[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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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.
[[Page 63]]
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
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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.
[[Page 71]]
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
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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:
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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
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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
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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.]