[Senate Hearing 108-792]
[From the U.S. Government Publishing Office]
FOREIGN OPERATIONS, EXPORT FINANCING, AND RELATED PROGRAMS
APPROPRIATIONS FOR FISCAL YEAR 2005
----------
TUESDAY, MAY 18, 2004
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:35 a.m., in room SD-124, Dirksen
Senate Office Building, Hon. Mike DeWine presiding.
Present: Senators McConnell, DeWine, Leahy, Durbin, and
Landrieu.
DEPARTMENT OF STATE
Office of the U.S. Global AIDS Coordinator
STATEMENT OF HON. RANDALL L. TOBIAS, COORDINATOR
OPENING STATEMENT OF SENATOR MICHAEL DE WINE
Senator DeWine. Let me welcome all of you today. Senator
McConnell asked that I preside and begin the hearing as he
currently has another commitment, but he will be here shortly
to join us.
Today's subcommittee hearing on the fiscal year 2005 budget
request for HIV/AIDS consists of two panels. Global HIV/AIDS
Coordinator Randall Tobias will be the sole witness on the
first panel, followed by DATA founding member Bono on the
second.
Senator Leahy and I will make brief opening remarks,
followed by Ambassador Tobias. We will then proceed to 5-minute
rounds of questions and answers. At approximately 11:20, about
the time we may have a vote on the floor, we will move to our
second panel.
In the interest of time, I ask that our witnesses summarize
their remarks and we will insert their full statements into the
record. My colleagues should know that we will keep the record
open for any written questions they wish to submit to our
witnesses, and I request our witnesses to respond to these
questions, of course, in a timely manner.
Our hearing today is a chance for us to take a look at
where we have been in terms of how our funding allocations have
been spent in regard to AIDS and what the plans are for the
future of the President's Global AIDS Initiative. We are
privileged to have before us today on the first panel
Ambassador Tobias, who serves as the Coordinator of this very
important initiative. He will testify on the progress to date,
as well as provide us with details on what lies ahead for the
initiative.
We have an historic opportunity with the funding that has
been made available for the Global AIDS Initiative. I say that
because the money, that money, can and should be used not only
to fight HIV/AIDS, but also to lay a foundation for improved
health systems in the developing world: health care systems for
children, women, and families. The money that we put forward in
regard to this fight against AIDS has the potential to yield
tremendous dividends in other areas of public health.
The fact is that in many of the countries that we will be
spending and are spending this money for HIV/AIDS, many of
these countries do not currently have a good health
infrastructure. So it is really going to be impossible for us
to deal with the AIDS problem without helping these countries
build up that health infrastructure.
So the two are going to be linked. One of the things that I
want to explore with Ambassador Tobias today is how he sees us
working with these countries to build up their health
infrastructures.
I think that is going to also, though, while it is a
challenge, frankly it also has the benefit of providing extra
dividends: that what we will end up with, we hope, in the
future and what these countries and the people of these
countries will end up with is not only fighting AIDS, but end
up with the ability to do so much more in their health systems
and end up with truly a good health system in many of these
countries.
What I hope to hear from Ambassador Tobias today are his
plans on how to take advantage of the $15 billion in
opportunities over the next 5 years. How can we make certain
that we provide care and treatment to as many people as
possible, treatment that includes the millions of children with
HIV/AIDS and other infectious diseases like malaria and
tuberculosis?
Mr. Ambassador, having read your testimony, I know that you
will speak to the issues of procuring low-cost antiretroviral
medicines for adults. But what about the children? We need to
ensure that children infected with HIV are not overlooked in
the drug approval and procurement process. I would ask that in
your comments you clarify what your office is doing to ensure
safe pediatric formulations and how your office plans to
increase the number of children receiving treatment.
We know from experience that the core features of the
prevention of mother-to-child transmission programs--voluntary
counseling and testing, the establishment of pharmacies and
drug distribution mechanisms, and the training of health care
workers--all provide a sound foundation on which to build, on
which to build expanded care and treatment. So I would like to
hear from the Ambassador on his plans for the mother-to-child
transmission program. What are your plans to increase the
number of clinics capable of providing services to prevent the
transmission of the virus from mother to child, especially
since fewer than one percent of women have access to MTCT
services in some of the most infected countries. What can we do
to get more women treated before they give birth to HIV-
positive babies?
Let me say again, we have $15 billion in opportunities to
help build health care infrastructures, to increase the number
of children, women and families receiving treatment and care,
to invest in human capital development, and to put programs in
place to take care of orphans and other vulnerable children.
Let me again thank both of our witnesses for being here
today, and also thank both of them for their great commitment
to this cause. Ambassador Tobias, I look forward to hearing
your vision on how we can take advantage of these opportunities
and hearing what you have already done so far.
Let me also say that I am pleased that Bono could join us
and I look forward to hearing his thoughts on debt relief. We
do not know anyone else who has really had the vision in this
area and who has captured the attention of the public, not only
in the United States but around the world, and we salute him
for his great work as well.
Let me at this point turn to Senator Leahy, the ranking
member of this committee, who has also been just a great leader
in this anti-AIDS work. Senator Leahy, thank you.
OPENING STATEMENT OF SENATOR PATRICK J. LEAHY
Senator Leahy. Thank you, Mr. Chairman.
You know, it is interesting, some of the odd couplings in
the Senate. Not only is Senator DeWine a close personal friend,
but we have, coming from different parties and different
philosophical spectrums, we have worked very closely on these
issues.
Ambassador Tobias, I am glad to see you. I enjoyed our chat
outside before we came in and I really would welcome the
opportunity to travel to parts of Africa with you. I am
delighted that a long-time friend, Bono, is here. He is a close
friend of the Leahy family. We have spent time together, each
member of the family with him, and we think the world of him.
I met just briefly the lady from Uganda before and we will
be seeing more of her, of Agnes Nyamayarwo. And I probably--and
I apologize. I have probably totally butchered the
pronunciation of the name, and the poor reporter here is
getting panicky at how to handle that, and I know you will do
better. But I admire--as I told you privately before, I admire
your courage, I really do, and you are in our thoughts and
prayers.
When you think of the statistics--Ambassador, we talked
about that outside. We talked about these horrible statistics--
8,000 people will die of AIDS today. And as you said very
rightly, the number is overwhelming, but each one has a name.
And you have seen those, as has Bono and the others, as I. My
wife is a registered nurse. We have been in some of these
clinics. We have seen the people who are dying.
During the hour and a half of this hearing, 513 will die,
856 will become infected. That shows we have yet to confront
this disease.
I support President Bush's AIDS initiative. I have been
impressed with the progress you have made in the very short
time since you took on this responsibility. We are allocating
far more to this crisis. The momentum is positive. But the
President and Secretary Thompson and others in the
administration, as well as some in Congress who defend the
President's budget, say we are spending as much as can be
effectively used to prevent the spread of HIV and treat those
who are sick.
I disagree. I think that is misinformed. In any of your 14,
soon to be 15, focus countries, the medical facilities are
grossly inadequate, health care workers are too few, often
poorly trained, they are always underpaid. Private voluntary
organizations are overwhelmed. Orphans are caring for other
orphans. People are dying alone, often ostracized by their
families.
There is a huge unmet need to build the capacity in those
countries to fight this pandemic. That is how it is in your
focus countries, which are shown in white on this chart I have
got over here.
In the rest of the world, with half the HIV-infected
people, we either have no programs or funding has been frozen
at the fiscal year 2003 level due to a shortage of funds. So
while the rate of infection soars in some non-focus countries,
funding there is actually decreasing when you consider
inflation and the growing number of victims and people at risk.
This is a terrifying, terrifying chart.
The President has proposed to cut funding for the Global
Fund to Fight AIDS, TB, and Malaria from $547 million in 2004
to $200 million in 2005, at a time when the Global Fund says it
needs $3.6 billion, of which our share would be $1.2 billion.
And when we ask the administration, why can we not have
additional emergency funding to combat AIDS, we are told we do
not need it, we cannot use it.
It reminds you a little bit of the Department of Defense,
which, despite overwhelming evidence of the contrary, insists
we do not need more troops in Iraq.
Mr. Tobias, we should be allocating $28 billion next year,
not $2.8 billion. We are 20 years late, we are $20 billion
short.
Three other quick points. First, the generic drug issue,
which has been the subject of a lot of press attention and has
taken too long to resolve. Now that U.S. drug companies are
finally interested in manufacturing fixed-dose combinations,
the administration's opposition seems to have miraculously
disappeared and the FDA will soon be reviewing the safety of
these drugs. It makes you wonder.
Second is your emphasis on faith-based groups and
abstinence. Faith-based groups have a role to play and where
abstinence programs work we should support them, but we risk
millions of new infections if we apply an ideological lens to
prevention rather than relying on methods that have been tested
and proven and that deal with the world as it really is.
Then third is your definition of ``high risk'' group. I
heard, for example, that a 15-year-old girl in sub-Saharan
Africa, where the percentage of HIV-positive females can be as
high as 20 percent, could not receive condoms under your
program because she is not high-risk. Yet today that girl is
more likely to become infected and to die of AIDS than she is
to live her life free of AIDS, more likely to have it than not.
Now, I hope that girl does not have to expose herself to HIV
before she can receive condoms or even information about them
under your program.
Mr. Tobias, I have been trying for more than 15 years to
get more funding to combat AIDS. I believe we could and should
be doing more. But I hear good things, particularly from my own
staff, who traveled there, and the Global Health Council, which
I admire greatly, notwithstanding the fact it is based in my
home State of Vermont, I hear good things about the way you are
taking on this challenge, that you are doing it with great
energy and openness. I commend you for that.
PREPARED STATEMENT
Just as Senator DeWine and I work together, we all have to
work together. You know, when somebody is dying of AIDS we do
not ask them what their politics are. We ask what we could do
to stop it. Again, you look at that map; your heart has to cry
out.
Thank you.
Thank you, Mr. Chairman.
[The statement follows:]
Prepared Statement of Senator Patrick J. Leahy
Mr. Tobias, we appreciate you being here. We all know the
statistics. 8,000 people will die of AIDS today. Just during the hour
and a half of this hearing, 513 will die and another 856 will become
infected. To me, that shows that, so far, we have failed miserably to
confront this disease.
I support President Bush's AIDS initiative, and I have been
impressed with the progress you have made in the short time since you
took on this responsibility. We are allocating far more than before to
this crisis, and the momentum is positive. But the President, Secretary
Thompson, and others in the administration, as well as some in Congress
who defend the President's budget, say we are spending as much as can
be effectively used to prevent the spread of HIV and treat those who
are sick.
That is either misinformed, or disingenuous. In any of your 14--
soon to be 15--focus countries, medical facilities are grossly
inadequate, and health care workers are too few, often poorly trained,
and always underpaid. Private voluntary organizations are overwhelmed.
Orphans are caring for each other. People are dying alone, ostracized
by their families. There is a huge, unmet need to build the capacity in
those countries to fight this pandemic. That is how it is in your focus
countries, which are shown in white on this chart. In the rest of the
world--with half the HIV infected people--we either have no programs,
or you have frozen funding at the fiscal year 2003 level due to a
shortage of funds.
So while the rate of infection soars in some non-focus countries,
our funding there is actually decreasing, if you consider inflation and
the growing number of victims and people at risk of infection. And the
President proposes to cut funding for the Global Fund to Fight AIDS, TB
and Malaria from $547 million in 2004 to $200 million in 2005, at a
time when the Global Fund says it needs $3.6 billion, of which our
share would be $1.2 billion. Yet what we hear from the administration,
when we try to get additional emergency funding to combat AIDS, is that
we don't need it. We can't use it. It reminds me of the Department of
Defense, which despite overwhelming evidence to the contrary, insists
that we don't need more troops in Iraq.
Mr. Tobias, we should be allocating $28 billion next year, not $2.8
billion. We are twenty years late and $20 billion short.
Three other quick points:
First, the generic drug issue, which has been the subject of a lot
of press attention, has taken far too long to resolve. However, now
that U.S. drug companies are finally interested in manufacturing fixed-
dose combinations, the administration's opposition seems to have
miraculously disappeared and the FDA will soon be reviewing the safety
of these drugs. It makes you wonder.
Second is your emphasis on faith-based groups and abstinence.
Faith-based groups have a role to play and, where abstinence programs
work, we should support them. But we risk millions of new infections if
we apply an ideological lens to prevention, rather than relying on
methods that have been tested and proven, and that deal with the world
as it really is.
Third is your definition of ``high risk'' group. I heard, for
example, that a 15-year-old girl in sub-Saharan Africa, where the
percentage of HIV-positive females can be as high as 20 percent, could
not receive condoms under your program because she is not ``high
risk.''
Yet, today that girl is more likely to become infected and to die
of AIDS than she is to live her life free of AIDS. I hope that girl
does not have to expose herself to HIV before she can receive condoms,
or even information about condoms, under your program.
Mr. Tobias, I have been trying for more than 15 years to get more
funding to combat AIDS. I believe we could and should be doing much
more. But I hear good things--including from my staff and from the
Global Health Council in my own state of Vermont--about the way you are
taking on this challenge, with great energy and openness. I commend you
for that. We need to work together.
Senator DeWine. Mr. Ambassador, thank you very much for
joining us. We do have your written statement, which will be
made a part of the record, and will you please proceed.
SUMMARY STATEMENT OF HON. RANDALL L. TOBIAS
Ambassador Tobias. Mr. Chairman, members of the
subcommittee: I am very pleased to be here to testify this
morning in support of the President's budget request and to
report to you on the progress in implementing the President's
emergency plan for AIDS relief. I appreciate the committee's
indulgence in the fact that we were scheduled to do this
earlier and I was suffering from laryngitis, which as you can
probably tell I am not totally over yet; and then on another
occasion the President asked me to go to South Africa to
represent him at the inauguration of the president.
But I am very pleased to be here today and particularly to
be here with my friend Bono. It would be hard to find anybody
who is working any harder on this issue than he is. As you have
both said, this is a fight where we need everybody we can find
to work together.
With your permission, I will submit a longer written
statement for the record and I would like to make a few opening
comments.
As you are aware and as you have made reference to, 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 with $15 billion over 5 years, more money
than has ever been committed by any nation for any
international health initiative: $5 billion directed at 100
bilateral programs, $9 billion intended for new or expanded
programs in 14--soon to be 15--focus countries; and $1 billion
intended to support our principal multilateral partner, the
Global Fund.
The goals of this program are to help provide
antiretroviral treatment to 2 million people in the focus
countries, contribute to the prevention of 7 million new
infections, and to help provide care for 10 million who are
infected or affected, including the orphans and vulnerable
children.
Today I am pleased to report that we have made significant
progress in beginning to implement the actions that will be
necessary to achieve the goals of this initiative. On February
23, a very short time after Congress appropriated fiscal year
2004 funding for the first year of the plan, I announced the
first release of funds for the focus country programs, totaling
$350 million. This money is already being used in
antiretroviral treatment programs, prevention programs, safe
medical practices programs, and programs to provide care for
orphans and vulnerable children. With just this first round of
funding, an additional 50,000 people living with HIV/AIDS in
the 14 focus countries will receive treatment, which will
nearly double the number of people who are currently receiving
treatment in sub-Saharan Africa. Prevention programs will reach
about 500,000 additional people and about 60,000 additional
orphans will receive help.
For each of the focus countries, we have recently completed
reviews of their annual operational plans to be addressed with
the remaining 2004 appropriation. These plans represent the
overall U.S. Government-supported HIV/AIDS programs in each of
the focus countries.
As a result of these reviews, Mr. Chairman, we are already
moving beyond this first wave of funding, and we will be
providing to this committee and other congressional committees
very shortly the required notification for the obligation of
approximately $300 million in the next tranche of funding from
the Global AIDS Coordinator's Initiative and an additional $200
million in funds appropriated to the Department of Health and
Human Services and the U.S. Agency for International
Development. That will bring to about $850 million the funds
that we will have committed to new or expanded programs since
the first of the year.
While our short-term focus has been on putting funds to
work in the field quickly and with accountability to ensure
that those in need get help as quickly as possible, we are also
working to ensure that host governments and local organizations
are well prepared to fight this deadly disease. And similarly,
we need to ensure that our own U.S. Government staffs in the
field are properly sized in order to do this increased task
that they are facing.
But this is all only the first step. In fiscal year 2005 we
have requested $1.45 billion for the Office of the AIDS
Coordinator as part of the President's $2.8 billion total
request. The President's request represents a $400 million
increase over fiscal year 2004. An appropriation of $2.8
billion will keep the emergency plan on path toward meeting the
goals that have been set by the President and the Congress and
is in keeping with our belief that as the emergency plan takes
root and is scaled up additional resources are clearly going to
be needed to effectively deliver assistance.
Mr. Chairman, in February I also submitted to Congress a
comprehensive integrated 5-year strategy. This strategy is
driving everything that we are doing in the Office of the
Global AIDS Coordinator. We have enlisted the help of the U.S.
chief of mission in each country to bring together the local
country team so that everybody is working in a coordinated
effort, and I am very pleased with the way that effort is
working.
Within that framework, we are striving to coordinate and
collaborate our efforts in order to respond as best we can to
the priorities and the strategies of each of the host country
governments, challenges which in many cases are different. In
addition, we are increasingly coordinating our own worldwide
response with those of our international partners--U.N. AIDS,
the World Health Organization, the Global Fund--as well as
nongovernmental and faith-based and community-based
organizations and increasingly private sector companies who are
stepping into the fray.
Since my confirmation 7 months ago, I have had the
opportunity to visit many of the countries in which we are
focusing our efforts, including South Africa, Uganda, Kenya,
Botswana, Zambia, Namibia, Rwanda, Ethiopia, and Mozambique. I
will be leaving in a few days to visit Nigeria, Cote d'Ivoire,
and Tanzania, and then going to Haiti and Guyana in the early
summer.
Finally, Mr. Chairman, I would like to say a few words
about our policy to procure antiretroviral drugs under the
emergency plan, a topic that has generated a significant amount
of interest. I have consistently and repeatedly expressed our
intent to provide, through the emergency plan, AIDS drugs that
are acquired at the lowest possible cost, whether they are
brand name products, generics, or copies of brand name
products, regardless of their origin or who produces them, as
long as we know that they are safe and effective and of high
quality.
As you know, this past Sunday Health and Human Services
Secretary Thompson and I held a joint press conference in
Geneva, where the World Health Assembly is currently taking
place. Our purpose was to make two very important announcements
that impact these issues.
First, Secretary Thompson announced an expedited process
for FDA review of AIDS drugs that combine already-approved
individual HIV therapies into a single dose, known as fixed-
dose combination. The drugs that are approved under this
expedited process will meet all FDA standards for safety,
efficacy, and quality. This new FDA process will include the
review of applications that may come from research-based
companies that developed the individual therapies and now want
to put them into fixed-dose combinations, or the applications
may come from companies who are already manufacturing copies of
those drugs for sale in the developing nations.
For my part, I announced in Geneva that when a new
combination drug for AIDS treatment receives a positive outcome
under this expedited FDA review, then the Office of the Global
AIDS Coordinator will recognize that positive result as
evidence of the safety and efficacy of that drug, and thus the
drug will be eligible for funding by the President's emergency
plan so long as the various international patent agreements and
local government policies allow for their purpose.
Where it is necessary to do so, I will also use the
authority that has been given to me by the Congress to waive
buy-American requirements that might normally apply.
Thanks to the generosity of the American people, as well as
the growing number of donor nations, the donors to the Global
Fund, and other multilateral sources, the human and physical
capacity to deliver AIDS treatment is being scaled up to make
it possible for millions more patients to follow those who are
already receiving this life-extending therapy. As
infrastructure is scaled up, drug availability will also need
to be scaled up to an unprecedented level in order to fuel this
newly expanded set of health care systems that can deliver this
treatment capacity.
It is in some ways in large part because of the President's
emergency plan that the issue of drug safety needs to be
addressed on an entirely new scale. With such a massive
expansion of ARV treatment, the stakes have increased. If we do
not apply appropriate scientific scrutiny to this vastly
expanding flow of AIDS medicines, we will run the risk of
causing the HIV virus to mutate and overcome specific drugs or
even whole classes of drugs, and that is why getting it right
at the outset is so important and requires great care.
Our commitment from the beginning has been to move with
urgency to help build the human and physical capacity that is
needed to deliver this treatment and then to fund the purchase
of AIDS drugs to be used in providing this treatment at the
most cost-effective prices we can find, but only drugs that we
can be assured are safe and effective.
Patients in Africa deserve the same assurances of safety
and efficacy that we would expect for our own families here in
the United States. There should not be a double standard. But
how to do that has presented some serious challenges. So with
our colleagues at the World Health Organization and UNAIDS and
the Southern African Development Community, the U.S. Government
has been carefully examining this issue and considering
alternatives.
Many of the copies of the research-based AIDS drugs that
are on the market today in developing countries may very well
be totally safe and effective. The challenge stems in part from
the fact that they have never been reviewed by any of the
world's stringent regulatory authorities, and the same will
likely be true of the additional copies of these drugs that
will be coming to the market in the days ahead as new companies
and particularly indigenous companies enter this market,
something that we expect and indeed hope will happen.
Many people and organizations have noted the World Health
Organization's prequalification pilot program and have urged
that we simply rely on that. We have the highest respect for
the World Health Organization and for its program. However, the
World Health Organization is not a regulatory authority and
does not represent itself as such. And in my conversations with
Dr. J.W. Lee, Director General of the World Health
Organization, as recently as 2 days ago, he has been very
supportive, and has said so publicly, of what we are doing with
this new program.
For drugs that are used in the United States, the already
existing answer has been FDA approval, whether it is generic
drugs or brand name drugs. Now we have a process that every
drug company in the world who wants to participate in this
program can submit for review to the FDA and do this very
expeditiously.
Today the most limiting----
Senator DeWine. Mr. Ambassador, if you could wrap up.
Ambassador Tobias. Okay.
PREPARED STATEMENT
Today the most limiting factor in providing treatment is
not the drugs; it is the human and physical capacity in the
health care system in Africa. But we are making progress on
that and it is now time to get moving with the drugs.
I pledge that the Office of the Global AIDS Coordinator
will continue to move with urgency in all that we do, and I
appreciate very much the opportunity to be here today.
[The statement follows:]
Prepared Statement of Hon. Randall L. Tobias
Mr. Chairman, members of the subcommittee, I am pleased to appear
before you to testify in support of the President's Budget request for
fiscal year 2005 for global HIV/AIDS, and to report to you on our
progress in implement the President's Emergency Plan For AIDS Relief.
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:
--$5 billion intended to provide continuing support in the
approximately 100 nations where the U.S. Government currently
has bilateral, regional, and volunteer HIV/AIDS programs.
--$9 billion intended for new or expanded programs to address HIV/
AIDS in 14 of those countries that are among the world's most
affected--with a 15th country to be added shortly. The initial
14 countries account for approximately 50 percent of the
world's HIV/AIDS infections.
--And finally, $1 billion intended 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, I am pleased to report that we have made significant
progress in beginning to achieve the President's, the Congress's, and
the American public's goal of bringing prevention, treatment, and care
to millions of adults and children courageously living with HIV/AIDS
and replacing despair with hope.
On February 23, just 4\1/2\ months after we launched the Office of
the U.S. 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 for focus country programs totaling $350 million.
This money is being used by service providers who are bringing
relief to suffering people in some of the countries hardest-hit by the
HIV/AIDS pandemic to rapidly scale up programs that provide anti-
retroviral treatment; 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 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
anti-retroviral 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 anti-retroviral
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 World Relief and the
American Red Cross's Together We Can.
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. These care services will include providing critical social
services, scaling up basic community-care packages of preventive
treatment and safe water, as well as HIV/AIDS prevention education.
U.S. Government staff recently completed reviews of 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.
As a result of these reviews, Mr. Chairman, we will be providing to
this Committee and other congressional committees the required
notification for the obligation of approximately $300 million in the
next tranche of funding from the Global HIV/AIDS Initiative account. In
addition to that $300 million, another $200 million of funds
appropriated to the U.S. Department of Health and Human Services and
the U.S. Agency for International Development will be put to work in
the field, bringing to approximately $850 million the funds already
committed to new or expanded programs since the first of the year.
As we make additional awards, the numbers of persons receiving
treatment and care will increase substantially. I also expect our
efforts to strengthen and expand safe blood transfusion and safe
medical injection programs, as well as our efforts to strengthen human
and organizational capacity through healthcare twinning and volunteers.
And I also expect to place an additional focus on attracting new
partners, including more faith-based and community-based organizations
that can bring expanded capacity and innovative new thinking to this
effort.
Mr. Chairman, as I mentioned, our short-term focus has been putting
funding to work in the field quickly and with accountability to ensure
that those in need get help as quickly as possible. In addition to
these important ideals and the achievement of our treatment, prevention
and care goals, in the long term we are focused on strengthening
indigenous capacity. We need to ensure that host governments and local
organizations are well prepared to fight this deadly disease.
Similarly, we need to ensure that our own U.S. Government staff in the
field is properly sized to work closely with host governments over the
next four years in accomplishing the goals of the Emergency Plan.
But this is only the first step. In fiscal year 2005 we requested
$1.45 billion for the Office of the Coordinator as part of the
President's $2.8 billion request. With these funds we will continue to
expand access to care, treatment and prevention and also take the next
steps to build the necessary U.S. Government and host country capacity
needed for this Initiative. To this end, we are working with HHS and
USAID now to create a vehicle to help provide the necessary technical
assistance to small indigenous non-governmental and faith-based
organizations to become a more integral part of the solution to
fighting HIV/AIDS in their country. We are also working with USAID, HHS
and other relevant agencies to determine a long-term staffing plan.
As I mentioned, the President's total Emergency Plan request for
fiscal year 2005 is for $2.8 billion, a $400 million increase over the
fiscal year 2004 appropriation--the first year of the Emergency Plan.
This request is in keeping with our belief that as the Emergency Plan
takes root and is scaled up, additional resources will be needed to
effectively deliver assistance. An appropriation of $2.8 billion will
keep the Emergency Plan on the path toward meeting the prevention,
treatment and care goals set by the President and the Congress. The
appropriation will also maintain U.S. leadership in the Global Fund to
Fight AIDS, Tuberculosis and Malaria.
Mr. Chairman, in addition to announcing the 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 in February a comprehensive, integrated, five-year strategy
for the President's Emergency Plan for AIDS Relief.
This Strategic Plan is guiding our efforts to deploy our resources
to maximum effect:
--We are 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 help to provide anti-retroviral treatment for two million
people;
--We will contribute to the prevention of 7 million new HIV
infections; and,
--We will help 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 United 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.
Starting with this foundation, we are implementing a new leadership
model for those existing capabilities--a model that brings together,
under the direction of the U.S. Global AIDS Coordinator, all of the
programs and personnel of all agencies and departments of the U.S.
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 addition to
the work that has been done to develop the programs for fiscal year
2004 that we are or soon will be funding, 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 are striving 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.
Since my confirmation seven months ago, I have had the opportunity
to visit many of the countries in which we are focusing our efforts,
including South Africa, Uganda, Kenya, Botswana, Zambia, Namibia,
Rwanda, Ethiopia, and Mozambique. I'll be leaving in a few days for a
visit that will include Nigeria, Cote d'Ivoire and Tanzania.
In these visits, I have witnessed how these countries have
responded, in whatever way they can, to fellow community members in
need. As we embark on this effort, it is inspiring to observe the
remarkable self-help already under way in fighting HIV/AIDS by some of
the most under-resourced communities in the world. With our support, we
hope to broaden, deepen 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. I again seek
your support in ensuring that we are able to quickly move the
additional resources about to be sent up so we can respond with the
urgency these individuals in need require.
Finally, Mr. Chairman, I would like to say a few words about our
policy to procure anti-retroviral drugs under the Emergency Plan--a
topic that has generated a significant amount of interest.
I have consistently and repeatedly expressed our intent to provide,
through the Emergency Plan, AIDS drugs that are acquired at the lowest
possible cost, regardless of origin or who produces them, as long as we
know they are safe, effective, and of high quality. These drugs may
include brand name products, generics, or copies of brand name
products.
To define the terms here, when you or I go to our neighborhood
pharmacy and have a prescription filled with a generic drug, we do so
with the confidence that we are being given a drug that has undergone
regulatory review to ensure that it is comparable to the version
manufactured by the research-based company that originally created it,
but no longer has the patent rights to the product. It is the same drug
in dosage form, strength, route of administration, quality, performance
characteristics, and intended use. Drugs that have not gone through
such a process are more accurately described as copy drugs rather than
generics, as they are sometimes called.
This past Sunday, Health and Human Services Secretary Tommy
Thompson and I held a joint press conference in Geneva where the World
Health Assembly in currently taking place. Our purpose was to make two
very important announcements that impact on these issues.
First, Secretary Thompson announced an expedited process for FDA
review of applications for HIV/AIDS drug products that combine already-
approved individual HIV/AIDS therapies into a single dosage. These
combined therapies are known as fixed dose combinations or FDCs. Drugs
that are approved by FDA under this process will meet all FDA standards
for drug safety, efficacy, and quality.
This new FDA process will include the review of applications from
the research-based companies that developed the already-approved
individual therapies and want to put them into fixed dose combinations,
or from companies who are manufacturing copies of those drugs for sale
in developing nations. There are no true generic versions of these AIDS
drugs because they all remain under intellectual property protection
here in the United States.
For my part, I announced that when a new combination drug for AIDS
treatment receives a positive outcome under this expedited FDA review,
the Office of the Global AIDS Coordinator will recognize that result as
evidence of the safety and efficacy of that drug. Thus the drug will be
eligible to be a candidate for funding by the President's Emergency
Plan, so long as international patent agreements and local government
policies allow their purchase. Where it is necessary and appropriate to
do so, I will also use my authority to waive the ``Buy American''
requirements that might normally apply.
The issue of determining the safety and efficacy of the copy drugs
is, in some ways, a positive problem to have. Many have argued over the
years that bringing antiretroviral therapy to places like Africa on a
large scale could never happen--that the problems were too complex.
Well they were wrong. It is happening now--today.
Because of the President's Emergency Plan For AIDS Relief, and with
the partnerships between this initiative and those who are directly
delivering treatment--the NGO's and faith-based organizations, the
medical care-givers and the health-care delivery facilities of the
governments of these nations themselves, just a few short months after
launching the President's Emergency Plan, we have already increased by
thousands the numbers of patients suffering from HIV/AIDS who are now
on life-extending ARV treatment.
Thanks to the generosity of the American people as well as a
growing number of donor nations, the donors to the Global Fund and
other multi-lateral sources, companies in the private sector, private
foundations and others, as the human and physical capacity to deliver
AIDS treatment is scaled up to make it possible, millions more patients
will follow those who are already receiving this life extending
therapy.
Drug availability will also need to be scaled up to an
unprecedented level in order to fuel this newly expanded treatment
capacity. It is in large part because the President's Emergency Plan
for AIDS Relief has made such a dramatic commitment to making drug
treatment available that issues of safety need to be addressed on an
entirely new scale. With such a massive expansion of ARV treatment, the
stakes have increased.
If we don't apply appropriate scientific scrutiny to this vastly
expanded flow of AIDS medicines, we will run the risk of causing the
HIV virus to mutate and overcome specific drugs or even whole classes
of drugs. That could render our current drugs useless--and, incredibly,
it could leave Africa even worse off than it is today. That's why
getting this right at the outset is so important and requires great
care.
Our commitment, from the beginning, has been to move with urgency
to help build the human and physical capacity that is needed to deliver
this treatment, and then to fund the purchase of AIDS drugs to be used
in providing this treatment, at the most cost effective prices we can
find--but only drugs that we can be assured are safe and effective.
Patients in Africa deserve the same assurances of safety and efficacy
that we expect for our own families here in the United States. There
should not be a double standard. But how to do that has presented some
serious challenges. With our colleagues at the WHO, UNAIDS, the
Southern African Development Community, and many others, the U.S.
Government has been carefully examining this issue--and considering
alternatives.
Many of the copies of the research-based AIDS drugs that are on the
market today in developing countries may well be safe and effective.
The challenge stems in part from the fact that they have never been
reviewed by any of the world's stringent regulatory authorities. And
the same will likely be true of the additional copies of those drugs
that will surely be coming on the market in the days to come, as new
indigenous companies enter this market--something we expect and hope
will happen.
Many people and organizations have noted the World Health
Organization's prequalification pilot program and have urged that we
simply rely on it. We have the highest respect for the WHO and its
program. However, the WHO is not a regulatory authority and does not
represent itself as such.
For drugs that are used in the United States, the already existing
answer to ensuring safety and efficacy is simple: both research-based
companies and generic companies submit their products to the U.S. Food
and Drug Administration for review and approval. What FDA has announced
is a process that will not only make it possible, but relatively fast
and easy, for every manufacturer to now submit their AIDS drugs to that
same scrutiny, including those that will only be made available in
developing countries. If those drugs meet the appropriate standards--as
we hope many or all will do--they can then be approved for potential
funding by the President's Emergency Plan.
I hope that FDA will receive applications as soon as possible from
many companies that will want their drugs to be candidates for U.S.
funding for use in the treatment programs of the President's Emergency
Plan. If this process enables us to get safe and effective drugs at
lower prices than we do now, that would indeed be a great success.
Today the most limiting factor in providing treatment is not
drugs--it is the human and physical capacity in the health care systems
of Africa. The continent is desperately short of health care
infrastructure and health care workers. Both are needed in order to
deliver treatment broadly and effectively. We find that African leaders
and African AIDS advocates are quite focused on addressing this
limitation--because they know that all the drugs in the world won't do
any good if they're stuck in warehouses with no place to go to actually
be part of the delivery of treatment to those in need.
But as we successfully attack that issue and Africa's capacity to
deliver drug treatment grows, drug availability will become an
increasingly significant constraint on treatment. We can't let that
happen.
For our part, I pledge that the Office of the Global AIDS
Coordinator will continue to move with urgency in all that we do.
President Bush has made clear to me that this is an emergency at the
top of the list of America's priorities. We will act accordingly.
Mr. Chairman, I am grateful for this Committee's resolve to defeat
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 again moving forward
without the shadow of this terrible pandemic.
I would be pleased to respond to any questions you may have.
Senator DeWine. Mr. Ambassador, let me turn to the
prevention of mother-to-child transmission issue. Fiscal year
2004 is actually the last year of this program. My
understanding is that your plan is that beginning with fiscal
year 2005 the budget does not provide any specific line item
for this and that this program would be incorporated actually
under your office.
I wonder if you could tell us what you are anticipating for
this program, how much you are looking at spending under your
office, and what your plans are for the non-initiative
countries for this program?
Ambassador Tobias. Senator, the prevention of mother-to-
child transmission program has been very important, not only in
treatment terms but also one could argue in orphan terms. I
think you could make the case that the most effective orphan
program we can have is keeping the mothers alive so that we do
not have the orphans. The program to prevent mother-to-child
transmission has been very effective. It is relatively
inexpensive and it is a program that we will expand, not only
in the countries in the program where it exists but well beyond
that as we can.
We are now going to something that is generally referred to
as the mother-to-child transmission plus program, in that the
mother-to-child transmission program per se really focused on
protecting the health of the child and ensuring that when the
baby was born the odds were improved that the baby would be
infection-free. But what about the mother, what about the
father, what about the siblings that are in that family? So the
mother-to-child transmission plus program will begin to address
those, too.
This program, as you know, was started in the countries
that became the focus countries. I think it gave us an
important jump start on getting the emergency plan implemented.
I would hope that we can find ways to take the lessons that we
are learning in the focus countries and begin to expand those
lessons into the so-called non-focus countries as we go forward
and as funding permits.
Senator DeWine. The plus program is certainly a wonderful
idea and I think we all understand how important it is to keep
the mother alive and keep the mother there for the children. I
guess the concern would be that that prevents us--that focus
might--you know, these are tough choices--might prevent us from
moving forward into other communities and to other areas and
expanding the mother-to-child program.
What are the tradeoffs here? Let us be honest. What are we
talking about?
Ambassador Tobias. Well, you are exactly right with respect
to the issue of tradeoffs. There are tradeoffs virtually
everywhere we look.
Senator DeWine. I mean, the mother-to-child program can be
a fairly cheap program if you have got the infrastructure to
implement it. It certainly is cheap as far as what the drugs
cost if you can get the infrastructure going.
Ambassador Tobias. I certainly do not anticipate that we
are talking about an either-or situation here. I think that we
need to, as you suggest, expand the mother-to-child
transmission program, but with the building of increased
infrastructure and the capabilities that we are putting in
place I also believe that we can expand that into the mother-
to-child plus program also.
Much of what we do will be driven by the policies that are
established by the health officials and the government leaders
in each of the countries in which we operate, and we need to
pay close attention to that.
Senator DeWine. Let me move to another area because I have
one last question and my time is almost up. Let me move to the
pediatric treatment, which I touched on in my opening
statement. How does the President's 5-year strategy incorporate
the special needs of children who are infected with HIV and
require HIV treatment? What is the administration going to do
to ensure that all HIV/AIDS drugs are available for pediatric
use? And what is the administration going to do to ensure that
both pediatric professionals and other HIV/AIDS workers have
the necessary information and training to treat children
infected with HIV/AIDS?
Ambassador Tobias. I think you are very correct, Senator,
that not only in this field but in other fields the amount of
pediatric-specific research that has been done has been too
little, and we clearly need more in this field. I will rely on
the medical experts and the technical experts as to exactly how
we need to address this, but we do need to expand the care to
HIV-infected young people.
But again, the best answer to that is the mother-to-child
transmission program and things like that to keep that
infection from going----
Senator DeWine. No doubt about it, it is the most cost-
effective and we can save the most lives with the mother-to-
child. But still, every country I visited--and I visited a
number of them--we have got kids out there who are dying and
there are kids out there who could be saved if we could get the
treatment to them, and we do not want to forget them.
Senator Leahy.
Senator Leahy. Thank you, Mr. Chairman.
As you may have gathered by some of the demonstrators here
this morning, there is some concern on the question of generic
drugs. For months you had said: ``There is no process, no
principles, no standards in place today,'' to assure the safety
of generic fixed-dose combinations manufactured overseas. Now,
many health experts and the World Health Organization disagreed
with you.
Now we have a new review process. How do you answer the
fact that it appeared the review process came up after U.S.
companies were interested in manufacturing their own fixed-dose
combination drugs? And even then, how long is it going to take
for this review process? I am just wondering if we have just
one more unnecessary obstacle to getting these drugs out to the
people who need them desperately.
Ambassador Tobias. Well, Senator, first let me say that the
World Health Organization does not present their
prequalification program to be the equivalent of regulatory
review. I would simply refer to the statement that has been
released by Dr. J.W. Lee, the head of the World Health
Organization, in total support of the program that we are
putting in place to review these drugs.
Senator Leahy. When will we have the drugs out there?
Ambassador Tobias. The FDA tells me that if, for example,
companies are applying today, which they could, that in some
cases approval could be received in as little as 2 weeks. In
some cases it could be 6 weeks or so, depending on the data.
Then it will depend on the programs in individual countries.
But we will be certainly ready to go.
Senator Leahy. Would we have gone to a generic fixed-dose
combination if American drug companies had not shown an
interest in producing it themselves?
Ambassador Tobias. Well, the announcement that I have read
in the media, as you have, from the American companies, came
after we announced this program, which we have been working on
with the FDA for some time. I have said on a number of
occasions that we are totally in favor of fixed-dose
combinations. The issue has never been whether fixed-dose
combinations are good or bad. I do not think there is any
question with anybody that they are good because they make it
easier for doctors to administer the program and patients to
adhere.
Senator Leahy. I am just trying to see what this is. This
is today's New York Times and, for what it is worth: ``A WHO
official familiar with both his agency's approval process and
the outlines of the proposed American one said, `Although the
United States has not exactly been in love with our
prequalification process, they are now going to do exactly the
same. If they want to create a parallel structure and do a good
job, that is fine.' ''
Let me ask you this--and I will put the whole article in
the record. Over the next 5 years, you say you hope to prevent
7 million new HIV/AIDS infections. We all agree that would be a
great achievement. There are 5 million new ones each year. So
even if you succeed, there will be at least 18 million new
infected people by the end of 5 years, 2.5 times the number we
have prevented.
I raise this because in my opening statement you remember I
mentioned the issue of absorptive capacity, what can we do. How
did you come up with the number $2.8 billion for fiscal year
2005? Could we not be doing a lot more? Because it seems to me
we are in some ways chasing after the train. We are not keeping
up with even the rate of infection, to say nothing about
helping those who are direly in need.
I am told by so many that we have the capacity, if the
money was there, we have the capacity to do more. We have
private organizations, private groups. The Gates Foundation did
a lot more on this than the United States was willing to
initially.
[The information follows:]
[From the New York Times, Tuesday, May 19, 2004]
Views Mixed On U.S. Shift On Drugs For AIDS
(By Donald G. McNeil Jr.)
AIDS activists and doctors who treat patients in poor countries
greeted the Bush administration's shift in its policy on procuring AIDS
drugs with mixed reviews yesterday.
Many were delighted that the administration had decided to buy
anti-AIDS cocktails that combine three drugs in one pill, and that it
for the first time was willing to consider buying drugs from low-cost
generic manufacturers, who are now the only companies making 3-in-1
pills.
``I think it's fabulous,'' said Dr. Merle Sande, who treats 4,000
AIDS patients in Uganda, most of whom cannot afford drugs. Most of
those who can are on Triomune, a 3-in-1 pill from Cipla Ltd., an Indian
company. Three-in-one drugs, he said, ``are exactly what we need out
there.''
At the same time, some activists expressed frustration that the
White House had set up a new approval process overseen by the United
States Food and Drug Administration when one overseen by the World
Health Organization already existed.
``This just another roadblock,'' said William Haddad, an American
generic manufacturer who now consults for Cipla. ``The W.H.O. process
was a pain in the neck--it took us two years to get Triomune approved.
Why do we have to bend over and let them kick us again?''
Henry A. Waxman, a Democratic Los-Angeles area congressman who has
harshly criticized the Bush administration's previous refusal to spend
money on generic drugs said yesterday that he was ``disappointed that
the plan does not involve cooperation with the World Health
Organization.''
``We need to see the fine print before we can tell if the new
process will actually improve access to these affordable, effective
drugs,'' he said.
Even though the administration indicated that it would waive the
usual $500,000 fee for approving a drug and will let companies submit
published data instead of starting new clinical trials, any new
approval process involves reams of paperwork, legal expenses and time,
critics said.
The World Health Organization had no official reaction yet to the
decision, a spokeswoman said.
But a W.H.O. official familiar with both his agency's approval
process and the outlines of the proposed American one, speaking on
condition of anonymity, shrugged off the problem. ``Although the United
States has not exactly been in love with our prequalification process,
they are now going to do exactly the same,'' he said. ``If they want to
create a parallel structure and do a good job, that's fine.''
The official questioned how Tommy G. Thompson, the secretary of
health and human services, could promise to approve new drugs in as
little as two to six weeks unless it simply accepted all the data
submitted to the W.H.O. ``For us, even if everything is perfect, it
takes a minimum of three months,'' he said.
Dr. Mark Goldenberger, director of the Food and Drug
Administration's office that evaluates drugs for infectious diseases,
said that ``two weeks would be at the extreme short end'' and would
probably apply only to something like putting three already-approved
drugs in one plastic blister pack, because all the agency would look at
was the packaging.
Asked if the F.D.A. would accept information gathered by W.H.O.
inspectors, Jason Brodsky, an agency spokesman, said that there was not
any agreement allowing it, ''but we would be willing to consider any
information that we got from other countries in deciding whether or not
we'd inspect.''
On Sunday, as health ministers from around the world were gathering
in Geneva for their annual meeting, the Bush administration made a
surprise announcement that it would speed up its approval process for
AIDS drugs to be bought for very poor countries and would consider
generic drugs, 3-in-1 pills and letting different companies package
their drugs together. The administration had been expected to face
heavy criticism at the weeklong meeting for its previous reluctance to
approve generic AIDS drugs.
Some companies appeared to have been told of the administration's
announcement in advance. Merck, Bristol-Myers Squibb and Gilead
Sciences immediately issued a joint statement saying they planned to
develop a 3-in-1 pill. GlaxoSmithKline and Boehringer Ingelheim said
they were discussing packaging three of their drugs together.
``Obviously, they had inside information,'' complained Dr. Paul
Zeitz, director of the Global AIDS Alliance, which pushes for cheaper
AIDS drugs for the third world. ``That calls into question the honest
broker role' of the U.S. government.''
Ambassador Tobias. Senator, I think there is no question
that the magnitude, the broad magnitude of this problem, goes
well beyond the resources and the focus of the President's
emergency plan. I do not think the emergency plan was intended
to attack the entire problem. We need to get more resources and
more participation from other people in the world.
In 2003 the contributions of the U.S. Government for
international HIV/AIDS totaled more than the rest of the
world's governments combined. We are on a path so that in 2004
our contributions may well be close to twice as much as the
rest of the world combined. So we are doing a lot, but the rest
of the world needs to do more.
I think the issue is not where do these dollars fit in with
the magnitude of the problem. It really is can we efficiently
and effectively absorb the resources that we are bringing to
bear and use them as well as possible, and I think reasonable
people can disagree. But we are moving pretty quickly, and I
think we will know more in the months ahead.
Senator Leahy. My time is up, but I wonder if the chairman
would allow me one more question here. And we should carry on
that conversation.
Ambassador Tobias. Yes, sir.
Senator Leahy. Because I believe we could be doing a lot
more than we are, and I believe we have set some artificial
barriers to doing more.
But I looked at an editorial today saying that the
administration feels condoms are not effective in preventing
the spread of HIV in the general population. I mentioned in my
opening statement the 15-year-old African girl. ``On average,
adolescents become sexually active at 16 to 17 years of age,
some even younger. In some African countries, infections among
women are rising fastest among those who are married. Sexual
abuse and coercion within marriage is widespread.''
I mean, how long do you have to wait to receive accurate
information about the importance and effectiveness of condoms
in preventing AIDS? You have taken--I understand this was taken
off, this information was taken off the CDC and USAID web
sites. How do we answer these questions?
They say, in the editorial, it says: ``Randall Tobias, its
AIDS Coordinator, has said numerous times that condoms are not
effective at preventing the spread of AIDS in the general
population.'' The editorial goes on to say: ``Mr. Tobias is
wrong.''
Here is your chance to respond.
Ambassador Tobias. Senator, here is the report in my hand
from the London School----
Senator Leahy. School of Hygiene and Tropical Medicine.
Ambassador Tobias [continuing]. The London School of
Hygiene and Tropical Medicine, which allegedly does not exist.
And it says exactly what I have said before, that in their
study less than 7 percent of women used a condom in their last
sex act with their main partner; less than 50 percent of women
with casual partners used a condom.
There is a new study from----
Senator Leahy. Less than 50 percent do; does that mean
that, say, 40 percent or so do?
Ambassador Tobias. Well, this is again a study in a broad-
based population. But the point is--and let me make just one
more reference. There is a new UNAIDS study out that was peer-
reviewed by the Population Council's peer review process, and
just one quote from that: ``There are no clear examples that
have emerged yet of a country that has turned back a
generalized epidemic primarily by means of condom promotion.''
Senator Leahy. Primarily, primarily.
Ambassador Tobias. Yes.
Senator Leahy. Do you believe they should be withheld----
Ambassador Tobias. No.
Senator Leahy [continuing]. From 15- or 16-year-olds?
Ambassador Tobias. No, absolutely not. Our program is A, B,
C.
Senator Leahy. Absolutely not. A 15-year-old, it would not
be withheld?
Ambassador Tobias. The person that you described earlier,
as I understood your description, would be someone that ought
to have condoms available. I was in an area in northern Kenya
recently where the incidence rate in 15- to 24-year-old girls
is 24 percent and it is 4 percent in boys. But the evidence is
that is not going to solve the problem, and we need to do a
number of other things. That is why we are putting a lot of
emphasis on the messages that Uganda has proven can be
effective by getting young people to understand that if they
delay the age at which they become sexually active and then if
people who become sexually active reduce their number of
partners, hopefully to one, those are the two factors that have
been demonstrated to make a big difference.
But condoms are an important part of our program.
Senator Leahy. It would also help if that woman who reduces
it to one, if her partner had reduced it to that one, too.
Often that is not the case.
Ambassador Tobias. Well, and that is where testing is so
critically important. You are absolutely right.
Senator Leahy. Thank you, Mr. Chairman.
OPENING STATEMENT OF SENATOR MITCH MC CONNELL
Senator McConnell [presiding]. Thank you, Senator Leahy.
The President's HIV/AIDS initiative is focused on 14
countries in Africa and the Caribbean. Congress added an
additional country in the fiscal year 2004 Foreign Operations
bill. Have you identified the fifteenth focus country and what
criteria are you using to select that country?
Ambassador Tobias. Senator, we have not identified the
country yet. I have gotten input from a variety of sources
throughout the government and beyond. We identified 39
candidate countries that anybody could think of. We put
together a list of criteria looking at the infection rate, the
health care system, the national leadership, which is a
critically important issue, and how helpful the leadership
could be and so forth.
We are in the process of getting that down to a very short
list and I am hoping that in a relatively short time we will be
in a position to make that selection.
Senator McConnell. Some have expressed concern that the
administration is actually shortchanging countries that are not
on the focus list of 15 and that more should be done to address
rising infection rates in certain non-focus countries. Do you
have any response to those criticisms? And are non-focus
countries targeted for increases in bilateral assistance next
year?
Ambassador Tobias. Senator, one of the important principles
of the President's program is focus. It is to try to keep this
from being an inch wide--or an inch deep and a thousand miles
wide and not really being able to make an impact.
But we also need to recognize that this is not a disease
that respects political boundaries. So we need to do what we
can in the so-called non-focus countries. I am looking for some
ways to shift at least some amount of resources into some of
the non-focus countries that are being hit the hardest. But I
think it is very important that we not lose sight of the focus
aspect of this program, because the focus countries really
represent 50 percent of the infections in the world and I think
it is very important that we make a major impact there.
Senator McConnell. I agree.
The fiscal 2005 budget request for a contribution to the
Global Fund to Fight AIDS, Tuberculosis, and Malaria is $200
million. In the fiscal year 2004 Foreign Operations bill
Congress provided not less than $400 million as a contribution
to the Fund, which was $200 million above the request.
Has the congressionally mandated increase leveraged
additional contributions from other donors? How can we get, for
example, donors like Russia--$20 million, Saudi Arabia--$10
million, and Singapore--$1 million--to contribute more?
Ambassador Tobias. Well, I think there are a number of ways
we can do that. One of them is leadership. I have asked the
President to mention this subject every time he has the
opportunity. The Secretary of State is doing the same thing. I
think the work that Bono is doing to draw attention to this and
encourage the rest of the world to step up to this is extremely
important, because we need to make this a program that gets
broad support from all governments.
Senator McConnell. Do you think Congress should provide
$400 million for the Global Fund next year? And if we did that,
do you anticipate U.S. contributions exceeding 33 percent of
the total amount contributed to the fund?
Ambassador Tobias. Mr. Chairman, the amount that the
President has requested in his budget of $200 million is
consistent with the original $15 billion proposal. This is one
of those arguable tradeoff areas in the sense that the
incremental difference between what the administration
requested and what was appropriated to the Global Fund is money
that might have been available for us to use to focus on the
non-focus countries.
So it is a matter of the tradeoffs of how we want to do
that. The Global Fund is a very important part of our overall
strategy.
Senator McConnell. Is it being effective, yielding results
out in the field?
Ambassador Tobias. Well, it is new. It is only 2\1/2\ years
old. They are experiencing the kinds of growing pains that
would be expected. We are putting money into technical support
in countries where the Global Fund is issuing grants in order
to try to help those countries, first of all, be more effective
in writing their grant proposals to the Global Fund, and then
in utilizing and implementing the resources that come from the
Global Fund.
PREPARED STATEMENT
Senator McConnell. I have great hope for the Global Fund
over time. But again, it is relatively new and it is just
getting started.
Thank you, Mr. Ambassador.
[The statement follows:]
Prepared Statement of Senator Mitch McConnell
Today, HIV/AIDS is recognized as a significant transnational crisis
that poses an immediate and growing threat to social, economic and
political stability across the globe. While it may be expedient to
frame the pandemic in geopolitical terms, it is far more difficult--
indeed horrific--to comprehend the devastation of the virus in
personal, human terms.
The statistics are staggering. As many as 46 million people live
with HIV/AIDS today, and an estimated 20 million have already perished
from complications of the virus. Last year alone, 5 million people
became newly infected, and 3 million died from AIDS complications.
This viral holocaust creates widows and orphans and destroys entire
families. It is especially brutal to youth, and saps the hope and
promise of future generations. If left unchecked in developing
countries, it is conceivable that HIV/AIDS will destroy entire
societies, economies and political systems.
Under President Bush's leadership, America has significantly
increased its contributions to combating this disease. Over a five year
period, we will contribute a total of $15 billion to HIV/AIDS programs
and activities. Fifteen countries, primarily in Africa and the
Caribbean, are the main focus of this initiative, although funding will
continue to some 100 countries where we have ongoing programs, and to
the Global Fund to Fight AIDS, Tuberculosis and Malaria.
There are no shortages to the challenges in successfully managing
this disease. Some argue that we--and other nations--should spend more
on HIV/AIDS, and that we shortchange the cause by not providing the $3
billion authorized by Congress in the AIDS bill.
Perhaps America should spend more, but that will ultimately be
determined by fiscal constraints. I would point out, however, that last
year's budget request for HIV/AIDS programs exceeded the total amount
provided from fiscal years 1993 through 2001. Further, the President's
plan gradually increases spending over the five year period so that
beginning in fiscal year 2006, the budget request exceeds $3 billion
and tops nearly $4 billion in fiscal year 2008.
Funding alone is not enough. To stem the tide of HIV/AIDS, nations
must have committed leadership, the most basic health care delivery
systems, and the capacity to absorb substantial assistance targeted
toward the health and welfare of all people--regardless of ethnic,
tribal, political, gender, or religious affiliation.
It will be an uphill battle. Of the 12 focus countries included in
the Transparency International Corruption Perception Index 2003, only
one--Botswana--is above a half-way mark of five. Nine countries rated
below a three. In 2003, Freedom House scored only four focus counties
as ``free''--seven were rated ``partly free'' and three ``not free''.
``A business as usual'' approach by focus countries will only
translate into more lost lives and greater tragedy for millions of
people. Many stand ready to help, including such faith-based
organization as Lott-Carey International (LCI). I strongly encourage
the Coordinator's office to use the experience and indigenous contacts
that LCI and other groups bring to this effort.
Let me close with brief comments on Burma and South Africa--
countries which represent the range of freedom in the developing world.
In Burma, a military junta daily abuses and denies the rights of its
citizenry, including access to even the most basic health care and
medicines. While we may not accurately know the extent of the HIV/AIDS
infection rate in Burma, we do know that the pandemic cannot be
addressed by an illegitimate regime that places the welfare of the
people far below the acquisition of Russian MiGs, nuclear reactors and
money laundering.
In South Africa, a country whose journey toward democracy has been
nothing but inspirational, the lack of political will by the Mbeki
government to address the HIV/AIDS pandemic head-on has wasted precious
time in stemming the tide. South Africa's heroes are the health care
workers at the grassroots level; the current government must be willing
to partner with them--and available science--to combat the disease.
It is my hope that in the future President Mbeki will be as
vigilant on this issue as both our witnesses here today.
Senator McConnell. Senator Durbin.
OPENING STATEMENT OF SENATOR RICHARD J. DURBIN
Senator Durbin. Mr. Ambassador, thank you very much.
Sometimes I get the impression that different rooms on
Capitol Hill are really living in different worlds. Last week
we entertained people from the administration who, having told
us in February they would need no additional funds for the war
in Iraq, had a different point of view and came to tell us that
they needed $25 billion and then, Assistant Secretary Wolfowitz
said, maybe $50 billion on an emergency basis.
The reasoning was hard to argue with. They said the war is
not going well, our national interests are at stake, we cannot
turn our back on our commitments, and we cannot turn our backs
on people whose lives are at stake as well.
I might say the same thing about the global AIDS epidemic.
That war is not going well either, our national interests are
at stake, we cannot turn our back on our commitments, there are
people who have their lives at stake.
As I look at the administration, I thought that the
President's announcement a little over a year ago of a $15
billion commitment was historic, receiving broad bipartisan
support. His first budget request, the first of the 5 years was
$2 billion. With the kind efforts of Senator DeWine and my
colleagues, we raised that to $2.4 billion on the floor.
Then came this year's budget request of $2.8 billion, still
short of the mark of keeping up with the $15 billion
commitment. With Senator Lugar and Senator DeWine and others,
we brought this up to $3.3 billion in the budget resolution.
But, going to a point that Chairman McConnell raised, how
can we rationalize or justify such a dramatic decrease in our
commitment to the Global Fund? You received a letter from Dr.
Feicham on March 25 of this year and he made it clear that the
amount that we are talking about appropriating for the Global
Fund is dramatically inadequate. For this effort to reach its
goal and to save lives across America, he believes $1.2 billion
is needed from the United States.
I think good evidence is there to support that position.
Why do you feel that, instead of increasing our commitment to
the war on AIDS, that we can start retrenching and pulling back
in this next fiscal year?
Ambassador Tobias. Well, Senator, the budget request for
2005 is in fact the same amount that the administration
requested in the previous year and that is reflected in the
billion dollar component of the first $15 billion request. I am
very supportive of the Global Fund, but I am also very
supportive of the President's emergency plan. I want to be sure
that we are not making tradeoffs that get in the way of our
doing the things that we are demonstrating we can do of getting
the money out and getting it to work very quickly.
Dr. Feachem is talking about the broad need out there. I
think we need to focus on the money we are getting out the door
today and next month and in the next year.
Senator Durbin. So do you think he is overstating his need
for next year?
Ambassador Tobias. No, I do not think he is overstating the
need, but he may be overstating the ability to utilize those
funds that quickly. But again, I want to make clear that the
Global Fund is certainly a very important aspect of our overall
strategy.
Senator Durbin. I would say, Ambassador, that that is a
fundamental error of this administration. I believe it is
important for us to maintain our bilateral commitment to the 14
nations, ultimately 15. But the Global Fund is serving a large
part of the world that we are not addressing with bilateral
assistance. I have seen that part of the world--India for
example, desperate to see their Global Fund projects not only
initially authorized, but carried on. When we fall so far short
of what is needed, it is going to mean a cutback on fighting
this epidemic in India.
Let me also address the cutbacks in the budget relative to
TB and malaria, a cutback of some $46 billion. I have been to
India just a few weeks ago to see DOTS, the Direct Observed
Therapy, and it is done on the cheap. I saw it in a shoe store
in one of the poorest neighborhoods in New Delhi.
How can we, in light of the fact that TB is such a killer
and linked so many times to HIV/AIDS, how can we rationalize or
justify cutting back in our commitment to TB and malaria?
Ambassador Tobias. Well, TB and malaria are very important
components of the program. Testing people who have HIV to
determine whether or not they have TB and can be put into TB
programs is a very important component of this. We do need to
stay very focused on TB and malaria.
Senator Durbin. We need more than focus; we need money.
Focus is good; money is better. In this situation, a little bit
of money goes a long, long way. Ten dollars for the therapy to
deal with tuberculosis, and the observation of a shoe store
owner of a person taking their medicine has created a health
infrastructure which nobody knew could exist in this country,
this vast country of India.
I am just troubled by the fact that with such facility we
talk about $25 billion more here and $50 billion more there,
and when it comes to these issues of the war on AIDS and the
war on tuberculosis, frankly, we are talking about a hollow
army and a hollow commitment. I think we can do better. I think
the President called on us to do better. But frankly, the
President's rhetoric is not matched by his budget numbers, and
people will die as a result of that.
Ambassador Tobias. Well, we are very much on a path to meet
the President's commitment of $15 billion over 5 years and we
are implementing the needs in people and infrastructure in a
very aggressive way. I think as we get more health care system
improvement in place we are certainly going to be able to
implement more quickly.
Senator Durbin. My last point--thank you for your
forbearance, Mr. Chairman--is that is an argument I
categorically reject, and here is how it goes: We cannot give
them the money; they do not have the health infrastructure.
Well, how do you get the health infrastructure? You start
training people to be doctors and nurses and medical
professionals. You start setting up clinics.
How are they going to do that? Is this supposed to spring
just automatically? I think we have to invest in the
infrastructure to deliver the drugs, to bring the people in, to
monitor their activity, for public education. To say we are
going to wait on the infrastructure before we send the money
means basically we may not ever send the money.
Ambassador Tobias. Well, we are not waiting on the
infrastructure. That is exactly where the initial money is
going, is to help build the health care systems and the
infrastructure. The greater operating expense going forward is
going to be the things that we put into that system.
But there is no question that the magnitude of this problem
is well beyond what this program is focused on and we need to
get more help from everybody that we can find that will provide
help.
Senator Durbin. Thank you.
Senator McConnell. Thank you, Mr. Tobias.
Thank you, Senator Durbin. We are going to complete your
appearance right now, Mr. Tobias. Any Senators who wish to
submit questions in writing, may do so. We have a vote at
11:30, so what I am going to do is to have a very short recess.
We are going to catch the vote. We will come back and have the
second panel as soon as I return, which will be shortly.
Senator Leahy. Mr. Chairman.
Senator McConnell. Senator Leahy.
Senator Leahy. If I might, there will be questions for the
record. I would just let Ambassador Tobias know that one
question I will ask, and I really want a straight answer on
this, is that we have been told that even though the
administration's own experts have rated some of the faith-based
organizations very, very low as to their abilities, they are
getting preference for funding.
I have some faith-based organizations I feel highly about.
But what I feel most urgently is to do something to stop AIDS,
and I do not want to think, with all the money we are doing,
that it is being passed out as a political goodie. So look at
my question. It is a very, very serious one.
Senator McConnell. All right. We thank you, Mr. Tobias. We
will take a brief recess and then resume the hearing shortly.
STATEMENT OF BONO, FOUNDER OF DATA, DEBT AIDS TRADE
AFRICA
ACCOMPANIED BY AGNES NYAMAYARWO, NURSE AND AIDS ACTIVIST, UGANDA
Senator McConnell. This hearing will resume.
Our second witness needs no introduction. In this town he
is known as much for his music as he is for his work on behalf
of HIV/AIDS and debt relief. He is an effective spokesman for
these causes and his political skills are as good as any on
this subcommittee, perhaps even better.
So welcome, Bono. I understand that with you is Ms. Agnes
Nyamayarwo, a nurse and AIDS activist from Uganda. I will leave
the formal introduction of her to you, but I would request Ms.
Nyamayarwo take a seat next to Bono, if you will. We want to
give our colleagues an opportunity to ask questions to someone
whose personal insights will undoubtedly be very, very helpful.
Before you make a brief opening statement, let me take a
moment to thank you for your eloquent description in Time
magazine, Bono, of a woman we both admire and support, Burmese
democracy leader Aung San Suu Kyi. Last week she, the National
League for Democracy and ethnic nationalities made the
courageous and correct decision to boycott the junta's sham
constitutional convention in Rangoon.
I unabashedly use this opportunity, while the spotlight
shines on a high-profile activist such as yourself, to
highlight her plight. At this critical moment she and the
people of Burma need the world's attention and support. I am
pleased that the United Nations, the European Union, Japan,
Malaysia, and Thailand have expressed concern with the regime's
unwillingness to move forward in a meaningful reconciliation
process with the NLD and the ethnic minorities.
The Burmese people should find encouragement from these
remarks. As we approach the anniversary of Burma's 1990
elections and last year's massacre, which almost took Suu's
life, I would urge my colleagues in both the Senate and House
to quickly renew import sanctions against the junta. Bono, I
know you agree that we cannot fail Suu Kyi or freedom in Burma.
Senator Leahy will be back shortly and I will allow him to
make his comments then. I think what we will do is proceed,
Bono, with your opening remarks.
Bono. Thank you very much. Thank you very much, Chairman
McConnell. It is an honor to be asked to share my thoughts
today. I would like to thank friends Leahy, DeWine, and Durbin.
When they come back I will. They have shown great leadership on
this subject and, I have to say, patience in dealing with a
rock star, and a rock star who asks for a seat at your
distinguished table, then refuses to leave. And frankly, there
is a lot of people who wish I had stayed in the studio,
including my band.
But you let me in the door. You let me in the door on debt
relief. We have worked together on AIDS and the Millennium
Challenge. And now I am going to abuse your hospitality by
hanging around, talking loudly, when you really ought to be
hearing from people who truly live the subject, like Jim Kim at
the World Health Organization or a treatment advocate like
Zackie Achmet in South Africa, or indeed a true heroine like
Agnes here, whom many of you know.
But I promise to talk briefly and politely. I think it is
really brilliant to be here, and my testimony will be suitable
for family audiences. Your children, your country, are safe,
safe from my exuberant language.
I have just come back from Philadelphia and it was an
extraordinary day there yesterday with various religious groups
and student activists. We are putting together a campaign to
unite everybody all across the country, all across the United
States, to unite the country under this issue of AIDS and
extreme poverty.
I think we are going to succeed. You listen to these people
talk about America taking the lead on this and you would be
very proud. I think they know--their message to me was: This is
a critical time. And I think we all agree with that.
We are making progress in the fight against AIDS. We are
gaining speed, building momentum, but only as long as we keep
our foot on the gas, because, Senator, as you know, we have a
lot more road ahead. Our success so far should make us
confident, but it cannot make us content. We are off to a great
start. Only you here can make sure that it is not a false
start. If we stop at AIDS, oddly enough, we will not beat AIDS,
because we need to do more about the conditions, the extreme
poverty in which AIDS thrives.
But lest this sound like a burden or ``more money, more
money,'' can I just say this is actually the exciting bit,
because we can use this disease to knock poverty out. This is
an incredible opportunity for America. I am not a Pollyanna on
this stuff. I have seen it work. I have seen it save and
transform lives.
Just at this moment in the world, it just feels important,
as a fan of America, to see America knocking poverty out and
taking the lead on AIDS. I think it is a great, great message.
So let me talk a little bit about the results that we are
seeing, because a few years back I was here to talk about debt
cancellation and I think it is important that I give you a
report back on what we did with that money. I remember sitting
in your office, Senator McConnell, and going through this, and
you were listening to this. It was my first sort of foray here
and you were very patient with me as I had my hand in your
wallet.
But I feel an obligation to explain to you all on this
committee what we did with that money, because it is an
astonishing thing, and I hope America is aware of what it did.
There are 27 countries who had chronic debts owed to the United
States from way back and they have been cancelled. With that
money there has been astonishing results.
Three times the amount of children, where Agnes is from,
three times the amount of children going to school. What an
astonishing thing. I have even had Senator Frist witness some
of this stuff. Together we saw water holes built by moneys
freed up by debt cancellation. When others said the money was
going down a rat hole, in fact it was going down a water hole.
A very, very proud moment for me and I hope for America.
So more recently we have been working together on the
Millennium Challenge, something we worked on with this
administration and then across with support on both sides of
the aisle. This is important stuff and I am not sure people
have--it has really sank in what the Millennium Challenge was
all about. It is important. It is a paradigm shift because it
is rewarding countries that are fighting corruption and that
are actually tackling poverty and the poverty of their people.
Because wherever we go in America, that is the only issue
we hear about that makes people cautious about development
assistance. They want to know that the money is going to the
people it is promised to. So corruption is absolutely essential
that we deal with.
The Millennium Challenge is this kind of new way of seeing
aid as a reward for people who do the right thing. Where there
is civil society, clear and transparent process, good
governance, let us fast track those people. It is common sense
and, by the way, it is going to be imitated around the world
and it was invented here in this city. It is a new paradigm
shift, deserves a lot of support.
The President asked you for $2.5 billion for 2005 and I
figure that is a little more persuasive than my asking you, but
I will just urge you to support him on that. DATA, D-A-T-A, the
organization I helped start, has found that the 16 well-
governed poor countries selected for the Millennium Challenge,
are ready to use all of that funding on sound poverty reduction
plans. They need only what you can give them, which is really a
chance. So it is a good start, but only that, a start.
We are not here today for a victory lap. We are here to
pick up the pace, because AIDS, as Senator Durbin mentioned, is
outrunning us. It is killing 6,500 Africans a day, 7,000
Africans a day. Whoever you are talking to, the number is hard
to stomach. 9,000 more Africans a day infected.
The most incredible part about this is it is fully
preventable and treatable, which is an incredible opportunity
for America. As I say, at this moment of all moments, when
people are not necessarily sure about us in the West that our
intentions are benign even in Europe and America, there is a
lot of suspicion about our intentions in the rest, in the wider
world, this is an incredible opportunity because America has
the power to make this stop. It is an achievable goal.
There will soon be a day when AIDS is gone. There will be a
vaccine, it will be gone. I think when the history books are
written, would it not be nice to see the United States right
out in front. Like going to the Moon: We did it first, there it
is.
The tough thing about this realization that we have the
power to make it stop is that it means we have actually got to
do something about it. For the first time in history, we have
the know-how, we have the cash, we have the life-saving drugs.
Do we have the political will?
Ambassador Tobias does. As we heard, he sees the fire
raging and he has got a fire brigade. That is a great thing. He
needs your support, fully funding of around $2.5 billion for
the bilateral programs. Every dollar counts.
That is why the debate over generic medications is so
frustrating, because when there is a fire raging you do not
fight it with bottled spring water; you turn on the hose and
put the fire out. There are safe generic drugs saving lives
right now at a fraction of the price of their brand-named
twins. Here is an advert for one sitting right beside me,
someone who is a great advertisement for those generic drugs.
And we have to ask the experts, like Medecin Sans Frontier, one
of the first people to involve ARV's in the treatment of AIDS.
They are doctors. They believe it is safe.
I think what we talk about--President Bush when he spoke
about AIDS he was very inspiring because he spoke about
bicycles: We will get them on bicycles and motorcycles. This is
exactly the tone, this is what we need. But the bicycles right
now are wrapped in red tape, is the truth, and we need to cut
through the red tape. We need the spirit of that announcement
of $15 billion over 5 years in the actual follow-through.
So we have this news in the last couple of days that could
be great news, that we are considering generics and fast-
tracking a breakthrough on generics in 6 weeks. But this is, 6
weeks of red tape, is very costly. That is 250,000 lives. So I
would just caution us, this 6 weeks.
So Americans want the biggest bang for their buck, that is
true. They want to treat as many people as possible. Let us get
together on that and make sure they get the biggest bang for
their buck.
Every dollar counts, but some dollars count for triple. By
this I am talking about the Global Health Fund, an essential
part of the fight and a vital partner to what the United States
is doing. Every contribution America makes gets other countries
to kick in more. Tony Blair says so, so does President Chirac,
so does Paul Martin. I know because I have spoken to all these
people recently. I make their lives miserable, too, you will be
relieved to hear.
But to date the United States has made one-third of the
fund's contributions. I would urge you to maintain that
commitment in the neighborhood of $1.2 billion for next year.
Yes, the fund has growing pains, but the fact that it is
growing in scale and in impact, not only on AIDS but on other
killer diseases that worsen it like malaria and TB, is
encouraging.
Of course miracle drugs alone are no miracle cure. We
cannot defeat AIDS unless we do more about the extreme poverty
in which it spreads. Otherwise our efforts will come to naught.
You cannot take a pill if you do not have water to swallow it,
clean water that is. You cannot strengthen your immune system
if there is no food in your belly. And you cannot teach kids to
protect themselves if they do not go to school. That is why the
Millennium Challenge and other key programs you fund through
USAID are essential.
More investment is needed, a lot more investment is needed.
President Bush has asked for a lot more, over $21 billion in
total for foreign ops in 2005. I think that is because he, like
many of you, sees that a victory in this battle is vital to
national security.
Our issues, people tend to think of them as fringe, not
central to the action here in Washington, D.C. If I can
convince you of one thing, it is that at this time in the world
these issues that you have gathered to talk about on this
committee has a role to play in very central policymaking that
will affect the way America is viewed everywhere in the world.
It is where America meets the world, outside of commerce and
the military.
The Senate, in passing a bipartisan budget resolution, has
gone a step further on these issues, and I applaud that. I
trust the Senate will hold on to increases in the
appropriations process. I do want to say thank you personally
to the Senate for their leadership here and all of you sitting
here. It is very, very, very important.
Let me say this in closing. I know I spend a lot of time in
this country and I am sure it is too much for your liking. But
I also spend a lot of time in buses, truck stops, town halls,
church halls, and I am not even running for office. But I have
spent a lot of time in this country campaigning on these
issues.
You know what is amazing? Everywhere I go, people feel more
American when you talk about these issues that affect people
whom they have never met and who live far away. They feel more
American. It is kind of extraordinary to me as an Irishman to
observe this.
I think that they are thinking big, as you always have.
Sixty years ago there was another continent in trouble, my
continent Europe in ruins after the Second World War. America
liberated Europe, but not just liberated Europe; it rebuilt
Europe. This was extraordinary. And it was not just out of the
goodness of your heart, which it certainly was. It was very
smart and strategic, because the money spent in the Marshall
Plan was indeed wise money. It was a bulwark against Sovietism
in the cold war.
It was 1 percent of GDP over 4 years, I believe. I would
argue that this stuff we are discussing today is a bulwark
against the extremism of our age in the hot war. I believe
there is an analogy.
I believe brand USA, because all countries are brands in a
certain sense, never shone brighter than after the Second World
War, when a lot of people in my country and around the world
just wanted to be American--wanted to wear your jeans, wanted
to listen to your stereos, wanted to watch your movies. That
was because this is an astonishing place, America.
It cost money, that place in the world, I know, and I know
how expensive the Marshall Plan was--point one. We are looking
for numbers that I think are about half that to completely turn
the world around at a time--on a positive thing, like a health
crisis, making that a positive thing. So please bear with us.
In turbulent times it is cheaper and smarter to make
friends out of potential enemies than to defend yourself
against them. A better world happens to be a safer one as well.
I think it is a pretty good bargain.
PREPARED STATEMENT
The attention of the world might sometimes be somewhere
else, but history is watching. It is taking notes and it is
going to hold us to account, each of us. There is so much you
can do with your power, with your leadership, to ensure that
America here is on the right side of history. When the story of
these times gets written, we want to say that we did all we
could and it was more than anyone could have imagined.
Thank you.
[The statement follows:]
Prepared Statement of Bono
Thank you, Chairman McConnell. It is an honour to be asked to share
my thoughts today. Let me also thank some very good friends: Senators
Leahy, DeWine, Durbin and so many others who have shown such leadership
on these issues.
And such patience in dealing with a rock star who asks for a seat
at your distinguished table, then refuses to leave or to turn down the
music he's blasting. Frankly there are a lot of people who wish I'd
stay in the studio--including my band.
You let me in the door on debt relief; we've worked together on
AIDS and the Millennium Challenge; and now I'm going to abuse your
hospitality by hanging round and talking loudly when you really ought
to be hearing from someone who knows better--a medical doctor like Jim
Kim at WHO, or a treatment advocate like Zackie Achmet of South Africa,
or a true heroine like Agnes, here, whom many of you know.
That said, I promise to talk briefly--and politely. Though I think
it's really brilliant to be here my testimony will be suitable for
family audiences. Your children, your country, are safe from my
exuberant language.
I've just returned from your nation's first capital--Philadelphia--
where my organisation, DATA, and an array of other groups launched a
new effort we're calling ``The ONE Campaign.'' These organisations
represent millions of Americans, from evangelicals to student
activists. They came from all over the country. And they're speaking
with one voice in the fight against AIDS and extreme poverty.
What are they saying?
They're saying--as I think we all agree--this is a critical moment.
We're making progress in the fight against AIDS. Gaining speed.
Building momentum. But only as long as we keep our foot on the gas.
Senators, as you know, we've got a lot more road ahead.
Our success so far should make us confident. But it can't make us
content. We're off to a great start--but only you can make sure it's
not a false start. If we stop at AIDS, we won't beat AIDS. We need to
do more about the conditions--the extreme poverty--in which AIDS
thrives.
Now, I'm not a Pollyanna on this stuff; I've seen it work. I've
seen it save and transform lives. So let me talk briefly about the
results we're seeing.
As I mentioned, I met many of you a few years back when we worked
to cancel the debt that burdens the poorest countries. Today, 27
countries--almost all in Africa--are investing that money in schools,
vaccinations, and roads instead of in debt payments. In Uganda, I've
stood with Senator Frist at a clean water well built thanks to debt
relief. Debt money didn't go down a rathole--it went down a waterhole.
More recently, we've all worked together on the Millennium
Challenge. This is smart money, new aid in new ways, rewarding poor
countries who are leading in the fight against corruption. Though it's
only just up and running, it's already having an impact, encouraging
countries to reform.
The President has asked you for another $2.5 billion for 2005. I
figure that's a little more persuasive than my asking you, so I'll just
urge you to support him on that. DATA, the organization I helped start,
has found that the 16 well-governed poor countries selected for MCA are
ready to use all of that funding on sound poverty reduction plans. They
need what only you can give them: a chance.
All in all, then, we've made a good start. But only that. A start.
We're not here today for a victory lap; we're here to pick up the
pace. Because AIDS is outrunning us, Senators; it's killing 6,300
Africans a day, infecting 8,800 more Africans a day; and the most
incredible part is it's fully preventable, it's fully treatable.
We actually have the power to make this stop. But the tough thing
about that realization is that it means you've actually got to do
something about it. For the first time in history, we have the brains,
we have the cash, and we have the life-saving drugs. But do we have the
political will?
Ambassador Tobias does. As we heard, he sees the fire raging and he
is leading a fire brigade, and that's a great thing. He needs your
support, full funding of around $2.5 billion for bilateral programs.
Every dollar counts. That's why the whole debate over generic
medications is frankly frustrating. When there's a fire raging, you
don't fight it with the finest spring water You turn on the hose and
put the fire out. There are safe generic drugs saving lives right now
at a fraction of the price of their brand-name twins.
I know that Americans want to get the biggest bang for their buck:
to treat as many people as possible. That's the whole point, right? If
that's your goal, isn't the administration's position on generics
untenable? Hopefully this is starting to change, we still need to hear
the details.
As I said, every dollar counts, and some dollars count for triple.
I'm talking about your contributions to the Global Fund--an essential
part of the fight and a vital partner to what the United States is
doing. Every contribution America makes gets other countries to kick in
more. Tony Blair says so. So does President Chirac. So does Paul
Martin. I know because I've been making the rounds with the tin-cup in
those countries too.
To date, the United States has made one-third of the Fund's
contributions--I urge you to maintain that commitment, in the
neighbourhood of $1.2 billion for next year. Yes, the Fund has had
growing pains, but the fact is it's growing--in scale and in impact:
not only on AIDS but on the other killer diseases that worsen it,
malaria and TB. Combined with bilateral, this is about $3.6 billion
which is allowed under last year's law.
Of course, miracle drugs alone are no miracle cure: we can't defeat
AIDS unless we do more about the extreme poverty in which it spreads.
Otherwise our efforts will come to naught. You can't take a pill if you
don't have clean water to swallow it. You can't strengthen your immune
system if there's no food in your belly. And you can't teach kids to
protect themselves if they don't go to school.
That's why the Millennium Challenge and other key programs you fund
through USAID are essential. More investment is needed a lot more.
President Bush has asked for a lot more--over $21 billion total--for
Foreign Operations for 2005, because he, like many of you, I think,
sees victory in this battle as vital to your national security. The
Senate in passing a bipartisan budget resolution has gone a step
further on these issues, and I applaud that. I trust the Senate will
hold onto its minimum amounts and keep up the pressure for more.
Let me say this in closing.
Senators, I spend a lot of time in this country. Maybe too much for
your liking. I spend a lot of time in buses. At truck stops. In town
halls. In church halls. I do all this, and I'm not even running for
office.
But you know what's amazing? Everywhere I go, I see very much the
same thing. I see the same compassion for people who live half a world
away. I see the same concern about events beyond these borders. And,
increasingly, I see the same conviction that we can and we must join
together to stop the scourge of AIDS and poverty.
Americans are thinking big. As you always have. You know, almost 60
years ago, another continent was in danger of terminal decline--not
Africa, but Europe. And Europe is strong today thanks in part to the
Marshall Plan. It was great for Europe, but it was also great for
America. Brand USA never shined brighter.
Today we need the same audacity, imagination, and all-out
commitment of a modern Marshall Plan. The Marshall Plan built a bulwark
against Communism; today, for half the cost, we can build a bulwark
against the extremism of our age.
In turbulent times it's cheaper, and smarter, to make friends out
of potential enemies than to defend yourself against them. A better
world happens to be a safer one as well. That's a pretty good bargain.
The attention of the world might sometimes be elsewhere, but
history is watching. It's taking notes. And it's going to hold us to
account, each of us. There is so much you can do, with your power, with
your leadership, to ensure that America is on the right side of
history. When the story of these times gets written, we want it to say
that we did all we could, and it was more than anyone could have
imagined.
Thank you.
Senator McConnell. Thank you very much, Bono.
Ms. Nyamayarwo, I see that you have a piece of paper in
front of you. Do you want to make a brief statement as well?
SUMMARY STATEMENT OF AGNES NYAMAYARWO
Ms. Nyamayarwo. Thank you so much. I am happy to be in this
house today. I want first of all to introduce myself. I am
Agnes Nyamayarwo. I come from Uganda from an AIDS organization
called TASO, the AIDS Support Organization in Uganda. I am a
nurse and working as a volunteer with this organization.
I have lived with HIV for 15 years. I want to share with
you briefly what happened to my family with the AIDS epidemic.
My husband died of AIDS in 1992. My youngest son died of AIDS
at the age of 6\1/2\ because I passed the virus to him
unknowingly. You can imagine as a parent giving a death
sentence to a child. It is very painful.
My other son, who was age 17, got overwhelmed by the
problem of AIDS in the family and suffered depression and he
disappeared from my family and up to today I have never seen
him again, still searching for him.
I have been very lucky. I have been on treatment,
antiretroviral treatment. I started by taking generic drugs and
now I am on the branded drugs from TASO, which is supported by
the U.S. Government, and I am very grateful for that. Actually,
I see that they work the same, because I was down and I started
with generic drugs and they improved my life, and now that
there are branded drugs I started taking branded drugs and they
work exactly the same.
Last year in July I met with President Bush and I told him
I was in treatment and my life had improved, but my concern is
the other people living with HIV in Uganda and in Africa who
die every day. And every time I go back to the community, where
we move around creating awareness about HIV/AIDS, I find so
many people have died, so many people dying. That is very
painful indeed.
The President promised that he was going to give treatment
to all people living with AIDS in Africa quickly and
immediately. It is almost a year now. We have just got money to
start on treatment on not even a quarter of the people in my
organization. So it has given me hope, it has given us hope,
all of us. But we are still asking for more.
In my work with DATA I have been in about 10 States in
America. It exposed me to many Americans and their response was
excellent and they were willing to help. This has always given
me a lot of hope, although every time I go back my people think
I have carried medicines for them. But I tell them: I have
hope; Americans are ready to help.
Today I am here to request this house as you are going to
make decisions on the programs to fund just to remember me, my
family, and all the people living with HIV in Uganda and
Africa, and the many orphans in Africa, and the young people
who need the education, because the more they keep in school
the more they delay to get infection, and the more they are
educated the more they know about how they can avoid catching
HIV. So good education is very, very important.
Then we also have that problem of poverty. Even with the
mother-to-child transmission, mothers are given the medicine to
reduce the infection, but these mothers have to give the
formula and they do not have the formula. They do not even have
the money to buy it. Or if they have it, they may mix it with
dirty water and these children end up dying of diarrhea. So
clean water is also very, very important.
I am still also asking you to really look at the trade with
Africa. It is very important because one day maybe we shall be
able to stand on our own. So please, help us fight AIDS and
poverty in Africa.
Thank you so much.
Senator McConnell. Thank you very much.
Even though this hearing is about HIV/AIDS, I do want to
address once again, Bono, an issue that you and I are extremely
interested in. For the record, do you support renewal of import
sanctions against the Burmese junta, as Senator Leahy and I
have proposed?
Bono. I do not just support it; I applaud it as loudly as I
can. Let me say, your leadership on this--there is no one
leading support for Aung San Suu Kyi like you, and to have
Senator Leahy by your side, and make sure that this is the
support of all Americans is amazing.
These toenail-pullers, these thugs, are also running this
country like a business, so the place they will feel the pain
is in business. Sanctions are crucial.
Senator McConnell. One of my big frustrations, which I know
you share, is that the only way sanctions are going to really
have an impact is if they are multilateral. Is there anything
we could do that we are not currently doing to convince the
European Union that a tougher approach ought to be in place
toward the generals in Rangoon?
I had hoped that the attempted assassination of Suu Kyi
last year might have gotten their attention, but apparently
not. What thoughts do you have about how we get the Europeans
fully engaged in the sanctions regime?
Bono. I am deeply ashamed as a European of the pitiful lack
of volume in support for her. I think Prime Minister Blair has
been doing some good work, but we need more and we need the
rest of Europe to pay attention. I will personally speak to
Roman Prodi, who is the President of the European Union, about
this and see at their next meeting if we can get a resolution.
Senator McConnell. In your statement you indicated that
America must have the political will to combat HIV/AIDS. How do
you cultivate political will in countries that do not respect
the basic rights of their citizens? In Burma, for example,
where, instead of stopping HIV/AIDS and poverty, the junta may
actually be spreading the disease and misery through rape,
forced labor, and illicit narcotics?
Bono. I think what is extraordinary about the Millennium
Challenge Account, which I was talking about earlier, is that
it provides assistance for countries who are doing the right
thing by their people and tackling corruption, etcetera. I
think with Burma we have a particular evil to deal with that
needs a different and stronger response.
So I would suggest sanctions. I think they should be
punitive and I think those people should feel our mettle. They
cannot walk over this woman, who is a true hero. In a way, with
the Millennium Challenge we are trying to encourage the kind of
leadership she represents. This is the future in the end for
all of the issues that we are talking about today, is
leadership. Leadership is everything.
Even with AIDS, we talk about A, B, C. What is important is
a balanced approach. But you know, the reason why abstinence
and these kinds of programs, preventive programs, worked in
Uganda was because of another letter ``L'', ``L'' for
leadership and ``L'' for local, understanding the local. To me,
Aung San Suu Kyi is great leadership.
Senator McConnell. Ms. Nyamayarwo, in Cambodia sex workers
refused to participate in a Gates Foundation-funded anti-HIV
drug test because of concerns with potential long-term health
impacts. How do we ensure that impacted groups, such as
Cambodian sex workers, have the will themselves to participate
in education and treatment programs?
Ms. Nyamayarwo. Back in the country where I come from, they
have been asking us about the sustainability of this treatment
and that was--maybe that may have been the same reason why in
Cambodia these people are not going in for this treatment. But
as a person living with HIV I told them that for me if I live
another 5 years for my children that is very important indeed,
because they will have the guidance from me and the parental
care.
So I think maybe we need to, Uganda needs to go and share
with those people what is happening in Uganda and what we
people living with HIV in Uganda feel about this treatment.
Senator McConnell. Thank you.
Senator Leahy.
Senator Leahy. Thank you, Mr. Chairman.
Bono, you and I have been friends for many years. I think
we also, on this Appropriations Committee, we also sit on the
question of money for terrorism, and of course if somebody
comes up and says this is for terrorism we can find enormous
amounts of money.
But I was struck by something you said in your statement,
and I wrote it down: A better world is also a safer world. That
really goes to the bottom line on everything you are trying to
do. You have seen probably more than anybody this effect of
AIDS and what is being done to combat it. You have traveled
everywhere.
You heard me ask Mr. Tobias about the potential of these
countries to absorb more funds. Can they absorb more funds? And
if they can, what would they spend it on? What should they
spend it on?
Bono. You know, we use this word ``absorptive capacity'' a
lot, but the truth is there is a distributive capacity problem.
I think what I object to sometimes was when it is characterized
as, oh, Africa or whatever country in Africa or elsewhere, they
just could not take the money, so it is kind of their fault. I
object to that.
I think what we should say is: Yes, there are difficulties
spending the money effectively and efficiently, but we have to
spend on building the capacity. That is what you do in an
emergency, in a war. You have to build the infrastructure. And
this is a war against AIDS.
What is great about this war is we really are going to win.
The only opposition is our own indifference.
Senator Leahy. But you also have a chicken-egg sort of
thing.
Bono. Yes.
Senator Leahy. You say building the capacity, but that can
be done. There are models for doing that in parts of the world,
bringing in everything from the roads to the training. We are
not talking about building Johns Hopkins in every village that
we see.
Bono. No.
Senator Leahy. But the basics are so absent. And I agree
with you, we could be doing more.
We are somewhat limited in time and I know you have to
leave. An area that we are aware of, we do not talk enough
about: What about AIDS orphans? What do we do to help the AIDS
orphans?
Bono. There is your chaos right there. Again, maybe
sometimes it is obvious. It sounds grating to always describe,
to describe the war against poverty as being connected to the
war against terror, but I did not say that; Secretary of State
Colin Powell said that. And it is very wise when a military man
starts talking like that.
There is a connection. We have a situation now--and I have
seen it first-hand myself--where you have children bringing up
children. And we should see Africa as not the front line in the
war against terror, but it might be one day. You take a country
like Nigeria, Nigeria is an oil-wealthy nation. It has 120
million people. It is the whole of west Africa, essentially. In
northern Nigeria every week a new village falls under sharia
law and they are then--we have the madrassas, we have the
schools that teach them to hate us.
So these groups, they take advantage of the chaos, though
in northern Nigeria the chaos is not as great as it is in
southern, in some of the southern African countries. It is an
example, the AIDS orphans is an example of the chaos waiting
for order to be brought to it, either by them or by us. I am
arguing that it is cheaper to prevent the fires than to put
them out later.
Senator Leahy. Oh, I agree with you.
Mrs. Nyamayarwo, like you my wife was trained as a nurse,
and I appreciate our conversations we had before this hearing.
I do not know if I mentioned to you, we traveled to Uganda back
in 1990. We visited a TASO center. We met HIV-positive
volunteers there. In fact, most of the volunteers were HIV-
positive. We were so impressed by their courage, their
selflessness, and the fact they were helping others even though
they were living under a death sentence.
In Uganda, if you could just take that one country, what
has worked best in combatting AIDS? What could you use the
most?
Ms. Nyamayarwo. In Uganda it is not one thing, but first we
have the good leadership of our president who has been open
about HIV and AIDS and accepted to support us. The government
has involved people living with HIV, and people living with HIV
have got the heart to save other people's lives, like the
volunteers in TASO. Myself, after losing my child to AIDS, I
felt I should go out with those volunteers and talk to people,
talk to parents, so that they do not go through what I went
through, because it was very difficult for me, to try to save
lives, go to schools and try to save the youth, to know more
about HIV/AIDS.
I think the education has been very, very important on this
issue. That is why I feel that education is real great. Then
there is one problem which still stands, is the poverty. The
orphans remain vulnerable. It is going to be like a circle, re-
infection, because they do not have the support. Debt
cancellation helps children to go to school just through
primary. They cannot go to secondary schools, they cannot go to
technical institutions. If all that is in place, I think we
shall be able to really fight AIDS in Uganda.
Senator McConnell. Thanks.
Senator Leahy. Thank you very much.
Senator McConnell. Because of the lateness of the hour, we
are going to do one round of questioning and we will have to
submit the others.
Senator DeWine.
Senator DeWine. Mr. Chairman, thank you very much.
Mrs. Nyamayarwo, thank you very much for your very
compelling testimony. We just very, very much appreciate it.
Bono, thank you very much for being with us again. Again,
very compelling testimony as well. You have really been at the
forefront. If you look at the issues that matter, the
Millennium Challenge, you have advocated for that. Debt relief,
that matters so very much. AIDS. All three of those issues, you
have been there. You have been a leader.
Your testimony today I think has been so compelling because
you have talked about AIDS from really a holistic point of
view, that we cannot just look at AIDS separately; we have to
look at it from the point of poverty, we have to look at it
from the point of view of the whole medical system when we go
into these countries that is connected to everything else.
You truly understand this issue. You have done such a good
job, I think, of focusing the public's attention on AIDS. I
would just ask you, as you have gone around, not just in the
United States, but in other countries, what works and what does
not work when you are either addressing people in towns in the
United States or when you are dealing with leaders in other
countries? What is compelling and what is not compelling when
you talk about this issue? What works and what does not work?
And how are we doing with other countries, too?
Bono. I think we need both bilateral and multilateral, is
the truth. But we need them, we need everyone talking together.
What does not work is when we play politics with people's
lives. When everyone can get--when there is a parity of pain
and sort of parity of applause--I think it is important there
are people in other countries who are doing a lot more as a
percentage of their GDP than the United States, and they get
very upset when, just because the United States is giving more
money--they say, well, hold on a second; we are spending a lot
more as a percentage. So that does not work.
I think some humility in saying we have different ways of
doing things, but we want to work together and we are not
trying to score points, that works. I think this is an
opportunity to unite people in a way that there is very little
else out there to. I think you have--what else are President
Chirac, President Bush, and President Blair going to agree on?
This is the one thing they can all hold hands on, and I
think that might be a good symbol right now in the world. Maybe
not holding hands, but--and I think seeing the historic side of
things works. To tell--I know it is an absurd, an Irish rock
star to do this, but to explain that when the dust settles and
when the history books have been written, this entire era will
be remembered for probably three things: the Internet, the war
against terror, and what we did or did not do about this AIDS
virus and what it did, what it did.
It will be astonishing, like your children, like me,
reading about the bubonic plague in the Middle Ages, which took
a third of Europe. A third of Europe died from the bubonic
plague, the Black Death. Now, imagine if China, say, had
treatment at that time that could have saved those lives, but
did not get it out there because, ah, it was a little difficult
and it was expensive. How would we be reading about China now?
That is the position we are in. That is where Europe and
America is right now, and I think it is a great opportunity.
Senator DeWine. Thank you very much.
Thank you, Mr. Chairman.
Senator McConnell. Thank you, Senator DeWine.
Senator Durbin, you are it. After you finish the hearing is
completed except for whatever questions that we may want to
submit. So if you would proceed.
Senator Durbin. That is a lot of pressure, Mr. Chairman.
Senator McConnell. See how short you can be.
Senator Durbin. Well, I thank you very much.
I want to thank our witnesses for your patience in waiting
for us to vote and come back and do other things in an
extremely important session.
Thank you for your leadership. I have told you, Bono, that
you are a consummate pest on Capitol Hill and please keep up
your good work, pestering us to be mindful of the rest of the
world and what we are facing.
It is no, I think, revelation that over the past several
weeks we in America have been embarrassed and ashamed by some
of the disclosures in the world press. The President has said
and we have repeated that what happened in that prison is not
indicative of American values. What I have found interesting in
your tour of Wheaton College and other places in my State was
that time and again you have said that you find us to be a good
and caring people, and as a good and caring people there are
things that we can do to prove that premise.
I find the same thing when it comes to this commitment,
when it comes to global AIDS. You really call on us to do our
best and I think we should and we must.
I would like to ask you specifically on this Global Fund
issue. I am very concerned. If we do not increase the $200
million commitment in this budget to a much higher level, I am
fearful that ongoing projects may be cut back and new ones will
not even be considered. What has been your impression of the
work of Global Fund and if they had to retrench and fall back
the impact it would have on this battle?
Bono. There are some difficulties with the Global Fund
right now, growing pains. I might suggest that some of those
difficulties come out of an environment and a mood where they
just do not want to make a mistake, because they know if they
do make a mistake there is a lot at stake. I actually, I can
understand their caution. They just do not want to screw up,
and I think as a result things have moved a little slowly
there.
However, they have in Richard Feachem a really great
leader. They have in their structure of the organization a
really great design. And I think in a funny way it is a very
American design. It is McKinsey Management. They have a 4
percent overhead. They have auditors in place, PriceWaterhouse,
Stokes Kennedy Crowell, all these people. Where the money is
being spent on the ground, they have cut deals with them to
make sure that these things are being effectively operated.
Is there enough money out the door at the moment? No. But
remember, they cannot--without having the cash in their bank,
they cannot even have the discussion with the groups on the
ground.
The most important message to get out to Americans about
the Global Health Fund is it is not a new bureaucracy. They are
just supplying people in the regions who have effective
programs with more money. They are scaling them up. It is
really important. Some people do not understand that.
So I think they are critical, they are extremely critical,
because President Bush's brilliant AIDS initiative only applies
to 16 countries. So this is the other side. This is the rest of
the world. It has to work. It will work.
I tried to say to them, you know, you are going to make
mistakes; it is wonderful that you are so careful, but actually
you are going to make mistakes; relax just a little bit about
that.
Senator Durbin. If I might ask you one last question. I do
thank the committee for their patience here. People here in the
audience earlier were removed with signs relative to drug
companies and pharmaceutical companies and how much they are
doing. I have heard you say something which is kind of self-
confessional about your own attitude in dealing and working
with pharmaceutical companies and drug companies. Tell us now
what you think is the appropriate approach to make certain that
as quickly as possible affordable medications are in the hands
of the poorest people in the world?
Bono. Okay. Well, let me just say I fully, fully understand
the frustration of my friends behind me who have their hopes
raised when they hear of a $15 billion AIDS initiative and then
have them dashed when they hear that none of the money is going
to go to the cheapest drugs.
What I would say to this issue is we need the
pharmaceutical companies, is the truth. We need their brains,
we need their know-how, we need their scientists. But there is
an opportunity for them here to compete that they have not as
yet made. They could really be heroes of the hour here. We need
them.
I want them involved, and I am not going to ask a business
to behave like a philanthropy. I do not think we should do
that. But make their profits. Sure, make their profits--just
not on the greatest health crisis in 600 years, on the backs of
poor people. I think they do a great business. I am happy for
them to make profit on me, make profit on my friends, make
profit on everyone in this room, in this country, but not on
what is going on in the everyday lives of people like Agnes
here.
So I would say these drugs are a great advertisement for
America. I told President Bush: Paint them red, white, and
blue, you know, whatever. Get them out there. They are the best
of the West.
So that is my own position and I hope that is clear.
Senator Durbin. Thank you, Agnes. Thank you, Bono.
Thank you, Mr. Chairman.
Senator McConnell. Thank you, Senator Durbin.
Thank you, Bono. Thank you, Ms. Nyamayarwo. It is nice of
you to be here and to tell your story. It was very helpful.
ADDITIONAL COMMITTEE QUESTIONS
There will be some additional questions which will be
submitted for your response in the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Mitch McConnell
Question. Voices for Humanity (VFH), a Kentucky-based non-profit,
is slated to receive funding from USAID for a pilot project on HIV/AIDS
education in Nigeria using cutting edge information technology. I
strongly encourage you to follow VFH's efforts in Nigeria.
What importance do you place in using cutting edge information
technology to educate and inform illiterate or semi-literate
populations?
Answer. The unprecedented goals set by the President's Emergency
Plan for AIDS Relief--to provide treatment to 2 million persons living
with HIV, to prevent 7 million new HIV infections, and to provide care
to 10 million people infected and affected by HIV/AIDS, including
orphans and vulnerable children, will require that we actively seek new
approaches to addressing HIV/AIDS, including through the use of cutting
edge information technologies to reach as many people as possible.
The Emergency Plan not only brings hope through the commitment of
extraordinary resources, but, as important, the opportunity to find new
and more effective ways to fight the HIV/AIDS pandemic--our approach
will not be ``business as usual.'' We are committed to implementing
programs that are responsive to local needs--countries and communities
are at different stages of HIV/AIDS response and have unique drivers of
HIV, distinctive social and cultural patterns, and different political
and economic conditions. Effective interventions must be informed by
local circumstances and coordinated with local efforts.
The Office of the U.S. Global AIDS Coordinator has met with
representatives of Voices for Humanity to be briefed on their project
in Nigeria and will be meeting with them again as the project is
implemented.
Question. Faith-based organizations, such as Lott Carey
International (LCI), have decades of experience working overseas and
have cultivated broad contacts among indigenous organizations and
groups.
A. What are your goals and objective for utilizing faith-based
organizations in combating HIV/AIDS?
B. Do you have a recruitment plan or strategy to increase
participation of these groups?
C. How many faith-based organizations currently receive funding for
HIV/AIDS activities--from USAID and your office?
Faith-based and other organizations interested in combating HIV/
AIDS have contacted the Subcommittee to complain that the process for
securing funding under this initiative is NOT user friendly.
D. Are you aware of these difficulties, and what steps can you take
to ensure that the funding process is less bureaucratically cumbersome?
Answer. In implementing the President's Emergency Plan for AIDS
Relief, we have sought to fund a broad range of innovative new
partners, including faith-based and community-based organizations, to
bring not only expanded capacity but also innovative new thinking to
our efforts. Faith-based organizations not only bring expanded capacity
and innovative new thinking to our efforts, but they are also among the
first responders to the international HIV/AIDS pandemic, delivering
much needed care and support for fellow human beings in need. Their
reach, authority, and legitimacy--like other organizations--identifies
them as crucial partners in the fight against HIV/AIDS, and we are
committed to encouraging and strengthening such partners.
Our intent in the initial, first round of grants under the
Emergency Plan has been to move as quickly as possible to bring
immediate relief to those who are suffering the devastation of HIV/
AIDS. The Office of the Global AIDS Coordinator chose programs in the
first round because they have existing operations among the focus
countries of the Emergency Plan, have a proven track record, and have
the capacity to rapidly scale up their operations and begin having an
immediate impact.
By initially concentrating on scaling up existing programs that
have proven experience and measurable track records, an additional
175,000 people living with HIV/AIDS in the 14 initial focus countries
will begin to receive anti-retroviral treatment. Prevention through
abstinence messages will reach about 500,000 additional young people,
and assistance in the care of about 60,000 additional orphans will soon
commence in those same countries.
As of March 30, 2004, we have partnered or sub-partnered with some
45 faith-based organizations. Grants to these organizations total
$57,528,298 thus far, and we are committed to expanding our work with
both new and current faith-based organizations as Emergency Plan
implementation progresses.
We recognize that the windows for applications in our initial
rounds of funding have been relatively quick, and anticipate that
future rounds will allow more time for applicants to prepare and submit
funding proposals.
Question. Repressive regimes that commit widespread human rights--
such as the Burmese junta's policies of rape, forced labor, and use of
child soldiers--have a direct and substantial impact on the general
health of the population.
A. What programs or projects can the Coordinator's office support
to better understand--and mitigate--the impact widespread human rights
violations have on populations, including the failure to prioritize
HIV/AIDS prevention and treatment in places such as Burma, China and
Russia?
B. How can ``political will'' be cultivated in repressive countries
to address the HIV/AIDS pandemic, or to ensure the treatment is
provided on an equitable basis and not only to supporters of a regime,
for example?
Answer. The Emergency Plan for AIDS Relief Emergency Plan is the
largest commitment ever by a single nation toward an international
health care initiative. The vision of the President's Plan embraces a
multifaceted global approach to combating the HIV/AIDS pandemic. Within
this global framework, leadership is a fundamental lever to ensure that
governments respect human rights and appropriately prioritize HIV/AIDS
prevention, treatment, and care.
The mission of the U.S. Office of the Global AIDS Coordinator is to
work with leaders throughout the world to combat HIV/AIDS, promoting
integrated prevention, treatment, and care interventions. While we are
proceeding with an urgent focus on 15 countries that are among the most
afflicted nations of the world, we continue to pursue on going
bilateral programs in more than 100 countries, including Burma, China,
and Russia. Our Five-Year Strategy for the Emergency Plan, released in
February, articulates our goals, including a commitment to encourage
bold leadership nationally at every level to fight HIV/AIDS.
Under the Emergency Plan, USAID's fiscal year 2004 budget for its
South East Asia Regional HIV/AIDS programs includes an additional $1
million for programs in Burma, primarily in Shan and Karen States,
which border China and Thailand. We are committed to ensuring that our
assistance is consistent with our primary objectives of supporting
democracy and improved human rights in Burma. No assistance is being
provided directly to the regime. Our support is channeled though
established international non-governmental organizations, such as
Medicins Sans Frontiers, renowned for their resistance to government
interference. In conjunction with the President's Plan, HHS recently
launched its Global AIDS Program (GAP) in China, the offices of which
HHS Secretary Tommy G. Thompson helped inaugurate in October 2003. In
an unmistakable demonstration of leadership, U.S. Ambassador to China
Clark Randt led the Embassy delegation and attended a ceremony at the
rural village with the first recorded case of AIDS in China. In March
1998, the United States and Russia began collaborating to control the
spread of HIV and other sexually transmitted diseases. Since then, the
United States and Russia have steadily advanced joint programs for HIV/
AIDS prevention and capacity building. At their bilateral summit
meeting in September 2003, Presidents Bush and Putin committed to
reinforce this joint cooperation and coordination. At the just held G-8
Summit in Sea Island, they reaffirmed the U.S.-Russian HIV/AIDS
Cooperation initiative with focus on: prevention, treatment, and care;
surveillance and epidemiology; basic and applied research, including
vaccine development; bilateral policy coordination in Eurasia and with
the Global Fund for AIDS, Tuberculosis, and Malaria; and involving
senior officials in support of public-private partnerships to combat
AIDS. Such leadership at the highest levels underscores the President's
commitment to ensure that all governments pursue appropriate national
strategies to confront the HIV/AIDS pandemic as the global health
emergency it is.
Regarding political will, as noted above, the Emergency Plan places
a high value on leadership to persuade all governments to address the
HIV/AIDS pandemic and to ensure that HIV/AIDS services are provided on
an equitable basis to all comers based on clinical eligibility,
particularly with repressive government. We are committed to encourage
our partners, including multilateral organizations and other host
governments, to coordinate at all levels to strengthen response
efforts, to embrace best practices, to adhere to principles of sound
management, and to harmonize monitoring and evaluation efforts to
ensure the most effective and efficient use of resources.
In the global battle against HIV/AIDS, it is imperative that the
many actors coordinate their efforts and make maximum use of increasing
but still limited resources. To this end, in April, the United States,
through the Office of the Global AIDS Coordinator, was instrumental in
achieving donor government approval for a set of principles dubbed the
``Three Ones'' by UNAIDS. These basic principles, aimed at coordinating
national responses to HIV/AIDS and applicable to all stakeholders
involved in country-level HIV/AIDS, are: one agreed HIV/AIDS Action
Framework that provides the basis for coordinating the work of all
partners; one National AIDS Coordinating Authority, with a broad based
multi-sector mandate; and one agreed country level monitoring and
evaluation system.
The ``Three Ones'' Principles provide a constructive framework for
coordination while permitting individual donors to fulfill their own
program goals and mandates and disburse money to partners in their own
ways, without having any one government or organization claim exclusive
ownership of the coordinating authority. For the Emergency Plan, our
focus worldwide is anchored in care, treatment, and prevention
available to all comers based on clinical eligibility.
Question. On March 9, 2004, Director of Central Intelligence George
Tenet testified that HIV/AIDS continues to endanger social and
political stability, and warned that the virus is gaining a foothold in
the Middle East and North Africa, ``where governments may be lulled
into overconfidence by the protective effects of social and cultural
conservatism''.
Do you agree with the Tenet's assessment that HIV/AIDS is gaining a
foothold in the Middle East and North Africa?
Answer. As it has around the globe, AIDS is certainly gaining a
foothold in the region. Although the Middle East as a region has one of
the lowest rates of HIV/AIDS infection (an estimated 0.3 percent) of
its adult population, even this rate is higher than East Asia and the
Pacific region, and by UNAIDS' estimates the Middle East and Near Asia
has the second-highest rate of increase of HIV after the former Soviet
Union and Eastern Europe. While not a health and social crisis
presently, HIV/AIDS is a growing and potentially serious problem in the
region.
Drug use is on the rise in the Middle East, and in some countries
such as Bahrain and Iran, injecting drug use is the primary cause of
HIV infection. Prevailing social attitudes, cultural norms and
religious tradition limit discussion of premarital sex, homosexuality,
and adultery, all sexual behaviors that contribute to the spread of
HIV/AIDS. Civil society, which in many other regions actively combats
the disease, has not yet taken up the HIV/AIDS problem in the region.
Unsafe medical practices are also a mode of HIV/AIDS transmission in
countries such as Algeria and Iraq.
The underlying vulnerability of the region, therefore, is
significant, especially given rapidly changing social norms in many
countries and exposure to high-risk behaviors for HIV/AIDS
transmission. Poverty and pronounced gender inequality in the region
are also drivers of the epidemic.
While not calling for large-scale interventions or program
investments, the HIV/AIDS situation in the region needs to be closely
monitored. Middle Eastern and North African governments need to be
urged to assess the vulnerability of their own countries and respond
appropriately. Leadership by religious and political leaders at all
levels at this early stage of the epidemic is the most effective means
to ensure that its potential destructiveness is not realized.
Question. AIDS orphans generally do not have access to education in
Africa, which often requires the payment of a school fee.
Do school fees create obstacles to stemming the spread of the
disease by excluding vulnerable segments of the population to both the
traditional ABC's and ``Abstain, Be Faithful, use Condoms''?
Answer. Many children in Africa, particularly those impacted by
HIV/AIDS, are unable to attend school because their families do not
have the resources to pay school fees. This is particularly an issue
for children orphaned due to HIV/AIDS. As part of a comprehensive
assistance package for children affected by AIDS, school fees are
sometimes included. However, it is important to note that school fees
are often only one of several barriers to accessing education, and the
right intervention can only be determined at the local level.
Basic education is the linchpin for success in many of the U.S.
Government's development activities, including family planning, child
health and HIV/AIDS. In order to be successful in the fight against
HIV/AIDS, it is essential that we wrap all of our development programs
around HIV/AIDS programs. We have been working around the world to
integrate AIDS prevention messages into all of the other sectors,
including education.
Question. Given Rotary International's superb work in combating
polio internationally, do you have any plans to use Rotary--and its
networks--to tackle HIV/AIDS, malaria or TB issues?
Answer. In implementing the President's Emergency Plan for AIDS
Relief, we have sought to fund a broad range of innovative new partners
to bring not only expanded capacity but also innovative new thinking to
our efforts. We would welcome the opportunity to consider partnering
with Rotary International in our efforts, especially in countries such
as Kenya with strong local clubs. Health and Human Services Secretary
Tommy G. Thompson traveled with the Chairman of the Rotary
International Foundation, Jim Lacy, to India, Pakistan and Afghanistan
in April 2004, and encouraged him to fund ways for the Foundation and
individual Rotary chapters to engage with the President's Emergency
Plan.
Question. The 2002-2003 outbreak of SARS in Asia highlighted
deficiencies in mounting a concerted international response to a
rapidly spreading disease. In a recent GAO report, delays in the
initial response were attributed to China's reluctance to share
information on SARS or to invite specialists to investigate the
outbreak in a timely manner.
A. With respect to HIV/AIDS, are there particular countries that
are less than willing to provide information or access to international
medical specialists to help stem the spread of the disease?
B. Given that SARS underscored weaknesses in many Asian
governments' disease surveillance systems and public health
capacities--to say nothing of communications systems and effective
leadership--how confident should we be that these same governments are
capable of monitoring HIV/AIDS?
Answer. In Asia, as with other regions of the developing world,
there has been a perceived reluctance on the part of some countries to
share specific information, including numbers of HIV/AIDS cases, issues
relating to safe blood supplies, and other information relating to the
treatment and care of HIV/AIDS patients. There are a number of
political, cultural, economic, and security reasons that influence some
East and Southeast Asian countries to withhold valuable information
during health and environmental crises and fail to seek appropriate
outside assistance. In recent years, the world has increasingly
acknowledged the dire threat that HIV/AIDS poses, not only as a health
crisis, but also as a threat to economic growth, an overwhelming burden
on health care infrastructure, and the potential for undermining
national stability. Recently, there have been positive developments in
Asia demonstrating a new level of political will to meet the challenges
imposed by the pandemic. In addition, the inadequate response to the
SARS epidemic served as an important lesson, particularly for China, on
the consequences of inaction during a health crisis. Since the Severe
Acute Respiratory Syndrome (SARS) emergency, China has significantly
strengthened its political will to openly address the HIV/AIDS
pandemic. China has formed the State Council Working Group on HIV/AIDS,
which includes 21 ministries and has increasingly sought information on
the most effective way to respond to HIV/AIDS, including dialogue on
technical assistance to support the health care sector and health
infrastructure.
With regard to monitoring for HIV/AIDS, along with an increased
level of political will to effectively address HIV/AIDS, many Asian
countries now recognize the importance of significantly improving data
quality. For example, in China, the Global AIDS Program of the U.S.
Department of Health and Human Services has a surveillance component as
part of its technical assistance project in China. This will help the
country develop systems to monitor rates of infection and the impact of
prevention programs. The Chinese government is supportive of this type
of technical assistance, and continues to work with donor countries and
nongovernmental organizations to develop more effective strategies in
the fight against HIV/AIDS.
Question. What weight do you put on efforts to combat malaria--
which kills over 1 million people a year--and what is the role of your
office in anti-malarial efforts of the U.S. Government?
Answer. As you suggest, opportunistic infections, such as
tuberculosis (TB) and malaria, play a fundamental role in the overall
health of HIV infected individuals. Malaria is the most common life-
threatening infection in the world. It is endemic in more than 90
countries, and a child dies every 30 seconds from it, mostly in Africa.
Causing more than one million deaths and 500 million infections
annually, malaria impedes economic development in Africa, Asia, and the
Americas. Because of the annual loss of economic growth caused by
malaria, gross domestic product in endemic African countries is up to
20 percent lower than it would have been if there were no malaria in
the last 15 years.
The Emergency Plan for AIDS Relief, will coordinate and integrate
anti-malarial efforts into HIV/AIDS prevention, care and treatment.
This is especially critical in the context of providing HIV care to
pregnant women. Moreover, the Office of the U.S. Global AIDS
Coordinator is committed to coordinating with the global anti-malarial
activities of both the U.S. Agency for International Development and
the U.S. Department of Health and Human Services.
______
Questions Submitted by Senator Patrick J. Leahy
Question. Do you agree that any faith-based organization that
receives U.S. funds, if it provides information about condoms the
information must be ``medically accurate and include the public health
benefits and failure rates of such use?'' Do grant agreements with
faith-based groups require them to adhere to this requirement, as
Senator Frist and I recommended in a colloquy on the Senate floor? How
do you plan to monitor adherence to the law?
I am told that funding for USAID's commodity fund to purchase
condoms has remained stagnant for several years, despite the steady
increase in HIV infections. Do you plan to spend more on condoms in
fiscal year 2005 than last year, or less?
Answer. In the Acquisition and Assistance Policy Directive dated
February 26, 2004, the U.S. Agency for International Development
mandates that information provided by any organization receiving
funding--including faith-based groups--must be medically accurate.
Specifically, the following wording is now included as a standard
provision of all new agreements, as well as older agreements that add
new funding:
``Information provided about the use of condoms as part of projects
or activities that are funded under this agreement shall be medically
accurate and shall include the public health benefits and failure rates
of such use.''
Organizations not in compliance could be considered in violation of
the terms of their agreement.
The Commodity Fund was established in fiscal year 2002 to remove
financial constraints to the availability of condoms for missions who
wish to make them available as part of their AIDS prevention programs.
The amount allocated for this purpose increased in 2003, and then
remained constant in 2004. Funding decisions have not yet been made for
fiscal year 2005, but the importance of this resource is acknowledged.
Total condom shipments--paid by central and field resources--have
increased significantly from 233 million units in calendar year 2002 to
550 million units expected by final shipment in 2004.
Question. The Administration declined to apply the Mexico City
Policy to HIV/AIDS funds, but there is still confusion in the field
about this. Can you clarify for U.S. officials and foreign NGOs that
there is no legal impediment to supporting a foreign NGO for AIDS
prevention or treatment efforts, even if that organization would be
barred under Mexico City from receiving family planning funds?
Answer. As you note, the Mexico City Policy applies only to
assistance for family planning activities by foreign non-governmental
organizations, not to assistance for HIV/AIDS funding or other health
activities that do not involve assistance for family planning. The
President's extension last year of the Mexico City Policy to State
Department programs expressly did not apply to HIV/AIDS assistance. Any
group, subject to other relevant provisions of U.S. law, will be
eligible to apply for HIV/AIDS funding under the President's Emergency
Plan.
Question. The Statement of Managers accompanying the Fiscal Year
2004 Foreign Operations Act requires you to report back to us by April
1 (60 days after enactment) on how much the Administration will spend
this year on AIDS prevention activities and what amount of that will go
towards ``abstinence until marriage'' programs. As far as I know, the
report has not been submitted, or am I mistaken? When will we get it?
A provision in the United States Leadership Against HIV/AIDS,
Tuberculosis and Malaria Act of 2003 requires that at least one-third
of all global HIV/AIDS prevention funds be set aside for ``abstinence-
until-marriage'' programs. When Senator Feinstein offered an amendment
to the Fiscal Year 2004 Foreign Operations Appropriations bill to
clarify the congressional intent of the provision, you wrote a letter
to Senator McConnell that was read on the Senate floor expressing
opposition on the grounds that it would have restricted the
administration's flexibility and undermined your ability to implement
the full variety of abstinence until marriage approaches.
How exactly do you define an ``abstinence-until-marriage'' program?
Was this definition available during debate on the Fiscal Year 2004
Foreign Operations Appropriations bill? If not, why were you so sure
that Senator Feinstein's amendment would have undermined your ability
to fund the full variety of abstinence until marriage approaches?
If a program is successful in leading to increased abstinence with
a comprehensive message that places a priority, rather than exclusive,
emphasis on abstinence, would it be eligible for funds under the one-
third earmark?
Based on your experience, is it appropriate to devote one-third of
prevention funds to abstinence until marriage programs? If so, what
empirical evidence do you base that on?
Answer. First, the Office of the U.S. Global AIDS Coordinator
apologizes for the delay in submitting the report in question to
Congress. The Office is working on completing the report and submitting
it to Congress within the next several weeks.
Under the Emergency Plan for AIDS Relief, the ``ABC'' model
(Abstinence, Be Faithful, and, when appropriate, correctly and
consistently use of Condoms) will support behavior change for the
prevention of the spread of HIV. The Emergency Plan will balance and
target the application of A, B, and C interventions according to the
needs and specific circumstances of different populations and
individuals.
The success of the ABC model in countries such as Uganda, Zambia,
and Ethiopia, among others, has demonstrated that promoting behavior
change and healthy lifestyles, including abstinence and delayed sexual
initiation, faithfulness and fidelity in marriage and other committed
relationships, reduction in the number of partners, consistent and
correct use of condoms, and avoidance of substance abuse, has been and
can be successful in preventing the spread of HIV/AIDS.
Abstinence-until-marriage programs, as part of a comprehensive
prevention approach, should appeal to the specific needs of specific
groups. For example, in many countries the average age of marriage is
17 or 18. Once married, a message underlining the importance of
faithfulness is more appropriate than an abstinence-only approach that
would be appropriate for unmarried, single, school-age youth. Reliable
data exists to show that youth can and do respond to abstinence-until-
marriage messages and programs, and that delaying sexual activity and
being faithful to one partner is not only protective for young people
but can also have widespread impact on the growth of the HIV/AIDS
pandemic.
As such, under the Emergency Plan for AIDS Relief, abstinence-
until-marriage programs will include two goals:
--Encouraging individuals to be abstinent from sexual activity
outside of marriage as a way to be protected from exposure to
HIV and other sexually transmitted infections (STIs). These
activities or programs will promote the following:
--Importance of abstinence in reducing HIV transmission among
unmarried individuals;
--Decision of unmarried individuals to delay sexual activity until
marriage;
--Development of skills in unmarried individuals for practicing
abstinence; and
--Adoption of social and community norms that support delaying sex
until marriage and that denounce forced sexual activity
among unmarried individuals.
--Encouraging individuals to practice fidelity in sexual
relationships, including marriage, as a way to reduce risk of
exposure to HIV. These activities or programs will promote the
following:
--Importance of faithfulness in reducing the transmission of HIV
among individuals in long-term sexual partnerships,
including marriage;
--Elimination of casual sexual partnerships;
--Development of skills for sustaining marital fidelity, including
the ability to voluntarily seek counseling and testing to
know the serostatus of persons in relationship;
--Endorsement of social and community norms supportive of
refraining from sex outside of marriage, partner reduction,
and marital fidelity using strategies that respect and
respond to local customs and norms; and,
--Diffusion of social and community norms that denounce forced
sexual activity in marriage or long-term partnerships.
Question. The President's Emergency Global AIDS Plan does not
ensure that additional funds will be available for developing safe and
effective microbicides. The plan appears to leave this to the
discretion of HHS and NIH. Yet NIH spends barely 2 percent of its HIV/
AIDS research budget on microbicides.
Given that married women who get infected from their husbands
urgently need options like microbicides, what if anything do you plan
to do to mobilize more funds for this research?
Answer. Microbicides, once successfully developed, will help reduce
the transmission of HIV/AIDS. Under the Emergency Plan, the National
Institutes of Health (NIH) within the U.S. Department of Health and
Human Services (HHS) is pursuing a comprehensive program for
discovering, developing, testing, and evaluating microbicides for HIV
prevention. HHS/NIH is the major federal sponsor of microbicide
research and development. The Emergency Plan provides opportunities for
HHS/NIH to expand its HIV Prevention Trials Network, a worldwide
network of clinical trial sites established to evaluate the high
priority area of safety and efficacy of non-vaccine HIV prevention
interventions such as microbicides. As we use the tools available today
to bring immediate relief to the millions suffering from consequences
of HIV/AIDS, we will continue to pursue strategies, such as
microbicides, that will allow us to make greater strides against this
disease in the future.
We appreciate the concerns voiced by many about the vulnerabilities
of women and girls to HIV/AIDS, including women coerced or forced to
have sex, and who have few options for negotiating sex with their male
partners. There is increasing recognition that women and girls
represent nearly half of all HIV infections worldwide and that the
disease disproportionately affects them in many ways. HHS/NIH supports
an extensive AIDS research portfolio on women and girls. The President
preceded his announcement of the Emergency Plan by his announcement in
June 2002 of his $500 million International Mother-and-Child HIV
Prevention Initiative for Africa and the Caribbean. That initiative,
now part of the Emergency Plan, is intended to treat one million women
annually and reduce mother-to-child transmission of HIV by 40 percent
within five years or less in target countries.
Several U.S. Government agencies, including the U.S. Agency for
International Development (USAID) and the U.S. Department of Health and
Human Services (HHS), are working with women's organizations, public
health groups, and others to define mechanisms to address even better
the gender dimensions of the HIV/AIDS pandemic. For example, USAID is
supporting policy changes, research and interventions that address
issues related to gender and HIV/AIDS and seeks to reduce women and
girls' vulnerabilities to HIV/AIDS. Such activities include public
outreach materials and peer-education programs directed toward men and
boys to address cultural norms about violence and sexual promiscuity;
promotion of abstinence and fidelity; research on issues related to
women's vulnerability, including cross-generational sex, stigma, and
gender-based violence; and identifying and training women's grassroots
organizations to participate in policy making processes regarding HIV/
AIDS.
Question. We have reports of preferential treatment in the
allocation of U.S. funds to ``faith-based'' organizations. We have
heard that in several instances, organizations with little or no
experience in public health; with ideological or religious objections
to offering information about safer sex and condoms; and whose
proposals for funding received low scores under review by technical
experts, nevertheless were given preference for funding over other
organizations with strong technical capability and long-term
experience. Can we get copies of the recent proposals and scores
evaluating organizations that are receiving funding?
What specific guidelines are there to ensure that scientific,
medical, and public health expertise is put above religious or
ideological preferences in the granting of contracts?
Answer. In implementing the President's Emergency Plan for AIDS
Relief, we have sought to fund a broad range of innovative partners,
including host government agencies, non-governmental organizations,
faith-based organizations, networks of persons living with HIV/AIDS and
their families, and U.S. institutions, to bring not only expanded
capacity but also innovative new thinking to our efforts. The Office of
the Global AIDS Coordinator has provide general guidance to U.S.
Government agencies in the field to foster partnerships with a broad
array of organizations, including organizations that minimize
administrative and other costs that do not directly contribute to
prevention, treatment and care for persons in needs. Guidance has also
been provided that a partnering organization should not be required, as
a condition of receiving assistance, to endorse or use a multi-sectoral
approach to combating HIV/AIDS, or to endorse, use, or participate in a
prevention method or treatment program to which the organization has a
religious or moral objection. Neither should any organization advocate
against any other component of the U.S. Government's programs. In
reviewing funding proposals, criteria for the eligibility of
applications include that organizations have a track record of
experience in directly providing or assisting in providing treatment,
care and prevention in the focus countries of the Emergency Plan.
Faith-based organizations were among the first responders to the
international HIV/AIDS pandemic, and deliver much needed care and
support for fellow human beings in need. Their reach, authority, and
legitimacy--like other organizations--identify them as crucial partners
in the fight against HIV/AIDS; we are committed to encouraging and
strengthening such partners. No organization, secular or faith-based,
however, has received preferential treatment in funding on the basis of
its affiliation or background.
Our intent in the initial, first round of grants under the
Emergency Plan has been to move as quickly as possible to bring
immediate relief to those who are suffering the devastation of HIV/
AIDS. The Office of the Global AIDS Coordinator chose programs for
funding in the first round because their recipients have existing
operations among the focus countries of the Emergency Plan, have a
proven track record, and have the capacity to rapidly scale up their
operations and begin having an immediate impact.
By initially concentrating on scaling up existing programs that
have proven experience and measurable track records, an additional
175,000 people living with HIV/AIDS in the 14 initial focus countries
will begin to receive anti-retroviral treatment. Prevention through
abstinence messages will reach about 500,000 additional young people,
and assistance in the care of about 60,000 additional orphans will soon
commence in those same programs.
Regarding copies of proposals and evaluation scores, the Office of
the U.S. Global AIDS Coordinator did not contract directly for these
proposals, but rather worked through our partner U.S. Government
agencies--the U.S. Agency for International Development and the U.S.
Department of Health and Human Services. Each has advised that federal
executive guidelines establish that absent a Committee request (and the
strict protections that are imposed pursuant to such release),
proposals or evaluation materials are not released to Members of
Congress as a matter of course when they contain (1) proprietary
business confidential or ``competitively useful'' information and (2)
protectable deliberative process and privacy information that might be
publicly disclosed pursuant to such release. Please see, by reference,
Federal Acquisition Regulation 5.403 and . Both HHS and USAID, however, have
expressed their willingness to release, on an expedited basis, the
requested Request for Applications (RFA), which include the evaluation
criteria, and any actual awards that have been made, such awards being
appropriately redacted to reflect business proprietary or privacy
concerns.
Question. Our law requires recipients of U.S. funds to have a
policy opposing prostitution and sex trafficking. However, Senator
Frist and I made clear in a colloquy that this requirement would be
satisfied if the grant agreement for United States funding states that
the grantee opposes prostitution and sex trafficking, rather than by
requiring the grantee to have an explicit policy to that effect. Is
that colloquy being followed, both with respect to United States and
foreign organizations?
Answer. As you note, Section 301(f) of the United States Leadership
Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (Public Law
108-25) states that ``No funds made available to carry out this Act, or
any amendment made by this Act, may be used to provide assistance to
any group or organization that does not have a policy explicitly
opposing prostitution and sex trafficking.'' Also of note is Section
301(e), which expressly prohibits funds from being used to promote or
advocate the legalization or practice of prostitution or sex
trafficking; yet does allow for the provision of HIV/AIDS prevention,
treatment and care services to victims of prostitution or sex
trafficking.
Proper implementation of these two provisions is critical, and the
Office of the U.S. Global AIDS Coordinator intends to implement the law
consistent with the U.S. Government's opposition to prostitution and
related activities, especially those that contribute to trafficking in
persons. To this end, Congress's views, including the legislative
history, report language and floor statements, have been informative
and helpful.
To ensure that the relevant provisions of Public Law 108-25 are
met, both the U.S. Department of Health and Human Services (HHS) and
the U.S. Agency for International Development (USAID) require that
primary grantees affirmatively certify their compliance with the
applicable restrictions regarding prostitution and related activities
prior to the receipt of any federal funds.
In addition, under the Emergency Plan, HHS and USAID are including
the limitation on funds expressed in Section 301(e) in HIV/AIDS funded
grants and requiring that primary recipients include the funding
limitation in all subagreements. USAID is applying this same process
for all HIV/AIDS funded contracts.
Regarding the implementation of Section 301(f), the Office of Legal
Counsel (OLC) in the U.S. Department of Justice is considering the
constitutional implications of the funding restrictions of Public Law
108-25, particularly Section 301(f). In provisional advice, OLC
determined that Section 301(f) can only be constitutionally applied to
foreign organizations when they are engaged in activities outside of
the United States.
Currently, HHS and USAID are including the Section 301(f)
limitation in their international HIV/AIDS funded grants, cooperative
agreements, contracts and subagreements with foreign organizations. If
a U.S. organization is the primary recipient of funds, they must
include the Section 301(f) limitation in any subagreement with a
foreign organization, as well as ensure, through contract,
certification, audit, and/or any other necessary means, that the
foreign organization complies with the limitation.
In addition, the Fiscal Year 2004 Foreign Operations, Export
Financing and Related Programs Appropriations Act amends Section 301(f)
of Public Law 108-25 by exempting the Global Fund to Fight AIDS,
Tuberculosis and Malaria (Global Fund), the World Health Organization
(WHO), the International AIDS Vaccine Initiative (IAVI) and United
Nations agencies from that section. Awards to these organizations
include the limitation on funds expressed in Section 301(e).
Question. Ambassador Tobias, you have said that the fact that less
than 7 percent of women used a condom in their last sex act with their
main partner and that less than 50 percent of women have used a condom
with casual parters shows that condom are not effective. Would you also
say that the low abstinence rates that exist in many countries show
that abstinence promotion is not effective in the general population
and should therefore be abandoned?
Answer. Under the President's Emergency Plan for AIDS Relief,
policy decisions will be evidence-based and will build on the best
practices established in the fight against HIV/AIDS. I am committed to
bringing the resources of sound science to bear in selecting and
developing interventions that achieve real results. Determining which
approach is best will depend upon numerous variables, including local
needs and circumstances. The Office of the U.S. Global AIDS Coordinator
will promote the proper application of the ABC approach through
population-specific interventions that emphasize abstinence for youth,
including the delay of sexual debut, fidelity for sexually active
couples, and correct and consistent use of condoms by persons engaging
in behaviors that put them at increased risk for HIV transmission. The
success of the ABC model in countries such as Uganda, Zambia, and
Ethiopia, among others, has demonstrated that promoting behavior change
and healthy lifestyles, including abstinence and delayed sexual
initiation, faithfulness and fidelity in marriage and other committed
relationships, reduction in the number of partners, and consistent and
correct use of condoms, has been and can be successful in preventing
the spread of HIV/AIDS. Under the Emergency Plan, abstinence-until-
marriage programs will have two goals: (1) Encouraging individuals to
be abstinent from sexual activity outside of marriage, and (2)
Encouraging individuals to practice fidelity in sexual relationships,
including marriage, as ways to reduce risk of exposure to HIV and other
sexually transmitted infections (STIs).
Abstinence from sexual intercourse or maintaining a mutually
faithful long-term relationship between partners known to be uninfected
is the surest way to avoid transmission of HIV and other sexually
transmitted infections (STIs). Outside of those conditions, condoms
have been an important and successful intervention in many places,
particularly when made available in commercial and other casual sexual
encounters, areas of high prevalence, or amongst those who do not know
their serostatus. While no barrier method is 100 percent effective,
correct and consistent use of latex condoms can reduce the risk of
transmission of HIV by about 90 percent. The body of research on the
effectiveness of latex condoms in reducing sexual transmission of HIV
is both comprehensive and conclusive--if they are used correctly and
consistently. Certainly, in many of the Emergency Plan focus countries,
gender inequities and other issues may impact whether or not people can
and will use condoms. However, part of our role in these countries will
be to facilitate a shift in cultural norms around HIV prevention
behaviors--abstinence, being faithful, and when necessary correct and
consistent condom use. When cultural norms shift and prevention
mechanism is available, great changes can occur. For example, Thailand
slowed its explosive HIV epidemic by promoting ``100 percent condom''
use in brothels but at the same time discouraging men from visiting
prostitutes. As a result of this policy and an accompanying public
information campaign, as well as improved STI treatment services,
condom use among sex workers increased to more than 90 percent,
reported visits to sex workers by men declined by about half, HIV
infection rates among military recruits decreased by about half, and
the cases of five other STIs decreased by nearly 80 percent among
brothel workers. Given the evidence around condom effectiveness, condom
use programs the Emergency Plan supports will be leveraged across a
range of situations in which those persons at increased risk for
becoming infected by or for transmitting HIV will have access to them,
and will include communication components to encourage responsible
behavior.
______
Questions Submitted by Senator Barbara A. Mikulski
Question. PEPFAR only covers 14 countries in Africa and the
Caribbean. Other regions such as Eastern Europe, Latin America and Asia
are left behind. Reports indicate that although Africa and the
Caribbean have the largest rates of infection presently, however if
left unaddressed, countries like China and India, with their large
populations will easily overtake Africa in number of infections. For
example, estimates show that by 2010, the number of HIV infections in
India is predicted to rise from 4 million to 20-25 million, the current
number of infections on the entire continent of Africa.
How are we looking to the future and addressing the emerging
threats in other parts of the world?
Answer. The vision of the President's Emergency Plan is to turn the
tide of HIV/AIDS. Recognizing that HIV is a virus that knows no
borders, the Emergency Plan continues to support strengthened
programming across the world in order to achieve this vision. The
President's Emergency Plan includes nearly $5 billion to support on-
going bilateral HIV/AIDS programs in approximately 100 countries
worldwide.
Question. In 2003, 58 percent of the 26.6 million people living
with HIV/AIDS in sub-Saharan Africa were women. Young women between the
ages of 15-24 in Africa and the Caribbean are 2.5 times more likely to
have HIV than young men and teenage women are 5 times as likely. The
vast majority of these women are identified as having only one mode of
exposure to HIV--sex with their husbands.
Given that most sexually transmitted HIV infections in females
occur either inside marriage or in relationships women believe to be
monogamous, what targeted and appropriate prevention policy do we have
that addresses this most vulnerable segment of the population?
Answer. I share your concerns about the vulnerabilities of young
women to HIV/AIDS. Targeted and appropriate prevention strategies to
address the vulnerability of women to exposure to HIV are integral to
the President's Emergency Plan. The U.S. Five Year Global HIV/AIDS
Strategy includes not only preventing seven million infections in some
of the most afflicted countries in the world, but also continues
bilateral, regional and multilateral efforts to prevent new infections.
Limitations in human resources and sites able to provide PMTCT are
major impediments to implementing national PMTCT programs. The
President's Mother and Child Initiative, now folded into the Emergency
Plan.focused on the need to develop capacity to effectively scale-up
programs. Through the President's International Mother and Child HIV
Prevention Initiative and the Emergency Plan for AIDS Relief, the U.S.
Government provided $143 million for PMTCT activities and programs from
October 1, 2002, to March 31, 2004. As a result, 14,700 health workers
received training in the provision of PMTCT services and 900 health
facilities received financial and technical support, which enabled the
provision of a minimum package of PMTCT care, including (1) voluntary
counseling and testing for pregnant women, (2) anti-retroviral
prophylaxis to HIV-infected women to prevent HIV transmission, (3)
counseling and support for safe infant-feeding practices, and (4)
voluntary family planning counseling and referral. The focus on
training and developing sites for PMTCT lays the foundation for
scaling-up national programs, thus making a substantial step towards
the Emergency Plan goal of averting seven million new HIV infections.
Moreover, reaching women during pregnancy provides a critical
opportunity for those who test negative to receive counseling to avoid
infection.
PMTCT centers also foster and build healthy families by offering
counseling and testing for expectant fathers. For example, the U.S.
Government and the Elisabeth Glaser Pediatric AIDS Foundation support
the Masaka Health Center in Rwanda. It has developed unique program to
encourage couples to participate jointly in pre-natal care and
subsequently HIV testing. A personalized written invitation is prepared
in the local language (Kinyarwanda) for all women who participate in
pre-natal care at the center and agree to be tested for HIV after
counseling. They are invited to return with their partner the following
weekend for a special session. This approach has resulted in a 74
percent HIV testing rate for male partners at Masaka, as compared to 13
percent for 12 other sites in the same program. Based on the success of
this approach, the Foundation intends to introduce this concept to its
other sites as part of an overall initiative to increase partner
testing.
Under the Emergency Plan, we also foster approaches that recognize
father/husband have a role to play as far as violence and HIV
prevention are concerned. In Soweto, South Africa a PMTCT unit employed
six counselors in 2003, one of whom one was an HIV-positive male who
lost his baby son to HIV/AIDS. This counselor helped men talk about
their disease and its consequences.
The Emergency Plan also supports activities to stimulate male
involvement in HIV/AIDS prevention efforts. On March 27, 2004, a
Solidarity Center in South Africa supported by the Emergency Plan
organized a ``Men as Partners'' and voluntary counseling and testing
(VCT) day for various workers unions in the community. The daylong
program was designed to get men involved in preventing HIV transmission
and violence against women.
Increasingly, young women and men who are sexually active are
committing to a monogamous relationship. The President's Emergency Plan
Strategy supports comprehensive and effective prevention approaches
that reflect the complex influences on young people's decision-making
and the need to address the broader social factors that shape their
behaviors. Internationally, a number of programs have proven successful
in increasing abstinence until marriage, delaying first sex, reducing
the number of partners, and achieving ``secondary abstinence'' among
sexually experienced youth.
The Emergency Plan recognizes several categories of activities as
part of its rapid scale-up of prevention programs for young adults:
Scale up skills-based HIV education, especially for younger youth
and girls.--We need to reach young people early, before they begin
having sex, with skills-based HIV education that provides focused
messages about the benefits of abstinence until marriage and other safe
behaviors. Best practices suggest that curricula that target specific
risk factors for early sexual activity in the local context, delivered
through interactive methods that help young people clarify values,
build communication skills and personalize risk are most effective.
Ideally, programs go beyond sexuality to build on young people's assets
of character and encourage them to stay in school and plan for their
futures.
Broad social discourse on safer norms and behaviors.--Communities
need to mobilize to address the norms, attitudes, values, and behaviors
that increase vulnerability to HIV, including multiple casual sex
partners and cross-generational and transactional sex. The Emergency
Plan supports groups that seek to generate public discussion about
harmful social and sexual behaviors through a variety of media and
other activities, at both the community and national levels.
Reinforcement of the role of parents and other protective
factors.--Parents are potentially the most powerful protective factors
in young people's lives; they have great potential to guide youth
toward healthy and responsible decision-making and safer behaviors. In
Emergency Plan countries, where many youth have lost their parents to
AIDS, other adult caregivers and mentors also have an important role to
play in providing guidance to youth. The Emergency Plan will support
efforts to reach out to parents and other adult caregivers to educate
and involve them in issues relating to youth and HIV and to empower
them by improving their communication skills in the areas of sexuality
as well as broader limit-setting and mentoring.
Address sexual coercion and exploitation of young people.--
Adolescents need a safe environment where they can grow and develop
without fear of forced or unwanted sex, which often precludes the
option of abstinence. The Emergency Plan supports psychosocial and
other assistance for victims of sexual abuse. The Emergency Plan also
supports efforts to target men with messages that challenge norms about
masculinity and emphasize the need to stop sexual violence and
coercion.
In sum, the President's Plan recognizes that prevention is a
continuum in which all members of the community the young and the
mature, girls and women, and boys and men must be meaningfully engaged
to prevent the spread of HIV/AIDS.
Question. There are currently 14 million people co-infected with TB
and HIV. TB is the leading killer worldwide of people who die of AIDS,
responsible for one third of all AIDS deaths. Fewer than half of those
with HIV who are sick with TB in the 14 countries targeted in PEPFAR
have access to TB treatment.
How does the PEPFAR initiative address the issue of TB co-
infection?
Answer. The Office of the U.S. Global AIDS Coordinator is committed
to the appropriate coordination, integration and support of
tuberculosis (TB) and HIV/AIDS services and programs. As you are aware,
opportunistic infections, such as TB and malaria, play a fundamental
role in the overall health of HIV infected individuals. TB is
frequently the first manifestation of HIV/AIDS disease, the reason many
people first present themselves for medical care, and the leading
killer of people with HIV/AIDS.
Since both tuberculosis treatment and HIV/AIDS treatment require
longitudinal care and follow-up, successful TB programs provide
excellent platforms upon which to build capacity for HIV/AIDS
treatment. The Emergency Plan for AIDS Relief will support TB treatment
for those who are HIV-infected and develop HIV treatment capacity in TB
programs. In addition, interventions that increase the number of
persons diagnosed and treated for HIV/AIDS will increase the need for
TB treatment and care. Therefore, action is required to build or
maintain necessary tuberculosis treatment capacity. For example,
laboratories, clinical staff, community networks, and management
structures used for TB control can be upgraded to accommodate HIV/AIDS
treatment. Finally, because the prevalence of HIV infection is high
among persons with tuberculosis, TB programs will be important sites
for HIV testing in the focus countries, and the Emergency Plan will
work toward ensuring the availability of TB testing in HIV testing,
treatment and care sites.
Question. The Global Fund to Fight AIDS, TB and Malaria
specifically addresses co-infection issues has seen a cut in funding.
How can you justify this?
Answer. The President's Emergency Plan for AIDS Relief made a
pledge of $200 million each year for the five-year period of 2004-2008.
Our fiscal year 2005 request therefore remains the same as our request
in fiscal year 2004. We were the first donor to make such a long-term
pledge of support to the Global Fund, which together with our previous
donations to the Fund still represents nearly 40 percent of all pledges
and contributions through 2008.
The American people can be extremely proud of our record of support
for the Global Fund, which is an integral part of the Emergency Plan
for AIDS Relief. When the United States contributes to a project of the
Global Fund, it means that our dollars are leveraged in these grants by
a factor of two, since the United States thus far has provided one-
third of all Fund monies. The Fund has so far committed $2.1 billion to
224 grants in 121 countries and three territories. So it is in our
interests, as well as the interest of all people struggling against
HIV/AIDS, malaria and tuberculosis, to see to it that the Global Fund
is an effective partner in the fight against these diseases.
The Global Fund nevertheless is a relatively new organization,
particularly in comparison to the 20 years of bilateral HIV/AIDS
programs carried out by the United States and other bilateral donors.
As of May 15, 2004, the Global Fund had disbursed approximately $311
million since the Global Fund's Board approved its first round of
funding in January 2002. This compares to the first $350 million under
the President's Emergency Plan sent to our focus countries only three
weeks after the program first received its funding.
This is not to criticize the Global Fund for being slow--indeed,
the United States is one of the donors that has been urging the Global
Fund to move carefully to ensure accountability and avoid waste. It
does highlight, however, the potential effectiveness of bilateral
assistance where donors already have an in-country presence.
We need both multilateral and bilateral avenues of assistance;
neither the Global Fund nor bilateral donors can do it all. Other
bilateral donors also need to step up with greater technical assistance
to Global Fund projects, without which those projects will founder.
In addition, the United States believes that in order for funds to
be effectively and efficiently disbursed, Country Coordinating
Mechanisms (CCMs) and Local Fund Agents (LFAs) must actively engage in
overseeing the implementation of grant activities. The United States
would like to see, in particular, a stronger representation of the
private sector, non-governmental organizations, and people living with
the diseases on CCMs, largely chaired now by government ministries.
Engaging a broader representation of various stakeholders will help
reduce potential acts of corruption and will allow for a wider
distribution of funds to serve more individuals in need.
The Global Fund has already announced, in advance of the June Board
meeting, that Round Four proposals approved by the Technical Review
Panel will not exceed the cash already on-hand, so that, at least
through this Round, no funding gap exists. And we, along with other
donors, believe that as a new organization, the Global Fund should not
press its current capacity too far, and our position is that Round Five
should not occur until late 2005 and Round Six no earlier than the
following year. The Fund's first projects will not come up for review
and possible renewal until August 2004, and we will have a better sense
at that time of its performance record and future needs.
Question. On April 6, 2004, the Global Fund to Fight AIDS, TB and
Malaria, the World Bank, UNICEF and the Clinton Foundation brokered a
deal to announce that high quality AIDS medicines would be available
for prices 50 percent less than currently available.
Will the President's initiative take advantage of these of these
options?
Answer. It has always been our policy to provide, through the
Emergency Plan, drugs that are acquired at the lowest possible cost,
regardless of origin or who produces them, as long as we know they are
safe, effective, and of high quality. These drugs could include brand-
name products, generics or copies of brand-name products.
Our commitment from the beginning has been to move with urgency to
help build the human and physical capacity needed to deliver this
treatment, and to fund the purchase of HIV/AIDS drugs to provide this
treatment at the most cost-effective prices we can find--but only drugs
we can assure ourselves are safe and effective. The people we are
serving deserve the same assurances of safety and efficacy that we
expect for our own families here in the United States. There should not
be a double standard for quality and safety.
On May 16, Health and Human Services (HHS) Secretary Tommy G.
Thompson and U.S. Global AIDS Coordinator Ambassador Randall L. Tobias
held a joint press conference in Geneva, Switzerland, in advance of the
World Health Assembly. Secretary Thompson and Ambassador Tobias made
two very important announcements on these issues.
First, Secretary Thompson announced an expedited process for HHS,
through its Food and Drug Administration (FDA), to review applications
for HIV/AIDS drug products that combine already-approved individual
HIV/AIDS therapies into a single dosage, often referred to as ``fixed-
dose combinations'' (FDCs), and for co-packaged products, often
referred to as ``blister packs.'' Drugs approved by HHS/FDA under this
process will meet all normal HHS/FDA standards for drug safety,
efficacy, and quality.
This new HHS/FDA process will include the review of applications
from research-based companies that have developed already-approved
individual therapies, or from companies that are manufacturing copies
of those drugs for sale in developing nations. There are no true
generic versions of these HIV/AIDS drugs because they all remain under
intellectual property protection here in the United States. The steps
taken by HHS/FDA could encourage the development of new and better
therapies to help win the war against HIV/AIDS.
Second, Ambassador Tobias announced that when a new combination
drug for HIV/AIDS treatment receives a positive outcome under this
expedited HHS/FDA review, the Office of the U.S. Global AIDS
Coordinator will recognize that evaluation as evidence of the safety
and efficacy of that drug. Thus the drug will be eligible to be a
candidate for funding by the Emergency Plan for AIDS Relief, so long as
international patent agreements and local government policies allow
their purchase. Where it is necessary and appropriate to do so,
Ambassador Tobias will also use his authority to waive the ``Buy
American'' requirements that might normally apply.
We hope HHS/FDA will receive applications as soon as possible from
many companies that will want their drugs to be candidates for use in
the treatment programs of the President's Emergency Plan.
Because of the President's Emergency Plan for AIDS Relief, and with
the partnerships between the Emergency Plan and those individuals and
organizations who are delivering treatment on the ground, we expect to
increase the number of HIV-infected persons who are receiving treatment
in our 14 focus countries by approximately 175,000. Today, patients are
receiving treatment in Kenya and Uganda because of the Emergency Plan,
and I expect that as we and others scale up our efforts, millions of
more people will follow those who are already receiving this life-
extending therapy.
Finally, we note that the most limiting factor in providing HIV/
AIDS treatment is not drugs--it is the human and physical capacity in
the health care systems in the countries we are seeking to assist. Many
countries are desperately short of health care infrastructure and
health care workers. Both are needed to deliver treatment broadly and
effectively. We are focused on addressing this limitation as well.
______
Questions Submitted by Senator Richard J. Durbin
Question. Mr. Ambassador, I would like to get clarification on the
Administration's position on contributions to the Global Fund for 2005.
The President's 2005 budget provides only $200 million for the
Global Fund in 2005. This is less than half of the $547 million
Congress provided in 2004 and far less than the most conservative
estimate of Global Fund need from the United States for 2005 of $1.2
billion. The Global Fund is a critical partner in the 14 countries that
are part of the President's Emergency Plan for AIDS Relief (PEPFAR) and
is needed in all the other countries that PEPFAR won't reach (the
Global Fund currently has grants in 122 countries). The Global Fund is
currently the most important new funder of TB and malaria, as well as
AIDS programs, globally.
(1) Mr. Ambassador, can you justify the President's $200 million
request for the Global Fund in 2005, explaining why this amount is
sufficient when it represents only 37 percent of what was appropriated
for the Global Fund for 2004, only 24 percent of what the Global Fund
has already raised for 2005, and only 6 percent of what the Global Fund
will need in 2005 if it approves two rounds for that year?
(2) Why has the Administration proposed such severe cuts to the
Global Fund?
(3) How can we provide leadership to the Fund while providing only
$200 million, only six percent? $200 million isn't even a third of
what's needed to keep existing programs running--that would be around
$530m.
(4) How will the Global Fund be able to renew existing grant awards
from Rounds 1-3 and be able to award grants in Rounds 5 and 6 to the
many countries left out of your 14 country initiative, yet equally
needy?
(5) Will you support funding the Global Fund at a level of $1.2
billion to meet its 2005 need?
Answer. The President's Emergency Plan for AIDS Relief made a $200
million per year commitment of pledges for the five-year period of
2004-2008. Our fiscal year 2005 request therefore remains the same as
our request in fiscal year 2004. We were the first donor to make such a
long-term pledge of support to the Global Fund, which together with our
previous donations to the Fund still represents nearly 40 percent of
all pledges and contributions through 2008.
The American people can be extremely proud of our record of support
for the Global Fund, which is an integral part of the Emergency Plan
for AIDS Relief. As you note, we cannot make every country a focus
country, and there are other nations equally needy. When the United
States contributes to a project of the Global Fund, it means that our
dollars are leveraged in these grants by a factor of two, since the
United States thus far has provided one-third of all Fund monies. The
Fund has so far committed $2.1 billion to 224 grants in 121 countries
and three territories. So it is in our interests, as well as the
interest of all people struggling against HIV/AIDS, malaria and
tuberculosis, to see to it that the Global Fund is an effective partner
in the fight against these diseases.
The Global Fund nevertheless is a relatively new organization,
particularly in comparison to the 20 years of bilateral HIV/AIDS
programs carried out by the United States and other bilateral donors.
Like all new organizations, it is quite understandably undergoing some
growing pains. As of May 15, 2004, the Global Fund had disbursed
approximately $311 million to Principal Recipients since the Global
Fund's Board approved its first round of funding in January 2002. This
compares to the first $350 million under the President's Emergency Plan
sent to our focus countries only three weeks after the program first
received its funding.
This is not to criticize the Global Fund for being slow--indeed,
the United States is one of the donors that has been urging the Global
Fund to move carefully to ensure accountability and avoid waste. It
does highlight, however, the potential effectiveness of bilateral
assistance where donors already have an in-country presence.
We need both multilateral and bilateral avenues of assistance;
neither the Global Fund nor bilateral donors can do it all. Other
bilateral donors also need to step up with greater technical assistance
to Global Fund projects, since without which those projects will
founder.
In addition, the United States believes that to disburse funds
effectively and efficiently, Country Coordinating Mechanisms (CCMs) and
Local Fund Agents (LFAs) must get actively engaged in overseeing the
implementation of grant activities. The United States in particular
would like to see a stronger representation of the private sector, non-
governmental organizations, and people living with the diseases on
CCMs, which are largely (approximately 85 percent) chaired by
government ministries. Engaging a broader representation of various
stakeholders will help reduce potential acts of corruption, and will
allow for a wider distribution of funds so that more individuals in
need can be served.
The Global Fund has already announced, in advance of the June Board
meeting, that the two-year budgets of Round Four proposals recommended
by the independent Technical Review Panel will not exceed the cash
already on-hand, so that, at least through this Round, no funding gap
exists. And we, along with other donors, believe that as a new
organization, it might be best for the Global Fund not to press its
current capacity too far, and our position is that Round Five should
not occur until late 2005 and Round Six no earlier than the following
year. The Global Fund's first projects will not come up for review and
possible renewal until August 2004, and we will have a better sense at
that time of its performance record and future financial needs.
Question. Ambassador Tobias, tuberculosis is the greatest curable
infectious killer on the planet and the biggest killer of people with
HIV. Treating TB in people with HIV can extend their lives from weeks
to years. I am very concerned that the President's 2005 budget actually
cuts TB and malaria funding by some $46 million. And the President's
AIDS initiative fails to focus on expanding TB treatment as the most
important thing we can do right now to keep people with AIDS alive and
the best way to identify those with AIDS who are candidates for anti-
retroviral drugs.
I was just in India where TB is a currently far greater problem
than HIV--though AIDS is rapidly catching up--and a new WHO report has
shown that parts of the former Soviet Union and Eastern Europe have
rates of dangerous drug resistant TB 10 TIMES the global average! TB
rates have skyrocketed in Africa in conjunction with HIV, and yet only
one in three people with HIV in Africa who are sick with TB even have
access to basic life-saving TB treatment. We are missing the boat on
this issue--at our own risk! The cuts in TB funding are short-sighted
and I think TB efforts should be expanded.
(6) Make it a priority to expand access to TB treatment for all HIV
patients with TB and link TB programs to voluntary counseling and
testing for HIV.
(7) Push to expand overall funding to fight TB to our fair share of
the global effort? (The United States is currently investing about $175
million in TB from all sources, including our contribution to the
Global Fund.)
(8) Consider appointing a high-level person in your office to be
the point person for TB efforts?
Answer. The Office of the U.S. Global AIDS Coordinator is committed
to the appropriate coordination, integration and support of
tuberculosis (TB) and HIV/AIDS services and programs across the U.S.
Government. As you are aware, opportunistic infections, such as TB and
malaria, are great risks to the overall health of HIV-infected
individuals. TB is frequently the first manifestation of HIV/AIDS
disease, the reason many people first present themselves for medical
care, and the leading killer of people with HIV/AIDS.
Since both tuberculosis treatment and HIV/AIDS treatment require
longitudinal care and follow-up, successful TB programs provide
excellent platforms upon which to build capacity for HIV/AIDS
treatment. The Emergency Plan will improve referral for TB patients to
HIV testing and care, support TB treatment for those who are HIV-
infected and develop HIV treatment capacity in TB programs. In
addition, interventions that increase the number of persons diagnosed
and treated for HIV/AIDS will increase the need for TB treatment and
care. Therefore, action is required to build or maintain necessary
tuberculosis treatment capacity. For example, laboratories, clinical
staff, community networks, and management structures used for TB
control can be upgraded to accommodate HIV/AIDS treatment. Finally,
because the prevalence of HIV infection is high among persons with
tuberculosis, TB programs will be important sites for HIV testing in
the focus countries as well as ensuring that TB testing is available in
HIV testing, treatment and care sites.
Finally, the Office of the U.S. Global AIDS Coordinator will take
into consideration your suggestion for identifying an individual within
the Office of the Coordinator to have specific responsibilities related
to coordinating TB and HIV/AIDS efforts.
Question. Ambassador Tobias, in September 2002, the National
Intelligence Council released a report that identified India, China,
Nigeria, Ethiopia and Russia, countries with large populations and of
strategic interest to the US, as the ``next wave'' where HIV is
spreading rapidly. India already contains one-third of the global TB
burden, and because AIDS fuels TB, TB rates will also skyrocket as AIDS
spreads.
(9) Congress mandated a 15th country be included as a part of the
President's AIDS Initiative. The PEPFAR strategy report stated that
this 15th country will be named shortly. When will you make a decision?
Do you know what country this will be?
(10) What consideration is being given to including India as the
15th country, given the large number of HIV cases already present, the
growing HIV problem that is likely to become a more generalized
epidemic and India's strategic importance?
India also has a remarkable TB program that has expanded over 40
fold in the last 5 years, and treated 3 million patients and trained
300,000 health workers. I would suggest that India's TB program has
important lessons for scale-up of AIDS treatment programs in India and
globally and we should support it and use it as a model.
Answer. Consultations regarding the selection of a 15th country
have been underway. As a first step, the U.S. Global AIDS Coordinator
has consulted with senior officials within the Administration,
including at the U.S. Agency for International Development (USAID), the
U.S. Department of Health and Human Services (HHS), and the U.S.
Department of State, about possible candidate countries for the 15th
focus country. From this consultative process, the Coordinator's Office
has identified the following list of 39 countries by one or more of the
agencies named above as a potential candidate for the 15th focus
country.
emergency plan for aids relief 15th focus country--initial candidate
countries
Albania, Armenia, Azerbaijan, Bangladesh, Belarus, Bolivia, Brazil,
Burma, Cambodia, China, Croatia, Egypt, El Salvador, Estonia, Georgia,
Guatemala, Honduras, India, Indonesia, Jordan, Kazakhstan, Kyrgystan,
Latvia, Lithuania, Macedonia, Mexico, Moldova, Nepal, Nicaragua, Peru,
Philippines, Romania, Russia, Tajikistan, Thailand, Turkmenistan,
Ukraine, Uzbekistan, and Vietnam.
Currently, these countries are being considered in the context of
the 10 standards listed below. These considerations provide a basis for
comparative analysis and discussion regarding the potential candidates.
It is important to note that these do not represent weighted criteria
against which Ambassador Tobias will quantitatively evaluate to
recommend one to the President. We do not expect that any one country
will excel in all areas; instead, Ambassador Tobias and his staff are
evaluating each country for its collective strengths and weaknesses.
--Severity and Magnitude of the Epidemic.--The prevalence rate, the
rate of increase in HIV infection, and the total number of
people living with HIV/AIDS.
--Commitment of Host-Country Government.--The basis of leadership's
willingness to address HIV/AIDS and stigma and its desire to
partner in an amplified response.
--Host-Country commitment of resource potential.--The degree to which
the host government has the capacity and the determination to
make trade-offs among national priorities and resources to
combat HIV/AIDS.
--Enabling Environment.--The level of corruption, stigma, free press,
state of government bureaucracies and the strength of bilateral
partnerships, all of which help determine whether we can use
Emergency Plan resources effectively.
--U.S. Government In-country Presence.--Whether the country has a
strong U.S. Government bilateral in-country presence through
USAID and/or HHS.
--Applicability of Emergency Plan Approaches.--Whether modes of
transmission of HIV/AIDS in the host country are receptive to
Emergency Plan interventions.
--Potential Impact of Emergency Plan Interventions.--How many people
we can reach and the effect of intervention on the trajectory
of disease.
--Gaps in Response.--Whether the U.S. Government's technical
expertise, training, development and strengthening of health
care systems and infrastructure would fill gaps in the current
response.
--Existence of Other Partners.--Whether non-governmental
organizations and other partners have a substantial in-country
presence and can facilitate rapid expansion of services and the
efficient use of funds.
--U.S. Strategic Interests.--The Emergency Plan is ultimately a
humanitarian endeavor. At the same time, applicability of U.S.
strategic interests could further the sustainability of
programming, engender new sources of support, and offer
increased opportunities for partnerships.
With regard to India, it is among the potential candidates for the
15th focus country. As you know, India has the second-largest
population of HIV-infected persons in the world, second only to South
Africa. Regardless of its selection as a 15th focus country, an
amplified response is necessary to stem the potential for a generalized
epidemic that would greatly increase India's HIV/AIDS burden. India has
a well-developed national strategic plan to address HIV/AIDS and a
comparatively large pool of health professionals to assist in its
implementation.
In addition, the Emergency Plan for AIDS Relief includes nearly $5
billion to support on-going bilateral HIV/AIDS programs in
approximately 100 countries worldwide, including India. USAID and HHS
are highly engaged and active in the HIV/AIDS response in India. India
is a participating country in HHS' Global AIDS Program through which
the Department allocated $2.3 million for HIV/AIDS programs in India in
fiscal year 2002, and $3.6 million in fiscal year 2003. USAID allocated
$12.2 million to HIV/AIDS prevention and care activities in India in
fiscal year 2002, and $13.5 million in fiscal year 2003. Additionally,
both the U.S. Departments of Defense and Labor have HIV/AIDS programs
underway in India. Numerous other donors, including governments, the
private sector, multilateral organizations, and foundations, also fund
HIV/AIDS programs in India.
With regard to using India's tuberculosis program as a model for
HIV/AIDS treatment, the President's Emergency Plan for AIDS Relief is
focused on identifying and promoting evidence-based best practices in
combating HIV/AIDS. The Directly Observed Therapy Short-Course (DOTS)
treatment that has been so effective in India has served as a model for
HIV/AIDS treatment programs in Haiti and elsewhere. One of the most
important lessons drawn from the DOTS program is its use of community
health workers to expand access to treatment. The network model of
treatment and care promoted by the President's Emergency Plan
implements this lesson by using community health workers to expand
access to HIV/AIDS treatment in rural areas where consistent access to
medical health professionals is limited.
The President's Emergency Plan for AIDS Relief also recognizes the
importance of local context in implementing effective HIV/AIDS
treatment programs. India's human resource capacity is significantly
greater than that of many focus countries of the President's Emergency
Plan, as is the reach of its health care infrastructure. These
advantages play a significant role in India's tuberculosis treatment
success, but represent limiting factors in access to treatment in the
focus countries. Thus, the Emergency Plan, while actively implementing
best practices identified from the success of DOTS therapy, focuses
significant resources in building human capacity and strengthening
health infrastructure in the focus countries to support expanded
treatment programs.
Question. In a press release of April 13, 2004, USAID announced the
first round of grants made under PEPFAR with fiscal year 2004 funding.
Five grants were announced for projects in just some of the 14
countries eligible for PEPFAR funding, totaling less than $35 million.
Only three of these grants--totaling just $18 million were directed to
orphans and vulnerable children (OVC) programs. Not one of these grants
exceeded $7 million, even though all were for efforts in multiple
countries.
Given the magnitude of the orphan problem, and the grave
consequences it has for the children, their families and communities,
and for their countries, these efforts seems far too tentative and too
limited, far smaller than the effort anticipated by Congress in
allocating 10 percent of fiscal year 2004 HIV/AIDS funds for OVC
programs.
I am concerned that our financial support to date is too limited to
effectively address the needs of rapidly growing numbers of orphans and
other children affected by AIDS.
(11) Can you tell me how much of the fiscal year 2004 appropriation
for HIV/AIDS has in fact been committed to date for this purpose and
how much will be committed in fiscal year 2005?
(12) Can you assure me that fully 10 percent of the 2005
appropriations will be dedicated to this critical problem and that
funding for OVC programs will expand significantly from what appears to
be a slow and tentative beginning?
Answer. Each of the identified focus countries has submitted a
Country Operational Plan (COP) for approval to Office of the U.S.
Global AIDS Coordinator. Each COP describes the activities the U.S.
Government will undertake for the remainder of fiscal year 2004 in that
country. Once these plans are approved, the amount of fiscal year 2004
resources committed for activities to address orphans and vulnerable
children will be available, and the Global AIDS Coordinator will be
pleased to share the information with your office.
The United States Leadership Against HIV/AIDS, Tuberculosis, and
Malaria Act of 2003 (Public Law 108-25) provides that for fiscal years
2006 through 2008 not less than 10 percent of the amounts appropriated
for bilateral HIV/AIDS assistance be expended for assistance for
orphans and vulnerable children affected by HIV/AIDS. The Office of the
U.S. Global AIDS Coordinator is committed to meeting this funding
requirement through a broad-range of activities targeted at the needs
of orphans and vulnerable children. In addition, USAID has recognized
the importance of funding programs to support children affected by HIV/
AIDS for the past few years. USAID's programs in this area are
beginning to grow significantly under the Emergency Plan. Grants for
orphans and vulnerable children were some of the first announced under
the Emergency Plan. These grants will provide resources to assist in
the care of about 60,000 additional orphans in the Emergency Plan's 14
focus countries in Africa and the Caribbean. Approaches to care will
include providing critical, basic social services, scaling up basic
community-care packages of preventive treatment and safe water, as well
as HIV/AIDS prevention education.
Prior to the implementation of the Emergency Plan, USAID was
funding over 125 programs in 27 countries to specifically respond to
the unique issues facing children affected by HIV/AIDS. In addition,
USAID funds a consortium of groups who are working together as the
``Hope for Africa's Children Initiative.''
Question. Scale-Up: The HIV/AIDS pandemic has had an enormous
impact on the world's youth. To date, 13-14 million children have been
orphaned by AIDS, and that number is expected to reach more than 25
million by 2010. The virtual ``tsunami'' of orphans in sub-Saharan
Africa will spread to new countries in Africa and to Asia as death
rates from AIDS rise in those regions.
(13) Within PEPFAR and other programs, what are you currently doing
to scale-up efforts as regards AIDS treatment, health care and getting
these children in school?
Answer. Under the Emergency Plan for AIDS Relief, activities
targeted at orphans and vulnerable children will be aimed at improving
the lives of children and families affected by HIV/AIDS. The emphasis
is on strengthening communities and families to meet the needs of
orphans and vulnerable children affected by HIV/AIDS, supporting
community-based responses, helping children and adolescents meet their
own needs, and creating a supportive social environment. Program
activities could include the following:
--Training caregivers;
--Increasing access to education;
--Economic support;
--Targeted food and nutrition support;
--Legal aid;
--Support of institutional responses;
--Medical, psychological, or emotional care; and,
--Other social and material support.
Question. Yesterday Secretary Thompson announced a major shift in
AIDS policy relating to anti-retroviral (ARV) drugs. It is good news
that the administration has created a policy that will be more
streamlined than the usual HHS/FDA process for approval of anti-
retroviral (ARV) generic and combination drugs. But it also seems to be
creating a parallel process to that which the World Health Organization
has set up to pre-qualify generic and combination ARV drugs.
I am concerned that this policy undermines the authority of the
World Health Organization, which did such an admirable job combating
SARS and that we need now to be strong in fighting AIDS. It also seems
a slap in the face to our European allies whose regulatory authorities
are the underpinning of the WHO's pre-qualification process.
(14) Are you at all concerned at the message this sends to our
partners abroad about the level of respect we are prepared to give
them?
(15) How will you ensure that the WHO retains its role and has the
resources to expand its provision of technical assistance?
Answer. It has always been our policy to provide, through the
Emergency Plan, drugs that are acquired at the lowest possible cost,
regardless of origin or who produces them, as long as we know they are
safe, effective, and of high quality. These drugs could include brand-
name products, generics or copies of brand-name products.
Our commitment from the beginning has been to move with urgency to
help build the human and physical capacity needed to deliver this
treatment, and to fund the purchase of HIV/AIDS drugs to provide this
treatment at the most cost-effective prices we can find--but only drugs
we can assure ourselves are safe and effective. The people we are
serving deserve the same assurances of safety and efficacy that we
expect for our own families here in the United States. There should not
be a double standard for quality and safety.
On May 16, Health and Human Services (HHS) Secretary Tommy G.
Thompson and U.S. Global AIDS Coordinator Ambassador Randall L. Tobias
held a joint press conference in Geneva, Switzerland, in advance of the
World Health Assembly. Secretary Thompson and Ambassador Tobias made
two very important announcements that impact on these issues.
First, Secretary Thompson announced an expedited process for HHS,
through its Food and Drug Administration (FDA), to review applications
for HIV/AIDS drug products that combine already-approved individual
HIV/AIDS therapies into a single dosage, often referred to as ``fixed-
dose combinations'' (FDCs), and for co-packaged products, often
referred to as ``blister packs.'' Drugs approved by HHS/FDA under this
process will meet all normal HHS/FDA standards for drug safety,
efficacy, and quality.
This new HHS/FDA process will include the review of applications
from research-based companies that have developed already-approved
individual therapies, or from companies that are manufacturing copies
of those drugs for sale in developing nations. There are no true
generic versions of these HIV/AIDS drugs because they all remain under
intellectual property protection here in the United States. The steps
taken by the HHS/FDA could encourage the development of new and better
therapies to help win the war against HIV/AIDS.
Second, Ambassador Tobias announced that when a new combination
drug for HIV/AIDS treatment receives a positive outcome under this
expedited HHS/FDA review, the Office of the U.S. Global AIDS
Coordinator will recognize that evaluation as evidence of the safety
and efficacy of that drug. Thus the drug will be eligible to be a
candidate for funding by the Emergency Plan for AIDS Relief, so long as
international patent agreements and local government policies allow
their purchase. Where it is necessary and appropriate to do so,
Ambassador Tobias will also use his authority to waive the ``Buy
American'' requirements that might normally apply.
We hope HHS/FDA will receive applications as soon as possible from
many companies that will want their drugs to be candidates for use in
the treatment programs of the President's Emergency Plan.
With regard to the World Health Organization (WHO), we have the
highest respect for the WHO and its prequalification pilot program.
However, the WHO is not a regulatory authority. We must be assured the
drugs we provide meet acceptable safety and efficacy standards and are
of high quality. Under the Emergency Plan, we intend to support
programs that will have a sustainable positive impact on health. If the
medications in question have not been adequately evaluated, have had
problems with safety or cause resistance issues in the future, the
patients we serve and the international community we appropriately hold
us accountable. We will continue to work with the WHO and the
international community on this important area.
Because of the President's Emergency Plan for AIDS Relief, and with
the partnerships between the Emergency Plan and those individuals and
organizations that are delivering treatment on the ground, we expect to
increase the number of HIV-infected persons who are receiving treatment
by approximately 175,000. Today, patients are receiving treatment in
Kenya and Uganda because of the Emergency Plan, and we expect that as
we and others scale up our efforts, millions of more people will follow
those who are already receiving this life extending therapy.
Finally, we note that the most limiting factor in providing HIV/
AIDS treatment is not drugs--it is the human and physical capacity in
the health care systems in the countries we are seeking to assist. Many
countries are desperately short of health care infrastructure and
health care workers. Both are needed to deliver treatment broadly and
effectively. We are focused on addressing this limitation as well.
Question. Ambassador Tobias, while we know that your PEPFAR mandate
keeps you focused on ramping up treatment and current preventive tools
as quickly as possible in the countries hit hardest by the epidemic,
the unfortunate truth is that treatment is unlikely to keep up with the
growth of the epidemic. The President's plan calls for putting two
million people on much-needed treatment by 2008, yet millions more will
have been infected by then--5 million a year, according to UNAIDS.
(16) What role do you see your office playing to catalyze efforts
underway to develop and distribute a preventive vaccine?
(17) What synergies do you see between the medical infrastructure
needed for providing testing and treatment, and ongoing clinical trials
in the developing world?
(18) How can PEPFAR programs lay the groundwork for future delivery
of vaccines and other preventive technologies like microbicides?
Answer. I am strongly supportive of the need for research and
development on new technologies for preventing HIV transmission, such
as a preventive HIV vaccine, microbicides, and improved means to
prevent mother-to-child HIV transmission (PMTCT). The U.S. Government,
through the U.S. Department of Health and Human Services (HHS), the
U.S. Department of Defense, and the U.S. Agency for International
Development, has been substantially engaged in biomedical and
behavioral research efforts in these areas for the past 20 years.
Findings from HHS/National Institutes of Health (NIH) sponsored
research provide the crucial scientific basis for HIV/AIDS treatment
regimens, prevention interventions, and standards of care. My office
intends to continue to support and promote research through leadership
in continuing to advocate for such research, and to assure that it is
well-coordinated with the goals of the President's Emergency Plan for
AIDS Relief.
In the field, there are a number of ways our new and expanded
programs for HIV/AIDS prevention, care, and treatment will help to
promote this important research into new prevention technologies.
First, the core of our treatment and care activities will be
implemented through the ``Network Model''. This model supports Central
Medical Centers and other community settings where prevention research
can take place in a quality health care setting, including the
provision of anti-retroviral therapy and other HIV/AIDS prevention,
care, and treatment (including PMTCT). Expanding these services through
the Emergency Plan will provide an increased number of settings where
HIV/AIDS prevention research can be supported. Second, the emphasis on
``institutional twinning'' (defined as matching hospitals; clinics;
schools of medicine, nursing, pharmacy, public administration, and
management; and other institutions in the United States and other
countries with counterparts in the 14 focus countries for the purposes
of training and exchanging information and best practices) primarily
focused on improving the capacity to provide HIV prevention, care, and
treatment, will serve to expand strong relationships among institutions
that also conduct research. Third, the capacity-building supported
through the Emergency Plan that develops infrastructure and trains
staff will have a spillover effect in ways that will promote research,
such as training health care workers, establishing public health
communications infrastructure, and improving clinical and laboratory
capacity.
It is not a coincidence that it has been the same developing
countries that, with assistance from the U.S. Government, first
participated in extensive clinical and vaccine research efforts that
also have been the most successful in fighting the HIV/AIDS epidemic,
especially by translating knowledge gained from clinical research into
medical practice (e.g., Thailand, Uganda, Senegal, and Brazil). A
robust clinical research infrastructure can be a foundation for
building excellent clinical care and making the best use of the
investments of the Emergency Plan for AIDS Relief.
In addition to catalyzing research into new preventive
technologies, the Emergency Plan also will lay the groundwork that will
accelerate the ability to implement any new technologies that are found
to be safe and effective. For instance, if a safe and effective HIV
vaccine is identified, high-risk HIV-uninfected persons will be an
appropriate target group for implementation. Such persons could be
identified through the network of HIV testing sites built up through
Emergency Plan investments. Likewise, if a safe and effective HIV
microbicide is identified, it could be promoted widely through the same
behavior change programs we are expanding to meet the HIV prevention
goals of the Emergency Plan, and supplies of microbicide could be
distributed through the same supply-chain management systems
strengthened through Emergency Plan investments.
______
Questions Submitted by Senator Mary L. Landrieu
Question. (1) Domestic Violence.--Women make up 58 percent of the
HIV/AIDS population in Africa. This higher number can be attributed to
cultural vices within Africa about the reluctance permit women to take
drugs to prevent mother-to-child transmissions and a high rate of
domestic violence where men refuse to let women negotiate condom use,
according to Human Rights Watch.
What efforts are you pursuing to overcome the cultural obstacles to
effectively treat and prevent HIV/AIDS? What efforts are you
undertaking to curb domestic violence so that women may have a stake in
both their physical safety from abuse and their medical well-being?
Answer. Stigma and discrimination against persons living with HIV
and AIDS, real or perceived, does present a significant obstacle to
combating HIV/AIDS. It strengthens existing social inequalities and
cultural prejudices, especially those related to gender, sexual
orientation, economic status, and race. Stigma and denial also create
barriers to our integrated multifaceted prevention, treatment, and care
strategy.
Under the Emergency Plan for AIDS Relief, we will act boldly to
address stigma and denial through three operational strategies: (1)
Engage local and national political, community, and religious leaders,
and popular entertainers to speak out boldly against HIV/AIDS-related
stigma and violence against women, and to promote messages that address
gender inequality, encourage men to behave responsibly, promote HIV
testing, and support those found to be HIV-positive to seek treatment;
(2) Identify and build the capacity of new partners from a variety of
sectors to highlight the harm of stigma and denial and promote the
benefits of greater HIV/AIDS openness; and (3) Promote hope by
highlighting the many important contributions of people living with
HIV/AIDS, providing anti-retroviral treatment to those who are
medically eligible, and involving those who are HIV-positive in
meaningful roles in all aspects of HIV/AIDS programming.
With regard to domestic violence, evidence from Uganda, Tanzania,
and Zambia shows that violence against women is both a cause and
consequence of rising rates of HIV infection--a cause because rape and
sexual violence pose a major risk factor for women, and a consequence
because studies have shown that HIV-positive women are more likely to
suffer violence at the hands of a partner than those who are not
infected. For many women, fear of sexual coercion and violence often
precludes the option of abstinence or holds them hostage to their
husband's or partner's infidelity. The Emergency Plan will work closely
with communities, donors, and other stakeholders to reduce stigma,
protect women from sexual violence related to HIV, promote gender
equality, and build family skills through conflict resolution. The
Emergency Plan will also support interventions to eradicate
prostitution, sexual trafficking, rape, assault, and sexual
exploitation of women and children.
Question. (2) Orphans.--Ambassador Tobias, as you may know, I am
the Chair of the Congressional Coalition on Adoption, and I will be
traveling next week to Uganda with a focus on orphans and Uganda's
efforts to curb the HIV/AIDS epidemic. Last year's legislation to
combat the international HIV/AIDS epidemic included language to
allocate 10 percent of U.S. funding to assist children orphaned by
AIDS. The United Nations estimates we could have 20 million AIDS
orphans by 2010.
Could you outline how you office plans to use its funds to benefit
orphans? What efforts are you taking to make it possible for these
children to be adopted?
Answer. The United States Leadership Against HIV/AIDS,
Tuberculosis, and Malaria Act of 2003 (Public Law 108-25) provides that
for fiscal years 2006 through 2008 not less than 10 percent of the
amounts appropriated for bilateral HIV/AIDS assistance be expended for
assistance for orphans and vulnerable children affected by HIV/AIDS.
The Office of the U.S. Global AIDS Coordinator is committed to meeting
this funding requirement through a broad-range of activities targeted
at the needs of orphans and vulnerable children. The Emergency Plan for
AIDS Relief, will aim activities at improving the lives of orphans and
vulnerable children affected by HIV/AIDS and their families. The
emphasis is on strengthening communities and families to meet the needs
of orphans and vulnerable children affected by HIV/AIDS, supporting
community-based responses, helping children and adolescents meet their
own needs, and creating a supportive social environment. Program
activities could include the following:
--Training caregivers;
--Increasing access to education;
--Economic support;
--Targeted food and nutrition support;
--Legal aid;
--Support of institutional responses;
--Medical, psychological, or emotional care; and,
--Other social and material support.
U.S. policy is to encourage extended families to care for children
who have lost their parents. If families are not available, the
Emergency Plan will often provide support to communities to care for
children orphaned by AIDS. For example, several programs in the focus
countries are supporting the integration or re-integration of orphans
and vulnerable children into their communities of origin, as well as
identifying foster families in local communities to care for affected
children.
Programs that are part of the Emergency Plan for AIDS Relief are
coordinated with polices and strategies of host governments and are
responsive to local needs. Countries and communities are at different
stages of HIV/AIDS response and have unique drivers of HIV, distinctive
social and cultural patterns, and different political and economic
conditions. Local circumstances must inform effective interventions,
and the Emergency Plan will coordinate with local efforts.
Question. (3) I mentioned, I will be traveling to Uganda next week,
and Uganda has been praised for its ABC Plan, Abstinence, Be Faithful,
and Condoms. Even with their successes, they still have a long way to
go.
Could you please name some of the countries taking proactive steps
to fight HIV/AIDS? As I mentioned, even those countries taking the
right steps have a long way to go, and will need long-term assistance
to from the United States. Are there any efforts set up a graduation
plan whereby countries will stop receiving U.S. assistance for meeting
certain milestones? I worry we often set the bar too low for
graduation. I see that in Eastern Europe we are curbing assistance
because they are ``graduating'' toward democracies and market
economies. What steps are being taken to make sure countries don't
graduate too soon from HIV/AIDS assistance?
Answer. All of the focus countries of the Emergency Plan for AIDS
Relief are taking proactive steps to address the HIV/AIDS pandemic in
their country. Examples include beginning anti-retroviral treatment
pilot programs (Mozambique, Guyana), scaling up anti-retroviral
treatment sites (Haiti, Namibia, South Africa, Uganda), increasing HIV
testing and counseling opportunities through the expanded use of
community health workers (Namibia), enhancing HIV surveillance,
laboratory support, and blood-safety efforts (Tanzania), distributing
culturally relevant HIV-prevention messages (Botswana) and working to
effectively integrate or re-integrate orphans and vulnerable children
into local communities (Haiti, Rwanda). However, as you suggest, these
countries are facing many difficult challenges in fully addressing
their HIV/AIDS epidemic. These challenges must be addressed before any
of these countries are positioned to respond on their own.
As you know, the Emergency Plan for AIDS Relief is a $15 billion,
five-year initiative targeted to reaching the following goals across
the 15 focus countries:
--Providing treatment to 2 million HIV-infected adults and children;
--Preventing 7 million new HIV infections; and,
--Providing care to 10 million people infected and affected by HIV/
AIDS, including orphans and vulnerable children.
By developing and strengthening integrated HIV/AIDS prevention,
treatment, and care, the Emergency Plan is focused on building local
capacity to provide long-term, widespread, essential HIV/AIDS services
to the maximum number of those in need. Key strategies include creating
and/or enhancing the human and physical infrastructure needed to
deliver care; supporting the host government and local, indigenous-led
organizations in their response to their nation's epidemic; ensuring a
continuous and secure supply of high-quality products to patients who
need them at all levels of the health system; and coordinating with
other donors to eliminate duplication of efforts and fill gaps. As the
five-year initiative comes to a close, assessments will be made about
the continuing need for U.S. Government bilateral support, especially
in light of the host government's HIV/AIDS activities and the impact of
the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
Question. (4) African Capacity to Make Its Own Drugs--
Independence.--The Bible tells us that if you give a man a fish he will
eat for a day. If you teach a man to fish he will eat for a lifetime.
Africa has very little capacity to treat this pandemic with its own
resources. All drugs are imported and there have been reports of price
gauging or the purchasing of dummy drugs.
What efforts is your office undertaking to increase Africa's
capacity to make its own drugs, to create a pharmaceutical
infrastructure within Africa that can go from manufacturer to clinic to
patient? This should reduce the cost for drugs.
Answer. Ensuring procurement of high quality pharmaceutical
products is absolutely essential for the HIV/AIDS programs under the
Emergency Plan. The U.S. Department of Health and Human Services (HHS)
recently announced an expedited process for U.S. Food and Drug
Administration (FDA) review of applications for HIV/AIDS drug products
that combine already-approved individual HIV/AIDS therapies into a
single dosage--many of these products are currently made in the
developing countries, including South Africa. The Office of the U.S.
Global AIDS Coordinator also announced that when a new combination drug
for HIV/AIDS treatment receives a positive outcome under this expedited
HHS/FDA review, it will recognize that tentative approval as evidence
of the safety and efficacy of that drug. Thus the drug will be eligible
to be a candidate for funding by the Emergency Plan, so long as
international patent agreements and local government policies allow its
purchase. Where necessary and appropriate to do so, the U.S. Global
AIDS Coordinator will also use his authority to waive the ``Buy
American'' requirements that might normally apply. Second, HHS plans to
announce a solicitation for a contract to provide technical assistance
to regulatory authorities and pharmaceutical quality assurance. The
U.S. Government will seek a contractor to perform specified tasks
related to the quality assurance of HIV/AIDS-related pharmaceutical
products. Final products purchased by the supply management system will
meet appropriate standards for quality, safety and effectiveness. This
activity will also be able to support provision of direct technical
assistance to increase the capacity for quality assurance in-country
and strengthen quality-testing procedures.
Question. (5) Tulane/West Africa Health Organization.--Congress has
expressed its support for a West African AIDS Initiative involving the
Economic Community of West African States (ECOWAS), the West African
Health Organization (WAHO) and American schools of public health
(TULANE). The objective of such an initiative would be to develop and
implement a coordinated effort to provide AIDS education, prevention
and treatment in the West African states. As in all African countries,
the ECOWAS nations struggle with overwhelming rates of infection for
HIV/AIDS, a situation that poses grave potential crises in the loss of
human life among the people of Africa. What are your views on such an
initiative involving the West African Health Organization, supported by
ECOWAS and American schools of public health?
Answer. The scope and urgent timing for expansion of training
programs places a high priority in recruiting all available,
experienced institutions for the effort in fighting the global HIV/AIDS
pandemic, including outstanding implementing partners like Tulane that
are interested and willing to establish twinning relationships with
local institutions in the 15 focus countries of the President's
Emergency Plan. Tulane is already highly involved, and its involvement
was recently and substantially scaled up, through the HHS University
Technical Assistance Program (UTAP). We expect to depend greatly on the
steadily expanding work of all such outstanding partners over the
course of this Initiative.
Questions. (6) Ambassador Tobias, would you explain how you plan to
ship the anti-retrovirals and other drugs needed to treat HIV/AIDS, TB
and malaria to Africa? Do you intend to use containerized shipping?
(7) In light of this, to what extent do you expect the drugs to
experience degradation in quality as a result of high temperatures and
humidity during oceanic shipment and port clearance?
(8) What is the effect of such degradation on resistance to anti-
retrovirals among the patient population?
(9) Would you agree that production of these drugs in Africa could
address this problem of degradation if accompanied by stringent quality
controls?
Answer. On behalf of the U.S. Global AIDS Coordinator, the U.S.
Agency for International Development (USAID) plans to announce for
public comment imminently a request for proposal for a supply-chain
management contract. The purpose of this contract is to establish a
safe, secure, reliable, and sustainable supply chain and to procure
pharmaceuticals and other products needed to provide care and treatment
of persons with HIV/AIDS and related infections. This contract will ask
for a consortium to perform a number of tasks, including procurement,
in-country assistance, logistical management information system, as
well as freight forwarding. We anticipate the contractor will ensure
timely, accurate, safe, and cost-effective freight-forwarding services
for all products, and we will expect it to make efforts to minimize any
product degradation. The contractor will conduct periodic reviews of
freight-forwarding practices, and identify special or reoccurring
delivery problems and devise timely and cost-effective solutions for
them. In addition, the contractor will establish quality-assurance
procedures to ensure that required storage and handling standards for
products shipped are met, to guarantee that a safe, effective, and
high-quality product reaches the patient. To make certain of that, we
anticipate the contractor will devise and carry out random testing of
production lots purchased by the system and released for shipment. The
contractor will make efforts to purchase products that require minimal
shipping times, as long as it meets the Emergency Plan's goal of
procuring pharmaceuticals at the lowest possible cost while
guaranteeing safety, quality and effectiveness.
Question. (10) Finally, in last year's appropriations report
language, the managers encouraged you to consider a pilot program,
including public-private partnerships and faith-based organizations,
aimed at increasing sustainability through indigenous production of
drugs in Africa. What steps, if any, have you taken to explore the
possibility of producing the required drugs in Africa while respecting
intellectual property rights?
Answer. Ensuring procurement of high quality pharmaceutical
products is absolutely essential for the HIV/AIDS programs under the
Emergency Plan. The U.S. Department of Health and Human Services (HHS)
recently announced an expedited process for U.S. Food and Drug
Administration (FDA) review of applications for HIV/AIDS drug products
that combine already-approved individual HIV/AIDS therapies into a
single dosage--many of these products are currently made in the
developing countries, including South Africa. The Office of the U.S.
Global AIDS Coordinator also announced that when a new combination drug
for HIV/AIDS treatment receives a positive outcome under this expedited
HHS/FDA review, it will recognize that tentative approval as evidence
of the safety and efficacy of that drug. Thus the drug will be eligible
to be a candidate for funding by the Emergency Plan, so long as
international patent agreements and local government policies allow its
purchase. Where necessary and appropriate to do so, the U.S. Global
AIDS Coordinator will also use his authority to waive the ``Buy
American'' requirements that might normally apply. Secondly, HHS plans
to announce a solicitation for a contract to provide technical
assistance to regulatory authorities and pharmaceutical quality
assurance. The U.S. Government will seek a contractor to perform
specified tasks related to the quality assurance of HIV/AIDS-related
pharmaceutical products. Final products purchased by the supply
management system will meet appropriate standards for quality, safety
and effectiveness. This activity will also be able to support provision
of direct technical assistance to increase the capacity for quality
assurance in-country and strengthen quality-testing procedures.
Question. (11) Fixed-Dose Combinations and Pediatric Treatment.--
Children are not small adults when it comes to medicines and HIV/AIDS
is no exception. Many AIDS medicines, particularly fixed dose
combinations and other non-brand medicines have yet to be tested for
use by children. With 2.5 million children infected with HIV around the
world, it is essential that children are not an afterthought in our
care and treatment activities.
A. Will the new HHS/FDA review process require that fixed-dose
combinations (FDCs), both generic and brand, be available for pediatric
use?
B. How does the President's five year strategy address the special
needs of children who require HIV treatment?
C. What is the Administration doing to ensure that both medical
professionals and others have the necessary information, equipment and
training to treat children with HIV/AIDS?
Answer. The announcement on May 16 by U.S. Health and Human
Services Secretary Tommy G. Thompson and U.S. Global AIDS Coordinator
Ambassador Randall L. Tobias included two important components that
address these issues.
First, Secretary Thompson announced an expedited process for the
U.S. Department of Health and Human Services (HHS), through its Food
and Drug Administration (FDA), to review of applications for HIV/AIDS
drug products that combine already-approved individual HIV/AIDS
therapies into a single dosage, often referred to as ``fixed-dose
combinations (FDCs),'' and for co-packaged products, often referred to
as blister packs. Drugs HHS/FDA approves under this process will meet
all normal HHS/FDA standards for drug safety, efficacy, and quality.
This new HHS/FDA process will include the review of applications
from research-based companies that have developed already-approved
individual therapies, or from companies that are manufacturing copies
of those drugs for sale in developing nations. There are no true
generic versions of these HIV/AIDS drugs because they all remain under
intellectual property protection here in the United States. The steps
taken by HHS/FDA could encourage the development of new and better
therapies to help win the war against HIV/AIDS.
Second, Ambassador Tobias announced that when a new combination
drug for HIV/AIDS treatment receives a positive outcome under this
expedited HHS/FDA review, the Office of the U.S. Global AIDS
Coordinator will recognize that evaluation as evidence of the safety
and efficacy of that drug. Thus the drug will be eligible to be a
candidate for funding by the Emergency Plan for AIDS Relief, so long as
international patent agreements and local government policies allow its
purchase.
We hope HHS/FDA will receive applications as soon as possible from
many companies that will want their drugs, including drugs for treating
children, to be candidates for use in the treatment programs of the
President's Emergency Plan.
With regard to how the President's Emergency Plan will further
address the special needs of children who require HIV treatment, you
might recall that before the President announced the Emergency Plan in
his January 2003 State of the Union address, in June 2002 he announced
his $500 million International Mother-and-Child HIV Prevention
Initiative for Africa and the Caribbean. After more than a year of
implementation, that initiative is now part of the Emergency Plan, and
is intended to treat one million women annually and reduce mother-to-
child transmission of HIV by 40 percent within five years or less in
target countries.
With regard to ensuring that both medical professionals and others
have the necessary information, equipment, and training to treat
children with HIV/AIDS, under the Emergency Plan we are committed to
developing sustainable HIV/AIDS healthcare networks. We recognize the
limits of health resources and capacity in many, particularly rural,
communities. To more effectively address that shortfall, we will build
on and strengthen systems of HIV/AIDS healthcare based on the
``network'' model. Prevention, treatment, and care protocols will be
developed, enhanced, and promoted in concert with local governments and
Ministries of Health. With interventions emphasizing technical
assistance and training of healthcare professionals, healthcare
workers, community-based groups, and faith-based organizations, we will
build local capacity to provide long-term, widespread, essential HIV/
AIDS care to the maximum number of those in need.
Question. (12) Prevention of Mother-to-Child Transmission (MTCT).--
The President's Global HIV/AIDS strategy recognizes that by giving a
simple dose of anti-retroviral drugs to pregnant women and to the
infant shortly after delivery, we can reduce mother-to-child
transmission of HIV by almost 50 percent. For fiscal year 2005, MTCT
activities will be integrated and financed through the Global HIV/AIDS
Initiative.
A. Out of your $1.4 billion request, how much are you requesting
for MTCT?
B. Will funding for MTCT be considered as part of the 55 percent
target for treatment programs? If so, will you track spending and
numbers of people covered separately for these MTCT activities?
C. In countries hardest hit by the pandemic, less than 1 percent of
women have access to MTCT services. Do you have any plans to scale up
existing MTCT programs? If so, how will this be implemented?
D. How will the Administration expand MTCT services to people who
do not have access?
Answer. Ambassador Tobias will make fiscal year 2005 funding
decisions based upon the submission of a unified annual Country
Operational Plan (COP) from each of the 15 focus countries. This plan
maximizes the core competencies and comparative advantages of all U.S.
Government departments and agencies with in-country HIV/AIDS activities
and allocates resources according to those core competencies and
comparative advantages. The COPs for fiscal year 2005 will further
illuminate how each focus country will harness those core competencies
to reach the overall five-year Emergency Plan goals and how the
allocation of resources among departments and agencies in the annual
operational plan will contribute to reaching those goals. After
Ambassador Tobias has approved the COPs, the Office of the U.S. Global
AIDS Coordinator will be able to determine how much of fiscal year 2005
funding to allocate to the prevention of mother-to-child transmission
(PMTCT) activities.
Regarding program classification, the Emergency Plan will consider
traditional PMTCT activities as prevention activities and tracked
accordingly. Under the Emergency Plan, the package of care for
preventing mother-to-child transmission will include counseling and
testing for pregnant women; anti-retroviral prophylaxis to prevent
mother-to-child transmission; counseling and support for safe infant
feeding practices; and voluntary family planning counseling or
referral. The Emergency Plan will consider PMTCT-plus (HIV anti-
retroviral treatment for HIV-infected mothers and other members of the
child's immediate family) treatment activities.
As you note, the President's International Mother and Child HIV
Prevention Initiative (MTCT Initiative) has become a major pillar of
the President's Emergency Plan for AIDS Relief. During the initial
phase of the MTCT Initiative's programming, anti-retroviral treatment
was not broadly available, and our emphasis was on saving those babies
at-risk for HIV infection during childbirth and early infancy. Now, the
Emergency Plan is scaling up ARV treatment programs to provide ongoing
ARV therapy to communities at large.
Building on the significant work already accomplished under the
MTCT Initiative in 14 of the 15 focus countries, the Emergency Plan is:
--Scaling up existing PMTCT programs by rapidly mobilizing resources;
--Providing technical assistance and expanded training for health
care providers (including family planning providers,
traditional birth attendants, and others) on appropriate
antenatal care, safe labor and delivery practices,
breastfeeding, malaria prevention and treatment, and voluntary
family planning;
--Strengthening the referral links among health care providers;
--Ensuring effective supply-chain management of the range of PMTCT-
related products and equipment; and,
--Expanding PMTCT programs to include HIV anti-retroviral treatment
for HIV-infected mothers and other members of the child's
immediate family (commonly known as ``PMTCT-plus'').
In addition, two key strategic principles of the Emergency Plan are
the development and strengthening of integrated HIV/AIDS prevention,
treatment, and care and the development of sustainable HIV/AIDS health
care networks. With interventions that emphasize technical assistance
and training of health care professionals, health care workers,
community-based groups, and faith-based organizations, the Emergency
Plan is committed to building local capacity to provide long-term,
widespread, essential HIV/AIDS care to the maximum number of those in
need.
Question. (13) HHS/FDA Process for Review of Fixed Dose Combination
(FDC) Products.--Two days ago, Secretary Thompson announced that HHS/
FDA will establish an expedited review process for products that
combine individual HIV/AIDS therapies into a single pill, also known as
fixed-dose combination drugs. For the Administration's global AIDS
initiative to be successful, it is critically important that we are
able to purchase high-quality drugs at the most affordable price. If we
move quickly, we can serve larger numbers of children and adults who
are in need of AIDS drugs.
A. How soon do you expect this new system to be in place, and when
do you think we'll have FDCs approved for use in resource-poor nations?
B. Some countries only allow for the purchase of brand or generic
drugs. For example, in South Africa you can only buy brand drugs. Do
you think this new process will provide momentum for countries to allow
for the purchase of both brand and generic drugs? What are we doing in
this area?
C. I understand that you will also be creating a competitive
procurement process to purchase medications. When will this process be
in place? Do you have estimates for how much drugs might cost under
this system?
Answer. Guidance proposed by the U.S. Department of Health and
Human Services (HHS) through its Food and Drug Administration (FDA) to
implement the rapid review process of fixed-dose combination and co-
packaged HIV/AIDS drugs has outlined four scenarios for reviewing
different FDC and co-packaged products. Some of the scenarios could
permit approval in as little as two to six weeks after submission of a
high-quality application. For companies that make products for which
another firm owns the U.S. patent rights, HHS/FDA could issue a
tentative approval when it finds the product meets the agency's normal
safety and efficacy standards.
To obtain approval of new products, manufacturers could cite
existing clinical data to demonstrate the safety and effectiveness of
the individual drugs in the new combined product--and new data to show
effectiveness of the new combination could be developed quickly. HHS/
FDA has pledged to work with companies to help them develop that data
rapidly if they do not already have access to such data. HHS/FDA is
also evaluating whether it can waive or reduce user fees, normally
charged to companies making new drug applications, for products
reviewed under this rapid review process.
With regard to the creation of a competitive procurement process to
purchase HIV/AIDS medications under the Emergency Plan, as described in
the answer to questions 6-9 above, USAID plans to announce for public
comment imminently a request for proposal for a supply-chain Management
contract. The purpose of this contract is to establish a safe, secure,
reliable, and sustainable supply chain for the Emergency Plan and to
procure pharmaceuticals and other products needed to provide care and
treatment of persons with HIV/AIDS and related infections at the lowest
possible cost with guaranteed safety, quality and effectiveness. This
contract will include procurement, in-country assistance, logistical
management information system, as well as freight forwarding.
Question. (14) a. Given that other disease treatment programs
involving inexpensive drugs and treatments are still major health
problems in Africa due to the lack of a human resource infrastructure
(malaria being a very good example), why do you believe that the more
complex to deliver anti-retroviral programs for HIV/AIDS will succeed?
What needs to be in place for this effort to be successful?
Answer. A lack of human resources for health (HRH) is holding back
health interventions in Africa for malaria and other health problems,
even though the interventions for malaria and other are technically
much cheaper and simpler than anti-retroviral treatment. The Emergency
Plan needs several things to be successful:
A. Better data on the current health workforce in place in
countries (both employed and unemployed), a better understanding of the
underlying reasons for the dismal current status, morale and
performance of HRH, and concerted short- and medium-term actions by the
U.S. Government in collaboration with national governments and other
donors to address those causes;
B. Short-term actions to rapidly prepare and deploy more health
care workers to meet the requirements for emergency delivery of needed
care [local health care workers (nationals) must be the bulwark of the
response, but expatriate volunteers placed through institutional
twinning arrangements can be important in assisting in emergency care
and in the initial phase of building sustainable capacity for ongoing
training in more complex interventions such as anti-retroviral
treatment]; and
C. Medium-term actions to begin increasing the numbers of health
care workers available to the expanding HIV/AIDS needs (while not
damaging other important efforts such as those against malaria), and to
better use scarce resources, such as doctors, nurses, pharmacists, and
other cadres through realigning certain tasks to less intensively-
trained staff (such as community health workers).
Each of these activities are underway as part of the Emergency
Plan; all will likely need to be done in nearly all countries in a
concerted fashion if the Emergency Plan is to ultimately succeed. If
done properly with careful design and implementation, the Emergency
Plan could begin a reversal of the serious decline in HRH seen in sub-
Saharan Africa and the Caribbean over the past two decades.
Question. (14) b. Does USAID have an estimate of the additional
trained individuals required to implement retro-viral programs? Have
you analyzed the need for retraining current tertiary service delivery
personnel for the HIV/AIDS initiatives?
Answer. The U.S. Global AIDS Coordinator's Office, in collaboration
with USAID and other partners, does have preliminary estimates of the
additional trained personnel needed, based on the targets proposed in
the first-year plans. However, those estimates are based on crudely
estimated numbers of providers already trained and in place. Moreover,
they are lacking essential data such as the current attrition rate from
HIV/AIDS care programs, either from brain drain, retirement, HIV/AIDS
infection itself, or other reasons. A critical step over the next few
months and first full year of the Emergency Plan is to establish a
reliable database with estimates of: (1) the currently qualified
workforce, and (2) the workforce required to meet the Emergency Plan
goals for each year of the Emergency Plan. Retraining current tertiary
service delivery personnel is usually the quickest route to rapidly
initiating anti-retroviral treatment programs, and is part of every
country's program.
Question. (14) c. There is only a handful of institutions in the
United States that have a history of supporting African health training
institutions. For example, Tulane University and its School of Public
Health and Tropical Medicine have played a very significant role in
terms of the number of African health professionals trained over the
years. Are these institutions actively involved in the HIV/AIDS human
resource development and training efforts?
Answer. The scope and urgent timing for expansion of training
programs places a high priority in recruiting all available,
experienced institutions for the effort in combating HIV/AIDS,
including outstanding implementing partners like Tulane that are
interested and willing to establish twinning relationships with local
institutions in the 15 focus countries of the President's Emergency
Plan. Tulane is already highly involved, and their involvement was
recently substantially scaled up, through the HHS University Technical
Assistance Program (UTAP). We expect to depend greatly on the steadily
expanding work of all such outstanding partners over the course of the
Emergency Plan.
Question. (14) d. Is the Agency exploring the use of information
technology as a means of getting the message for HIV/AIDS training to
the local institutions as efficiently as possible?
Answer. The Office of the U.S. Global AIDS Coordinator is
interested in the most cost-effective, sustainable approaches to
meeting the goals of the Emergency Plan. We try to match the
technological approach to the specific needs and context of the
training situation, rather than the other way around. In that context,
we do expect (and will pay for) information technology for training as
well as to support the strengthening of networks for bi-directional
communication that enhances the quality of health care. We expect
exciting models for a mixture of e-learning, telemedicine, and enhanced
monitoring and evaluation to emerge from our U.S. Government staff's
efforts at problem-solving and building sustainable capacity in the
coming years.
Question. (14) e. To what extent are capacity building efforts
among appropriate African educational and research institutions being
involved to create an environment that can sustain the President's
initiatives?
Answer. The dual principles of cost-effectiveness and
sustainability require us to conduct training predominantly through
African educational and training institutions. The Emergency Plan will
look for African (or Caribbean) institutions to be implementers at
every opportunity, especially to have them work with their peers in
other of the 15 focus countries. In the many contexts in which
technical assistance from United States or third-country providers
might be needed to initiate programs, a requirement of all grants will
be to force international grantees to have a plan to develop capacity
such that they can turn their activities over to local, in-country
organizations.
CONCLUSION OF HEARINGS
Senator McConnell. Thank you all very much for being here.
That concludes our hearing.
[Whereupon, at 12:36 p.m., Tuesday, May 18, the hearings
were concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]