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FOIA Number: 2011-0586-F
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This is not a textual record. This is used as an
administrative marker by the William J. Clinton
Presidential Library Staff.
Collection/Record Group:
Clinton Presidential Records
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Press Secretary
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Mike McCurry
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AIDS
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94
3
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1
4:11:97
Question:
This week, the Vice President announced that the Health Care Financing
Administration (HCFA) is going to extend Medicaid coverage to all
people with HIV. Can you explain?
Answer:
The Vice President did announce that we are directing HCFA to determine the
feasibility of establishing a demonstration to permit earlier Medicaid coverage
of people with HIV/AIDS in the next thirty days. This demonstration would
enable people with HIV/AIDS to access coverage of new drug interventions,
including protease inhibitors, which often delay the onset of symptoms that
are much more expensive and difficult to treat. The demonstration is being
designed to determine if earlier access to Medicaid coverage not only
improves the health and well being of people with AIDS, but also reduces
long-term health care costs.
Today, HIV/AIDS patients have to wait until they become sick enough to
qualify for Medicaid through a disability determination. As a result, they often
cannot afford our newest and most effective drug therapies. The action by the
Vice President clears the way to a more compassionate and potentially
cost-effective Medicaid program for people with HIV/AIDS
Question:
Isn't this eligibility expansion going to be extremely expensive?
Answer:
We actually believe that this expansion has the potential to be cost-effective
Under this demonstration, we would begin to treat people at the point when
their HIV is detected, rather then waiting until they are extremely sick This
could improve the likelihood that these new drug therapies will help maintain
the health and well-being of people with HIV/AIDS, reducing the need for
costly long-term health care services.
Chris Jennings, DPC
4.7.97
Press Guidance
April 7, 1997
Question and Answer on Needle Exchange
Background: There is a statutory prohibition on federal funding for needle distribution unless the
Secretary of HHS can determine 1.) That needle exchange programs reduce HIV transmission and
2.) That they do not encourage the use of illegal drugs. To answer Congress' call for a study of
the needle exchange programs federal funding has been used to conduct research.
Q:
Will You work to lift the ban on federal funding of needle exchange programs?
A:
Not at this time. As you know, the congressional ban remains in effect until the Secretary
of HHS can certify that needle programs reduce the transmission of AIDS and that such
programs do not encourage illicit drug use. The scientific studies done so far provide
strong evidence that needle exchange programs reduce HIV transmission, but they don't
yet offer sufficient evidence of the effect of these programs on illicit drug use. We
strongly support continued study of this question so we can know whether needle
exchange programs in fact encourage drug use. In the meantime, local communities
remain free, as they should, to establish and support needle exchange programs if they
choose to do so.
JSilverman
Per conversation with Elena Kagan/OPD
4.8.97
THE WHITE HOUSE
Office of the Press Secretary
DRAFT For immediate release
April 7, 1997
PRESIDENT NAMES SANDRA L. THURMAN
AS DIRECTOR OF THE OFFICE OF NATIONAL AIDS POLICY
The President today announced his intention to appoint Sandra L. Thurman as Director of
the Office of National AIDS Policy.
For more than a decade, Ms. Thurman has been a leader and advocate for people with
AIDS at the local, state, and federal levels.
From 1988 to 1993, Sandra L. Thurman, of Atlanta, Georgia, served as the Executive
Director of AID Atlanta, a community based organization which provides health and support
services to people with HIV/AIDS and offers an array of HIV prevention programs. Under her
leadership, AID Atlanta, the largest and oldest AIDS service organization in the south, tripled in
size and became a multi-million dollar, direct-service agency with 90 staff members and over 1000
volunteers.
From 1993 to 1996, Ms. Thurman was the Director of Advocacy Programs at The Task
Force for Child Survival and Development at The Carter Center in Atlanta, Georgia. As Director,
she focused on the global health concerns of children, including immunization and the eradication
of polio. She is currently Director of Citizen Exchanges at the United States Information Agency.
Ms. Thurman is a Member of the Presidential Advisory Council on HIV/AIDS and of the
Georgia State AIDS Task Force, the Fulton County HIV Planning Council and the Executive
Committee of Cities Advocating Emergency AIDS Relief (CAEAR). She has served on the
Board of Directors of the National Episcopal AIDS Coalition, AID Atlanta, Sisterlove, Inc., and
the Atlanta AIDS Interfaith Network, among others. She is a recognized expert on AIDS issues
and has provided testimony before the United States Senate, the White House Conference on
HIV/AIDS and the National Commission on AIDS. Ms. Thurman earned a Bachelor's degree
from Mercer University.
The Office of National AIDS Policy is responsible for coordinating federal policy and
programs on HIV/AIDS, and with building partnerships between Federal agencies, the AIDS
community, AIDS service providers, state and local officials, and major business leaders. The
objective of the ONAP is to increase the rate of progress in treatment and education, and to
maintain the focus on science and scientific research.
--30--
THE CLINTON ADMINISTRATION
ON HIV/AIDS
Revising eligibility rules for Social Security Disability
Insurance to make it easier for people living with HIV
"Our common goal must ultimately be a cure, a cure for all
to qualify for benefits.
those who are living with HIV, and a vaccine to protect all
the rest of us from the virus. A cure and a vaccine, that
Signing the Kennedy-Kassebaum Health Insurance
must be our first and top priority.
Portability and Accountability Act, which bans
President Clinton
insurance discrimination against people with pre-
White House Conference on HIV/AIDS
existing medical conditions including HIV/AIDS.
Launching a four-year $100 million effort to develop
In his four years in office, President Clinton has sharply
topical microbicides to allow people to protect
increased the Federal government's commitment to
themselves from HIV.
ending the epidemic of HIV/AIDS that has already taken
the lives of more than 300,000 Americans. He has done
Establishing the HIV prevention community planning
partnership, which empowers local communities to
that by:
make decisions about the direction of AIDS prevention
programs.
Increasing overall AIDS funding by more than 56% in
four years.
Launching the Prevention Marketing Initiative,
focusing on the risk to young adults (18-25) with frank
Creating a White House Office of National AIDS
public service announcements recommending sexual
Policy to bring greater direction and visibility to the
war on AIDS.
abstinence and, for those who are sexually active, the
correct and consistent use of latex condoms.
Convening the first-ever White House Conference on
Vigorously enforcing the Americans with Disabilities
HIV/AIDS and appointing the Presidential Advisory
Council on HIV and AIDS.
Act, which prohibits discrimination against people
with HIV/AIDS. More than 800 charges of AIDS-
Increasing funding for the Ryan White CARE Act
related discrimination have been settled in four years.
186% in four years to nearly $1 billion.
Leading the fight to repeal the discriminatory "Dornar
Amendment," which would have discharged all HIV-
Tripling federal funding for the AIDS Drug Assistance
positive military personnel.
Program to help those without insurance coverage
obtain prescription drugs.
Creating the Forum for Collaborative HIV Research to
improve knowledge of HIV treatment methods.
Strengthening the Office of AIDS Research at NIH
and vesting it with new authority to plan and carry out
Working with AIDS activists to protect the rights of
the AIDS research agenda.
immigrants with HIV and PLWA's enrolled in
managed care plans.
Accelerating AIDS drug approval to record times.
In four years, FDA has approved 16 new AIDS
Creating the Advisory Commission on Consumer
drugs and 3 new diagnostic tests.
Protection and Quality in the Health Care Industry to
increase consumers' rights.
Doubling funding for Housing Opportunities for
People with AIDS.
Winning the fight to preserve the Medicaid guarantee
of coverage for the more than 50% of people living
THE CLINTON ADMINISTRATION
with AIDS who rely on Medicaid for health coverage.
Meeting America's Challenges and Protecting Our Values
Paid for by Clinton/Gore '96
02/18/27 TUE 15:02 FAX 2026905673
DHHS/ASPA
002
Questions and Answers on Needle Exchange
- Background . For Internal Use Only
On the New Report:
Q. Why did you do this report on needle exchange?
A. The report is in accordance with the September 12, 1996 request of the Senate Committee
on Appropriations for the Departments of Labor, Health and Human Services, Education,
and Related Agencies.
Q. Based on this report, are you lifting the ban on the use of Federal funds for needle
exchange programs?
A. No, we are not. In its request for this report (Senate Report 104-368, p.68), the
Committee specifically asked us to report on the effect of clean needle exchange programs
on reducing HIV transmission, and on whether such programs encourage illicit drug use.
Based on the studies conducted to date, as the report says, "needle exchange programs can
be an effective component of a strategy to prevent HIV and other blood borne infectious
diseases in communities that choose to include them." However, the studies in the report
do not indicate a similar degree of evidence on the question of whether such programs
encourage drug use. Therefore, the prohibition remains in effect. However, local
communities remain free to use non-Federal funds to support such programs if they so
choose.
Q. Why does the report draw conclusions about the efficacy of needle exchange programs in
HIV reduction and not about their effects on drug abuse?
A. Because the scientific evidence is strong enough on the first question, and not on the
second. As the report says, the existing body of research suggests that "needle exchange
programs can be an effective component of a strategy to prevent HIV and other blood
borne infectious diseases in communities that choose to include them." That statement is
backed up by empirical evidence (i.e., measurable differences in HIV transmission rates) in
several studies, including reviews by the GAO and the IOM.
Similar scientific evidence does not exist to meet the congressional test that needle
exchange programs also reduce drug use.
Q. Are you saying needle exchange programs encourage illegal drug use?
A. No, we are not saying that at all. What we are saying is that the evidence gathered to date
does not provide us with conclusive evidence that needle exchange programs do not
encourage drug use - the standard set by Congress. We will continue to support research
into this question.
02/18/97 TUE 15:02 FAX 2026905673
DHHS/ASPA
003
On Views on Needle Exchange:
Q. Do you think communities should fund needle exchange programs?
A. It is up to each community to decide if they want to fund needle exchange programs. It's
important to note that dozens of locally and privately funded needle exchange programs are
underway around the country. We are interested in reviewing their research, but it is
appropriate for local communities to take the lead.
Q. If you think the research shows this is a good policy, why not fund it?
A. Congress has set very high thresholds for funding such programs. Those hurdles have not
been met yet.
Q. Why not ask Congress to lift the ban or change the standards so that federal funds can be
used for needle exchange?
A. Congress has made clear its intent that both of the standards be met. We share Congress's
concern about making sure that our efforts do not encourage illegal drug use. We will
continue to work with Congress on this important matter.
Q. If you say needle exchange programs are effective in reducing HIV transmission, isn't it
unnecessary to fund the Alaska needle exchange demonstration?
A. The Alaska program looks at a very specific question - whether over the counter sales of
needles is more or less effective than a needle exchange program. These are two kinds of
interventions and they need to be evaluated. We have built in specific safeguards to make
sure this demonstration is conducted in an ethical manner.
Q. Isn't there $17 million in new federal funds for other programs designed to prevent
HIV/AIDS transmission among intravenous drug users? Are you going to use that money
for needle exchange programs - or for something else?
A. CDC plans to use those funds for other programs designed to prevent HIV/AIDS
transmission in this group - for education and treatment, for example. The goal of any
intervention with this group is to provide an entry into treatment programs and to reduce
the transmission of hepatitis and HIV.
02/18/07 TUE 15:03 FAX 2026905673
DHHS/ASPA
004
On Needle Exchange and Drugs:
Q. Why give needles to drug addicts at all? Why not just throw them in jail?
A. The intravenous use of illegal drugs is clearly a major law enforcement concern, and it is
also an urgent public health problem. We are extremely concerned with
preventing the spread of HIV, which is the leading cause of death among adults age
25-44, and the seventh leading cause of death among all Americans. The goal of
needle exchange programs is to provide an entry into treatment programs and to
reduce the transmission of hepatitis and HIV. To realize our goal of effective HIV
prevention, it is vital that we identify and evaluate sound public health strategies to
address the twin epidemics of HIV and substance abuse.
Researching NEPs is just one part of the Clinton Administration's intensive strategy of
AIDS research, prevention and treatment. We also have a comprehensive drug strategy to
prevent the use of illicit drugs, reduce drug-related crime and violence, reduce the number
of chronic drug users, and increase drug treatment capacity, outreach, and effectiveness.
Q. But doesn't NIDA grow marijuana, and doesn't FDA provide it to some seriously ill
patients?
A. NIDA grows marijuana for research purposes only. We stopped adding people to
the FDA's "compassionate use" program in 1992, and that policy was reexamined and
reaffirmed in 1994, based on a medical review by PHS.
Q. How can the Secretary say that the Clinton Administration wants to send "clear, consistent
no-use messages" about drugs, but still condone giving needles to drug addicts? Isn't that
inconsistent?
A. There is no inconsistency - we believe that any use of drugs is illegal, unhealthy and
wrong. We have also said consistently that illegal use of intravenous drugs can cause HIV
and AIDS.
The Clinton Administration has a comprehensive strategy of AIDS research,
prevention and treatment. We also have a comprehensive drug strategy to prevent
the use of illicit drugs, prosecute drug pushers, reduce the number of hard-core
drug users, and increase drug treatment options.
02/18/97 TUE 15:03 FAX 2026905673
DHHS/ASPA
005
On Background:
Q. What criteria has Congress required us to meet regarding federal funding for needle
exchange programs?
A. In its request for this report (Senate Report 104-368, p.68), the Committee specifically
asked us to report on the effect of clean needle exchange programs on reducing HIV
transmission, and on whether such programs encourage illicit drug use.
In addition, there are two public laws restricting the use of federal funding for
needle exchange programs until certain criteria are met, specifically:
Our appropriation, Public law 104-208, requires the Secretary to certify that such
programs reduce the spread of HIV and do not encourage drug abuse.
The second standard, in the Substance Abuse block grant, is even tougher. It
requires certification that such programs both reduce the spread of HIV and reduce
drug abuse.
Needle Exchange/AIDS Policy Office Director
February 12, 1997
There are several AIDS and needle exchange related events coming together at the end of this
week.
FYI BACKGROUND --
Tomorrow, the NIH concludes a three day conference addressing "at risk" behaviors
associated with AIDS, mostly centering on education, condom use, etc. The conference
was partly funded by NIH and outside groups. There is a final press conference
tomorrow, but it will be handled by NIH and shouldn't come to our press corps.
Saturday 2/15 is the deadline for the NIH to deliver a report to Congress on the status of
current research on needle exchange programs. (The report is actually expected to be
delivered to Congress on Tuesday. Folks here will be briefed later this week.) The report
is an examination of current research on needle exchange programs and does not make
recommendations pro or con. This will likely upset AIDS groups, which think enough
research has been done to lift the current federal ban on federal funding for needle
distribution.
Friday is Patsy Fleming's last day as Director of the Office of National AIDS Policy. We
are actively reviewing candidates to replace her, but have not yet made a final selection.
POINTS:
Q:
What is your position on needle exchange programs?
A:
There is a statutory prohibition on federal funding for needle distribution unless the
Secretary of Health and Human Services can determine 1.) That needle exchange programs
reduce HIV transmissions and 2.) That they do not encourage the use of illegal drugs. Up until
now HHS has not been able to determine that we can meet those standards, so federal funding
has not been available. To answer Congress' call for a study of needle exchange programs,
federal funding has been used to conduct research into whether such programs can work. Dozens
of local communities around the country have needle exchange programs which are privately
funded.
Q:
When will you have a new AIDS Czar?
A:
We are actively reviewing candidates and moving forward to find the best peson for the
job. (Off-the-record -- we will not let the position go vacant and will likely name someone in an
acting capacity Friday while the search goes forward.)
KMcKiernan per conversation with Melissa Skolfield, HHS, 690-7850 and Richard Sorien,
AIDS Policy Office
SENT BY:Xerox Telecopier 7020 :10-18-96 :10:35AM ;
2026321096-2024566210
:# 2
10-18-96
Additional points re:
aids
Illegal immigrants and AIDS care
The provision in the immigration bill that the Administration fought successfully to remove
would have permitted testing and treatment for communicable diseases, except for HIV or
AIDS. [Draft conference report, HR 2022, September 10, 1996]
This was described by the President of the American Public Health Association as "an
outrage against the public health." He said this would make it "much harder to control the
spread of HIV and AIDS." [Newsday, September 25, 1996]
Some are saying AIDS care costs $119,000 a year. The most recent estimate of the
lifetime (not annual) cost of AIDS treatment is $119,000 [Journal of the American Medical
Association, July 28, 1993].
Dical
*
Per Patsy Flemming, 632.1090
40-17-96 03:01PM FROM OASPA NEWS DIV
TO M. E. GLYNN/WH PRESS P002/004
10-18-96
ands
Note to White House Press Office (Mike, Mary Ellen, Kathy, April, et al)
From Victor Zonana, HHS
Alaska Needle Exchange Study Controversy
Background and TPs, and Q's & A's
Background: The public-interest group Public Citizen has asked the National
Institutes of Health to cancel a $2.4 million research project into the
effectiveness of needle-exchange programs in Anchorage, Alaska. The group
charges that the study is ethically flawed for a number of reasons, and goes SO
far as to compare the Alaska experiment to the infamous Tuskegree Syphillis
Study. In response to Public Citizen's letter, NIH director Dr. Harold Varmus
has agreed to review the study, which was not scheduled to enroll participants
until December.
All inquiries should be referred to NIH chief spokesperson Anne Thomas at 301-
496-5787. Here, however, are some TP's and Q's and A's.
NIH Director Dr. Harold Varmus has decided to review the study.
The fact that NIH is reviewing the Alaska study should not be construed as a
change in the federal government's policy on needle exchange. [The federal
government, by Congressional stricture, does not fund needle exchange
programs, but can fund research to determine whether such programs are
*
effective in slowing the spread of HIV and drug abuse.]
The study was not scheduled to begin enrolling participants until December.
The needles that would have been distributed in the study would not have
been paid for with federal funds, but by a private foundation.
Questions and answers:
Q: What is the purpose of the study?
A: To examine the relative efficacy of pharmacy sales versus a needle
exchange program on reducing risk behaviors and the transmission of Hepatitis
B and HIV in injection drug users.
10-17-96 03:01PM FROM OASPA NEWS DIV
TO M.E. GLYNN/WH PRESS P003/004
Q: What is Dr. Varmus' response to the Public Citizen letter?
A: Although he agrees with the need to conduct further research into the
effectiveness of needle exchange programs in reducing risky behavior, he has
asked for a review of the ethical issues and other questions that have been
raised.
Q: Does this mean that Dr. Varmus agrees with Public Citizen's assertion that
"almost all scientists who have conducted research in this area believe that
NEP's can reduce the risk of transmission of HIV and do not lead to increases in
drug use?"
A: No. He has questions about spending $2.4 million for a study in Alaska,
where there are so few people infected with HIV. He's also concerned about a
number of ethical issues, including the potential for drug users in both research
groups to contract Hepatitis B when an effective vaccine for this disease exists.
Q: Is the government re-assessing it's position on NEPs?
A: No. We're simply looking at the ethical and other questions that have been
raised in connection with this specific study.
Q: Is the federal government paying for the needles?
A: No. They are being paid for from local community funds from the Alaska
Science and Technology Foundation?
Q: Why was the Alaska study funded in the first place?
The study has been through multiple reviews. It was reviewed and approved by
the University of Alaska's Institutional Review Board. It was also approved by
the NIH's Office for the Protection of Research Risks. A Data and Safety
Monitoring Board will oversee this study and will have an oversight role over the
ethical issues involved.
Still, given the questions that have been raised, Dr. Varmus thought it was
appropriate to take another look.
10-17-96 03:01PM FROM OASPA NEWS DIV
TO M.E. GLYNN/WH PRESS P004/004
Basic HHS Needle Exchange Talking Points:
(Zonana/HHS)
-- We're deeply concerned about the spread of HIV.
--The issue of whether to provide federal funding for needle exchange programs is
complex and difficult.
-- As you know, Congress has set very high thresholds for funding such programs and
they would need to be proven to reduce both HIV transmission and drug use. That
hurdle has not been met. However, we are financing research into such programs.
- It's also important to note that dozens of locally and privately-funded needle
exchange programs are underway around the country. As our review of the research
continues, it's appropriate for local communities to take the lead.
Follow -up question: What are the Congressional restrictions?
There are two: Our appropriation requires the Secretary to certify that such programs
reduce the spread of HIV and do not encourage drug abuse.
The second standard, in the Substance Abuse block grant, is even tougher. It requires
certification that such programs both reduce the spread of HIV and reduce drug abuse.
07/08/96 MON 11:33 FAX 2026321090
AIDS POLICY
002
AIDS
"Progress Report" by the
President's Advisory Council on HIV and AIDS
Background
President Clinton created the President's Advisory Council on HIV and AIDS in
June 1995 to provide him and his Administration with an independent external
group to advise them on key policy issues related to the AIDS epidemic. The
Council has issued three reports. The Progress Report being released today
assesses the Administration's response to the first two sets of recommendations
issued in July 1995 and December 1995.
Key Points
The President has not yet seen the report. He is receiving it today.
We welcome the report as clear evidence that the President is responding
aggressively to the very real needs of the AIDS epidemic.
The report says, and 1 quote: "The President's personal leadership and
commitment in the battle against AIDs is clearly unmatched by his
)*
*
predecessors."
"This Administration has clearly made an unprecedented and laudable
investment of funding, human resources, and genuine personal
commitment."
As the report points out:
The President has increased funding for AIDS by 43 percent in the four
budgets he has presented to the Congress.
The President has used his personal leadership to rally the nation to respond
to the epidemic, including holding the first-ever White House Conference on
HIV and AIDS on Dec. 6, 1995.
The President has exhibited "consistent leadership" In defending Medicaid.
The President has more than doubled funding for the Ryan White CARE Act.
The Administration has strongly enforced the Americans with Disabilities Act
and its protections against discrimination against people with AIDS.
The President has made a "strong commitment" to AIDS research and
strengthening the Office of AIDS Research at NIH.
07/08/96 MON 11:33 FAX 2026321090
AIDS POLICY
003
Areas of Criticism
The report notes several areas where the Council would like to see further
progress. They include:
1. A National AIDS Plan. The Office of National AIDS Policy has drafted a
national AIDS strategic plan and it is in final review. It will be released next
month.
2. Housing for People with AIDS. In the first two years of the Clinton
Administration, funding for housing for people with AIDS increased by 43 percent.
One of the first votes of the Republican Congress was to eliminate funding for this
program. The President has successfully defended the program and continued its
funding. Secretary Cisneros is examining ways to further increase funding for this
program.
3. AIDS Prevention. The President has consistently requested additional funds for
AIDS prevention and the Congress has, so far, refused to approve those funds.
Despite that fact, we have launched innovative education programs recommending
abstinence and greater condom use. CDC has empowered local communities to
decide how to spend prevention dollars.
4. Needle Exchange. In 1988 and again in 1990, the Congress restricted use of
federal funds for needle exchange programs. State and local funds are used for
such programs when local government deems it necessary. Federal funds are used
to evaluate the effectiveness of those programs.
Richard Sarian 632-1090
5.19.97
AIDS VACCINE Q&AS
Q:
DOESN'T THE PRESIDENT'S CHALLENGE RING HOLLOW SINCE YOU
ARE NOT INVESTING ANY NEW RESOURCES DEVELOPING AN AIDS
VACCINE?
A:
The President has committed additional resources to developing an AIDS vaccine. In the
last two years, he has increased funding for the AIDS vaccine by 33 percent and his FY
1998 budget increases spending for AIDS vaccine research by $17 million.
Moreover, scientists have informed the President that it is not only money that we need to
meet the challenge of finding an AIDS vaccine, but that we also need to promote
collaboration between experts in this area. That is why the President has announced that
there will be a new AIDS Vaccine Center at NIH which will unite scientists in
immunology, virology, and vaccinology to join in a highly collaborative effort to develop
an AIDS vaccine.
That is also why is he calling on the leaders of the eight major industrialized nations
meeting at the Denver summit in June to support a worldwide AIDS vaccine research
initiative. These important initiatives are what scientists believe we need to do to fully
commit ourselves to the goal of developing an AIDS vaccine.
Q:
IN 1985, MARGARET HECKLER PREDICTED THAT WE WOULD HAVE AN
AIDS VACCINE IN TWO YEARS. THAT WAS OVER TEN YEARS AGO.
MOREOVER, AT A RECENT CONFERENCE, DR. ROBERT GALLO
INDICATED THAT WE MAY NEVER SEE AN EFFECTIVE AIDS VACCINE.
WHY SHOULD WE BELIEVE THAT THE PRESIDENT'S PROMISE THAT WE
CAN DEVELOP AN AIDS VACCINE IN A DECADE?
A:
We know much more about the AIDS virus today than we knew in 1985 or even in 1995.
Recent scientific advances have taught a great deal about how the AIDS virus infiltrates
the human and begins to destroy the human immune system. We have developed a whole
new series of drugs that inhabit the reproduction of the AIDS virus.
There are many credible scientists and medical researchers who are believe that it is not a
question of whether we will ever get an AIDS vaccine but when. The scientific leaders at
the National Institutes of Health have said that are extremely encouraged by recent
progress in the AIDS vaccine and believe that the development of a vaccine is feasible.
In fact, there were numerous presentations at the conference that spoke about the
tremendous progress we have made in the AIDS vaccine development and in vaccine
development in general.
The President announced today that we should commit ourselves to developing an AIDS
vaccine in the next ten years. He acknowledged that there are no guarantees. But he
believes that we should commit our energy, our focus, and the efforts from our greatest
minds to finding an AIDS vaccine.
Q:
HOW ARE THE INITIATIVES THE PRESIDENT ANNOUNCED TODAY
BEING PAID FOR? ARE THEY A PART OF THE BALANCED BUDGET
AGREEMENT?
A:
All of the costs for developing an AIDS vaccine are being paid for by NIH's existing
budget. NIH has already increased funding for AIDS vaccine research by 33 percent in
the last two years -- from $111 million in FY 1996 to $148 million proposed in the
President's FY 1998 budget. The President's FY 1998 budget alone calls for a $17
million increase.
Q:
IF WE ARE INVESTING MORE TO DEVELOP AN AID VACCINE AREN'T WE
TAKING AWAY FROM INVESTMENTS ON TREATING PEOPLE WHO
ALREADY SUFFER FROM THIS DISEASE?
A:
Since he took office, the President has made an extraordinary commitment to increasing
our investments in AIDS. Funding for AIDS research, prevention and care increased by
more than 50 percent in the first four years of the Clinton Administration. Funding for
AIDS Drug Assistance Programs (ADAP), which help low-income people purchase
needed therapies, has tripled, while funding for the Ryan White CARE Act increased 158
percent. The President believes that we need to continue to increase our investments in
all of these areas and his FY 1998 budget reflects that commitment, with additional
investments in AIDS research, prevention and care.
Q:
THE BALANCED BUDGET AGREEMENT CALLS FOR CAPS ON
DISCRETIONARY DOMESTIC SPENDING. WON'T ADDITIONAL FUNDING
FOR AN AIDS VACCINE MEAN LESS FOR OTHER IMPORTANT
PRIORITIES? WHY NOT EXPEND THIS KIND OF ENERGY AND
RESOURCES ON A CURE FOR BREAST CANCER OR HEART DISEASE OR
DIABETES?
A:
This Administration has made a strong improving biomedical research an extremely
important priority. We have increased investments in biomedical research at the National
Institutes of Health by an impressive 16 percent since the President took office.
These additional investments has been used to increase investments in biomedical
research in a number of important areas. For example, funding for breast cancer research
has increased by 76 percent since the President took office
Developing an AIDS vaccine is one important priority in our investments in biomedical
research. Without an effective vaccine, AIDS will soon take over as the leading cause of
death for persons between the ages of 25 and 44. Between 650,00 and 900,000 Americans
are estimated to be living with HIV and over 300,000 have died of AIDS.
While we have made enormous strides in the last year in treating AIDS, these treatments
are not always effective and are often prohibitively expensive both for Americans and
throughout the world. Also scientists at NIH believe that it is only a matter of time before
we develop an AIDS vaccine. Increasing our commitment to developing a vaccine could
make an enormous difference and save millions of lives both in this country and
throughout the world.
12-17-96
aids
Health
THE WHITE HOUSE
Office of the Press Secretary
For Immediate Release
December 17, 1996
Statement by the President
I am pleased today to receive the first-ever National AIDS Strategy. In the fifteen years
of this epidemic, we have never had such a unified strategy. This strategy represents an
important milestone in the history of the fight to defeat this epidemic.
The National Strategy reiterates our administration's and our nation's commitment to
winning the battle against AIDS. It establishes six major goals for our national efforts: to find a
cure and a vaccine; to reduce new HIV infections; to assure people living with HIV and AIDS
access to high-quality care; to fight AIDS-related discrimination at every turn; to lead the global
fight to end AIDS; and to translate our research advances into treatment as quickly as possible.
These goals will help to guide our work in the coming term, and more specifically in the
coming year. We have made significant progress in the last four years. Researchers working
toward a cure and a vaccine are reporting encouraging news and giving us hope. New
treatments, approved by the FDA in record time, are producing some very encouraging results in
terms of the quality of people's lives and the potential for extending the length of life.
This progress results from more than a decade of investment in AIDS research,
prevention, and care. I am very proud that in the four budgets my Administration has produced,
funding for AIDS programs has increased by 55 percent. We have also strengthened the Office of
AIDS Research at NIH and tripled funding for AIDS drug assistance programs.
Despite this progress, we must recognize that the AIDS epidemic is not over. Far too
many of our sons and daughters are still losing their lives to this epidemic every day. Far too
many are still becoming infected. We will win the battle against HIV, but to do so we must stand
shoulder to shoulder in the fight and we must build on the strides we have made. I am confident
that my Administration will do its part and that we have taken yet another step forward in that
battle today.
-30-30-30-
12/17/96 TUE 09:39 FAX 2026321090
AIDS POLICY
002
National AIDS Strategy
Talking Points
What is the National AIDS Strategy?
This is a time of extraordinary change in the AIDS epidemic and it is essential that the
government have its act together so that we can take advantage of these opportunities. The
Strategy does three things: First, it establishes six long-term goals for the President's second term.
Second, it establishes short-term opportunities for progress in the next 12 months to move us
toward these goals. Third, it lays out dollar-for-dollar what the government is spending NOW on
AIDS programs across the government.
What are some of those opportunities for progress?
One example is the new coordinated AIDS vaccine initiative at NIH headed by Nobel Laureate
Dr. David Baltimore. A second example is the recent progress in reducing the number of infants
born with HIV in this country That number has declined by 27 percent since the President took
office and we want to make further progress in the year ahead. Finally, a third area is the
development of better information for patients and their doctors on the best use of the new
combination drug therapies.
How is this different from the myriad of other plans that have been issued in the past?
This is the first time the Federal government -- and the President of the United States -- has put
together a comprehensive planning document. All of the commissions established in the past have
called for the development of such a strategy. This is not a report to be studied, it is a plan that
will guide this Administration's activities for the next four years.
Critics say the Strategy doesn't go far enough, that it's too vague, and that it dodges all the
controversial issues. Your response?
The Strategy is a far-reaching document that covers every Department of the Federal government
involved with AIDS. It lists specific opportunities for progress in the year ahead and provides a
framework our efforts to combat the epidemic. The implementation of this Strategy will involve
the relevant Federal Agencies, the private sector, community-based organizations, the Presidential
Advisory Council on HIV/AIDS, and people who are living with HIV and AIDS. It will be
directed by the Office of National AIDS Policy.
What about needle exchange programs?
The report clearly identifies drugs users and their sexual partners as a population that requires
priority attention. The question of how to specifically address those issues is part of the
implementation process. The Congress has asked the Department of Health and Human Services
to prepare a report on this issue that is due in mid-February. It would be inappropriate for this
Strategy to interfere with or pre-empt that process.
12/17/96 TUE 09:39 FAX 2026321090
AIDS POLICY
1003
Why did it take so long?
The development of this Strategy began a little more than a year ago. It required the involvement
of all relevant Federal Agencies. But more importantly it also required outreach to those who are
on the front lines of the epidemic. The Office of National AIDS Policy conducted 13 town hall
meetings around the country to ask the affected communities what they would like to see in a
National AIDS Strategy and what kind of goals the President should set. This input was
extremely valuable to the creation of this document. We also sought the advice of the Presidential
Advisory Council on HIV/AIDS and national AIDS organizations.
What difference with this Strategy make in the lives of people with AIDS?
It is our hope that it will make a significant difference in terms of better treatments for people
living with AIDS not only in this country but for people around the world. They will have better
information about the way those treatments should be used and better prevention programs to
protect people from infection.
How will the departure of Patsy Fleming as National AIDS Policy Director affect this
Strategy?
Ms. Fleming has indicated her intention to step down in mid-February and the process of choosing
a new director is already underway. We fully expect the new director to be on board when Ms.
Fleming leaves. The new director will be an important player in the implementation process.
AIDS REPORT
Q: Why unveil an AIDS strategy?
There has been a significant increase in spending in the area of AIDS and many agencies are
involved. Today's report establishes unified strategy to make the most new resources and ensure
that research advances translate into clinical practice.
Q: Does the Administration have a strategy to combat any other major diseases
The Department of Health and Human Services has a strategy to fight breast cancer, the National
Cancer Institute obviously has a plan for fighting cancer more broadly, and on any disease the
Department of Health and Human Services coordinates with the National Institutes of Health and
the Center for Disease Control among others.
While AIDS is not the only disease with a plan, it is one in which there has been amazing
breakthroughs recently (i.e. protease inhibitors). AIDS remains an infectious disease which
continues to spread without a cure.
Per JBen-Ami, Mskofield, VZonana
Recent AIDS statements
1. On December 3rd 1996, the President met with Secretary Shalala, research leaders from NIH,
and prevention leaders from CDC for a briefing on the progress in AIDS research. (pool
coverage)
2. In October, the President and Mrs. Clinton visited the Names Project Quilt. He was the first
President to visit the Quilt. The Vice President and Mrs. Gore also read names at the Quilt. (
pool coverage)
3. On May 20, 1996 -- the President signed the Ryan White Care Act in a public ceremony in the
Roosevelt Room (pool coverage)
4. In his State of the Union Address, the President made reference to AIDS and cited the disease
as one of the reasons to preserve Medicaid eligibility.
6. December 5, 1995 - the President convened the first ever White House Conference on AIDS
at which he delivered a major address. (pool coverage)
(Later that day, when he vetoed the Republican budget, he cited its impact on AIDS (through
Medicaid) as one of the reasons he took such action)
Additional dates of significance:
July of 1995, he met with his presidential advisory council on AIDS
November 10, 1994, the President announced Patsy Fleming as Director of the Office of AIDS
Policy
June 1993, he announced the creation of a National AIDS Policy Office and named Kristine
Gebbie
December 1, 1993, the President delivered a major policy address at Georgetown (World AIDS
Day)
Per Richard Sorian
4.23.97
GUIDANCE ON HIV EXPERIMENTS IN AFRICA
APRIL 23, 1997
(Post piece today (attached) suggests that HHS-sponsored AIDS-related experiments in Africa
are giving placebos to people inappropriately, thus denying them the benefits of AIDS drugs,
leading to comparisons to Tuskegee.)
*
A variety of different trials are planned to help find treatments that can prevent mother-to-
child transmission of HIV in developing countries.
The full AZT regimen, which is the standard of care in this country, is not
economically feasible for these countries. In cooperation with international health
agencies and the host governments, we are seeking treatments that will be effective,
affordable, and practical in those countries.
I want to point out that the Department of Health and Human Services has worked
with the World Health Organization, UNAIDS, and the host governments to design
these trials, and they are fully supported by the international bodies and the host
governments. Likewise the trials have been reviewed from an ethical standpoint by the
CDC and NIH institutional review boards and by the host countries.
Nevertheless, the Public Citizen letter makes some serious charges, and HHS is reviewing
those charges. They will certainly be prepared to say more when they have had an
opportunity to do that.
TOIV
Based on guidance from HHS
By David Brown
Washington Post
A
al watchdog organization
said Jack Killen, director of the divi-
yesterday charged that the U.S. gov-
sion of AIDS at the NIH's National
ernment was sponsoring nine medi-
Institute of Allergy and Infectious
cal studies in the developing world
Diseases.
that are unethical because they fail
A landmark study, published in
to provide all pregnant women with
1994, found that the mother-to-child
a drug that could protect their in-
rate of transmission of HIV could by
fants from acquiring the AIDS virus
cut from 23 percent to 8 percent if
during childbirth.
the pregnant woman was given AZT
AIDS Drug Tests in Africa for Using Placebo
The studies seek to learn whether
tablets for the last one-third of her
brief use of AZT, or other drugs, will
pregnancy, intravenous AZT during
decrease the mother-to-child trans-
labor, and if the newborn got the
mission of human immunodeficiency
drug for the first six weeks of life. In
virus (HIV). A complicated, three-
a more recent study, the transmis-
part treatment with the antiviral
sion rate with treatment dropped to
drug AZT reduces that transmission
4.8 percent. The cost of that pre-
by two-thirds, but is viewed by gov-
ventive treatment ranges from $400
ernments and AIDS researchers as
to $900.
far too expensive and cumbersome
for the developing world.
Because many countries with high
The key criticism voiced yester-
prevalence of AIDS are unable to af-
day was that the studies included
ford that regimen or, in many places,
some HIV-infected women who are
deliver the intravenous medicine
being randomly assigned to receive
even if it were available, many AIDS
no AZT or other "active" drug any-
researchers wondered if a simpler,
time during the experiment. In the
cheaper, but still effective alterna-
countries where the studies are be-
tive existed.
ing carried out-mostly nations of
The countries. include Ivory
West and Central Africa-AZT is
Coast, Uganda, Tanzania, South Af-
largely unavailable.
rica, Ethiopia, Burkina Faso, Malawi,
"These are as unethical as any ex-
and Zimbabwe. In all, more than
periments we have ever seen since
12,000 women are involved in the
the end of the Second World War,"
U.S.-funded studies. All participation
said Sidney Wolfe, director of the
is voluntary, and the women are
Public Citizen Health Research
counseled on the infection and the
Group, an organization that analyzes
details of the study.
research, treatment and public
health policy.
In most of the studies, the length
of time women take AZT before de-
"What has happened here is Tus-
keegee, part two
in which even
livery, as well as the length of time
more people will die," said Peter Lu-
their babies take it after birth, has
rie, an AIDS researcher who assis-
been shortened. Pills have been sub-
ted Wolfe in analyzing the studies.
stituted for the intravenous dose giv-
Lurie's reference was to the infa-
en during labor. In some of those
The Washington Post
WEDNESDAY, APRIL 23, 1997
mous four-decade study in which
three treatment intervals, a placebo
black Alabama sharecroppers with
is given instead of AZT. In most of
syphilis were observed and not of-
them, there is one "arm" of the study
fered treatment until long after it
in which women and babies get only
was widely available.
placebo.
In a letter distributed to reporters
At the news conference, Wolfe
at a news conference here, Wolfe
and Lurie said that about 1,000 ba-
asked Donna E. Shalala, secretary of
bies are likely to become infected
health and human services, to order
with the AIDS virus because their
researchers to provide all women is
thers are randomly assigned to
the studies with at least some AZT,
these all-placebo options. While they
since that drug has been shown to be
caid they do not object to studies
more effective than nothing.
that give women placebo for some of
Seven of the studies are being
funded by the National Institutes of
the intervals, the all-placebo arms
Medical Group Condemns U.S.
Health (NIH), and two by the Cen-
are unethical because they, in effect,
ters for Disease Control and Preven-
knowingly give experimental sub-
tion (CDC).
jects substandard care.
Various scientists and officials
However, Timothy Dondero, of
overseeing the experiments, how-
the CDC, said the sort of studies
ever, said they reached consensus
Wolfe and Lurie advocate would not
years ago that the experiments criti-
answer the fundamental question: Is
cized by Wolfe were etnical and well-
any drug treatment better than the
designed. They said it is escential to
treatment women are getting now?
compare."short-course"AZTutreaty compare "short-course"
Both Dondero and Saba said that
ment to what infected pregnant
in order to marshal international
women in the study countries now
support and money for HIV testing,
are getting-which is nothing. All of
counseling and treatment for mil-
fies in question have been ap-
lions of pregnant women in poor
proved by research review boards in
countries, scientists must present
the United States and the host coun-
unassailable proof of AZT's effec-
tries.
tiveness-which requires trials that
"All this debate came up in 1994,
include-all-placebo arms.
and it was felt that the best way to
Further, Saba said, doing studies
go, and the best interest of the de-
without all-placebo arms would take
veloping world, was to have placebo-
far longer, delaying implementation
controlled trials, where you get ac-
of potentially effective treatment
curate data quickly," said Joseph Sa-
and resulting in far more HIV
ba, a research official of UNAIDS,
deaths.
the new AIDS program run by the
United Nations, World Health Orga-
nization, World Bank, and several
other international agencies.
"These studies are attempting to
define regimens of treatment that
are actually usable in most of the
world. They have been put together
with extraordinary support and con-
sensus on an international level,"