New Hampshire
BARBARA A. MIKULSKI, Maryland        LAMAR ALEXANDER, Tennessee
JEFF BINGAMAN, New Mexico            RICHARD BURR, North Carolina
PATTY MURRAY, Washington             JOHNNY ISAKSON, Georgia
JACK REED, Rhode Island              LISA MURKOWSKI, Alaska
HILLARY RODHAM CLINTON, New York     ORRIN G. HATCH, Utah
BARACK OBAMA, Illinois               PAT ROBERTS, Kansas
BERNARD SANDERS (I), Vermont         WAYNE ALLARD, Colorado
SHERROD BROWN, Ohio                  TOM COBURN, M.D., Oklahoma

           J. Michael Myers, Staff Director and Chief Counsel

           Katherine Brunett McGuire, Minority Staff Director

                                  (ii)



                            C O N T E N T S

                               __________

                               STATEMENTS

                       TUESDAY, DECEMBER 11, 2007

                                                                   Page
Kennedy, Hon. Edward M., Chairman, Committee on Health, 
  Education, Labor, and Pensions, opening statement..............     1
Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming, 
  opening statement..............................................     3
    Prepared statement...........................................     5
Dybul, Mark, Ambassador, U.S. Global AIDS Coordinator, 
  Washington, DC.................................................     7
    Prepared statement...........................................    10
Gerberding, Julie, Director, Centers for Disease Control and 
  Prevention, Washington, DC.....................................    18
    Prepared statement...........................................    21
Zulu, Princess Kasune, HIV/AIDS Educator, World Vision, Federal 
  Way, Washington, DC............................................    43
    Prepared statement...........................................    44
Hearst, Norman, Professor, University of California San 
  Francisco, San Francisco, CA...................................    44
    Prepared statement...........................................    45
Smits, Helen, Vice Chair, IOM Evaluation Committee, Washington, 
  DC.............................................................    46
Piot, Peter, Executive Director, UNAIDS, Switzerland.............    47
    Prepared statement...........................................    48

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
        Edward C. Green, Harvard University......................    59
        Response to questions of Senators Kennedy, Enzi, Dodd, 
          Clinton, Brown, and Coburn by Mark Dybul...............    62
        Response to questions of Senator Kennedy by Princess Zulu    79
        Reponse to questions of Senators Kennedy, Enzi, Dodd, and 
          Brown 
          by Helen Smits.........................................    79
        Response to questions of Senators Kennedy, Enzi, and Dodd 
          by Peter Piot..........................................    84

                                 (iii)


[[Page (1)]]



          MEETING THE GLOBAL CHALLENGE OF AIDS, TB AND MALARIA

                              ----------                              


                       TUESDAY, DECEMBER 11, 2007

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:00 a.m., in 
Room SR-325, Russell Senate Office Building, Hon. Edward M. 
Kennedy, chairman of the committee, presiding.
    Present: Senator Kennedy, Brown, Enzi, Isakson, Allard, and 
Coburn.

                  Opening Statement of Senator Kennedy

    The Chairman. We'll come to order. The hearing this morning 
is on the reauthorization of the President's Emergency Plan for 
AIDS Relief, PEPFAR. And I thank all of our witnesses and our 
colleagues on the committee for joining us at a busy time.
    There are many issues before us that have wide ranging 
affects on vast numbers of people. But few are as consequential 
as our response to the global HIV/AIDS epidemic where entire 
societies are at risk. Sometimes history is changed by great 
leaders, by wars, by scientific breakthroughs and sometimes 
history is transformed by something as tiny as a virus.
    We have seen the devastating effects of HIV/AIDS on our own 
shores with our own citizens. The fight against HIV/AIDS here 
at home continues as we are reminded that our responsibilities 
here at home are far from over. But we also know that in recent 
years the HIV virus has affected the lives of millions of 
people across the globe. It's destroyed families, even whole 
villages. It threatens the well being of entire nations.
    At times this disease has brought out the worst in mankind. 
Children orphaned by AIDS have been deprived of their rights. 
Women and girls have been shamefully exploited. And millions of 
people living with HIV/AIDS have faced stigma, fear and 
discrimination.
    But we've also seen the best in mankind. Nation after 
nation has pledged to help. Scientists have devoted their lives 
to finding better ways to prevent and treat AIDS. Doctors, 
nurses and other health professionals that work tirelessly in 
cities and towns and villages across the world to give hope and 
help to persons living with AIDS.
    But the true heroes of this global challenges are those 
that struggle with the epidemic everyday. The parents who fight 
to provide a better life for their children, the grandparents 
who take on the

[[Page 2]]

unexpected responsibility of caring for children whose parents 
have been lost, the millions of people who face their 
extraordinary challenges with quiet dignity and unshakeable 
determination. We're here to help these heroes win their battle 
for a better, healthier life for themselves and for their 
children.
    We must set ourselves the goal that within our lifetimes we 
will be able to say no child was left an orphan by AIDS today. 
No life was cut short by this dread disease. Our Nation has 
stepped forward and applied our resources and expertise, not 
only to combat HIV in our country, but for people around the 
world. And I commend President Bush for launching the PEPFAR 
Global AIDS Initiative to help meet these challenges and for 
joining Democrats and Republicans in calling for its renewal.
    PEPFAR and our contributions to the Global Fund have made a 
real difference in the lives of millions of people. PEPFAR 
currently supports treatment with life saving antiretroviral 
drugs for nearly 1\1/2\ million people. The program supported 
services to prevent mother-to-child transmissions of HIV for 
over 10 million pregnancies and has provided help for 2.7 
million orphans and vulnerable children.
    We must build on these successes and examine where the 
program needs improvement. With our colleagues on the Foreign 
Relations Committee we have a special responsibility in this 
task since so many of the key elements of PEPFAR are within our 
scope.
    We're honored today by Julie Gerberding, the leader of the 
CDC, with us today to help provide her insight and 
recommendations. And we are also honored to join with the U.S. 
Global AIDS Coordinator, Dr. Mark Dybul. We are joined today by 
an extraordinary panel of witnesses who bring important 
perspectives to inform our discussion.
    Our work in evaluating this program has been assisted by 
the thoughtful analysis of expert bodies such as the Institute 
of Medicine that have examined the PEPFAR program and made 
recommendations for improvement. One major conclusion from all 
these reviews is that the rigid funding allocations included in 
the original legislation hamper the flexibility that is 
essential in a program that spans the globe. We must examine 
how generic medicines become eligible for funding under PEPFAR. 
At the time of the original legislation, Senator McCain and I 
offered an amendment to require PEPFAR to adopt the same 
standards that other major donors use. Our amendment was 
rejected but the PEPFAR program has since acted to improve the 
use of genetic drugs and our committee must determine whether 
this process is working effectively to bring safe and low-cost 
medicines to the people who need them.
    Finally, the challenge in renewing PEPFAR is to make the 
transition from short-term emergency response to a long-term 
sustainable initiative. This means many things including 
investing in effective prevention efforts and finding ways to 
assist other nations in strengthening their health systems. The 
President has called for $30 billion for PEPFAR in the years to 
come. Many experts believe that this is insufficient to meet 
the need.
    Nations around the world are calling on us to act and act 
quickly to renew the promise of PEPFAR. We are answering that 
call. Our

[[Page 3]]

hearing is part of an extensive process of consultation that 
our committee has undertaken to prepare for the 
reauthorization. Our colleagues on the Foreign Relations 
committee have been just as diligent.
    It's our intention to take action on this important 
responsibility as soon as possible in the New Year. 
Reauthorization will be a bipartisan inclusive process. Senator 
Enzi has a strong commitment to renewing and improving PEPFAR 
and the same commitment is shared by the members of the 
committee on both sides of the aisle.
    We also look forward to working with Senator Biden, Senator 
Lugar and all our colleagues from the Foreign Relations 
committee. Most of all we look forward to learning from the 
real experts, those who work everyday to improve the lives of 
persons with HIV/AIDS. To facilitate our discussion, we're 
convening in a roundtable format.
    After Senator Enzi makes his comments we'll hear from the 
testimony of our two Administration witnesses, Julie Gerberding 
and Mark Dybul and we will then have a period of questions for 
these witnesses. On conclusion of that period I'd like to 
invite our extraordinary panel of outside witnesses to join our 
roundtable, make brief comments, introduce themselves to the 
committee. And I hope that our Administration witnesses will 
join us in this discussion which will be informative with their 
comments.
    I'll close with my thanks to all our witnesses many of whom 
have changed plans to travel great distances to be with us 
today. Their commitment is the most eloquent testimony to the 
importance of the task before us. Thank you all for joining us 
today. We look forward to your recommendations.
    Senator Enzi.

                   Opening Statement of Senator Enzi

    Senator Enzi. Thank you Mr. Chairman. And I thank you for 
holding this hearing. The global challenge of AIDS, 
tuberculosis and malaria quite properly reaffirms our 
commitment in Congress for a global response to these terrible 
diseases. Anything less would not get the job done.
    I would ask that my full statement be a part of the record.
    The Chairman. It will be a part of the record.
    Senator Enzi. I remember when the President shocked all of 
us at a State of the Union speech when he suggested that we 
ought to put $15 billion into AIDS. I'm sure the Democrats and 
the Republicans were both shocked for a different reason, but 
we were both shocked.
    [Laughter.]
    And that was a lot of money. And so it drew a lot of 
interest in Congress and there were a lot of people working on 
it. In May 2003, the Senate passed the President's Emergency 
Plan for AIDS Relief and it was a breakthrough piece of 
legislation that underscored our commitment to bring relief to 
the nations fighting the high infection rate of diseases. And I 
don't think we really had any idea at that time how infectious 
or how universal or how distressing the whole problem could be.
    After we passed the bill there were a number of us that 
were sent to Africa to take a look at the problem. That's often 
how Con

[[Page 4]]

gress does things. Solve it and then we go look at it. And I've 
got to tell you that it was terribly shocking to me. I found 
out that the two fastest growing businesses in Africa were 
funeral parlors and coffin makers. In some of the countries 
they didn't have enough wood to go around so they were saving 
newspapers to make paper mache coffins and re-using the 
coffins.
    I don't know how anyone could see these things and not feel 
changed. We came back pleased that we were doing something and 
fortunately we were able to take that action and make a 
difference. But we struggled with how to provide additional 
funding and how to take care of things.
    When we were in South Africa, we met with the Health 
Minister who thinks that it's an American plot to eliminate 
Africans. And she suggests that lemon juice and garlic are a 
solution for the pill that she personally sells. We talked to 
traditional healers and they had learned some things about 
AIDS. They found out that they shouldn't bleed two people with 
the same knife.
    We learned about the mother-to-child transmission of the 
disease and found that there is a cure for that but it has a 
lot of requirements with it. And one is that the mother have 
the tablet at the time she goes into labor and then the child 
being able to get a liquid dose at the time that the baby is 
born. We in the United States anticipate that most babies are 
born in a hospital. In Africa, the difficult cases are all 
deliveries in hospitals. As soon as the baby is born, they 
leave.
    So we found some different methods for getting that to 
them, but there's a previous problem that exists with it and 
that's testing for HIV/AIDS in the first place. And it is 
important to keep a faith-based concept as a part of HIV/AIDS. 
They were the ones providing solutions at that time.
    We visited an orphanage that the Salvation Army was running 
and there were 32 beds around the room. I asked how many kids 
were being treated for AIDS, they said five. I asked how many 
should be treated for AIDS. They kind of danced around the 
answer. Later the doctor caught up with me and he said you 
realize that any child that's not being treated for AIDS will 
die before they're 5 years old? So out of those 32 the 
Salvation Army has had to select the five that are going to get 
to live. And that's the kind of thing that we can change with 
this legislation.
    We also found that most countries don't have the sexual 
harassment laws that we have in the United States and that it 
leads to more problems with AIDS. And when the husband finds 
out that there's a problem the woman is beaten up and thrown 
out of the house. Consequently people in other countries don't 
test for AIDS so it's difficult to know who needs the AIDS 
drugs.
    There's a lot of stigma that's involved with it. Uganda has 
solved the problem best. But that's because the leaders of that 
country took an active role. They got the test, publicly and 
eliminated a lot of the stigma. One bad thing that we learned 
on the trip was that the NGOs from the United States were 
hiring up the providers in these other countries as fast as 
they could, even before the legislation went into effect, which 
caused a shortage of providers that had been taking care of 
AIDS in those countries.

[[Page 5]]

    I want to add a final note about Bill Gates and a hospital 
that he had over there that was just jammed packed with people. 
Other places that we visited hardly had any patients and we 
wondered what the difference was. The difference was 
transportation.
    They bought a bunch of Suburbans. The Suburbans have been 
remodeled. There were benches down the two sides and a double 
bench down the center. And the driver got up each morning and 
drove 50 to 100 kilometers picking people up and taking them to 
this hospital. They put them in one end of these double wide 
trailer houses and later in the day after they had received 
their prescription, picked them up on the other end and deliver 
them back to their house. And every day he drove a different 
route over a 2-week period.
    Transportation. We take that for granted in this country. 
But in the countries with these kinds of problems, you can't 
take that for granted.
    I'll have a lot more comments as we go on through this, but 
as we work to re-examine the legislative framework that has 
been successful we have to maintain a high level of 
accountability for the results. While some have stated that 
there needs to be more flexibility in the program, any 
additional flexibility must come with corresponding 
accountability to make sure our tax dollars are being spent 
wisely and efficiently because that's the only way we'll be 
encouraged to put more into the program. And make our fight 
against global HIV/AIDS successful.
    I look forward to hearing from the witnesses today. And I 
hope this hearing will provide a strong start to our efforts to 
re-examine these key programs. And I thank the Chairman for 
this roundtable format. It brings us a lot more information 
sometimes than we get from just a regular hearing. Thank you, 
Mr. Chairman.
    [The prepared statement of Senator Enzi follows:]

                   Prepared Statement of Senator Enzi

    Today's hearing about the global challenge of AIDS, 
tuberculosis and malaria quite properly reaffirms our 
commitment in Congress for a global response to these terrible 
diseases. Anything less just would not get the job done.
    It wasn't all that long ago, May 16, 2003, when the Senate 
passed the President's Emergency Plan for AIDS Relief. At the 
time, it was a breakthrough piece of legislation that 
underscored our commitment to bring relief to those nations 
fighting a high infection rate of these diseases. AIDS, 
tuberculosis, and malaria threatened to claim unthinkable 
numbers of people.
    When this legislation was passed, there was still some 
uncertainty as to how well it would work. Some thought that the 
treatment it would provide would not be enough. Others thought 
that the stigma that comes along with being identified as an 
AIDS patient would doom efforts to fail. Still others were 
certain that prevention and education wouldn't make a 
difference in those countries and would fail to increase 
awareness among the population.
    It has been nearly 5 years since Congress took that vital 
first step to address the global epidemic facing far too many 
nations of the world. Now we have a legislative framework from 
which we can build and improve upon those early efforts. We 
have a program in

[[Page 6]]

place that has been successful in supporting community outreach 
activities to educate nearly 61.5 million people and make them 
aware of the importance of preventing the transmission of these 
diseases and teach them how to keep themselves safe and 
infection-free. It has provided antiretroviral prophylaxis for 
HIV-positive women to deal with over 500,000 pregnancies, which 
has helped to avert more than 100,000 infant HIV infections. It 
has also funded life-saving antiretroviral treatment for nearly 
1\1/2\ million men, women and children.
    In the years since we passed that landmark legislation I 
have had a chance to visit Africa and see firsthand how efforts 
are progressing to deal with that disease throughout the 
continent.
    I will never forget the people I spoke to and the concerns 
and comments they made to me about their fear of these 
diseases. As you can imagine, they are worried about things 
like losing their insurance if they are diagnosed with AIDS. 
Apparently that is common in high incidence AIDS countries.
    In addition, we found that the two fastest growing 
businesses are funeral parlors and coffin makers. Namibia 
doesn't have enough wood to go around, so people save their 
newspapers so coffins can be made of paper mache.
    How could anyone see things like these and not feel 
changed? We all came back wanting to do something. Fortunately, 
we were able to take action several years ago that has begun to 
make a difference.
    Today, the hope of the people of those countries is again 
centered on us, and their belief that we will renew our 
commitment to fight HIV/AIDS. We must increase our assistance 
to them so that their children and their children's children 
might be safe from these terrible diseases.
    Initially, I struggled with how quickly we could provide 
additional funding so we could scale up new programs to address 
the need that grows larger every day. Now, we are moving from 
that quick scale up to a more sustained response. In that 
sustained response, we must better share information among 
those who are providing HIV prevention, care and treatment. For 
instance, we need better linkages between the Department of 
Labor's work with employers to de-stigmatize the disease and 
help them stay connected to testing and treatment 
possibilities.
    We must also increase the connections between the various 
HIV programs and other key developmental programs that are 
designed to provide food, clean water, safe roads and 
transportation, among other programs. The global AIDS programs 
cannot be responsible for general development activities. 
Rather, it must retain its focus on providing HIV prevention, 
care, and treatment. However, it will be most successful if it 
links to those other key development programs.
    Finally, as we work to re-examine the legislative framework 
that has been so successful, we must maintain a high level of 
accountability for results. While some have stated that there 
needs to be more flexibility in the program, any additional 
flexibility must come with corresponding accountability to make 
sure our tax dollars are being spent wisely and efficiently, 
and our fight against global HIV/AIDS is successful.

[[Page 7]]

    I look forward to hearing from the witnesses today. I hope 
this hearing will provide a strong start to our efforts to re-
examine these key programs.
    The Chairman. Thank you. We call the roundtable the Enzi 
format. This is really developed by Senator Enzi. And we look 
forward to our witnesses. I see my friend, Mike Kiscowitz, 
who's in the back who remembers that the first HELP AIDS 
funding was $5 million that we offered in 1987, I think. So 
we've made progress in terms of resources, still a ways to go. 
Listening to Mike Enzi reminds us of the challenges that are 
out there and we look forward to our witnesses we have this 
morning.
    They're well known, but I'm going to include the brief 
comment of both, that they certainly deserve the recognition. 
Ambassador Dybul serves as the U.S. Global AIDS Coordinator. 
Before coming to the Coordinator's office, Ambassador Dybul 
served on the Planning Task Force for the Emergency Plan. He 
continues to be the staff clinician in the laboratory in NIAID-
NIH, maintains an active role as the principle investigator for 
clinical and basic research for U.S. international protocols, 
emphasis on HIV therapy.
    Dr. Julie Gerberding has been the Acting Director of CDC 
since 2002. Before becoming CDC Director, Dr. Gerberding was 
Acting Deputy Director of the NIH National Center for 
Infectious Disease. She played a major role in leading CDC's 
response to the Anthrax bioterrorism events of 2001.
    Prior to coming to CDC, Dr. Gerberding was a faculty member 
at the University of California, San Francisco, directed the 
Prevention Epicenter in a multidisciplinary research, training, 
and clinical service program that focused on preventing 
infections in patients and their healthcare providers. She's 
been a great public servant. And has been of enormous value and 
help to our committee on a wide range of health measures.
    So we're delighted to have a very distinguished panel. And 
we'll ask if you'd be ready to proceed, Ambassador?

     STATEMENT OF AMBASSADOR MARK DYBUL, U.S. GLOBAL AIDS 
                  COORDINATOR, WASHINGTON, DC.

    Ambassador Dybul. Thank you very much, Mr. Chairman, 
Senator Enzi, members of the committee. It's a great pleasure 
for me to be here my first time before this committee. We 
greatly appreciate the long standing effort of this committee 
and its members and staff in support of HIV/AIDS, in particular 
for this committee hearing, Global HIV/AIDS.
    It's a great pleasure to be on a panel with Dr. Gerberding 
who represents the Department of Health and Human Services. The 
Secretaries, both Secretary Leavitt and Thompson--I've been 
privileged to travel with them to Africa. I have a deep 
commitment to HIV/AIDS. And HHS joins a strong interagency 
program with USAID, with the Department of Defense, the Peace 
Corps, Department of Labor, bringing the full expertise of the 
U.S. government together in an interagency way to combat global 
HIV/AIDS.
    And through this strong interagency effort and actually 
outside commentators have called it one of the best, if not the 
best, interagency efforts our government has engaged in right 
now. By bringing all this expertise together we are tackling 
HIV/AIDS in around

[[Page 8]]

120 countries around the world through bilateral programs which 
is part of the Emergency Plan, but specifically in 15 focus 
countries. And those 15 focus countries, 12 in Sub-Saharan 
Africa, Vietnam, Haiti and Guyana represent half the disease in 
the world. It's rather remarkable that 15 countries have 50 
percent of the disease. And so we're particularly focused 
there.
    But this strong bilateral program is not just a bilateral 
program. This interagency approach also supports the Global 
Fund to fight AIDS, tuberculosis and malaria, a multilateral 
effort where the largest contributors, by 30 percent of the 
Global Fund resources come from the American people as part of 
PEPFAR. But we also support in terms of administrative and 
secretarial and making the program work. We have a very strong 
interagency team that does that. So PEPFAR is both multilateral 
and bilateral.
    Now in the history of public health I think PEPFAR will be 
remembered for two principle things: its scope and its size. In 
terms of size, Senator--Mr. Chairman, you mentioned where we 
were not too long ago. Now the $15 billion is the largest 
international health initiative in history ever for a single 
disease. I'm told it's the largest development initiative today 
anywhere in the world for anything. So the size is 
extraordinary.
    But Senator Enzi as you pointed out, it's not just about 
money. It's also about results. And so it came tagged with 
specific goals to support treatment for 2 million, to support 
prevention of 7 million new infections and to support care for 
10 million people including orphans and vulnerable children. 
And to put that size of effort in perspective, when the 
President announced this only 50,000 people in Sub-Saharan 
Africa were receiving treatment. That 7 million infections is a 
60 percent reduction in projected new infections. So it's a 
very ambitious effort in terms of size and really an 
extraordinary effort going forward. And we're on track, as you 
pointed out Mr. Chairman, to achieve those goals with great 
success so far.
    The second main thing PEPFAR will be remembered for is its 
scope. And I think this is critically important and it touches 
on some of the issues the Chairman and ranking member mentioned 
in their opening comments. The first issue of scope is 
integrated prevention, treatment and care. This is the first 
time we came together and said you can't just do one? You need 
to do prevention, treatment and care.
    And I think we've all seen pendulum swings. I think this 
committee has, between treatment and prevention, now back to 
prevention a bit. Sadly, care always gets lost. Care for 
orphans and vulnerable children, care for people living with 
HIV/AIDS.
    The President and Congress got it right the first time. And 
a bipartisan, bicameral Congress has been so important to the 
success of this program. We have to have integrated prevention, 
treatment and care, not one or the other.
    People won't get tested for HIV if they don't have 
treatment available. We know this. If people don't get tested 
they can't get treated. If people don't get tested we can't 
target our prevention programs more effectively and so we need 
an integrated approach. Without care the orphans aren't taken 
care of and so an entire society and social fabric begins to 
break apart.

[[Page 9]]

    But importantly, prevention has got to be at the heart of 
what we do because ultimately the way to care for an orphan or 
to treat someone for HIV is for someone not to get infected to 
begin with. And the sad fact is that we will probably not be 
able to keep pace with the treatment demand if we don't tackle 
new infections. And so integrated prevention, treatment and 
care is essential. Prevention is the bedrock, but it's a shaky 
foundation without care and treatment.
    Now the Emergency Plan has probably the most balanced, 
comprehensive approach to prevention in the world. It includes 
prevention of mother-to-child transmission. It includes safe 
blood and as was talked about not re-using needles, 
particularly in kids. Now blood programs and those re-use of 
needles don't contribute a lot to infection in Sub-Saharan 
Africa in particular, but it's important that we do it.
    But as I mentioned we're heavily targeted in Sub-Saharan 
Africa and there in generalized epidemics, it's mostly a 
sexually transmitted disease. About 90 percent of new 
infections are from heterosexual transmission. And so much of 
our prevention program targets sexual transmission.
    I'd like to talk a little bit about that. Our approach is 
founded in something that was created in Africa. The ABCs: 
Abstain, Be faithful, and Correct and Consistent Condom Use.
    But I think it's important to talk about what that means on 
the ground. What it means is prevention is a chronic activity. 
You have to start with very young children and walk with that 
person through the rest of their lives. And the messages change 
as you grow older.
    And so you begin with programs, they're called life skills 
now for the most part, where you get to very young children and 
teach them to respect themselves and to respect others. And if 
you do that it has consequences including better personal 
responsibility in your sexual activity. It also means young 
boys shouldn't abuse young girls and so a lot of gender 
activity is built into this. It also means older men should not 
prey on younger girls which is contributing to infection.
    So a lot of gender equality issues are built into 
Abstaining, Be faithful and Correct and Consistent Condom Use. 
It must be because it's part of this overall effort. And the 
data are there. What we've seen in Sub-Saharan Africa is that 
these three components are critical in turning the tide against 
HIV. But we also have to incorporate new approaches including 
male circumcision.
    Now the second major part of scope and I think this is very 
important is this is the first time in the history of 
development the United States or anyone else is tackling a 
chronic disease. We've tended to do immunizations or things 
that are one offs, ins and outs. This is a chronic disease and 
it's chronic for prevention, treatment and care.
    Care and treatment, of course, is chronic, but so is 
prevention. It's not one off. Prevention is beginning with a 
10-year-old and staying with that person until they're beyond 
risk, which is well into their fifties and sixties if the 
person is still alive.
    And that means building health systems. So a fundamental 
aspect of what we do to achieve prevention, care and treatment 
re

[[Page 10]]

sults is building health systems because you have to do that 
for chronic care. And that means national systems. And that's 
why we have focus countries to support the expansion of the 
health workforce, to build systems like logistic systems and 
communication systems, things that aren't too sexy but are 
essential if we're going to tackle a chronic disease. And so 
the chronic nature of this disease requires us to build those 
health systems and be more heavily dedicated to it in resources 
and commitment.
    Now I would just like to end by talking briefly about 
reauthorization because it came up. The bipartisan, bicameral 
approach the last time is something we strongly support and 
want to be as heavily engaged in it as possible as the 
President said. The President has called for a doubling of the 
original commitment, what was already the largest international 
health initiative.
    The first law was a very good law. It wasn't a perfect law, 
but I believe as you say often Mr. Chairman, ``let's not let 
the perfect be the enemy of the good'' and in this case, the 
very, very good. Now there are some things that need to be 
changed, but in general, as you can see from the success of the 
program so far, not a lot needs to be changed, just a couple of 
things.
    And the Institute of Medicine actually called PEPFAR a 
learning organization. It's an organization that looks at 
itself. That is very self aware of what needs to be changed and 
we're constantly changing and progressing in the areas that 
need to be changed. And the current law allows us, for the most 
part, the flexibility to do that. So we look forward to working 
with your committee and the entire Congress to develop a 
bipartisan, bicameral bill that can have that strong support 
that we've had going forward.
    I wanted to end with a piece of why we think this is 
important. Not only because of what we're doing on a 
humanitarian basis because it's also good for the American 
people. It's good in two ways.
    One, it gives people of the world a new window into our 
hearts. People know what we stand for, when we stand with them. 
And I can tell you there are a couple of anecdotes in my 
written testimony about how people view the United States with 
these humanitarian efforts.
    I happened to be with the Ambassador from Rwanda to the 
United States last night. He used to be governor of a province 
in Rwanda. He told me that he was just home recently and every 
one in the province was talking about what the American people 
are doing on HIV/AIDS through PEPFAR, everyone in his province. 
And that's what we see over and over again. People know who we 
are and what we stand for through these programs. And also as 
President Bush said, this is good for our national character, 
our national soul, our national conscience.
    So we look forward to working with you to continue in this 
important work for humanitarian purposes but also because it's 
also both a noble work and an ennobling work. Thank you for 
your time. Thank you for your interest.
    [The prepared statement of Ambassador Dybul follows:]
              Prepared Statement of Ambassador Mark Dybul
    Mr. Chairman, Senator Enzi, members of the committee and staff: let 
me begin by thanking you for your leadership and commitment on global 
HIV/AIDS, for your actions in 2003 to pass the authorizing legislation 
for the President's Emergency

[[Page 11]]

Plan for AIDS Relief (PEPFAR), and for your actions leading to today's 
hearing on reauthorization of this historic legislation and program.
    Just 5 years ago, many wondered whether prevention, treatment and 
care could ever successfully be provided in resource-limited settings 
where HIV was a death sentence. Only 50,000 people living with HIV in 
all of Sub-Saharan Africa were receiving antiretroviral treatment.
    President Bush and a bipartisan, bicameral Congress reflected the 
compassion and generosity of the American people as together you led 
our Nation to lead the world in restoring hope by combating this 
devastating pandemic. You recognized that HIV/AIDS was and is a global 
health emergency requiring emergency action. But to respond in an 
effective way, it has been necessary to build systems and sustainable 
programs as care is rapidly provided, creating the foundation for 
further expansion of care to those in need. The success of PEPFAR is 
firmly rooted in these partnerships, in the American people supporting 
the people of the countries in which we are privileged to serve--
including governments, non-governmental organizations including faith- 
and community-based organizations and the private sector--to build 
their systems and to empower individuals, communities and nations to 
tackle HIV/AIDS. And in just 3\1/2\ years, it is working.
                                results
    In rolling out the largest international public health initiative 
in history, we have acted quickly. We have obligated 94 percent of the 
funds appropriated to PEPFAR so far, and outlayed or expended 67 
percent of them. But success is not measured in dollars spent: it is 
measured in services provided and lives saved.
    PEPFAR is well on the way to achieving its ambitious 5-year targets 
of supporting treatment for 2 million people, prevention of 7 million 
new infections, and care for 10 million people infected and affected by 
HIV/AIDS, including orphans and vulnerable children.
    PEPFAR-supported programs have reached tens of millions of people 
with prevention messages. Since 2004 the U.S. Government has supplied 
1.8 billion condoms worldwide--as Dr. Piot of UNAIDS has said, more 
than all other developed countries combined. PEPFAR has supported 
antiretroviral prophylaxis during approximately 800,000 pregnancies, 
preventing an estimated 152,000 infant HIV infections. In fact, five of 
the focus countries have greater than 50 percent coverage of pregnant 
women--the goal of the President's International Mother and Child 
Prevention Initiative (which preceded the Emergency Plan)--and Botswana 
has achieved a 4 percent national mother-to-child transmission rate, 
which approximates that of the United States and Europe. With Emergency 
Plan support, focus countries have scaled up their safe blood programs, 
and 13 of them can now meet two-thirds of their national demand for 
safe blood--up from just 45 percent when PEPFAR started. PEPFAR has 
supported HIV testing and counseling for 30 million people, and 
supported care for nearly 6.7 million, including more than 2.7 million 
orphans and vulnerable children infected and affected by HIV. And 
through September 2007, PEPFAR supported antiretroviral treatment for 
approximately 1.45 million men, women, and children worldwide. Of 
these, approximately 1.36 million are in the focus countries, and more 
than 1.33 million are in Sub-Saharan Africa.
               success requires a comprehensive strategy
    When the history of public health is written, the global HIV/AIDS 
action of the American people will be remembered for its size, but also 
for its scope: the insistence that prevention, treatment and care--all 
three components, with goals for each--are all required to turn the 
tide against HIV/AIDS.
    Within the past decade, the pendulum of preferred interventions has 
swung from prevention to treatment and back to prevention. By the way, 
care always, and tragically, seems to get lost. Using these pendulum 
swings to determine policy and programs can be dangerous--and even 
deadly.
    The President and a bipartisan Congress got it right the first 
time, because a comprehensive program that includes prevention, 
treatment and care reflects basic public health realities:

     Without treatment, people are not motivated to be tested 
and learn their HIV status.
     Without testing, we cannot identify HIV-positive persons 
and so we cannot teach them safe behavior, and they cannot protect 
others.
     Without care and treatment programs, we do not have 
regular access to HIV-positive persons to constantly reinforce safe 
behaviors--a key component of prevention.

[[Page 12]]

     Without testing and treatment, we cannot ``medicalize'' 
the disease, which is essential to reducing stigma and discrimination--
which, in turn, is essential for effective prevention and compassionate 
care for those infected and affected by HIV.
     Without testing and treatment, we have no hope of 
identifying discordant couples, and women have no possibility of 
getting their partners tested so that they can protect themselves.
     And, of course, without prevention, we cannot keep up with 
the ever-growing pool of people who need care and treatment.

    Currently, we're spending 46 percent of our programmatic funds on 
treatment. When you include counseling and testing as a prevention 
intervention, as most of our international partners do, we're spending 
29 percent of our funds on prevention. The rest is going to care.
    Will that be the right mix going forward? It's impossible to know, 
because there is no way to know what the HIV/AIDS landscape will look 
like in 3 to 7 years. This is why, as we've discussed reauthorization 
with many of you and your staff, we've supported an approach to 
reauthorization that doesn't include specific directives for the 
allocation among those three broad categories.
    Part of the reasoning behind this is that we are one piece--albeit 
a very large piece--of a complex puzzle of partners engaged in 
combating HIV/AIDS. The other pieces include: the contributions of the 
countries themselves, including remarkable efforts by people living 
with HIV, families, communities, and national leaders, and which can 
include substantial financial contributions in countries such as South 
Africa, Botswana, Namibia and others; the Global Fund to Fight AIDS, 
Tuberculosis and Malaria--for which the American people provide 30 
percent of its budget and which is an important piece of our overall 
global strategy--and other multilateral organizations; other nations' 
bilateral programs; private foundations; and many others. We constantly 
adapt the shape of our bilateral programming piece to fill its place in 
this puzzle, so flexibility is needed.
                  prevention is the bedrock of pepfar
    That being said, prevention is the bedrock of an effective global 
response to HIV/AIDS. In PEPFAR's Five-Year Strategy, in each Annual 
Report, in nearly every public document or statement, including those 
before Congress, we have been clear that we cannot treat our way out of 
this pandemic, and that prevention is the most important piece for 
success.
    Prevention is also the greatest challenge in the fight against HIV/
AIDS. Globally, and certainly in the hardest-hit countries, which are 
in Africa, the vast majority of HIV is transmitted through sexual 
contact. Changing human behavior is very difficult--far more difficult 
than determining the right prescription of antiretroviral drugs, 
building a health system or creating a better life for orphans and 
vulnerable children.
    Not only is effective behavior change and, therefore, prevention, 
more difficult than care and treatment, measuring success is also far 
more complicated. While it is possible to rapidly and regularly report 
on numbers of people receiving care and treatment, prevention is 
evaluated every few years, with metrics and mathematical methods that 
are constantly being refined. We must currently rely on estimating 
prevalence--or the percent of HIV-positive persons in a population--
rather than evaluating directly the rate of new infections, which would 
be a far better indicator of success of interventions. In addition, as 
treatment programs are scaled up, fewer people die and prevalence may 
actually go up despite successful prevention efforts. Therefore, we 
cannot provide updates on success in prevention in the same way we do 
for care and treatment
    But that does not mean that prevention has failed--as some seem to 
want to say. A recent UNAIDS report stated that:

          ``In most of sub-Saharan Africa, national HIV prevalence has 
        either stabilized or is showing signs of a decline. Cote 
        d'Ivoire, Kenya and Zimbabwe have all seen declines in national 
        prevalence, continuing earlier trends.''

    The report further states that:

          ``Global HIV incidence likely peaked in the late 1990s at 
        over 3 million new infections per year, and was estimated to be 
        2.5 million new infections in 2007 . . . This reduction in HIV 
        incidence likely reflects natural trends in the epidemic as 
        well as the result of prevention programmes resulting in 
        behavioural change in different contexts.''

    I do not mean to minimize the seriousness of disturbing increases 
that we're seeing in certain places, nor the fact that there is an 
urgent need for greater progress in every country and region. But I 
highlight these successes because the data make

[[Page 13]]

something very clear. Our best hope for generalized epidemics--the most 
common type of epidemic in Africa, which is home to more than 60 
percent of the global epidemic and where our efforts are highly 
concentrated--is ABC behavior change: Abstain, Be faithful, and correct 
and consistent use of Condoms. Of course, bringing about these 
behaviors, as Uganda did during the 1990s, is a far more complex task 
than the simple letters suggest, because the roots of human behavior 
are so complex.
    ABC requires significant cultural changes. We have to reach 
children at an early age if they are to delay sexual debut and limit 
their number of partners. We must partner with children's parents and 
caregivers, supporting their efforts to teach children to respect 
themselves and each other--the only way to truly change unhealthy 
gender dynamics. We are rapidly expanding life skills programs for kids 
because of the generational impact they can have--changing a 10-year-
old's behavior is far easier than changing a 25-year-old's. Behavior 
changes due to programs for children may not immediately be apparent, 
because you're working to change their future behavior rather than 
their immediate behavior. Yet we must be patient and persistent--we are 
only 3\1/2\ years into PEPFAR's generational approach to prevention.
    For older adolescents and adults who are sexually active, ABC 
includes reducing casual and multiple concurrent partnerships, which 
can rapidly spread HIV infection through broad networks of people. We 
must also identify discordant couples, in which one partner is HIV-
positive and the other is HIV-negative--especially in countries like 
Uganda where they represent a significant contribution to the 
epidemic--and focus prevention efforts on them.
    We also need to teach correct and consistent condom use for those 
who are sexually active, and ensure a supply of condoms--and we are 
doing just that.
    ABC also includes changing gender norms. As young people are taught 
to respect themselves and respect others, they learn about gender 
equality. Through teaching delayed sexual debut, secondary abstinence, 
fidelity to a single partner, partner reduction and correct and 
consistent condom use to boys and men, ABC contributes to changing 
unhealthy cultural gender norms.
    And, of course, we need to reduce stigma against people with HIV--
and also reduce stigma against those who choose healthy lifestyles. On 
the other hand, we must identify and stigmatize transgenerational sex 
and the phenomenon of older men preying on young girls, and we must 
also prevent sexual violence. Again, life skills education--a part of 
ABC--is key.
                  taking prevention to the next level
    While PEPFAR is aggressively pursuing prevention as the bedrock of 
our efforts, it is also true that we need to improve what we are 
doing--in every area of our work. We need to take prevention to the 
next level. I'd like to share with you some of our lessons learned in 
prevention and give a glimpse of some new directions.
Know Your Epidemic
    First, you must know your epidemic and tailor your prevention 
strategy accordingly. While ABC behavior change must undeniably be at 
the core of prevention programs, we also recognize that one-size-does-
not-fit-all.
    This is why we take different approaches depending on whether a 
country has a generalized and/or a concentrated epidemic. It's 
surprising how little this is understood. The existing congressional 
directive that 33 percent of prevention funding be spent on abstinence 
and faithfulness programs is applied across the focus countries 
collectively, not on a country-by-country basis--and certainly not to 
countries with concentrated epidemics.
    Even speaking of the epidemic at a country level can be misleading, 
in fact, because a country can have both a concentrated epidemic and a 
generalized one. Even in generalized epidemics, we must identify 
vulnerable groups with especially high prevalence rates, such as people 
engaged in prostitution, and tailor prevention approaches to reach 
them. On recent trips, I've seen great examples of this sort of program 
in Haiti, Cote d'Ivoire and Ghana.
    Moreover, epidemics can shift over time. In Uganda, for example, 
ABC behavior change had such a significant impact that we now see the 
highest infection risk in discordant couples.
Combination Prevention
    While much progress has been made in effective prevention, often we 
are still using prevention techniques developed 20 years ago. It is 
important for prevention activities to enter the 21st Century, to use 
techniques and modalities that have been developed to change human 
behavior, especially those developed in the private sector for 
commercial marketing.

[[Page 14]]

    We also need a focused and concentrated effort that mirrors 
progress in treatment. As we need combination therapy for treatment, we 
need combination prevention. Combination prevention includes using many 
different modalities to affect behavior change, but it also includes 
geographic concentration of those different modalities and adding 
existing and new clinical interventions as they become available. 
PEPFAR is supporting many extraordinary prevention programs, but they 
are not always concentrated in the same geographic area. We need to 
make sure that, wherever people are, we are there to meet them at every 
turn with appropriate knowledge and skills. For example, many youth 
listen to faith leaders, while others don't. Many youth hear prevention 
messages in church or in school, but then hang out with their friends 
and hear conflicting messages. Many have no access to either school or 
church. We need to make sure that we blanket geographic areas with 
varied prevention modalities, so that all the youth hear the messages 
and can change their behavior accordingly.
    We also need to create effective approaches to older populations, 
including discordant couples, and have them in the same geographic 
concentration as the youth programs. Effectively reaching these 
populations demands work that is outside the traditional realm of 
public health, such as gender, education and income-generation 
programs, for example.
    We have made great strides to provide both linkages and direct 
interventions in these areas under the expansive existing authorities 
of the Leadership Act. But we also need to evaluate these combination 
programs with real science to know how best to do them. Some things 
might be good for general development, but if they don't prevent 
infections in a significant way, they are the purview of USAID and 
Millennium Challenge Corporation (MCC) development programs, not those 
of PEPFAR.
    As part of the effort to implement innovative prevention programs, 
while evalu-
ating their impact, we are developing several exciting and future-
leaning public-
private partnerships for combination prevention. Part of this effort 
includes ``modularizing'' successful prevention programs so that the 
components found to be most effective and easy to transfer to other 
geographic areas can be rapidly scaled up.
Integrating Scientific Advances
    Part of combination prevention is to rapidly incorporate the latest 
scientific, clinical advances to expand the effectiveness of behavior 
change programs. As you know, recent studies have shown that medical 
male circumcision can significantly reduce the risk of HIV transmission 
for men. PEPFAR, working closely with the Gates Foundation, has been 
the most aggressive of any international partner in pursuing 
implementation. We have to be clear that this is not a silver bullet, 
but rather one part of a broad prevention arsenal that must and will be 
used. We also need to ensure that programs demonstrate cultural 
sensitivity and incorporate ABC behavior change education.
    We need to manage rollout carefully, beginning in areas of high HIV 
prevalence and with those at greatest risk of becoming infected. For 
example, male circumcision could be very important in discordant 
couples in which the woman is HIV-positive.
    As for other promising biomedical prevention approaches, we are 
also hoping for more scientific evidence on the effectiveness of pre-
exposure prophylaxis to prevent infection, which could be another 
valuable tool for most-at-risk populations. Microbicides and vaccines 
still appear to be a long way off. Yet thanks to our wide network of 
care and treatment sites, we will be able to implement these methods 
rapidly whenever they become available--demonstrating again the value 
of integrated programs.
    Along with these prevention interventions, we are also 
incorporating the latest scientific advances in evaluation. We hope to 
have markers for incidence--new infections--available in the field 
soon: they have been validated, and we are now awaiting calibration. 
These will make evaluation of prevention programs and our overall 
impact much easier, leading to program improvement and perhaps 
cushioning against pendulum swings.
Confronting Gender Realities
    Addressing the distinctive needs of women and girls is critical to 
effective prevention, as well as to treatment and care. Taken as a 
whole, the Leadership Act specifies five high-priority gender 
strategies: increasing gender equity in HIV/AIDS activities and 
services; reducing violence and coercion; addressing male norms and 
behaviors; increasing women's legal protection; and increasing women's 
access to income and productive resources. In fiscal year 2007, a total 
of $906 million is dedicated to 1,091 interventions which include one 
or more of these gender strategies.

[[Page 15]]

    For example, PEPFAR supports the Kenya Federation of Women Lawyers, 
which provides legal advice to people living with HIV/AIDS concerning 
rape, sexual assault, and property and inheritance rights. In Namibia, 
PEPFAR supports the Village Health Fund Project, a micro-credit program 
that provides vulnerable populations, such as widows and grandmothers 
who care for orphaned grandchildren, with start-up capital for income-
generating projects. In South Africa, PEPFAR supports the Men as 
Partners project, which tailors behavior change interventions to define 
masculinity and strength in terms of men taking responsible actions to 
prevent HIV infection and gender-based violence.
    PEPFAR has been a leader in addressing gender issues and has 
incorporated gender across its prevention, treatment and care programs. 
The Emergency Plan was the first international HIV/AIDS program to 
disaggregate results data by sex. Sex-disaggregated data is critical to 
understanding the extent to which women and men are reached by life-
saving interventions, and helps implementers to better understand 
whether programs are achieving gender equity. For example, an estimated 
62 percent of those receiving antiretroviral treatment through 
downstream U.S. Government support in fiscal year 2007 were women. 
Girls represent 50 percent of OVCs who receive care.
                        building health systems
    While HIV/AIDS remains a global emergency, which we are responding 
to as such, we are also focused on building capacity for a sustainable 
response. As President Bush has said, the people of host nations are 
the leaders in this fight, and our role is to support them. Eighty-five 
percent of our partners are local organizations.
    An important part of that effort is the construction and 
strengthening of health systems. Like the pendulum swing between 
prevention and treatment, discussions here sometimes reflect 
misconceptions and unsubstantiated opinions on the effect of HIV/AIDS 
programs on the capacity of health systems. Some wonder whether by 
putting money into HIV/AIDS, we're having a negative impact on other 
areas of health systems.
    Yet all the data suggest just the opposite. A peer-reviewed paper 
from Haiti showed that HIV resources are building health systems, not 
siphoning resources from them. A study in Rwanda showed that the 
addition of basic HIV care into primary health centers contributed to 
an increase in utilization of maternal and reproductive health, 
prenatal, pediatric and general health care. It found statistically 
significant increases in delivery of non-HIV services in 17 out of 22 
indicators. Effects included a 24 percent increase in outpatient 
consultations, and a rise in syphilis screenings of pregnant women from 
one test in the 6 months prior to the introduction of HIV care to 79 
tests after HIV services began. Large jumps were also seen in 
utilization of non-HIV-related lab testing, antenatal care and family 
planning. In Botswana, infant mortality rose and life expectancy 
dropped by one-third because of HIV/AIDS despite significant increases 
in resources for child and basic health by the Government of Botswana. 
Now, because President Mogae has led an all-out battle against HIV/
AIDS, infant mortality is declining and life expectancy is increasing.
    The reasons for these improvements make sense. For one thing, 
PEPFAR works within the general health sector. When we improve a 
laboratory to provide more reliable HIV testing or train a nurse in 
clinical diagnosis of opportunistic infections of AIDS patients, that 
doesn't just benefit people with HIV--it benefits everyone else who 
comes in contact with that clinic or nurse, too. Through September 30, 
2006, PEPFAR had provided nearly $200 million to support 1.7 million 
training and retraining encounters for health care workers.
    A recent study of PEPFAR-supported treatment sites in four 
countries found that PEPFAR supported a median of 92 percent of the 
investments in health infrastructure to provide comprehensive HIV 
treatment and associated care, including building construction and 
renovation, lab and other equipment, and training--and the support was 
higher in the public sector than the non-governmental sector. In fact, 
many of our NGO partners are working in the public sector. In Namibia, 
the salaries of nearly all clinical staff doing treatment work and 
nearly all of those doing counseling and testing in the public sector 
are supported by PEPFAR. In Ethiopia, PEPFAR supports the Government's 
program to train 30,000 health extension workers in order to place two 
of these community health workers in every rural village; 16,000 have 
already been trained. So it is clear where those broader improvements 
are coming from. We estimate that nearly $640 million of fiscal year 
2007 funding were directed toward systems-strengthening activities, 
including pre-service and in-service training of health workers. In 
Rwanda, for example, these systems-strengthening efforts have enabled 
us to begin using performance-based contracts that resemble the block 
grants used in our domestic treatment programs. In areas where

[[Page 16]]

that capacity has not yet been created, however, such an approach is 
not currently possible, and so PEPFAR supports the provision of 
treatment through other means.
    Another key fact is that in the hardest-hit countries, an estimated 
50 percent of hospital admissions are due to HIV/AIDS. As effective HIV 
programs are implemented, hospital admissions plummet, easing the 
burden on health care staff throughout the system. In the Rwanda study 
I just mentioned, the average number of new hospitalizations dropped by 
21 percent at 7 sites that had been offering antiretroviral treatment 
for more than 2 months.
    As the Chair of the Institute of Medicine panel that reviewed 
PEPFAR's implementation put it, ``[O]verall, PEPFAR is contributing to 
make health systems stronger, not weakening them.''
    We know that building health systems and workforce is fundamental 
to our work, and PEPFAR will remain focused on it. We are working to 
improve our interagency coordination on construction, and we recently 
tripled the amount of resources available for pre-service training of 
health workers. We've already trained or retrained 1.7 million health 
care workers, and we need to continue to expand that number in order to 
keep scaling up our programs.
                 ``connecting the dots'' of development
    At this point, I want to step back and offer a look at a larger 
picture: the role of PEPFAR in ``connecting the dots'' of development. 
PEPFAR is an important part of the President's expansive development 
agenda, with strong bipartisan support from Congress. Together, we have 
doubled support for development, quadrupled resources for Africa, 
supported innovative programs like the MCC, President's Malaria 
Initiative (PMI), Women's Empowerment and Justice Initiative (WEJI) and 
African Education Initiative (AEI), as well as more than doubling trade 
with Africa and providing 100 percent debt relief to the poorest 
countries.
    In Haiti, for example, the Emergency Plan works with partner 
organizations to meet the food and nutrition needs of orphans and 
vulnerable children (OVCs) using a community-based approach. The kids 
participate in a school nutrition program using USAID-Title II 
resources. This program is also committed to developing sustainable 
sources of food, and so the staff has aggressively supported community 
gardens primarily for OVC consumption, and also to generate revenue 
through the marketing of vegetables.
    In education, we have developed a strong partnership with the 
President's African Education Initiative, implemented through USAID. In 
Zambia, PEPFAR and AEI fund a scholarship program that helps to keep in 
school nearly 4,000 orphans in grades 10 to 12 who have lost one or 
both parents to AIDS or who are HIV-positive, in addition to pre-school 
programs and support for orphans in primary school. Similar 
partnerships exist in Rwanda, where PEPFAR and AEI are working together 
to strengthen life-skills and prevention curricula in schools. This 
program, with $2 million in funding in fiscal year 2007, targeted 4 
million children and 5,000 teachers.
    We are also working with the President's Malaria Initiative and the 
Millennium Challenge Corporation to coordinate our activities in 
countries where there are common programs. In Zambia, by using PEPFAR's 
distribution infrastructure, known as RAPIDS, PMI delivered nearly 
500,000 bed nets between May and November of this year at a 75 percent 
savings--and the U.S. Government saved half the remaining cost of nets 
through a public-private partnership led by the Global Business 
Coalition on HIV/AIDS, Tuberculosis and Malaria. In Lesotho, PEPFAR is 
co-locating our staff with that of MCC to ensure that we are jointly 
supporting the expansion of health and HIV/AIDS services.
    Broadly speaking, PEPFAR is contributing to general development in 
the following ways:

    (1) leveraging an infrastructure developed for HIV/AIDS for general 
health and development, as demonstrated by the data from Rwanda, the 
Zambia malaria initiative and other examples;
    (2) supporting aspects of general development activities with a 
direct and significant impact on HIV/AIDS, as demonstrated by OVC 
education programs, and in aspects of general prevention such as gender 
equality and income generation if scientific evaluations show that they 
impact significantly on HIV/AIDS; and
    (3) providing a piece of a larger approach, for example by 
supporting the HIV/AIDS component of Ethiopia's community health worker 
project.

    When President Bush called for reauthorization of the Leadership 
Act, he emphasized the need to better connect the dots of development. 
The Leadership Act provides us with expansive authorities for such 
work, and we are constantly trying to improve our efforts.

[[Page 17]]

    But let me candidly make clear our view of the appropriate limits 
of PEPFAR's role. While we want to connect dots, PEPFAR cannot and 
should not become USAID, MCC, PMI, or any of its sister initiatives or 
agencies. Nearly every person affected by HIV/AIDS could certainly 
benefit from additional food support, greater access to education, 
economic opportunities and clean water, but so could the broader 
communities in which they live. We must integrate with other 
development programs, but we cannot, and should not, become them. 
PEPFAR is part of a larger whole. Congress got this right in the 
original legislation, and that is the right position going forward.
                   improving indicators and reporting
    As we improve the linkages between our programs and other related 
areas of development, we also need to do a better job of measuring the 
impact and outcomes of our programs. We need to know not just the 
number of people that we support on treatment, but also what impact 
that is having on morbidity and mortality. We need to know not only how 
many infections we're averting, but also how we're doing at changing 
societal norms such as the age at sexual debut, the number of multiple 
concurrent partnerships, or the status of women. To do this, we have 
instructed our technical working groups to develop a new series of 
impact indicators, in consultation with implementers and other 
interested groups. These new indicators should be completed by early 
next year, and we will then incorporate them into our planning and 
reporting systems.
    Of course, not all of the new indicators will be reported up to 
headquarters--we don't need all that information, and we don't want to 
burden our staff in the field with more reporting requirements. But we 
believe they will be useful to the country teams as they plan and 
evaluate their own programs, giving them a better idea of the impact 
they're having and where improvements can be made.
    We believe that kind of information can improve the overall quality 
of programs and potentially reduce the demands on one of our most 
valuable assets--our U.S. Government staff in the field, both American 
citizens and Locally Employed Staff. Our Staffing for Results 
initiative also seeks to ensure that we have the right people in the 
right place in each country so that we can avoid unnecessary 
duplication of work and make the best use of our extraordinary human 
resources.
                       reauthorization of pepfar
    I think the understanding that PEPFAR is essentially in the 
position it needs to be in going forward is critical in the 
conversation about reauthorization. We could spend a lot of time 
debating new authorities and new earmarks on everything from the amount 
of money we spend on operations research to the number of community 
health workers we train. Yet the bottom line is that the Leadership Act 
already has the authorities we need, and provides the right amount of 
flexibility to put them into use. None of the issues being discussed 
truly require significant changes in the law. The Institute of Medicine 
called PEPFAR a learning organization. We have used the flexibilities 
of the original legislation to learn, and to constantly change our 
approach based on the lessons learned.
    Congress enacted a good law the first time. It's not perfect, but 
it's very good--that is clear from its results. While there are some 
modifications that are needed, rather than letting the perfect be the 
enemy of the good, it should be possible to take the time that is 
needed to develop a thoughtful, solid, bipartisan bill. And the 
President has made clear the Administration's desire to do just that. 
It is in no one's interest to be hasty--global HIV/AIDS is too 
important. But with a solid foundation in the first, good law, it is 
possible to move expeditiously.
    And thoughtful but rapid action is important. In Haiti, a few weeks 
ago the Minister of Health expressed the same concern as every other 
country I have been to--``Will this continue? Can we scale up now or 
should we wait to see what happens? '' A recent letter from the Health 
Ministers of our focus countries conveyed this same urgency. While 
U.S.-based or local organizations experienced in the workings of the 
U.S. Government might have less concern, the policymakers who set 
standards and must decide the level of scale-up to allow in their 
countries are asking for rapid action. They need to be convinced that 
it is prudent to attempt the significant expansion in prevention, and 
especially care and treatment services, that is needed in 2008, to 
achieve our original goals and to save the maximum number of lives.
    Because of this reality, President Bush has called for early, 
bipartisan, bicameral action. He has announced the Administration's 
commitment to double the initial commitment to $30 billion, along with 
setting new goals--increasing prevention from 7 to 12 million, 
treatment from 2 to 2.5 million and care from 10 to 12 million, 
including--for the first time--an OVC goal of 5 million. These goals 
reflect the need

[[Page 18]]

for increased focus on prevention within our comprehensive program--
that's why our prevention goal would nearly double while care and 
treatment would see smaller increases. President Bush challenged the G-
8 leaders to respond to the U.S. commitment, and in June the G-8 
committed $60 billion to support HIV/AIDS, tuberculosis and malaria 
programs over the next few years. For the first time, the other leaders 
also agreed to join us in supporting country-owned, national programs 
to meet specific, numerical goals. President Bush has also called for 
enhanced effort on connecting the dots of development and strengthening 
partnerships for greater efficacy and increased sustainability.
                       a noble and ennobling work
    Mr. Chairman, Senator Enzi and members of the committee, through 
PEPFAR and our broader development agenda, the American people have 
engaged in one of the great humanitarian efforts in history. Through 
this partnership, people of distant lands have a new window into the 
hearts of Americans. They know what we stand for when we stand with 
them.
    One year ago, I was in rural east Africa. With the power lines 
hidden in the mist of daybreak, the town seemed to be set hundreds of 
years ago--streams of people, robed in white, riding or walking their 
camels and donkeys to market or morning prayers. We visited a clinic 
there, where the American people are supporting life-giving care and 
treatment. The head of the clinic, who was also one of the four town 
elders, mentioned ``PEPFAR'' a few times. Acronyms are not as common in 
rural Africa as Washington so I asked him what PEPFAR meant--expecting 
him to say ``the President's Emergency Plan for AIDS Relief''. He said, 
``PEPFAR means the American people care about us''--the American people 
care about us. In rural Namibia, a brilliant young doctor ended a 
detailed and clinically impressive presentation on the scale-up of 
prevention, treatment and care they had accomplished with PEPFAR 
support with a slide that read ``God bless America.''
    In the new era of development, we too have a new window into the 
hearts, cultures and abilities of our global brothers and sisters. The 
time is long past to discard notions of ``donors'' and ``recipients,'' 
notions that we are coming to help poor, uneducated people, notions 
that chronic health care is not possible in resource-poor settings. 
While poor in resources, these distant lands are rich in some of the 
most talented, dedicated and compassionate people in the world. Those 
whom we think have nothing, give everything they have and everything of 
themselves for others. We are partners with many thousands of heroes, 
and even a few saints.
    Finally, as President Bush has said, the new era of development is 
good for our national character, our national soul. When we base our 
policies and politics in the dignity and worth of every human life and 
dedicate ourselves to the service of others, we are dignified and have 
a great dignity of purpose.
    We are, together, embarked on great works of goodness. This noble 
and ennobling work has only just begun. Working together through the 
power of partnerships, everything is possible.

    The Chairman. Thank you very much. Excellent statement.
    Dr. Gerberding.

   STATEMENT OF DR. JULIE GERBERDING, DIRECTOR, CENTERS FOR 
        DISEASE CONTROL AND PREVENTION, WASHINGTON, DC.

    Dr. Gerberding. Good morning. And thank you so much for 
including me as a representative of CDC and the Department here 
on this very important panel. I really appreciate the 
opportunity to provide a witness. I appreciate the committee's 
interest.
    I'm a very privileged CDC Director and part of that 
privilege is having the chance to go into the field and see our 
work first hand. Many of the people who do this work have 
joined me here today from CDC. We have distinguished 
scientists, but also some very passionate public health workers 
who really have provided some of the boots on the ground 
workforce to help make the success evolve and evolve so quickly 
in the 15 focus countries as well as many other places around 
the world.

[[Page 19]]

    I've put a picture up here that shows the 15 focus 
countries and gives you a little bit of impression of the scope 
of the problem that we're dealing with and if you just turn to 
the next graphic where the numbers are put in more concrete 
terms. This lists the 15 countries and the prevalence of HIV. 
What this means is that basically in some of these countries, 
one in every four persons has HIV. Imagine a country where 25 
percent of the adults in that country are infected with this 
virus. That is a big challenge and PEPFAR is the first scaled 
investment that anyone has made on a scope large enough to 
really have an impact on those kinds of figures.
    The Chairman. Those indicate that they're more in the 
southern part of Africa. I mean if you look at the percentages. 
You've got Zambia and South Africa and Botswana. It seems to--
--
    Dr. Gerberding. Go back.
    The Chairman [continuing]. Indicate that these are the 
places where it's primarily focused.
    Dr. Gerberding. If you look in the color coding----
    The Chairman. The color probably reflects that.
    Dr. Gerberding. The redder the country the higher the 
prevalence.
    The Chairman. Ok.
    Dr. Gerberding. I think that's shown very nicely here on 
this map.
    The Chairman. Alright, thank you.
    Dr. Gerberding. So, it's a big challenge. It's 33 million 
people who have this virus around the world. We have tackled 
big problems before but as the Ambassador said, not necessarily 
chronic disease verses the ability----
    The Chairman. Can I ask Dr. Gerberding, in--I don't want to 
interrupt until the questions, but if you could also talk about 
the countries as you're moving on through. I think the 
Ambassador had indicated what countries we're doing. Well, we 
can get into the specific kind of questions, where you've got 
the greatest concentration are you finding the best programming 
or are there trends that you can identify where there's smaller 
concentrations, countries able to handle it, large 
concentrations, not. I'd just be interested as you're going 
through the survey here, any observations you can make on it.
    Dr. Gerberding. What I can tell you in shorthand is that 
one of the important lessons we have learned is that we have to 
develop plans that make sense from the country's point of view. 
And it's different in every country.
    The Chairman. Ok.
    Dr. Gerberding. The kind of problem, the kind of 
transmission, the people at risk aren't the same everywhere so 
we have to be able to have the flexibility and adopt our 
programs to adjust to whatever the issue is in the specific 
environment. But that is a very important point.
    When you have a big challenge like this you try to look 
around and figure out what are the ways to address it. And I 
agree that PEPFAR is a very, very, very good program. It has 
three characteristics that are the hallmarks of successful 
solutions to very difficult health problems.

[[Page 20]]

    One of those is commitment to a set of goals. And in 
PEPFAR, our government committed to accomplish certain things 
over a certain period of time with a certain level of 
investment and we are on track to achieve those commitments. 
And I think that's very, very important to make that visible 
and to hold ourselves accountable to it.
    The second ingredient is building capacity. There are two 
kinds of capacity at stake here. One is technical capacity and 
I think on the next couple of slides, I've illustrated some of 
the key components of technical capacity.
    First is the capacity to diagnose the disease. New 
innovations have helped a lot: rapid tests where people don't 
have to wait a long time to get their test result or it can be 
tested with saliva or blood on the spot. These really help 
speed up people's ability to know they're infected and we know 
that knowing your status is one of the single most important 
things you can do to prevent transmission because when people 
know they take steps to protect others.
    Another very important component of capacity is illustrated 
on the next graphic which is the importance of building the 
laboratory. As Ambassador Dybul said, we are investing in the 
health system because by solving the laboratory dilemmas we 
have with HIV, we're also creating the technical capability to 
look at malaria and TB and many of the other problems that this 
same set of people have. We've been able to develop training 
laboratories, a very large reference training laboratory in 
South Africa, so that we can train Africans to be able to work 
in their own laboratories and sustain that effort as it goes 
forward.
    On the next graphic I've illustrated a very, very important 
component of capacity that really brings all of these things 
together, the prevention of maternal child transmission, as 
well as early diagnosis of infants. These require the technical 
capability to identify the women at risk, get them rapidly 
tested, intervene with antiviral drugs if they're infected. But 
also the ability to test their infants after birth to know 
whether or not that child is infected. And for complicated 
medical reasons it's difficult to tell early on whether a child 
is truly infected or is passively carrying its mother's 
antibodies. So we've been able to develop new tests and new 
technology that are based on finding the DNA of the virus in 
the baby to help us make that diagnosis much earlier.
    And on the next graphic mention the importance of care and 
treatment and the technical support for doing that in a 
sustainable, long-term way, but I think it also brings up the 
other dimension of capacity which is the social capacity. We 
can do a lot with our technology and that's one of the ways 
that the Department is contributing. But social capacity is 
much harder.
    And social capacity are the things that we've referenced 
already, the laws that protect the safety of women, the laws 
that allow women to inherit property, the support for jobs and 
micro economies to keep people employed, the social, cultural 
changes necessary to make it inappropriate for older men to 
prey on younger women or for rape and assault to be part of a 
common pattern of behavior in certain communities in certain 
areas. So, we are work

[[Page 21]]

ing on the social capacity which is a much harder challenge 
than some of the technical capacities that we've addressed.
    The third component of a successful program is 
connectivity. It's building the network of people who need to 
come together to be successful. And I'm proud today to 
represent the connectivity within the Department of Health and 
Human Services where HRSA and FDA and SAMHSA and all of our 
agencies are working together as well as the relationship that 
we have with the Department of State and other government 
cabinets. You referenced the connectivity between the 
Republicans and the Democrats and the Administration and the 
Congress and the coming together to work collaboratively on 
such an important project.
    But that connectivity goes way beyond us or our government. 
It extends to governments everywhere in the developed and the 
developing world. It extends to international organizations 
like the World Health Organization and the U.N. It extends to 
faith-based and community-based organizations. And I think most 
importantly, it includes the American people and our people to 
people, health diplomacy that is really at the heart and soul 
of our ability to spend the tax payers dollars for this kind of 
a program.
    So I've talked about commitment, capacity and connectivity 
and I guess the fourth C that I would end with is probably the 
most important of all and that's the compassion. It takes a lot 
of compassion to look at people in a country where 25 percent 
of the people are infected and not feel it in your heart.
    [The prepared statement of Dr. Gerberding follows:]
          Prepared Statement of Julie L. Gerberding, M.D., MPH
    Mr. Chairman and members of the committee, I am pleased to be here 
to discuss with you the role of the U.S. Department of Health and Human 
Services (HHS) in the implementation of the President's Emergency Plan 
for AIDS Relief. I will cover a number of our Department's recent 
accomplishments under the Emergency Plan, as well as provide some 
considerations for the future. We, at HHS, are proud to be one of the 
main implementing agencies of the Emergency Plan, under the leadership 
of Ambassador Mark Dybul, M.D., and I am pleased to join him to 
represent the Department and Secretary Mike Leavitt at this hearing 
today. I had the privilege of traveling with Secretary Leavitt and 
Ambassador Dybul in August of this year to four Emergency Plan focus 
countries in Africa, and saw first-hand the programs' results and 
challenges.
    HHS has a long history in global health, and all of us appreciate 
this committee's bipartisan support for our international work. The 
Department, through the Centers for Disease Control and Prevention 
(CDC), played a leadership role in the eradication of smallpox, and is 
currently working to eradicate polio and guinea worm, and eliminate 
measles. Over the years, the scope of HHS' global efforts has expanded 
to strengthen the capacity of other countries to conduct critical 
public-health activities. Today, we have made global health a central 
part of our mission, and HHS continues to be on the frontlines of 
international disease eradication, health promotion and, increasingly 
in the 21st century, global health preparedness--focused on protecting 
the United States and the world from emerging, and re-emerging, 
worldwide threats.
    HHS has been proud to play a seminal role in the early development 
of The Emergency Plan and its precursors. A number of our Operating and 
Staff Divisions have been involved in the design and scale-up of the 
U.S. Government's expanded battle against HIV/AIDS since the beginning 
of the Administration, and indeed, since the early days of the HIV/AIDS 
pandemic. Work at HHS also led to the ideas the President endorsed when 
he called in 2001 for the creation of what became the Global Fund to 
Fight AIDS, Tuberculosis and Malaria and made the founding contribution 
to the Fund. We, at the Department, have stayed closely involved in the 
governance structure of the Fund, and in the creation and 
implementation of many of its projects around the world.

[[Page 22]]

    The Department received a total of more than $1 billion in fiscal 
year 2007 to carry out activities under the Emergency Plan in the 
treatment, care and prevention of HIV/AIDS, and we are active in more 
than 30 countries, and support an additional 30 countries through 
regional programs and headquarters. Everything we do on behalf of the 
Emergency Plan is part of a well-coordinated, cross-Government team, 
both here in Washington and Atlanta, and in the field. We believe in a 
``One U.S. Government'' approach. We participate in the inter-agency 
technical working groups that oversee the implementation of the 
Emergency Plan, provide scientific counsel to Ambassador Dybul, review 
proposals for public-health evaluations or operational research on 
aspects of the Plan's work, and provide a network of technical staff of 
medical and public-health experts who do the day-to-day work of the 
Plan on the ground. HHS staff scientists, medical officers and public-
health experts serve on nearly all the Technical Working Groups and 
inter-agency committees that give policy advice to Ambassador Dybul and 
review the yearly Country Operational Plans that U.S. Embassies around 
the world develop with local partners. Finally, the Department has 
detailed staff members to the Office of the Global AIDS Coordinator in 
leadership and expert advisory roles since the inception of the 
program.
    In the same way each Federal partner brings a well-defined 
contribution to our bilateral programs in global health, under the 
Emergency Plan, each HHS agency contributes its expertise to tackle the 
many facets of the HIV/AIDS pandemic. As of May 2007, HHS has 
approximately 120 direct-hire staff assigned to 26 countries around the 
world to work on the Emergency Plan, part of a total complement of 
nearly 270 staff overseas, who represent a range of scientific 
expertise in environmental health, infectious disease, chronic disease, 
and injury prevention and control. The vast majority of these personnel 
come from HHS/CDC. The Department also employs approximately 1,400 
local staff in host countries to support its global programs, and has 
approximately 40 U.S. experts detailed to work with international 
organizations, especially the World Health Organization (WHO) and the 
United Nations Children's Fund. Supporting these in-country staff are 
teams in Atlanta and at other HHS Operating Divisions, who facilitate 
the sharing of best practices, provide technical assistance, and who, 
in addition to being renowned experts in their own right, draw on the 
capacities of the Department's domestic efforts.
    HHS's main role in the Emergency Plan is to provide scientific and 
technical expertise to build the capacity of host-country health-care 
institutions to respond to HIV/AIDS. We work in collaboration with the 
U.S. Agency for International Development (USAID), the U.S. Department 
of State, and other Federal Departments and agencies; national 
Ministries of Health (MOH) and their sub-components; and international 
partners such as the WHO and the Joint United Nations Programme on HIV/
AIDS (UNAIDS). HHS provides the scientific and medical evidence base 
for implementing treatment, care, and laboratory support within the 
Emergency Plan, and plays a critical role in gathering strategic 
information, including through disease surveillance, epidemiology, 
evaluation, research, and health informatics. I would like to highlight 
a few areas that demonstrate our Department's critical and substantial 
contributions.
Prevention of New HIV Infections
    The prevention of new infections represents the only long-term, 
sustainable means to stem the global HIV/AIDS pandemic. As Ambassador 
Dybul has said, we cannot defeat the HIV/AIDS pandemic through 
treatment alone. To support the Emergency Plan's prevention activities, 
HHS/CDC assists with the development of comprehensive, evidence-based 
programs to prevent the spread of HIV/AIDS through sexual and nonsexual 
transmission. In addition, in collaboration with the HHS National 
Institutes of Health (NIH), HHS/CDC supports research internationally 
to identify new prevention interventions, such as microbicides, 
vaccines, and the prophylactic use of anti-retroviral (ARV) 
medications. HHS/CDC also collaborates with the WHO Secretariat and 
UNAIDS to develop guidelines, protocols, and training curricula to 
support nations in their efforts to prevent new HIV infections. The 
following are some of the Department's recent activities and 
accomplishments in support of prevention under the President's 
Emergency Plan:

     Prevention with HIV-positive individuals: ``Prevention 
with positives'' (PwP) involves working with HIV-positive individuals 
and their partners to prevent further HIV transmission. HHS/CDC 
spearheaded a new, provider-initiated intervention for HIV-infected 
individuals in Kenya, and we are now implementing it in countries 
throughout Africa under the guidance of the Office of the U.S. Global 
AIDS Coordinator. This technique gives providers the tools and skills 
to deliver tailored prevention messages to HIV-infected persons at the 
end of every routine clinic visit. Mes

[[Page 23]]

sages focus on the disclosure of HIV status, partner testing, the 
reduction of transmission to others, and the prevention of other 
sexually transmitted infections.
     Addressing drug and alcohol abuse as drivers of the 
epidemic: The Substance Abuse and Mental Health Services Administration 
(SAMHSA) within HHS is engaging with U.S. Government Emergency Plan 
country teams to address the role abuse of alcohol and injectable drugs 
are playing to spread HIV in focus countries. As part of this work, 
under the Emergency Plan HHS/SAMHSA has assigned an expert to work in 
the field overseas for the first time, to help design HIV-prevention 
and drug-treatment programs in Viet Nam, which has a concentrated 
epidemic driven in many places by heroin abuse.
     Provider-initiated voluntary testing and counseling: 
Assuring access to quality HIV testing is a necessary step in 
preventing transmission and treating HIV-infected persons. HHS/CDC is 
taking a lead role to help make provider-initiated voluntary testing 
and counseling routine in medical facilities in Emergency Plan focus 
countries through training, the development of curricula, and pediatric 
counseling and testing. HHS/CDC is also collaborating with the WHO 
Secretariat in the development of normative guidance on provider-
initiated testing and counseling, to encourage host Governments in 
high-prevalence countries to assure everyone has an opportunity to get 
an HIV test during all medical encounters. This summer, Secretary 
Leavitt and I saw the power of testing in action as he participated in 
``know-your-status'' events in several countries, but we will never 
reach the number of people we need to unless more individuals have a 
chance to receive an HIV test every time they come in contact with the 
health-care system.
     Preventing HIV infection in children: Through the 
Emergency Plan, HHS supports a wide range of activities, including 
support to countries in the rapid scale-up of the prevention of mother-
to-child transmission (PMTCT), such as counseling and testing and ART 
for pregnant women, and the expansion of polymerase chain reaction 
(PCR) testing for early infant diagnosis. In addition to the prevention 
of pediatric HIV/AIDS, HHS is committed to building national capacity 
and policy regarding formulations for and access to appropriate long-
term combination anti-retrovirals for HIV-infected children. HHS also 
supports the international scale-up of comprehensive, quality PMTCT and 
pediatric programs by providing leadership and technical expertise for 
country programs, Emergency Plan Technical Working Groups (TWGs) and 
public-health evaluation (PHE) teams, U.S. Government partners, and 
international organizations.
     Male circumcision: As a result of research funded by the 
HHS National Institutes of Health (NIH), evidence from several African 
countries has now shown medically provided adult male circumcision can 
decrease the rate of heterosexual HIV acquisition in men. Under the 
guidance of the Office of the Global AIDS Coordinator and local 
legislation, HHS is providing support and technical assistance to many 
Ministries of Health, including the South Africa National Department of 
Health, to formulate policies and guidelines in this area. In fiscal 
year 2008, the Emergency Plan's specific activities will include 
working with local health officials on the development and 
dissemination of policies related to safe male circumcision, working 
with traditional healers regarding safe circumcision, and incorporating 
HIV-prevention messaging into circumcision activities.
Clinical and Behavioral Research, Public-Health Evaluation, and Disease 
        Surveillance
    Research conducted over the past 26 years with funding from the 
HHS/NIH National Institute of Allergy and Infectious Diseases and other 
HHS/NIH Institutes and Centers, and to a lesser extent HHS/CDC, has 
provided the scientific and clinical tools to allow the Emergency Plan 
to provide HIV/AIDS care to millions. HHS/NIH's role in the Emergency 
Plan has been a specific and defined one in providing expertise to the 
Office of the Global AIDS Coordinator to assure it reviews and 
implements service-provision programs that are in keeping with the most 
current scientific findings. Grantees funded by HHS/NIH in the United 
States and elsewhere have the opportunity to seek financial support 
from the Emergency Plan for partnerships that can help improve 
individual survival and quality of life, while also helping to 
strengthen the Plan's programs. Also, by studying populations served by 
the Emergency Plan, researchers can address key questions important to 
the countries most severely affected by HIV/AIDS, tuberculosis (TB) and 
associated co-infections.
    Through CDC and NIH, HHS provides critical support to public-health 
evaluations (PHE) under the Emergency Plan, which ensures all 
interventions are scientifically sound and delivered as effectively and 
efficiently as possible. PHEs are necessary to understand the outcomes 
and effects of Emergency Plan activities, to inform the design of 
current and future programs, as well as to optimize allocation

[[Page 24]]

of human and financial resources. HHS also contributes to the Emergency 
Plan a wide range of scientific and technical resources that inform 
practice in the field, such as scientific and operational research, 
technical guidelines, standard operating procedures for laboratories, 
curricula and other training materials. A partial list of PHE 
activities supported by HHS in support of the Emergency Plan includes 
the following:

     Anti-retroviral costing studies: Efficient scale-up of ARV 
treatment requires an accurate estimation of resource needs and an 
understanding of how these needs change over time as a result of 
changes in the epidemic. HHS/CDC is providing technical support on ARV 
costing/budgeting in five countries--Nigeria, Uganda, Ethiopia, 
Botswana and Viet Nam. Preliminary analysis of data indicates treatment 
costs vary widely across facilities, and that the composition of 
spending changes markedly as programs mature. This ongoing study will 
strengthen knowledge about the costs of comprehensive HIV treatment to 
inform efficient and cost-effective policy and planning.
     Evaluating barriers to care and treatment: HHS/NIH is 
helping enable the Office of the Global AIDS Coordinator to investigate 
the biological and behavioral predictors of adult and pediatric 
treatment compliance and success, while HHS/CDC is supporting studies 
in Mozambique and Tanzania to evaluate the key enabling factors and 
barriers within the community and the health system that affect 
children's access to and use of HIV care and treatment. This evaluation 
will include examining the beliefs, attitudes and experiences of 
clients, health-care providers and community members associated with 
providing or seeking access to care and treatment for children. 
Identifying reasons for the poor access to and use of HIV care and 
treatment will help to identify policies and specific interventions 
that can improve the identification of more effective strategies and 
best practices. It will also help reduce loss to follow up of HIV-
exposed and infected children, and thus improve their survival.
     Disease surveillance: HHS/CDC is at the forefront in 
developing new surveillance and reporting tools to help track and fight 
the global HIV/AIDS epidemic. Working with Ministries of Health and 
international partners, HHS/CDC is helping to build capacity in focus 
countries to design and implement HIV/AIDS surveillance systems and 
surveys, and to monitor and evaluate the process, outcomes, and impact 
of HIV programs. The recent estimates of the scale of the HIV/AIDS 
epidemic released by the WHO Secretariat and UNAIDS are, in part, the 
fruits of this investment.
Capacity-Building
    A good public-health laboratory network is a cornerstone of a 
strong response to HIV/AIDS in any country. Without laboratory support, 
it is difficult to diagnose HIV infection and provide high-quality care 
and treatment for people who are living with HIV/AIDS. Under the 
Emergency Plan, HHS/CDC is building capacity for high-quality 
laboratory services to assist with the rapid expansion of HIV 
treatment, and the accompanying need for HIV diagnosis and associated 
care. This year, HHS/CDC's Global AIDS Program (GAP) laboratory in 
Atlanta received the internationally recognized accreditation of the 
College of American Pathologists (CAP), and provides critical, external 
quality-control and quality-assurance programs for partner laboratories 
that are helping to implement the Emergency Plan throughout the world.
    Similarly, health-care workers who have participated in training 
and research-
capacity programs funded by HHS/NIH have used the expertise gained 
through this training to become the core personnel who are helping to 
implement in-country treatment programs under the Emergency Plan, and 
are also serving as trainers of other health-care providers. As part of 
HHS/NIH-funded research training supported by the Fogarty International 
Center and other HHS/NIH Institutes/Centers, scores of clinicians have 
learned how to optimally treat HIV/AIDS by using anti-retroviral 
therapy, and how best to manage co-infections. In addition, these 
scientists have learned how to evaluate and analyze health outcomes in 
clinical settings, and to incorporate these new findings into the 
design of prevention and treatment programs.
    In an innovative partnership through a ``Twinning Center'' managed 
by the American International Health Alliance, the HHS Health Resources 
and Services Administration (HRSA) is helping to match U.S. 
institutions with indigenous groups in Emergency Plan focus countries 
to transfer skills and train local professionals. These peer-to-peer, 
collaborative relationships between American universities and other 
organizations with partners in seven of the Emergency Plan focus 
countries are proving an effective way to share best practices and 
create sustainability.
    HHS/HRSA supports the International AIDS Education and Training 
Center 
(I-TECH), the American International Health Alliance, the Georgetown 
Nursing

[[Page 25]]

School and numerous other partners to provide training to HIV 
professionals and paraprofessionals in nine African countries, as well 
as in India, the Caribbean, and Viet Nam. This multiple-agency effort 
was responsible for training 8,783 health-care workers across 25 
countries during fiscal year 2007.
Care and Treatment
    As President Bush announced on November 30, 2007, the Emergency 
Plan is supporting anti-retroviral (ARV) treatment to more than 
1,445,500 individuals throughout the world, approximately 1,358,500 of 
whom are men, women and children in the 15 focus countries in Sub-
Saharan Africa, Asia and the Caribbean. Complementing the work of USAID 
and in conjunction with local partners, HHS has made strong 
contributions to the success of the Emergency Plan in this area. We 
supervise treatment grants at the field level in the focus countries, 
and manage four, large, multi-country grants through HHS/CDC and HHS/
HRSA that deliver anti-retroviral treatment to 300,000 people among the 
total above. We also provide direct technical assistance to help host 
countries integrate HIV prevention, care and treatment with TB care; 
help teach medical professionals to prevent, diagnose, and treat 
opportunistic infections, including TB; and support the prevention of 
mother-to-child transmission (PMTCT) of HIV. HHS also works with the 
Ministry of Health in each Emergency Plan focus country to develop 
guidelines for HIV care and treatment that address first- and second-
line drug regimens, as well as how to apply WHO guidelines for 
beginning treatment and changing regimens. Recent examples of successes 
by HHS in care and treatment in support of the Emergency Plan include 
the following:

     Basic Care Package: HHS/CDC led groundbreaking research 
conducted in rural Uganda and elsewhere that used an integrated package 
of interventions to minimize the susceptibility of HIV-positive persons 
to common opportunistic infections and illnesses spread by unsanitary 
water. This research demonstrated the Basic Care Package is a low-cost, 
evidence-based way to reduce deaths, hospital visits, and illnesses, 
including malaria and diarrhea, among HIV-positive people and their 
families. The package includes insecticide-treated mosquito nets; a 
safe-water vessel, filter cloth, and bleach solution to disinfect 
water; information on how to obtain HIV family counseling, HIV testing; 
and cotrimoxazole--an antibiotic that reduces opportunistic infections 
among HIV-positive persons. Armed with the evidence we gathered in 
Uganda, the Emergency Plan is now rolling out the Basic Care Package in 
a number of focus countries.
     Quality improvement: To answer the need for the systematic 
measurement of quality improvement and to promote consistent quality 
standards for care and treatment in Emergency Plan programs, HHS/HRSA 
works in partnership with the International HIV and AIDS Quality Center 
to support the expansion of the New York AIDS Institute's HIVQUAL 
initiative, which has already implemented quality-management programs 
in Thailand, Uganda, and Mozambique, and this year initiated programs 
in Namibia and Nigeria.
     The review and use of safe and effective anti-retroviral 
drugs: Since 2004, the HHS Food and Drug Administration (FDA) has 
ensured the availability of safe and effective anti-retrovirals to meet 
the President's treatment goals through (1) an intensive process to 
help generic manufacturers from developing countries that are not 
familiar with HHS/FDA procedures to prepare high-quality applications 
and prepare for inspections; (2) an expedited review of generic ARVs, 
including combination products and pediatric formulations; and, (3) 
tentative approval for generic ARVs that meet U.S. safety and efficacy 
standards, but for which existing patents and/or market exclusivity 
prevent their immediate approval for marketing in this country. Through 
this fast-track process, HHS/FDA has approved or tentatively approved 
56 low-cost, high-quality, generic anti-retroviral therapies since 
December 2004, and, in August 2007, tentatively approved the first 
fixed-dose anti-HIV product designed to treat children under the age of 
12 years. All of these products are now available for purchase by the 
Emergency Plan. Also, through a confidentiality arrangement with the 
Quality Assurance and Safety Medicines Unit of the WHO that allows the 
exchange of sensitive data, HHS/FDA tentatively approved products move 
quickly onto the WHO pre-qualification list that many Governments use 
as the basis for their national drug-registration and procurement 
decisions. More than 90 percent of ARV purchases under the Emergency 
Plan are now generic products given approval or tentative approval by 
HHS/FDA, which is saving lives while also reducing the cost of 
treatment by millions of dollars.
     HIV/TB integration: TB is the leading cause of death among 
HIV-infected individuals, and one of their most common opportunistic 
infections. The prevalence of HIV infection among patients in TB 
clinical settings is high--up to 80 percent in some countries. In many 
countries, including Botswana, Ethiopia, Kenya, Rwanda

[[Page 26]]

and Tanzania, HHS has worked with partners to support the expansion of 
provider-initiated testing and counseling among TB patients, and 
collaborated with international partners to develop and disseminate 
protocols, training and policy to improve the integration of HIV and TB 
service care.
     HIV/Malaria integration: In Sub-Saharan Africa, co-
infection with malaria and HIV is common. The President's Malaria 
Initiative (PMI) presents us with a perfect opportunity for 
collaboration to reduce the dual burden of HIV/AIDS and malaria and to 
create synergies between two major international initiatives in the 
eight focus countries they share. Examples of successful collaborations 
between PMI and the Emergency Plan in the field include the following: 
(1) distributing long-lasting, insecticide-treated mosquito bed nets 
through a home-based-care network funded by the Emergency Plan in 
Zambia; (2) streamlining supply-chain coordination for malaria and HIV/
AIDS commodities under one manager in Mozambique; and (3) integrating 
Emergency Plan PMTCT program activities, such as testing, counseling 
and treatment, with general maternal and child health care, and 
including malaria prevention in these activities by providing bed nets 
to expectant and new mothers.
                             the road ahead
    HHS is proud of our role in helping to design and implement the 
President's Emergency Plan, and we look forward to our continued 
participation in this important initiative. Mr. Chairman, I would like 
to share with you and your colleagues some observations for the road 
ahead, based on my recent travels in Emergency Plan focus countries.
Preventing New Infections is Key
    Prevention of HIV is the single most critical factor for turning 
the tide against the global HIV/AIDS epidemic. We must work intensively 
with Governments and the private and not-for-profit sectors to ensure 
they put HIV prevention at the top of their agendas. In the coming 
years, the Emergency Plan should place additional emphasis on the 
following approaches: (1) carefully defining current and emerging risk 
groups who are contributing to new infections so our field teams and 
partners can appropriately target prevention interventions; (2) 
intensively rolling out prevention for discordant couples and 
concurrent partners; (3) assuring maximum coverage of proven prevention 
interventions--including male circumcision, consonant with local laws 
and regulations--and ensuring prevention of HIV transmission for all 
infants; (4) exploring the potential of pre-exposure prophylaxis; (5) 
maximizing behavior-change interventions with all infected persons to 
decrease the rate of HIV transmission, such as the evidenced-based, 
balanced ``ABC'' approach--abstinence, being faithful, and correct and 
consistent use of condoms; and (6) making provider-initiated testing 
routine in all health-care settings.
Infrastructure and Human Capacity
    Another key challenge for the Emergency Plan is sustainability, 
which will largely depend on strengthening indigenous infrastructure 
and local human capacity. Additional laboratory infrastructure is 
necessary to provide adequate geographic coverage across Africa and 
Asia. In addition to continuing to provide focus countries the 
technical expertise to establish regional training and reference 
laboratories, we also need to make sure we can leverage our investments 
in labs through other programs, such as pandemic-influenza preparedness 
and HHS/NIH grants, and avoid duplication.
    In the area of human resources, the Emergency Plan should continue 
to increase our efforts to train local health-care workers and public-
health specialists; the so-called ``task-shifting'' Secretary Leavitt 
and I saw in Africa that has increased the use and skills of community 
health workers is one answer. To the greatest extent possible, we 
should increasingly rely on local service providers to assure 
sustainability and to lower per-person costs.
    We should also expand appropriate training programs by HHS/CDC and 
HHS/NIH to help produce more skilled health professionals who can 
investigate disease outbreaks, strengthen surveillance and laboratory 
systems, conduct cutting-edge research studies and serve as mentors for 
future public-health officers in their countries.
Better Data
    The increased scale-up of HIV/AIDS prevention, care, and treatment 
activities has increased the demand for accurate, sophisticated data on 
the epidemic. The Emergency Plan has successfully supported Ministries 
of Health to implement innovative surveillance and data-collection 
systems. The result has been better, more informed

[[Page 27]]

programming. Still, many countries have collected data that sit unused, 
and we need to help our partners analyze and use these data for 
decisionmaking.
Public Health Research and Translation
    Increased focus on Public Health Research and Translation is also 
critical to our success in fighting the HIV/AIDS epidemic through the 
Emergency Plan. As we move from emergency responses to sustainable 
strategies, and from individual-, project- or activity-focused 
effectiveness to community or population-wide impact, we need to be 
asking ourselves questions such as: (1) Is what we thought would work--
based on best evidence and principles--actually working?; (2) How do we 
best move beyond the basics, to enhancing quality and complexity of 
interventions?; and (3) What needs to be done to expand prevention, 
care, and treatment to more difficult-to-reach populations? HHS-
supported research and translation is critical for the scale-up and 
sustainability of Emergency Plan programs. Research should be 
undertaken strategically to answer questions critical to improving the 
quality, scope, effectiveness, and impact of our programs. When 
effective interventions are identified, HHS should support the 
translation into practice, as well as the scale-up and roll out of 
these interventions by HHS and other U.S. Government agencies.
Integration of the Emergency Plan With Other Programs
    While the Emergency Plan is the largest investment the American 
people are making in health in the developing world, it is not the only 
one. An important emphasis for the coming years should be cross-program 
collaboration on key global initiatives, such as pandemic influenza, 
global disease detection, neglected tropical diseases, and the 
President's Malaria Initiative. Increasingly, HIV and malaria programs 
are conducting joint planning and program execution. Linking our HIV 
and TB investments will bring more care and treatment to the large 
numbers of co-
infected people. Comprehensive and integrated service delivery is key 
to the sustainability of the Emergency Plan, and can increase its 
impact and reach. To ensure our own U.S. Government complement of 
experts in our focus countries has the right mix of skills, we should 
expand the ``Staffing for Results'' exercise that Ambassador Dybul has 
begun, so we can place the right experts in the right places, 
regardless of their home-agency affiliation.
Better Branding of Our Assistance
    Finally, we should work to maximize the public-diplomacy impact of 
our investments under the Emergency Plan. Secretary Leavitt and I 
toured more than a dozen sites funded by the Emergency Plan in four 
countries, from rural clinics to urban hospitals to schools and 
universities. We noticed that we need to pay even more attention to 
assuring that the generosity of the American people is evident where we 
are working in partnership with health-care providers around the world. 
To this end, HHS will enhance our efforts to assure the programs 
implemented with Emergency Plan support make the commitment of the 
American people more evident. Furthermore, we will continue to work 
with our colleagues in other U.S. Government agencies to promote a 
``One-U.S. Government'' approach to branding and communicating about 
the Emergency Plan, so both Americans and the people we are serving 
overseas have a clearer understanding of what we are doing together to 
fight this pandemic.
                               conclusion
    HHS has contributed significantly to the Emergency Plan's 
remarkable achievements in HIV prevention, care, treatment and training 
of local health professionals. We look forward to continued 
collaboration with our sister Federal Departments and agencies to 
implement the President's vision for this life-saving program. 
Secretary Leavitt and I, and our colleagues across HHS, greatly 
appreciate the committee's interest in these important issues, and I am 
happy to answer questions from you on their behalf.
    I would be happy to answer any questions.

    The Chairman. Ok. Thank you very much. Excellent comments, 
enormously helpful to us.
    Let me get both of your reactions then. There was no 
question that in the early years there was some general 
reluctance in a number of the countries to move forward in the 
comprehensive ways which you've each described. You know 
whether it's prevention, the treatment, the caring, the 
prescription drugs, other kinds of things.

[[Page 28]]

    What can you tell us now in terms of the region? Have all 
of the countries basically been willing to understand that we 
need a science-based solution to this issue? Maybe you can just 
describe briefly the transition that's taken place. Is there 
still work to do? What needs to be done? How is that best done? 
Maybe each of you could comment on that?
    Ambassador Dybul. It's a very important question and I 
think it's a mix of all the above. You know, actually a lot of 
the countries were ready to go. What they didn't have were the 
resources. So countries like Uganda, for example, had a 
national plan. Rwanda had a national plan. They just didn't 
have the resources.
    So some countries are ready to go and those are the 
countries that are achieving extraordinary coverage and 
prevention, treatment and care. Other countries were a little 
bit behind both in capacity and planning. They've all caught 
up. And even in countries where some of the governments have 
made statements that some might have difficulty with, they 
still have good programs going on.
    And what we see is that all the countries are on the same 
basic trajectory which is very common in public health. You 
start very slowly and then you uptake rapidly. And we're seeing 
that exact pattern in all of the countries in prevention, 
treatment and care. It's rather extraordinary. It's the exact 
same pattern when you put them all together, but also 
individually. Some countries started at different points at 
that trajectory.
    But there's work to be done. And both the Chair and the 
Ranking Member mentioned some of them. We have to work on 
gender equality. We have to work on workforce policies. We have 
to work on more comprehensive prevention programs.
    We don't always have the same geographic coverage. You 
know, children and youth aren't very single dimensional. They 
have many different parts of their life and we're not 
addressing each aspect of their life all the time. So there's a 
lot of work to be done. We can improve everything we're doing.
    But the trajectory is right. And the commitment is there. 
And I think one thing we should recognize is we really should 
get away from terms like help and aid in this. It's not us. 
It's really the most extraordinary people you'll ever meet like 
Princess Zulu and others on the ground from every walk of life, 
from the private sector, from faith- and community-based 
organizations, the government who are giving everything they 
have. People who often have very little giving everything they 
have in the service of others.
    So we're really supporting this extraordinary ground swell 
from every sector and country. And it's extraordinary to see.
    The Chairman. Let me just move on, just because my time is 
limited too.
    Ambassador, the IOM recommended in their recommendations, 
that some of the rigid budget allocations currently in the 
PEPFAR be eliminated to allow countries to adapt their work, 
fit their needs of their country. What's your view on the 
budget allocations?
    Ambassador Dybul. Our view is that we don't need a number 
of the current allocations. So, the allocations that we think 
are important in going forward are the 10 percent for orphan 
and vulnerable children and a directive that has a 
comprehensive prevention ap

[[Page 29]]

proach. And so, for example, the language that Senator Lugar 
has proposed is language that we think gets us there.
    And the reason for that is when we started this program we 
needed to do more in treatment, for example. So it was 
appropriate to have that type of directive. The purpose of 
directives from our standpoint is to make sure we're doing 
things that we might not otherwise do or the government has not 
traditionally done.
    We're still pretty far behind in orphan care. We're not 
doing well enough in orphan care. So we think there needs to be 
a continuing directive there.
    We also don't think we're quite where we need to be in 
prevention. That a comprehensive approach that includes all the 
components could get lost in the next 5 years unless we 
continue to have a directive that ensures we have all three of 
those pieces, A, B and C in the complex and comprehensive way I 
discussed.
    So those are the two directives we think we need going 
forward. Otherwise, we think we're ok without them.
    The Chairman. I've got just a short time left. I can come 
back to this. But with regards to the GAO and the IOM 
recommendations on the budget--the elimination of the earmarks, 
do you support the 33 percent earmark for the abstinence-only 
prevention? And what's your reaction to those recommendations 
of the GAO and IOM on that?
    Ambassador Dybul. Well, we want to pursue an evidenced-
based approach and evidenced-based requires that we do 
effectively the A, B, C approach. The data from generalized 
epidemics in Sub-
Saharan Africa indicate that reductions in HIV rates require 
all three of those activities. As I mentioned, I don't think 
we're quite in the position to ensure that the government would 
have that without a directive of some type.
    Now in terms of the current 33 percent, we tend to support 
something more like Senator Lugar's language which is a little 
bit different than the 33 percent, but still ensures that we 
have a directive going forward.
    The Chairman. Alright. Just finally, Dr. Gerberding, you 
mentioned the work in the maternal to child transmission. Can 
you just mention about how this works? Have you got it 
coordinated with the other prevention, treatment works and 
PEPFAR?
    Dr. Gerberding. Yes , I think----
    The Chairman. And how does the women's access to the other 
women's health services factor into this?
    Dr. Gerberding. I don't want to underestimate the 
challenge. Cultural practice and birthing practices and where 
women have access to treatment and care when they're pregnant 
is very variable and requires a great deal of surround in 
connecting the dots so to speak. But I think the maternal-child 
program is extremely successful. We've had life-saving 
interventions in community after community.
    The biggest barrier is finding women early in their 
pregnancy and getting them tested. And overcoming the barriers 
to testing is still something that we're working on. But I 
think it is one of the areas of the PEPFAR Program where we can 
take the most pride in documenting our prevention impact.
    The Chairman. Senator Enzi.

[[Page 30]]

    Senator Enzi. Thank you, Mr. Chairman. Following up on that 
last answer that you gave, Dr. Gerberding, in Namibia we were 
visiting one of the hospitals there and we asked the question 
of what percentage of the women were tested for HIV to see what 
the transmission rate was and again it was a faith-based 
operation. The rather tall, German, catholic nurse put her 
hands on her hips and said, 100 percent. And I'm pretty sure 
nobody would have told her no to being tested.
    What do you find to be the biggest similarities and 
differences between the prevention strategies with those 
countries with the high percentage of individuals and the low 
percentage with HIV? Are there some similarities and 
differences there?
    Dr. Gerberding. I think we got into the countries when the 
pattern of the epidemic was largely already set. And so it's 
not necessarily a correlation of a success or failure of the 
PEPFAR prevention programs as much as it was--what was the 
situation that we found when we got started. And as you know we 
selected PEPFAR countries for many reasons including having a 
high burden or a high potential burden.
    So I'm not sure there's a correlation between low 
prevalence and success of the prevention program per se as much 
as there is a correlation between the change in who's got it 
and how frequently it's been transmitted once the program was 
started. Am I answering your question?
    Senator Enzi. Yes, but would you anticipate that there are 
tensions between the government and the non-government grantees 
or what are some of the problems that are caused, you know, 
with the process of actually giving the treatment, the 
prevention, the connectivity out there that you mentioned.
    Dr. Gerberding. One of the things that I didn't mention in 
my list of success factors and Mark, the Ambassador, has 
alluded to indirectly is the importance of country leadership. 
And we do see much higher rates of uptake and initiation and, I 
think, penetration in countries where the leaders are visibly 
and vocally involved and committed in supporting the program 
and the changes that are necessary.
    So it is important that the country and the country 
leaders, not just the government leaders, but the health 
leaders and the health ministry are fully behind these programs 
and supporting their introduction and development. It also has 
a very major role to play in developing capacity to imagine 
sustainability over long periods of time.
    Senator Enzi. Thank you. Mr. Ambassador is there any 
relationship then between the leadership and the people in the 
countries and allocation of funding? Are there some more 
efficient ways that we could be allocating the funding? And the 
same question to you, the tensions between government and 
nongovernment entities.
    Ambassador Dybul. There can be tensions. And I do think we 
need to talk about leadership at every level. There's 
governmental leadership, but really you need to get down to the 
community level and that involves tribal leaders. It involves 
local leaders. It involves faith and community leaders. Often 
you'll go to a village and the only thing there is a church, so 
you need to work with the faith

[[Page 31]]

leaders if you're going to affect an epidemic there. So it's 
leadership at every level.
    We have not, to this point tagged resources in the first 
part of the emergency plan to leadership as a prerequisite, for 
example. And the reason for that is half the disease was in 
these 15 countries. And so we needed to just go in and work 
with the countries to make it happen. And that's happening.
    But for the second phase the President has called for $30 
billion and goals, but hasn't said necessarily where the money 
ought to go. What he said was let's work on partnership 
compacts. Work with countries that want to tackle their 
epidemics, that will contribute their own resources, both in 
terms of financial resources, if they can, but also in terms of 
leadership and policy changes that will effect outcome like 
gender equality, like orphan protection, like, for example, the 
use of opt-out testing which we know is a critical piece of 
prevention of mother-to-child transmission.
    You'll go from 50 percent coverage to 95 percent coverage 
if you have opt-out testing. So why do you put a lot of money 
in that country that doesn't want to do opt-out testing when 
the tax payer dollar could go further in a country that does. 
So this is the approach that we're trying to take--going 
forward to say, ``let's work with countries that want to work 
on their epidemic at multiple levels in the next phase of the 
Emergency Plan.''
    Senator Enzi. In the early days there were some problems 
with warehouses full of the pharmaceuticals that were expiring 
on the shelf and also a problem with companies that were 
donating pharmaceuticals being charged a tariff for the value 
of the pharmaceuticals even though they weren't receiving 
anything. Have those problems pretty well been overcome?
    Ambassador Dybul. They have and this is one of the 
advantages of the interagency approach. The Foreign Assistance 
Act which is where most of the resources to the Department of 
Health and Human Services come from, the vast majority, 
actually has a penalty of 200-fold for any taxation. So we 
actually are free from those taxations for drugs and for 
commodities and actually any services that are provided for the 
Emergency Plan. It's one of the advantages of doing this under 
the Foreign Assistance Act.
    In terms of products and warehouses, that's actually not a 
problem anymore. We've actually supported a developmental 
supply chain management system. There was no supply system in 
most of these countries before. And now that we have a supply 
system built, it's not just for HIV/AIDS products. They're 
putting their malaria, TB and all their other products through 
this system as well.
    We're negotiating lower prices. We now get the lowest price 
in the world, $89 a year for the three-in-one combination 
through the system because we do bulk procurement. We have 
regional warehouses developed for the first time in Africa to 
avoid stock out. Stock out is actually more of a problem now 
because the programs are moving so rapidly. And now with this 
regional warehouse system we've avoided stock out, not only for 
us but also for multilaterals like the Global Fund.
    It's really extraordinary. It's extraordinary what's 
happening in this way. So the progress at every level has been 
extraordinary, but we still have a lot to do. We've got a lot 
more to do. We've got a

[[Page 32]]

lot to work on. But the progress here has been rather 
extraordinary.
    Senator Enzi. Thank you. My time's expired.
    The Chairman. Senator Brown.
    Senator Brown. Thank you, Mr. Chairman. Dr. Gerberding and 
Ambassador Dybul, thank you for all your work and all you do on 
international health issues and your infectious enthusiasm too, 
thank you for that.
    I want to follow on Senator Enzi and Senator Kennedy's 
comments and questions about pregnant women. And the numbers 
that I have seen is that about one-sixth of new infections 
occur in children and yet children get significantly less 
antiretrovirals. Could you talk, either of you, talk that 
through what we need to do to make sure that in--and my 
understanding is in three-quarters of those children after 
being infected die likely at a very young age. But how do we 
address that, either of you?
    Dr. Gerberding. I'll start by just talking about again some 
important progress that's been made. They're acknowledging that 
we've got a lot of work to do to get children treatment options 
as good as they are for adults. Overall the FDA has tentatively 
approved or made available through our approval process 56 
drugs.
    And in August a combination pediatric drug tablet was 
approved, making it much easier to treat children.
    Senator Brown. Is this a different antiretroviral or just a 
low dosage?
    Dr. Gerberding. Two-in-one pill to make compliance and 
tablet taking----
    Senator Brown. Easier with the child.
    Dr. Gerberding. Much easier with the children.
    Senator Brown. But the same antiretroviral in a lower 
dosage but combining two-in-one.
    Dr. Gerberding. Exactly. Exactly. So we are all aware 
that's it's a tremendous need and in an area where we need to 
do more than we're doing right now. But we have made a lot of 
progress in some real tangible improvements in the ability to 
treat children. It's actually a problem in developing countries 
as well. It's just a little bit slower and takes a little bit 
longer to get the pediatric drug pipeline as robust as it is 
for the adults.
    Ambassador Dybul. I think there are multiple components 
here. We should also point out there's been success. I mean 
just in the past 6 months we've seen a 77 percent increase in 
the number of children we're supporting for treatment. So there 
is growth there.
    But there are a couple of issues. One is the availability 
of drugs that are easy to use. The second is people who are 
trained. Adult doctors are generally, like myself, scared to 
death of children. And it takes a while to teach them to take 
care of children and to teach them how to do pediatric care and 
treatment because it's a little bit more complicated.
    But one of the most important things is diagnosing the 
children. We don't have DNA testing yet available in many 
laboratories or RNA testing, looking for the virus itself. We 
look for the antibody that the human body creates to the virus. 
And that actually continues in the child for months after 
they're born if the mother was

[[Page 33]]

infected. So it's very difficult to tell if a child is actually 
HIV positive without this testing.
    But one of the things CDC is----
    Senator Brown. The child has the antibody whether or not he 
or she is----
    Ambassador Dybul. Could have, whether or not----
    Senator Brown [continuing]. Has positive HIV.
    Ambassador Dybul. But CDC--and we're supporting this 
national scale up in Namibia and Botswana and a number of 
countries to actually do the test that allows us to identify 
whether or not a child is positive. One of the things CDC is 
doing by building this laboratory capacity to do that. So we'll 
be able to identify the kids appropriately so that we can treat 
them.
    But it's part of a cascade. On the other hand, we know it 
will succeed. There are hospitals for example in northern Kenya 
where 20 percent of the treatment is going for children in 
excess of the international goal of 15 percent. So we know it 
can be done we just need to do it.
    But there are these steps and bottlenecks we need to 
overcome and it's one of the things we want to work on going 
forward.
    Dr. Gerberding. There's one other issue here that I 
neglected to mention that has to do with the nutritional status 
of children. Because when you're taking antiretroviral drugs 
it's very important that you have a decent level of nutrition. 
And so, the program does support, for people who meet criteria 
for malnourishment, to also provide food supplementation to 
help assure that when they take drugs, they're effective and 
the side effects are as low as possible.
    Senator Brown. Is it at all common that children infected 
with HIV at in vitro and then you treat, that they are carrying 
the tuberculosis bacteria too? Is that very common?
    Dr. Gerberding. It's very common for babies to acquire 
tuberculosis after birth.
    Senator Brown. After birth.
    Dr. Gerberding. After birth generally because they're held 
close to somebody who's coughing with tuberculosis and they're 
in the breathing zone of the people who are infectious and 
transmitting the bacteria. So it's almost impossible for a 
child in that situation not to catch tuberculosis if someone 
else in the home is infectious. Of course with HIV infection, 
if the parent has HIV they're much more likely to activate 
their tuberculosis and serve as a source of infection.
    So it is a very important----
    Senator Brown. So many of these babies or small children 
are being treated for tuberculosis also at the same time?
    Ambassador Dybul. That is the goal and what is being worked 
on. It's not just for tuberculosis but for a number of other 
diseases as well. Malaria is a part of our program as well 
because young HIV positive children and mothers are actually--
more for pregnant women--are more prone to malaria so we're 
working on combining malaria as well.
    Malnutrition is an issue for the children. Also 
pneumocystis, one--some of the lung infections could be common 
in the young children. So that's why care is important, not 
just antiretrovirals.

[[Page 34]]

    Dr. Gerberding. I don't want to take your time so, but 
there is just a vignette that I think illustrates what you're 
talking about so powerfully in my mind. I visited a hut out in 
Western Uganda where we were delivering drugs on motorcycles to 
people. You can't get it there any other way because there were 
no roads.
    And in this household a woman was near death from HIV. And 
the first thing the CDC team gave her was a clean water vessel 
so that the family had decent drinking water. And then they 
diagnosed and treated her tuberculosis. And when you talk to 
her she says that that's the intervention that was the most 
life saving for her and helped her feel healthier so that she 
could go back to feeding her family.
    Then she eventually got started on AIDS treatment. The 
family got bed nets. The children gained weight. The whole 
household benefited from our care and treatment intervention.
    So we just don't treat the mother with the HIV. We're 
treating the whole family. Creating an environment where the 
whole family is healthier.
    Senator Brown. Could I just ask one more brief question, 
Mr. Chairman? I apologize.
    As you talk about nutrition, you talk about HIV, you talk 
about TB with children, are you satisfied with the progress 
that the Global Health community is making on leaving a public 
health infrastructure behind as you do this? I mean, it seems 
you are doing a more comprehensive treatment than just taking 
care of their HIV. Are you making good progress that way?
    Ambassador Dybul. We're making good progress, but to be 
honest, if we're ever satisfied then I'm going to be worried. 
We can improve everything we're doing. And we need to improve 
this as well.
    But I do think, and this is why I emphasize the fact that 
we're treating a chronic disease. Systems that never existed 
before are being built. Health systems are being created and 
they will last as long as we continue to support them. And so I 
wouldn't say we're satisfied, but we see a lot of progress and 
a lot of success. And that we need to build on.
    Senator Brown. Thank you. Thank you, Mr. Chairman.
    Senator Isakson. Well, first of all being a Georgian, I 
just want to reiterate our great pride in being the home of CDC 
and our great pride in the work that Dr. Gerberding does. Thank 
you very much for what you do.
    I had the privilege of being in Ethiopia in 2002 and ran 
into by accident in the back country of Owasa, Ethiopia, a CDC 
team. They were working in the early process of identifying 
what we could do and the work these people do when I heard you 
talk about delivering on motorcycle. If the average American 
could only see what might describe this testimony in terms of 
what a challenge you have in Africa. I commend you and your 
staff at CDC for all that you do, all of you over there.
    Mr. Dybul, Ambassador Dybul, in your written--and I had to 
go for an interview so I missed part of the testimony. I 
apologize. But in your written testimony you say right now 
you're deploying about 46 percent into treatment and 29 percent 
of your funds into prevention. And then on the next page you 
say, ``prevention is the bed

[[Page 35]]

rock of getting our arms around the epidemic.'' And you talk 
about flexibility in funding.
    Would you elaborate on that for me?
    Ambassador Dybul. Prevention, ultimately, is how we can 
tackle this epidemic right now. Unfortunately we don't have a 
vaccine or even a microbicide on the horizon. And while 
compassionate care and treatment is essential, ultimately we 
want to avoid new orphans. We want to avoid people that require 
care and treatment, both for humanitarian reason, but also for 
a cost reason.
    Constantly keeping up with people or a new infection in 
care and treatment is something in terms of cost, but also in a 
health system. That's going to be very difficult to sustain. So 
we need to prevent infections. But you have to do it all 
together. And that's why I think it's so important. What this 
initiative did to integrate prevention, treatment and care was 
so critical. Because before, everyone was just talking about 
treatment or just talking about prevention, but care no one was 
talking about and still unfortunately are not. You got to do 
them all together.
    And you won't have as good a prevention program if you 
don't have treatment. And you won't have as good a care 
program. And you won't have as good a prevention program. 
You've got to put it all together. That's public health. That's 
public health, you can't do it independently.
    And so our budgetary allocations are determined largely by 
the countries with congressional guidance in terms of where we 
should be. That 29 percent includes counseling and testing. If 
you take counseling and testing out it's about 22 percent for 
our prevention activities.
    You can't look at dollar amounts and say, ``that's the 
priority.'' You know, it's only 29 percent for prevention 
therefore prevention is less of a priority. The fact of the 
matter is that treatment is more expensive than most prevention 
interventions. Another reason it's important to focus on 
prevention.
    So you can't look at the budgetary allocations and say, 
``there's your priority.'' The priority is to have an 
integrated balance prevention, care and treatment program 
because that's good public health.
    Senator Isakson. And I know this is going to be a hard 
question to answer, but this is just really an opinion but take 
before the program started, and take now, what percentage of 
those potentially infected, people who could potentially be 
infected, do you think we're now reaching with prevention 
programs and actually stopping from becoming infected. Is it 10 
percent over what it was? Is it 20? What do you think?
    Ambassador Dybul. It's hard to say and it's different by 
country. We can say with treatment and we can say with 
prevention of mother-to-child transmission. We know that we've 
reached 61, more than 61 million people with prevention 
messages, but whether or not that led to behavior changes, 
something that we're just beginning to see.
    Part of the problem--outside of prevention of mother-to-
child transmission--as Dr. Gerberding mentioned, it's very 
difficult to track in the way we can report to you, in the last 
6 months, the number of people received treatment because it's 
based on demographic health surveys which occur twice or three 
times over the

[[Page 36]]

life of the emergency plan. But we are starting to see some 
tremendous signs of improvement.
    Dr. Piot will be on the next panel and UNAIDS just reported 
on behavior changes that we're seeing in countries. In some 
countries that behavior change correlating with changes in 
infection rates. And those behaviors are delaying sexual debut, 
reducing your partner or abstinence, also secondary abstinence, 
people who were sexually active refraining from sexual 
activity. There's great data in Kenya for that. Reduction in 
numbers of partners, 50 percent of young men reducing casual 
partnerships. Some increase in condom use, but that doesn't 
mean the condoms don't work.
    What it means is that we focused so much on that before--
you know, what we're getting in terms of new people using them 
is less than some of the other behavior changes. So we're 
starting to see the behavior change that correlate with change. 
And so we're very optimistic. But we've got a lot of work to 
do.
    Senator Isakson. My time's running out. But Dr. Gerberding, 
one quick question on the tuberculosis. Within the United 
States is there an increase in the incidents of tuberculosis in 
this country?
    Dr. Gerberding. There's not an increase in active 
tuberculosis in the country. In fact we have the lowest rate of 
tuberculosis ever, so that's very good news. What there is an 
increase in is the proportion of those cases that are drug 
resistant. And that's a very worrisome marker.
    There's also an increase in the proportion of our cases in 
tuberculosis that were the result of people being infected 
elsewhere in the world and coming into the country. And that's 
a very, very important focus for us in terms of international 
tuberculosis control because we're beginning to see that drug 
resistance emerging in more and more parts of the world, not 
just in the AIDS areas, but in other parts of the world as 
well.
    Senator Isakson. Thank you. My time is up.
    The Chairman. Senator Allard.
    Senator Allard. Mr. Chairman, thank you. I want to thank 
the witnesses for their testimony. And we also share some CDC 
facilities in Colorado.
    Senator Isakson. That's right.
    [Laughter.]
    Senator Allard. And we're very proud of it. Vector-Borne 
Diseases and we're very proud of the workforce and the great 
job that they do there. We also recognize that the CDC lab, 
generally does a very good job and very much appreciate the 
work that you're doing.
    I guess I want to look at this as little more than an 
epidemiological aspect. In those countries where there is an 
epidemic, what sort of risk do they pose to domestic 
populations in the United States or any country out there in 
the modern world, or currently how are they affecting it? And, 
in the future how could they have an impact on our populations, 
if any?
    Dr. Gerberding. Well, first of all AIDS or any other virus 
and bacteria doesn't appreciate borders and there's not a wall 
that will keep them out. I can guarantee that. And so we have 
to recognize that whatever promotes transmission within 
someone's country is

[[Page 37]]

also capable of promoting transmission across that country and 
in ours.
    In the case of HIV the major vector of transmission is sex. 
So any opportunity for people from different parts of the world 
to socialize and engage in risk behavior is an opportunity for 
the virus to be transmitted. We know that this is a global 
pandemic. And it got there because people move and the virus 
moves with them. And it can spread very quickly in populations 
that have high risk.
    So I think the frame for CDC's work and you know as a 
veterinarian, our interest in zoonotic diseases, but the frame 
for this is a very good metaphor for the whole arena of 
infectious diseases today. It's a flat world. And it's very 
flat for viruses and bacteria that can spread far faster and 
quicker than we can develop vaccines or drugs to combat them.
    Senator Allard. I've noticed in your budget--I was looking 
at some of the budget figures that we have there on the CDC 
lab. The question that comes to my mind is what proportion of 
your budget goes into testing?
    Dr. Gerberding. From a domestic perspective or the 
international?
    Senator Allard. Well, let's talk about both perspectives, 
but I'm mainly--I mean this hearing is about the international 
perspective. So I'm particularly interested in the 
international perspective.
    Dr. Gerberding. You want to answer that for the 
international?
    Ambassador Dybul. You can start. You do a lot on that.
    Dr. Gerberding. The prevention budget is 33 percent and of 
that about 80 percent of that or so is for counseling and 
testing, for voluntary counseling and testing programs.
    Senator Allard. So whenever you have a counseling session 
you automatically do a test?
    Dr. Gerberding. Well, that's----
    Senator Allard. It's kind of hard to break. I'm trying to 
break this out a little better than which you did. Yeah.
    Dr. Gerberding. Yeah. First of all I am going to make sure 
that we make the point about testing, because the traditional 
model you had, to go in and have a very comprehensive, 
educational session and get informed consent and so forth 
before anyone could do a test, is not the only approach to 
getting people tested anymore. We thankfully----
    Senator Allard. You're talking about in the United States 
now, domestic.
    Dr. Gerberding. Internationally as well.
    Senator Allard. Oh, internationally, have the informed 
consent?
    Dr. Gerberding. Yeah, the CDC developed a pilot program in 
Kenya on provider initiated testing so that anytime someone 
comes in and has contact with the health care environment 
they're automatically encouraged to get a HIV test. And in some 
cases it's really an opt-out mechanism where it's done unless 
the person says, ``no,'' I don't want to have the test done 
which is exactly what we're trying to do here in the United 
States. And the States are slowly changing their laws so that 
we can accomplish that.
    So the Ambassador talks about A, B, C, but I like to talk 
about A, B, C, D because I think D, the diagnostic testing is 
absolutely

[[Page 38]]

critical to solving this problem anywhere in the world, 
including in the United States. And we need to be doing a lot 
more of that.
    Ambassador Dybul. Over the last several years many of the 
countries have adopted these opt-out approaches. They're not 
always implemented to the full extent. But where they are 
implemented is tremendously successful.
    Some Presidents and leaders are really coming to this. Mrs. 
Bush proposed an international testing day which was adopted by 
the United Nations on this topic. President Kikwete in Tanzania 
has been publicly tested. Ethiopia is reporting a quintupling 
of numbers of people being tested.
    So these opt-out approaches are being widespread--being 
moved in a wide way and it's having a very important impact. 
The reason for it is likely because treatment is available. As 
in this country 20 years ago, people won't go in to get tested 
if it's a death sentence and there's nothing they can do about 
it. The availability of treatment, the Lazarus Effect that 
people talk about----
    Senator Allard. That leads to my next question. Push on 
because my time's running out here.
    How much of your budget goes toward research? I mean it 
seems like there's a real research need. I'm trying to get a 
handle on how much research is done in the private sector 
companies and everything that might be developing products, how 
much you would be doing in the communal disease center on 
understanding vaccines and how they act with maybe some 
particular types of medications that wouldn't be effective on 
treatment.
    Dr. Gerberding. Let me really emphasize the point that in 
my opinion not enough of the learn-as-you-go kind of research 
is being done. But many of the things that have led to success 
in this program occurred because we were able to do field work 
to evaluate them and then disseminate those innovations to the 
other program countries. But we are not doing enough so that 
we've got a lot of questions about practical on the ground 
things that we're doing that we need answers to.
    There's also an investment in the NIH in some of the more 
basic research. That's not part of the PEPFAR program dollars. 
That money is separate and it needs to be separate in my 
opinion because it really provides the foundation that leads to 
the development of drugs and vaccines. And that's going on in a 
very robust way. Of course Dr. Fauci is the best person to 
describe that work.
    And then we do have the flexibility within the PEPFAR 
program to do some evaluation of our success and to try to 
understand why is it working here and why isn't it working 
there. But we need to continue to have that flexibility because 
the worst possible outcome is that we would make a macro 
investment in a set of interventions and never know for sure 
which of them was the most powerful or the most important or 
which of the ones weren't really contributing at all. So we've 
got to have that learn-as-you-go research capability.
    Ambassador Dybul. About 3 percent of our current budget 
goes for that activity, but to be honest we're not doing a good 
job. And we've created a new approach called Public Health 
Evaluation to have an integrated approach that asks those 
important questions. What is it we need to know to affect our 
programs? And it's just begun. We've actually detailed someone 
from CDC and NIH to our

[[Page 39]]

office to help put this together. But I think it will be a very 
important approach going forward.
    Senator Allard. Thank you. Thank you, Mr. Chairman.
    Senator Coburn. Thank you, Mr. Chairman. And I want to 
personally thank each of you for your dedication and service to 
our country. Tough jobs.
    I'm excited to hear about what we're doing on 
infrastructure and how the CDC is helping guide that because we 
can offer treatments, but if we don't have infrastructure to do 
it we'll never get there. I'm also extremely appreciative of 
you, Ambassador Dybul, for your balanced approach and how you 
look at it. I think you're a great representative for us in 
terms of how the world views you, your plain spokenness comes 
across with compassion combined with it and I think you're a 
great representative for our Nation and what we're trying to 
do.
    I have some real concerns, as we reauthorize this, that we 
make sure prevention is our key. We've decided to treat, but 
even if we're highly successful with treatment, if we don't 
markedly slow down new cases then we won't have the finances 
and neither will the world to actually make a difference in so 
many Africans lives. And it really is too early to know, you 
know, what the effect of delayed sexual debut is going to be 
and truly abstinence and secondary abstinence. We don't know 
that yet because it's too early in the program.
    And you testified that we need all three of the components 
and I would really agree with you. My worry is the Lugar bill 
doesn't have any minimum requirement in it. You know, it's not 
solid. There's no requirement for an abstinence portion or a 
secondary abstinence or delayed sexual debuts.
    And my concern is where we were versus where we go and I 
don't want to see us go back the other way. And we're not the 
only ones that are participating in this spot. We are, though, 
very significantly the leaders in terms of trying to prevent 
through sexual delay, debut, as well as abstinence, as well as 
secondary abstinence and fidelity with that.
    And so my concern comes is if we take away these minimums, 
not just on abstinence but also on a percentage of the amount 
of money that actually has to go for treatment. And I know this 
is a changing picture for you. What kind of assurance can you 
give me that we're not going to fall back to the same thing 
where we're advertising condoms only and this is the solution? 
Where, in fact, that's not the solution, it's a part of the 
solution. Can you give me some reassurance on that?
    Ambassador Dybul. Yes and we actually would strongly favor 
a minimum standard in terms of resource allocation and for a 
comprehensive approach. You know the language Senator Lugar's 
proposing again. You know this needs to be a bipartisan, 
bicameral approach. But there actually is a percent there. It's 
at least 50 percent of resources dedicated to sexual 
transmission need to go for the A B component. So it is to 
ensure it's comprehensive, and A, B, and C is the mechanism we 
discussed.
    And the 33 percent currently needs to be applied to 
prevention of mother-to-child transmission and safe blood 
activities because

[[Page 40]]

it's 33 percent of all prevention and that didn't seem to make 
a great----
    Senator Coburn. Yes, I agree with you.
    Ambassador Dybul. So now it is applied only to those 
resources dedicated to sexual transmission, but it does have a 
minimum requirement there of at least 50 percent and we do 
believe that's necessary. I'm not sure in 5 more years it will 
be necessary because so much progress has been made. There are 
so many data out there on the effectiveness of these approaches 
in generalized epidemics.
    But for the moment we do think we need to maintain that to 
ensure that we do have a comprehensive program going forward.
    Senator Coburn. Yeah, my staff tells me there's no absolute 
requirement on allocations in the Lugar bill. So I'll be happy 
to help you with it and we'll work on that and I'll work with 
Senator Lugar on that.
    Dr. Gerberding, working to increase voluntary testing and 
counseling in the focus countries, do we know what the rate of 
return is on clients who get tested and then come back to find 
out the results?
    Dr. Gerberding. Well.
    Senator Coburn. Or are we using all rapid testing now?
    Dr. Gerberding. We are trying to move in the direction of 
rapid testing for exactly the reason that you've described and 
that is just get instant results back.
    Senator Coburn. We don't know the data on that though right 
now where we're not using rapid testing? Do we know that, 
Ambassador Dybul?
    Ambassador Dybul. We do and this is in our annual report. 
Most countries now have adopted a rapid test approach on paper. 
It's just implementing it. And many have moved toward it but 
not effectively.
    One of the things we're seeing is people are doing rapid 
tests but then they're drawing blood for the rapid test and 
they're sending it to the lab technician. So they're using 
technically on paper our rapid test, but they're not actually 
implementing a rapid test. Elizabeth Marum from CDC actually 
says that's like using a mobile phone but keeping it plugged 
into the wall.
    I mean, so you need to actually move toward implementing 
the rapid test where you're doing a finger stick rather than 
drawing blood and you're allowing a lay counselor to do it. 
Also nurses are still doing a lot. Nurses don't need to be 
doing this. We could increase health care capacity tomorrow by 
allowing lay counselors to do this.
    Now I don't want to get too severe there because we also 
want a comprehensive approach. Sometimes they draw blood so 
they can do syphilis testing and other testing as well. So you 
have to be balanced in it and I don't want to get too far one 
way. But countries are moving there. We need to keep pushing 
them to move there.
    And that's why for these partnerships compacts this is one 
thing we want to work on the countries with. This is something 
we need to be doing.
    Senator Coburn. Yes. Ok, right.
    Dr. Gerberding, you're here on behalf of all HHS efforts 
and not just CDC. This question really is for you. The Global 
Fund shares

[[Page 41]]

administrative links with the World Health Organization which 
is part of the United Nations system. The U.N. system is un-
transparent at best and one of the things we'd like to see is 
transparency because we know that leads to accountability. And 
at worst it's corrupt.
    The U.N.'s own auditors found that 40 percent of all U.N. 
procurement is tainted by fraud and corruption. That's $4 out 
of every $10. Given this record I think it's important that our 
efforts through the Global Fund establish administrative and 
financial independence from the U.N. Is there any plan to sever 
that link with the U.N. so that we don't have the potential, 
and I'm not saying we're actually doing that, but have the 
potential to have 40 percent of what we're doing through the 
Global Fund defrauded or corrupted?
    Ambassador Dybul. I can probably answer that. I happen to 
be the Chair of the Finance and Audit Committee of the Global 
Fund Board.
    [Laughter.]
    Senator Coburn. Oh, great.
    Ambassador Dybul. Yes. And this is an area the United 
States has cared about deeply. And, in fact, at the last board 
meeting, strongly from U.S. efforts, we have an agreement that 
the administrative services agreement with the World Health 
Organization will end by December 31 of next year. And there's 
a process that this committee is following to have that occur. 
So that's a decision that the board took and the full 
separation will be complete by the end of next year.
    Senator Coburn. In terms of the nations where the primary 
recipient, the principle recipient ends up being a government 
agency, where do we see the transparency with that versus 
others?
    Ambassador Dybul. Well, this is an issue and has been in 
development for quite a while and one of the other things that 
is being worked on is enhancing those transparency and 
accountability measures. Currently the Global Fund has local 
funding agents that monitor flow of resources. Another thing 
the board has decided to do is to beef up those local fund 
agents and go deeper with them.
    We also just hired an inspector general who will be in 
charge and with a fully staffed office that will be charged 
with looking at these. Unfortunately it's not just governmental 
agencies that sometimes have problems, sometimes it's 
nongovernmental agencies too. So we need to keep a watchful 
eye. The American people need to know their tax dollars, both 
for bilateral and multilateral, are going to good use.
    Senator Coburn. Mr. Chairman, could I have the privilege of 
just asking one short question? Would you think that it would 
be prudent that the money that the Federal Government, our 
government, gives to the Global Fund be conditioned on the fact 
that the purchasing and contracting be transparent within that 
fund?
    Ambassador Dybul. Well there's no question that all 
purchasing needs to be transparent. And it would depend on how 
that is developed, but I think we do need to have transparency 
and accountability for everything, not just purchasing but for 
everything, grant making, everything. And we need to do it in 
our own program.

[[Page 42]]

    Senator Coburn. So you would be supportive of the funds 
being conditioned on the fact that we have transparency that 
will lead to accountability? This year, as a matter of fact 
this week, we're going to announce all the transparency for 
this government. It's actually coming online, on time, and when 
we require that of our funds that we spend within our 
government here, it's actually by law, mandated, that the 
Global Fund will do that too, to be in compliance with the 
Federal Financial Accountability and Transparency Act.
    We should have that and how we do it. I think we can do it 
in a manner that does not disrupt but at the same time gives 
transparency that leads to accountability. And I'd be very 
hopeful that you'd support those efforts. Thank you, Mr. 
Chairman.
    The Chairman. Thank you. Thanks very much. On the 
transparency, I think all of us are mindful that we haven't had 
that as much and certainly at the Defense Department area over 
the period of recent years that we're all very mindful of. So 
it is something the American people want and need and deserve.
    You've been a terrific, a great panel. And I think all of 
us have additional kinds of questions--but we have some other 
witnesses as well. But I would like to ask you, if you can, to 
remain. We have four other witnesses and we want to try and get 
some interchange here. I know you've got schedules to do but 
this has been enormously helpful. And if you can remain with us 
we'd be grateful. I don't know whether you feel that you have 
to depart.
    Ambassador Dybul. Unfortunately, I think we probably do. 
But thank you for the kind offer. You have a wonderful panel. 
We wouldn't want to interfere with their----
    The Chairman. Well you leave that up to us. If you have to 
depart, you can depart. But we make our judgments on that.
    We'll submit some other questions to you.
    Ambassador Dybul. Thank you.
    The Chairman. Thank you very much.
    We'll ask Princess Zulu, Kasune Zulu is it, if she would 
come forward, if the witnesses come forward as we mention them, 
is a native of Zambia, has been a HIV/AIDS advocate and 
educator for World Vision HIV and AIDS Hope Initiative since 
2001. After losing both parents to AIDS by the time she was 17, 
Zulu herself tested positive in 1997. In 2003 Zulu was part of 
a delegation to the White House Oval Office that met with 
President Bush, former Secretary of State Colin Powell 
convincing the U.S. government to commit $15 billion to the 
AIDS epidemic in Sub-Saharan Africa.
    Norman Hearst, Dr. Hearst is a professor of family 
community medicine, epidemiology and biostatistics at 
University of California San Francisco, School of Medicine. Dr. 
Hearst has worked extensively on HIV, epidemiology and 
prevention in the developing world especially Latin America. 
His other areas of international health experience include 
health sector reform and research capacity development.
    Dr. Helen Smits, Vice Chair of the Institute of Medicine's 
Evaluation Implementation Phase of PEPFAR released in March of 
this year. Prior to this, Dr. Smits taught a Master's of Public 
Health program in Mozambique, during her 3 years in Mozambique 
she also served as a volunteer at the Clinton Foundation HIV/
AIDS Initiative, and participated in the first AIDS treatment 
plan. In the

[[Page 43]]

United States, Dr. Smits held the position of Deputy 
Administrator Chief Medical Officer of the Health Care 
Financing Administration, known as CMS, during President 
Clinton's term.
    And then Dr. Piot, Executive Director of UNAIDS and since 
its creation in 1995 and under Secretary General of the United 
Nations, Dr. Piot has challenged world leaders to view AIDS in 
the context of social economic development as well as security. 
Collaborative effort, Dr. Piot launched in Zaire in the 1980s 
was the first international project on AIDS in Africa, widely 
acknowledged as having provided the foundation of understanding 
of HIV/AIDS infection in Africa.
    So this is a very distinguished group. We'll start off with 
Princess Zulu. And then go to Dr. Hearst and then Helen Smits 
and then Peter Piot. Go in that order, please.

  STATEMENT OF PRINCESS KASUNE ZULU, HIV/AIDS EDUCATOR, WORLD 
              VISION, FEDERAL WAY, WASHINGTON, DC.

    Ms. Zulu. Good morning. My name is Princess Kasune Zulu and 
I work with World Vision as a child advocate. World Vision is 
nearly 100 countries in the world and it is a Christian 
humanitarian organization.
    The Chairman. Princess Zulu, the acoustics in here, I was 
trying to listen carefully to our other--the echoing and all 
the rest, so I want to make sure we hear. I'm trying to listen 
carefully to every word on our last panel. So would you just 
speak just a tiny bit slower so----
    Ms. Zulu. Ok.
    The Chairman. At least I'll be able to hear? There's a lot 
of echo. This is a magnificent room, but once in a while we 
miss an important panel. And we look forward to hearing from 
you. Thank you.
    Ms. Zulu. Thank you, Mr. Chair. Like I said my name is 
Princess Kasune Zulu and I'm excited to be here. I'm a child 
advocate for World Vision. And World Vision is a Christian 
humanitarian organization working in nearly 100 countries in 
the world. Thank you, Mr. Chair for holding this hearing today. 
And thank you to all that the U.S. government is doing in 
fighting the global AIDS.
    HIV and AIDS is very personal to me. At the age of 17 I had 
already lost both of my parents to HIV and AIDS, as well as two 
siblings. I was then left to care for eight other children in 
Zambia, three of them being my siblings, three being my cousins 
as well as two of my nephews.
    I then tested HIV positive in Zambia in 1997. I decided to 
go public about my HIV status as to break the silence, the 
stigma and the discrimination attached to people living with 
HIV and AIDS. But I also knew that it was important to raise 
the awareness so I went to schools, churches and other 
businesses.
    Global AIDS has a major impact on children everyday. 
Thousands of children lose a parent due to HIV and AIDS. 
Worldwide 15 million children have been orphaned due to HIV and 
AIDS. Either they have lost one parent or both due to AIDS.
    It is for this reason that World Vision strongly supports 
the reauthorization of the Global bill as well as continued 
provision of 10 percent of the resources be allocated directly 
to the care of orphans

[[Page 44]]

and vulnerable children. Thank you for having me and I look 
forward to our discussion this morning. Thank you.
    [The prepared statement of Ms. Zulu follows:]
               Prepared Statement of Princess Kasune Zulu
    Good morning. It is a pleasure to be with you today. My name is 
Princess Kasune Zulu and I work with World Vision as an advocate for 
children. World Vision is a Christian humanitarian organization 
dedicated to working with children, families and their communities 
worldwide to reach their full potential by tackling the causes of 
poverty and injustice. World Vision has programs in nearly 100 
countries with 5 million donors, supporters, and volunteers in the 
United States. Today, World Vision runs AIDS prevention and care 
programs in more than 60 countries.
    First, I want to say thank you to the Senators on this important 
committee, the full U.S. Congress, and President Bush for your 
leadership on Global AIDS. The President's Emergency Plan for AIDS 
Relief is saving lives. It is a holistic approach focusing on 
treatment, prevention and care. However, more needs to be done to fight 
the AIDS pandemic.
    Global AIDS is very real to me. By the time I was 17, I had lost 
both of my parents and a baby sister to AIDS-related illnesses. I was 
left alone in Zambia to care for nine children--four younger siblings, 
three of my cousins and two nephews. I tested positive for HIV 
infection in 1997. At that time in Zambia, AIDS was rarely discussed 
and it carried a heavy stigma, yet I went public with my diagnosis. I 
launched a campaign to educate other Zambians about AIDS. I spoke to 
truckers, gave seminars to businesses and worked with churches and 
schools. I even hosted my own national radio show in Zambia to educate 
people about the dangers of AIDS. It was called ``Positive Living'' and 
received an award from the U.S. Embassy in Zambia for excellence in 
broadcasting on HIV and AIDS.
    Global AIDS is having a major impact on children. Every day 
thousands of children lose a parent to AIDS. Worldwide, more than 15 
million children have lost one or both parents to AIDS. World Vision 
supports continuing the requirement which was included in Public Law 
108-25, ``The United States Leadership Against HIV/AIDS, Tuberculosis 
and Malaria Act of 2003,'' to require that 10 percent of all resources 
in this act are directed to the care of orphans and vulnerable 
children. World Vision strongly supports the reauthorization of the 
Global AIDS, TB and Malaria bill. Congress must act on this legislation 
quickly to ensure continuation of the live-saving global AIDS programs. 
Congress must also ensure that adequate resources are provided so the 
United States can hold up its end of the promise all G8 leaders made in 
2005 to provide universal access to AIDS treatment, prevention and care 
by 2010.
    I will be glad to elaborate more with the committee during the 
question and answer session on the real-life challenges that exist in 
Africa for children, women and families responding to the devastation 
of AIDS. I look forward to our discussion.

    The Chairman. Alright.
    Dr. Hearst.

   STATEMENT OF DR. NORMAN HEARST, PROFESSOR, UNIVERSITY OF 
             CALIFORNIA, SAN FRANCISCO, CALIFORNIA

    Dr. Hearst. Thank you, Mr. Chairman. PEPFAR II is all about 
sustainability and that has to mean prevention despite all the 
progress we're making and the tremendous efforts being made, 
people continue to get infected in Africa much more quickly 
than we can get them onto treatment. We cannot treat our way 
out of this epidemic.
    Like many people, I used to believe that condoms would be 
the key to prevention in the generalized AIDS epidemic that 
ravaged many African countries, but experience has proven 
otherwise. Unfortunately, the condoms first approach used for 
so many years simply hasn't worked. What has worked in Africa, 
first in Uganda and now elsewhere is when people change their 
sexual behavior.
    I'm here today to encourage you to make sure that PEPFAR II 
maintains and strengthens its focus on promoting healthy sexual

[[Page 45]]

behavior. We must avoid the easy trap that so many AIDS 
programs fall into of putting all of their money into the same 
old strategies that haven't worked in Africa. Similarly we 
can't be distracted by those who in the name of A, B, C-plus 
would siphon off AIDS prevention dollars to whatever other good 
cause they're promoting. I go into more detail about this in my 
written testimony and I look forward to our discussion.
    [The prepared statement of Dr. Hearst follows:]
             Prepared Statement of Norman Hearst, M.D., MPH
    We're here today to talk about making PEPFAR sustainable, and the 
key to sustainability must be prevention. We cannot treat our way out 
of this epidemic. Even now, five people are being infected with HIV in 
Africa for every one starting treatment. And treatment or not, these 
people will die of AIDS.
    For prevention, it's fundamental to distinguish between 
``concentrated'' and ``generalized'' HIV epidemics. These are different 
situations that require very different strategies. In most countries, 
HIV is mainly transmitted in high risk settings and groups, including 
men who have sex with men, injecting drug users, and commercial sex, so 
that's where you need to do prevention.
    But in generalized epidemics, transmission is widespread in the 
heterosexual population, so you can't focus only on high risk groups. 
Just a few countries in eastern and southern Africa have this pattern. 
But these countries, because of their very high infection rates, 
account for most of the world's HIV infections. Most PEPFAR priority 
countries have generalized epidemics.
    Five years ago, I was commissioned by UNAIDS to conduct a technical 
review of how well condoms have worked for AIDS prevention in the 
developing world. My associates and I collected mountains of data, and 
here's what we found.
    First, condoms are 85-90 percent effective for preventing HIV 
transmission when used consistently. We then looked at whether condom 
promotion has been successful as a public health strategy--something 
very different from individual effectiveness. Here we found good 
evidence for effectiveness in concentrated epidemics. For example, 
condoms made an important contribution to controlling HIV among gay men 
in places like San Francisco and epidemics driven by commercial sex in 
places like Thailand.
    We then looked for evidence of a public health impact for condoms 
in generalized epidemics. To our surprise, we couldn't find any. No 
generalized HIV epidemic has ever been rolled back by a prevention 
strategy based primarily on condoms. Instead, the few successes in 
turning around generalized HIV epidemics, such as in Uganda, were 
achieved not through condoms but by getting people to change their 
sexual behavior.
    UNAIDS did not publish the results of our review, but we did 
ourselves. I would like to have the following article entered into the 
record: Hearst N, Chen S. Condoms for AIDS Prevention in the Developing 
World: Is It Working? Studies in Family Planning 2004;35:39-47 (see 
http://www.usp.br/nepaids/condom.pdf).
    These are not just our conclusions. A recent consensus statement in 
The Lancet was endorsed by 150 AIDS experts, including Nobel laureates, 
the president of Uganda, and officials of most international AIDS 
organizations. This statement endorses the ABC approach to AIDS 
prevention: Abstinence, Be faithful, and Condoms. It goes further. It 
says that in generalized epidemics, the priority for adults should be B 
(limiting one's number of partners). The priority for young people 
should be A (not starting sexual activity too soon). C (condoms) should 
be the main emphasis only in settings of concentrated transmission, 
like commercial sex. I also ask that this article be entered into the 
record: Halperin DT, Steiner MJ, Cassell MM, Green EC, Hearst N, Kirby 
D, Gayle HD, Cates W. The time has come for common ground on preventing 
sexual transmission of HIV. Lancet 2004; 364: 1913-1915 (see http://
www.thelancet.com/journals/lancet/article/PIIS0140673604174874/full 
text).
    PEPFAR follows this ABC approach. Last year, I was on a team 
reviewing PEPFAR's prevention activities in three African countries for 
the Office of the Global AIDS Coordinator. We found a strong portfolio 
of prevention activities that mixed A, B, and C (though, in my opinion, 
probably not enough B). This contrasted with other funders that often 
officially endorse ABC but in practice continue to put their money into 
the same old strategies that have been so unsuccessful in Africa for 
the past 15 years: condoms, HIV testing, and treating other sexually 
transmitted infections.

[[Page 46]]

    One might ask why they continue to do this despite all the 
evidence. It's difficult to convey the tremendous inertia for doing the 
same old things. First, they're relatively easy to do. Second, many of 
the implementing organizations and individuals have backgrounds in 
family planning. They're good at distributing condoms and providing 
clinical services but may have no idea how to get people to change 
sexual behavior. Third, decisions are often made by expatriates and 
westernized locals trained in rich countries who have internalized 
prevention models from concentrated epidemics. Finally, if you try to 
do everything, expensive clinical services quickly eat up budgets, 
leaving little for the critical A and B of ABC.
    Let me close with a warning regarding talk about ``ABC-plus'' or 
``moving beyond ABC'' and diverting AIDS prevention funding to whatever 
other good cause people are promoting. Always ask, ``Where is the 
evidence?'' For example, I'm all in favor of poverty alleviation. But 
in most countries with generalized epidemics, the rich have higher HIV 
infection rates than the poor. I ask that the following article which 
documents this be entered into the record: Mishra V, Assche SB, Greener 
R, et al. HIV infection does not disproportionately affect the poorer 
in sub-Saharan Africa. AIDS 2007; 21 (suppl 7): S17-S28 (see http://
www.ncbi.nlm.nih.gov/pubmed/18040161) .
    Similarly, for gender equity, many of the African countries with 
the best records in this regard (like Botswana) have the highest rates 
of HIV infection. The question here is not whether poverty alleviation, 
treating STI's, and improving the status of women are important. Of 
course they are. The question is whether they are where we should put 
our limited AIDS prevention dollars. This decision needs to be based on 
evidence of effectiveness, not facile sociologic arguments. Are there 
credible scientific studies showing proof that poverty alleviation 
programs reduce HIV transmission? There are none. Are there specific 
examples of programs to improve the status of women that resulted in 
reduced rates of HIV? There are none. Are there randomized controlled 
trials showing that treating STI's reduces HIV transmission? There is 
one, but there are five others that showed no such effect.
    PEPFAR must instead put its money into strategies that have been 
proven to be effective. The most notable of these was the home-grown 
Ugandan ``Zero Grazing'' approach. When Ugandans decided to tackle 
their AIDS problem head on in the late 1980s, they did not say, ``We 
must alleviate poverty before we can control AIDS,'' or ``We must 
improve the status of women before we can fight AIDS.'' Instead, they 
took a common sense approach based on the knowledge that HIV is 
sexually transmitted. They mobilized all sectors of society to get 
people to change their sexual behavior, and they succeeded with little 
outside help and very limited funding.
    PEPFAR has been a leader among international AIDS prevention 
programs by truly putting its money into ABC and not just giving it lip 
service while spending most of its prevention budget on other things. 
It would be foolish to change this without clear evidence that other 
approaches are more effective, not just emotional arguments that would 
divert energy and funding in unproven directions. Anything that dilutes 
the focus of AIDS prevention in Africa from changing sexual behavior 
may do more harm than good.

    The Chairman. Very fine.
    Dr. Smits.

   STATEMENT OF DR. HELEN SMITS, VICE CHAIR, IOM EVALUATION 
                   COMMITTEE, WASHINGTON, DC.

    Dr. Smits. I'm Dr. Helen Smits. I served as Vice Chair to 
the Institute of Medicine Committee. I'd like to start by 
thanking the large multinational committee that I worked with 
for all their efforts, as well as the staff at the Institute of 
Medicine. This was a big report and people worked very hard on 
it.
    We visited 13 of the 15 focus countries and did extensive 
telephone interviews with the other two. Those were remarkable 
visits for me. I told people I was evaluating, but people 
thanked me. It was amazing. People sang. They danced. They gave 
us presents. Sometimes we had to give them back.
    There is enormous appreciation and I would like to bring 
that appreciation back to the members of this committee. People 
really see what we've done. And they thank us for it.

[[Page 47]]

    I was also very impressed to meet some of the African 
leaders who are devoting their lives to fighting this epidemic. 
They're ready to do a good job. And we have given them 
resources to help them.
    The Institute of Medicine came up with a series of 
recommendations about a future PEPFAR, that is integrated, 
that's sustainable, that's highly flexible to be able to 
respond to the differences across the countries and also to the 
differences in inside countries over time. I heard a very 
interesting speech by the head--at the implementers meeting by 
the head of Uganda's AIDS effort and we should talk about that 
later in terms of what he now sees as what he needs in 
prevention.
    Our recommendation to the Congress is to support that 
sustainability and flexibility by eliminating all earmarks but 
substituting accountability. We are not suggesting you just 
hand off the money, but rather that you work with the agencies 
to set goals for areas that you're particularly concerned about 
such as the children.
    So, thank you for the chance to be here. I've always 
enjoyed talking about this work. And I'm looking forward to the 
discussion.*
---------------------------------------------------------------------------
    * The prepared statement submitted by Dr. Smits regarding ``PEPFAR 
Implementation: Progress and Promise'' can be viewed on the following 
Web site: http://www.nap.edu/catalog/11905.html.
---------------------------------------------------------------------------
    The Chairman. Fine.
    Dr. Piot.

   STATEMENT OF DR. PETER PIOT, EXECUTIVE DIRECTOR, UNAIDS, 
                          SWITZERLAND

    Dr. Piot. Thank you, Mr. Chairman. I'm Peter Piot and I'm 
heading UNAIDS which is coordinating the AIDS efforts of the 
U.N. system from the World Bank, UNICEF to the World Health 
Organization and thereby also spearheading U.N. reform and 
maximizing our effectiveness.
    We're supporting country's efforts on AIDS. We've got staff 
on the ground in 81 countries. And our mantra is making the 
money work for people. All the money that is there for AIDS, to 
make sure it is getting there where it is making a difference.
    I would like really to thank you for U.S. leadership. It 
can't be said enough that PEPFAR has really changed completely 
the landscape and the response to AIDS in the world and it is 
making a measureable difference. And we're starting to see a 
return on the investment, meaning we're entering a new phase.
    And PEPFAR reauthorization is an opportunity to keep the 
momentum, not only for the United States, but also for other 
countries. Because what you will decide here will set a trend 
for other countries. Other western countries as PEPFAR I has 
done because other dominations have followed that trend.
    Finally let me mention three things for your consideration 
when reauthorizing PEPFAR. The first one is to build on 
PEPFAR's success. Along the same lines, increase the resources, 
commensurate with the magnitude of the challenge and in keeping 
with strong U.S. leadership.
    Second as mentioned by many others, add a sustainability 
strategy to the current emergency, the E in PEPFAR. But there's 
still a crisis. Let's not forget the 5,800 people dying every 
single day.

[[Page 48]]

But it means also a better balance between prevention and 
treatment and more investments to strengthen health care 
systems, and human resources for community-based organizations.
    And third, to maximize our collective effectiveness of 
these investments through increased partnership and 
coordination. Thank you, Mr. Chair.
    [The prepared statement of Dr. Piot follows:]
             Prepared Statement of Peter Piot, M.D., Ph.D.
    My name is Peter Piot and I am executive director of UNAIDS. Thank 
you for inviting me to testify today before the Senate Health, 
Education, Labor, and Pensions Committee about the HIV/AIDS epidemic, 
the work of UNAIDS to address this epidemic, and the critical 
difference that PEPFAR has made in the global fight against HIV/AIDS.
    A quarter of a century into this epidemic, we are at a critical 
juncture. It is a turning point that beckons us to not only manage the 
urgent and daily emergencies presented by the epidemic--but also forces 
us to take a long-term view and to establish a sustainable response.
    According to our most recent UNAIDS figures, there are an estimated 
33.2 million people living with HIV. Each day, there are more than 
6,800 new infections and over 5,700 people die of AIDS.
    The encouraging news is that HIV prevalence has been leveling off, 
and is declining in Sub-Saharan Africa. That's a real tribute to the 
significant investment that the G-8 countries, led by the extraordinary 
commitment of the United States, have made in prevention, care and 
treatment.
    Yet, while the prevalence is leveling off, the sheer number of 
people in the world living with HIV continues to increase. Moreover, 
AIDS is still a leading global cause of mortality, and remains the 
primary cause of death in Sub-Saharan Africa.
    Prevention and treatment efforts that save lives still remain 
available to only a small percentage of those who need it. Both new 
infections and early deaths are preventable if the global community 
continues its commitment to scaling up essential prevention, treatment, 
care and support efforts worldwide. Even the most conservative resource 
need estimates demonstrate that the global need far outpaces the global 
response to it.
    It's important to take a moment and note a few trends of the 
epidemic. First, the epidemic is still expanding. In fact, it is 
globalizing. This disease, a disease that was not even known 26 years 
ago, is now the fourth cause of death in the world; the fourth cause 
after heart disease, stroke, and respiratory illness. This is clearly 
not a marginal phenomenon.
    Second, there is the feminization of the epidemic. In every single 
region in the world, including here in the United States, the 
proportion of women among those who are becoming infected with HIV is 
increasing. Half of those living with HIV today are women. Globally, 
15.4 million women are currently living with HIV. In Sub-Saharan 
Africa, approximately 61 percent of people living with HIV are women. 
In the United States, AIDS is now the leading cause of death for 
African-American women ages 25-34. In hard hit areas, AIDS is undoing 
any development gains for women and girls.
    Third, we're seeing a tremendous human and social capital loss in 
the worse affected countries as a result of this epidemic. I refer to 
it as reverse development or un-development. We estimate that by 2010 
the five most affected countries in Africa will have lost about one in 
five workers due to AIDS. Some sectors that drive national economies 
are really reaching the crisis point. For example, the mining industry 
in Botswana loses more than 8 percent of its profits every year because 
of costs related to HIV. And in the tourism industry in Zambia, which 
is one of the future assets of the country, HIV-related costs total 
nearly 11 percent every year.
    And there is also the absolutely devastating human toll. The 
numbers of orphans, of vulnerable children in Africa and elsewhere, 
remains unacceptable. For example, 19 million orphans and vulnerable 
children will need our help by 2010.
    When we look at these trends, it is fair to say that we have a good 
understanding of the biological drivers--the virology of the disease. 
However, the societal drivers, which are basically the reason that we 
have this epidemic, have not been studied that well. And unlike what is 
often said, AIDS is not just a disease of poverty; AIDS is a disease of 
inequality, gender inequality being the most striking. When you look at 
HIV infection rates by income, it's the highest income in most African 
countries that have had the highest HIV rates. That is very unlike any 
other health problem.

[[Page 49]]

When you look at maternal mortality, child mortality and similar global 
health challenges, there's a direct link with low income and poverty, 
but that's simply less true for AIDS.
    Economic inequality, social inequality, marginalization of groups 
because of sexual orientation or drug use or other factors; immigrants, 
gender inequality, lack of access to service--all of this has created a 
perfect storm. A perfect storm that sets AIDS apart from other health 
issues. A perfect storm that forces us to design strategies that 
directly meet the challenges of this epidemic.
    And the AIDS community has worked hard to design and implement 
country-driven, country-specific strategies. That's why I feel that we 
are at a real turning point--a real time for hope. And it's evidence-
based or evidence-informed hope; it's not just something that we wish 
will happen, or had happened. It's supported by facts. An estimated 2.5 
million people are on antiretroviral therapy today in the developing 
world. Just 6 years ago, when the United Nations held an historic 
special session in the General Assembly on AIDS, only about 100,000 men 
and women were receiving antiretroviral therapy in the developing 
world. Most of these individuals receiving treatment were men living in 
Brazil because it was the first country in the developing world to 
offer treatment at state expense.
    We're also starting to see the impressive results of prevention 
efforts. Prevalence is leveling off. In Uganda, we are beginning to 
witness a reversal in some communities, just as we are seeing it in gay 
communities in Western Europe. This is the first time in the history of 
this epidemic that we're seeing these kinds of real results on such a 
large scale.
    A less well known, but equally important development is that 
investments in the fight against AIDS are having a measurable impact 
beyond AIDS. A recent study done by FHI in Rwanda shows that primary 
health care centers where basic AIDS activities were introduced, have 
seen a much higher coverage and uptake of services beyond AIDS--
particularly maternal and child health services and family planning 
services.
    We're also seeing for the first time that there are investments in 
programs on violence, particularly sexual violence, against women. This 
issue predates by far the AIDS epidemic, but had received very little 
attention with the exception of small microfinance programs. So in many 
cases, it's the first time that longstanding issues have been given 
some serious investments, and in that sense, work on AIDS is opening 
many doors for development.
    All of this is positive news, but also reminds us that we cannot 
become complacent in our early successes. All of the lives saved are 
the direct result of the significant increase in the world's commitment 
to fighting AIDS. When UNAIDS began its work in 1996, about $250 
million was spent on AIDS in developing countries. This year, we 
estimate that the global investment in this effort will be about $10 
billion total in the world.
    There is no doubt that the most significant infusion of leadership, 
commitment, and resources has come from the United States, through 
PEPFAR. U.S. leadership has truly transformed the global response to 
AIDS and the course of the epidemic. It has enabled all of us to make a 
qualitative and quantum leap forward.
    At the 2005 G8 summit at Gleneagles, the leaders of the most 
powerful economies of the world made a commitment that was incredibly 
bold, to come as close as possible, as the text said, to universal 
access to HIV prevention, treatment, care and support. And that was 
affirmed later by the General Assembly of the U.N., and is really our 
ultimate goal. We cannot rest until the last person living with HIV has 
access to treatment. We cannot rest until we're reaching everybody with 
prevention activities, and transmission is stopped.
    This needs to be our mission, but we have a lot of work to do if we 
are to truly achieve this mission. At the current pace, there will be 
fewer than 5 million people on treatment by 2010; just over half of the 
people who will need it. And when you look at coverage of mother-to-
child transmission prevention programs, they are extremely low in many 
countries with the exception of Botswana which is, thankfully, doing 
remarkably well.
    So, what does this all mean for PEPFAR? Simply put, just as we are 
at a turning point in the fight against AIDS, we are also at a turning 
point in the world's response to AIDS. We are at a point where we must 
acknowledge that AIDS is not just a short-term emergency, but also a 
long-term crisis that will require serious commitment and serious 
resources for decades, not years, to come.
    We have reached the point where we must ensure that everything we 
do contributes to an effective response that can be sustained over the 
longer term. This means taking a cold hard look at what we are doing, 
dropping what doesn't work and consolidating and scaling up what does.

[[Page 50]]

    And it also means that we must continue to make needed investments. 
It is not an understatement to say that we wouldn't be where we are 
today without the commitment and leadership of the United States.
    Reauthorizing PEPFAR is critical because PEPFAR is making a real 
difference. In looking ahead to reauthorization, UNAIDS offers three 
overarching recommendations:

     Promote a truly global effort supported by bold new 
investments. This means building on PEPFAR I successes, increasing 
resources commensurate with the magnitude of the challenge and ensuring 
the strong leadership of the United States. It means continuing support 
to ``focus countries'' and expanding support in other parts of the 
world where significant and high yield opportunities exist.
     Move from an Emergency to a Sustainability Strategy. We 
must support a country-driven and flexible approach that allows for an 
enhanced focus on prevention while also strengthening health care 
delivery systems, human resource capacity, and local community-based 
service organizations. We must also break down implementation barriers 
and bottlenecks to getting the job done by supporting reform of legal 
and regulatory processes and policies, as well as research and 
development to accelerate access to affordable and high quality 
commodities, medicines, and diagnostics.
     Maximize effectiveness of investments through partnership 
and coordination. At UNAIDS, we call this ``Make the Money Work.''

    Our recommendations are largely based on some extensive surveys 
that we had with our field operations. On the first point of supporting 
bold new investments, let's look at where we are. This year, 
approximately $10 billion will be spent. While that's a considerable 
investment, it's only slightly more than half of the global need. If we 
are going to achieve universal access to HIV prevention, treatment, 
care, we will need a major increase in funds.
    In terms of PEPFAR Reauthorization, President Bush has requested 
$30 billion. That is definitely a very generous proposed investment. 
But given that the United States will likely contribute more than $5.5 
billion this year, quite frankly, greater increases will be needed to 
keep the global momentum growing. The good news is that U.S. leadership 
leverages action by both partner governments and other donor countries.
    With that in mind, I urge Congress and the President to go further, 
to continue on the same upward trajectory that Congress and the 
Administration have been following during the first 5 years of this 
landmark legislation. Substantial progress has been achieved in 
bringing essential HIV services to those in need in the low- and 
middle-income countries where 95 percent of all people living with HIV 
reside. The number of people receiving antiretrovirals in these 
countries increased five-fold between 2003 and 2006, and declines in 
HIV prevention have been reported in several countries following the 
implementation of strong HIV measures.
    According to the September 2007 UNAIDS ``Financial Resources 
Required to Achieve Universal Access to HIV Prevention, Treatment, Care 
and Support'' Report, available financial resources must more than 
quadruple by 2010 compared to 2007--up to $42 billion.
    We simply cannot afford to slow down now. Just consider five 
points. First, the most obvious one is that failure to increase efforts 
will not keep pace with increased needs, and will result in far more 
deaths.
    Second, what we have learned in the fight against AIDS is that it's 
either act now or pay later. If we had acted 10 or 20 years ago with 
the same resources, determination and political will that we have 
today, the AIDS bill would have been much cheaper. So if we delay 
increased investments now, 5 years from now the bill will be even 
greater, particularly if we continue to fall short on HIV prevention. 
As the UNAIDS Report states,

          ``Had the world made prudent investments 10-20 years ago--in 
        prevention, in strengthening health systems in low- and middle-
        income countries, in preserving and building essential human 
        resources, in addressing the corrosive effects of gender 
        inequities and other drivers of the epidemic--much smaller 
        amounts would be required today.''

    The same principle holds true today--we cannot afford the costs of 
inaction. A comprehensive, scaled-up HIV prevention response would 
avert more than half of all new infections that are projected to occur 
between 2005 and 2015. Unless we can prevent new infections, future 
treatment costs will continue to mount.
    Third, putting resources into combating AIDS is also key to 
improving health systems, if only because in many countries 50 percent 
of hospital beds are occupied due to AIDS. And if we can't reduce that 
burden through antiretroviral therapy, it's only going to get worse.

[[Page 51]]

    Fourth, because of the work we have done, we are now set to be more 
efficient in the future. A great deal of energy and time has been 
invested in setting up systems--supply chain management, procurement, 
community activities--which will provide us with greater economies of 
scale in the future.
    And, finally, earlier investments that have been made will be lost 
if we do not continue to trend upward. And as a European, I can also 
say that putting more money into PEPFAR will compel the rest of the 
world to do the same.
    We saw that when President Bush announced in his State of the Union 
in 2003 that this country would put $15 billion on the table in the 
fight against AIDS. And the Congress has actually appropriated more 
than the $15 billion pledged. This global leadership was followed by 
others--first the UK and, then others. This has happened time and again 
and demonstrates the true power of American leadership.
    In addition to increasing investments, we must maximize the 
effectiveness of our investments through partnerships and better 
coordination. We must make the money work more for people on the ground 
by spending it more efficiently. At UNAIDS, ``Making the money work'' 
is our mantra. That is what every staff member knows, that is what we 
are working for in countries in partnership with national governments 
and NGOs, PEPFAR and the Global Fund. It means maximizing our 
effectiveness by improving coordination among donors, government 
implementers, and everyone in the global fight against AIDS.
    It is no surprise that working in partnership produces significant 
results. In Rwanda, where governments are full partners, and the U.S. 
effort is fully integrated with national strategies, progress has been 
measurable. All this may sound a bit bureaucratic, but it means the 
difference between fighting AIDS effectively or losing ground.
    And finally, UNAIDS believes strongly that now is the time to add a 
long-term view, and sustainable strategies to the emergency response, 
the ``E'' in PEPFAR. This shift has a number of implications. First, it 
means supporting a country-driven and flexible response that allows for 
an enhanced focus on prevention. For every person who is put on 
antiretroviral therapy, six become infected with HIV. To get ahead of 
this epidemic, greater investments in prevention are absolutely 
essential. Furthermore, strategies must be designed and implemented 
that respond to the epidemic in that country, and the cultural and 
social context. It also means minimizing programmatic setasides to 
foster an appropriate balance among prevention, treatment, care and 
support in each country. We must increase support for solutions that 
work best for the particular country.
    When it comes to addressing AIDS, anything that has the word 
``only'' in it doesn't work--whether it's treatment only, prevention 
only, condoms only, abstinence only, male circumcision only. The fact 
is that we need it all to reach our goals. And, more importantly, we 
need to be smart and effective in our investments. We can benefit from 
lessons learned. And we have the added benefit that learning from our 
lessons will save lives.
    In conclusion, there is no doubt that, in large part due to U.S. 
leadership, we have made major progress in the fight against AIDS 
worldwide. As we prepare for the years to come, and as we make our 
budgets and formalize our plans, we must commit ourselves to not simply 
continuing our efforts, but intensifying them and adapting them to the 
new reality on the ground. We must adapt them to the new and 
encouraging reality that we've all created through U.S. and global 
investments and efforts.
    I am a big believer in the fact that while we cannot predict the 
future, we can create it. We have a road map for the fight against 
AIDS. We have the evidence to know what works. We have reached a 
turning point where even turning back slightly is a slippery slope that 
will jeopardize progress for years to come. We must continue the 
trajectory upward. And that will require your continued leadership and 
unwavering support.
    This committee, under the extraordinary leadership of Senator 
Kennedy, has been a true catalyst for progress and for saving lives--
for fighting AIDS and building sustainable health systems. I am 
confident that in the context of PEPFAR Reauthorization, this 
longstanding tradition will continue.
    UNAIDS stands ready to support this bipartisan effort in any way we 
can. To that end, I have included a host of recent UNAIDS publications 
that I hope you will find useful in your effort.
    Thank you very much.

    The Chairman. Thank you. Thank you very much. There's just 
three of us here so if it's alright with Senator Enzi, we might 
just take 7 minutes. Five minutes goes by quickly.

[[Page 52]]

    Dr. Zulu, how do you keep your sense of passion about this 
issue? What continues to motivate you? You've had an 
extraordinary career, faced incredible tragedy. Obviously had a 
very important impact in terms of altering and changing 
national, international policy. What sort of keeps you going?
    Ms. Zulu. Well, I think my story can be echoed by many 
children, as well as women in particular, in Africa. And that 
is why it's important to continue to ask for 10 percent to be 
allocated to the direct support of orphans and vulnerable 
children. And also the story that I bring here was once 
orphaned being the head of the house which many people have 
already spoken to, that we need to continue to support those 
African mothers, where community workers are helping child-
headed household and grandparent-headed household as well 
because we, the children, have been orphaned by HIV.
    We are growing. Today I'm a 31-year-old woman. And we are 
not just victims. But we want to be part of making the 
difference. And that is what it's all about.
    The Chairman. Are you basically more hopeful and optimistic 
given all of the focus and attention and both not just what 
you've heard today, but what you've seen over your 
extraordinary life about the concern and actions that have been 
taken?
    Ms. Zulu. Yes, absolutely. I think what the U.S. government 
has done through the Global bill is very important and the 
PEPFAR. But we also need to continue raising awareness in terms 
of the nutritional needs for people living with HIV and AIDS 
because when people are HIV positive, they have a higher 
request for nutrition. And if they do not have those things 
that drives them to involve themselves in risky behaviors and 
that also leads to a lot of children dropping out of school to 
work for food. So I think we need to work on that as well as 
gender equality issues.
    The Chairman. Well thank you very much. You're an 
inspiration to all of us.
    Dr. Hearst, I thank you for your focus and attention on the 
areas of prevention. You're familiar with the Institute of 
Medicine. They're passed the comments of even those that want 
to get the earmarking of percentages here. That they feel that 
there is a very, very important role for prevention, but 
there's also recognition that with the progress that's been 
made in recent times that there ought to be more flexibility 
that will permit these countries and these societies and these 
communities to develop their own kinds of programs, in their 
own kind of way with a tight kind of accountability. What's 
really wrong with that?
    Dr. Hearst. Well, I agree that in an ideal world there 
would be no need for these earmarks, but we have to be 
realistic when we talk about countries developing their own 
plans. I'm just back from Uganda, for example which is where A, 
B, C got started and was putting together their new 5-year 
plan. Really these plans get largely put together by a group of 
foreign consultants, westernized, local experts, who have 
absorbed the western model of dealing with concentrated 
epidemics where, for example the condom approach has been much 
more effective than it has been in Africa.
    And when you say let local people decide it ends up being 
this small circle that decides. The new Uganda report, for 
example, a

[[Page 53]]

nearly final version had almost removed all mention of A and B 
and it wasn't included in the numerical targets at all. That 
got, fortunately, improved.
    But I think the earmarks in PEPFAR I, in my opinion, have 
certainly done more good than harm. And I personally don't 
believe that we are ready to remove them. I don't think that 
would be a good idea.
    I'm not saying they couldn't be re-changed, recast, but we 
must keep our eye on the prize. Even this Uganda report with 
its improvements, 96 percent of the budget is being spent on 
things other than changing sexual behavior which is the thing 
that worked so spectacularly in Uganda.
    The Chairman. Dr. Smits, this is Dr. Hearst. He says 
they're there for the prevention aspects and that the countries 
aren't quite ready to make that kind of a judgment yet. And 
that this is a program that does work.
    You mentioned even in your very brief opening that Uganda 
has a prevention program. You've also indicated that you didn't 
need the earmarks and wanted accountability but what about the 
fact that in too many of these countries or many of these 
countries these programs are being drafted by people that are 
not of the people so to speak. Would you?
    Dr. Smits. I don't think that's entirely fair. I have only 
been to Uganda through the airport. So I really can't speak 
personally about the country.
    I did hear an outstanding speech at the implementers 
meeting by the leader of their AIDS program, who said, ``the 
way to fight this disease''--and he's in a country that's had 
great success--``to fight this disease in a prevention sense, 
is to identify the cause of the last thousand cases and focus 
on them.'' He went on to say, that in his country discourtened 
couples, people who are faithful to one another where one is 
positive and one is not are one of the biggest risk factors, if 
not the biggest risk factor.
    That means you need a new kind of counseling. You need to 
ensure partner testing for every time you identify one person, 
you have to find out the other. And you do need a different 
emphasis on condoms. This is not a country that is--that I 
perceived as rejecting the abstinence message.
    The Chairman. But just quickly, because my time's going to 
run out and I have one question for Dr. Piot. Just generally, 
without getting into one particular country, can you make the 
evaluation about all of these nations that are developing these 
different programs? We did know that there was initially a lot 
of reluctance in terms of moving. Some countries move much more 
rapidly than others.
    Dr. Smits. I found----
    The Chairman. But now we've made a very important and 
significant progress as we've heard from the earlier panel.
    Dr. Smits [continuing]. I find many, the countries that I 
do know well, have a lot of natural sympathy with the 
abstinence message and use it very effectively. But there are 
other prevention things that are needed and strict earmarks get 
in your way. You need to spend quite a bit of money for a few 
years to catch up with the demand for male circumcision, for 
example in some settings.

[[Page 54]]

    If your real problem is discourtened couples then you need 
to focus on educating them and on providing condoms. So that 
you need to know where your epidemic is right now and put your 
fight there.
    The Chairman. Ok.
    Dr. Smits. But let me just remind you, we have recommended 
an elimination of all earmarks, not just the abstinence one.
    The Chairman. Ok.
    Dr. Smits. We think the segregation into prevention, 
treatment and care is more of a problem in the field than 
Ambassador Dybul suggested simply because the funding streams 
force it.
    The Chairman. We might come back to that. Let me just ask 
in the final moment I have here, Dr. Piot. Your testimony 
highlights new estimates in declining of the prevalence of the 
disease. Can you describe how your organization tamed the 
latest HIV data estimates and how the data represents the 
current state of the epidemic?
    Dr. Piot. Yes, a few weeks ago, we announced a new estimate 
and one of the byproducts of the greater investments in AIDS is 
that we have much better information. Better information, I'll 
just give you one example. In India, 5 years ago, there were 
100 sites where HIV prevalence in pregnant women was followed. 
Today there are about 1,300. Of course, it is still for a 
country of one billion population.
    In addition there have been demographic and health surveys 
particularly starting in 2004, 2005, 2006. The results become 
available. And that led us to much better estimates.
    One of the key messages is that we're going into a far more 
complex picture of AIDS in the world. There are countries who 
will see a real decline in new infections. Take Kenya, as a 
result of among others the PEPFAR program, with a spectacular 
decline. They are now at the same level as Uganda because of 
prevention efforts. And that's true for most East African 
countries.
    We see a decline in mortality for the first time the last 3 
years. And that's probably due to treatment programs. And it 
comes much earlier than we thought. On the other hand we see 
countries like Mozambique where infections are going up and 
particularly in Eastern Europe, 150 percent increase in people 
with HIV over the last 5 years. And we see also an increase in 
East Asia.
    So the picture is becoming more and more complex but the 
good news is we're seeing results. We're seeing measureable 
results for all of our efforts.
    The Chairman. Senator Enzi.
    Senator Enzi. Thank you, Mr. Chairman. Dr. Smits, I thank 
you for the time that you spent with the Minister of Health in 
Mozambique. So far that's the poorest country that I've ever 
visited and I was just astounded by some of their challenges 
there.
    One of the challenges is languages. Virtually every tribe 
has a different language which prevents a lot of communication, 
particularly on AIDS, but other things as well. I asked the 
President of the country what his No. 1 goal was and it was to 
have everybody within 5 miles to have clean water. That's quite 
a shock to an American. You know, we just turn on the tap and 
we expect it to be cleaner than clean.

[[Page 55]]

    And I also found out during the course of that trip that if 
the cattle drank out of that, it was contaminated and people 
did their laundry in it and bathed in it. It was within 5 
miles. It met the country goal. And so there are a lot of 
challenges there and in the other countries.
    In your IOM recommendations you said that Congress should 
remove budget allocations and replace them with appropriate 
mechanisms to ensure accountability for results. Could you 
further discuss what those other appropriate accountability 
measures would be? That's one of the keys, I think.
    Dr. Smits. Well we could have days of seminar on that, but 
just a few examples. In treatment you want to have both the raw 
numbers. You have adherence of how people are taking the 
treatment, how long people stay on treatment and crucially do 
they return to a healthy and productive life.
    And you can measure do the children stay in school? Do the 
adults go back to work? Very important issues and if the 
program can bring those numbers to you, you should be comforted 
that they're doing what they should.
    In prevention you want to look very carefully at some of 
the surveys that Dr. Piot has mentioned, particularly behavior 
change surveys, delaying sexual initiation, different patterns 
of relationships. Some of these countries have, what I as an 
American, regard as problems with polygamy so that there are 
some issues there. Some of that's changing, but it's changing 
slowly.
    So that you can ask to see what's changing, what's been 
accomplished with the money rather than specifying percentages. 
That way if a country suddenly discovers it has a big problem 
with needle sharing where it hadn't been seen as a big problem 
before, they can focus all their prevention efforts, all their 
new prevention efforts there for a year and try to stamp it 
out.
    So that my sense is we understand the epidemic better, the 
local leaders understand it very well. And there are ways to 
target. And I have a lot of Mozambiquean friends who are really 
concerned about the new numbers. I need to talk to Dr. Piot 
about it afterwards.
    Senator Enzi. Well I'll follow up with some written 
questions on that.
    Dr. Smits. Yes, we'd be happy to respond to written 
questions.
    Senator Enzi. As the only accountant in the Senate, I love 
this accounting stuff, so----
    [Laughter.]
    I don't know if they'd be any good. Princess Zulu, from 
your experience what's been the best method to educate the at-
risk communities? What method draws the most positive attention 
to the pandemic? What would you suggest is the best way to 
educate without alienating?
    Ms. Zulu. I think it's critical that all methods are 
included. Abstinence and being faithful is very important to 
the approach, but it's just part of the whole approach of A, B, 
and C because we live in the real world and people are going to 
make different decisions. And so I think we have to be 
inclusive to everyone else.
    And again, I continue to go back to children are the faces 
of HIV and AIDS today. And they need to be taken into 
consideration. And

[[Page 56]]

direct care for them is critical and their voices need to be 
heard as well.
    Senator Enzi. Thank you.
    Dr. Smits. Could I just add briefly that advocates like 
Princess Zulu are incredibly important. I've met many of them, 
people under treatment who have become the message of 
prevention. I think that's one of the big changes I saw when 
going on the official visit.
    So I thank her. But I thank all the thousands of women like 
her.
    Senator Enzi. Yes. Thank you. Dr. Hearst, from a social 
standpoint there are a lot of challenges to educating 
individuals about HIV/AIDS. What programs have worked in 
relation to prevention and resulted in behavioral changes or 
shown signs of social stigma lessening, particularly the social 
stigma lessening?
    Dr. Hearst. Well, I think if we want to look at examples of 
success in changing behavior, certainly the earliest and 
perhaps still the best example is what happened in Uganda in 
the late 1980s and early 1990s when with very little 
international help--and probably if they'd had international 
help they wouldn't have done such a good job, frankly. Uganda 
decided to confront their AIDS epidemic and their approach was 
what we now call A, B, C. They really didn't call it that then. 
The emphasis was on zero grazing which means don't let your cow 
graze outside the family compound. In other words, don't go 
outside the home for sex.
    And you know we tend to get into this polarizing debate 
between A, abstinence and C, condoms, but really the main thing 
was B, the fidelity, reducing the number of partners. We have 
very good data on that--in fact, there were dramatic changes in 
sexual behavior. No, not everyone changed, but the proportion 
of people with multiple partners went way, way down.
    Also there was some increase in the age of sexual debut. 
And condoms were part of the message but the message was not, 
``here use condoms, do whatever you want, now it's ok.'' The 
message was, ``stick to your partner, but don't start sexual 
activity at too young an age'' and as the President himself 
often put it, and if you're going to do something really stupid 
anyway, at least use a condom. And rates went way down. 
Prevalence went down by two-thirds. Incidents went down. New 
infections went down even more than that.
    We're seeing now in many other African countries rates of 
infection, new infections going down. In almost every one of 
those countries that is preceded by changes in sexual behavior. 
Reductions in how many people have multiple partners. Seems 
that multiple concurrent partners, in other words, two or more 
ongoing relationships at once are particularly dangerous for 
how the virus spreads.
    We are not necessarily seeing in these countries 
differences in condom use. So as far as stigma goes, Uganda was 
a leader in reducing stigma. Reducing stigma can be part of 
prevention. It isn't necessarily prevention. You can reduce 
stigma without doing prevention. Reducing stigma is a good 
thing in and of itself.
    Similarly testing, testing is a great thing for treatment 
and very important for prevention of mother-to-child 
transmission that I think people have an exaggerated idea that 
getting everyone tested will immediately get them to change 
their behavior. In fact, the latest evidence from Africa is 
that in a randomized control trial in

[[Page 57]]

Zimbabwe, testing in fact, tend to make behavior worse. People 
who test negative think, oh, I'm ok. I don't have to worry 
anymore.
    We really have to keep our eye on the prize which is 
reducing multiple sexual partnerships which is how the virus 
spreads in a generalized epidemic.
    Senator Enzi. I think this has been one of the most 
shocking things to me mostly due to my lack of knowledge on it. 
I've been learning a little bit about it, but I was surprised 
at the lack of sex education, the taboo in fact. We've been 
talking about it. A father couldn't talk to a son. A mother 
couldn't talk to a daughter. And of course a father couldn't 
talk to a daughter or a mother to a son. And that's where a lot 
of that information could come from.
    But I found that there are some unique ways of conveying 
that information, but very difficult ways. One country was 
using the commercial sex workers to carry the message. So thank 
you for your answers. I have more that I will follow up with in 
writing. Thank you.
    The Chairman. Thank you.
    Senator Coburn.
    Senator Coburn. Thank you, Mr. Chairman. You know one of 
the things that strikes me both with our last panel and this 
panel is the assumption that our policy on prevention in terms 
of abstinence and fidelity and then condoms is not needed 
because we're there. We're the only country that has any 
emphasis on true prevention. All the rest of the world is 
spending their money on treatment and condoms. And so for us to 
discuss this in a vacuum saying we no longer need it when we're 
the only ones that are actually funding that message strikes me 
as unaware of what's actually happening.
    What I'm fearful of is like it was, early in 2005, when we 
looked at USAIDs malaria program in Africa, where less than 4 
percent of the money was actually going to treatment. We funded 
a lot of technical assistance programs and a lot of conferences 
and a lot of other things, but we didn't make any difference in 
anybody's lives in Africa. And I'm happy to say over 90 percent 
of the money now is actually going for treatment of malaria 
through the USAID program.
    And so this worry about having a mandate or an earmark for 
abstinence and for prevention, I think is critical because 
we're the only ones sending the message with our dollars. We're 
not the only ones sending the message, but we're the only ones 
saying a certain percentage of dollars.
    Dr. Hearst, thank you for coming all the way here. Your 
collaboration with Dr. Helene Gayle who was at the forefront of 
the knowledge as this epidemic was coming about and is not a 
conservative by any means and your study. Would you take just a 
minute to summarize the findings of your study because I think 
they're very instructional for us in terms of where we go?
    Dr. Hearst. I think you're referring to the study that was 
a few years ago, that was funded by UNAIDS to do a review of 
the evidence for how well condoms are working for AIDS 
prevention. And we pulled together a lot of information. I 
would say when I went into this I was pretty much your standard 
middle of the road per

[[Page 58]]

son in AIDS who was doing research on how to get people in 
Africa to use condoms.
    And we found that condoms are about 85 to 90 percent 
effective when they're used consistently and correctly. And 
that they have had a public health impact in concentrated 
epidemics, situations like, gay men in my hometown, San 
Francisco, or in Thailand where the epidemic was concentrated 
in commercial sex. But try as we might we could not find any 
good evidence that they have had any impact in generalized 
epidemics like most of the PEPFAR countries are.
    This was a surprise to me. I think it was a surprise to 
UNAIDS when I turned in the report. I think it's becoming a 
little bit more accepted now that certainly the condom-only 
approach is not the right approach. And apply the condom-first 
approach isn't the right approach either.
    I support the A, B, C approach which includes the C. I'm in 
no way opposed to condoms but I think there are a lot of 
reasons why condoms haven't worked as well in generalized 
epidemics. And I could go on about why I think that is, but the 
bottom line isn't for me to prove I know why they haven't 
worked. The bottom line is that they haven't. Thank you.
    Senator Coburn. Thank you. Dr. Smits, in your report in 
terms of your recommendations, were African leaders asking you 
or did we have complaints as you looked at this, that we should 
not be spending money on abstinence? Was there an African 
nation in PEPFAR that came to you and said, ``this is crazy?'' 
We shouldn't be doing this. We don't think this is a valid 
method as you bring it and make an agreement that somehow we're 
going to treat this epidemic.
    Dr. Smits. No, no. I don't believe. Everyone that we met 
with, well not everyone, but most of the people that we met 
with at the leadership level and that's the African leadership 
level, had very strong commitment to the abstinence message. 
They simply wanted more flexibility in terms of being able to 
pinpoint the sort of danger zones in the epidemic in their 
country.
    Since our visits, that pinpointing issue has become--a lot 
of that is male circumcision. As a physician, I'm sure you 
realize that's not an economical or easy intervention to 
undertake. It will cost a fair amount of money for several 
years in areas where there is demand--you can't force it, where 
men are now not circumcised. But it will have a big impact if 
we can get it done.
    So it's more the flexibility--it's not so much I don't 
approve of abstinence. It's I would like to focus on some other 
things.
    Senator Coburn. Is there any trend and I probably should 
have asked this of Ambassador Dybul or Dr. Gerberding, is there 
any trend in male circumcision at birth of the male children? 
Are we starting to see that? We know the lesser effective 
transmission with circumcision but is there now a trend in 
terms of public health strategy for male circumcision at birth?
    Dr. Smits. Dr. Piot could probably answer that better than 
I can. That news is very new.
    Senator Coburn. Yes.
    Dr. Smits. I mean there haven't been a whole lot of babies 
born since it. The tradition or circumcising or not 
circumcising in in

[[Page 59]]

fancy has very profound cultural implications. So I wouldn't 
expect to see it change rapidly.
    Senator Coburn. Ok.
    Dr. Piot.
    Dr. Piot. Dr. Coburn, I would say that we've been working 
with a number of countries particularly Swaziland, Mozambique 
where I met with the President a few months ago and who 
announced that they would launch now a program for circumcision 
both to offer it to adolescent and adult men, which is one 
quite complicated issue as you know very well, but then also 
starting it now with neonates, which I think is the best option 
in the long-term.
    So we're starting to see that translation of research into 
policy.
    Senator Coburn. I'd like the unanimous consent to introduce 
into the record from Dr. Edward Green from Harvard his PEPFAR 
and the IOM report and his analysis of that, if I may?
    The Chairman. Yes, it will be so included.
    [The information previously referred to follows:]
       Prepared Statement of Edward C. Green, Harvard University
    In anticipation of funding a 5-year extension of PEPFAR, the 
Institute of Medicine (IOM) was asked to carry out a general evaluation 
of what PEPFAR has accomplished to date. In spite of the long and 
impressive list of scientists who were consulted on this, or who are 
authors of the IOM report, there seems to be an underlying assumption 
that abstinence or even abstinence--fidelity/partner reduction together 
are only distractions from better interventions, such as condoms. In 
the parts of the report where the Uganda ABC approach is mentioned, it 
is often either mischaracterized or shown in a rather negative light. 
For example, ``It is important to understand that ABC represents 
neither a program nor a strategy, but a goal of changing key 
behaviors.'' Allocation of funds for AB programs would therefore be 
without merit if neither A nor B are programs or strategies, but just 
well-meaning but unachievable ideas or ideals.
    The report also sets up the usual straw man, abstinence-only, and 
then knocks it down, e.g., ``The committee has been unable to find 
evidence for the position that abstinence can stand alone or that 33 
percent is the appropriate allocation for such activities even within 
integrated programs.'' Who required that it stand alone? Abstinence 
should be part of a balanced, comprehensive program of prevention, 
relevant mostly for young people, especially if they have not yet 
became sexually active. It is regrettable that the language of the 
congressional earmark gave the impression that ``abstinence-only'' was 
the new policy, as if this were a stand-alone and time-unlimited 
intervention for all youth (many females in Africa marry while in their 
teens).
    There are some other weaknesses in the IOM report, in fact outright 
errors. It states: ``The epidemiologic facts are clear . . . the rate 
of new HIV infections continues to grow.''
    Of course this is not the case. UNAIDS has finally posted the data 
on its Web site that HIV incidence has been declining worldwide for 
about a decade. IOM must know the data, because even HIV prevalence 
(which occurs later than changes in incidence) has been declining 
globally for several years, with a few exceptions. It is now 
increasingly acknowledged that HIV incidence peaked globally in the 
mid- or late-1990s. To suggest otherwise reflects the advocacy (rather 
than scientific) posture of UNAIDS and other activist groups who 
continuously ask for more funds, yet no amount is ever enough.
    After the above comment, the report urges that we ``put the accent 
on preventive measures of proven efficacy on a much larger scale.'' 
``Proven efficacy does not seem to refer to A or B programs, even 
though we always see significant declines in the proportion of men and 
women reporting more than one sex partner in the past year in the 7-8 
African countries where prevalence decline has been established 
(literature the IOM seems unfamiliar with.)
    A related oddity: the AIDS prevention component of PEPFAR is meant 
to demonstrate that by concentrating resources on the 14 original focus 
countries, programs can have an impact on HIV prevalence. As it 
happens, prevalence is declining in at least half of the focus 
countries, yet nowhere is this acknowledged. This is truly a baffling 
oversight that demands some explanation. One might only refrain

[[Page 60]]

from mention of impact if there had been none, but this was not the 
case. This is not to say PEPFAR can necessarily claim credit for the 
improvements in HIV infection rates, but these improvements should be 
mentioned along with monitoring and impact evaluation strategies to 
determine any links between interventions and biological outcomes. 
There have been positive behavioral outcomes as well.
    The U.S. taxpayer deserves to know the impact of a $15 billion 
expenditure.
    As a recent member of the Presidential Advisory Council on HIV/
AIDS, International Committee, I helped write an internal document, a 
White Paper on PEPFAR, that we hope will influence the design of PEPFAR 
II. It is more evidence-based than the IOM report, which seems more a 
political consensus document.

    Senator Coburn. I just want to make one last point. And I 
want to show the poster of an ad. This ad tells the problem. 
Not everybody is so focused on a balanced approach and the 
fears that I have.
    I believe we need to change somehow some of the mix. But 
Botswana was essentially offended by this ad and you can 
understand why. It is that we're now endorsing through the use 
of a condom, the opposite of abstinence, the opposite of 
fidelity. And this is done with international dollars to make a 
point.
    But the fact is, that's the wrong message. And so you can 
see. You can take that down. You can see--I'll read it to you 
if you want.
    Here's what she says, Ke le, ``I'm 14 and I'm going out 
with an older man who adds flavor to my life. And one thing I 
do is have protected sex using lovers-plus condoms every 
time.'' Well this is a 14-year-old girl--that we're now 
encouraging the rest of the 14-year-old girls that you don't 
have to make a difference.
    The fact is, that's not the message. And the problem is, 
will we get back to that again? I was in Cote D'Ivoire in 2001 
and I saw the condom promotion, but that was all it was. There 
wasn't anything else there. And Cote D'Ivoire has a fairly 
high, you know, I think it's a 7 or 8 percent prevalence rate. 
And yet probably that prevalence right there is because it's 
seen in light of just that.
    You know, I've delivered 4,000 babies. I've done all sorts 
of things in this country. And I always tell all of my patients 
if you're going to do the other thing always use a condom.
    I believe there's another thing that we're not talking 
about and I know you're aware of it. And I know Dr. Hearst is 
aware of it. Is that we have an epidemic cervical cancer in 
Africa. And a condom doesn't do anything to prevent that.
    But fidelity, sexual delay and marked decrease in the 
number of partners are directly correlated with a woman not 
dying from cervical cancer. They don't usually die in this 
country because we have a wonderful health care system where 
women get PAPs and it's identified very early and treated 
before it can harm.
    But I guess the point I would make is we're going to have 
to have some strong discussions as we do this, as we modulate 
this. And I think it's very important and I hope that all would 
agree that we need to look at the dollars going into condoms 
and treatment and prevention in total. But we can't ignore the 
fact that we're the only ones talking about international 
dollars on A and B.
    We're the only ones who are mandating that money needs to 
be spent there. And in light of the total dollars it's not 
something we should walk away from if we really want to have a 
long-term impact on this epidemic. Thank you, Mr. Chairman.

[[Page 61]]

    The Chairman. Thank you and thank the panel. We're going to 
submit some additional questions.
    I think we all understand, certainly from this morning's 
testimony of all of our panelists that the years of evidence 
demonstrate that comprehensive prevention for HIV works. And 
we're now using the comprehensive prevention methods: 
abstinence, partnership reduction and consistent and corrective 
use of condoms. And Dr. Gerberding testified, Ambassador Dybul, 
the IOM, GAO will support a comprehensive support. And I 
believe that's what we should support as well.
    I want to thank all of our panelist. Very, very helpful. 
We'll be submitting some additional questions to you. We didn't 
get into the issues of prescription drugs and the differences 
that we have in terms of the FDA and other kind in the World 
Health Organization. There's other kinds of issues as well that 
I'd like to try to get into. So we'll be inquiring of you on a 
number of different kinds of matters that we'll be interested 
in, our committee's interested in as well. But this has been 
very, very valuable and we're grateful to all of you. The 
committee will stand in recess.
    [Additional material follows.]

[[Page 62]]

                          ADDITIONAL MATERIAL

Response to Questions of Senators Kennedy, Enzi, Dodd, Clinton, Brown, 
                        and Coburn by Mark Dybul
                      questions of senator kennedy
    Question 1. The IOM PEPFAR evaluation recommends that you study the 
WHO Pre-qualification Process and determine what it would take for that 
process to provide sufficient assurance of the quality of generic ARVs 
for purchase by PEPFAR so that we can transition to using that 
globally-accepted process as soon as feasible.
    How are you responding to this recommendation? Could you please 
explain precisely how FDA is regulating drugs in the focus countries? 
Do you see this as being a workable approach in the long-term, 
especially given the goals of harmonization and supporting countries to 
develop the capacity to sustain their own programs?
    Answer 1. The President's Emergency Plan for AIDS Relief (PEPFAR/
Emergency Plan) and the World Health Organization (WHO) are working 
together to make essential antiretroviral drugs (ARVs) more rapidly 
available in countries where they are most urgently needed. The U.S. 
Department of Health and Human Services (HHS)/Food and Drug 
Administration (FDA) and the WHO Pre-qualification Program have 
established a confidentiality agreement by which, with company 
permission, the two organizations share dossier information regarding 
reviews and inspections. As a result, generic ARVs which have been HHS/
FDA-approved or tentatively approved can be added rapidly to the WHO 
pre-qualification list. The rapid WHO pre-qualification of these 
medications hastens in-country drug regulatory review and, 
consequently, the availability of lower-cost, high-quality ARVs in-
country.
    The WHO pre-qualification program with generic drug manufacturers 
provides a valuable framework to assist countries in their procurement 
of medicines. The WHO pre-qualification program does not serve as a 
drug authority/agency but serves as a mechanism to evaluate and help 
ensure minimum drug quality. As drugs are reviewed and approved for 
addition to the ``pre-qualified'' list, this greatly aids developing 
countries as they seek to ensure quality when purchasing 
pharmaceuticals using resources from the Global Fund, other 
international partners, or country governments.
    In regard to regulating drugs in the focus countries, HHS/FDA does 
not regulate the approval or marketing of drugs in the focus countries 
of the Emergency Plan, or in any other countries outside of the United 
States. Each country maintains its own drug-regulatory system.
    However, approval or tentative approval from HHS/FDA of a drug 
(including a generic antiretroviral) is necessary for U.S. Government 
country teams and grantees to purchase that drug under the Emergency 
Plan. In May 2004, former HHS Secretary Tommy H. Thompson and former 
U.S. Global AIDS Coordinator Randall L. Tobias announced an expedited 
process through which HHS/FDA would review applications from generic 
manufacturers of antiretroviral medications for use under the Emergency 
Plan. That program has successfully given approval or tentative 
approval to 62 generic antiretroviral formulations. (If a product still 
has marketing protection in the United States, HHS/FDA issues a 
``tentative approval'' rather than a ``full'' approval. The 
``tentative'' approval signifies that a product meets all safety, 
efficacy, and manufacturing-quality standards for marketing in the 
United States, but existing patents and/or exclusivity prevent its full 
approval for marketing in the United States.)
    At the same time, HHS/FDA has worked to strengthen the knowledge 
and training of national drug-regulatory authorities in the Emergency 
Plan focus countries, alone and in collaboration with each other, so 
they can better ensure the quality of the medical products available to 
their citizens. Since 2005, FDA has held five drug-regulatory fora for 
international regulatory authorities. Representatives of 14 of the 15 
focus countries attended the first forum, and some countries have been 
able to send experts to subsequent fora in an attempt to train multiple 
members of their regulatory staffs.

    Question 2. Ambassador Dybul, the FDA has a program to tentatively 
approve generic HIV drugs, which can then be purchased with PEPFAR 
funds. This program supposedly provides for fast FDA reviews, of only 
several weeks. I understand, however, that in at least one instance, 
FDA's review of a generic HIV drug, the triple combination anti-
retroviral drug, took 3 years. Such a delay would delay PEPFAR access 
to the cheaper generic version of a drug, and in this case would have 
required patients to take several pills several times a day, instead of 
just one pill in the morning and one pill at night.

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    Could you send me information on the FDA review time for each drug 
that has been given tentative approval for purchase by PEPFAR?
    Answer 2. With respect to the drug referenced in the question, the 
3-year figure includes the time it took for the company in question to 
conduct studies against the U.S.-reference standard for the underlying, 
branded drugs in the fixed-dose combination, and to submit the results 
to HHS/FDA. Once the company submitted its full and complete 
application, HHS/FDA approved the generic HIV drug in less than 6 
months. We should note that the approval of this product marked the 
first time this particular triple-combination anti-retroviral therapy 
had met the standards of a stringent drug-regulatory authority.
    Since December 2004, HHS/FDA has approved or tentatively approved 
62 antiretroviral formulations under the expedited review program 
associated with PEPFAR. Timeframes vary for the review process for each 
product, which includes the time it takes for the companies to respond 
to requests for information. These products appear on the HHS/FDA Web 
site at http://www.fda.gov/oia/pepfar.htm, and on the Web site http://
www.globalhealth.gov. Antiretroviral formulations that receive approval 
or tentative approval from HHS/FDA also become eligible for procurement 
by grantees of the Global Fund to Fight AIDS, Tuberculosis and Malaria, 
and, through a special information-sharing arrangement, quickly appear 
on the pre-qualification list maintained by the Secretariat of the 
World Health Organization (WHO). The HHS/FDA expedited review process 
today facilitates the purchase by the Emergency Plan of approximately 
90 percent of its antiretroviral drugs from generic manufacturers, many 
in the developing world, and has greatly expanded the global 
marketplace for these companies because of our arrangements with the 
Global Fund and the WHO.
    The time for review by HHS/FDA for each drug given approval or 
tentative approval can vary, but, in large part, depends on the 
timeliness and completeness of the applications submitted by the 
companies. HHS/ FDA reviews the marketing applications by using its 
normal standards for approval. If a product still has marketing 
protection in the United States, HHS/FDA issues a ``tentative 
approval'' rather than a ``full'' approval. The ``tentative'' approval 
signifies that the product meets all safety, efficacy, and 
manufacturing-quality standards for marketing in the United States, but 
existing patents and/or exclusivity prevent it from being approved for 
marketing in the United States. Once any existing patents or 
exclusivities have expired, tentatively approved products can receive a 
full approval, which allows them to be marketed in the United States. 
Since the expedited review process began, HHS/FDA has fully approved 
seven drugs in this way.
    Under the expedited review process associated with the Emergency 
Plan, HHS/FDA works intensively with manufacturers that have not 
interacted with the agency previously to help them prepare an HHS/FDA 
application and to prepare for the requisite HHS/FDA inspections of 
their clinical trials and manufacturing facilities. Because of the 
significant public health impact of these products on the individual 
and population levels, HHS/FDA prioritizes the review of these 
marketing submissions. The review process can take a longer time when 
companies submit incomplete applications, or when follow up is 
required.

    Question 3. According to many experts, operations research is the 
best method of evaluating HIV/AIDS programs and service delivery and 
maximizing PEPFAR's financial investment and lifesaving impact--is this 
a priority for OGAC?
    Can you describe what OGAC has done in this regard? What are your 
recommendations for us to address operations research in PEPFAR 
Reauthorization?
    Answer 3. PEPFAR dedicated approximately $46.4 million to 
operations research and evaluation in fiscal year 2007, including 
spending for public health evaluations funded through PEPFAR's Country 
Operational Plan (COP), process, public health evaluations funded 
centrally by PEPFAR, and other operations research activities. Of this, 
$26.4 million was directed toward operations research in priority 
prevention activities, including those associated with gender-based 
violence, male circumcision, prevention with positives, adolescent and 
young girls, and men as partners. PEPFAR further spends over $135 
million on strategic information in all countries, including monitoring 
and evaluation activities that may include operational research. Some 
monitoring and evaluation activities are budgeted by countries under 
prevention, care, and treatment categories.
    Operations research and evaluation, including public health 
evaluations, are integral to guiding program implementation and 
improvement under PEPFAR, and significant resources are dedicated to 
this area. Guidance to country teams in PEPFAR focus countries suggests 
1 to 4 percent as a reasonable spending range to support public health 
evaluations in the COP planning process. This level of spending is ap

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propriate and compares to that provided under the Ryan White Care Act, 
which provides a useful domestic benchmark for the PEPFAR program.
    Another vitally important component of PEPFAR's program and its 
continued success is monitoring and evaluation (M&E). Indeed, PEPFAR's 
intensive focus on measuring progress, establishing evidence, and 
adapting to experience prompted the Institute of Medicine to label it a 
``learning organization'' in its congressionally mandated assessment in 
2006. PEPFAR guidance for country operational plans states that PEPFAR 
country teams should spend approximately 7 percent of their budget on 
strategic information, including M&E. M&E projects can be found 
throughout Country Operational Plans in every intervention area.
    One of the most useful ways to improve the impact of monitoring and 
evaluation in the next phase of PEPFAR is through an initiative to 
improve the quality of PEPFAR program indicators. PEPFAR is developing 
outcome-based indicators for programs in addition to its existing 
output indicators, which have centered on the number of people trained 
or served. These second generation indicators will help improve 
reporting on whether programs are having a positive or negative impact 
on the outcomes, such as risk behavior in youth, and also help 
strengthen monitoring at the individual, clinic/facility and program 
level. Monitoring and evaluation, therefore, will have a continued 
strategic role in assessing program effectiveness. Each PEPFAR 
technical working group (TWG) will develop a set of these indicators in 
consultation with country teams and international experts.
    Additionally, in 2007, PEPFAR developed the Public Health 
Evaluation (PHE) Framework to provide strategic coordination of 
evaluation activities. This framework monitors and supports country 
evaluation activities to help reduce redundancy and to share 
information across programs. More importantly, this framework supports 
broader strategic operations research that measures the effectiveness 
of programmatic interventions across populations and even countries, 
aiming to answer some of the most critical programmatic questions 
PEPFAR faces. All PHE activities are guided by interagency committees 
of strategic information experts, and successful evaluation activities 
are shared at the annual HIV/AIDS Implementers' Meeting to disseminate 
program results and thereby strengthen PEPFAR (and other) programs. The 
PHE framework will increase the impact, use, and dissemination of 
evaluation studies conducted in PEPFAR countries throughout the next 
phase. In fiscal year 2008, the PEPFAR interagency PHE Subcommittee and 
Scientific Steering Committee directed that PHE emphasize applied 
research efforts that: (1) address high-priority public health 
questions to inform and improve how services are delivered; (2) PEPFAR 
programs and partners are uniquely poised to address; and, (3) take 
advantage of central coordination of multi-country efforts to ensure 
sufficient scale and rigor. PEPFAR has moved aggressively toward 
implementing this heightened focus on coordinated multi-country PHE 
activities, in order to ensure that PHE studies might provide PEPFAR 
with definitive, scientifically informed operations research to guide 
the design and implementation of PEPFAR programmatic activities.
    Last, the role of monitoring and evaluation will be undertaken 
consistent with PEPFAR's continued support for the UNAIDS ``Three 
Ones'' principles: one agreed HIV/AIDS Action Framework that provides 
the basis for coordinating the work of all partners; one National AIDS 
Coordinating Authority, with a broad-based multi-sectoral mandate; and 
one agreed country-level M&E System. This commitment means that PEPFAR 
coordinates at a national level to support patient monitoring, program 
evaluation, and quality assurance activities, among others. PEPFAR has 
been a leader in building national capacity in the Ministries of Health 
and important civil society partners to manage the M&E portfolio. These 
efforts have included building surveillance and patient monitoring 
systems and training staff in the analysis and use of data for 
programmatic decisionmaking. In these efforts, PEPFAR is not the sole 
M&E provider but part of a team, working in coordination with other 
partners to ensure sustained country ownership, the continued support 
of other international partners, and ultimately, the sustainability of 
the national M&E program. PEPFAR investments in operations research are 
quite extensive under the current authorities of the Leadership Act and 
we look forward to working with you to develop further guidance and 
oversight.

    Question 4. What is the role of other agencies in the planning and 
reviewing of the yearly country operational plans? Is the time and 
level of feedback appropriate and most reflective of the knowledge on-
the-ground?
    Answer 4. PEPFAR is built upon a model of interagency coordination 
to achieve shared HIV prevention, care, and treatment goals. 
Collaboration among agencies occurs at the planning, implementation, 
and evaluation stages of HIV activities, as well as at the 
decisionmaking level.

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    In each country that receives PEPFAR support, a PEPFAR country team 
including representatives from USG agencies in-country (e.g. USAID, 
CDC, Peace Corps, and Department of Defense) works together to plan 
HIV/AIDS activities, in coordination with the host government and civil 
society. This process requires agencies to consider comparative 
strengths, avoid duplication, and provide technical coordination and 
support to one another to deliver one HIV/AIDS program with a shared 
set of targets at the country level. An ongoing ``staffing for 
results'' effort has further strengthened the concept of one 
interagency country team to achieve common targets, by profiling the 
expertise and function of each agency staff member and making sure she 
or he fits efficiently into one USG country team, without unnecessary 
overlaps between agencies. After planning, these USG country teams 
continue to work closely together to make sure that they achieve their 
shared targets. This includes regular technical and operational 
meetings, site monitoring, and evaluation visits.
    The Country Operational Plans (COPs) and results of each country 
program are assessed through a rigorous series of technical and 
programmatic reviews, which are conducted by working groups with 
participation from USAID, Department of State, Department of Health and 
Human Services (including National Institutes of Health, Health 
Resources and Services Administration, and Centers for Disease Control 
and Prevention), Department of Labor, Department of Commerce, Peace 
Corps, and Department of Defense. These interagency COP reviews are a 
complex and labor-intensive process that takes approximately 3 months. 
Further, PEPFAR's principals and deputy principals committees are 
interagency bodies that provide senior policy and implementation 
leadership. These committees meet regularly to make collaborative 
decisions on operational, technical, and policy issues.
    Collaborations with other agencies/offices of the USG also occur 
continuously to integrate HIV/AIDS activities with other development 
programs. PEPFAR's Public-Private Partnership section works closely 
with USAID's Global Development Alliance (GDA) to further integrate 
public-private partnerships in these and other areas.
    At the headquarters level, PEPFAR collaborates with other agencies 
through technical bodies such as the ``HIV/Food and nutrition working 
group,'' comprised of USAID Food for Peace and PEPFAR technical 
advisors that coordinate integrated HIV/food and nutrition activities. 
Further integration takes place through joint programming in-country, 
where country teams ``wrap around'' HIV prevention, care, and treatment 
activities with non-HIV activities. Every year, countries show 
increasing investment in these models of service integration.
    PEPFAR welcomes further dialogue and coordination at the 
headquarters level to share information, develop improved field 
guidance, and plan special initiatives. At the same time, decisions on 
the delivery of integrated and wrap-around programs will continue to 
take place at the country level, to make sure that interventions are 
appropriate to local needs. For this reason, PEPFAR reaches out on a 
continual basis to other agencies and offices so they can strengthen 
wrap-around programs by supporting PEPFAR field teams--such as through 
site visits and technical assistance during the COP planning season. 
Rather than making recommendations at headquarters during COP review, 
ongoing contact between programs in each country throughout the 
planning cycle is essential for wrap-around partners to have their 
input fully reflected in the COP document.
                        question of senator enzi
    Question 1. In relation to my question regarding barriers created 
by tariffs and duties, have you noticed any obstacles with tariffs and 
duties on goods, such as drugs, water, food, supplies, etc., that are 
donated by organizations outside of PEPFAR? Is this a concern we should 
focus on during reauthorization?
    Answer 1. The President's Emergency Plan for AIDS Relief (PEPFAR/
Emergency Plan) does not allow tariffs on commodities procured with its 
resources. U.S. Government bilateral Agreements, in particular 
agreements negotiated by the U.S. Agency for International Development 
(USAID) and the U.S. Department of Health and Human Services (HHS), 
provide exemption from tariffs and duties on goods.
    Standard terms for the USAID Agreements have evolved over the 
years, and in some cases agreements implementing arrangements with 
host-country Governments supplement the Agreements. However, the USAID 
Agreements all provide exemption from tariffs and customs duties (in 
addition to other tax exemptions), and generally extend these benefits 
to implementing partners and their employees. To avoid having such 
costs added to contracts, USAID staff negotiate these Agreements to 
stipulate the host government will allow implementing partners to 
import materials and equipment required under their contract free of 
customs duties and tariffs.

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Under a business model to pursue an interagency approach across the 
U.S. government, HHS, as one of PEPFAR's main implementing agencies, 
has used the USAID Agreements to leverage host Governments to provide 
exemption from customs duties and taxes for its agencies and 
implementing partners.
    Challenges remain to the tax- or customs-free delivery of goods and 
services in the name of humanitarian aid. USAID bilateral Agreements 
signed at the national level do not always translate down to 
operational levels, which can require ongoing efforts to ensure proper 
implementation. Donor organizations that are working independently in a 
country can still face multiple obstacles in negotiating with 
Government officials to import products duty-free. For pharmaceuticals, 
an added issue is registration for local use of the donated product, as 
well as the expiration date; any donated pharmaceutical product must be 
able to be fully incorporated into the existing health-care regimens.
    These Arrangements to implement assistance under PEPFAR on the 
ground generally function well for U.S. Government Departments and 
agencies and their implementing partners. However, taxes, fees, and 
customs duties are still a reality for several independent donors. The 
U.S. Government is working through multilateral channels to raise 
awareness of the barrier that taxes, fees, and customs duties place on 
assistance, and to the scaling-up of HIV/AIDS prevention, treatment and 
care programs to provide universal access. This ongoing, multilateral 
approach is the most effective means to advocate that host-country 
Governments adopt appropriate policies to exempt foreign assistance 
from such charges.
                       questions of senator dodd
Sustainability
    Question 1. When Congress passed PEPFAR in 2003, it was widely 
recognized that the HIV/AIDS pandemic in developing countries had 
reached crisis proportions and required an emergency response. During 
the next phase of PEPFAR this sense of urgency should be maintained--
the global pandemic clearly demands it. At the same time, country 
capacity must be dramatically expanded, to meet the current and future 
challenges of the pandemic and to achieve success and sustainability.
    The Institute of Medicine's 2007 report on PEPFAR implementation 
states,

          ``The continuing challenge for PEPFAR is to simultaneously 
        maintain the urgency and intensity that have allowed it to 
        support a substantial expansion of HIV/AIDS services in a 
        relatively short period of time while also placing greater 
        emphasis on long-term strategic planning and increasing the 
        attention and resources directed to capacity building for 
        sustainability . . . ''

    While there is a general consensus around the importance of moving 
toward sustainability, there is a need for clarity and definition to 
guide this transition. How would you define the term sustainability? 
How do you believe it should be put into practice in the field in this 
next phase of PEPFAR?
    Answer 1. There are three major areas where sustainability is a 
critical concern and a focus of Emergency Plan/PEPFAR programming: 
sustainability of services, organizational sustainability and financial 
sustainability. Achieving increased levels of sustainability through 
the greater assumption of responsibility over programming and 
management by host country nationals, as well as support for developing 
the capacity of local indigenous organizations, are key considerations 
in developing Emergency Plan Country Operational Plans (COP).
    The increase in PEPFAR funding coupled with changes in host nation 
policies has led, in many cases, to large increases in patient load and 
demand for treatment, counseling and testing, care and prevention 
programs. Host nation human resource capacity is being stretched to its 
limit. Since the government is one of the most sustainable 
organizations implementing HIV/AIDS programs in many countries, 
technical assistance is provided to human resource units of ministries 
of health to help facilities conduct workforce analyses to provide HIV/
AIDS services without compromising the budget or manpower for other 
health services. U.S. Government (USG) implementing partners working 
with nongovernmental organizations (NGOs) providing HIV/AIDS services 
are encouraged to harmonize local compensation practices with the 
ministries of health compensation for health workers with the 
understanding that they do not have to match government salaries but, 
in general, should not exceed them.
    The organizing structure, management, coordination and leadership 
provided by host governments and local NGOs are essential to an 
effective, efficient and sustainable HIV/AIDS response. Strengthening 
the institutional capacity of host governments and national systems is 
a fundamental strategy of the Emergency Plan. Activities are designed 
to increase the number of indigenous partners to help expand and 
diversify the country's base of partners and support a sustainable 
response.

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    In addition to efforts to support governmental and non-governmental 
capacity-building, other important activities for sustainability 
include: enhancing the capacity of health systems and health care 
workers; strengthening quality assurance; improving financial 
management and accounting systems; building health infrastructure; and 
improving commodity distribution and control. Where feasible, national 
information systems and supply chain management systems that serve an 
array of governmental and non-governmental partners are supported as 
opposed to separate costly systems for each partner.
    Country estimates of the number of health workers and other health 
managers that PEPFAR supports remain important as we maintain our 
longstanding emphasis on sustainable programs and scaling up country 
activities. In the fiscal year 2008 COP we requested that countries 
provide estimates of the numbers of staff who will receive full or 
partial salary support in the following three categories: clinical 
services staff; community services staff; and managerial and support 
staff. Staff in these three categories totaled 111,300 health care 
workers in the 15 focus countries plus India, Malawi, and Cambodia.
    While PEPFAR does not generally support salaries for government 
employees, there are many areas where PEPFAR is supporting staff in 
ministries and government facilities through technical advisors, 
recruiting agencies, and others.
    At present, host nations' ability to finance HIV/AIDS and other 
health efforts on the scale required varies widely. Many deeply-
impoverished nations are years from being able to mount comprehensive 
programs with their own resources alone, yet it is essential that these 
countries appropriately prioritize HIV/AIDS and do what they can to 
fight the disease with locally-available resources, including financial 
resources. A growing number are doing so. Many other nations do have 
significant resources, and are in a position to finance much of their 
own HIV/AIDS responses. Some countries are making progress, and a 
growing number of nations are investing in fighting HIV/AIDS on a scale 
commensurate with their financial capacity. In some cases, for example, 
host nations are procuring all or a portion of their own antiretroviral 
drugs (ARVs), while PEPFAR provides support for other aspects of 
quality treatment. These developments within hard-hit nations build 
sustainability in each country's fight against HIV/AIDS.
    With support from PEPFAR, host countries are developing and 
expanding a culture of accountability that is rooted in country, 
community, and individual ownership of and participation in the 
response to HIV/AIDS. PEPFAR is collaborating with host nations, UNAIDS 
and the World Bank to estimate the cost of national HIV/AIDS plans, a 
key step toward accountability. Businesses are increasingly eager to 
collaborate with the Emergency Plan, and public-private partnerships 
are fostering joint prevention, treatment, and care programs.
    While HIV/AIDS is unmistakably the focus of PEPFAR, the 
initiative's support for technical and organizational capacity-building 
for local organizations has important spill-over effects that support 
nations' broader efforts for sustainable development. Organizations 
whose capacity is expanded in order to meet fiduciary accountability 
requirements are also in an improved position to apply for funding for 
other activities or from other sources. Expanded health system capacity 
improves responses for diseases other than HIV/AIDS. Capacity-building 
in supply chain management improves procurement for general health 
commodities. Improving the capacity to report on results fosters 
quality/systems improvement, and the resulting accountability helps to 
develop good governance and democracy.
                       healthcare worker capacity
    Question 2. How is PEPFAR building health care worker capacity in 
the countries in which it operates?
    Answer 2. PEPFAR focuses on areas that most directly impact HIV/
AIDS programs: HIV/AIDS training for existing clinical staff such as 
physicians, nurses, pharmacists, lab technicians; management and 
leadership development for health care workers; and building new cadres 
of health workers. This support of local efforts to build a trained and 
effective workforce has provided the foundation for the rapid scale-up 
of prevention, treatment, and care that national programs are 
achieving, and provides a solid platform on which other health programs 
can build.
    Recognizing the continued importance of human capacity development, 
for fiscal year 2008 PEPFAR country teams were asked to estimate the 
amount of training they planned to support. They reported that they 
plan to support nearly 2.7 million training and re-training encounters 
in fiscal year 2008 alone, more than the cumulative total in the 
preceding 4 years.
    Pre-service training: It is clear that the expansion of care and 
treatment requires an expansion in the workforce to provide these 
services. In fiscal year 2008 the

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amount of PEPFAR funds each country team could use to support long-term 
pre-service training of health professionals was increased threefold, 
to $3 million. Unfortunately, few country teams took advantage of this 
opportunity, and long-term pre-service training will be a focus for the 
coming year. Namibia is one country that took advantage of this new 
allowance. There are no schools of medicine and pharmacy in Namibia, so 
in fiscal year 2008, there are plans to scale up an existing 
scholarship program for students in these disciplines to attend 
training institutions in South Africa, with a requirement to return. In 
Kenya, an HIV fellowship program has been developed to train senior HIV 
program managers. In Vietnam, PEPFAR is working with the Hanoi School 
of Public Health to increase the number of health professionals 
receiving advanced degrees in public health and management. There has 
also been a significant increase in support for expanding HIV curricula 
in pre-service training programs. These efforts reflect the increase in 
resources dedicated to training of new doctors, nurses, clinical 
officers, laboratory technicians, and pharmacists in HIV/AIDS.
    Support for salaries: Along with support for training, supporting 
new highly trained health professionals and task-shifting, PEPFAR 
supports the growing number of personnel necessary to provide HIV/AIDS 
services. To capture this support more comprehensively, in the fiscal 
year 2008 Country Operational Plans (COPs) PEPFAR country teams 
estimated the number of health care workers whose salaries PEPFAR is 
supporting. They reported support for over 111,000 workers, 
illustrating PEPFAR's commitment. PEPFAR has worked to ensure that 
these positions are sustainable for the long term. In Kenya, for 
example, PEPFAR has reached an agreement with the Ministry of Health to 
incrementally absorb these personnel into the public health system, 
providing long-term sustainability while also allowing for rapid hiring 
and deployment.

    Question 3. What is PEPFAR doing to help support ``task-shifting,'' 
the process of delegation whereby tasks are moved, when appropriate, to 
less specialized health workers?
    Answer 3. While building cadres of new highly trained professionals 
is a long-term objective of PEPFAR and other development initiatives, 
that takes years and we do not have years to wait. As experts from 
PEPFAR and the World Health Organization (WHO) argued in an article 
published in the New England Journal of Medicine, policy change to 
allow task-shifting from more specialized to less-specialized health 
workers is the one strategy that will have the most significant and 
immediate effect on increasing the pool of health workers in resource-
limited settings. Changing national and local policies to support task-
shifting can foster dramatic progress in expanding access to HIV 
prevention, treatment, and care, as well as other health programs. The 
Emergency Plan supported WHO's efforts to develop the first-ever set of 
task-shifting guidelines, released in January 2008. This continues and 
expands PEPFAR's support for the leadership of its host country 
partners in broadening national policies to allow trained members of 
the community--including people living with HIV/AIDS--to become part of 
clinical teams as community health workers.

    Question 4. What is PEPFAR doing to specifically address the need 
for providers trained to address the special needs of children with 
HIV/AIDS? What are the unique challenges for providers of pediatric and 
family-centered care?
    Answer 4. A number of challenges remain to scaling up services to 
meet the unique needs of children.

Challenge 1: HIV Diagnostic Testing

    Most pediatric HIV infections worldwide are attributable to mother-
to-child transmission, with transmission occurring during pregnancy, 
around the time of birth, or through breast feeding. Barriers to 
testing infants and children for HIV infection lead to a delay in 
diagnosis, and many infants and young children die before HIV is 
diagnosed or treatment can be given. It is estimated that 50 percent of 
HIV-
positive children will die before the age of 2 years if they are not 
treated.
    For adults and children older than 18 months, diagnosis of HIV 
infection is made by identification of antibodies to HIV in serum. 
However, because of the transfer of maternal HIV antibodies to the 
infant, newborn infants and children younger than 18 months will often 
test positive for the presence of anti-HIV antibodies even in the 
absence of true infection. Therefore, definitive diagnosis of HIV 
infection among infants and children younger than 18 months often 
requires the use of special infant diagnostic tests (i.e., HIV-specific 
RNA or DNA) to detect the virus itself, instead of the inexpensive and 
readily available antibody tests that can be used in adults and 
children older than 18 months. These special tests are more complex to

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perform and more expensive, and are not available in many resource-
constrained areas of the world in which the risk of HIV infection in 
infancy is highest.
    PEPFAR's existing authorities have allowed it to respond to this 
challenge. PEPFAR supported the development of the innovative dried 
blood spot polymerase chain reaction (PCR) test, for HIV-specific RNA 
or DNA, improving the rate of accurate and timely HIV diagnosis in 
infants under 18 months. PEPFAR is now supporting a significant scale-
up of this new testing technology in Botswana, Rwanda, South Africa, 
Uganda, Namibia, Zambia, Kenya, Mozambique, Ethiopia, Cote d'Ivoire, 
Nigeria, Malawi and China, through the establishment of national 
guidelines, training of personnel, and implementation support. This 
effort will help to identify more quickly HIV-positive infants under 18 
months and to link them to care and treatment programs.
    PEPFAR also helped develop guidelines for the use of HIV rapid 
tests that have been disseminated to PEPFAR countries to support a 
systematic scale-up of rapid HIV counseling and testing for children, 
adolescents, and adults. PEPFAR is further supporting policy 
development and program implementation to hire thousands of lay 
counselors to implement quality HIV counseling and rapid testing 
throughout PEPFAR focus countries, including among infants and children 
over 18 months. A priority for such counseling and testing activities 
is to establish adequate linkages for infants and children to care and 
treatment services.
    An important component of the scale-up of infant diagnosis will be 
the expansion of sites where infants at risk of HIV can be identified 
and tested. Prevention of mother-to-child HIV transmission (PMTCT) 
programs at antenatal care sites provide excellent access to infants at 
risk of HIV. PEPFAR is substantially increasing its support for the 
national scale-up of PMTCT programs through the development of national 
PMTCT policies, strategies and program plans; provision of training, 
infrastructure support, and assistance for monitoring and evaluation 
activities; development of key reference PMTCT tools for program 
implementation and country adaptation; and collaboration with 
multilateral partners, including WHO and UNICEF.
    A foundational component of PEPFAR's scale-up of infant diagnosis 
is PEPFAR's continued strengthening of national, tiered laboratory 
networks that have the capacity for accurate and timely infant 
diagnostics. This includes training and mentoring laboratory personnel, 
establishing standard laboratory operating procedures for HIV and TB 
diagnostics, providing a reliable supply of test kits and laboratory 
reagents, renovating and constructing laboratories, and developing 
quality assurance mechanisms, among other activities. In fiscal year 
2007, PEPFAR invested over $160 million in strengthening laboratory 
systems.
    Scaling up infant diagnostic testing, rapid HIV testing, laboratory 
strengthening, and linkages from testing to infant and child care and 
treatment will continue to be priorities for PEPFAR in the next phase.

Challenge 2: Clinicians to Provide Care for Children With HIV

    Even where appropriate HIV diagnostic testing is available and 
drugs for treatment of HIV infection and prophylaxis for HIV-associated 
infections are accessible, lack of personnel trained in treatment of 
children with HIV severely limits access to treatment for large numbers 
of children. In many areas of the world, medical care is provided by 
physicians, nurses, and other clinicians with training and experience 
in the management of adult, but not pediatric, patients. Additional 
efforts are needed to expand the availability of clinicians who are 
skilled in pediatric HIV care in resource-limited areas of the world.
    PEPFAR has made sizeable investments in building the health 
workforce capacity in PEPFAR countries to provide pediatric care and 
treatment, and will continue to do so. First, PEPFAR provides partial 
and full salary support for physicians, clinical officers, and nurses 
providing HIV care and treatment for infants and children across 
national HIV/AIDS programs.
    Second, PEPFAR strengthens pre-service training institutions, such 
as schools of medicine, nursing, and pharmacy, to produce graduates 
qualified to work in pediatric HIV care and treatment. Activities 
include developing curricula, hiring and training faculty, and 
providing scholarships for students to attend school within or outside 
their countries. In the case of Namibia, no schools of medicine or 
pharmacy exist, so an ongoing scholarship program supported by PEPFAR 
has successfully subsidized students to study in South Africa, with the 
agreement to serve in the public health system for 2 years upon 
completion of their degree.
    Third, PEPFAR has supported the on-going training and mentorship of 
thousands of medical providers, nurses, and pharmacists in pediatric 
care and treatment services. Notably, PEPFAR has been promoting and 
supporting a standardized model of pediatric care and treatment in the 
focus countries. This 10-Point Package for Com

[[Page 70]]

prehensive Care of an exposed/infected child includes: (1) Early infant 
diagnosis; (2) Growth and development monitoring; (3) Routine health 
maintenance; (4) Prophylaxis for opportunistic infections (5) Early 
diagnosis and treatment of infections; (6) Nutrition counseling; (7) 
HIV disease staging; (8) ART for eligible children; (9) Psychosocial 
support to the child and family; and (10) Referral for additional care. 
Providing a standardized model of care helps ensure PEPFAR countries 
are providing quality care for infants and children in a systematic 
manner.
    Fourth, PEPFAR has further supported the development of ``centers 
of pediatric treatment excellence,'' which establish best practices and 
facilitate training and skills-building among pediatric providers in 
multiple PEPFAR countries. PEPFAR will continue to leverage the current 
rapid expansion of care and treatment services for people living with 
HIV/AIDS to expand pediatric access beyond centers of excellence to 
community-based health facilities. In Zambia, for example, with support 
from PEPFAR and the Global Fund, the government expanded antiretroviral 
treatment to children at primary health care centers, using a model led 
by nurses and clinical officers. The program resulted in strong health 
outcomes, providing further evidence for the PEPFAR-supported model of 
``task-shifting,'' or the shifting of care responsibilities from more 
specialized providers to less specialized.
    Last, a WHO-PEPFAR collaboration on task-shifting in seven 
countries mapped the provision of care and treatment services by all 
levels of providers, including providers of care to children. WHO 
normative guidelines on task-shifting for HIV prevention, care, and 
treatment were developed and are now available on the WHO Web site. 
These guidelines will help countries scale up pediatric and adult care 
and treatment more rapidly, by making strategic use of their existing 
health workforce.

Challenge 3: ARV Formulations

    Assuming that appropriate HIV diagnostic testing is available, and 
the necessary clinical personnel are available to provide care and 
treatment to HIV-infected children, appropriate formulations of 
antiretroviral drug (ARV) agents for children are also necessary. 
However, pediatric formulations may cost up to four times as much as 
adult formulations, and the regimens can be complex and difficult to 
follow. Lack of availability of appropriate ARV formulations that are 
inexpensive and easily usable is a major impediment to access for 
children with HIV.
    PEPFAR's existing authorities have allowed it to respond to this 
challenge. Most notably, PEPFAR has announced an unprecedented public-
private partnership to promote scientific and technical solutions for 
pediatric HIV treatment, formulations, and access. This partnership 
seeks to capitalize on the current strengths and resources of: 
innovator pharmaceutical companies in developing, producing and 
distributing new and improved pediatric ARV preparations; generic 
pharmaceutical companies that manufacture pediatric ARVs or have 
pediatric drug development programs; the U.S. Government in expediting 
regulatory review of new pediatric ARV preparations and supporting 
programs to address structural barriers to delivering ART to children; 
and civil society/multilateral organizations to provide their expertise 
to support the success of the partnership.
    The partners are working to identify scientific obstacles to 
treatment for children that the cooperative relationship could address. 
They are also sharing best practices on the scientific issues 
surrounding dosing of ARVs for pediatric applications. Finally, the 
partners are developing systems for clinical and technical support to 
facilitate rapid regulatory review, approval, manufacturing and 
availability of pediatric ARV formulations. An upcoming meeting of the 
pediatric public-private partnership will highlight the group's 
progress to date.

Challenge 4: Appropriate Dosing of ARVs in Children

    Even when appropriate formulations of ARV agents are available for 
children, pharmacokinetic data may be insufficient to appropriately 
guide drug dosing, especially in the youngest children (who metabolize 
these drugs differently) but also in adolescents, who may need higher 
than the ``maximum adult dose'' for adequate drug exposure. Earlier 
evaluation of ARV safety and pharmacokinetics in children is needed so 
that when new ARV formulations are approved for use in adults, there 
are also preparations available for children; enough information about 
drug pharmacokinetics in children is available to allow rational dosing 
recommendations. Appropriate dosing of drugs in pediatric patients 
requires measurement of weight and height and the complex calculation 
of body surface area. The requirement for different doses according to 
age, weight, and body surface area may put accurate prescribing and 
safe dispensing of ARVs and other drugs to pediatric patients beyond 
the reach of many of the front-line health care professionals who treat 
children with HIV.

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    Under existing authorities, PEPFAR has supported the development 
and implementation of WHO-simplified dosing guides, which are readily 
available to clinicians who care for children and adolescents with HIV 
infection in resource-limited settings (available at www.who.int/hiv/
paediatric/en/index.html). These guides will increase the accuracy of 
dosing and dispensing ARV medications to children. The PEPFAR pediatric 
technical working group has also assisted in the development of the 
``Handbook for Pediatric AIDS in Africa,'' which provides instructions 
and job aids on simplified dosing and quality services in pediatric 
care and treatment.
    Moreover, through a fast-track approval process developed under 
PEPFAR, HHS/FDA recently approved the first-ever fixed-dose pediatric 
formulation, which simplifies dosing of, and adherence to, a triple 
combination of pediatric ARV innovator drugs for use in children under 
12 years old. This formulation is one of 51 HIV/AIDS drugs approved or 
tentatively approved for purchase under PEPFAR by HHS/FDA. Further, 
through an existing agreement with WHO, this HHS/FDA-approved 
formulation is added automatically to the WHO prequalification list, 
which will expedite the regulatory processing of this formulation at 
the national level across PEPFAR countries.
    Lastly, concerning family-centered care, this type of care offers 
members of a single household access to HIV testing, treatment, 
prevention services such as bed nets for malaria, and other care 
services in one encounter with the healthcare system, whether in the 
home or in a facility. It represents a public health approach that 
recognizes the link between the family environment and health and 
leverages the availability of the healthcare worker to provide 
consistent care and prevention messages to an entire family. Although 
widely accepted as a model of delivering care, family-centered care 
requires healthcare providers to provide care to both adults and to 
children, and in some cases may raise issues around confidentiality 
within families. Both of these challenges are routinely overcome 
through healthcare worker training, and the use of a public health 
model of delivering care and services.
Prevention of Mother-to-Child Transmission (PMTCT)
    Question 5. Every day more than 1,100 children across the globe are 
infected with HIV, the vast majority through mother-to-child 
transmission. What is most tragic is that research has shown that these 
infections are largely preventable. The simple reason that the 
infection rate among children remains so high is that pregnant mothers 
and their babies are not getting the life-saving care they need. Less 
than 10 percent of pregnant women with HIV in resource-poor countries 
have access to prevention of mother-to-child transmission services.
    What do you think have been the specific barriers to reaching more 
mothers and babies?
    Answer 5. Mother-to-child transmission remains the leading source 
of child HIV infections, and prevention of mother-to-child transmission 
(PMTCT) remains an essential challenge. According to UNAIDS, the global 
number of children who became infected with HIV has dropped slightly, 
from 460,000 in 2001 to 420,000 in 2007.
    Access to vital antenatal clinic (ANC) interventions varies across 
the focus countries. As a key element of its support for comprehensive 
programs, the Emergency Plan supports host governments' and other 
partners' efforts to provide PMTCT interventions, including HIV 
counseling and testing, for all women who attend ANCs. Key obstacles to 
successful scale-up of PMTCT programs that PEPFAR is working to address 
include: (1) failure to adopt and fully implement ``opt-out'' provider-
initiated counseling and testing; (2) lack of integration of PMTCT as a 
basic part of maternal and child health care; (3) difficulties 
extending coverage to peripheral and rural sites; and (4) challenges in 
developing effective linkages with HIV care and treatment services.
    Despite significant resources from PEPFAR, levels of PMTCT coverage 
continue to vary dramatically from country to country. While all PEPFAR 
focus countries have scaled up services significantly in recent years, 
the results in some countries remain disappointing. Yet, nations that 
have adopted and implemented opt-out testing have dramatically 
increased the rate of uptake among pregnant women, from low levels to 
around 90 percent at many sites.
    Barriers currently limiting the scale-up of pediatric treatment and 
care services for children infected through maternal transmission 
include a lack of providers equipped with the necessary skills to 
address the special needs of HIV-positive children, the relatively high 
cost of pediatric ARV formulations, regulatory barriers to registering 
pediatric ARV formulations, weak linkages between PMTCT and treatment 
services, and limited information about pediatric doses of medicines at 
different ages and weights.


[[Page 72]]


    Question 6. Where is PEPFAR succeeding in overcoming these barriers 
and where is it falling short?
    Answer 6. To address these barriers, PEPFAR has supported host 
nations' efforts to provide PMTCT services, including HIV counseling 
and testing, for all women who attend antenatal clinics (ANCs), and 
sharply increased its PMTCT resources in fiscal year 2007. PEPFAR has 
supported PMTCT services for women during approximately 10 million 
pregnancies to date, providing antiretroviral prophylaxis for over 
827,000 women who were determined to be HIV-positive, preventing an 
estimated 157,000 infections of newborns.
    Some countries, such as Botswana and South Africa, had already 
started their PMTCT programs before the U.S. Government's Mother and 
Child HIV Prevention Initiative was launched in 2002. Many nations have 
made very significant progress in reaching pregnant women with PMTCT 
interventions with PEPFAR support in the last 4 years. In other 
countries, progress has been slower, and the Emergency Plan is 
supporting these nations in redoubling efforts to close the gap. When 
comparing results from the first year of PEPFAR in fiscal year 2004 to 
fiscal year 2007, all countries have scaled up, and most have 
dramatically improved availability of PMTCT services to pregnant women.
    Under the highly successful national program in Botswana, where 
approximately 13,000 HIV-infected women give birth annually, the 
country has increased the proportion of pregnant women being tested for 
HIV from 58 percent in fiscal year 2004 to 92 percent in fiscal year 
2007. The percentage of infants born infected has declined to 
approximately 4 percent, compared to about 35 percent without a PMTCT 
program. This type of change can be seen in other countries as well. It 
reflects a combination of political leadership, adoption of opt-out 
testing policies, and the introduction of rapid testing. Increased 
integration of maternal and pediatric care services is another critical 
piece of successful programs, and is another component of the technical 
guidance provided to countries as they prepare their PEPFAR country 
operational plans. Without effective implementation of the policies, 
success similar to that achieved by Botswana is unlikely to occur.
    PEPFAR has also expanded access to treatment for children, with the 
number of children receiving antiretroviral treatment through 
downstream PEPFAR support increasing 77 percent from fiscal year 2006 
to fiscal year 2007. PEPFAR dedicated nearly $191.5 million to 
pediatric treatment in fiscal year 2006 and 2007 combined, reaching 
approximately 85,900 children with downstream support in fiscal year 
2007, compared with only 4,800 in fiscal year 2004.
    In the same way that successful maternal health programs have 
supported human resource development and training and use of lower 
level providers such as nurse midwives where appropriate, PEPFAR 
supports training programs for healthcare workers in HIV prevention, 
care and treatment and task-shifting to make the best use of the 
available health workforce. In fiscal year 2008 Country Operational 
Plans (COPs), PEPFAR country teams estimated that PEPFAR is supporting 
the salaries for over 111,000 workers and is working with governments 
to ensure the sustainability of these positions. Additionally, it is 
estimated that PEPFAR supported training or re-training of 109,826 
individuals in the prevention of mother-to-child transmission between 
fiscal year 2004 and fiscal year 2007. This high level of support of 
human resource development, along with increasing support of maternal 
and pediatric antiretroviral treatment, is further evidence of PEPFAR's 
commitment to reducing transmission of HIV to children and supporting 
those children infected and affected by HIV/AIDS.

    Question 7. In 2001 the United Nations set a goal to cut the number 
of pediatric infections by half in 2010. To reach this goal, it is 
estimated that 80 percent of pregnant women must have access to PMTCT 
services. As you may know, I recently introduced the ``Global Pediatric 
HIV/AIDS Prevention and Treatment Act,'' along with Senator Gordon 
Smith, which would set a target that within 5 years (by 2013), in those 
countries most affected, 80 percent of pregnant women receive HIV 
counseling and testing, with all those testing positive receiving 
antiretroviral medications for the prevention of mother-to-child 
transmission.
    Can you provide your thoughts on such a target?
    Answer 7. Prevention of mother-to-child transmission (PMTCT) is a 
key element of the prevention strategies of host nations, and PEPFAR is 
supporting their efforts. Across focus countries, the Emergency Plan 
has increased the estimated coverage of pregnant women receiving HIV 
counseling and testing from 6 percent in fiscal year 2004 to 23 percent 
in fiscal year 2007. As noted in the answer to Question #2, the 
Emergency Plan's goal is to replicate the results of the highly 
successful national program in Botswana, where approximately 13,000 
HIV-infected women give birth annually, the country has increased the 
proportion of pregnant women being

[[Page 73]]

tested for HIV from 58 percent in fiscal year 2004 to 92 percent in 
fiscal year 2007. The percentage of infants born infected has declined 
to approximately 4 percent, compared to about 35 percent without PMTCT 
interventions. This type of change can be seen in other countries as 
well. It reflects a combination of political leadership, and 
implementation of opt-out and rapid testing. Without these changes of 
policy--and effective implementation of the policies--success similar 
to that achieved by Botswana is unlikely to occur.
    Nations have sought to ensure that all women receive the option of 
an HIV test through pre-test counseling during pregnancy (or at or 
after delivery, if they do not seek care before delivery). By promoting 
the routine, voluntary offer of HIV testing--so that women receive 
testing unless they opt-out--host nations have increased the rate of 
uptake among pregnant women from low levels to around 90 percent at 
many sites. Adoption and effective implementation of opt-out testing, 
rapid testing, and other essential policy changes, is essential for 
success and providing pregnant women with as much access to PMTCT 
interventions as possible.

    Question 8. How is PEPFAR currently integrating PMTCT services with 
continuum of care services for mothers and families? How can PEPFAR 
improve the integration of PMTCT services with other prevention, care 
and treatment programs?
    Answer 8. Mother-to-child transmission remains the leading source 
of child HIV infections, and prevention of mother-to-child transmission 
(PMTCT) remains an essential challenge. As a result, PEPFAR programs 
are increasingly linked to other important programs in prevention, 
treatment, and care--including those of other USG agencies and other 
international partners--that meet the needs of people infected or 
affected by HIV/AIDS in such areas as nutrition, education, and gender.
    For example, in Uganda, PEPFAR and the President's Malaria 
Initiative (PMI) are providing joint funding of a nationwide health 
facility survey. Several PEPFAR partners have gained access to free 
insecticide-treated nets (ITN) through PMI support, and PEPFAR and PMI 
are providing joint support for antenatal clinic (ANC) interventions 
for malaria and HIV/AIDS (e.g., distribution of ITNs through ANCs, and 
integrated training linking PMTCT and malaria prevention to maternal 
and child health curriculums).

    Question 9. Do you agree that voluntary family planning services 
are an essential component of comprehensive PMTCT?
    Answer 9. No. HIV prevention and voluntary family planning are two 
distinct activities with distinct purposes, and are supported through 
distinct U.S. programs. PEPFAR does, however, support linkages between 
HIV/AIDS and voluntary family planning programs, including those 
supported through USAID's Office of Population and Reproductive Health 
(PRH). PEPFAR works to link family planning clients with HIV 
prevention, treatment and care, particularly in areas with high HIV 
prevalence and strong voluntary family planning systems. Voluntary 
family planning programs provide a key venue in which to reach women 
who may be at high risk for HIV infection. PEPFAR supports the 
provision of confidential HIV counseling and testing within family 
planning sites, as well as linkages with HIV care and treatment for 
women who test HIV-positive. Ensuring that family planning clients have 
an opportunity to learn their HIV status also facilitates early up-take 
and access to PMTCT services for those women who test HIV-positive. 
PEPFAR's efforts remain focused on HIV/AIDS prevention, treatment and 
care, complementing the efforts of USAID/PRH programs and other 
partners.
                      questions of senator clinton
    Question 1. In your testimony, you note that the U.S. government 
has provided treatment for more than 1 million individuals worldwide. 
How many women are currently receiving treatment through the 
President's Emergency Plan for AIDS Relief (PEPFAR)? How many of them 
are pregnant women enrolled in programs to prevent mother-to-child 
transmission of HIV, and how many of them are non-pregnant women? How 
many children are enrolled in U.S.-funded treatment programs?
    Answer 1. Globally, the President's Emergency Plan for AIDS Relief 
(PEPFAR/Emergency Plan) supported life-saving antiretroviral treatment 
for approximately 1,445,500 men, women and children through September 
30, 2007. Of the 1 million people receiving antiretroviral treatment 
through direct U.S. Government (USG) support in the focus countries, 
nearly 86,000, or 9 percent, are children age 14 and under. This 
represents a 77 percent increase over the number of children on PEPFAR-
supported treatment in fiscal year 2006. In the focus countries, 62 
percent, or approximately 620,000, of the 1 million individuals on 
antiretroviral treatment as a result of direct PEPFAR support are women 
and girls.

[[Page 74]]

    In addition, the Emergency Plan has supported through September 30, 
2007 in PEPFAR's 15 focus countries: prevention of mother-to-child HIV 
transmission services for women during more than 10 million 
pregnancies; antiretroviral prophylaxis for women in 827,000 
pregnancies; prevention of an estimated 157,000 infant infections; care 
for more than 6.6 million people, including care for more than 2.7 
million orphans and vulnerable children; and over 33 million counseling 
and testing sessions for men, women and children.

    Question 2. According to the Government Accountability Office 
(GAO), your office has mandated that 66 percent of sexual prevention 
funding be spent on ``AB'' activities--activities that focus on 
abstinence and being faithful. However, more than 40 percent of women 
in Africa are married before their 18th birthday, and may have little 
control or influence over the sexual activities of their partners. 
Given these factors, how does your office justify the 66 percent 
spending requirement? How are you working to protect women who need 
information beyond what is provided through ``AB'' activities?
    Answer 2. Millions of women and girls do not have the power to make 
sexual decisions. Abstinence, like condom use, is not an option when 
you lack the power to choose or are faced with sexual coercion or rape. 
Therefore, girls' education and women's empowerment are critical in the 
fight against AIDS. PEPFAR strongly supports addressing gender dynamics 
in all aspects of programming. Young girls who are married must receive 
a comprehensive Abstain, Be faithful, correct and consistent use of 
Condoms (ABC) prevention intervention. While ABC programs must be 
comprehensive to be effective, they also must be tailored to the 
contours of the epidemic in its specific time and place. ABC behavior 
change must undeniably be at the core of prevention programs, but one-
size-does-not-fit-all. This is why PEPFAR takes different approaches, 
depending on whether a country has a generalized and/or a concentrated 
epidemic. The existing directive that 33 percent of prevention funding 
be spent on abstinence and faithfulness programs is applied across the 
focus countries collectively, not on a country-by-country basis--and 
certainly not to countries with concentrated epidemics.
    In countries with concentrated epidemics where, for example, 90 
percent of infections are among persons in prostitution and their 
clients, the epidemiology dictates a response more heavily focused on B 
and C interventions. For this reason, PEPFAR changed its fiscal year 
2008 guidance to waive the directive that abstinence and faithfulness 
programs receive at least one-third of prevention resources for 
countries with concentrated epidemics--defined as a prevalence rate 
below 1 percent. (It was possible to do this because compliance with 
the directive is assessed for PEPFAR as a whole.) In countries with 
prevalence above 1 percent where PEPFAR teams believe meeting the 
abstinence and faithfulness directive would not make epidemiological 
sense, programs may also submit a justification explaining why they 
have chosen not to meet the requirement. PEPFAR has never rejected such 
a justification, and the number submitted by the focus countries has 
grown from 8 in fiscal year 2006 to 11 each in fiscal years 2007 and 
2008.
    Moreover, PEPFAR fully integrates gender considerations into all 
its prevention, care, and treatment programs, recognizing the critical 
need to address the inequalities between women and men that influence 
sexual behavior and put women at higher risk of infection--as well as 
those that create barriers to men's and women's access to HIV/AIDS 
services.
    Additionally, the Emergency Plan supports five key cross-cutting 
gender strategies that are critical to curbing the HIV/AIDS epidemic, 
ensuring access to quality services, and mitigating the consequences of 
the epidemic: increasing gender equity in HIV/AIDS activities and 
services; reducing violence and coercion; addressing male norms and 
behaviors; increasing women's legal protection; and increasing women's 
access to income and productive resources. Activities in support of 
these focus areas are monitored annually during the Country Operational 
Plan (COP) review process. In fiscal year 2007, a total of $906 million 
was dedicated to 1,091 activities that included interventions to 
address one or more of these gender focus areas; in fiscal year 2008, 
the total is expected to rise to approximately $1.03 billion.
    In 2007, three special gender initiatives were launched in nine 
countries to intensify program efforts in three of these focus areas: 
scaling up evidence-based programs to address male norms and behaviors; 
strengthening interventions for victims of sexual violence, including 
antiretroviral post-exposure prophylaxis (PEP) to prevent HIV 
infection; and reducing inequities that fuel girls' vulnerability to 
HIV/AIDS.
    Gender issues are central to many HIV prevention programs, 
particularly those focused on youth. As young people are taught through 
the ABC approach to respect themselves and respect others, they learn 
about gender equity. While gender equity

[[Page 75]]

does not directly reduce HIV transmission, the ABC approach is 
particularly important for the protection of women and girls, 
particularly when men successfully change their behaviors. By 
supporting delayed sexual debut, secondary abstinence, fidelity to a 
single partner, partner reduction, and correct and consistent condom 
use, ABC interventions can address unhealthy cultural gender norms 
among boys, girls, men, and women.

    Question 3. In your testimony, I appreciate your mention of 
incorporating new biomedical prevention approaches, but also believe we 
can and should be devoting additional resources to identifying and 
replicating effective behavioral interventions. How much funding is the 
Office of the Global AIDS Coordinator devoting to operations research, 
not counting routine monitoring and evaluation activities that are 
carried out in the focus countries?
    Answer 3. PEPFAR dedicated approximately $46.4 million to 
operations research and evaluation in fiscal year 2007, including 
spending for public health evaluations funded through PEPFAR's Country 
Operational Plan (COP), process, public health evaluations funded 
centrally by PEPFAR, and other operations research activities. Of this, 
$26.4 million was directed toward operations research in priority 
prevention activities, including those associated with gender-based 
violence, male circumcision, prevention with positives, adolescent and 
young girls, and men as partners. PEPFAR further spends over $135 
million on strategic information in all countries, including monitoring 
and evaluation activities that may include operational research. Some 
monitoring and evaluation activities are budgeted by countries under 
prevention, care, and treatment categories.
                       question of senator brown
    Question 1. The Administration has shown impressive leadership in 
HIV/AIDS, TB, and malaria. However, the investment in funding for TB 
control and research could be stronger. As you know, TB is a 
preventable and curable disease and no region of the world is 
unaffected. Without access to antiretrovirals and proper TB treatment, 
most people living with HIV who are co-infected with TB will die 
quickly, sometimes in a matter of weeks. We cannot seriously talk about 
addressing HIV/AIDS without a massive increase in our investment into 
TB control and new tools research. The Stop TB Partnership's Global 
Plan to Stop TB sets 2015 targets so that at least 85 percent of TB 
patients should be counseled and tested for HIV and 57 percent of HIV+ 
TB patients should be initiated on ART.
    How close are we to achieving these goals? Should addressing the 
crossover between TB and HIV services be a greater focus in PEPFAR 
reauthorization?
    Answer 1. The co-infection of TB and HIV is a serious threat to the 
public health progress of many countries supported by the President's 
Emergency Plan for AIDS Relief (PEPFAR/Emergency Plan) and addressing 
the crossover between the two diseases will remain a priority in the 
next phase of the Emergency Plan. The Emergency Plan has invested 
significant resources in combating the co-infection of TB and HIV, 
leading a unified U.S. Government (USG) response to fully integrate HIV 
prevention, treatment, and care with TB services at the country level 
in Emergency Plan countries. PEPFAR is the largest bilateral supporter 
of TB programs in the world, investing resources in three primary ways.
    First, PEPFAR increased its funding for HIV/TB five-fold, from $26 
million in fiscal year 2005 to $131 million in fiscal year 2007, and a 
planned level of $150 million for fiscal year 2008. Funding supports 
providing HIV testing for people with TB 
and TB screening and diagnosis for people living with HIV; ensuring 
eligible TB pa-
tients receive HIV/AIDS prevention, treatment and care; implementing 
the WHO-
recommended TB treatment protocol, Directly Observed Therapy-Short 
Course (DOTS); bolstering surveillance and infection control 
activities; strengthening laboratory capacity and supply chain 
management; and working with the U.S. Federal TB Task Force to 
coordinate the USG response.
    Second, the USG is the largest contributor to our most significant 
partner in the prevention and control of TB--the Global Fund to Fight 
AIDS, Tuberculosis, and Malaria. The U.S. Government, through PEPFAR, 
has contributed roughly 30 percent of the Global Fund's contributions 
from all sources, as well as technical assistance to the Global Fund 
country coordinating mechanisms to strengthen the planning, 
implementation, and evaluation of TB grant activities. With these 
resources, the Global Fund has committed roughly 17 percent of its 
funding to national TB programs around the world. PEPFAR is also 
involved in the oversight and management of the Global Fund, with high-
level representation on the Board and several Global Fund committees, 
to ensure effective program delivery.
    Third, the Emergency Plan invests additional resources for TB 
globally through strategic partnerships with the World Health 
Organization, and the STOP TB Part

[[Page 76]]

nership. The Emergency Plan worked closely with WHO to implement a 2-
year collaborative effort to support scale-up of TB/HIV services in 
Rwanda, Kenya and Ethiopia. Lessons learned in this process are being 
replicated in other countries? TB/HIV scale-up plans. With the STOP TB 
Partnership, the Emergency Plan provides technical assistance for the 
Advocacy, Communication and Social Mobilization (ACSM) components of 
Global Fund TB grant programs to stimulate demand for TB services.
    Through these three major mechanisms for reducing TB globally--(1) 
direct funding for PEPFAR TB/HIV activities, (2) financial and 
technical support for the Global Fund TB activities, and (3) financial 
and technical support for other major international TB partnerships--
PEPFAR is a leader in global contributions to international TB efforts. 
The Emergency Plan will continue its efforts to control the spread of 
TB/HIV in the next phase.
    PEPFAR plans to continue investing significantly in the integration 
and coordination of HIV/AIDS and TB programs in clinical and laboratory 
facilities, as well as at the level of policy, surveillance, and 
monitoring and evaluation systems. PEPFAR support for HIV care and 
treatment provides an extensive platform for intensified TB case 
finding. This includes routine screening for signs and symptoms of TB 
disease and rapid initiation of appropriate treatment. This effort also 
has the important effect of interrupting transmission of TB among 
susceptible individuals--including people living with HIV--and the 
community at large.
    As country capacity and programming expands, PEPFAR will continue 
to focus on the TB/HIV nexus in its bilateral programs and in its 
collaboration with other USG TB efforts, the Global Fund, and host 
nations.
                      questions of senator coburn
    Question 1. You testify that 46 percent of PEPFAR funding goes to 
treatment. The law requires 55 percent at minimum. What are the reasons 
for the disparity? Given that the President's targets were not required 
by law, though they were encouraged in the Leadership Act, but the 55 
percent allocation to treatment was required by the law, if you were 
able to meet the targets spending less than 55 percent, wouldn't you 
agree that you are still required by the law to treat more people than 
the President's minimum?
    Answer 1. The treatment funding directive was set before there was 
solid information on the cost of treatment in developing nations, such 
as those in Africa. Costs of treatment have fallen dramatically since 
2003--largely because costs of antiretroviral drugs (ARVs) have 
plummeted, now accounting for only 20-30 percent of total cost of 
treatment. With treatment becoming so much cheaper, to spend 55 percent 
of program funds on treatment (and 75 percent of that amount on ARVs) 
would unnecessarily have starved programs for prevention (including 
behavior change, such as abstinence and faithfulness) and care 
(including care for orphans and vulnerable children as well as people 
living with HIV/AIDS)--programs that can prevent people from ever 
needing treatment. It was not possible to meet these directives while 
also meeting the prevention and care goals established by Congress. We 
have notified Congress of this situation each year.

    Question 2a. Your testimony rightly acknowledges that the United 
States was not supporting treatment prior to the implementation of 
PEPFAR, only a few years ago. Today, as you testify, 46 percent of 
billions of dollars are spent on treatment. Also prior to the 
implementation of PEPFAR, very little if any was being spent by any 
donor on delayed sexual debut and partner reduction. Today, a third of 
billions of dollars of prevention money is spent on those critical 
interventions.
    Would you agree that the allocations are largely responsible for 
creating this sea-change in priorities?
    Answer 2a. As mentioned previously, our experience over the last 
several years has shown that while ARV prices vary (affecting the 
overall percentage of resources devoted to treatment in a given year), 
having a concrete goal of 2 million people receiving treatment has been 
a far more important benchmark and driver both in the field and in a 
broader international context. Because it is relatively easy to measure 
regularly the number of people on treatment, a results-based goal 
(rather than a funding-based one) has had the greatest impact in this 
area.
    In the case of prevention, in contrast, the overall goal of 7 
million infections averted does not by itself require a specified level 
of spending on abstinence and faithfulness activities. In this area, 
the abstinence and faithfulness directive has played a helpful role in 
re-orienting the U.S. Government's prevention portfolio. Moreover, 
because it is harder to measure the results of prevention programs 
quickly enough to adjust programmatic budgets on a yearly basis, an 
inputs-based requirement has

[[Page 77]]

helped to ensure balanced prevention programs that maximize our impact 
in preventing new infections.

    Question 2b. Isn't it true that most of the USAID staff are still 
the same as they were several years ago? And although we have brought 
in lots of new partners as grantees under PEPFAR, aren't we also still 
funding the same ones we used to before PEPFAR?
    Answer 2b. While many new USAID personnel have begun service since 
2003, it is also true that many staff have been serving since before 
that date. Implementing partners are a mix of pre-existing and new 
partners, and PEPFAR has sought to increase the number of the latter 
category. An important part of systems-strengthening is PEPFAR's 
support for local organizations, including host government 
institutions, organizations of HIV-positive people and faith- and 
community-based organizations. Review of annual PEPFAR Country 
Operational Plans (COPs) includes evaluation of efforts to increase the 
number of indigenous organizations partnering with the Emergency Plan. 
In fiscal year 2007, PEPFAR partnered with 2,217 local organizations--
up from 1,588 in fiscal year 2004--and 87 percent of partners were 
local. Reliance on such local organizations, while sometimes 
challenging, is essential for PEPFAR to fulfill its promise to partner 
with host nations to develop sustainable responses.
    As another step in the direction of sustainability, PEPFAR country 
programs may devote no more than a maximum of 8 percent of funding to a 
single partner (with exceptions made for host government partners, 
commodity procurement, and ``umbrella contractors'' for smaller 
organizations). This requirement is helping to expand and diversify 
PEPFAR's base of partners, and to facilitate efforts to reach out to 
new partners, particularly local partners--a key to sustainability. The 
exception for umbrella contracts is based on a desire to support large 
organizations in mentoring smaller local organizations, supporting 
capacity-building in challenging areas such as management and 
reporting. PEPFAR has also worked with its international implementing 
partners to ensure that they have strategies to hand over programs to 
local organizations as those groups develop the capacity to work 
directly with the USG.
    President Bush launched the New Partners Initiative (NPI), part of 
PEPFAR's broader effort to increase the number of local organizations, 
including faith- and community-based organizations (FBOs and CBOs), 
that work with the Emergency Plan. Through NPI, PEPFAR is enhancing the 
technical and organizational capacity of local partners, and is working 
to ensure sustainable, high-quality HIV/AIDS programs by building 
community ownership. NPI supports organizations that have previously 
worked as PEPFAR subpartners' receiving PEPFAR funds through larger 
organizations--in graduating to prime partner status. Each grantee 
receives comprehensive technical and organizational support through 
NPI, including support for financial and reporting capacity, enabling 
them to compete not only for PEPFAR prevention and care resources but 
also for grants and contracts from other sources of funding.

    Question 2c. You, Ambassador Dybul, might be committed to the 
current mix of funding even if you weren't required to be by law. But 
when you're gone in a year, what assurance can you give that, without 
the allocations for treatment and for delayed sexual debut and partner 
reduction, the USAID staff and old implementing partners won't go right 
back to the interventions they were promoting before the law required 
them to change?
    Answer 2c. The budget allocations expire with fiscal year 2008 (and 
the abstinence/be faithful directive, was removed even for fiscal year 
2008 by appropriations action). Of course this Administration cannot 
offer any assurances about what will follow, but the reauthorization 
process provides a vehicle to address the issue of sustainability of 
the new directions this initiative has begun. It will be important for 
Members of Congress to review the successes we have had over the first 
4\1/2\ years of implementation and evaluate an appropriate balance of 
flexibility and encouragement when determining the appropriate goals 
and mix of funding.

    Question 3. Your testimony says: ``In Rwanda, for example, these 
systems-strengthening efforts have enabled us to begin using 
performance-based contracts that resemble the block grants used in our 
domestic treatment programs.'' Can you elaborate on this?
    Answer 3. Performance-based financing (PBF) is an approach to 
health financing that emphasizes outputs in health services. In an 
important test of this approach, Rwanda's Ministry of Health and PEPFAR 
are working together to roll out national performance-based financing 
for the prevention, care and treatment of HIV/AIDS and a basic and 
complementary package of health services. PBF offers financial in

[[Page 78]]

centives to health facilities to increase the quantity and improve the 
quality of health services provided. In Rwanda, PBF is operational in 
health facilities in 23 of the country's 30 districts. With U.S. 
support, the Government of Rwanda created a detailed system to track 
and monitor the number of individuals who receive health services and 
the overall quality of each health facility. Each facility is 
responsible for tracking the quantity of services provided, and the 
overall quality of the facility is assessed by independent and external 
evaluations conducted by district health professionals with assistance 
from technical assistants from the Ministry of Health, international 
partners and implementing partners. The Government of Rwanda pays for 
the provision of basic health services, while PEPFAR funds HIV/AIDS 
services, which includes voluntary counseling and testing, prevention 
of mother-to-child transmission and treatment for those who are HIV-
positive.
    Health facilities enrolled in the performance-based financing 
initiative use the additional funding due to improved performance to 
address whatever needs the managers have identified. PBF has given 
health facilities the ability to increase staff support and improve 
infrastructure, and it has provided communities with greater access to 
health services.
    Early results are promising. Across four health centers in Gicumbi 
District over a 12-month period that began in October 2006, the number 
of people receiving voluntary counseling and testing for HIV increased 
by 246 percent, from 417 to 1,443 tests per month.
    In another early example, clinic staff at the Rwesero Health Center 
in Gicumbi District have made their services available to a greater 
number of people, with the number of clients who received voluntary HIV 
tests increasing 294 percent in just over a year. The Rwesero Health 
Center now has the means to regularly offer co-trimoxazole (CTX), an 
essential antibiotic that is used to help prevent opportunistic 
infections in those who are HIV-positive. Prior to PBF it was difficult 
for the health center to apply this national treatment guideline. 
However, under PBF, the number of such people receiving CTX in Rwesero 
each month has increased from 0 to 66.
    While Rwanda's situation is unique and many countries are not yet 
in a position to implement PBF as Rwanda is doing, PEPFAR is closely 
examining this experience to assess its replicability in other venues.

    Question 4. For years, CDC has been asking this committee to grant 
construction authority so that CDC can support its programs properly 
with the clinics and labs that rural Africa needs. Now, I'm not 
suggesting that CDC should run wild building buildings all over the 
world, especially buildings that are named after Senators. However, 
when the agency keeps asking again and again and makes the case that 
the backlogs at the State Department bureaucracy won't allow them to 
build what they need to build in order to run effective programs, I 
have to wonder if maybe they might have a real need for independent 
construction authority.
    Why is the State Department continuing to thwart HHS efforts to 
meet this public health need, either through outright prohibition or 
bureaucratic obstruction? When will State back off and let CDC do 
what's necessary to effectively run PEPFAR programs in rural areas 
where there are no buildings to renovate and new buildings need to be 
built?
    Answer 4. PEPFAR is working through a policy process to finalize 
Administration guidance on construction authority provided in law under 
PEPFAR; the process is intended to clarify legal interpretation of this 
current authority and therefore the use of funding. This process should 
be complete in the near future and will reduce future impediments to 
using PEPFAR funding for the construction needs of PEPFAR.
    The Department of Health and Human Services/Centers for Disease 
Control and Prevention (HHS/CDC) is currently able to procure overseas 
construction projects through the State Department's Regional 
Procurement Support Offices (RPSO) in Ft. Lauderdale, Florida, and 
Frankfurt, Germany. The increase in PEPFAR-funded construction and 
renovation projects, especially in Africa, over the last 2 years has 
taxed the existing capacity at RPSO/Frankfurt, and we have been working 
with RPSO and its parent bureau in Washington to increase its capacity 
to manage the increased number of PEPFAR projects. Pending the guidance 
described above, we also are working to educate our field teams on how 
to engage RPSO in the most effective manner.

    Question 5. There is no question that HIV/AIDS has a significant 
impact on the overall development of countries in which the pandemic is 
prevalent. I understand that a number of members and interest groups 
are advocating that PEPFAR funds increasingly be diverted away from 
purely HIV/AIDS programming to related programs such as education, 
nutrition, and family planning, that aren't necessarily the

[[Page 79]]

primary focus of PEPFAR. I am concerned about this ``mission creep'' 
and PEPFAR losing its focus. Should PEPFAR be replacing USAID, 
Millennium Challenge and other programs?
    Answer 5. The Emergency Plan is central to U.S. efforts to 
``connect the dots'' of international development. PEPFAR programs are 
increasingly linked to other important programs--including those of 
other U.S. Government agencies and other international partners--that 
meet the needs of people infected or affected by HIV/AIDS in such areas 
as nutrition, education and gender.
    But while PEPFAR is an important part of connecting the development 
dots, it does not--and could not--replace USAID, MCC, PMI, or any of 
its sister initiatives or agencies. Nearly every person affected by 
HIV/AIDS can benefit from additional food support, greater access to 
education, economic opportunities and clean water, but so could the 
broader communities in which they live. In order to respond effectively 
to the many interrelated causes and effects of the epidemic, PEPFAR 
must integrate with other development programs, as part of a larger 
whole.
       Response to Questions of Senator Kennedy by Princess Zulu
    Question 1. We have heard from many experts and program 
implementers about the particular impact of gender inequalities for 
women and children affected by HIV.
    Can you share with the Committee your knowledge of this issue as an 
HIV/AIDS educator?
    Answer 1. Based on my own personal experience and observations in 
communities across Africa, gender inequality is a very real and 
compelling problem. Gender inequality leaves a lot of women and girls 
underpowered, and often results in the denial of their basic rights, 
including inheritance rights. Lack of financial independence or 
education can exacerbate these inequities. In some cases, women are 
unable to protect themselves and say no to sex or may be forced to 
engage in risky sexual behavior in order to provide basic necessities 
for their families such as food, shelter and school fees. Their 
children are also likely to drop out of school to work for food and 
other basic needs and, tragically, may be left orphaned if one or more 
of their parents succumbs to AIDS.
    Combating the gender inequalities that influence HIV/AIDS among 
women and children requires the collaboration of governments, civil 
society groups and family units. In my experience, success can begin at 
the community level, where men and women, boys and girls, are empowered 
and provided with preventive information that positively influences 
their behavior.

    Question 2. According to UNAIDS and WHO, young people are at 
greater risk for HIV infection, especially since many young people do 
not have access to HIV information and prevention services and do not 
believe that HIV is a threat to them and do not know how to protect 
themselves.
    Answer 2. Evidence suggests young people who are uninformed about 
how to prevent transmission of HIV are more likely to be infected with 
the virus. As such, every effort must be made to fully inform young 
people about HIV and AIDS and empower youth to make positive decisions 
about their sexual behavior. With sexual transmission comprising a vast 
majority of new HIV infections in Africa, equipping young people with 
the information they need to make more informed decisions about 
abstinence, delaying sexual debut and being faithful to one partner and 
proper condom use is an absolute necessity.
    Adequate funding for programs that promote abstinence, being 
faithful and consistent and correct use of condoms should be a top 
priority for HIV and AIDS programs funded by the United States. In my 
experience, young people are capable of making informed decisions about 
sexual activity when they are empowered, aware of the options before 
them and provided support in changing their behavioral patterns. If we 
hope to have an impact on the spread of HIV among young people, 
particularly in sub-Saharan Africa, we have to be investing in the 
activities that most effectively prevent spread of the virus through a 
change in sexual attitudes and behaviors. I urge Congress to include 
provisions for these types of prevention programs in the 
reauthorization of the Global AIDS bill.
   Response to Questions of Senators Kennedy, Enzi, Dodd, and Brown 
                             by Helen Smits
                      Questions of Senator Kennedy
    Question 1. There are some who believe that attention to the 
``legal, economic, educational and social'' status of women is beyond 
the scope of a health program.

[[Page 80]]

    Why is PEPFAR working in this area and why has the IOM recommended 
greater attention to this area?
    Answer 1. PEPFAR is working in this area because the U.S. 
Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (the 
Leadership Act) requires it to do so--see Chapter 8 of the IOM report 
(page 249).
    The IOM Committee found that the Leadership Act's emphasis on women 
and girls was warranted--see Chapter 2 of the IOM report which 
discusses the increasing burden of HIV/AIDS on women and girls, pages 
52-54 (emphasis added):

    ``As of 2006, almost half of all people living worldwide with HIV/
AIDS were women (UNAIDS, 2006). In sub-Saharan Africa, however, women 
now represent 59 percent of all people living with HIV/AIDS, and the 
proportion is growing (UNAIDS, 2006). Today's statistics are the 
product of a trend toward increasing rates of infection among women, 
given that the pandemic started in men. The reasons underlying this 
trend include the inferior social and economic status of women in many 
countries, which affects their chances of gaining access to either 
means for prevention of or treatment for HIV/AIDS and related 
complications; violence against women and girls, including domestic, 
sexual, and war-related violence; and biological factors that increase 
the susceptibility of women to infection. UNAIDS has expressed concern 
about gender-based inequalities in access to treatment, with some 
evidence of women paying more for services and being hospitalized less 
frequently when clinically appropriate (UNAIDS, 2004b).
    Teens and young adults (aged 15 to 24) continue to be at the center 
of the epidemic with heavy concentrations among those newly infected, 
accounting for more than 40 percent of new adult HIV infections in 
2000. In sub-Saharan Africa, three young women are infected for every 
young man in this age group. The situation is similar in the Caribbean, 
where young women are about twice as likely as men their age to be 
infected with HIV (UNAIDS, 2006).
    Biological characteristics place women at greater risk than men of 
contracting the virus from engaging in unprotected sex, but gender 
disparities and inequity are probably more responsible for rising 
infection rates in women.''

    The IOM committee also found that PEPFAR was supporting numerous 
programs and services directed at reducing the risks faced by women and 
girls, but was unable to determine either the individual or collective 
impact of these activities on the status of and risks to women and 
girls (see Chapter 8, pages 249-252). The IOM committee recommends that 
the U.S. Global AIDS Initiative continue to increase its focus on the 
factors that put women at greater risk of HIV/AIDS and to support 
improvements in the legal, economic, educational, and social status of 
women and girls. The IOM committee believes such improvements are 
necessary to create conditions that will facilitate the access of women 
and girls to HIV/AIDS services; support them in changing behaviors that 
put them at risk for HIV transmission; allow them to better care for 
themselves, their families, and their communities; and enhance their 
ability to lead and be part of their country's response to its HIV/AIDS 
epidemic.
    Specifically, the IOM committee was encouraged by OGAC's formation 
of the Technical Working Group on Gender and the focus that it could 
bring on the needs of women and girls and approaches to meet them. The 
IOM Committee also urges The Global AIDS Coordinator to keep his 
commitment to implement expeditiously the recommendations developed as 
a result of the June 2006 ``Gender Consultation'' hosted by PEPFAR.
    In fighting this epidemic, we need to take the steps that work. The 
consensus opinion, both of the experts on the committee and of those 
with whom we consulted, is that increased economic empowerment for 
women is a critical step in allowing them to protect themselves from 
infection.
    The problem can be seen very clearly in the prevalence rates of HIV 
by age and gender, which are remarkably consistent across African 
countries. Girls contract AIDS much earlier than boys, largely as the 
result of transactional sex with older men. Parents, we were told, are 
often complicit in such an arrangement because any additional resources 
help the family to survive. A girl who knows she can continue her 
education and who sees a clear path to a better economic future is more 
likely to resist the temptation of a cell phone and a nice dinner now; 
a mother who can comfortably feed the family is more likely to tell her 
daughter to resist.

    Question 2. Your report states that to succeed in building long 
term sustainability PEPFAR must strengthen national health systems and 
the healthcare workforce. And you specifically recommend an increase in 
support to expand workforce capacity for the education of new health 
care workers.

[[Page 81]]

    Many other stakeholders believe task shifting is a sufficient 
strategy to deal with health worker shortages--do you agree with this 
statement?
    Answer 2. The IOM committee found that while task shifting is an 
important component of a strategy to deal with health worker shortages, 
it is not by itself sufficient (see Chapter 8, pages 255-259). The IOM 
Committee also observed that while PEPFAR provides support for 
virtually all aspects of workforce capacity-building, it provides 
little to no support for training new health workers, even when it is a 
key component of a country's strategy.
    The numbers that we saw regarding health professionals made clear 
to us that no degree of task shifting would, by itself, solve the 
problem. We should note that some of the countries that have done 
particularly well with task shifting have also increased the number of 
health workers in order to ensure that the nurses and clinical officers 
now involved in AIDS treatment do not leave a vulnerable health system 
even more vulnerable.
    I would like to stress that in recommending an increase in support 
for the training of new health workers, we also emphasized that ``such 
support should be planned in conjunction with other donors to ensure 
that comparative advantages are maximized and be provided in the 
context of national human resource strategies that include relevant 
stakeholders.''
                       questions of senator enzi
    Question 1. In reference to your response regarding accountability 
measures, could you elaborate on the suggestions you gave during your 
testimony? Are any of these recommendations referenced in the IOM 
report?
    Answer 1. Although the IOM committee did not develop specific 
accountability measures, it outlined the general types and foci of 
measures that should be developed to allow Congress to better 
understand PEPFAR's accomplishments.
    Generally, the IOM committee argues for the following shifts in the 
foci and types of measures:

     From measures of spending (inputs) to measures of results 
(outputs and beyond);
     From ``counts'' of programs funded or people receiving 
services to measures of the effectiveness of the programs funded and 
effects on the people being served;
     From measures that promote rigid categorization to ones 
that promote comprehensive, integrated, and tailored programming and 
implementation; and
     From HIV/AIDS-specific measures exclusively to measures 
that include effects on population health and systems generally.

    The IOM report also emphasizes the need for accountability measures 
to be harmonized with those of partner countries, coordinated with 
other donors, and sensitive to the burdens that can be created when 
specific attribution is demanded. The IOM report also underscores the 
need to support the monitoring and evaluation (accountability) 
enterprises of the partner countries as a critical component of 
capacity building.
    More specifically, the section on Targets in Chapter 3 (see pages 
101-102) recognizes that the measures PEPFAR has been reporting are 
reasonable for the short-term and acknowledges that the program has 
plans to measure more meaningful mid- and long-term results. In this 
section, the IOM committee makes two suggestions about setting future 
targets:

    ``PEPFAR would do well to consider a step taken by some other large 
donors: evaluating Country Teams on how well they cooperate with the 
partner government and the donor group as a whole and how effective 
they are at leveraging a successful package of services.
    Finally, targets that are defined in terms of whether programs meet 
the full spectrum of needs of an individual person across his or her 
lifespan, of all members of the family or household, and of communities 
as a whole would create improved incentives for programming that is 
comprehensive, integrated, and accountable to those being served.''

    Most specifically, the IOM committee recommends that a distinct 
target be set for orphans and other vulnerable children (see page 13 of 
the Summary)--currently, they are included within the Care target. Such 
a target will be especially critical when the budget allocations are 
removed, because currently the allocation for orphans and other 
vulnerable children is the only accountability measure for this 
population.
    Also, in Chapter 8, the IOM Committee outlines a long list of 
questions that need to be asked and answered (see pages 261-267) and 
emphasizes the need to ``measure what really matters'' (see page 267), 
including:


[[Page 82]]


     reductions in disability, disease, and death from HIV/
AIDS;
     increases in the capacity of partner countries to sustain 
and expand HIV/AIDS programs without setbacks in other aspects of their 
public health systems; and
     improvements in the lives of the people living in these 
countries.

    To understand whether countries are achieving these ultimate goals 
and what contributions the U.S. Global AIDS Initiative is making to 
their achievement, the initiative will need to study national trends, 
such as:

     rates of new HIV and other infections;
     rates of survival from HIV/AIDS and other diseases;
     child survival, development, and well-being; and
     general health status of the population and key 
subpopulations.

    In addition, the last part of the committee's work was a workshop 
to discuss evaluation of the impact of PEPFAR. All of the materials 
from this workshop are available on the project webpage--www.iom.edu/
pepfar--or, more specifically, at the following link: http://
www.iom.edu/CMS/3783/24770/42120.aspx. A summary of this workshop is 
forthcoming and we will transmit it to you as soon as it is available.

    Question 2. As the IOM reviewed the situation of women and girls, 
you noted that there was no evidence that women and girls were unable 
to access treatment. In fact, you noted that women comprised 70 percent 
of the individuals receiving care under the global AIDS program. What 
more should we do to emphasize family-centered care?
    Answer 2. See response above re: developing targets that then drive 
program planning and implementation. To enable and promote family-
centered care, the targets should be defined in terms of whether 
programs meet the full spectrum of needs of an individual person across 
his or her lifespan, of all members of the family or household, and of 
communities as a whole.
    The IOM report discusses at length the benefits of community-based, 
family-centered care and suggests successful approaches to this 
important area (see especially Chapters 6 and 7). We note, for example, 
that ``interventions at the community level involving the active 
engagement and participation of the community have the greatest 
likelihood of success.''
    The IOM Committee observed that conceptualizing programs in terms 
of the needs of families and communities--rather than categorically in 
terms of prevention, treatment, and care--better promotes 
comprehensive, integrated care.
    ``During its visits to the focus countries, the committee observed 
several positive examples of integration among PEPFAR-supported 
programs--of systems for referral from counseling and testing programs 
to ART programs, of linkages between ART services and home-based care 
services, and of integration of HIV and tuberculosis testing and 
treatment. But the committee also observed many missed opportunities 
for improving the comprehensiveness and effectiveness of services 
through better integration--for example, between programs aimed at 
prevention of mother-to-child transmission and infant feeding programs; 
between counseling and testing services and further counseling 
services, ART, and other treatment; between counseling and testing and 
clinics addressing sexually transmitted infections and reproductive 
health; between HIV and tuberculosis testing and treatment services; 
among multisectoral services for orphans and other vulnerable children; 
and between HIV/AIDS and food aid programs.''
                       questions of senator dodd
Prevention of Mother-to-Child Transmission (PMTCT)
    Question 1. Every day more than 1,100 children across the globe are 
infected with HIV, the vast majority through mother-to-child 
transmission. What is most tragic is that research has shown that these 
infections are largely preventable. The simple reason that the 
infection rate among children remains so high is that pregnant mothers 
and their babies are not getting the life-saving care they need. Less 
than 10 percent of pregnant women with HIV in resource-poor countries 
have access to prevention of mother-to-child transmission services.
    What do you think have been the specific barriers to reaching more 
mothers and babies?
    Where is PEPFAR succeeding in overcoming these barriers and where 
is it falling short?
    In 2001 the United Nations set a goal to cut the number of 
pediatric infections by half in 2010. To reach this goal, it is 
estimated that 80 percent of pregnant women must have access to PMTCT 
services. As you may know, I recently introduced the ``Global Pediatric 
HIV/AIDS Prevention and Treatment Act,'' along with Senator Gordon 
Smith, which would set a target that within 5 years (by 2013), in

[[Page 83]]

those countries most affected, 80 percent of pregnant women receive HIV 
counseling and testing, with all those testing positive receiving 
antiretroviral medications for the prevention of mother-to-child 
transmission.
    Are you supportive of such a target?
    Answer 1. Prevention of mother to child transmission has continued 
to be one of the challenging aspects of the PEPFAR program. In order to 
be successful, a program must ensure that each mother-infant pair 
participates in a cascade of events that begins with HIV testing and 
continues through post delivery follow-up and testing (see pages 125-
126). The report notes that ``declines in participation have been found 
at each one of these steps as the result of a variety of factors, 
including denial of HIV infection, opposition from male partners, 
women's fear of disclosure of HIV status to their partner and fear of 
being `found out' if they are taking drugs or not breastfeeding, 
concern about taking drugs in pregnancy, failure to return for checkups 
in the month before delivery, home delivery and premature delivery 
before treatment can be given.''
    Evaluating individual programs was beyond the scope of the IOM 
committee. Consultation with PEPFAR's PMTCT Technical Working Group may 
be useful for you in answering this question. In addition, a number of 
best practices were also reported at the Implementers' Meeting last 
July and at previous meetings.
    In principal, the IOM report is strongly supportive of setting 
meaningful targets and of expanding and improving PMTCT services. We 
did not, however, evaluate this specific target and thus cannot comment 
on it.
Pediatric Treatment
    Question 2. Despite the recent expansion in HIV/AIDS care and 
treatment around the world, children continue to lag behind adults in 
access to lifesaving medicines. Of the 2.5 million-plus new HIV 
infections in 2007, more than 420,000 were in children. But while 
children account for almost 16 percent of all new HIV infections, they 
make up only 9 percent of those on treatment under PEPFAR. Without 
proper care and treatment, half of these newly-infected children will 
die before their second birthday, and 75 percent will die before their 
fifth.
    What steps do you believe should be taken in PEPFAR reauthorization 
to level the playing field for children, so that they are accessing 
treatment at the same rate as adults?
    The legislation I introduced with Senator Smith sets a target that 
within 5 years (by 2013), 15 percent of those receiving treatment under 
PEPFAR be children, to keep pace with the infection rate.
    Are you supportive of such a target?
    Answer 2. The IOM report both acknowledges the difficulties 
inherent in treating children and commends PEPFAR for the creation, in 
2006, of a public-private partnership devoted to the scientific and 
technical discussion of solutions for the challenges of pediatric 
treatment, formulations and access. As the report notes, the scientific 
problems of dosing are among the most difficult barriers to overcome.
    On a personal note, I was pleased to hear, at the Implementers' 
Meeting, a number of reports of best practice in this area. Many PEPFAR 
participants are very concerned about the treatment of children; my 
impression is that progress is being made.
    In principal, the IOM report is strongly supportive of setting 
meaningful targets and of expanding and improving services for 
children. The IOM committee recommended setting a distinct and 
meaningful target for orphans and other vulnerable children because 
none currently exists. We did not, however, evaluate this specific 
target and thus cannot comment on it.
                       question of senator brown
    Question 1. What progress have we made in implementing the 
recommendations of the IOM PEPFAR evaluation report? What are the 
challenges to fully implementing these recommendations?
    Answer 1. The response of PEPFAR staff to the report has been 
largely appreciative and supportive. We are unable to answer questions 
about what PEPFAR is doing to implement the IOM recommendations because 
they have not issued a recommendation-by-recommendation response to our 
report. I am sure that Ambassador Dybul will be pleased to describe for 
you how PEPFAR is responding.

[[Page 84]]

Response to Questions of Senators Kennedy, Enzi, and Dodd by Peter Piot
                      questions of senator kennedy
    Question 1. Numerous stakeholder reports and discussions with 
implementing partners and agencies have shed light on the need to 
better communicate and coordinate across all management levels to 
ensure enhanced coordination of fiscal management, policy guidance, and 
planning and reporting. Based on your work, can you speak to the 
special challenges of central, intra-agency, field team and donor 
coordination? Please comment on ways of improving upon coordination and 
communication between implementing agencies, donors, and teams to help 
us plan for transitioning from an emergency effort toward a sustainable 
long-term strategy?
    Answer 1. At UNAIDS, ``making the money work'' is paramount, a 
principal question through which we critically evaluate the relative 
strength of HIV programming. We aim to strengthen coordination for 
countries in partnerships with national governments and non-
governmental organizations, the U.S. Global AIDS Initiative, and the 
Global Fund. It means maximizing our effectiveness by improving 
coordination among donors, government implementers, and everyone in the 
global response to AIDS. Partnering where possible produces significant 
coordination and significant results. In Rwanda, where governments are 
full partners, and the U.S. Global AIDS Initiative effort is fully 
integrated with national strategies, progress has been measurable, 
meaning the difference between fighting AIDS effectively and losing 
ground.
    Until recently, AIDS advocacy focused largely on (1) fostering 
leadership and commitment and (2) mobilizing the financial resources 
required to mount an effective response to AIDS, globally and within 
countries. More leadership and more money are still urgently needed, 
and thus these two areas of focus remain essential, but now there is 
widespread recognition that a third focus is also vital: making the 
money work more effectively.
    In Washington, DC., April 25, 2004, UNAIDS, the governments of the 
United States and the United Kingdom, and the World Bank brought 
together representatives from governments, donors, international 
organizations and civil society who considered and endorsed the ``Three 
Ones'' principles for concerted action against AIDS at country level as 
follows:

     One agreed AIDS action framework that provides the basis 
for coordinating the work of all partners;
     One national AIDS coordinating authority, with a broad-
based multisectoral mandate; and
     One agreed country-level monitoring and evaluation system.

    All donors pledged to support implementation of these principles 
and UNAIDS was called on to help facilitate this process.
    In London on March 9, 2005, UNAIDS, the governments of the United 
States, the United Kingdom, and France, as well as other key 
stakeholders again gathered and stated: ``We affirm our commitment to 
promoting and supporting the application of the `Three Ones' 
principles, recognizing that their application will result in 
adaptations appropriate to each country and the situations and 
institutions concerned. We affirm that the development and adaptation 
of the `Three Ones' is intended to be a consultative and iterative 
process between donors, multilateral and country-level partners. We 
note the leading role of national governments in ensuring the full 
implementation of the `Three Ones' principles.'' With that in mind, all 
participants agreed to review their individual practices and to work 
closely with partners at country level to accelerate the effective 
implementation of the ``Three Ones.''
    To examine and assist in this implementation effort, UNAIDS and the 
United States President's Emergency Plan for AIDS Relief held a 
bilateral meeting in Washington, DC. on April 27 and 28, 2005.
    What follows are key points of agreement that arose from these 
discussions. While the actions delineated below were discussed and 
agreed to as part of a UNAIDS-U.S. Office of the Global AIDS 
Coordinator bilateral partnership, participants noted that they are 
best executed, not as bilateral actions, but in the context of 
nationally-led processes that involve all key stakeholders--as 
envisioned by the ``Three Ones.''

A. The ``Three Ones''

One National AIDS Action Framework
    1. Support national government leadership in a broadly 
participatory process for developing and regularly updating the 
national AIDS action framework, including the development of a costed 
and results-based annual operational plan.
    2. Support the national AIDS action framework and operational plan, 
by basing individual programming and assistance within these national 
guiding documents.

[[Page 85]]

    3. In an effort to maximize coordination and complementarity, make 
every effort to harmonize support with that of others, through ongoing 
dialogue with government and other key stakeholders about priorities, 
geographic and service mix, and division of labor, recognizing that 
each partner works within the specific parameters of its own mandates 
and rules (including procurement).
    4. Work together to harmonize key programmatic tools (i.e. reviews 
of national response, technical working groups, activities database), 
and promote and participate in joint action in these areas. The 
formation of joint working groups on the key crosscutting issues of 
procurement, gender, and human resources were suggested. Avoid the 
establishment of parallel tools, groups and systems whenever possible.
    5. Promote and participate in ``partnership forums'' to share 
information and coordinate implementation.
One National AIDS Coordinating Authority
    1. Within the context of the Three Ones, urge each country to 
conduct a government-led joint assessment of the national coordinating 
authority leading to clear recommendations for strengthening its 
effectiveness including attention to areas such as: human capacity 
requirements, financial resource requirements, infrastructure needs, 
streamlining of operations, performance-based monitoring systems.
    2. Provide support (financial and technical) to the national 
coordinating authority based on these recommendations. Some donors may 
consider performance-based incentive mechanisms in the provision of 
their support.
    3. Strengthen political leadership and government commitment to a 
multisectoral national coordinating authority through diplomatic 
engagement at the highest levels.
    4. Implement programming and assistance within the overall 
framework of the national coordinating authority and, to the greatest 
extent possible, within an agreed to division of labor.
One Monitoring and Evaluation System
    1. Build local monitoring and evaluation capacity, participate 
regularly in national monitoring and evaluation activities, and support 
the development and operationalization of one national monitoring and 
evaluation system for the national AIDS response with a set of 
standardized and multisectoral indicators.
    2. Support the development of a set of best practices for 
monitoring and evaluation for broad dissemination of lessons learned 
for replication.
    3. Develop mechanisms for data and report sharing as well as data 
utilization for evidence-based program planning.
    4. To the fullest extent possible, seek to synchronize the timing 
of surveys and reporting cycles among partners and the government in an 
effort to maximize harmonization opportunities.
    5. Participate in joint monitoring and evaluation team visits by 
donors and multilateral partners to assess and support further progress 
on the above described monitoring and evaluation actions, to avoid 
duplication of effort, and to decrease the burden of individual agency 
missions on the national coordinating authority and other local 
stakeholders.

B. Other Key Issues

    Central to the effective implementation of the ``Three Ones'' at 
country level are issues related to policy development and the 
coordination of technical assistance. Therefore key points of agreement 
have been put forward in these areas as well.

Policy

    AIDS policy dialogue and development should actively involve all 
partners--government, donors, multilaterals, and non-governmental 
stakeholders such as non-governmental organizations, faith-based 
organizations, civil society, persons living with HIV, and the private 
sector.
    Engage in consensus-building processes to:

     support the capacity of national authorities to develop 
and monitor policies; and
     seek policy agreement to the fullest extent possible and, 
in areas where differing policy approaches exist, seek to maximize 
complementarity, recognizing the conditionality of some sources of 
funding.

Technical Support

    Technical support needs are best identified at the country level, 
and the development of in-country capacity is essential to an effective 
national AIDS response. To the fullest extent possible, technical 
support should be provided by local expertise.
    Work within the national AIDS action framework to develop and 
implement a joint technical support plan which:


[[Page 86]]


     recognizes and responds to the specific country context;
     identifies technical support needs;
     identifies core expertise and comparative advantages of 
individual partners to meet those needs; and
     provides for the sharing of terms of reference, results, 
and reports.
Continuum of Coordination & Collaboration
    It is envisioned that collaboration will evolve along a continuum 
ranging from the current levels of engagement, whatever they are, 
toward the goal of full and complete implementation of the ``Three 
Ones.'' Obviously, current placement along this continuum varies from 
country to country as does the timing and support needed to effectively 
move toward the ideal collaboration embodied in the ``Three Ones.'' The 
chart below seeks to provide an illustration of how progress along this 
continuum plays out in the context of the each of the ``Three Ones.''


----------------------------------------------------------------------------------------------------------------
                                                                    Coordination and
         Three Ones Principle             Minimal Engagement      Collaboration Around     Ideal Collaboration
                                                                    Specific Issues
----------------------------------------------------------------------------------------------------------------
One National AIDS Action Framework...  Sharing information on   Participate in periodic  Joint planning and
                                        individual programs.     reviews and updates of   shared division of
                                                                 National Strategic       labor on
                                                                 Frameworks.              implementation of
                                                                                          overall response.
One National AIDS Coordinating         Attending meetings of    Jointly identify         Provide ongoing
 Authority.                             the National AIDS        country needs in         coordinated support to
                                        Authority.               specific areas (i.e.,    the National AIDS
                                                                 TA needs), and jointly   Authority.
                                                                 respond.
One Monitoring and Evaluation System.  Sharing program          Harmonizing program      Support the
                                        indicators..             indicators.              establishment of, and
                                                                                          utilize, one national
                                                                                          monitoring and
                                                                                          evaluation system.
----------------------------------------------------------------------------------------------------------------

    As these programs and services are in place, they need reliable 
information to monitor their outputs (e.g. the number of people 
provided with preventive education) and outcomes (e.g. changes in the 
number of people using condoms) and longer-term impacts (e.g. changes 
in HIV prevalence). The third ``One,'' an agreed country-level 
monitoring and evaluation system, points to the most efficient and 
effective way of gathering, analyzing, and reporting this information.
    The U.S. Global AIDS Initiative and other external partners' 
efforts have had their greatest successes (i.e. Rwanda) where 
governments are full partners and the United States' response is fully 
integrated into national strategies.
    To that end, United States' efforts can empower ``country-driven'' 
efforts to increase access by:

     Actively engaging in national planning, costing and joint 
evaluation/review processes and sharing information it gathers to 
support and improve national program implementation;
     Aligning U.S. Global AIDS Initiative investments with 
national AIDS strategies, priorities, plans, and targets and 
synchronizing the timing of U.S. Global AIDS Initiative planning and 
reporting cycles with those of the national AIDS authority to the 
fullest extent possible;
     Expanding access to technical assistance through support 
for the development of national technical assistance plans, quality 
assurance, coordination of technical assistance provision and follow 
up, (including utilizing innovative mechanisms such as the UNAIDS 
technical support facilities and technical assistance funds.)

    As highlighted by the United States Leadership Against HIV/AIDS, 
Tuberculosis, and Malaria Act of 2003, a key feature of United States' 
leadership is commitment to coordination at all levels.
    At the global level, it is essential for the United States to 
continue to work closely with UNAIDS, the Global Fund, and other 
multilateral and bilateral donors to ensure that the comparative 
strengths of each are maximized and have a positive, synergistic impact 
on countries, rather than a duplicative, inefficient, and empowering 
one.

    Question 2. There has been much talk lately about the need to 
strengthen health systems in developing countries. How can PEPFAR help 
to improve the health systems in developing countries and address 
health worker shortages? Have we consid

[[Page 87]]

ered how to use our technological prowess to address the challenge of 
the health care brain drain?
    Answer 2. The world is now paying the price, in the context of the 
AIDS crisis, for decades of inadequate investment in the developing 
world's public and private services to promote education and health. 
Lack of human capacity is the single biggest obstacle to an effective 
response to AIDS in many developing countries. Poor surveillance, 
planning and administration; bottlenecks in the distribution of funds; 
failures in the implementation, monitoring, and evaluation of 
activities; and inadequate provision of services are all largely due to 
systems of too few people with too few skills. According to the WHO 
World Health Report 2006, there is currently an estimated shortage of 
almost 4.3 million doctors, midwives, nurses, and support workers 
worldwide. The shortage of trained health-care workers is due in part 
to the ongoing ``brain drain'' of health-care providers from Africa and 
other heavily affected areas. A recent study estimated that, to cope 
effectively with AIDS and other health emergencies, sub-Saharan Africa 
will need to find 620,000 new nurses over the next few years (Chaguturu 
and Vallabhaneni, 2005).

     Curbing this exodus of professional people calls for 
action at both ends. Measures to improve working conditions and 
remuneration and other incentives to keep trained people at home are 
essential, as are formal agreements between countries and recruitment 
practices.
     National governments and international donors should take 
measures, where needed, to retain and motivate health workers, 
educators and community workers, and to increase financing for training 
and accreditation centers in countries facing severe human resource 
shortages.
     Speeding recruitment and training of health workers at all 
levels is also urgent. Countries should identify opportunities for 
drawing in new players from populations or sectors that are not yet 
fully engaged with the response, and should consider innovative ways of 
educating and training people.
     Where needed, countries should adopt alternative and 
simplified delivery models to strengthen the community-level provision 
of HIV prevention, treatment, care and support, including measures to 
enable ``task shifting.''
     National governments should also greatly expand their 
capacity to deliver comprehensive AIDS programs in ways that strengthen 
existing health and social systems, including by integrating AIDS 
interventions into programs for primary health care, mother and child 
health, sexual and reproductive health, and diagnosis and treatment of 
tuberculosis, malaria, and sexually transmitted infections.
     Education and other systems must be simultaneously 
strengthened. Most HIV prevention takes place outside the health-care 
delivery system, making the private and voluntary sectors particularly 
important.

    A principal UNAIDS recommendation for reauthorization of the U.S. 
Global AIDS Initiative is to prioritize the strengthening of health 
care delivery systems, human resource capacity, and local community-
based service organizations. Specifically, we recommend that the U.S. 
Global AIDS Initiative:

     Maximize current capacity by task-shifting, in-service and 
pre-service training/retraining, and increasing incentives for 
retention;
     Build greater indigenous national and local capacity 
``from doctors to nurses to community health workers and persons living 
with HIV'' through training, accreditation, and adequate support and 
supervision;
     Target HIV training to education and social services 
sectors as well; and
     Support strategies that help countries operate their 
national AIDS program over the long term and avoid creating parallel 
U.S. systems and structures.

    Many country teams have previously expressed concern that they were 
not allowed to fund activities unless they were specifically part of 
the AIDS response and thus could not support, for example, the training 
of new clinical officers, who in some countries are the mainstay of the 
treatment effort. UNAIDS maintains that the successful creation and 
sustainability of an HIV care delivery system should be fashioned in a 
manner that enhances the larger health care workforce/public health 
infrastructure rather than detracts from it.
    UNAIDS supports Recommendation 8-3 of the recent Institute of 
Medicine (IOM) report which addressed the implementation of the U.S. 
Global AIDS Initiative: ``To meet existing targets for prevention, 
treatment, and care, the U.S. Global AIDS Initiative should increase 
the support available to expand workforce capacity in heavily affected 
countries. These efforts should include education of new health care 
workers in addition to AIDS-related training for existing health care 
workers. Such support should be planned in conjunction with other 
donors to ensure that comparative advantages are maximized and be 
provided in the context of national human resource strategies that 
include relevant stakeholders, such as the ministries of

[[Page 88]]

health, labor, and education; other ministries; employers; regulatory 
bodies; professional associations; training institutions; and 
consumers.''
                        question of senator enzi
    Question 1. With the AIDS epidemic in the United States we were 
able to curtail the spread of the disease by closing bath houses in San 
Francisco. This direct threat to one of the cities social norms was 
effective, yet controversial. What prevailing social norms are 
assisting in the spread of HIV/AIDS in PEPFAR countries? What is the 
best and most appropriate way to stop them from occurring and educate 
individuals on this danger?
    Answer 1. As I said on September 20, 2007 to the Woodrow Wilson 
International Center for Scholars, ``anything that has the word `only' 
in it doesn't work for AIDS, whether it is treatment only, prevention 
only, condoms only, abstinence only, male-circumcision only . . . we 
need it all.''
    Risk behaviors and vulnerabilities are linked to economic, legal, 
political, cultural and social norms that must be analyzed and 
addressed at the policy and program levels. Therefore, comprehensive 
programming is necessary for the effective prevention of this disease. 
Effective HIV prevention programming focuses on the critical 
relationships between the epidemiology of HIV infection, the risk 
behaviors that transmit HIV and the social and cultural factors that 
aid or impede peoples' abilities to access and use HIV information and 
services, and can thus make them more or less vulnerable to HIV 
infection. The term ``driver'' relates to the structural and social 
factors, such as poverty, gender inequality and human rights issues 
that are not easily measured that increase people's vulnerability to 
HIV infection.
    The prevailing social norm driving the epidemic worldwide is 
inequality. In the UNAIDS Practical guidelines for intensifying HIV 
prevention, there is clear recognition of the importance of tackling 
the social drivers of the epidemic. Three specific social drivers (all 
examples of inequality) are repeatedly cited as being central:

     Human rights,
     HIV-related stigma and discrimination,
     Gender inequality.

    These may express themselves in dozens of different ways including: 
child marriage; transgenerational sex; the sexual exploitation of 
girls; violence against women; multiple partners inside and outside of 
marriage; the taboo of condom use; the disenfranchisement of high-
impacted populations such as men who have sex with men, injecting drug 
users, sex workers, and others (which drives the epidemic further 
underground); and so forth.
    Recognizing that each country is different, UNAIDS' Practical 
Guidelines are designed to provide policymakers and planners with 
practical guidance to tailor their national HIV prevention response so 
that they respond to the epidemic dynamics and social context of the 
country and populations who remain most vulnerable to and at risk of 
HIV infection.
    Reforming laws and policies that are based in deeply-rooted social 
attitudes and norms such as gender inequality requires multisectoral 
collaboration. Civil society, including organizations of people living 
with HIV, international organizations, and donors, have a critically 
important role to play. The protection of human rights, both of those 
vulnerable to infection and those already infected, is not only right, 
but also produces positive public health results against HIV.
                       questions of senator dodd
Prevention of Mother-to-Child Transmission (PMTCT)
    Question 1. Every day more than 1,100 children across the globe are 
infected with HIV, the vast majority through mother-to-child 
transmission. What is most tragic is that research has shown that these 
infections are largely preventable. The simple reason that the 
infection rate among children remains so high is that pregnant mothers 
and their babies are not getting the life-saving care they need. Less 
than 10 percent of pregnant women with HIV in resource-poor countries 
have access to prevention of mother-to-child transmission services.
    What do you think have been the specific barriers to reaching more 
mothers and babies?
    Where is PEPFAR succeeding in overcoming these barriers and where 
is it falling short?
    In 2001 the United Nations set a goal to cut the number of 
pediatric infections by half in 2010. To reach this goal, it is 
estimated that 80 percent of pregnant women must have access to PMTCT 
services. As you may know, I recently intro

[[Page 89]]

duced the ``Global Pediatric HIV/AIDS Prevention and Treatment Act,'' 
along with Senator Gordon Smith, which would set a target that within 5 
years (by 2013), in those countries most affected, 80 percent of 
pregnant women receive HIV counseling and testing, with all those 
testing positive receiving antiretroviral medications for the 
prevention of mother-to-child transmission.
    Are you supportive of such a target?
    Answer 1. UNAIDS agrees that prevention of mother-to-child 
transmission (PMTCT) is a critical priority for the use of prevention 
dollars through the U.S. Global AIDS Initiative. A comprehensive set of 
activities--including counseling and testing, prophylactic 
antiretroviral therapy in late pregnancy and delivery, as well as for 
the newborn; safe delivery practices; and use of breast milk 
substitutes when safe water is available--has been found to be 
effective in preventing transmission of HIV to infants.
    We agree that to be fully successful in the prevention of HIV 
transmission to newborns that multiple interventions throughout 
pregnancy and nursing are required including: HIV counseling and 
testing of pregnant women; the provision of antiretroviral prophylaxis; 
counseling of behavior modification around breast-feeding; follow-up 
with mother and child post-delivery; and HIV testing and assessment for 
the infant at 18 months. In addition, interventions should also include 
primary HIV prevention for women (including integration of HIV 
prevention into reproductive and sexual health services), prevention of 
unintended pregnancies in HIV-positive women, and broader access to 
antenatal care.
    There are a number of factors that impede the full prevention of 
HIV testing from mother to child in PEPFAR-focus countries including: 
denial of HIV infection among pregnant women, opposition from male 
partners, women's fear of disclosure of HIV status to their partner and 
fear of being ``found out'' if they are taking drugs or not 
breastfeeding, concern about taking drugs during pregnancy, failure to 
return for checkups in the month before delivery, home delivery, and 
premature delivery before treatment can be given.
    Though there have been significant successes in mother-to-child 
prevention through the U.S. Global AIDS Initiative. At the national 
level, the initiative provides technical assistance to host governments 
in the development and adoption of guidelines and policies aimed at 
improving the standardization and quality of such efforts. In addition, 
by helping to strengthen commodity management systems, partners of the 
U.S. Global AIDS Initiative increase the availability of many 
commodities essential to these prevention efforts including medications 
and test kits.
    According to the United States Office of the Global AIDS 
Coordinator in 2007, approximately 6 million women in the focus 
countries have received PEPFAR-supported services to prevent mother-to-
child transmission. The proportion of eligible pregnant women receiving 
services such as counseling and testing has increased from 7 to 16 
percent, and the proportion of HIV-positive pregnant women receiving 
antiretroviral prophylaxis has increased from 9 to 21 percent.
    UNAIDS is supportive of an aggressive target as high as 80 percent 
of pregnant women having access to prevention of mother-to-child 
transmission services as we have been since 2001.
Pediatric Treatment
    Question 2. Despite the recent expansion in HIV/AIDS care and 
treatment around the world, children continue to lag behind adults in 
access to lifesaving medicines. Of the 2.5 million-plus new HIV 
infections in 2007, more than 420,000 were in children. But while 
children account for almost 16 percent of all new HIV infections, they 
make up only 9 percent of those on treatment under PEPFAR. Without 
proper care and treatment, half of these newly-infected children will 
die before their second birthday, and 75 percent will die before their 
fifth.
    What steps do you believe should be taken in PEPFAR reauthorization 
to level the playing field for children, so that they are accessing 
treatment at the same rate as adults?
    The legislation I introduced with Senator Smith sets a target that 
within 5 years (by 2013), 15 percent of those receiving treatment under 
PEPFAR be children, to keep pace with the infection rate.
    Are you supportive of such a target?
    Answer 2. UNAIDS recognizes the disappointing statistics regarding 
the number of HIV-infected children who are not antiretroviral 
therapies that could delay or prevent the life-threatening illnesses of 
untreated HIV disease. We agree with the following statement from the 
recent Institute of Medicine report addressing PEPFAR implementation: 
``The reasons for this are multiple and most are being addressed by 
PEPFAR. Diagnosis of HIV-related disease in children has been limited 
in part because most counseling and testing programs in the focus 
countries have

[[Page 90]]

targeted primarily young adults. The general lack of linkage of 
prevention of mother-to-child-transmission to infants and small 
children has lessened the likelihood of identifying those who are HIV-
positive at that level. Many children who are found to be HIV-positive 
are orphans or living with orphan heads of households, further 
complicating adherence to treatment regimens and follow-up clinical 
visits.''
    With over 600,000 children contracting HIV infection each year, 
mostly through mother-to-child-transmission, access to affordable HIV 
diagnostics and treatment responses represents an urgent global health 
priority. In 2005, UNAIDS and UNICEF issued a global call to action 
that challenges the world to ensure that antiretroviral therapy and 
prophylaxis with the antibiotic cotrimoxazole reach 80 percent of 
children in need by 2010. The U.S. Global AIDS Initiative is vital 
towards achieving that goal.
    Accurate diagnosis of HIV infection in children can be difficult in 
resource-limited settings. Because of the persistence of maternal 
antibodies up to 18 months after birth, highly sensitive tests such as 
polymerase chain reaction or viral load testing are typically needed to 
render a definitive diagnosis in infants. While such tests have long 
been regarded as not feasible in low-resource settings (because of 
their high cost and the difficulty of collecting blood from newborn 
infants), more recent technical developments using dried blood spots 
show promise, enabling earlier diagnosis and avoiding the need to take 
blood from a vein.
    Formulations of antiretrovirals suitable for use in children remain 
rare and tend to be more expensive than adult regimens. Most pediatric 
antiretroviral formulations are syrups that taste unpleasant to many 
children, potentially complicating adherence. Some must be diluted with 
drinking water or refrigerated, which may be unpractical in certain 
settings. In many places, dosages of adult medications are simply 
reduced for children, risking under-treatment (which can lead to drug 
resistance) or over-treatment (which can produce side-effects because 
of the drugs' toxicity). Recently, some manufacturers have piloted the 
production of mini-pills, which are particularly suitable for young 
children. However, all new products need to be properly tested, pre-
qualified and licensed to use.
    Access to cotrimoxazle is critical, especially in settings where 
antiretrovirals are not yet accessible. The antibiotic, which provides 
protection against life-threatening opportunistic infections and can 
delay the need to initiate antiretroviral therapy, has been shown to 
reduce the risk of death in children living with HIV by more than 40 
percent (Chintu, et al., 2004). However, even though cotrimoxazole 
costs as little as 3 cents a day, an estimated 4 million children who 
need the drug are currently unable to obtain it (WHO and UNAIDS, 2005).
    Because HIV-positive children are vulnerable to severe infections, 
timely and proper immunization is especially important. Routine 
vaccinations are generally safe to administer to HIV-infected children, 
but additional research is needed to find ways to ensure the 
effectiveness of routine immunization in children living with HIV and 
to enable clinicians to make more informed treatment decisions (Obaro 
et al., 2004).
    There are still no available FDA-approved combination preparations 
in dosages appropriate for small children and infants. This problem is 
exacerbated by the fact that several focus countries have few, if any, 
pediatricians and general practitioners are often reluctant to assume 
responsibility for treatment of small children with HIV-related 
disease.
    UNAIDS believes that all of the above issues and strategies should 
be addressed in the upcoming reauthorization of the U.S. Global AIDS 
Initiative. Moreover, UNAIDS supports the prioritization of basic and 
clinical research within the NIH and other prominent research 
facilities to assess the pharmacokinetics for the safe and effective 
development of antiretroviral therapies for infants and children. We 
recognize the limited options available to be a significant barrier to 
the effective delivery of treatment to HIV-infected children around the 
world.
    UNAIDS supports aggressive targets for aligning the percentages of 
those on antiretroviral treatment to mirror percentages by age of those 
who are infected.

    [Whereupon, at 11:59 a.m., the hearing was adjourned.]

                                    

      
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