Wednesday, June 23, 2004

SOURCE White House Press Office
Web Site: http://www.whitehouse.gov/

Background Briefing on the President's Pending HIV/AIDS Relief Announcements Via Conference Call By Senior Administration Officials

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/06-22-2004/0002198271&EDATE=

WASHINGTON, June 22 /PRNewswire/ -- The following is a background briefing
on the President's pending HIV/AIDS relief announcements:

5:05 P.M. EDT

SENIOR ADMINISTRATION OFFICIAL: Thank you. Thanks everybody for joining
us this afternoon. This is the conference call on the President's HIV/AIDS
plan, both internationally and domestically, he'll be providing in a speech
tomorrow.
We have three senior administration officials with us today. This will be
a background briefing, and the senior administration officials should be
referenced as such. So I'll just turn it over to my colleague. We'll each
make quick opening remarks, and then turn it over to your questions.

SENIOR ADMINISTRATION OFFICIAL: Good afternoon. The President will
deliver remarks tomorrow in Philadelphia at the Greater Exodus Baptist Church
on the importance of fighting HIV/AIDS both globally and here at home. In
2003, the President announced the emergency plan for AIDS relief and committed
$15 billion over five years to treat 2 million HIV-infected people, prevent 7
million infections, and care for 10 million individuals. We remain on track to
meet the President's commitment, and within this first year of implementation,
expect to provide care and support to approximately 1.1 million people, and
antiretroviral treatment to approximately 200,000.
The President will make two announcements tomorrow regarding the emergency
plan. The President will also outline his strategy for fighting AIDS here at
home. For African Americans aged 25 through 44, HIV is now the second-leading
cause of death. The President's '05 budget would support $17.1 billion in
domestic spending on research, care, prevention, and treatment, which is a 27
percent increase over '01 funding. He has also supported increases in other
AIDS-related programs, including substance abuse treatment and community
health centers. However, he believes there's more to do. And tomorrow he'll
lay out proposals related to domestic programs, including reauthorization of
the Ryan White Care Act.
Finally, the President will talk about the importance of medical research
in preventing, treating, and some day curing this disease. His '05 budget for
the National Institutes of Health request $2.8 billion for AIDS research,
which is a $586 million, or a 26 percent increase over '01 funding, including
$530 million for vaccine development.
HHS recently announced a new initiative to feed approvals of advanced
antiretroviral drugs. And tomorrow, the President will discuss steps to
encourage vaccine research. And with that, I'll turn it over to a senior
administration official to discuss the emergency plan.
SENIOR ADMINISTRATION OFFICIAL: As my colleague reminded you, in his 2003
State of the Union Address, the President launched the emergency plan for AIDS
relief. An important element of that plan was to provide strategic focus to
14 countries -- 12 in Africa and two in the Caribbean -- that account for
about 50 percent of the infections in the world.
Earlier this year, Congress directed that we select a 15th country,
somewhere other than Africa and the Caribbean, and the President will announce
tomorrow that that 15th country will be Vietnam. The administration considers
that Vietnam is a place where the American people's money can really make a
tremendous impact because it is on the brink of a very explosive epidemic.
Vietnam currently has 130,000 persons living with AIDS, but it is predicted
that that could increase to as many as a million people by 2010. And if that
happens, the magnitude of that increase will be eight times the current number
of people infected. And that is, in fact, a greater increase, a greater
multiplier than India or Russia or China in that same period, which are three
of the countries that have been referred to as the "next wave" countries.
Vietnam is a relatively large country with a population of over 80 million
people. And in fact, as it joins the focus countries, the 15 now focus
countries, it becomes the second largest focus country in the group. We also
believe that U.S. intervention is very timely because up to this point, the
epidemic has largely been concentrated in intravenous drug users and
commercial sex workers, but it is now spreading into the general population.
It is present in all 61 provinces, and the data suggests that about 80 percent
of all new infections are being sexually transmitted.
Vietnam did a very good job of dealing with SARS. And we're confident
that we can work effectively with nongovernment organizations and with the
coordination and help of the Ministry of Health in Vietnam in addressing this
issue.
On another matter, the President will also announce tomorrow that we are
prepared to soon release $500 million in additional funding, which when added
to the $350 million we released in February, will bring to $850 million the
amount of money that the emergency plan has released for use in the focus
countries so far this year.
We have notified Congress, as we are required to do, about our intent with
the $500 million. They are reviewing that now. And as soon as they are
prepared to release the funds, then those funds will begin to go to work to
help the people involved. So those are the two announcements that the
President will be making tomorrow about the emergency plan.

SENIOR ADMINISTRATION OFFICIAL: On the domestic front, as stated before,
the President will be making comments regarding care and treatment, prevention
and vaccine research. The President will be discussing that he's committed to
re-authorizing the Ryan White Care Act, which is up for reauthorization in the
fall of 2005. And there are three guiding principles that the President will
pursue in reauthorization. The first is to focus federal resources to ensure
that life-saving AIDS medications and care are available to those who cannot
provide for themselves. Second, to provide more flexibility in the targeting
of funds to ensure that they are provided to communities that need them. And
third, to ensure accountability by measuring results and encouraging
participation of any provider who can show those results.
Another key piece in the message tomorrow will be that the President
recognizes the dire need to promote prevention using proven methods. These
include emphasizing abstinence for young people through the ABC model.
Abstinence is the only sure way to prevent sexual transmission of AIDS and
other sexually transmitted diseases, and to encourage testing.
Approximately 40,000 Americans continue to become infected every year in
this country. The President wants anyone who is at risk to get tested. That's
the only way we're going to be able to control and arrest this epidemic is by
having people recognize that they are infected. Knowing your status is
important. And we need to highlight that National Testing Day will be on June
27th. It has been made easier than ever as the FDA has facilitated quick
approval of a non-invasive, rapid HIV test.

SENIOR ADMINISTRATION OFFICIAL: The President will also discuss the
importance of research related to fighting HIV/AIDS. FDA recently announced
an initiative to rapidly review the safety of those brand name and generic
drugs. This new procedure will allow the emergency plan and other AIDS
programs to purchase drugs -- low cost and high quality drugs -- with
assurances of their safety.

In addition, the President recently at the G8 announced a proposal for a
global vaccine enterprise, which will help bring some strategic vision to
development of a vaccine. And tomorrow, he'll talk about the importance of
pursuing those efforts.

SENIOR ADMINISTRATION OFFICIAL: And with that, we'll take your questions.

Q Yes, I wanted to ask about the decision to select Vietnam instead of
India, for example. A number of people, as you suggested, have been pressing
for India, which is a higher infection rate. The numbers are much greater in
India. And there have been some suggestions from some on the Hill that this
is politically motivated as appealing to the Vietnamese community. I'm
wondering if you can go over in detail why Vietnam over India?

SENIOR ADMINISTRATION OFFICIAL: Well, the reason that we chose Vietnam is
that Vietnam is the place where we believe we can address our money and our
attention and really make the greatest impact. And it's very timely because
the epidemic in Vietnam is about to go more broadly into the general
population, whereas it has been concentrated largely among commercial sex
workers and intravenous drug users.
The multiplier effect of looking at the number of people who are infected
in Vietnam today, about 130,000 versus the estimate in 2010, is eight times.
So we're talking really about explosive growth in a part of the world that
will have a tremendous impact not only on Asia and Southeast Asia, but
potentially on the rest of the world. That compares with a three times
increase in that same period in India, a four times increase in Russia, and a
seven and a half times increase in China -- all of which are very, very big
numbers.
India was certainly a place that we considered, but one other factor I
think that was something that we considered was the degree of commitment that
existed in Vietnam today where Vietnam is spending about $36 per person
infected with AIDS, as compared to India that's spending about $6 per person
infected with AIDS. India is a somewhat different country than all of the
other countries in the plan in that they have a growing middle class. They
have a growing economy, and they really have the ability to make some trade-
off decisions themselves to prioritize more resources in this direction.
This was not an easy call. There are a number of countries in the world
that would be very good candidates. But in the end, we concluded that Vietnam
was really the best choice.
I might just add one additional point and that is that our commitment in
India currently is over $20 million. It is the largest of our non-focus
countries. And so we're already doing a great deal in India, and I would
expect in the years ahead we will continue that and probably increase it.

Q I'd just like to follow up on that. So this has nothing to do with
India's role in making generic drugs, which some people have made that
accusation?

SENIOR ADMINISTRATION OFFICIAL: Our policy from the very beginning of the
emergency plan, which we have clearly stated over and over is that we will buy
the least expensive drugs we can find without regard to the country of origin,
without regard to who manufactures them, without regard to whether they're
brand name or copies or generics, as long as we can be assured that they're
safe and effective, so with the new program that the FDA has put in place for
very accelerated review of AIDS drugs, and the decision we've made in my
office that if the FDA, in fact, provides tentative approval of any drug for
which the manufacturer applies for approval, then that drug will be eligible
for funding. And we have been in contact, as a matter of fact, with a couple
of the major manufacturers in India, encouraging them to apply for this
accelerated approval. We hope that virtually any company in the world that's
manufacturing AIDS drugs will, in fact, apply for this FDA review.

Q This thing again on the question of why not India, there were
reports also that Indian officials themselves had done some heavy lobbying to
persuade people not to name them the 15th country because India, in the view
of some -- first of all, Indian officials have -- some of them are said to be
in a state of denial about the degree of the problem in India. What's more,
they did not want the stigma of being a country heavily infected with AIDS to
be further ratified by being named a focus country. Would you comment on that?

SENIOR ADMINISTRATION OFFICIAL: Well, not only did the drug issue not
have anything to do with this decision, that's the first time I've heard of
that really one way or the other. So that had nothing to do with this
decision either.

Q So you never had any indication from Indian officials that they
would prefer not to be named a focus country?

SENIOR ADMINISTRATION OFFICIAL: Not to my knowledge.

Q I want to just talk about the $500 million and correct some numbers
here. You said $500 million in additional funding added to how many million?

SENIOR ADMINISTRATION OFFICIAL: In February, we announced $350 million in
the first round of funding that was going out to various organizations that
are helping us implement the program the 14 focus countries.
We have notified the Congress of our readiness to expend another $500
million. Congress is reviewing that at the moment. When that money goes out,
that will be a total of about $850. It's actually a little over $500 million.
So that will bring the total to $850 million. And that takes us totally on
track with our objectives for the funding that's available this fiscal year.

Q And what is that $500 million going to?

SENIOR ADMINISTRATION OFFICIAL: Well, this will go to a variety of
programs in the 14, now 15 focus countries -- on prevention programs,
treatment programs, and care programs. So this will be funding, in some
cases, the building up of both human and physical infrastructure for providing
treatment. In some cases, it will be paying for the acquisition of
antiretroviral drugs. And we expect to have about 200,000 people in this
program who will be on treatment by the end of the first year. Some of the
money will be going to prevention programs. Some of the money will be going
to care programs -- palliative care for people who are in the last stages of
life, and care programs to take care of the literally thousands -- tens of
thousands -- hundreds of thousands of orphans that have been created as a
result of this. So it's across this broad range of the President's objectives
of prevention, treatment and care.

Q And I just can't remember the number off the top of my head.
President Bush had dedicated -- was it $10 billion, $15 billion?

SENIOR ADMINISTRATION OFFICIAL: In the total program, the President has
dedicated $15 billion over five years.

Q Over five years. And so out of $15 billion in five years, we've
only put out $850 million. But that still keeps us on track?

SENIOR ADMINISTRATION OFFICIAL: No, actually this year we will spend $2.4
billion. The $850 million we're talking about is that portion of this year's
$2.4 billion expenditure that is dedicated to new programs, or to increasing
existing programs in the 14 focus countries. We will provide funding -- about
$500 million in funding to bilateral programs in a number of other countries,
money for research, money for the global fund. And all of those things taken
together total $2.4 billion. And we will expend that entire amount this year.

Q Thank you.

Q I have two quick questions. One is, is this going to be a
traditional speech? Or is this going to be one of the President's forums like

he's done with other people? The other question is, is this information
embargoed, or is this information for publication now?

SENIOR ADMINISTRATION OFFICIAL: One, it's remarks. It's not a
conversation. And, two, it's not embargoed.

Q It's not embargoed, okay.

SENIOR ADMINISTRATION OFFICIAL: Correct.

Q All right.

Q This is sort of along the lines of the earlier questions about why
not India. I'm told that Cambodia has about 10 times more AIDS cases, or HIV
infections as Vietnam. So I wondered what tipped the balance to Vietnam
rather than Cambodia? And secondly, I don't understand enough about the
process to know how the monies get allocated. But I wonder if there's any way
you could suggest how much money this might -- what the range of money might
be that Vietnam would get as a result of this designation?

SENIOR ADMINISTRATION OFFICIAL: Well, first of all, with respect to
Cambodia, Cambodia is one of the countries that we looked at. And Cambodia
has made a great deal of progress in bringing their infection rate down
through their own initiative and funding that has been received from other
sources.
And so we really thought we could make a bigger impact in Vietnam, which
was the reason that we went to Vietnam. Our estimate is that in this first
year, we will probably be spending something in the range of $8 million to $10
million in Vietnam. But that will very much depend on our ability to work our
arrangements with organizations that we will be working with in Vietnam. And
then in the following years, Vietnam will become just like the other 15
countries. And so we will look at a variety of factors, including the
capacity of the country to absorb the money, and how much money we really
think we can effectively put to use. So I couldn't make a more specific
estimate than that in terms of the amount.

Q When you were mentioning the domestic funds in the President's
comments, could you just go over again what the three guiding principles you
said that he was going to have in the speech?

SENIOR ADMINISTRATION OFFICIAL: Certainly, one is to focus federal
resources to ensure that lifesaving HIV-related medications and care are
available to those who can't provide them for themselves; two, to provide more
flexibility in the targeting of funds within the Ryan White Care Act to ensure
that they can be provided to communities who need them the most; and third is
to ensure accountability by measuring results and encouraging participation of
any provider, including any faith-based provider who can show those results.

Q I was wondering if you could talk for a moment about whether the
generic manufacturers in India whom you spoke with responded to your
suggestion that they seek approval in the U.S. for their medicines? And
secondly, could you talk about whether prevention efforts in the focus
countries would include efforts that go beyond abstinence?

SENIOR ADMINISTRATION OFFICIAL: Well, with respect to your first
question, I can't answer specifically. I think from the reports I've had from
the people who visited the companies in India, they were very well received.
There were lots of questions and a very positive reaction. But as to whether
or not they specifically plan to apply for a review or when, I don't know. I
certainly want to encourage these companies and every other company that's in
this business to do so.
Secondly, with respect to prevention, the President's program is a balance
ABC program of abstinence, being faithful within a marriage or a committed
relationship, and for those people who chose to engage in risky behavior, the
correct and consistent use of condoms. And our expectation is that that
balanced program of A and B and C is exactly what we're implementing now and
would intend to implement in Vietnam.

Q First of all, going back to the dollar figures here, with this
$800,000, what does that bring the total for the year? Does that bring it
close to the $3 billion-a-year average under the President's $15 billion
initiative? And second, I assume these are senior administration officials.
I just didn't get your names at the beginning.

SENIOR ADMINISTRATION OFFICIAL: They are senior administration officials.
I'll go back and recap who they are at the end for everybody who got on late.
The dollars that we have talked about for this year, in February, the
emergency plan funded plans of $350 million. We have notified the Congress of
our readiness to put out another $500 million or a little more than $500
million. The total of those two would take us to $850 million. And that is
the component of the $2.4 billion in funding for this year for global
HIV/AIDS. That is the component for funding new or expanded prevention
treatment or care programs in the focus countries. So that takes us totally
on target.

Q So right now it's $2.4 billion. But wouldn't the target be $3
billion, though, under five years, $15 billion?

SENIOR ADMINISTRATION OFFICIAL: No. I think a lot of people have made
the mistake of taking $15 billion and dividing it by five years and coming up
with three. And in fact, in many of these countries -- I just came back from
Ethiopia, for example, which has a population of about 18 million people and
600 doctors -- in many of these countries, physical infrastructure and human
infrastructure has to be put in place, which is what we're helping to do
before we can really expand a lot of these programs.
But we can more effectively use the money if it is rolled out in
increasing amounts over the five years. The President's request for fiscal
year 2005 is $2.8 billion, and it will increase obviously from there so that
at the end of the five years, if you add the five years together, it's our
expectation it will total $15 billion.

Q I was just curious since the announcement last month of the new
approval process to try to quicken and make these drugs safe and effective,
where does that stand now? Have you had many companies apply to go through
this yet? Or are you getting some resistance from those who say we don't want
to go through this process and the WHO process together?

SENIOR ADMINISTRATION OFFICIAL: So far the process has been very well
received. There are a number of companies that have announced that they're
working to put together proposals. And we expect applications to come in, in
the near future.

Q A couple quick questions. Maybe this is my ignorance of budgeting,
but why was the $500 million not included in the original budget request for
this year? And the second question is, you mentioned condoms, does the
program include distribution of condoms? And will that happen in Vietnam?

SENIOR ADMINISTRATION OFFICIAL: The answer to your second question is yes
and yes.
With respect to the $500 million, there was an appropriation of $2.4
billion. And this $500 million is included in that appropriation. What's
happening now is that we have identified specific programs to fund in the
focus countries. And we have now -- under the rules that are in place -- we
have notified the Congress of the specific details of those programs that we
wish to fund. And after the Congress has had an opportunity to look at that
and provide some guidance, then we expect that that $500 million will be going
out the door and into funding these programs.

SENIOR ADMINISTRATION OFFICIAL: Okay, thanks again for joining us.

END 5:34 P.M. EDT

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