[Senate Hearing 108-560]
[From the U.S. Government Publishing Office]



 
                                                        S. Hrg. 108-560

             FIGHTING HIV/AIDS IN AFRICA: A PROGRESS REPORT

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

                                HEARING

                               BEFORE THE

                    SUBCOMMITTEE ON AFRICAN AFFAIRS

                                 OF THE

                     COMMITTEE ON FOREIGN RELATIONS
                          UNITED STATES SENATE

                      ONE HUNDRED EIGHTH CONGRESS

                             SECOND SESSION

                               __________

                              APRIL 7, 2004

                               __________

       Printed for the use of the Committee on Foreign Relations


 Available via the World Wide Web: http://www.access.gpo.gov/congress/
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                     COMMITTEE ON FOREIGN RELATIONS

                  RICHARD G. LUGAR, Indiana, Chairman

CHUCK HAGEL, Nebraska                JOSEPH R. BIDEN, Jr., Delaware
LINCOLN CHAFEE, Rhode Island         PAUL S. SARBANES, Maryland
GEORGE ALLEN, Virginia               CHRISTOPHER J. DODD, Connecticut
SAM BROWNBACK, Kansas                JOHN F. KERRY, Massachusetts
MICHAEL B. ENZI, Wyoming             RUSSELL D. FEINGOLD, Wisconsin
GEORGE V. VOINOVICH, Ohio            BARBARA BOXER, California
LAMAR ALEXANDER, Tennessee           BILL NELSON, Florida
NORM COLEMAN, Minnesota              JOHN D. ROCKEFELLER IV, West 
JOHN E. SUNUNU, New Hampshire            Virginia
                                     JON S. CORZINE, New Jersey

                 Kenneth A. Myers, Jr., Staff Director
              Antony J. Blinken, Democratic Staff Director

                                 ------                                

                    SUBCOMMITTEE ON AFRICAN AFFAIRS

                  LAMAR ALEXANDER, Tennessee, Chairman

SAM BROWNBACK, Kansas                RUSSELL D. FEINGOLD, Wisconsin
NORM COLEMAN, Minnesota              CHRISTOPHER J. DODD, Connecticut
JOHN E. SUNUNU, New Hampshire        BILL NELSON, Florida

                                  (ii)




                            C O N T E N T S

                              ----------                              
                                                                   Page

Alexander, Hon. Lamar, U.S. Senator from Tennessee, opening 
  statement......................................................     1
Darkoh, Dr. Ernest, M.D., M.P.H., M.B.A., Operations Manager, 
  Botswana National ARV Program (Masa), Botswana Ministry of 
  Health and African Comprehensive HIV/AIDS Partnership (ACHAP), 
  Gaborone, Botswana.............................................    38
    Prepared statement...........................................    42
Feingold, Hon. Russell D., U.S. Senator from Wisconsin, opening 
  statement......................................................     4
Global AIDS Alliance, statement submitted for the record.........    68
Mermin, Dr. Jonathan H., M.D., M.P.H., Public Health 
  Epidemiologist, Centers for Disease Control and Prevention, 
  Department of Health and Human Services, Country Director for 
  GAP Uganda, Kampala, Uganda....................................    22
    Prepared statement...........................................    24
Oguda, Dr. Lulu, returned volunteer and field doctor, 
  representing Doctors Without Borders/Medecins Sans Frontieres, 
  Cambridge, MA..................................................    53
    Prepared statement...........................................    55
Tobias, Amb. Randall L., U.S. Global AIDS Coordinator, U.S. 
  Department of State, Washington, DC............................     6
    Prepared statement...........................................     8

                                 (iii)

  


             FIGHTING HIV/AIDS IN AFRICA: A PROGRESS REPORT

                              ----------                              


                        WEDNESDAY, APRIL 7, 2004

                               U.S. Senate,
                   Subcommittee on African Affairs,
                            Committee on Foreign Relations,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 2:50 p.m., in 
room SD-419, Dirksen Senate Office Building, Hon. Lamar 
Alexander (chairman of the subcommittee), presiding.
    Present: Senators Alexander and Feingold.


              opening statement of senator lamar alexander


    Senator Alexander. Good afternoon. Thank you for waiting. 
We had a couple of votes. I thought it best to go ahead and 
cast mine and get on over here. It helps to have your last name 
begin with an A because you can get through earlier.
    Senator Feingold will be here, I'm sure, before very long, 
and other Senators perhaps, but out of respect to the time of 
the witnesses, I'd like to go ahead and begin the hearing.
    The Subcommittee on African Affairs is now called to order. 
We're here to update America's 5-year $15 billion commitment to 
fight HIV/AIDS. We're looking specifically at the African 
portion of this commitment. Twelve of the 15 countries that we 
call focus countries are in Africa.
    I believe this is Ambassador Tobias' first appearance 
before a Senate subcommittee since Congress funded this 
initiative in January, and we welcome him here, as we welcome 
the other witnesses who we will hear very shortly. So, this is 
an important opportunity for a progress report.
    Our objective today has three parts. First, what are our 
goals for the next 5 years as a nation? The President has 
outlined three major goals: to treat 2 million people, to 
provide care for 10 million, and to prevent 7 million new HIV/
AIDS infections. But what are the smaller goals that were set 
to get us on the path to meeting those three big goals?
    Second objective. Are we meeting those goals? Do we have 
real benchmarks to measure progress as we move forward in 
meeting those goals? It's important that we have a way to tell 
if we're on the right path or not, so the next time we hold a 
hearing on this topic, we may be able to say we are.
    By way of analogy, during the war with Iraq, winning the 
war, it was fairly easy to tell what progress we were making. 
We had daily reports. Generals made the reports. They had clear 
benchmarks about their progress and we could see the progress. 
Winning the peace has proved to be a lot more difficult and 
it's more difficult to establish the benchmarks, but 
nevertheless benchmarks are important, and it is the oversight 
responsibility of Congress to help establish benchmarks for 
progress, and to make those benchmarks public. Over a period of 
time to measure whether we're reaching those benchmarks is 
important to do in our second objective.
    And third, are we spending the taxpayers' money wisely to 
reach these goals? Our majority leader of the Senate, Senator 
Bill Frist, has recently reminded us that this is the largest 
public health initiative we've ever undertaken abroad. Fifteen 
billion is a lot of money. We need to ensure that money is 
spent on the most effective means of reaching our goals.
    May I say at the outset, I don't think there are any in the 
Congress or in the administration who doubt we will spend the 
$15 billion. That is a commitment of the President. That is the 
commitment of the Congress in a remarkable accord. The 
questions that we need to discuss are how to spend it and when 
to spend it and what comes first?
    We often hear the statistics about how horrible the AIDS 
pandemic is in Africa. Over 40 million people infected with HIV 
around the world, three-fourths, 30 million of them in the 48 
African countries south of the Sahara Desert. The figures are 
staggering, are so large that they get bandied about so much 
that we sometimes forget what they mean or have a hard time 
imagining what they can mean.
    I've been trying to think of a way to explain this in more 
personal terms that will remind us of how serious this crisis 
is, and let's take the example of Botswana. We're going to hear 
some about Botswana today, but if you step back from Botswana 
and look at it, it has a lot going for it. It has a stable 
government, good governance, almost no corruption, very 
transparent, stability, elections. It has a good national park 
system. Most of its citizens have access to medical care. It 
stands out as an emerging country not only in Africa but it 
would in any other part of the world.
    Yet, one thing is threatening to literally destroy the 
country, in the words of its President, HIV/AIDS. Nearly 40 
percent of Botswanians are infected with HIV/AIDS. Think of 
what that might mean to a family of 5. It would mean that you 
could expect that 2 of those 5 family members are infected. In 
effect, they have received a death sentence. They may already 
be sick. Likely, they do not even know they are sick.
    Now, multiply that by an entire country, 1.7 million in 
that case, and you'd have something of the sense of the 
devastation that this disease is causing and that is just one 
country, one country that in many other respects is a model for 
progress.
    America's stepping up to the plate to combat this disease 
or to help with it. Here's what's happened so far.
    No. 1. A year ago in January in his State of the Union 
Address, President Bush led us in confronting AIDS by proposing 
an Emergency Plan for AIDS Relief.
    No. 2. Congress passed legislation authorizing the 
President's Emergency Plan for AIDS Relief [PEPFAR] 5 months 
later in May.
    No. 3. Ambassador Randall Tobias, who is here today, whose 
Office of Global AIDS Coordinator was created by that 
legislation, was confirmed last October.
    No. 4. The first year's money for the President's plan was 
appropriated in January of this year, just 3 months ago. Since 
that appropriation 3 months ago, Ambassador Tobias and his team 
have been busy, and we look forward to an update of what he and 
they have accomplished so far.
    Today, I hope we will make an honest assessment of what 
things we can do to move us quickly toward reaching our goals. 
For example, reducing unsafe medical practices could be an 
early goal. We've heard testimony in other Senate committees, 
Senator Sessions of Alabama has, for example, been a leader in 
looking into this, that unsafe medical practices account for at 
least 5 percent of the transmission of this infection. It could 
be a lot more.
    We know what to do about that, and we can move to do it 
quickly, or stepping up efforts to prevent mother-to-child 
transmission of HIV since this requires getting a single drug 
just before and after birth. We know how to do this, too, and 
in addition, work has already started during the last several 
years supported by this country. So, there's some things that 
we can do immediately that can make a big difference, and save 
the lives of lots of people.
    But we need to have an honest discussion, especially about 
those things that will take longer and about what the 
priorities are for those. Things like building capacity to 
deliver care and treatment and choosing the right drugs. Do you 
spend the money cleaning the water? Do you spend the money 
buying drugs? Do you spend it helping find more doctors to 
volunteer? Do you spend it building hospitals? Do you spend it, 
as I mentioned earlier, on mother-to-child transmission or on 
unsafe medical practices? Do you spend it on fighting TB and 
malaria? Which do you work on first or, if you do several 
things at one time, what is the allocation of funds, and then 
to whom do you give the money? Who's ready to spend it wisely 
and properly?
    Even if we have $15 billion, that money can be spent very 
quickly if it's not spent wisely. A person on antiretroviral 
drug therapy must take multiple drugs one or two times every 
day for the rest of his life. Each individual's response to 
these drugs must be monitored to ensure resistance doesn't 
develop. When it does, that the drug combination is altered to 
deal with the resistance.
    These simple facts make treatment of AIDS both complicated 
and expensive, and when one adds the challenges of attracting 
patients, perhaps as many as 90 percent of HIV-positive 
individuals don't know that they're ill and many who are living 
with AIDS are too ashamed to seek help, it becomes even more 
complicated.
    Then take the example of Mozambique, where we were in 
August, which has 400 to 500 doctors for a population of 17.6 
million. Obviously, we need to build a lot of new capacity 
there. Let me compare that to the conditions in the United 
States. Florida has about the same number of people Mozambique 
does, about 17 million. In Florida, they have 36,000 doctors. 
In Mozambique, 400 to 500. There are 90 times more doctors in 
Florida than there are in Mozambique per person.
    So, that's why I think it's important for us to be 
realistic in setting expectations for progress in the battle 
against this terrible disease. I believe we can reach the goals 
set by the President. I don't expect us to make steady progress 
toward them in each of the 5 years, especially in the area of 
treatment.
    While our initial ramp-up of already active programs will 
provide a quick boost to our numbers, it may very well be that 
the first few years will be dedicated to building the capacity 
to deliver treatment and more of the last few years dedicated 
toward utilizing that capacity to provide treatment. I would be 
interested in the comments of the witnesses on this idea.
    Said another way, we may expect a quick rise in the number 
of people on treatment followed by a period of slow growth 
followed by a surge toward the end of the 5 years, a surge that 
will hopefully reach or exceed the President's goal of 2 
million on treatment.
    Today's hearing provides a unique opportunity to assess our 
progress to date and consider how to reach or exceed the goals 
the President has set. We have a distinguished group to help us 
do that.
    First, Ambassador Randall Tobias, who coordinates America's 
responsibility to the global AIDS response to the crisis, will 
testify.
    Then, on our second panel following Ambassador Tobias, 
we'll hear from three individuals who have run or are running 
successful AIDS treatment programs in Africa. Dr. Jonathan 
Mermin of the Centers for Disease Control and Prevention will 
go first to talk about CDC's home-based treatment program in 
rural southeastern Uganda. That will be our second panel.
    Third, we will have two witnesses, Dr. Ernest Darkoh, whom 
I had the privilege of meeting last August, operations manager 
for the treatment program in Botswana, which is funded in part 
by the Gates and Merck Foundations, and Dr. Lulu Oguda, who's 
served as field director at two Doctors Without Borders 
treatment programs in Malawi and Zambia.
    It's not often we get advice from people who are doing so 
much important work on the ground in Africa where we hope to be 
of help, and we look forward very much to their testimony and 
are grateful for their coming here.
    But before we begin, let me turn to my colleague, Senator 
Feingold, the ranking member of our subcommittee, who has for 
several years been a leader in the Senate, both generally on 
African affairs and especially on the plague of HIV/AIDS.
    Senator Feingold.


            opening statement of senator russell d. feingold


    Senator Feingold. Thank you very much, Mr. Chairman, for 
the kind words and for calling this important hearing today.
    The chairman has made it his business to become very 
knowledgeable about the challenges confronting AIDS-affected 
communities in Africa and to follow very closely the U.S. 
Government efforts that are underway, and I commend him for his 
steady focus and leadership on this issue.
    Of course, we all want these efforts to succeed. The 
President's historic State of the Union commitment to fighting 
AIDS raised the hopes of communities all over the world, and it 
gave the ongoing and bipartisan effort to respond to this 
crisis new momentum and vigor. Today, we have come such a long 
way.
    We have moved past the days when talking about scaling up 
treatment made one a radical, past the days when policymakers 
had to be convinced that this is an urgent and critically 
important crisis. We've moved past any notion that we can 
protect our interests and meet our basic human obligations by 
addressing AIDS on the cheap. But now comes the hardest part, 
getting the response right.
    Now, we have to think about the management challenges that 
come with such a large increase in U.S. resources directed at 
fighting HIV/AIDS. Now, more than ever, we have to emphasize 
the importance of coordinating our efforts wisely with other 
U.S. assistance priorities, so that we can maximize positive 
spill-over effects wherever possible.
    Now, we have to find ways to transform the discussion about 
factors that make women and girls so vulnerable to AIDS into 
concrete action to address these sensitive but crucially 
important issues. Now, we need to think about how to buildup, 
rather than siphon off, Africa's human resources--the doctors, 
the nurses, the community health workers--as we proceed with 
this massive effort. Now we need to ensure that we are making 
sound treatment choices that save as many lives as possible.
    I look forward to discussing the issue of fixed dose 
combination therapy with our witnesses. I don't believe that 
the American taxpayers will tolerate decisions that favor 
saving fewer lives with patented pricey medications, if we can 
help more people with cheaper generic drug regimens that are 
actually easier to adhere to, diminishing the prospects of 
resistance.
    We can all agree that safety and efficacy are critically 
important, but it puzzles me that the U.S. Government seems to 
be sort of behind the curve when it comes to resolving this 
problem. Yesterday's Washington Post heralded an agreement 
involving the World Bank, the Global Fund, UNICEF, and the 
Clinton Foundation that should help most of the developing 
world get access to more affordable drugs to treat AIDS, but 
the news is not all good.
    According to the Post, ``missing, however, was one 
prominent funder, the U.S. Government which has its own plan to 
help AIDS patients in poor countries. The $15 billion U.S. plan 
seeks to buy medicines involving multiple combination of pills 
from Western pharmaceutical companies that hold patents on 
their drugs while yesterday's deal will rely on fixed dose 
medicines made in India and South Africa which combined three 
drugs in one pill.''
    So, what I want to know is why does the U.S. Government 
seem to be in such a lonely place? Surely we are not alone in 
being concerned about drug safety.
    I appreciate all of the work that went into the report 
submitted to Congress on February 23 of this year, and I find 
the report full of laudable goals and sound thinking, but I do 
share some of the views of House International Relations 
Committee Chairman Hyde, who noted that the plan we have before 
us is long on general principles but short on implementation 
specifics.
    I welcome this opportunity to dive into some of those 
specifics and details today. I want to thank Ambassador Tobias 
for being here today and thank all of our witnesses for taking 
the time to share their insights with this subcommittee, and I 
do look forward to the discussion.
    Thank you, Mr. Chairman.
    Senator Alexander. Thank you, Senator Feingold.
    Ambassador Tobias, we want you to take the time you need to 
make your presentation. If you are comfortable summarizing it 
in 5 or 7 or 8 minutes, then Senator Feingold and I can ask you 
questions and then we'll excuse you and go on to the second 
panel.
    You were confirmed, I believe, about 6 months ago. The 
Congress appropriated money about 3 months ago. We're here to 
find out what's happened so far and where we go from here.
    Thank you for coming.

 STATEMENT OF AMB. RANDALL L. TOBIAS, GLOBAL AIDS COORDINATOR, 
                    U.S. DEPARTMENT OF STATE

    Mr. Tobias. Mr. Chairman, Senator Feingold, thank you very 
much for the opportunity to report today, and I thank you both 
for your interest in and your support for the President's 
Emergency Plan for AIDS Relief.
    At the beginning, I want to apologize for my voice. I have 
been fighting laryngitis here for almost 2 weeks which I think 
may be in part cherry blossom pollen-induced. So, I will, with 
your permission, abbreviate my opening remarks and save my 
voice for responding to your questions.
    As you noted, Mr. Chairman, the President in his State of 
the Union Address last year called indeed for an unprecedented 
act of compassion to turn the tide against the ravages of HIV/
AIDS in his $15 billion Emergency Plan for AIDS Relief.
    Today, President Bush's vision is becoming a reality. 
Yesterday, I would note, as you just did, happens to be the 6-
month anniversary of my being sworn into this job, and on 
February 23, just 4\1/2\ months after we launched the Office of 
the Global AIDS Coordinator and less than a month after 
Congress appropriated the fiscal year 2004 funding, I was able 
to announce the first release of funds totaling $350 million.
    This money is being used as we speak to scale up programs 
that provide antiretroviral treatment, abstinence-based 
prevention programs focused on young people, safe medical 
practice programs and programs to provide care for orphans and 
vulnerable children.
    Our intent has been to move as quickly as possible to bring 
immediate relief to those who are suffering the devastation of 
HIV/AIDS, and with this first round of funds, an additional 
50,000 people living with HIV/AIDS in the 14 focus countries 
are beginning to receive antiretroviral treatment which will 
nearly double the number of people who are currently receiving 
treatment in sub-Saharan Africa.
    Today, activities have been approved for treatment in 
Kenya, Nigeria, and Zambia, and patients are receiving 
treatment in South Africa and Uganda because of the Emergency 
Plan for AIDS Relief.
    In addition, prevention messages will reach about 500,000 
additional young people and we will also be providing resources 
to assist in the care of about 60,000 additional orphans in the 
plan's 14 focus countries. Care services will include providing 
critical social services, scaling up basic community care 
packages of preventive treatment and safe water as well as AIDS 
prevention education.
    As we meet today, the U.S. Government staff from a number 
of agencies and departments are working together with my office 
to review as we speak each of the focus countries' annual 
operational plans to be addressed with the remaining fiscal 
year 2004 appropriation and those plans will provide the 
foundation for the operational plans for the other 4 years in 
the program.
    These plans represent the overall U.S. Government-supported 
HIV/AIDS prevention, treatment, and care activities in each of 
the focus countries. By the end of April, the plans should be 
approved and funds available to the countries in early May.
    Mr. Chairman, in addition to announcing this first round of 
funding and preparing to obligate the remaining fiscal year 
2004 funds against approved operating plans, I also submitted 
to this committee and other appropriate congressional 
committees the comprehensive 5-year strategy for the 
President's Emergency Plan for AIDS Relief.
    The fact that the Emergency Plan has been able to begin to 
move so quickly rests in part on the combination of a new 
aggressive strategy and our ability to capitalize on the 
experiences of numerous Federal Government agencies that are 
not new to this. They have been fighting AIDS internationally 
for the past 20 years, and there are many lessons learned about 
what works and what does not.
    So, we are implementing not a new bureaucracy but rather a 
new leadership model for those existing capabilities and new 
ones that we need to build. A model that brings together, under 
the direction of the United States Global AIDS Coordinator, all 
of the programs and personnel of the agencies and departments 
of the U.S. Government who are engaged in this effort.
    This leadership model has been translated in the field 
where the U.S. Chief of Mission in each country is leading the 
interagency process that has led to the submission of the 
operating plans we are reviewing at the moment.
    In early fall, each country team will submit to my office a 
5-year overreaching strategic plan to define how the 
President's prevention, care, and treatment goals will be 
achieved in each country.
    Within the framework of the overall strategy and the 
strategic plans for each country, we will strive to coordinate 
and collaborate our efforts in order to respond in a very 
targeted way to local needs and do so in a way that is 
consistent with host government strategies and priorities.
    At the same time, we intend to amplify our own worldwide 
response to HIV/AIDS by working closely with a number of 
international partners, such as UNAIDS and the World Health 
Organization and the Global Fund, as well as through non-
governmental organizations, faith-based and community-based 
organizations, private sector companies, and others who can and 
are assisting in engendering new leadership and resources to 
fight this pandemic.
    There's absolutely no doubt that this is one of the 
greatest challenges of our time and it will indeed require 
constant and concerted commitment from all of us to address it 
and defeat it. The limits of what we can accomplish in 
eradicating HIV/AIDS and its consequences are, I believe, 
defined only by the limits of our collective moral and 
operational imagination, and that is why developing a new sense 
of urgency, getting the first wave of funding released quickly 
after the appropriation was so critical, and I very much 
appreciate the Congress's assistance in ensuring that was able 
to happen.
    Mr. Chairman, Senator Feingold, I am grateful to both of 
you for your support and for your resolve to provide leadership 
in defeating the HIV/AIDS pandemic. Your leadership has 
facilitated the speed with which we are responding to people in 
need and that commitment will ensure our success, success that 
will be measured in lives saved and families held intact and 
nations moving forward with development.
    Mr. Chairman, you noted the problem associated with our 
focusing on the huge magnitude of the numbers and to forget 
that this disease strikes people one person at a time. One 
number that has been meaningful to me is to imagine what our 
reaction would be if we got up every morning and opened the 
morning paper to find that 20 fully loaded Boeing 747s had 
crashed the preceding day, killing everybody on board, and then 
we got up the next day to discover another 20 Boeing 747s fully 
loaded had crashed, killing everybody on board, and if that 
happened every day because that is what's happening with this 
disease, 8,000 people around the world are dying every day. I 
cannot think of a better place for us to be spending our time 
and our energy and our creativity than addressing this issue.
    Thank you very much, and I'll be pleased to respond to your 
questions.
    [The prepared statement of Ambassador Tobias follows:]

              Prepared Statement of Amb. Randall L. Tobias

    Mr. Chairman, members of the Committee,
    In his State of the Union address last year, President Bush called 
for an unprecedented act of compassion to turn the tide against the 
ravages of HIV/AIDS.
    The President committed $15 billion over five years to address the 
global HIV/AIDS pandemic--more money than ever before committed by any 
nation for any international health care initiative.

   $9 billion will go to new programs to address HIV/AIDS in 14 
        of the world's most affected nations--with a 15th country to be 
        added shortly. Even without the addition of a 15th country, the 
        14 countries already account for approximately 50 percent of 
        the world's HIV/AIDS infections.

   $5 billion will go to provide continuing support in the 
        approximately 100 nations where the U.S. Government currently 
        has bilateral, regional, and volunteer HIV/AIDS programs.

   And $1 billion will go to support our principal multilateral 
        partner in this effort, the Global Fund to Fight AIDS, 
        Tuberculosis and Malaria, which the United States helped to 
        found with the first contribution in May 2001.

    Today, President Bush's vision is a reality.
    On February 23, just 4\1/2\ months after we launched the Office of 
the Global AIDS Coordinator, and less than a month after the Congress 
appropriated Fiscal Year 2004 funding for the first year of the 
President's Emergency Plan for AIDS Relief, I announced the first 
release of funds totaling $350 million.
    This money will be used to scale up programs that provide 
antiretroviral treatment; abstinence-based prevention programs, 
including those targeted at youth; safe medical practices programs; and 
programs to provide care for orphans and vulnerable children.
    These target areas were chosen because they are at the heart of the 
treatment, prevention and care goals of President Bush's Emergency 
Plan.
    The programs of these specific recipients were chosen because they 
have existing operations among the focus countries, have a proven track 
record, and have the capacity to rapidly scale up their operations and 
begin having an immediate impact.
    Our intent has been to move as quickly as possible to bring 
immediate relief to those who are suffering the devastation of HIV/
AIDS.
    By initially concentrating on scaling up existing programs that 
have proven experience and measurable track records, that's exactly 
what we have been able to do.
    With just this first round of funds, an additional 50,000 people 
living with HIV/AIDS in the 14 focus countries will begin to receive 
antiretroviral treatment, which will nearly double the number of people 
who are currently receiving treatment in all of sub-Saharan Africa. 
Today, activities have been approved for antiretroviral treatment in 
Kenya, Nigeria, and Zambia; and patients are receiving treatment in 
South Africa and Uganda because of the Emergency Plan.
    In addition, prevention through abstinence messages will reach 
about 500,000 additional young people in the Plan's 14 focus countries 
in Africa and the Caribbean through programs like the American Red 
Cross's Together We Can and World Relief.
    The first release of funding from the President's Emergency Plan 
will also provide resources to assist in the care of about 60,000 
additional orphans in the Plan's 14 focus countries in Africa and the 
Caribbean. Care services will include providing critical social 
services, scaling up basic community-care packages of preventive 
treatment and safe water as well as AIDS prevention education.
    As I meet with you today, U.S. Government staff are reviewing each 
of the focus country's annual operational plans to be addressed with 
the remaining Fiscal Year 2004 appropriation. These plans represent the 
overall U.S. Government-supported HIV/AIDS prevention, treatment, and 
care activities in each focus country. By the end of April, the plans 
should be approved and funds available to the countries in early May.
    With this next round of funding, I expect to see many new partners, 
including more faith-based and community-based organizations that can 
bring expanded capacity and innovative new thinking to this effort.
    Mr. Chairman, in addition to announcing this first round of funding 
and preparing to obligate the remaining Fiscal Year 2004 funds, I also 
submitted to this Committee and other appropriate Congressional 
committees a comprehensive, integrated, five-year strategy for the 
President's Emergency Plan for AIDS Relief.
    This Strategic Plan will guide us in deploying our resources to 
maximum effect:

 We will be concentrating on prevention, treatment and care, 
the focus of the President's Emergency Plan.

     In the 15 focus countries, over the five years of the 
Emergency Plan:

   We will provide antiretroviral treatment for two million 
        people living with HIV/AIDS;

   We will prevent seven million new HIV infections; and,

   We will provide care to 10 million people who are infected 
        or affected by the disease in the focus countries, including 
        orphans and vulnerable children.

 We are not starting from scratch. Rather, we are capitalizing 
on existing core strengths of the U.S. Government, including:

   Established funding and disbursement mechanisms;

   Two decades of expertise fighting HIV/AIDS in the Untied 
        States and worldwide;

   Field presence and strong relationships with host 
        governments in over 100 countries; and,

   Well-developed partnerships with non-governmental, faith-
        based and international organizations that can deliver HIV/AIDS 
        programs.

    And we are implementing not a new bureaucracy but a new leadership 
model for those existing capabilities--a model that brings together, 
under the direction of the United States Global AIDS Coordinator, all 
of the programs and personnel of all agencies and departments of the 
United States Government engaged in this effort. This leadership model 
has been translated to the field, where the U.S. Chief of Mission in 
each country is leading an interagency process on the ground. In early 
fall, each country team will submit to my office a unified five-year 
overarching strategic plan to define how the President's prevention, 
care and treatment goals will be achieved in that country.
    The Emergency Plan is built on four cornerstones, which guide my 
office:

          1. Rapidly expanding integrated prevention, care, and 
        treatment in the focus countries by building on existing 
        successful programs that are consistent with the principles of 
        the Plan--as we have already begun with the $350 million 
        announced in February.

          2. Identifying new partners, including faith-based and 
        community-based organizations, and building indigenous capacity 
        to sustain a long-term and broad local response.

          3. Encouraging bold national leadership around the world, and 
        engendering the creation of sound enabling policy environments 
        in every country for combating HIV/AIDS and mitigating its 
        consequences.

          4. Implementing strong strategic information systems that 
        will provide vital feedback and input to direct our continued 
        learning and identification of best practices.

    Within that framework, we will strive to coordinate and collaborate 
our efforts in order to respond to local needs and to be consistent 
with host government strategies and priorities.
    In addition, we intend to amplify our own worldwide response to 
HIV/AIDS by working with international partners, such as UNAIDS, the 
World Health Organization, and the Global Fund, as well as through non-
governmental organizations, faith- and community-based organizations, 
private-sector companies, and others who can assist us in engendering 
new leadership and resources to fight HIV/AIDS.
    There is no doubt that this is one of the greatest challenges of 
our time, and will require constant and concerted commitment from all 
of us to defeat.
    The limits of what we can accomplish in eradicating HIV/AIDS and 
its consequences are defined only by the limits of our collective moral 
imagination.
    What inspires me the most as we embark on this effort is the 
remarkable self-help already under way in fighting HIV/AIDS by some of 
the most under-resourced communities in the world.
    These communities have responded, in whatever way they can, to 
fellow community members in need. With our support, we hope to amplify 
and sustain their efforts to combat the devastation of HIV/AIDS.
    That is why getting the first wave of funding released quickly 
after the appropriation was so critical, and I appreciate the 
Congress's assistance in ensuring that was able to happen.
    Mr. Chairman, I am grateful for your and this Committee's resolve 
to defeating the HIV/AIDS pandemic. Your leadership and support has 
facilitated the speed with which we are responding to people in need, 
and that commitment will ensure our success--success that will be 
measured in lives saved, families held intact, and nations moving 
forward with development.
    I would be pleased to respond to any questions you may have.

    Senator Alexander. Thank you, Ambassador Tobias, and I 
might thank you for your service to our country. You have a 
distinguished background in business with Eli Lilly and with 
AT&T, and we're glad to have you where you are.
    I'll ask a few questions, and then I'll turn it over to 
Senator Feingold, and then we might go back and forth a little 
bit.
    With your business background, I would assume that a lot of 
what you used to do at Eli Lilly and AT&T was establish 
benchmarks and say to people within your organizations, OK, 
this all sounds pretty good, but how are we going to know if 
we're getting anywhere, and I heard--I think I heard you just 
say that you were beginning to develop country-by-country plans 
in the 12--is it 12 countries in sub-Saharan Africa that are 
part of this Emergency Plan, and that by this fall, those plans 
would be reviewed and approved or changed and approved and 
operational. Did I hear that right?
    Mr. Tobias. Actually, the operational plans we expect to 
have approved or not in the next 2 or 3 weeks, and based on 
those plans, the remainder of the 2004 appropriation will be 
obligated.
    At the same time, the countries are developing 5-year 
strategic plans, these first plans being more operational in 
nature, but 5-year strategic plans that will take a longer view 
at all of the things that have to be done while at the same 
time we're getting the effort going.
    Senator Alexander. What I'm trying to get in my mind is an 
idea, and I wouldn't necessarily expect you to have it today 
but before long, of exactly what a report card would look like. 
If we're reporting to the American people here's how we're 
spending $15 billion of your money that we could be spending 
for schools or clean air or AIDS in the United States, or 
reporting to people in 12 countries in Africa here's how we're 
spending $15 billion to help you because Americans are 
compassionate and care about you, I mean, I can think of 
categories.
    I can think, as I mentioned, of safe medical practices, 
here's where we are today, here's where we're supposed to be 
this month, here's where we're supposed to be next, TB, 
malaria, number of doctors, number of people treated.
    I'd like to get an idea whether you have such a report card 
today or, if you don't, what it will look like and at what 
point could we expect to see such a thing and see what progress 
we're making toward very specific objectives to reach the 
larger goals that the President has outlined.
    Mr. Tobias. Well, let me begin by saying one of the things 
I learned in business school 40 some years ago and has been 
confirmed repeatedly over time is that it's a good idea to 
start with the premise that if something can't be measured and 
isn't being measured, you need to question whether it's worth 
doing, because I find that as difficult as it may seem on the 
surface, most things can in fact be measured in one way or 
another and that's the attitude that we are taking with our 
approach.
    We begin with the overarching goals that you mentioned, the 
so-called 2, 7, and 10 goals, and are asking ourselves the 
question about everything we're doing, everything we're 
funding, all the decisions we are making, how does this 
activity reach back to the achievement of those goals, of 
getting 2 million people under treatment by the end of 5 years, 
of preventing 7 million infections and of providing care to 10 
million people who are in need of the care.
    One of the first important jobs I filled on my staff is the 
person who is responsible for the measurement and evaluation 
activity, Dr. Kathy Marconi, who's a career Federal employee 
who has been in the Department of Health and Human Services 
engaged in measuring these kinds of things for a long time.
    She and her colleagues across the government have been hard 
at work developing a framework for what we will measure and how 
we will measure it, and they have been also working with, I 
might say, a good deal of progress with a number of our 
international partners, including the Global Fund and the World 
Bank and others, in trying to harmonize the measurements that 
we are putting in place, all of us, in the Emergency Plan, the 
Global Fund, and so forth.
    So that, to the maximum degree we can, we are reducing the 
strain on the resources in the countries in which all of us are 
operating by trying to leverage creating one data base and one 
set of data, and we've had a very cooperative effort there.
    But in the meantime, we've set some goals that are more 
overarching goals for the first year, the first one being to 
get this office launched which we've done in the last 6 months, 
get an organization laid out and begin to attract and hire 
staff with the appropriate skills and commitment and experience 
to help get this done.
    Developing a comprehensive 5-year strategy was an important 
effort. Working then against this strategy to create a 
framework in each of the target countries so that there was a 
mechanism to develop specific plans in each country that are 
both consistent with the strategy but at the same time are 
addressing the unique needs in each country, and other 
activities of that nature that are the startup activities that 
are necessary to get this going.
    We've needed to identify appropriate strategies and 
mechanisms that we can use to address the capacity issues, both 
the infrastructure issues and the human capacity issues, going 
forward. As you know from your own visits to Africa, those 
issues are critical roadblocks to our ability to really scale 
this up, and when we do scale it up over the long-term, we've 
got to ensure that we're providing sustainable human capacity 
and infrastructure capacity that will last long into the future 
and will permit these countries to take on more and more of the 
burdens themselves.
    So, those are illustrative of some of the kinds of things 
that we focus on.
    Senator Alexander. If I could drive that a little further, 
the large goals, the number of people on treatment, the number 
of infections prevented, those are two or three specific goals, 
but are we likely to be able to get a report on a regular 
basis----
    Mr. Tobias. Yes.
    Senator Alexander [continuing]. On--for example, we know in 
the United States, I believe, the percent of HIV/AIDS 
transmitted from mother to child, and it's very, very low, and 
we know that it's significantly higher in Namibia.
    Is it likely that mother-to-child transmission will be a 
benchmark in Namibia, for example, and that we'll have where we 
are today and whether that's a priority and where we are a year 
from now and where we hope to be 5 years from now?
    Mr. Tobias. Yes, and in fact, I would hope to be able to 
report to you every 6 months on sets of data that flow from 
those goals, but then cascade down on a country-by-country 
basis and program-by-program within those countries, all of 
which are additive over the 5-year period to achieving those 
goals, but recognizing it's one person at a time, one program 
at a time, one day at a time.
    The quality of the data that is available of the type that 
you refer to varies across the map. In some countries, the data 
is pretty good. In other countries, we and other international 
partners are going to have to put some work into strategic 
information systems that are going to be important and critical 
to our ability to evaluate these programs and planning for that 
activity is underway.
    Senator Alexander. Well, but as you say, it can be 
measured. It may not be worth doing. So, it would be more 
helpful to me than any other aspect of our oversight. I don't 
think it's appropriate for us to try to manage what you're 
doing, that's your job, but I do think that one of the 
Senate's, the Congress's under utilized great powers is the 
oversight responsibility, and the single thing that would help 
me, and I believe other committee members the most, is if we 
could agree on some sort of report card about what the 
benchmarks are.
    And on a regular basis, either through a hearing or through 
a discussion of some type to which all members of the Foreign 
Relations Committee or African Affairs Subcommittee could be 
invited, if you could come in and say, here's where we were, 
here's where we are, here's where we're going, we're a little 
ahead on this one, we're a little behind on this one, and this 
is why we're spending more money here and less money here and 
less money here.
    The more specific that report card is, the better. We 
understand that there is, for example, in the safe medical 
practices, WHO says it may be 5 percent, others say it may be 
more. We don't need to argue about that too long, but if we can 
find some way to measure progress from wherever we are and 
wherever we hope to go----
    Mr. Tobias. Right.
    Senator Alexander [continuing]. That will mean more to me, 
and I think to other members, than almost anything else. And 
after that, we can come to our own conclusions and make our own 
speeches about what we think the priorities ought to be, but we 
at least will know what the plan is and what the benchmarks are 
and whether we're proceeding according to the plan.
    Mr. Tobias. Senator, I could not agree more with everything 
that you've said, and I think it probably would be a good idea 
if my staff and your staff collaborated in looking at the 
material we're putting together to get kind of a specific feel 
of the kinds of things that you think would be most meaningful 
to you, so that we can provide that data, but I'm happy to 
provide all the measurements that we're putting together.
    Senator Alexander. I would welcome the opportunity, and I 
imagine other Senators would as well.
    [The following information was subsequently supplied.]

    The U.S. Global AIDS Coordinator's Office intends to use an annual 
planning and performance cycle to measure our goals of providing 
treatment to two million persons living with HIV/AIDS by 2008; 
providing care to ten million people infected and affected by HIV/AIDS, 
including orphans and vulnerable children; and preventing seven million 
new HIV infections. Our annual planning cycle:

    Sets treatment, care, and prevention targets, and budgets for each 
fiscal year; and,

   Twice a year, measures the number of people treated and 
        cared for, estimates infections averted, and budget 
        obligations.

    To measure progress toward these targets, we track 15 budget/
program area categories:
Prevention
PMTCT
Abstinence/Be faithful
Medical transmission/blood safety
Medical transmission/injection safety
Other prevention activities
Care
Palliative Care: Basic health care and support
Palliative Care: TB/HIV
Orphans and Vulnerable Children
Counseling and testing
Treatment
HIV/AIDS treatment/ARV drugs
HIV/AIDS treatment/ARV services
Laboratory infrastructure
Other
Strategic Information
Other/policy analysis and system strengthening
Management and staffing

    For each budget/program area we use an annual planning/performance 
cycle that:

   Proposes annual budgets, partners, and activities and 
        targets by USG funding agency.

   Measures obligated funding levels and carryover.

   Identifies various types of partner and sub-partner 
        organizations--such as faith-based, local, new or existing 
        partnerships.

   Measures the number of people reached, number of provider 
        sites or programs, and number of service providers trained for 
        prevention, care, and treatment program areas.

   Collects gender and age information for prevention, care, 
        and treatment programs, when possible.

    Additionally, intermediate outcomes, such as changes in prevention 
behaviors and care-seeking behaviors, are tracked every 2 to 3 years 
using independent household surveys. UNAIDS estimates of HIV prevalence 
are used to track the epidemic.
    The above referenced information will be made available by January 
31 each year, as required by the ``U.S. Leadership Against HIV/AIDS 
Tuberculosis and Malaria Act of 2003'' (P.L. 108-25) Sec. 301(e).

    Senator Alexander. Senator Feingold.
    Senator Feingold. Mr. Chairman, let me first commend you 
for the emphasis on the benchmarks, and I would very much like 
to work with you and the Ambassador and others to make that 
happen.
    Let me first ask a question relating to one aspect of this 
issue. The legislation passed by Congress that created the 
coordinator's position and authorized much of the PEPFAR 
activity, also required that the strategy report submitted to 
Congress contain ``a description of the specific strategies 
developed to meet the unique needs of women, including the 
empowerment of women in interpersonal situations.''
    It also required ``a description of specific strategies 
developed to increase women's access to employment 
opportunities, income, reproductive resources, and microfinance 
programs.''
    We can all obviously agree that women and girls are 
especially vulnerable to HIV/AIDS because they're often not in 
a position to make choices that can keep them healthy. Girls 
may have their school fees paid by so-called sugar daddy 
figures, and women may not be able to negotiate condom use with 
their husbands. These issues are difficult to talk about, but 
they're very real, and no plan to roll back the epidemic can 
actually succeed without addressing these issues.
    So, what specifically are the strategies you are pursuing 
to address these kinds of issues?
    Mr. Tobias. Senator, I couldn't agree more that the issues 
relating to women and particularly younger women in the 
countries in which we are focusing our attention are of 
critical importance.
    We addressed those issues in a number of ways throughout 
the plan, and I expect that as the operational plans and the 
strategic plans come in that I referred to earlier, that we 
will be looking at on a country-by-country basis. That is one 
of the aspects of these plans that we're going to be very, very 
interested in.
    Certainly, in a general sense, addressing the issue of 
strong leadership, strong governmental leadership and 
leadership in other segments of society in these countries is a 
very important starting point in ensuring that each of these 
countries is taking this issue seriously, the issue of women 
and the empowerment of women and the cultural positioning of 
women and the attitudes of men toward women and the empowerment 
of women, in a number of ways.
    And I expect that we're going to have a better handle on 
the specifics of that in the next 90 days or so as we gather 
the best thinking of the people in the field who are working on 
this.
    But without question, this is clearly one of the critical 
issues that will need to be innovatively addressed if we're to 
be successful.
    Senator Feingold. Well, I certainly look forward to getting 
those specifics. I realize you certainly would not have them 
all worked out today, but based on my conversations, especially 
in my last trip to both South Africa and Botswana, there was 
this sort of overwhelming sense that this problem is in some 
ways at the core of a lot of the problems.
    I'm interested in what the strategies would involve. Would 
they involve women's property rights? Would they involve things 
having to do with the criminal law? Would they have to do with 
government initiatives to educate men about their 
responsibilities in this regard?
    I think how this is done specifically really does matter, 
and I know you agree with that, but it is important to me, just 
as the chairman was interested in some of the benchmarks. I 
really want to know what you're going to try to do in this area 
and how I can follow it.
    Mr. Tobias. Some of these issues, such as the ones that you 
addressed, are less easy to quantify, just given the nature of 
the issue. I mean, we can measure fairly precisely how many 
beds we're adding in a clinic or how much testing capacity or 
that sort of thing.
    What we're really talking about here, more than anything 
else, is changing cultures and influencing the change in 
behavior and, among other things, that's going to take some 
extraordinary diplomatic effort, if you will, to get that done 
and we're going to need a lot of innovative and creative work 
here.
    I was, in my last trip to Africa, I was in an area in one 
country, just to cite a specific example to illustrate your 
point, where the incidence rate of HIV-positive young women 
between 15 and 19 in that particular area was 24 percent. The 
infection rate, the incidence rate in young men in exactly the 
same geography, 15 to 19, was 4 percent.
    Now, I just think that underlines the importance of why we 
have to address this issue.
    Senator Feingold. And I do think that choosing this area to 
really emphasize with the officials in these countries is 
important because it is uncomfortable. It is uncomfortable to 
bring this up to the President of the country, but once it's 
done, I think it's significantly troubling to those hearing it, 
that it sort of frees them up to maybe take some action on it, 
and I urge some very specific strategies on this and look 
forward to working with you on it.
    Let me follow on another aspect of it. According to a 
recent New York Times article, the director of UNICEF and other 
United Nations officials recently announced the results of 
studies that found that teenage brides in some African 
countries are becoming infected with the AIDS virus at higher 
rates than sexually active unmarried girls of similar ages in 
the same areas.
    At least for me, this calls into question the idea that 
condom use should be a prevention strategy directed primarily 
at high-risk groups. Since the vast majority of people with HIV 
do not know that they are infected, it seems that married women 
are at a troubling risk. What's your response to that?
    Mr. Tobias. Well, Senator, you've identified a high-risk 
group of people in the particular category and the particular 
circumstances that you are talking about, and in many cases, 
these are issues of older men marrying younger women which gets 
back into the whole set of cultural issues about marriage and 
forced marriages and marriages that are arranged between older 
men and younger women and things that enlightened leadership 
really need to address. And we can see the results in places 
where strong national leadership is addressing these issues.
    Senator Feingold. And it is important to recognize that 
this is in fact a high-risk group and it really in fact relates 
to the relationship between B and C which are sometimes seen as 
separate steps and they're actually interrelated.
    Mr. Tobias. Well, there's a very a high percentage across 
the broad population that we're focusing on of so-called 
discordant couples, where one partner is infected and the other 
partner is not.
    What's worse is that of the 40 million or so people 
estimated to be HIV-positive in the world, some estimate that 
as many as 90 percent or more do not know their status, and so 
we've got to encourage and find new and innovative ways to be 
more successful in getting more people tested. And one of the 
categories of people who need to be tested are people who are 
in a dedicated committed relationship.
    Senator Feingold. Thank you, Mr. Ambassador. Could you 
explain how PEPFAR will help to build infrastructure capacity 
in Africa, particularly in the area of training health care 
practitioners, especially community health workers, and 
discouraging medical brain drain? Will implementing partners 
all adhere to a set of principles regarding hiring local staff 
to ensure that we do not siphon resources away from the 
domestic health infrastructure, which would obviously in the 
end make all of our hard work and efforts unsustainable?
    Mr. Tobias. There are a number of things in the short-term 
to address the human resource issue. Twinning, for example, 
finding partnerships between health care facilities in these 
countries and those in the United States where partnering 
training can be done.
    We need to address those roles that have traditionally been 
played by health care professionals, doctors and nurses, and 
find the examples that can be carved out of that where health 
care workers can be trained to focus very specifically on 
certain functions that can be carried out.
    In the short-term, there are things that we can do 
selectively with volunteers that can help, but over the long-
term that's not going to contribute to the sustainability of 
this. Training programs, the development of curriculum.
    I think some of the witnesses that I'm familiar with that I 
know you're going to hear from later today are involved already 
in programs where they're doing some very innovative things in 
that regard, but this clearly is, in many people's minds, the 
No. 1 roadblock to our making progress, is addressing both in 
the short-term and sustainability in the long-term how we get 
the human capacity into the equation here that is going to be 
so critical to getting this done.
    Senator Feingold. Thank you, Mr. Chairman. Perhaps I can 
turn it back to you for a round of questions.
    Senator Alexander. Some people say with so many people 
desperately ill, we should rush to spend every dollar we can 
get our hands on to provide drugs for treatment. Other people, 
as I have, look at Africa as an example or a situation and see 
9 out of 10 people don't even know they're infected.
    Persuading them to become aware of that and then counseling 
them on what to do about that and then working with them to 
help them continue to take a treatment, to train doctors and 
other health workers to be able to provide the treatment, to 
build hospitals and other places to care for people, to clean 
up unsafe medical practices. All these so-called capacity 
issues need to be done, too.
    I used the example a little earlier of how the State of 
Florida has 90 times more doctors per person than the country 
of Mozambique which has the same population.
    So, how are you going to resolve these competing claims, 
those who say let's spend every penny we can grab right now, 
people are dying, they need treatment, and those who say Mr. 
Ambassador, the first thing we need to do is to provide 
capacity, and to recruit volunteers and doctors and counselors 
and persuade people to come in? How do you do that?
    Mr. Tobias. Well, there's merit to each of these individual 
arguments and that's part of what makes it even more difficult, 
but I think that the plan that the President proposed and that 
the Congress has approved is a very sound plan, which is to 
approach this by integrating treatment and prevention and care 
and not approach it as either/or on any of those issues, but to 
address all of those issues and to do so in a way that 
integrates those three activities to the maximum degree we can.
    At the same time, I'm a proponent of focusing on those 
activities, of treatment, prevention, and care, while 
recognizing there are a number of other things that need to be 
done that this program needs to coordinate and harmonize with.
    For example, putting someone on antiretroviral treatment in 
the end is not going to accomplish the desired end result if 
that person is starving to death, but this is not a nutrition 
program. I met, as it happens, this morning with an Under 
Secretary of the Department of Agriculture to talk about ways 
in which--at his initiative, I might add, to talk about ways in 
which we can harmonize the things we're doing in this program 
with nutrition programs that exist there and in the U.N. World 
Food Program and USAID Food Program and elsewhere.
    I would take the view that it's a circle. It's hard to know 
whether to start with prevention or treatment or care. You can 
argue that if we don't do something more successfully than we 
have done in the past about prevention, then we run the risk of 
eventually having wonderful treatment programs that have more 
and more and more people on those treatment programs. We've got 
to stop the increase in the number of people who are getting 
infected.
    Part of that is education, part of it is doing something 
about testing and having testing become more of a routine part 
of accepted practices in life.
    At the same time, we are finding that in those places where 
we have implemented treatment programs, we're beginning to see 
at least anecdotally examples of communities being positively 
impacted by seeing the improvement in the health of someone who 
is infected who is on a treatment program and other people 
deciding they need to go and get tested and find out their 
status because there is now hope.
    At the same time, in a compassionate humanitarian way, we 
need to address the care needs of not only those who are dying 
but the orphans and the vulnerable children. So, I think we 
would be making a big mistake to put a disproportionate part of 
the money in any one of those things because I think they all 
need to work together in a very harmonious way and that's 
exactly what we are attempting to do in the strategy that we've 
put together.
    Senator Alexander. I've heard many say that, especially in 
the case of HIV/AIDS, treatment is the best prevention.
    Mr. Tobias. Well, I'd add to that, that the best orphan 
care program that I can think of is keeping a mother alive. So, 
it all really is very interrelated.
    Senator Alexander. Senator Feingold.
    Senator Feingold. Ambassador, let me first commend you on 
your comments you just made about the testing. My friend 
Ambassador Holbrook certainly has focused on this and it was 
one of the things I was going to ask you about, and I'm pleased 
to hear your emphasis on it.
    Mr. Tobias. Ambassador Holbrook and I have talked about 
this a great deal and have also talked about ways in which the 
work he is doing, particularly with the private sector, can be 
leveraged by what we're doing. And I in fact have been invited, 
and I've accepted, to make the keynote address at the worldwide 
annual meeting of his organization in Berlin coming up in a 
couple of weeks.
    Senator Feingold. Glad to hear that. Let me ask a few more 
nuts and bolts questions about drug procurement.
    Has your office provided any directives to the field 
regarding the use of generic versus patented drugs to date? Are 
grantees currently free to procure fixed dose combination drugs 
if they're approved for use by the host country and, if not, 
why not?
    Mr. Tobias. Senator, this is a very complex and has become 
in some quarters a controversial issue that I think is a very, 
very critical issue for all of us to provide our best thinking 
around.
    I have said from the beginning, and this is very consistent 
with what the President and others have said, that our policy 
is and will be to buy the lowest cost drugs that we can find 
that we can demonstrate are safe and effective. And getting to 
the answer of what does that mean, what drugs are safe and 
effective, is not as simple as it appears that it might be on 
the surface.
    The consequences of not doing that for the long-term are 
quite significant. The risks of exacerbating the issues of drug 
resistance, if we don't approach this very carefully, are in 
fact significant.
    The ability to have as part of the arsenal that physicians 
are using, combinations of drugs that are in fixed doses is a 
very important element because it certainly eases the adherence 
and the means by which patients can be put on programs and can 
adhere to those programs.
    When we hear the word ``generic'' here in the United 
States, I think we all conjure up the notion of taking a 
prescription to the pharmacy and getting it filled and if it's 
filled with a generic drug, we know what that means. We know 
that it's a drug that has been reviewed by a stringent 
regulatory authority, in our case the Food and Drug 
Administration, and it is not essentially--it is in reality, 
the identical version of the original drug that was made by the 
research-based pharmaceutical company that invented it and 
brought it to the market.
    Many of the drugs that are referred to as generic drugs are 
really not generic drugs in that sense, but rather they are 
copies of original drugs that may well be totally fine. They 
may well be totally safe. They may well be totally effective.
    But in the same way that we would not rely on and do not 
rely on the regulatory authorities in another country to review 
the dossier for a new drug application and then automatically 
take their evaluation and introduce that drug in the United 
States market, so, too, I believe, do we need some stringent 
international standards and principles that can be used to 
evaluate these drugs.
    Senator Feingold. I accept that. Let me understand the 
thinking behind it. Let me just get a couple of specific 
answers. Let me go back to the question, and I don't think 
you're being non-responsive. I just want to know exactly.
    Has your office provided any directives to the field 
regarding the use of generic versus patented drugs to date?
    Mr. Tobias. And the answer to that is that people are 
permitted to purchase, and use money from our program for drugs 
that have been approved by a stringent regulatory authority, 
and so the practical translation of that means that many of 
what people refer to as generic drugs have not been reviewed 
and approved by a stringent regulatory authority.
    Senator Feingold. So, grantees are not----
    Mr. Tobias. No, the answer is no.
    Senator Feingold. And grantees are not currently free to 
procure fixed dose combination drugs if they are simply 
approved for use by the host country? That's not sufficient 
under your current program?
    Mr. Tobias. No, no, no. If there was a stringent regulatory 
authority in the host country, they absolutely would. It's 
where there is not a regulatory authority that exists.
    Senator Feingold. So in some places, it may be permitted 
and some places not?
    Mr. Tobias. If it's been approved by an internationally 
recognized group.
    Senator Feingold. Well, let's go to that then. There are 
fixed dose combination drugs that are actually prequalified by 
the WHO. Isn't it true that the WHO uses standards and 
procedures comparable to those used by the FDA and regulatory 
agencies of other industrialized nations to evaluate the safety 
and the effectiveness of generic fixed dose combinations? Are 
there aspects of the WHO process that you feel are inadequate?
    Mr. Tobias. The WHO program, their prequalification 
program, is an important program. I have the highest respect 
for the World Health Organization, and they play a very 
important role in this in a number of ways, but they have put 
together this program in a way so that the program is not 
transparent and the data that they have collected from the 
companies whose dossiers that they have reviewed is not 
available nor is there any kind of ongoing monitoring of the 
good manufacturing practices that the FDA would use. And there 
are a number of other aspects that differentiate that program 
from the kind of program that a regulatory authority would use.
    Working with the WHO, in fact the WHO has been a co-chair 
of the effort that has been underway involving a number of 
countries and regulatory authorities around the world, we are 
examining ways in which international technical and medical 
authorities can put together a set of principles that can be 
used in order to make careful evaluations.
    Senator Feingold. Let me just end, and the chairman does 
need me to finish, so we can move on. Let me just make a point 
here, because this is so critically important. I know you 
agree.
    I take it that there's a sense here that the WHO is not a 
regulatory body and that somehow could not give the same 
assurance that the FDA or another regulatory body can give, but 
as I understand it, the evaluation process the administration 
is setting up via the Botswana conference will also not be a 
regulatory body, but the administration seems apparently 
perfectly willing to use that body's recommendation.
    On the point that the WHO may not inspect manufacturing 
plants.
    They do inspect, apparently in contract with agents from 
the developed world's, regulatory agencies, prior to approval 
and require followup inspections at least every 5 years which 
is the same timeframe for reinspection as FDA's.
    So, I guess the last followup I'd ask for is, if you 
believe there are specific deficiencies in the WHO drug 
evaluation process, has the administration made any effort to 
assist in strengthening the WHO process, and wouldn't this be a 
better strategy than simply setting up this new and possibly 
duplicative review process in Botswana?
    Mr. Tobias. Senator, I repeat, the WHO is a co-chair of the 
Botswana meeting and the Botswana effort, and we are working 
very collaboratively and cooperatively with the WHO toward an 
effort of getting an internationally accepted set of principles 
that people can use, the drug companies can use in submitting 
information, that makes the process transparent, that makes the 
data available to people who are making those decisions.
    And I'm very hopeful that in the weeks ahead that that will 
lead to some ability to make an informed set of decisions about 
these drugs.
    In the meantime, there are, I think the last number I saw, 
there are about a 150,000 people in the world who are on 
antiretroviral therapy, using drugs that have been approved by 
regulatory authorities.
    Senator Feingold. Well, my concern continues to be a 
possible reinventing of the wheel in some aspects here, but I'm 
willing to work with you and learn from you on this. I did want 
to raise those concerns.
    Finally, can you assure me that there will be full 
transparency in drug procurement, including the cost of drugs 
purchased and the consideration given to lower cost 
alternatives?
    Mr. Tobias. Absolutely.
    Senator Feingold. Thank you for your patience, Mr. 
Chairman. Thank you, Ambassador.
    Senator Alexander. Well, thank you, Senator Feingold. Those 
are important questions.
    Mr. Ambassador, we thank you for coming. We thank you for 
your work. I think it's fair to say both Senator Feingold and I 
look forward to working with you, supporting you, and we look 
forward to developing those benchmarks so that we can have a 
clear picture of what progress we're making toward this great 
goal that this country has embarked on, and so that we can see 
where we need to work a little harder or where we're having 
some success.
    Thank you very much.
    Mr. Tobias. Thank you very much.
    Senator Alexander. We'll now move to Dr. Jonathan Mermin. 
Dr. Mermin, welcome.
    I would like to say, Dr. Mermin, that one of the--I won't 
say it was a surprise, but one of the most pleasant things that 
occurred when Senator Frist led a delegation of six Senators 
last August to sub-Saharan African countries and we looked at 
HIV/AIDS, we were reminded that the United States has had for 
awhile some of our most talented employees hard at work in 
Africa helping with HIV/AIDS, and you're certainly one of 
those, and we thank you for that service and glad that the 
President and the Congress are now putting more of a spotlight 
on the work that you're doing.
    Dr. Jonathan Mermin is Country Director for GAP Uganda, and 
I hope you'll take at least a minute or two and say what that 
means when you begin your testimony. The home-based treatment 
program based in Uganda is run by the Centers for Disease 
Control and Prevention in cooperation with a Ugandan non-profit 
and is often cited as a model for how to provide AIDS treatment 
in rural Africa.
    Uganda itself is often cited as the model, as the country 
in Africa that has been most successful in, over a period of 
time, reversing, actually reversing the trends in HIV/AIDS. In 
most African countries, the terrible statistics we read about 
are only increasing. In Uganda, they've been able to turn that 
around.
    So, Dr. Mermin, we look forward to your testimony and to 
having the opportunity to ask you some questions. Thank you for 
being here.

   STATEMENT OF DR. JONATHAN H. MERMIN, M.D., M.P.H., PUBLIC 
    HEALTH EPIDEMIOLOGIST, CENTERS FOR DISEASE CONTROL AND 
 PREVENTION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, COUNTRY 
            DIRECTOR FOR GAP UGANDA, KAMPALA, UGANDA

    Dr. Mermin. Thank you, Mr. Chairman, and I'm grateful to 
have a chance to talk with you today.
    I'm an HHS physician and a public health epidemiologist at 
CDC. Since 1999, I've lived and worked in Uganda where I run 
the local HHS/CDC Global AIDS Program [GAP]. Our program 
supports comprehensive prevention, care, and treatment 
activities.
    As you know, Uganda is a poor country with a per capita GDP 
of $280 per year. Earnings are even less for persons living in 
rural areas where 85 percent of Ugandans live. The health 
infrastructure is worse now than 30 years ago. On any given day 
in Uganda, only 5 percent of health facilities can perform an 
HIV test and only 20 percent can diagnose and treat 
tuberculosis, the leading cause of death for persons with HIV 
in Africa.
    Even with these statistics and extreme poverty, Uganda was 
the first country in the world to show a decrease in HIV 
prevalence. Building upon the success, Uganda has embarked on 
the next stage, delivering effective treatment to the hundreds 
of thousands of people with HIV living in the country.
    One example is the Tororo Home-Based Care Program which is 
a collaboration of the AIDS Support Organization, TASO, a local 
NGO, the Ministry of Health, and CDC.
    Margaret Akware is HIV-positive and she's a participant in 
the program. Her husband died of AIDS in 1996. She's a 
subsistence farmer, living in a thatched-roof home with her two 
children and five orphans. Margaret speaks in public about 
having HIV and participates in community drama groups educating 
people about AIDS. She lives each day knowing that if she dies, 
her seven children will have no place to live. Without 
participating in the program, she would have died.
    Margaret is a unique individual, but her story represents 
millions of people living with AIDS in Africa. Like her family, 
74 percent of children living with 30,000 HIV-positive TASO 
clients are at immediate risk of becoming orphans because all 
of their living parents have HIV. Effective HIV treatment is 
one of the best orphan prevention programs in the world.
    In Uganda, as this photo indicates, we have focused on a 
family centered approach to care and prevention. This includes 
family based HIV testing and counseling, basic care, and access 
to antiretroviral therapy or ART.
    HIV counseling and testing is the first step to introducing 
people to effective care. However, a national study in Uganda 
showed that 70 percent of adults reported wanting to receive 
testing but only 10 percent had actually been tested.
    Another reason HIV counseling and testing is critical is 
for couples where one spouse is HIV-infected and the other is 
not. Among members of TASO, 35 percent of married clients have 
HIV-negative spouses. Because the spouses have not been tested, 
most couples think that both husband and wife are HIV-positive, 
and therefore they're not taking precautions to prevent 
infection.
    When offered home-based HIV testing and counseling, over 95 
percent of more than 5,000 family members of persons living 
with HIV in rural Uganda accepted testing. Widespread family 
based testing and what is known as prevention with positive 
counseling are important parts of any treatment program.
    In addition to ART, there are several other inexpensive 
effective interventions. For example, a cap full of diluted 
chlorine solution added to water and stored in a plastic vessel 
reduces diarrhea among persons with HIV by 35 percent. This 
provides the whole family with clean water and it costs less 
than $10 a year. In this photo,\1\ you can see one of our 
clients with her water vessel and her antiretroviral therapy.
---------------------------------------------------------------------------
    \1\ The photos referred to during Dr. Mermin's testimony can be 
found in his prepared statement on page 30.
---------------------------------------------------------------------------
    Malaria is twice as common with people with HIV than people 
without HIV. Insecticide-treated mosquito nets can prevent 
malaria and cost about $5 apiece. Additionally, a simple 
antibiotic invented 40 years ago, known as cotrimoxazole or 
Bactrim, is available even in the most rural villages in Africa 
and costs less than $10 a year per person. When taken daily, 
this drug reduces death by nearly 50 percent, malaria by 70 
percent, and diarrhea and hospitalizations.
    Currently, over 30,000 people in Uganda are taking it every 
day, and with funding from the Emergency Plan, it's expected 
that this number will increase to 300,000 in the next 4 years.
    Although these simple interventions can be rapidly 
implemented, their impact is modest when compared to 
antiretroviral therapy which dramatically reduces mortality. 
There are many challenges to developing rural ART-based care, 
including access to lab monitoring for evaluating drug failure, 
setting up a reliable drug distribution system, and supporting 
good adherence to taking drugs. Yet, even though most people in 
Africa are not used to taking pills to prevent illness, we have 
found that when provided education, people adhere extremely 
well to their drug regimens.
    In addition, we have reduced the cost of a CD4 cell count, 
a test used to monitor the effectiveness of ART, from $15 to $3 
and have shown that the blood can wait 5 days to be tested with 
completely accurate results. This allows transport of blood 
specimens once a week from remote sites to a central or 
regional laboratory. These types of practical evaluations are 
necessary if we are to adapt effective interventions to the 
complexities of life in Africa.
    One of the biggest obstacles to routine AIDS care is the 
inability to travel to a clinic to receive medication. To 
address this barrier with the Home-Based Care Program, we 
decided to bring health care to people instead of making them 
come to us.
    For example, community health workers travel to people's 
homes on motorcycles to provide basic care, counseling, and 
ART. We've already treated over 1,000 adults and 30 children in 
two districts and many Emergency Plan partners are applying 
some of the same interventions in many other Ugandan areas.
    Much of the initial work in setting up a care program in 
Africa is spent on planning the program, developing counseling 
protocols, and a drug distribution system, purchasing 
infrastructure and hiring staff. However, once in place, rapid 
expansion depends almost solely on funding.
    For example, we support a program in urban Kampala, a 
faith-based initiative, called Reach Out, that provided its 
first person with ART using Emergency Plan funds only 5 weeks 
after Congress passed the fiscal year 2004 budget.
    Jennifer Birungi, who you can see pictured with her 
community health volunteer, is one of the first persons to 
receive ART under the Emergency Plan. She's a 36-year-old woman 
with HIV and a widow with two children. Last month, she was 
diagnosed with cryptococcal meningitis. Without treatment, her 
life expectancy would have been 6 days.
    However, she was started on the drug for her meningitis, as 
well as ART, and is greatly improved. Although she never 
attended school and struggled to find enough food for her 
children, she's taken every dose of her medicine on time.
    Within the next year, partially or wholly supported by U.S. 
Government funds, over 24,000 Ugandans like Jennifer will be 
taking antiretroviral drugs. Over a 100,000 people with HIV 
will be receiving effective basic care and thousands of 
infections will have been prevented.
    As the Emergency Plan is implemented, these numbers will 
increase and what is currently working in Uganda will work even 
better on a larger scale.
    So, on behalf of my colleagues here and in Uganda who work 
against AIDS, I'd like to thank the President, Congress, and 
the role you have played in helping to fight what is the worst 
epidemic in recorded history.
    Thanks for the opportunity to speak today, and I'll be 
pleased to answer any questions.
    [The prepared statement of Dr. Mermin follows:]

              Prepared Statement of Dr. Jonathan H. Mermin

    Good afternoon, Mr. Chairman and members of the Subcommittee on 
African Affairs. I am grateful to have a chance to talk with you today 
about fighting HIV/AIDS in Africa. My name is Jonathan Mermin. I am a 
Department of Health and Human Services (HHS) physician and a public 
health epidemiologist at the Centers for Disease Control and Prevention 
(CDC). Since 1999, I have lived and worked in Uganda, where I run the 
local HHS/CDC Global AIDS Program (GAP). In Uganda our program has 
piloted comprehensive care and treatment projects that include strong 
preventive components. Information from these programs lays the 
groundwork for full-scale implementation of the President's Emergency 
Plan for AIDS Relief (Emergency Plan).
    I thank you and your colleagues on the Subcommittee on African 
Affairs, and the larger Foreign Relations Committee, for bringing 
attention to this important issue. My colleagues and I have been 
honored by several congressional visits to our program and, on behalf 
of the HHS Secretary Tommy G. Thompson and the Global AIDS Coordinator 
Ambassador Randall Tobias, I would like you to know that we welcome 
future visits from you and your colleagues.
    Under the guidance of the Global AIDS Coordinator's Office, HHS/
GAP's commitment in the fight against global HIV/AIDS is part of a 
collaborative United States (U.S.) Government effort. HHS/GAP helps 
resource-constrained countries prevent HIV infection, improve 
treatment, care, and support for people living with HIV; and build 
capacity and infrastructure to address the global HIV/AIDS pandemic in 
25 priority countries in Africa, Asia, Latin America, and the 
Caribbean.
    In Uganda, as in all of the HHS/GAP countries, HHS/GAP works with 
U.S. Agency for International Development (USAID) and other U.S. 
Government agencies, as well as with host-country governments and non-
governmental partners to help people with HIV/AIDS live longer and 
healthier lives and to prevent the spread of HIV.
                               background
    Uganda is an under-developed country, with a per capita Gross 
Domestic Product (GDP) of $280 per year. Earnings are even less for 
persons living in rural areas, where 85 percent of Ugandans live. The 
health infrastructure is worse now than 30 years ago. Most hospitals do 
not have working x-ray machines, basic laboratory testing, or a 
reliable supply of simple medicine. On any given day in Uganda, only 5 
percent of health facilities can perform a HIV test and only 20 percent 
can diagnose and treat tuberculosis--the leading cause of death for 
persons with HIV in Africa.
    In 2001, the Joint United Nations Program on HIV/AIDS (UNAIDS) 
estimated that there were 600,000 persons living with HIV and AIDS in 
Uganda, including 100,000 under the age of 15, out of a population of 
24 million. There were 880,000 children orphaned by AIDS and an 
estimated 84,000 AIDS-related deaths. UNAIDS currently estimates life 
expectancy in Uganda to be 42 years mostly because of AIDS.
    Even with these statistics and extreme poverty, Uganda was the 
first country in the world to show a decrease in HIV prevalence--a 
decrease of 50 percent since 1992. Uganda's success in mitigating HIV 
infection now frequently informs the many global efforts to combat HIV 
and often serves as a model. This success was in large part because of 
early, high-level political leadership in addressing HIV, resulting in 
a broad response that included many innovative prevention programs such 
as the promotion of the ABC method, A for abstinence, B for being 
faithful, and C for condoms, as appropriate. The President's Emergency 
Plan has adopted the promotion of the ABC method as a key component of 
its prevention strategy.
    HHS/GAP Uganda, a part of this historic, broad multi-sectoral 
response, has developed a wide range of indigenous partners whose HIV/
AIDS effort and expertise are critical to success in fighting the 
epidemic. These partners include The AIDS Support Organization (TASO), 
the first and largest indigenous organization in Africa providing care 
and support to people living with HIV/AIDS. With TASO and other key 
partners, HHS/GAP is studying how people living in rural, resource-
limited settings can best access quality, comprehensive HIV care, 
treatment and preventive servies that includes antiretroviral therapy 
(ART). This research study is known as the Home-Based Care Program and 
is based in the rural Tororo and Busia districts in eastern Uganda near 
the border with Kenya. Components of this program are further 
highlighted below. Building upon these types of projects, the Ugandan 
Government, with the help of HHS and others, has embarked on the next 
stage--delivering effective treatment to the hundreds of thousands of 
Ugandans with HIV who currently live with almost no access to basic 
medical care and who have no experience with taking medicine on a daily 
basis to prevent illness. The challenges to this task are best 
understood from the perspective of people living in Uganda. As many of 
you know, Secretary Thompson and Ambassador Tobias led a delegation of 
over 100 government, business, faith, and charitable leaders to Africa 
in December, when they visited Tororo and met many of our patients in 
their homes; some of you have heard Secretary Thompson speak of the two 
HIV-positive people he met, Samson and Rosemary. I'm going to share 
with you the stories of some other clients, every bit as sobering, yet 
hopeful.
    For example, Margaret Akware is HIV-positive and her husband died 
of AIDS in 1996. Margaret is a subsistence farmer, living in a thatch-
roofed home with her two children. In addition to these two children, 
she takes care of five AIDS orphans. She lives several miles from the 
nearest health center and her family cannot afford even a bicycle for 
transportation. She is a unique individual, but her story represents 
millions of people living with HIV in Africa.
    Margaret speaks in public about having HIV and participates in 
community drama groups and educational sessions throughout her 
District, encouraging people to get tested for HIV and to support 
people with AIDS. She lives each day knowing that if she dies, her 
seven children will have no place to live. Without the ART she is 
receiving through the U.S.-supported Home-Based Care Program described 
above, she most certainly would have died. In addition to ART, she also 
receives counseling to prevent transmission of HIV and a basic 
preventive care package consisting of a method for making safe drinking 
water, mosquito nets, and a simple antibiotic that prevents infections. 
With the help of this program, Margaret will stay alive longer and will 
help educate others while continuing to support her seven children. 
Like Margaret's family, 74 percent of children living with the 30,000 
TASO clients in Uganda are at immediate risk of becoming orphans, 
because all of their living parents. Effective HIV treatment is one of 
the best orphan prevention programs in the world.
                components of a home-based care program
Family-centered Basic Preventive Care Package
    In Uganda, HHS/GAP and its partners have focused on a family-
centered approach to care and prevention. Working with families 
increases the chance for success because it utilizes the family's 
support systems, encourages disclosure of HIV status, and emphasizes 
the benefits to the whole household of providing effective care for a 
family member with HIV. Through a home-based, family-centered, delivery 
approach, HHS/GAP is focusing on expanding HIV testing and counseling, 
providing a standardized, effective basic care package to all persons 
with HIV, and expanding access to ART.
HIV counseling and testing
    HIV counseling and testing is the first step to introducing people 
to effective HIV/AIDS care. However, a national study in Uganda showed 
that 70 percent of adults reported wanting to receive testing; only 10 
percent had actually been tested. Currently about 50 percent of people 
hospitalized in Uganda have HIV infection, but HIV testing is rarely 
available in hospitals and almost never offered to patients.
    Another reason HIV counseling and testing is critical in Uganda is 
for couples where one spouse is HIV infected and the other is not. 
Among HIV-infected members of TASO, 35 percent of married clients have 
HIV-negative spouses. Because the spouses have not been tested, many 
couples think that both husband and wife have HIV and are, therefore, 
not taking precautions to prevent infection. In Uganda, an estimated 40 
percent of new HIV infections are occurring among married couples 
because they do not know that they or their partners are at high risk 
of infection. These data call for widespread, family-based testing, as 
well as what is known as ``prevention with positives'' counseling, i.e. 
working with HIV-infected persons to change their behavior to reduce 
the chance that they will spread the virus to others. In addition, HIV 
testing and counseling is the first step to introducing people to 
effective AIDS care.
    HHS/GAP Uganda has developed a three-tiered testing program. Its 
goals are to expand traditional counseling and testing sites so that 
people can have easy access to testing; to begin routine, voluntary HIV 
counseling and testing at clinics and hospitals throughout the country; 
and to explore door-to-door, home-based testing and counseling using 
mobile teams to increase access to testing and, if needed, link people 
to care. When offered home-based HIV testing and counseling, over 95 
percent of more than 5,000 family members of persons living with HIV in 
rural Uganda have already been tested.
Additional tools for care
    While ART is essential for those living with HIV, a comprehensive 
package of care needs to include more than just antiretroviral therapy. 
There are several other inexpensive, effective treatments that are 
critical for preventing illness and death which are discussed below.
    For example, in Africa, according to the World Health Organization 
(WHO), diarrhea is responsible for as much as 8 percent of all deaths 
regardless of HIV infection status. A capful of diluted chlorine 
solution added to water and stored in a plastic vessel reduces diarrhea 
among persons with HIV by 35 percent. This provides the whole family 
with clean water and costs less than $10 a year.
    Malaria is a life-threatening parasitic disease transmitted from 
person to person through the bite of a mosquito. According to the WHO, 
the disease exerts its heaviest toll in Africa, where around 90 percent 
of the more than one million deaths from malaria worldwide occur each 
year,. Malaria is twice as common among adults and children living with 
HIV. Insecticide-treated mosquito nets can prevent malaria and cost 
about $5 a piece.
    Additionally, a simple antibiotic, known as cotrimoxazole or 
Bactrim, can be used to help prevent both diarrhea and malaria and 
prolong life. It is available even in the most rural villages in Africa 
and when purchased in bulk, treatment costs only $6 a year per person. 
When taken daily by persons with HIV in Africa, this drug reduces death 
by nearly 50 percent, malaria by 70 percent, and diarrhea and 
hospitalizations by 30 percent. HHS/GAP is working with the Ugandan 
Ministry of Health to develop a policy regarding its use. Currently 
over 30,000 people are taking it every day, and with funding from 
President Bush's Emergency Plan, it is expected that this number will 
increase to 300,000 in the next four years.
    In Uganda, HHS/GAP, as well as its partners in the President's 
Emergency Plan, are promoting the aforementioned strategies--a 
comprehensive package of care, that uses a family-centered approach 
that includes these simple, life-extending interventions--a method for 
making safe drinking water, mosquito nets, cotrimoxazole, testing and 
counseling, and ART, which is discussed in the next section. The 
strategies discussed above highlight the existence of simple 
interventions that prevent illness and death and can be rapidly 
implemented. However, the impact of these interventions is modest when 
compared to the life-extending, life-improving effects of ART.
                         antiretroviral therapy
    When AIDS was first recognized in 1981, patients with the disease 
were unlikely to live longer than a year or two. Since then, scientists 
have developed an effective arsenal of drugs that can help many people 
infected with HIV live longer and healthier lives. These drugs are 
called antiretroviral drugs because they attack HIV, which is a 
retrovirus. Antiretroviral therapy (ART) can significantly affect the 
disease progression of HIV/AIDS. The diagnosis of AIDS occurs when the 
count of a person's CD4 cells (a critical part of a person's immune 
system) is less than 200. As a comparison, a healthy HIV-negative 
person has a CD4 cell count of about 1,000. The death rate for persons 
with CD4 cell counts of less than 200 is 50 percent per year; however, 
the death rate is reduced to less than five percent per year with ART.
    Nevertheless, there are many challenges to developing rural ART-
based care in resource-limited settings. Drug adherence presents 
potential difficulties, leaving the possibility for the development of 
viral resistance. CD4 cell count and HIV viral load monitoring are 
traditional tools used to monitor the health of those living with HIV 
and to assess drug resistance, but providing this testing presents 
challenges in settings with limited infrastructure and trained 
personnel. There is often no system for sustained distribution of 
drugs. There is extreme poverty with no access to electricity. 
Sanitation and clean water are limited, and access to transportation is 
often unavailable creating a tremendous barrier for this widely 
dispersed population.
    In the U.S., persons with HIV started taking zidovudine, also known 
as AZT, when it was first developed, and later, with treatment 
advances, people had the opportunity to take two drugs at a time. While 
people with AIDS lived longer taking two drugs, it was soon realized 
that taking three drugs at a time was the optimal drug regimen to keep 
people alive longer and prevent the emergence of drug resistance. This 
is one of the reasons, in addition to adherence issues, that the United 
States is currently coping with the burden of multi-drug resistant 
cases of HIV infection. Governments, physicians, and people with HIV in 
Africa are concerned that they might have similar difficulties with 
drug resistance, especially since Africa does not have the 
sophisticated resistance testing available in other countries. In 
Africa we are starting with triple-therapy antiretroviral drugs (ARVs). 
This means that emergence of resistance will be delayed if people can 
adhere to the drug regimen. Adhering to the appropriate drug regimen is 
easier now than ever before--most regimens can be taken twice a day 
instead of four times a day as was the case 10 years ago. Even though 
most people in Africa are not used to taking pills to prevent illness, 
we have found that, when provided education on the importance of 
following drug regimens, people adhere extremely well.
    However, the traditional tools used for assessing drug resistance, 
CD4 cell count and HIV viral load monitoring, present challenges. In 
most African countries the cost of traditional CD4 cell count and HIV 
viral load monitoring is greater than the cost of ARV drugs. In 
addition, the machines for conducting the testing are usually available 
in only one or two laboratories in the country. To make the situation 
even more difficult, manufacturers of these testing machines currently 
recommend that CD4 cell counts must be conducted within two days of 
blood draw.
    HHS/CDC has spent the past four years developing less expensive 
ways of conducting CD4 cell counts. Now, using state-of-the-art 
technology, HHS/GAP Uganda has reduced the cost of a CD4 cell count 
from $15 to $3 and has shown that the blood can wait five days to be 
tested with completely accurate results. This allows transport of blood 
specimens once a week from remote sites to a central or regional 
laboratory. HHS/GAP is also conducting a study to see whether 
laboratory monitoring is necessary at all. It is possible that, through 
weekly or monthly monitoring by a trained lay person who also delivers 
the ART to a person's home, signs of drug failure such as weight loss 
and yeast infections can be detected quickly and the need to change 
drug regimens can be evaluated. These types of practical evaluations 
are necessary if we are to adapt effective interventions to the 
complexities of life in Africa.
    HHS/GAP has found that the biggest obstacle to ART, especially in 
rural areas, is the inability to travel to a clinic to receive 
medication. Many people live so far from clinics that transportation by 
bicycle or bus to pick up drugs is not available along the paths that 
lead to their homes. If transportation is available, it is too 
expensive. Many people with HIV have died at home simply because they 
could not afford to come to the clinic when they were sick or they 
could not afford their medication.
    To address this barrier, HHS/GAP and its partners have brought the 
health care system to people in these rural areas, using the Home-Based 
Care Program, the project Secretary Thompson and Ambassador Tobias 
visited in December. In this project, community health workers travel 
to people's homes on motorcycles to provide home-based HIV testing and 
counseling, cotrimoxazole prophylaxis, mosquito nets, clean water, 
tuberculosis treatment, prevention with positives counseling, and ART. 
They deliver drugs, ask a short, standardized symptom questionnaire, 
and support adherence to drug treatment. The project is based at one 
District hospital and is already treating over 1,000 persons in two 
Districts. Many Emergency Plan partners are applying some of the same 
interventions in other Ugandan areas.
Time
    Much of the initial work in setting up a program that delivers HIV 
testing, basic care, and ART in Africa is spent on planning the 
program, developing counseling protocols and drug distribution systems, 
purchasing infrastructure and hiring staff. Because HHS/GAP developed 
many of its own tools, the Home-Based Care Program in Tororo took a 
year to begin implementation. However, now that it is in place, rapid 
expansion depends almost solely on funding. For example, a HHS/GAP-
supported program in urban Kampala, a faith-based initiative called 
Reach Out, provided its first person ART using Emergency Plan funds 
only five weeks after Congress passed the FY2004 budget. Since this 
program had already planned for a family-centered program that adopted 
many of the interventions and materials that HHS/GAP had developed, 
they could immediately implement the program.
    Let me convey the importance of home-based care in the provision of 
ART through the story of Jennifer Birungi, one of the first persons to 
receive ART funded by the President's Emergency Plan. Jennifer is a 36-
year old woman with HIV and she is a widow with two children. Last 
month, she was diagnosed with cryptococcal meningitis, a painful and 
devastating infection for people with HIV. Without treatment, her life 
expectancy would have been six days. However, she was started on a drug 
for her meningitis infection as well as ART and has greatly improved. 
Although she has never attended school, lives in a one room house with 
no blankets or furniture, and struggles to find enough food for her 
children, she has taken every dose of her medicine on time.
    Christopher Omoit is a client of the Home-Based Care Program. He is 
53 years old and lives in rural Uganda with his wife, Florence, their 
five biologic children, and two orphans from his sister who died of 
AIDS. He was a laboratory technologist until 1999, when he became too 
sick to continue working and tested positive for HIV. Through U.S. 
Government support, his whole family was provided HIV testing and 
counseling. His wife was HIV-negative because they were counseled about 
how to prevent transmission, and today, she remains negative. HHS/GAP 
provided him with a basic care package, and since then he has reported, 
``I used to get sick a lot with diarrhea and malaria, but now I can do 
my work without falling sick.''
    The basic care package helped Christopher, but his CD4 cell count 
was 13 and he knew he would not live on the basic care package alone. 
At this point, to survive, ART was absolutely necessary. Just six 
months ago, his field officer came on a motorcycle and provided him 
with his first supply of ART. He has since established a support group 
for people taking ART and the group has started income-generating 
activities. Because he is part of a home-based program that focuses on 
preventive care, he rarely becomes ill, can avoid having to walk four 
miles to the nearest clinic, he and his family stay healthy, and he is 
strong enough to work. Because his ARVs are delivered to him on a 
regular basis and his family has been educated to help him remember to 
take his drugs, he is adhering to his regimen better than the average 
person with HIV in the United States.
    Within the next year, partially or wholly supported by U.S. 
Government funds, over 24,000 Ugandans like Christopher will be taking 
antiretroviral drugs, over 100,000 people with HIV will be receiving 
effective basic care, and thousands of infections will have been 
prevented. As the President's Emergency Plan is implemented, these 
numbers will increase. What is currently working in Uganda will work 
even better on a larger scale, and we can continue to make progress 
addressing the worst epidemic in recorded history.
    Lastly, the success of home-based care in Uganda in large part 
stems from the efforts President Bush and Congress have devoted to 
global AIDS over the past decade. The tremendous leadership of 
President Bush and members of Congress and their contribution toward 
the fight against global AIDS cannot be overstated. On behalf of my HHS 
and State Department colleagues and all those who work to combat global 
AIDS, I would like to thank Congress for the role you have played in 
helping to fight this global pandemic.
    In conclusion, I thank you for the opportunity to speak today and I 
would be pleased to answer any questions.









    Senator Alexander. Well, thank you, Dr. Mermin. We should 
be thanking you. You're doing the work.
    Let me ask you. Put yourself in our shoes a little bit, if 
you would. I'm sure you may have done that before and just not 
said it out loud to people. But if Senator Feingold and I are 
sitting here and charged with the responsibility for oversight 
of how we're helping to spend $15 billion over 5 years to help 
fight the worst epidemic in the history of the world, what 
should the benchmarks be? What kind of questions should we be 
asking?
    Let's just be specific. Let's take Uganda, where there's 
more success than any other place. Over the next few years, if 
you were sitting in our shoes, what questions should we be 
asking? What benchmarks should we be insisting on?
    Dr. Mermin. Thank you, Mr. Chairman. There are two kinds of 
benchmarks. The first kind is the direct outcome measures, and 
I think that the outcomes of number of HIV infections 
prevented, number of people getting routine basic care, and 
number of people getting ongoing ART, are very effective 
measures and they're very useful as a way to make sure that the 
programs that are being implemented stay on track.
    There's one level of measures beneath that called process 
indicators. Those indicators are as critical to making sure 
that we're on the right path. They include aspects of how many 
people have received voluntary counseling and testing. In what 
situations are we providing voluntary counseling and testing? 
What are we doing to actually counsel HIV discordant couples? 
What kind of educational activities do we have with youth, and 
are they changing their behavior?
    Those kind of process indicators are very important, and I 
would say that the measures that are currently being discussed 
with the Emergency Plan partners seem to be very effective.
    Senator Alexander. Are you a part of developing the Uganda 
plan?
    Dr. Mermin. Yes.
    Senator Alexander. And you're suggesting that such a plan 
will have outcome measures, but that we should also pay 
attention to the process measures? See, our tendency might be 
to say or mine would be to say--well, would be to pay a lot 
more attention to outcome than process.
    Are you suggesting that the process measures are helpful in 
understanding what the outcomes are or that they're important 
just by themselves?
    Dr. Mermin. Sometimes, they're important to make sure that 
the programs have good quality in areas that aren't measured 
within those three major outcome measures, but I think 
primarily they're useful for the program, for people involved 
in the program. And it's the ultimate outcomes that are going 
to be of most interest to people in your position.
    Senator Alexander. If you were looking ahead 3, 4, or 5 
years and looking at the resources that seem to be available, 
what's the prospect for fighting HIV/AIDS in Uganda over the 
next 5 years?
    Dr. Mermin. I think it's very hopeful. Uganda is a 
remarkable country with a great deal of both governmental and 
non-governmental support for AIDS activities. It's already 
decreased HIV prevalence by at least a half. We are involved 
in----
    Senator Alexander. From what to what?
    Dr. Mermin. Among women visiting antenatal clinics in urban 
settings, it's decreased from close to 30 percent to 12 
percent. In rural areas, it's decreased from about 15 percent 
to 6 percent. It's hard to take that information and translate 
it to an actual population-based number, but it's presumed that 
it was close to 10 percent and it's now close to 5 percent.
    One way of getting accurate information is something we've 
been working on for the past 3 years and is being implemented 
as we speak and that's a national HIV behavioral survey, and 
with the leadership of the Ministry of Health and support from 
the U.S. Government as well as UNAIDS and WHO, Uganda's 
currently carrying out a nationally representative survey where 
they go to people's homes in the country.
    They ask people to answer a questionnaire related to 
demographics and behavior, and then they also do HIV testing, 
and that information will provide the answer to your question 
much more accurately about what's actually going on with HIV 
prevalence today.
    Senator Alexander. This will be my last question before 
turning to Senator Feingold, but it relates to a subject he 
mentioned, that Ambassador Tobias also mentioned.
    What about new kinds of testing, the rapid tests? How 
important are those in helping to discover those people who are 
infected and then in persuading them to accept treatment and 
then to encourage them to use the treatment on a regular basis?
    Dr. Mermin. I appreciate your asking that question. CDC was 
initially involved in the mid-1990s with the AIDS Information 
Center in Uganda. This is the first and largest HIV testing 
center in Africa, and what we did is when we evaluated the 
program, we realized that about 25 percent of the people who 
were HIV-positive when they came in to get tested would never 
come back to receive the results 2 weeks later.
    So, we piloted using rapid HIV testing. It was still 
conducted in the laboratory at the AIC sites, but what it ended 
up doing, because people would get their results within 1 hour, 
was that we had everyone receive their results.
    Everyone received counseling and they left the center 
knowing their HIV status, and at this point, they also leave 
being screened for tuberculosis, getting treatment if they have 
tuberculosis, and getting access to other information that's 
necessary for them to take care of their lives and health.
    We didn't want to just rest with that, because what we 
found was that still the traditional rapid HIV tests also 
demand the kind of infrastructure that isn't available in most 
rural areas in Uganda.
    So, we completed about 6 months ago, again in collaboration 
with the Ministry of Health and WHO and AIC, a field assessment 
of the use of finger stick rapid testing in rural sites. People 
could just get a finger stick of blood, put it on a test and 
get an immediate result, and what we found was it works just as 
effectively as the traditional laboratory-based testing.
    Senator Alexander. You mean they could tell for themselves? 
They administer it to themselves and read the results 
themselves? They don't need a doctor or a health worker?
    Dr. Mermin. I'm sorry. I should clarify. It is being 
conducted in a facility, a health facility by--the test is 
being conducted by a laboratory technician or a nurse, but it's 
being done in the room with the person who is being counseled 
about HIV.
    That testing modality has been very--it looks like it will 
be successful and is quite popular already among different 
organizations to try to implement that because it can reach out 
to rural areas somewhat more quickly.
    In addition, one of the things we'll be exploring in the 
next year is the use of that kind of testing in people's homes 
because currently, our home-based VCT activity has involved 
going to people's homes, doing the finger stick, putting blood 
on filter paper, bringing it back to the laboratory and then 
returning to the home to give the results.
    And it might be more effective and less costly to actually 
be able to do the testing with a counselor directly in the 
home, provide people with the results right then and there, and 
then give them ongoing followup care if they need it.
    Senator Alexander. Senator Feingold.
    Senator Feingold. Thank you. Dr. Mermin, can you tell me a 
little bit more about the strategies that you're pursuing in 
Uganda to meet the specific needs of women and girls?
    Dr. Mermin. Thank you. There are actually several 
approaches to that question. The first involves HIV prevention 
education that's going on in many different ways in Uganda. One 
is through Straight Talk which is a newspaper insert that 
discusses HIV prevention and care, focused on youth, and that's 
been going on for several years in Uganda, and it's in the 
national newspaper and they translate it to multiple languages, 
so that it can reach even rural areas.
    There's a large school-based educational program that is 
actually led by the President of the country, and the U.S. 
Government has supported that program and the development of 
the books that are actually used by teachers to be able to 
educate their students.
    Then, in addition, we also have a special focus on families 
in some of the work that we're doing, where, by providing HIV 
counseling and testing to entire families, that gives us the 
opportunity not only to discuss with both men and women what it 
means to have HIV, to have them support each other, depending 
on the situation, especially if it's an HIV discordant couple, 
or if a woman has HIV and she needs to access prevention of 
mother-to-child transmission programs, or whether one of them 
actually ends up having to take antiretroviral therapy in the 
long term.
    We incorporate in that counseling issues related to writing 
wills, to domestic violence, and really have tried to look at 
the holistic aspects of a family because, at least from our 
experience, that's the best way to get effective results.
    Senator Feingold. Those are all encouraging. Let me ask if 
there's some kind of a gender advisory group that helps guide 
the country strategy with regard to the needs of women and 
girls.
    Dr. Mermin. Yes. The Ministry of Gender in Uganda actually 
is heavily involved in HIV/AIDS activities and a representative 
of that ministry is on our advisory board, the Emergency Plan 
Advisory Board. So, we gain guidance from both that ministry as 
well as from her.
    Senator Feingold. Does that group have people, like 
representatives from civil society, from women's groups, 
networks of women living with AIDS, service providers, those 
type of people?
    Dr. Mermin. Yes, all of the above.
    Senator Feingold. In an overall sense, with regard to 
Uganda, are you satisfied with the degree of interagency 
coordination, international donor coordination and coordination 
with the diverse Ugandan community working to fight AIDS on the 
ground, or is there some aspect of this that you'd like to see 
improved?
    Dr. Mermin. I think that Ambassador Tobias needs to be 
complimented on his approach to coordination within countries. 
Historically, the U.S. Government agencies in Uganda have 
gotten along very well and we've communicated about our 
activities well. We work very well with both UNAIDS, WHO, and 
other bilateral/multilateral donors through a partnership forum 
that's sponsored by the U.N.
    But what we hadn't done, at least within the U.S. 
Government, is actually planned together, and what's really 
remarkable over the past 6 months is that we're not just 
talking about each other's activities, we actually got together 
in a special strategic planning retreat and designed the 
Emergency Plan together.
    We held stakeholder meetings with the civil society, groups 
of people living with AIDS, and ministries and Uganda AIDS 
Commission, giving us advice about activities. And we ran those 
together, and we designed the proposal that Ambassador Tobias 
mentioned with information from both groups, looking at the 
strategic benefits of one or other agency either supporting 
that activity in particular or providing technical assistance.
    So, I think that I'm very encouraged over recent time about 
the way that the coordination is occurring in the country under 
the leadership of the Ambassador in the country. I think there 
will be continued improvement in those relationships and our 
ability to function effectively will continue to improve.
    Senator Feingold. Thank you, doctor. One more question in 
light of the fact that we want to see the successes of Uganda 
repeated in other places. Do you rely on the U.S. Embassy to 
handle contracting issues and the overall administrative burden 
of maintaining CDC's programs on the ground and, if so, how 
sizable of a burden is that on the embassy?
    Dr. Mermin. That's an insightful question. We do. CDC has 
certain authorities, and under our existing structures, we have 
to use the existing embassy personnel and systems to be able to 
purchase reagents, test kits, implement contracts, other than 
our large cooperative agreements which go through Atlanta. 
That's put a tremendous burden on the embassy.
    We are hiring new staff, as are they, to try to adapt to 
the situation, but it's an awkward situation because it doubles 
some of the administrative and bureaucratic burden on both 
agencies.
    And I think in the future, if there were a way for you and 
the chairman to be able to influence the ability for Health and 
Human Services to be able to act more independently and have 
some of the authorities of the State Department or similar 
authorities internationally, it probably would release some of 
the burden on the State Department and allow us to function a 
little bit more efficiently.
    Senator Feingold. That's the kind of candid response that 
can help us get out ahead of problems. So, I appreciate it.
    Thank you, Mr. Chairman.
    Senator Alexander. Good question, good answer and helpful 
answer. Thank you. Thank you, Dr. Mermin.
    We have two more witnesses and three potential Ambassadors 
to consider today. So, I'm going to thank you very much for 
your testimony and for your service, and I hope to see you in 
Uganda some time.
    Dr. Mermin. Thank you.
    Senator Alexander. On our final panel of witnesses, are two 
persons whom I will now introduce. Dr. Ernest Darkoh, 
operations manager for the ARV Project. I understand that a lot 
has happened since last August and we look to hearing more 
about that.
    Then following him, Dr. Lulu Oguda. She is now at Harvard 
University as a Fellow in the School of Public Health, but she 
has already earned her medical degree in Kenya. Previously, she 
spent 2 years as a field doctor for the non-profit Doctors 
Without Borders, working on HIV/AIDS projects in both Malawi 
and Zambia. She was involved in the provision of antiretroviral 
treatment in Zambia. She introduced the prevention of mother-
to-child transmission program and trained numerous staff.
    Dr. Darkoh and Dr. Oguda, thank you very much for being 
here, and why don't we begin with Dr. Darkoh and then Dr. 
Oguda.

     STATEMENT OF DR. ERNEST DARKOH, M.D., M.P.H., M.B.A., 
   OPERATIONS MANAGER, BOTSWANA NATIONAL ARV PROGRAM (MASA), 
BOTSWANA MINISTRY OF HEALTH AND AFRICAN COMPREHENSIVE HIV/AIDS 
            PARTNERSHIP (ACHAP), GABORONE, BOTSWANA

    Dr. Darkoh. Thank you, Senator Alexander, and Senator 
Feingold is not here, but I'll thank him in absentia.
    I applaud the President's initiative to commit major U.S. 
funding to address HIV/AIDS in parts of the world with the 
highest infection rates. I also appreciate that notice has been 
taken of Botswana's program which is, as it stands, the 
longest-running and largest public sector program in Africa, 
and I feel there's much to be learned from Botswana, and it's 
my pleasure to share our experiences with you.
    The Botswana National ARV Treatment Program was initiated 
through a partnership between the Merck and Gates Foundations 
and the Government of Botswana, and on the ground this 
partnership is called the African Comprehensive HIV/AIDS 
Partnership or ACHAP for short. So, I'll use that abbreviation 
in the presentation going forward.
    The Merck Company and the Gates Foundation each provided 
$50 million to support Botswana in its fight against HIV/AIDS. 
Some of this money is used to support the treatment program, 
but it also does support a whole broad range of other 
prevention programs in the country.
    As you mentioned earlier, out of a population of 1.7 
million, Botswana's estimated to have about 300,000 people who 
are HIV-positive, and 100,000 of whom would be instantly 
eligible for ARV therapy if you were able to test everyone in 
the country and do a CD4 test and use either CD4 of 200 or less 
or the presence of an AIDS-defining illness as criteria of 
being an HIV-positive child.
    So, under the courageous and inspirational leadership of 
President Festus Mogae, Botswana decided that treatment with 
antiretroviral therapy in the public health system should be 
introduced as a matter of national policy to address the 
emergency.
    The Government of Botswana approached ACHAP for assistance 
in establishing a national treatment program. A detailed 
implementation plan was developed in late 2001. I have provided 
a handout, I hope you have a copy, but it does sort of detail 
the statistics of our program. I'll briefly go through those.
    The National Treatment Program began in January 2002 and in 
27 months has enrolled over 20,000 patients in 12 operating 
sites. Of this 20,000, 12,000 are on ARV therapy. The split is 
about 64 percent women to 36 percent men. An additional 6,000 
plus patients are on ARV therapy in the private sector, making 
a total of 18,000 people on ARV therapy in Botswana.
    This represents approximately 16.4 percent of all eligible 
patients on ARV therapy and also 24 percent of eligible 
patients who know their status. This makes Botswana the leading 
country in terms of the proportion of HIV/AIDS-infected 
individuals on ARV therapy in Africa.
    Overall, the program and patients are doing remarkably 
well. Followup rates are above 90 percent, adherence rates 
above 85 percent. Eighty-five to 90 percent have fully 
suppressed viral loads at the 6-month point and CD4 levels are 
increasing. Patients with wasting syndrome are gaining weight 
and are able to return to work. The incidence of toxicity is 
low, below 7 percent, where it's severe enough to require a 
medication switch.
    The overall mortality after initiation is only 9 percent, 
despite the average CD4 count of the patient population still 
being at about 81. For the first year of the program, just to 
inform you, the CD4 count was between 50 and 60.
    There's also strong anecdotal evidence that hospital ward 
occupancy significantly decreases, even with relatively few 
patients on treatment. This is probably due to the high 
readmission rate of critically ill patients.
    As I said, our program is operating in 12 sites. Our plan 
is to scale up to all remaining district and primary hospitals 
in the country this calendar year. Each of those hospitals will 
have approximately two to four satellite clinics associated 
with it once fully rolled out. Therefore, we expect to have 32 
operating ARV sites in the country.
    Current cost per patient for drugs and diagnostics ranges 
between, U.S. dollars, $580 per patient per year to, U.S. 
dollars, $1,580 per patient per year, depending on the specific 
drug regimen prescribed. To date, ACHAP has spent about, U.S. 
dollars, $12 million on the ARV program. The government 
currently supports more than 90 percent of the overall costs.
    Some significant challenges do remain, however, despite the 
successes. The burden of disease is unprecedented and extremely 
large. Keep in mind that we're trying to at some point get 
almost 40 percent of the entire adult population on ARV therapy 
across a widely dispersed geographic distribution.
    Most people in the country still do not know their HIV 
status and present late, at a stage where they're very 
resource-intensive and that stretches already short staff on 
the ground. Civil society, NGOs and CBOs lack adequate capacity 
to provide the necessary supportive services, and there's also 
marked lack of management capacity and very intense 
communication needs across a broad array of internal and 
external stakeholders that needs to be accounted for.
    As I said, we've been running for a little over 2 years, 
and I would have to say that the overriding key success factor 
has been our ability to learn lessons quickly and readapt 
strategies as necessary.
    The first lesson that we have learned is that capacity 
buildup is not a linear process. It does take time. This is 
largely due to the fact that when the program begins, you have 
few trained staff. The newly trained inexperienced staff can 
see fewer patients per unit time, and the initial cohort of 
patients who present are very sick.
    So, that actually leads you to a situation where you have 
more of a compound interest-type curve and not a big bang where 
you can enroll people very rapidly. Treatment volume 
expectations must therefore be tempered and managed carefully.
    The second lesson is that a phased roll-out, if too slow, 
can result in initial sites being overwhelmed. This excessive 
demand can lead to perverse resource buildup in a few sites at 
the expense of rolling out to new sites that are closer to 
where people live.
    In addition, the fewer the sites, the longer distances 
people have to travel and that could negatively affect 
adherence.
    Third lesson. Each new site experiences the same teething 
problems and, as such, there's little to be gained by a slow 
scale-up. The best strategy is to spread as widely and quickly 
as possible after learning from your initial pilot sites.
    Fourth lesson. Training is the most critical rate-limiting 
step to scaling up. In our experience, the most effective and 
efficient mechanism of activating new sites is to provide 
onsite HIV specialist preceptors, doctors and adherence nurses, 
and usually from either the U.S. or Europe where there's been a 
long experience in treating with these medications, and they 
provide hands-on training and management support for a period 
of 3 to 6 months at a site to get them activated. Afterwards, 
they leave and the site does actually function on its own.
    The Debswana Mining Company in Botswana, they started their 
program before ours. It was a private sector program, and they 
addressed this critical lack of trained staff to provide the 
training through telemedicine and actually their staff on the 
ground had their decisions ratified and supported by a panel 
that sat in Cape Town, South Africa. That model was also quite 
effective.
    The sickest patients come forward first and even at 
relatively small numbers overwhelm the system. This is due to 
their intense resource requirements. This creates queues which 
are greatly exacerbated by the natural triage of the sickest of 
the sick on each given day to the front of the line. Now, if 
this dynamic is allowed to persist, you end up with a situation 
where ARV therapy is practiced as emergency therapy which is 
not the way it should be. With this happening then, patients 
begin to succumb in the queue.
    So, the solution we have had to implement is to split the 
queue with certain days reserved for people with highest CD4 
counts who you identify from your data base and then other days 
left as open enrollment where the more critically ill can still 
receive services. This model allows us to enroll more patients 
per unit time.
    The only rational way a program can manage demand and meet 
the challenge of enrolling such large numbers of patients and 
preserve their productivity is to find people before they are 
critically ill. I cannot emphasize this enough.
    Botswana, therefore, had to roll out a program of routine 
testing which I think quite a few people may have heard about 
and this is an effort really to identify as many people as 
possible before they are critically ill and enable the 
provision of preventive and supportive services to the current 
situation where the majority of patients, even though we keep 
them alive, at that point have lost their livelihood and are 
not supporting their families or themselves.
    The other thing then is that the most fundamental kind of 
ARV therapy is that a health professional knows who their 
patient is and can monitor what's happening with them. Patients 
will spend the vast majority, 99 percent, of their lives in the 
community, not in a hospital or not in a health facility, and 
with that being the case, it is somewhat dangerous to 
overemphasize the building of brick and mortar health care 
infrastructure at the expense of building systems that track 
and monitor patients as they move between health facility and 
the community and across different geographies.
    For any new program, therefore, that's starting, the 
highest priority and the bulk of the initial effort, I feel, 
should go toward establishing a robust and reliable patient 
tracking and monitoring and evaluation system.
    Public-private partnerships can help accelerate by acting 
as catalysts for action and by providing money that is faster 
and more flexible than that available from governments. The 
Merck/Gates/Botswana Partnership, as a conduit model through 
which key technical expertise has been introduced to supplement 
the Ministry of Health's management capacity, has proved 
particularly effective.
    Not only does this model allow for an unprecedented level 
of co-responsibility, mutual monitoring, and early problem 
identification, but it allows for real skills transfer to occur 
between the seconded experts and local staff.
    With the broader global epidemic in mind, it's clear that 
governments cannot fight this battle alone. All sectors and 
individuals must play an active role. However, in my 
experience, I've noticed that natural tendency to focus on 
developing and building only public sector capacity. However, a 
holistic and non-judgmental assessment often reveals numerous 
other potential sources of significant untapped capacity in the 
private sector, including private sector doctors, hospitals and 
laboratories, but also NGOs, CBOs, civil society, and faith-
based sectors and the community at large.
    The ACHAP Partnership has clearly demonstrated the 
catalytic value of tapping into non-traditional private 
sources, skills, expertise, and money. It has also demonstrated 
a feasible and viable mechanism through which tremendous skills 
and resources from the private sector can be leveraged for 
public good.
    The burden of disease in most countries is such that no 
sector is likely to be able to address the complexities 
singlehandedly. Looking continent-wide, it's clear that 
traditional models of linear thinking will never overcome this 
epidemic. Patients must be empowered and equipped to 
participate maximally in their own care. New mutually enriching 
partnerships and innovative models must rapidly be deployed and 
the appetite to take risks must be increased dramatically. This 
can be done safely if built on a foundation of sound 
management, monitoring, evaluation, accountability, and true 
ownership by countries.
    I thank you for your time and consideration and look 
forward to questions later.
    [The prepared statement of Dr. Darkoh follows:]

                Prepared Statement of Dr. Ernest Darkoh

    Thank you, Senator Alexander and distinguished members of the 
Africa Subcommittee. I am the Operations Manager of Botswana's National 
Antiretroviral Program. I applaud the President's Initiative to commit 
major US funding to address HIV/AIDS in the parts of the world with the 
highest infection rates. I also appreciate that notice has been taken 
of Botswana's National ARV Program and the Merck/Gates/Botswana 
Partnership, known as the ``African Comprehensive HIV/AIDS 
Partnerships'' (ACHAP), and our pioneering work in developing public-
private partnerships to address this epidemic. As the longest running 
and largest public sector treatment program in Africa, I feel there is 
much to be learned from Botswana and it is my pleasure to share our 
experiences with you.
    I am an American citizen who has spent most of his formative years 
and professional career in economically underdeveloped countries. To 
date I have worked on major HIV related public health projects in 
Botswana, South Africa and China. I have also supported numerous other 
initiatives in an advisory capacity across other developing countries. 
I did my MD and MPH at Harvard and subsequently an MBA at Oxford as a 
Fulbright Scholar. I then worked for the New York office of McKinsey & 
Company as a management consultant prior to my current position in 
Botswana. I am one of the Founding Partners of BroadReach Healthcare, a 
company that assists developing countries, funders and institutions 
strengthen health systems and implement appropriate, scaleable HIV/AIDS 
treatment models using public-private partnerships.
    Through BroadReach, I am hired by the Merck/Gates/Botswana 
Partnership (ACHAP) and then seconded into the Ministry of Health as 
the Operations Manager of Botswana's National ARV Treatment Program. 
ACHAP is a tri-partite partnership between the Bill & Melinda Gates 
Foundation, The Merck Company Foundation/Merck & Co., Inc. and the 
Government of Botswana. The Merck and Gates Foundations have 
contributed a total of US $100 million to Botswana, spread over 5 
years, to assist the country to combat HIV/AIDS. In addition, Merck 
donates its antiretroviral medicines to the ARV treatment program.
    In addition to a broad array of prevention, care and support 
programs, ACHAP was instrumental in launching, and currently supports, 
Botswana's ARV treatment initiative, called Masa, which is a Setswana 
word meaning ``New Dawn''.
    Botswana, with a relatively small population of 1.7 million, was in 
the unenviable situation of having the highest prevalence of HIV in the 
world in 2001 with a staggering 38.5% of 15-49 year olds infected. 
Under the courageous and inspirational leadership of President Festus 
Mogae, Botswana decided that treatment with anti-retroviral drugs (ARV 
therapy) in the public health system should be introduced as a matter 
of policy to address this emergency.
    The Government of Botswana approached ACHAP for assistance in 
establishing a National ARV treatment program. The first step was to 
conduct a detailed demand and supply analysis and to develop an 
implementation strategy. The services of McKinsey & Company were 
commissioned to assist a joint team consisting of Ministry of Health 
personnel, ACHAP staff and McKinsey consultants, who conducted a 2.5 
month detailed assessment of:

          1. How many people would require ARV therapy (demand).

          2. Based on that number, how well was the country prepared to 
        service this demand (supply).

          3. The resources that would be required to fill gaps in the 
        healthcare delivery system.

          4. The optimal implementation model and approach based on 
        organizational, political and contextual realities on the 
        ground.

    The assessment revealed that there were approximately 300,000 HIV 
infected people in the country, of whom approximately 110,000 would 
require ARV therapy based on eligibility criteria of either CD4 count 
of <200, presence of an AIDS defining illness (regardless of CD4) or 
being an HIV positive child. The assessment also revealed significant 
deficits in capacity to meet such a demand.
    The feasibility study culminated in a strategy document which 
explored and detailed a roadmap for how the Ministry of Health could 
build the requisite capacity and scale up of treatment. The national 
ARV Project team then developed a detailed implementation plan 
addressing the main areas requiring capacity/capability buildup which 
included:

   Policy, planning and project management (central and 
        facility level).

   Information, Education and Communication (IEC) and community 
        mobilization.

   Training of health professionals (in ARV therapy, IT, 
        laboratory, counseling, project management, monitoring & 
        evaluation, operational research).

   Staff recruitment and retention.

   Drug logistics (procurement, storage, distribution)

   Laboratory and testing logistics.

   Information technology for nation-wide tracking and 
        monitoring of patients, laboratory samples and medication 
        utilization.

   Procurement and upgrading of space.

   Monitoring, evaluation and operational research.

    The national treatment program began in January 2002 and in 27 
months has enrolled over 20,000 patients in 12 operating sites, of whom 
over 12,000 are on ARV therapy. The handout provides a detailed 
breakdown of patients by site. An additional 6000-plus patients are on 
ARV therapy in the private sector, making a total of over 18,000 people 
on ARV therapy in Botswana. This represents approximately 16.4% of all 
eligible patients on ARV therapy and makes Botswana the leading country 
in terms of proportion of HIV infected individuals on ARV therapy in 
Africa.
    Overall, the program and the patients are doing remarkably well. 
Follow-up rates are above 90%, adherence rates above 85%, 85-90% of 
viral loads are suppressed by 6 months, CD4 levels are increasing and 
patients with wasting regain weight and people are able to return to 
work. Overall mortality after initiation is only 9% despite the average 
CD4 count of the patient population still being very low (about 81). In 
the largest treatment center in Gaborone, doctors reported a 50% 
decrease in hospital ward occupancy when the site reached the 3,000 
patient level (that site currently has almost 5,000 on ARV therapy). 
This decrease was likely due to the fact that the initial cohort of 
very ill patients accounted for a disproportionately high number of 
hospital readmissions. Perhaps most heartening is the fact that there 
is a palpable elevation in the level and amount of dialogue about HIV 
in the general population and facilities are reporting an increase in 
the number of people who are coming forward and willing to get tested 
prior to becoming critically ill.
    The program is currently operating in 12 sites across the country 
and our plan is to scale up to all remaining district and primary 
hospitals (each with 2-4 associated satellite clinics) this financial 
year. When fully rolled out, there will be 32 operating ARV sites in 
the country.
    Current cost per patient for drugs and diagnostics ranges between 
US $580 to $1,580 per patient per year depending on the specific drug 
regimen prescribed. To date, the Merck/Gates/Botswana Partnership has 
spent about US $12 million on the ARV program. Over 90% of the overall 
program costs are supported by the Government of Botswana.
    Areas of support include:

 
----------------------------------------------------------------------------------------------------------------
                   Category                             Merck/Gates/Botswana Partnership (ACHAP) Support
----------------------------------------------------------------------------------------------------------------
Needs assessments and establishing systems,     ACHAP funded development of the initial ARV therapy feasibility
 policies and guidelines                         study with McKinsey & Company
----------------------------------------------------------------------------------------------------------------
Management support                              ACHAP has provided the Operations Manager, seconded to Ministry
                                                 of Health
----------------------------------------------------------------------------------------------------------------
Drug logistics                                  Merck donating Stocrin (Efavirenz) and Crixivan (Indinavir)
----------------------------------------------------------------------------------------------------------------
Recruitment of staff                            ACHAP has committed a total of 66 health workers and IT
                                                 positions
----------------------------------------------------------------------------------------------------------------
Training                                        ACHAP funding the National ARV training through KITSO and
                                                 Preceptorship Programs
----------------------------------------------------------------------------------------------------------------
Information, Education and Communication (IEC)  ACHAP has provided IEC consultant and IEC Officer and funded
 and Community Mobilisation                      development of all IEC materials
----------------------------------------------------------------------------------------------------------------
IT system                                       ACHAP has seconded an IT specialist and funded the rollout of an
                                                 interim IT solution, and provided computers to sites and
                                                 project office
----------------------------------------------------------------------------------------------------------------
Laboratory and testing                          ACHAP has funded CD4 and VL testing equipment in the National
                                                 Reference Laboratories
----------------------------------------------------------------------------------------------------------------
Space Procurement and upgrading                 ACHAP has constructed 4 treatment centers and funded the
                                                 expansion of space at 16 satellite clinics
----------------------------------------------------------------------------------------------------------------


    Despite the significant gains made in initially launching a 
national treatment program, we realize that we can not yet begin to 
congratulate ourselves because some significant challenges still 
remain, namely:

   The burden of disease is unprecedented and large (with a 
        need to reach close to 40% of adults with treatment) and the 
        geographic distribution of the population is wide.

   Most people in country (including patients) still do not 
        know their HIV status and only present for care at a very late 
        stage (with advanced disease).

   There is still a large initial burden of very sick patients 
        with extremely high ``resource intensity''. These patients take 
        up a disproportionately large amount of health worker time 
        leading to queues, which in turn can lead to a situation of 
        perpetually insatiable demand.

   There are significant staff shortages, and patient mobility 
        makes it difficult to train staff across the country in a 
        timely rate.

   Civil society, NGO and CBOs lack adequate capacity to absorb 
        the role of providing necessary supportive psychosocial and 
        social welfare programs for patients, meaning that most of the 
        burden falls on government.

   Maintaining high adherence levels as the patient population 
        gets larger (and less critically ill) will be a challenge.

   Ensuring drug supply security is always a priority, and will 
        become more challenging with additional end-point distribution 
        sites.

   Management and communications across a broad array of 
        internal and external stakeholders.

    The program has now been running for a little over two years and 
one of the key success factors has been the ability to learn lessons 
and quickly readapt strategies as necessary. The key lessons we have 
learned to date include the following:

          1. Capacity/capability build-up following a sigmoid rather 
        than linear curve. Exponential growth (scale-up) in patient 
        enrollment only after initial capacity is developed (like a 
        compound interest curve). This is largely due to the fact that, 
        as the program begins:

   There are few trained staff (providers, assistants, 
        administrators, etc);

   Those staff who have been trained are still ``green'';

   Newly trained staff see fewer patients per unit of time than 
        an experienced and tenured staff member; and

   The initial cohort of patients who come forward is very sick 
        and more complex (CD4 <80)--these patients require 5-10x the 
        amount of time and effort compared to that for patients with a 
        CD4 closer to 200.

    Treatment volume expectations must therefore be tempered and 
managed carefully.

          2. A phased rollout, if too slow, can result in the initial 
        sites being overwhelmed. This excessive demand can lead to 
        ``perverse'' resource buildup at a few sites at the expense of 
        rolling out to new sites closer to where people live. In 
        addition, the fewer the sites, the longer the distance patients 
        have to travel for routine visits and this increases the risks 
        of non-adherence.

          3. Each new site experiences the same ``teething problems'', 
        as such, there is little to be gained by slowly scaling up. The 
        best strategy is to spread as widely and quickly as possible 
        after the initial ``pilot'' sites.

          4. Training is one of the most critical rate limiting steps 
        to scaling up. Despite receiving classroom-based training, most 
        sites could still not commence service provision. The most 
        rapid and efficient mechanism of activating new sites is to 
        provide onsite HIV specialist preceptors (doctors and adherence 
        nurses), usually from the US or Europe (where there has been a 
        long experience using the drugs) to provide hands on training 
        and management support for a period of 3-6 months while the 
        site gets on its feet. The Debswana Mining Company, the largest 
        employer in Botswana, began their treatment program (private 
        sector) prior to the National program and addressed their 
        training needs through telemedicine where decisions of health 
        workers on the ground were consulted, ratified and supported by 
        an expert clinician panel based in South Africa. This 
        innovative model has proved successful and helps to overcome a 
        rate-limiting lack of clinician trainers by providing the 
        ability to leverage one HIV/AIDS expert clinician over a large 
        number of on-the-ground providers through technology.

          5. The pre-ARV opt-in testing mindset, procedures and 
        protocols were creating a functional bottleneck to people 
        receiving timely access to life saving services. The only way 
        to rationally manage demand for treatment and implement 
        effective prevention programs is to ensure that as many people 
        as possible have been tested and know their status. In Botswana 
        testing rates are still low with less than 10% of the 
        population knowing their HIV status. This is largely due to the 
        fact that until recently, ARV therapy was not available and, as 
        such, people had little incentive to test and know their 
        status. This scenario is a key driver of patients presenting 
        only after they fall critically ill. Other drivers are fear, 
        stigma and the natural tendency for people to wait until they 
        feel unwell before seeking health services. Testing is 
        therefore the most critical entry point for ARV therapy and 
        associated care and prevention services. The point of testing 
        provides direct access to positive and negative individuals and 
        allows targeted interventions to be administered. Botswana has 
        therefore become the first African country to implement routine 
        opt-out testing on a national level, starting with health 
        facilities. Routine opt-out testing will supplement the opt-in 
        VCT efforts in an attempt to reach as many people as possible 
        before they are critically ill. This will enable the provision 
        of supportive services and therapy and avert the current 
        situation where the majority of patients have completely lost 
        their livelihood even if they eventually end up successfully on 
        therapy.

          6. The sickest patients (and those previously on treatment in 
        the private sector) come forward first, and even at relatively 
        small numbers, overwhelm the system. Almost 2 years into the 
        program, the average CD4 count of patients at entry into the 
        program is about 80 (during the first year it was between 50-
        60). The time and resource intensiveness associated with 
        addressing the needs of such critically ill patients is 
        estimated to be 5-10 times that of patients who are not yet 
        critically ill and are initiated closer to a CD4 count of 200 
        (eligibility criteria). Over 90 percent of our patients do well 
        despite being initiated at such a late stage of the disease. 
        However, the result is that an unacceptably long queue begins 
        to grow. The situation is further exacerbated by the natural 
        triage that occurs at facility level. Health workers triage the 
        sickest of the sick to the front of the line on any given day, 
        creating a de facto lower CD4 eligibility criteria for actually 
        accessing therapy. If these dynamics are allowed to persist, 
        ARV therapy becomes ``emergency'' therapy resulting in an 
        effort-intensive race to save the patient, and resulting in a 
        higher potential for adverse outcomes and increased mortality. 
        The ideal scenario is for all HIV positive people to have CD4 
        tests and be monitored until the time it is appropriate to 
        start them on therapy, at which point they would have received 
        all the necessary counseling and would be in much less danger 
        of ``succumbing to the queue''. So, in addition to routine opt-
        out testing, the solution has been to split the queue, with 
        specific days and/or times reserved for those with higher CD4 
        counts (identified from the database) and other days open to 
        the normal first-come, first served patients (where patients 
        with very low CD4 counts and/or critically ill can still access 
        care). In this way, more patients can be enrolled per unit of 
        time and can be prevented from ever having to first become 
        critically ill inpatients in the hospitals (at which point most 
        have lost their livelihood).

          7. The bulk of work associated with implementing an ARV 
        program is not the initiation of patients on ARV therapy, but 
        rather the high levels of adherence and compliance required. 
        Since patients will spend the majority of their time in the 
        community, it is dangerous to over-emphasize the creation of 
        brick and mortar healthcare infrastructure at the expense of 
        building systems that track and monitor patients as they move 
        between the health facility and their community and across 
        different geographies. For any new program that is about to 
        start, the highest priority and bulk of initial effort should 
        go towards establishing a robust and reliable patient tracking 
        and Monitoring and Evaluation (M&E) system. With this in place, 
        it allows a country many degrees of freedom in experimenting 
        with different models of service provision (community outreach 
        worker models, traditional wheel and spoke ``network'' referral 
        models, observed therapy models etc) with the reassurance that 
        any negative deviations will be quickly identified and 
        remedied. The most fundamental tenet of ARV therapy is that the 
        health professional knows who their patient is and can monitor 
        what is happening with them.

          8. Public private partnerships can help accelerate 
        implementation by acting as key ``catalysts'' for action, and 
        by providing money which is ``faster and more flexible'' than 
        that spent by governments. The Merck/Gates/Botswana 
        Partnership's ``secondment'' model--through which key technical 
        expertise has been introduced to supplement the Ministry of 
        Health's management capacity--has proved particularly 
        effective. Not only does this model allow for an unprecedented 
        level of co-responsibility, mutual monitoring and early problem 
        identification, it allows for real skills transfer to occur 
        between the seconded experts and local staff.

          9. There are no easy solutions to the human resource 
        shortages. Botswana does not have a medical school and, as such 
        for doctors and certain other key cadres of staff, the country 
        is dependent on expatriate labor. Most expatriates do not speak 
        the language meaning that a large proportion of nurse time is 
        spend doing interpretation. The global market rates for staff 
        and lucrative opportunities presented by development partners 
        in the local market make it difficult to attract top talent at 
        current public sector rates.

          10. Although critical and fundamental for success, money is 
        but one of a series of numerous bottlenecks of increasing 
        complexity that must be overcome if ARV therapy is to be 
        offered successfully. Other equal, if not more important issues 
        to be addressed, are to do with availability of leadership, 
        management, political will (especially important is the 
        streamlining of bureaucracy), information for policy and 
        planning, accountability, and ultimately local capability and 
        capacity (human resources, skills, equipment, infrastructure 
        and systems). All these elements are essential for the ARV 
        supply chain to function and deliver a consistent reliable 
        service.

    With the broader global epidemic in mind, it is clear that 
governments cannot fight this battle alone. All sectors and individuals 
must play an active role. The natural tendency for governments is to 
focus on developing, building and utilizing only public sector 
capacity. However, a holistic and non-judgmental assessment often 
reveals numerous potential sources of significant untapped capacity in 
the private sector (including private sector doctors, hospitals, 
laboratories, etc), NGOs, CBOs, civil society, the faith-based sector, 
and the community at large. The Merck-Gates Partnership (ACHAP) has 
clearly demonstrated the ``catalytic'' value of tapping into non-
traditional private sources of skills, expertise and money. It has also 
demonstrated a feasible and viable mechanism through which the 
tremendous skills and resource base of the private sector can be 
leveraged for public good in a results-oriented fashion.
    The burden of disease in most countries is such that no sector is 
likely to be able to address the complexities single-handedly. Looking 
continent wide, it is clear that traditional models and linear thinking 
will never overcome this epidemic. Patients must be empowered and 
equipped to participate maximally in their own care. New mutually 
enriching partnerships and innovative models must rapidly be deployed 
and the appetite to take risks must be increased dramatically. This can 
be done safely if built on a foundation of sound management, 
monitoring, evaluation, accountability and true ownership by countries.
    Availability of treatment has introduced hope in an environment 
that had adapted to death and despair. Not only does availability of 
treatment save lives, there is strong anecdotal evidence that it 
provides concrete incentives and entry points for meaningful prevention 
programs and behavior change. We have an opportunity to capitalize on 
this link. A combination of strict results orientation coupled with 
willingness to explore new approaches that stretch our comfort zone 
will give us a realistic chance of turning the tide against this 
devastating disease.
    Thank you for your time and consideration.
                               references
    1. Botswana National ARV Program statistics and reports.
    2. ACHAP, Ministry of Health and McKinsey Feasibility Study.
    3. ACHAP Monitoring and Evaluation Unit research and abstract data.
    4. Botswana-Harvard Partnership research and abstract data: Wester 
et al.
    Preliminary Analysis Of Toxicity And Tolerability Among The First 
ARV
    Treatment Naive HIV 1c Infected Persons Of The Botswana National 
ARV
    Treatment Program, Paris 2nd IAS Conference On HIV Pathogenesis, 
And Treatment 13-16 July 2003.










    Senator Alexander. Thank you.
    Dr. Oguda, welcome.

   STATEMENT OF DR. LULU OGUDA, RETURNED VOLUNTEER AND FIELD 
  DOCTOR, REPRESENTING DOCTORS WITHOUT BORDERS/MEDECINS SANS 
                   FRONTIERES, CAMBRIDGE, MA

    Dr. Oguda. Thank you, Mr. Chairman and Senator Feingold, 
for this opportunity.
    My name is Dr. Lulu Oguda, and this afternoon, I'd like to 
share with you my perspective as an African physician who has 
been providing treatment for people with HIV in sub-Saharan 
Africa. I'll focus on my experience as a volunteer with Doctors 
Without Borders/Medecins Sans Frontieres, MSF, in Malawi.
    Malawi is one of the poorest countries of the world. It has 
11 million inhabitants and an HIV prevalence of 15 percent. I 
worked there as a field doctor in Chiradzulu district where 
25,000 people are living with HIV, 5,000 of whom are in urgent 
clinical need of antiretroviral treatment, ARV, or they will 
die.
    Before ARV treatment arrived in Chiradzulu, there was an 
atmosphere of despair. People with HIV had no hope. They simply 
waited for death. In the district hospital, wards were so 
crowded, you would have two to three patients assigned to one 
bed, so you'd find the patients in the bed and under the bed. 
I'll never forget seeing my patients like that. If you've not 
witnessed such a scene, you simply can't imagine it.
    In 2001, all this changed with the arrival of the ARVs in 
our program. Although it was not easy getting started, the 
benefits to the patients were amazing to witness. We saw 
farmers going back to their fields, teachers started to go back 
to school, families were going back to churches. Generally, the 
spirit of the community was uplifted.
    But there were challenges. In the beginning, our treatment 
protocol required our patients to take at least 6 to 8 pills 
each day. Second, only physicians could prescribe and monitor 
ARV therapy. We were only three physicians in the whole 
district. We could not possibly attend to all our patients.
    This meant that we were only able to enroll 20 patients on 
ARV treatment in a month. Today, with the same number of 
physicians, the program is providing treatment for more than 
2,500 people. We're enrolling 250 new patients every single 
month.
    In order to achieve this scale-up, we learned we had to 
simplify, adapt, and decentralize our approach. We set up 
mobile clinics at each of the 10 health centers feeding to the 
district hospital. We delegated responsibilities for basic 
patient care and followup to nurses and the clinical officers. 
We trained community counselors, including people with HIV, to 
carry out treatment literacy and adherence support.
    Clinical results from our project in Malawi are encouraging 
today in parallel to what was found in wealthy countries. At 12 
months, the probability of survival is 88 percent. The CD4 
count increase is at least at 192 cells, and the median weight 
gain is 4 kilograms, about 9 pounds. The average adherence 
rates of 90 percent even exceed those in wealthy countries.
    Our fundamental tool in simplifying, adapting, and 
decentralizing the program was the introduction of triple fixed 
dose combination, the FDCs. Today, approximately 70 percent of 
the patients in this program are taking one of the World Health 
Organization recommended FDCs. The availability of these FDCs 
made the lives of our patients easier.
    Taking just 2 pills a day, one in the morning, one in the 
evening, facilitated adherence, encouraging better clinical 
outcomes and potentially reducing the risk of resistance. In 
addition, we were able to quickly train our nurses and clinical 
officers to administer the standardized ARV treatment at the 
health center level and help alleviate the massive human 
resource constraint we were facing.
    It was easier now to project program needs and to procure 
our FDCs compared with the single drugs, all coming from 
different companies, requiring different transportation and 
coaching requirements, among other things, and this really 
reduced the risk of stuck-outs.
    Finally, the price of these FDCs, available only from the 
generic manufacturers due to the patent barriers, is the lowest 
of any ARV cocktail in the world. As little as $140 per person 
per year, which is four times less expensive than the single 
pills from the brand name producers.
    This certainly does not mean that the FDCs are the answer 
to all of our problems. In order to face the next generation of 
operational challenges, we urgently need new tools, such as 
affordable and simplified second-line drugs and diagnostics.
    In our experience globally, MSF is currently providing ARV 
treatment for about 12,000 patients in 20 countries. Adapting 
our clinical approach and using the FDCs was the most critical 
in scaling up our own programs, and we feel this is a lesson, a 
useful lesson to share with governments and various 
international initiators, including the President's Emergency 
Plan for AIDS Relief, who are focusing on scaling up.
    That's why it's quite bewildering to listen to the debate 
over the past few weeks about FDCs. I have heard some U.S. 
Government officials claim that generic AIDS medicines are not 
the same as the generic drugs sold in the United States, and 
they won't tolerate Africans being subjected to drugs not 
approved for use in the United States.
    As an African doctor, who has personally treated hundreds 
of patients with HIV with these FDCs and witnessed my patients 
return from death's door, I find these assertions appalling.
    The WHO has certified that these FDCs meet stringent 
international standards for quality, safety, and efficacy. They 
did so through a prequalification system of drug regulatory 
experts from North America and Europe to inspect the 
manufacturing sites and establish bioequivalence. This system 
is being utilized and respected by all key actors, except the 
United States, including the World Bank, UNICEF, and the Global 
Fund.
    These sorts of arguments only result in depriving Africans 
with HIV of affordable easy-to-use treatment. This could also 
lead to the creation of disruptive and parallel systems which 
will confuse Ministries of Health, health personnel, patients, 
undermine the confidence of existing programs, and waste scarce 
resources on more expensive brand name medicines.
    The consequences of all this could mean we prolong and 
improve one life instead of four. From a medical ethical point 
of view, this is intolerable. Millions of lives are at stake 
and we really don't have the luxury of time, not in Malawi and 
not anywhere.
    Thank you very much for your time.
    [The prepared statement of Dr. Oguda follows:]

                  Prepared Statement of Dr. Lulu Oguda

    Ladies and gentlemen, my name is Dr. Lulu Oguda, and I would like 
to share with you my perspective as an African physician that has been 
working to provide treatment for people with HIV/AIDS in sub-Saharan 
Africa, with a particular emphasis on my experience as a volunteer for 
Doctors Without Borders/Medecins Sans Frontieres (MSF) in Malawi.
    Malawi is a country of 11 million people, bordered by Mozambique 
and Tanzania to the north and Zambia to the west, with an HIV 
prevalence of 15%. It is one of the poorest countries in the world. 
HIV/AIDS is the leading cause of death in Malawi among people adults 
20-49 years of age. In the program that I worked in as a field doctor 
for one year, in Chiradzulu district in the south, over 20% of women in 
antenatal clinics test positive for HIV. Twenty-five thousand people--
one fifth of the population--are estimated to be living with HIV/AIDS, 
and 5,000 of them are estimated to clinically require antiretroviral 
(ARV) treatment now or else they will die.
    It is difficult for me to paint a picture of what Chiradzulu was 
like before ARV treatment arrived without making it sound like a 
caricature. There was a mixture between despair and anticipation. 
People with HIV/AIDS had no hope; they just thought they would die, but 
they were beginning to hear that ARVs would soon be available at the 
hospital. One patient of ours named Fred Minandi said:

          When I was sick then, I knew I had HIV, but I would never 
        admit it or speak about it. Speaking about it would have not 
        changed anything for me except making me depressed. My 
        neighbors were seeing me becoming weaker and weaker every day. 
        Of course, they all knew what I had, but nobody asked me. They 
        just gradually started to not come see me. Most of the people 
        are like that in Malawi: they don't speak because they don't 
        want to know. It is why my country is dying in silence.

    Health workers, many of whom were HIV positive themselves, were 
desperate, looking at the wards full of people they could do nothing 
for and not wanting to get their hopes up that ARVs would really come. 
Sometimes the wards in the hospital we worked in were so crowded you 
would have two or three people for each bed. It is an 80-bed hospital 
with an average daily occupancy of 200 patients. If you have not seen 
such a scene yourself, you simply cannot imagine it.
    Then, in 2001, all this changed with the arrival of ARVs in our 
program in Malawi. Although it was not easy getting started, the 
benefits to our patients were amazing to witness. After approximately 
one year on treatment, Fred said:

          I had 107 CD4 cells [medical indicator from a blood test for 
        the body's natural resistance capacity to infections] when I 
        started the treatment and today I have got 356 CD4 and I am 
        very proud. Today, I am back in my field, back in my church. I 
        can feed my family. I used to harvest only about two bags of 
        maize for the past years because I was too weak. Now I am 
        talking of harvesting 10 bags of maize just this year alone. I 
        feel I have a future. My neighbours started coming to see me 
        again like before.

    At first, our first-line treatment protocol was AZT/3TC/nevirapine 
or AZT/3TC/efavirenz. Patients would take six to eight pills each day, 
not including additional pills they may have needed to take for the 
treatment or prophylaxis of opportunistic infections. The program has 
always provided treatment for free.
    We also had to draw up eligibility criteria for enrollment in the 
program, because there were so many more people that needed treatment 
than we could accommodate at the time. First, we enrolled patients with 
advanced HIV disease (World Health Organization stage 3 or 4) and CD4 
counts of less than 200/ml of blood. In addition to the medical/
clinical criteria, patients had to be within two hours' walking 
distance from the hospital, so that they could make it in for 
appointments. But this was too stringent--people were coming from hours 
away to get treatment and we knew it--so we made it six hours. Imagine: 
a person with HIV co-infected with tuberculosis and an immune system so 
weakened getting out of bed was a struggle, having to walk six hours to 
get to the hospital.
    Although there were only expatriate doctors working in the hospital 
at the time and we could not possibly see all the patients who needed 
to start ARVs, only physicians could prescribe and monitor ARV therapy. 
We were enrolling an average of 20 patients per month.
    Today, MSF is able to provide treatment for more than 2,500 people 
in Chiradzulu, and we are enrolling 250 new patients in the program 
every month. In 2003 alone, the number of patients on ARV treatment 
increased by 420%. There are several factors that have enabled us to 
rapidly scale up access to ARV treatment in this district. Beginning in 
August 2002, we simplified, adapted, and decentralized our approach.
    We simplified treatment protocols by minimizing pill burden; 
adapted our clinical approach to suit the prevailing conditions in the 
district, meaning that we reduced the complexity of the inclusion 
process and started relying less on sophisticated laboratory tests; and 
decentralized the point of care from the hospital to health posts in 
rural areas while taking better advantage of the skills and resources 
of existing health care professionals such as clinical officers and 
nurses.
    We have set up mobile treatment clinics at each of 10 primary care 
health centers in the district, facilitating greater access to 
treatment in remote, rural communities. In effect, rather than asking 
patients to walk six hours to get their treatment, we are bringing it 
to them at the community level. Services at the health centers include 
voluntary testing and counseling with on-site rapid HIV tests, 
management of opportunistic infections, and treatment with ARVs 
including adherence counseling.
    Basic patient care and follow-up is delegated to nurses and health 
workers for medical monitoring and community counselors, including 
people living with HIV/AIDS, for education, adherence support and 
treatment literacy. The project follows uniform guidelines for 
treatment and minimizes use of laboratory tests, which facilitates 
access to care and treatment even for the most vulnerable people in 
this remote area where there are few doctors and even fewer 
laboratories. In many cases, treatment begins after a positive HIV test 
and clinical assessment by trained staff. We measure CD4 count at 
baseline and every 12 months, and have reduced reliance on biological 
follow-up tests, performing Hemoglobin and liver function tests, for 
example, on clinical indication only. Viral loads are not performed on 
an individual basis. Difficult cases are referred to the district 
hospital.
    Clinical results from Malawi are encouraging. The probability of 
survival at 12 months is 88%. Average CD4 increase among our patients 
is 192 cells/ml at 12 months, and the median weight gain is 4 kg at 12 
months. The adherence rate of our patients is high, averaging 
approximately 90%.
    Our fundamental tool in simplifying, adapting, and decentralizing 
the program has been triple fixed-dose combinations (FDCs) of ARVs--
three different ARV drugs taken in the form of one pill, twice a day. 
Approximately 70% of patients in the Chiradzulu program are taking the 
World Health Organization (WHO)-recommended fixed-dose combination of 
d4T/3TC/nevirapine for their first-line regimen.
    The availability of these FDCs has made the lives of our patients 
easier--taking just two pills a day facilitates adherence, which 
encourages better clinical outcomes and reduces the risk of resistance. 
It has also enabled nurses and clinical officers to administer 
standardized ARV treatment at the community health post level, and made 
training of on-ground personnel easier. It is easier to project program 
needs and procure FDCs compared with single agents with different 
transportation and cold-chain requirements, which lowers the risk of 
stockouts. And, of course, the price of these triple FDCs, available 
only from generic manufacturers because of patent barriers, is the 
lowest of any ARV cocktail in the world. In Malawi, we currently pay 
approximately $240 per person per year, compared with a minimum of $562 
if we were to purchase the same agents from originator companies. This 
is no small thing. It means we are able to treat two to three people 
rather than one with every $500-600 we allocate for the program.
    This certainly does not mean that the FDCs we use are the answer to 
all of our problems. For example, for any of you who has ever tried to 
decide the paediatric dose of a drug that is available in capsule form, 
or had to watch the face of a child take horrible tasting ARV syrups, 
or try to divide up an unscored tablet, you will agree that paediatric 
treatment is a literal nightmare. Clinicians and care-givers, who are 
usually elderly grandmothers because children's' mothers and fathers 
have already died of AIDS, need to be able to have fixed-dose liquid 
formulations for infants and low-dosage or breakable FDC tablets for 
children. Likewise, we need a first-line FDC that can be used in both 
people co-infected with HIV/TB and women of child-bearing age. We need 
affordable and simplified second-line drugs and simplified diagnostic 
tools to help monitor efficacy, detect treatment failure, and diagnose 
opportunistic infections, particularly TB in patients with HIV/AIDS. In 
order to face the next generation of operational challenges, we need 
these new tools and strategies.
    But when you consider that a safe, effective, and affordable first-
line treatment, which is easy-to-use could be prolonging millions of 
lives--not just thousands--it is a medical ethical imperative to make 
it more widely available to humans in peril as urgently as possible. 
And this is not a job that MSF has the capacity or mandate to do; that 
responsibility rests with governments.
    That is why I am truly bewildered by the debate I have been hearing 
over the past few weeks about FDCs.
    I have heard US government officials claim that the generic AIDS 
medicines, including FDCs, which are being used by MSF and others are 
not the same as ``generic drugs'' sold in the US and are sub-standard. 
But the World Health Organization (WHO) has certified that numerous 
medicines from both generic and brand-name companies, including generic 
FDCs, meet stringent international standards for quality, safety, and 
efficacy through a prequalification system that borrows drug regulatory 
experts from North America and Europe to inspect manufacturing sites 
and establish bioequivalence and is utilized and respected by all key 
actors, including the World Bank, UNICEF, and the Global Fund to Fight 
AIDS, TB and Malaria. In fact, these medicines are manufactured by the 
same pharmaceutical labs that produce hundreds of generic medicines 
used by Americans every day.
    I have heard US government officials say that there are no agreed 
upon principles for evaluating FDCs, and that without the approval of 
the US Food and Drug Administration (FDA) or a similarly stringent 
regulatory authority they cannot be proven safe or effective. But in 
2000, the FDA approved a brand-name triple combination therapy, 
GlaxoSmithKJine's Trizivir, on the basis of bioequivalence data, the 
very same data WHO has reviewed to certify the generic FDCs we use. 
There were no clinical trials conducted to compare the individual 
compounds with the fixed-dose combination.
    I have heard US government officials assert that use of these drugs 
could create resistance, which would be a disaster for the continent of 
Africa. Unfortunately, drug resistance is inevitable and, indeed, 
disastrous. It is something we are deeply concerned about as well. But 
this has nothing to do with the question of FDCs. In fact, it seems to 
me that if the US is concerned about resistance, it should be doing 
everything possible to ensure that FDCs are used--since they promote 
adherence, the key to delaying the onset of resistance--that 
communities are mobilized to carry out treatment education and 
adherence support, and that future FDCs are developed urgently so that 
when resistance does emerge, patients have viable treatment options.
    Finally, I have heard US government officials say that they will 
not tolerate a different standard for Africans. As an African doctor 
who has personally treated hundreds of people with HIV/AIDS using these 
medicines and witnessed my patients' spectacular return from death's 
door, I find this particularly appalling. It is simply untrue that 
generic FDCs are substandard. These sorts of baseless assertions will 
only result in depriving Africans of affordable, easy-to-use treatment; 
setting up disruptive and parallel systems, which will waste precious 
resources, confuse patients, and undermine confidence in existing 
programs; undermining national policies and protocols in African 
countries; and wasting money on ``brand name'' medicines, despite the 
fact that the difference in price will mean prolonging and improving 
the life of one person instead of four.
    That is intolerable.
    Millions of lives are at stake.

                                *  *  *

                                APPENDIX

                     general background information
    In the developing world today, over 40 million people are living 
with HIV/AIDS. Of the more than six million people in urgent clinical 
need of ARV treatment, only 400,000 have access to it, and one-third of 
them live in one country, Brazil. An estimated 8,000 people die each 
day of AIDS-related complications. These are premature, avoidable 
deaths.
    Currently, MSF is providing ARV treatment as part of a 
comprehensive continuum of care for over 11,000 people living with HIV/
AIDS in more than 20 countries in Africa, Asia, Latin America, and 
Eastern Europe. MSF is an international medical humanitarian 
organization with field operations in nearly 80 countries and the 
recipient of the 1999 Nobel Peace Prize.
    We have learned important lessons about both the benefits and 
challenges of providing ARV treatment in resource-limited settings and 
are in the process of adapting our approach to AIDS treatment to better 
fit the real-life conditions faced in developing countries. Our 
projects are using treatments with fewer pills, relying less on 
sophisticated laboratory tests, taking better advantage of the skills 
and resources of existing health care professionals such as clinical 
officers and nurses, and decentralizing the point of care to district 
hospitals and health posts.
    In addition, we have produced several reports, some of which are 
joint publications with the World Health Organizations (WHO), UNAIDS, 
and UNICEF, to help other providers of ARV treatment--including 
governments, non-governmental organizations (NGOs), and community-based 
organizations--identify sources, prices, and patent status of needed 
medicines and assist with strategies for efficient procurement of 
medicines. We have also participated actively in the development of the 
WHO initiative to scale up treatment to at least three million people 
by 2005 (``3x5'').
    While our ARV treatment programs have had a significant impact on 
the individuals and communities with whom we work and have demonstrated 
the feasibility of providing ARV treatment in resource-limited 
settings, they are relatively small-scale, and we have neither the 
capacity nor the mandate to provide the wide-scale access to treatment 
that is so urgently needed. That responsibility rests with national 
governments.
    We do, however, feel a responsibility to share our experience and 
impart the lessons we have learned in order to inform efforts to scale 
up access to treatment, including the United States President's 
Emergency Plan for AIDS Relief (PEPFAR). This is why we would like to 
highlight the following critical issues, which in our experience must 
be considered as utmost priorities as the US government begins to 
implement its PEPFAR:

   Simplifying treatment protocols, particularly by minimizing 
        patients' pill burden;

   Decentralizing and adapting clinical approaches to treatment 
        and monitoring;

   Decreasing the prices of medicines, ensuring efficient 
        procurement of medicines, and making treatment available for 
        free;

   Involving communities, including people living with HIV/
        AIDS, in treatment programs; and

   Promoting research and development for desperately needed 
        new tools.

                    msf's aids treatment experience
    MSF has been caring for people living with HIV/AIDS in developing 
countries since the early 1990s. In 2000, MSF started to provide ARV 
therapy in addition to other services. Approximately 11,000 people 
living with HIV/AIDS, including nearly 500 children, are currently on 
ARVs in more than 20 countries worldwide. These countries include 
Burkina Faso, Burundi, Cambodia, Cameroon, China, Democratic Republic 
of Congo, Guatemala, Honduras, Indonesia, Kenya, Laos, Malawi, 
Mozambique, Myanmar, Rwanda, South Africa, Thailand, Uganda, and 
Ukraine.
    MSF provides ARV treatment in both urban and rural settings, and in 
almost every project works within public sector health facilities--
including primary care clinics/community health posts, district 
hospitals, and provincial hospitals--in collaboration with national, 
provincial, or district departments of health. Clinical eligibility 
criteria are, for the most part, uniform throughout MSF projects (<200 
CD4 cells or 15% for children), though some projects are increasingly 
initiating treatment in very advanced patients on clinical grounds. In 
MSF projects, treatment is provided free of charge.\1\
---------------------------------------------------------------------------
    \1\ Except in Cameroon, due to government policy requiring entrance 
fee.
---------------------------------------------------------------------------
    Clinical outcomes in our projects are encouraging, and parallel 
those found in the US: patients' CD4 counts are increasing, they are 
gaining weight, and they are suffering from fewer opportunistic 
infections. Adherence rates are excellent, exceeding 90% in many 
projects. People are returning to work and again becoming productive 
members of their communities. In short, treatment is transforming the 
face of AIDS.
    MSF does not offer ARV treatment in a vacuum, so we aim to 
integrate treatment into a continuum of care that includes prevention 
efforts (e.g. health education, condom distribution, and prevention of 
mother-to-child transmission programs), voluntary counseling and 
testing, treatment and prevention of opportunistic infections, 
nutritional and psychosocial support, and palliative care.
    MSF expects the total number of patients treated in its projects to 
reach 25,000 in 25 countries by the end of 2004.
               lessons learned from msf's arv experience
    Although there are no simple formulas or models for providing ARV 
treatment, MSF has learned several clear lessons by delivering ARV in 
diverse settings, which could be helpful in designing and implementing 
initiatives aimed at scaling up access to ARV therapy, including 
PEPFAR. Below is a summary of some of the key lessons we have learned.
Simplify treatment
    One of the most important tools in simplifying and adapting 
treatment is fixed-dose combinations (FDCs) of ARVs. Today, 50% of 
patients in MSF projects, and 70% of those newly enrolled, are taking 
triple FDCs as their first-line treatment. That is, patients are taking 
the three different ARV drugs they need in the form of one pill, twice 
a day. Taking a smaller number of pills per day facilitates adherence, 
which encourages better clinical results and also lessens the risk of 
drug resistance, as it is impossible to take partial doses. The FDCs 
MSF uses, which have been pre-qualified by the World Health 
Organization (WHO), are also the most affordable combinations available 
worldwide and have significant distribution advantages (procurement and 
stock management).
Decentralize and adapt
    Treatment and monitoring protocols must be designed in a way that 
facilitates access even for the poorest and most vulnerable people in 
remote settings where there are few hospitals, few doctors and even 
fewer laboratories. In several MSF projects in Africa, including those 
in Malawi, Kenya, Mozambique, and South Africa, basic patient care and 
follow-up is being delegated to nurses and health workers (for medical 
monitoring) and community counselors (for education, adherence support 
and treatment literacy). MSF follows uniform guidelines for treatment 
minimizing use of laboratory tests; in many projects, treatment begins 
after a positive HIV test and clinical assessment by trained staff. 
More difficult cases are referred to district hospitals. In Chiradzulu, 
Malawi, this approach has allowed the number of patients under 
treatment in the district to rise quickly, to a rate of 250 new 
patients each month.
Decrease the price of medicines and ensure availability even for the 
        poorest
    The lower the price of medicines, the more patients can be treated 
and the more sustainable treatment is in the long term. Globally, the 
prices of AIDS drugs have dropped by over 98% in less than three years 
(see graph attached). Under certain circumstances, WHO prequalified 
FDCs cost less than $140 \2\ per person per year. These FDCs are 
available only from generic manufacturers due to patent barriers. In 
MSF's experience, crucial factors in bringing about lower prices for 
ARVs include government commitment to centralized procurement, 
overcoming patent barriers when necessary, and fostering generic 
competition. Come 2005, when most World Trade Organization (WTO) member 
states will have to become compliant with the WTO Agreement on Trade-
related Aspects of Intellectual Property Rights (TRIPS), generic 
production of patented medicines will rely upon compulsory licensing; 
therefore, flexible conditions for granting compulsory licenses must be 
in place. The right of countries to use this and other TRIPS-compliant 
public health safeguards is currently under threat, particularly in 
regional and bilateral trade negotiations launched by the US with a 
number of countries and regions heavily affected by HIV/AIDS. On a 
related note, the cost of treatment for the patient should never be a 
barrier, and that means treatment will have to be free for the majority 
of patients. The cost of drugs is frequently cited as a reason for 
treatment interruptions.
---------------------------------------------------------------------------
    \2\ Due to negotiations with genetic manufacturers brokered by the 
Clinton Foundation.
---------------------------------------------------------------------------
Involve the community
    The knowledge and meaningful participation of people living with 
HIV/AIDS is key to the success of treatment. At its HIV clinics in 
Khayelitsha, South Africa, MSF and grassroots treatment advocates have 
fostered community-based education programs. Through carefully designed 
patient-centered adherence programs (not directly observed therapy), 
people on ARVs in MSF programs have the support of their peers and of 
trained counselors. Community mobilization, in partnership with medical 
services, has had a powerful effect on the community, decreasing stigma 
and discrimination, and supporting prevention efforts. In Khayelitsha, 
there have been significant increases in the distribution and use of 
condoms, the number of sites providing voluntary counseling and 
testing, and the uptake rate of testing. According to a study conducted 
by the Center for AIDS Development, Research and Evaluation (CADRE) and 
the South African Department of Health, the self-reported condom use at 
last sexual intercourse, willingness to use a female condom, and 
consent to an HIV test in the Khayelitsha community is the highest in 
South Africa.
Urgently promote research and development of new tools
    It will not be possible to solely base scaling-up efforts on 
existing tools. New tools and strategies for treatment will have to be 
developed urgently. For example, at present, ARVs are not well-suited 
for use by children, so fixed-dose liquid formulations for infants and 
low-dosage or breakable FDC tablets for children are needed. The 
pharmaceutical industry is not going to spontaneously fill existing and 
future gaps such as easy-to-use first-line treatments for children, 
simplified second-line treatments and simplified diagnostic tools (e.g. 
semi-quantitative tools to measure CD4 and viral load). The public 
sector, with leadership from WHO, should therefore seek to define and 
lead the work on this research agenda. This needs to be a part of the 
overall U.S. global AIDS strategy. There is also an urgent need for 
operational research, for example on pediatric treatment, management of 
HIV/TB co-infection, ideal second-line regimens, and structured 
treatment interruptions. Furthermore, we will not be able to face the 
next generation of operational challenges without new tools and 
strategies: these challenges include the inevitable development of 
resistance to first-line drugs; the need for new strategies for 
monitoring efficacy and detecting treatment failure, particularly as we 
reduce reliance on lab monitoring; the price and practicality of 
second-line drugs; the management of side effects; and the role of 
prevention of mother-to-child-transmission (pMTCT) using monotherapy in 
the era of ARVs.


    Senator Alexander. Thank you, Dr. Oguda, for your comments 
and for being here.
    Dr. Darkoh, would you have any comment on what Dr. Oguda 
just said about the drugs?
    Dr. Darkoh. Well, I think we are in a slightly different 
position to most countries, because we started our program 
essentially 2 years before therapy became ``in fashion,'' and 
in fact, a lot of the veritable agencies that have been 
mentioned at the time actually came out formally against us at 
that time, saying that they did not support treatment.
    So, we were really on our own when we had to make these 
decisions, and at that time, it was definitely a situation 
where there was very little good information out there as to 
which way to go.
    Now, Botswana had already had its procedures in place for 
drug procurement and had a lot of good standing relationships 
with many different companies. Botswana does use generic 
medications for certain disease conditions. However, with ARV 
therapy at that time, it was not felt that there was enough 
information to actually make a decision to go with generics, 
especially keeping in mind that we're thinking about lifetime 
therapy and the need to have as many options as possible for 
people going forward.
    Now, fortunately, Botswana was not as cash constrained as 
most other African countries and therefore could afford to 
basically buy the brand name drugs at the time. Now, there have 
been significant price reductions, but still I say it would be 
out of reach for most other countries that would be considering 
something similar.
    Now, this said, we therefore, to simplify things, we made 
sure that we had first, second, third line of therapy, and 
there's a national mandate that all patients, be it public or 
private, must be initiated on a government regimen to basically 
ensure that we see the same patterns of resistance emerge when 
they emerge, and then on a country-wide level, we can make 
changes as necessary to the regimens.
    In principle, we are for basically drugs being as cheap as 
possible, but I guess the only thing I would add as a little 
bit of a caution is that in Botswana, we were in the maybe 
somewhat unique situation that we actually had money available 
to buy these drugs.
    We still face the same challenges of getting people 
enrolled, and I would hope that in this debate at the end of 
the day, we in Botswana would really like to learn from 
programs that have experience using FDCs. What I'm hearing, it 
sounds like something we definitely need to look at, but I'd 
also really, really like to caution the fact that in most 
countries, the systems just do not exist to make sure that 
whatever drugs we provide will reach patients.
    And to me, I think our biggest lesson has been that, 
despite having money, despite being able to get the drugs, the 
challenges still do remain very significant.
    Senator Alexander. We can go back to that subject. Maybe 
Senator Feingold will, too. But may I ask a somewhat different 
question of both of you?
    What about volunteer help? Americans have a tremendous 
instinct to volunteer to help, and in Africa, I've met a number 
of people who are there to help, some obviously being a great 
help. Doctors Without Borders is a wonderful example of 
physicians who try to help in the world.
    And so, one of my first instincts was, well, why don't we 
have a USAIDS Corps where we find some efficient way to gather 
up all the volunteerism instincts that we have in this country 
and channel people to Zambia or to Botswana to fit into 
whatever you're doing and relieve the burden, either for 
training people or for counseling people or for doing whatever 
needs to be done.
    But I got a lot of different responses to that. Some people 
said, well, that's pretty expensive to do, to find somebody 
here and fly them all the way over there. Others would say 
short-term volunteer help wouldn't be of very much value, long-
term help would be.
    Are there any suggestions that either of you could give to 
us about how the U.S. Government or the private sector could 
supplement the work that you've been doing by finding a way to 
channel more individuals from this country, whether in health 
care or in related fields, who would volunteer to help in what 
needs to happen in the next 5 years?
    Dr. Darkoh. OK. I'll start with that. I think there's a 
clear role for volunteerism, and I think it is necessary as a 
facilitating step toward building capacity in countries in 
Africa.
    I would, though, however, urge thinking in the direction of 
very targeted reasons and very specific groups of volunteers 
who are brought into accomplish goals, such that they leave 
something sustainable.
    For myself personally, having spent most of my formative 
years in Africa and having lived in quite a few different 
African countries to this point, I guess what concerns me the 
most is that after 40 years of NGOs, development assistance, 
the World Bank loans, et cetera, Africa's worse off now than it 
was 40 years ago, and I think we do seriously need to rethink 
the model and manner in which we do provide ``assistance'' to 
countries and make sure that the--I like the fact that you've 
been stressing results orientation during this hearing--that 
even from that perspective, when we do provide resources, it 
does yield a tangible meaningful, but somewhat maintainable 
result.
    Now, I do not believe that anything in life is truly 
sustainable. I mean, someone pays for it one way or another, 
but for that matter, I think what we have seen quite a bit of 
in Africa is a very, very severe syndrome of lack of ownership 
and therefore projects and programs collapse immediately after 
the donor sort of exits, and therefore, in our particular 
program, for example, we have the preceptorship model, and 
also, for example, even physicians like myself, it is by 
definition a short-term position.
    I am currently transferring skills to a local counterpart 
who will take over. Our preceptorship model is people who come 
in for a short term and their specific job is to get that site 
offering ARV therapy, but we don't keep them there forever.
    Now, that says you need to bring in people with the right 
skills, the right temperament, who can basically work in this 
environment and actually be productive, but I do believe in a 
model whereby, as much as possible, we should over time make 
sure that countries can do this for themselves.
    Senator Alexander. Dr. Oguda.
    Dr. Oguda. Thank you. I'll limit my answer to HIV programs 
in this particular instance. I do agree with what my colleague 
has said. Yes, expert expatriates do jet in and out of Africa, 
stay there for like 3 months, but they don't really leave 
anything that is tangible, that is sustainable.
    Unfortunately, because there's not much transfer of skills 
and knowledge, this leaves the staff on the ground more 
dependent on the aid and on the expatriates. The next 
expatriate coming in does not leave them with any sense of 
ownership or power.
    With the UNICEF programs, what we have done is we work 
within the public system. Immediately we get into the country, 
we work with the Ministry of Health, such that a doctor such as 
me who has worked with antiretroviral therapy will work 
alongside another doctor from that country, a clinical officer, 
in the same ward.
    I will not be working in a different hospital, not in a 
different clinic, not in a different lab. In the same ward that 
that national staff member is used to working in and transfer 
my skills, adapting to the local prevailing situation.
    I think volunteers are very important. If we can get 
skilled volunteers to go to Africa and transfer these skills, 
it will be very important, as long as our volunteers, as he 
said, are willing to adapt to the situation.
    Thank you.
    Senator Alexander. Thank you.
    Senator Feingold
    Senator Feingold. Thank you, Mr. Chairman. Let me ask a 
couple questions. First, I'll have Dr. Oguda respond and then 
Dr. Darkoh, if I could.
    First, Dr. Oguda, can you tell me what led the MSF to 
decide that fixed dose combination medicines are safe and 
effective? You started to talk about that a bit. Do you believe 
that there should be a different standard for making this 
determination for large-scale versus small-scale programs?
    Dr. Oguda. When we started the ARV programs, we started off 
with a brand name, the brand name drugs, but we realized it was 
too costly and we had to save lives.
    So, MSF headquarters approached the WHO and asked what can 
we do to hasten this process to provide these generic drugs in 
the field because we had to save lives. I believe that's how 
the prequalification system was set up, and basically, the WHO, 
with the pharmaceutical and medical doctors from North America 
and from Europe, visited the manufacturing sites with some 
representatives from MSF, too, visited the manufacturing sites, 
saw how the drugs were being made, tested the competence of the 
drugs and found them safe.
    They got back equivalence data which they used. I do 
believe that the FDA has also approved some drugs based on 
bioequivalence data, such as Trizivir, the fixed dose 
combination. Thus the change in the brand drugs to the generic 
drugs--but realize, no, there is no difference. There's 
actually no difference.
    The side effects reported by the manufacturing companies 
are the same side effects that will be reported by the brand 
name companies. So, if you're anticipating anemia from a drug 
like AZT, whether it's coming in the form of Combivir or it's 
coming in the form of duavir, it's anemia, you still have to 
treat with the same drug.
    No, I do not believe that different standards should be set 
up for different programs, whether it's a small program or 
large program. I think if the drugs work, let's get them out 
there to the patients.
    Senator Feingold. Dr. Darkoh, do you think different 
standards should apply for different size programs with regard 
to this point?
    Dr. Darkoh. I, in principle, do not, but I do realize that 
necessity at times may dictate your actions as opposed to 
necessarily what you may believe in principle. If you're faced 
with a dying patient, you'll use whatever is necessary, and I 
think--I mean, we've seen the number of people, for example in 
Botswana who, prior to ARV therapy being available, would go 
for all manner of traditional remedies in many cases that would 
end up being very toxic, especially with liver and kidney 
toxicity, but, I mean, when you're desperate, you'll try 
anything.
    That said, I do think that there is a role for there to be 
a body that actually does this for all of us as opposed to 
expecting each individual country to set up quality assurance 
and quality control labs, et cetera.
    Now, how that is arrived at, and I'll be very frank, I 
mean, obviously there's a lot of politics and interests and 
agendas. But I think regardless of how we arrive, and that is 
the natural process of life, but how we arrive there quickly 
such that we can basically receive guidance from, call it an 
authority that we all agree that will abide by the quality data 
that comes out of it and be reassured enough that there is 
enough rigor.
    One thing I do know from implementing a program my size is 
that when things do go wrong, nobody stands up to say I was the 
person who said that. So, I think it's important that for this 
one we really think about what's in the best interests of 
patients and make sure that that always remains central in our 
thinking and then hopefully come to some sort of consensus 
around this.
    We can receive information that is of an acceptable nature 
whereby the endorsement is really as complete as you can get 
and that we can all be accountable for whatever happens later.
    Senator Feingold. Dr. Oguda, I consider your detailing of 
MSF's experience providing antiretroviral therapy in resource-
poor settings to be one of the really important moments of this 
hearing.
    Dr. Oguda. Thank you.
    Senator Feingold. First to you, as you listened to the 
discussion about U.S. efforts to scale up treatment programs, 
what strikes you as the most dangerous potential pitfall of our 
effort? I'd like Dr. Darkoh to answer the same question.
    Dr. Oguda. Thank you. I sense that the number of patients 
who receive treatment will probably be not as large as the plan 
managers are hoping and that probably is because of the 
prohibitive costs of the treatment regimens that are being 
selected. That to me seems the biggest pitfall.
    Senator Feingold. OK. Dr. Darkoh.
    Dr. Darkoh. For me, the biggest pitfall would be rolling 
out the program without the requisite systems in place to 
actually make sure that things work.
    In my experience, I think one of the biggest deficits that 
we found is that risky systems just don't work and that's 
across the board and those have an impact. The question I 
always ask people is if you were told right now to deliver 
aspirin to 40 percent of the population or pick whatever you 
want, give a clean glass of water and make sure that people 
drink this twice a day, just a clean glass of water, freely 
available, how would you do that?
    I think you need to approach it from that perspective and 
say we need to put in place systems that ensure that at the end 
of the day, you can deliver what you want to deliver, but, more 
importantly, because of adherence and resistance-related 
concerns, follow and track what is going on with the patients.
    Senator Feingold. One more question for both of you and 
then I'll be concluded, Mr. Chairman.
    I'll start with Dr. Darkoh. Are you concerned about the 
prospect of the international community poaching more and more 
of the trained health workers from domestic health system as we 
scale up the world response to HIV/AIDS, and, if so, what do 
you recommend we do to address that problem?
    Dr. Darkoh. I am concerned. It is an area where--well, the 
human resource problem we have been facing in our program is 
twofold. One is that people know what their rate is in the 
global marketplace. Many of the health professionals in Africa 
in fact have been trained abroad. So, when you come back to 
Africa, you know what you could be making if you're still back 
in the U.K. or in the U.S. So, that's challenge No. 1.
    Challenge No. 2 is that when you do get back into your 
environment, I think the natural human tendency is to look for 
the best opportunities possible, and in many cases, when 
external agencies come in, they do offer better terms than the 
local conditions.
    Now, that creates internal market dynamics that are 
extremely disruptive to being able to maintain a high quality 
in particular public sector service. What happens then is the 
best people from the public sector end up being poached or 
leave the system in search of more lucrative deals within 
either the private sector or within the development partner 
world and that adds--more money flows in as more initiatives 
get launched, and we see this mushrooming of initiatives in 
countries.
    My fear is that we'll end up in a situation where already 
systems that were being held together by a very fragile balance 
will actually crumble and fall apart. We've experienced this 
quite significantly in Botswana and you feel--I'm always torn 
because doctors come to me and say, will you write me a 
recommendation, and I know this is our site manager from a 
particular site, and in reality, I cannot tell them don't do it 
because they have a family and children to maintain. But on the 
other hand, I know that what this is going to mean for the 
program will be quite detrimental.
    So, recommendation-wise, one thing we as ACHAP have very 
specifically done is when we do hire staff, we strictly keep 
them on the government pay scale so we exactly match the 
government terms, conditions, schemes of service, et cetera, 
when we hire staff, and that has helped somewhat in terms of 
making sure also that those staff can be owned later, once we 
depart, but it's definitely not been my consistent experience 
with all other agencies.
    Senator Feingold. Dr. Oguda.
    Dr. Oguda. Thank you. When I was working in Zambia, we had 
a meeting and discussed this issue. Zambia was training 20 
doctors in a year. They have only one medical school. They were 
training 20 doctors each year, and they were retaining 3 
doctors out of the 20 they trained. Why? Doctors were moving to 
greener pastures. South Africa, Botswana, the U.K., the U.S.
    It is a big problem, and it's inevitable because of poverty 
and the economics. Doctors want to move from--and nurses, too, 
clinical officers. They want to move from the rural area to the 
urban area. They want to move to places where they know their 
children can go to school. There are hospitals. Those are the 
basic facts of life.
    I would suggest that if programs are going to be set up for 
one, let's not set up parallel programs. Let's try and work 
within the existing structures. If we can use the money that we 
would spend setting up parallel programs to upgrade what we 
already have, I believe that will be money well spent.
    Second, I think in this instance, like for ARV treatment, 
we can start using lower health staff. We don't have to have a 
physician to start a patient on antiretroviral therapy. We 
don't have to have a lab technician to do an HIV test. Let's 
train those community health workers how to do the test. They 
are doing it in Zambia with the MSF program. We trained them. 
This is how you do the rapid test for malaria. This is how you 
do the rapid test for HIV. Train lower types of health 
personnel.
    Third, because of economics, definitely health personnel 
will want to move from the government system into the NGO 
system. Perhaps it's the time for donors and individual 
governments to think about topping up those health personnel 
salaries. Instead of hiring one more expatriate, taking out one 
doctor from the health system to hire him as an expatriate, top 
off the doctors' salaries there. Let them stay there and let 
the individual governments deal with the other issues.
    Senator Feingold. Mr. Chairman, let me thank you and this 
excellent panel very much.
    Senator Alexander. Thank you, Senator Feingold, for your 
leadership and your interest.
    I do want to thank the panel. This has been a very useful 
day for me and I think for all those watching and listening. We 
especially thank you, Dr. Oguda and Dr. Darkoh, for your hard 
work helping people and your willingness to come talk to us 
about it. We invite you to let us continue to hear from you as 
time goes on. We'd like to have your opinions and your views as 
we try to spend this $15 billion to help as many people as we 
possibly can.
    This hearing is adjourned.
    [Whereupon, at 5:01 p.m., the subcommittee adjourned, to 
reconvene subject to the call of the Chair.]

             Additional Statement Submitted for the Record

                              ----------                              


               Prepared Statement of Global AIDS Alliance

 global agreement reached on generic aids medications--will president 
           bush use taxpayer dollars wisely in fighting aids?
    Washington (April 6)--A breakthrough plan to provide safe, 
generically-manufactured AIDS medication to poor countries around the 
world was announced today by the Global Fund, WHO, UNICEF, and the 
Clinton Foundation.
    The announcement was made just as Ambassador Randall Tobias, 
President Bush's Global AIDS Coordinator, prepares to testify Wednesday 
April 7 before the Senate Foreign Relations Committee. Programs funded 
through his office are not permitted to purchase generic medications.
    ``The President's unilateralism is forcing our partners abroad to 
combine forces'' noted Dr. Paul Zeitz, Executive Director of the Global 
AIDS Alliance. ``To fight AIDS they know they must counter a policy 
based on ideology, not practical solutions. It's tragic that President 
Bush's approach to AIDS is another example of how unilateralism can 
hurt American leadership. We need to work together to stop AIDS. We 
call on President Bush to allow purchase of generics and stop trying to 
cut funding for international agencies that use them, like the Global 
Fund.''
    ``The World Health Organization's goal of ensuring 3 million people 
have access to AIDS medication by the end of 2005 is now a step closer 
to reality,'' stated Zeitz. ``Meeting WHO's goal is essential to 
preventing the orphans crisis from worsening. Now it's time for 
President Bush and Ambassador Tobias to get with the program, or else 
risk wasting US tax dollars. This plan is simply tremendous news for 
countries fighting AIDS, and it's exactly the kind of leadership that's 
needed.''
    The global agreement announced today is a powerful challenge to 
President Bush's ideological insistence that US global AIDS programs 
buy brand-name AIDS medication. Many countries and programs have been 
alarmed at the public health impact of this aspect of Bush's AIDS plan. 
Now the US government has an opportunity to join the international 
community in a coordinated response, rather than keep pursuing a US go-
it-alone strategy that was causing delay and confusion in the US 
response to AIDS.
    The Global Fund and WHO played important roles in brokering the 
agreement announced today. President Bush has proposed cutting the US 
contribution to the Fund by 64%, and he has not responded to appeals to 
increase US contributions to WHO.
    Last week Senators McCain, Snowe, Chaffee and Kennedy, as well as 
Representative Waxman, wrote to President Bush to urge he join an 
international consensus that generics are in fact safe and essential to 
reaching the President's goals for expanding treatment for people 
living with AIDS.

                                 
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