**Presidential Advisory Council on HIV/AIDS**

April 24-26, 1996

Radisson Plaza Hotel

Alexandria, VA

**Members present**

R. Scott Hitt, M.D., Chair, Stephen N. Abel, D.D.S., Terje Anderson,
Regina Aragon, Mary Boland, Nicholas Bollman, Tonio Burgos, Jerry Cade,
M.D., Robert Fogel, Debra Fraser-Howze, Kathleen Gerus, Edward Gould,
Phyllis Greenberger, Bob Hattoy, B. Thomas Henderson, Carole laFavor,
Jeremy Landau, Alexandra Mary Levine, Steve Lew, Helen H. Miramontes,
Altagracia Perez, Michael Rankin, M.D., H. Alexander Robinson, Debbie
Runions, Benjamin Schatz, Richard W. Stafford, Denise Stokes, Sandra
Thurman, Bruce Weniger, M.D.

**Opening Remarks**

Chair Dr. Scott Hitt welcomed members of the Presidential Advisory
Council on HIV/AIDS to the third meeting of the Council, voicing his
certainty that the meeting would be very productive. He then introduced
Ms. Patsy Fleming, Director, Office of National AIDS Policy (ONAP).

**Administration Presentation**

Ms. Fleming reported that the Administration had won a major victory the
preceding evening, when Congress repealed the amendment to the
Department of Defense reauthorization bill that would have mandated the
discharge of all military service personnel who test positive for HIV.
She said that the Continuing Resolution passed by Congress contained
favorable figures for AIDS for this fiscal year. Funding for the Ryan
White CARE Act program was increased by more than \$100 million over its
FY 1995 level. The Continuing Resolution did meet the President\'s
budget request for all other AIDS programs. There was a funding decrease
of \$4 million in the AIDS Education and Training Centers program in the
Health Resources and Services Administration (HRSA), however.

Ms. Fleming also recounted the Administration\'s accomplishments in AIDS
policy, including a 40-percent increase in funding commitment to AIDS
research, prevention, and care at a time when virtually all government
programs have been cut. She also credited the Administration with
strengthening the Office of AIDS Research (OAR) at the National
Institutes of Health (NIH) and the Administration\'s use of enforcement
authority to confront AIDS-related discrimination. She also noted the
accelerated approval process for AIDS drugs by the Food and Drug
Administration (FDA) and President Clinton\'s request, which was granted
by Congress, for an additional \$52 million in funding for the AIDS Drug
Assistance Program.

Ms. Fleming reported that Vice President Gore has met with
pharmaceutical manufacturers to spur communication and cooperation in
the development of vaccines, therapeutics, and microbicides. In the
summer of 1996, officials from around the United States will meet in
Atlanta to discuss coordinating AIDS prevention and substance abuse
prevention.

She also discussed Administration efforts to build on the momentum
established at the December 1995 White House Conference on AIDS through
visits by senior Administration officials and Council members to local
communities and AIDS service organizations. Other Administration efforts
establish and maintain a strong partnership between Government and
populations affected by HIV and AIDS and involve persons outside
Government to assess and suggest improvements in AIDS programs at the
Centers for Disease Control and Prevention (CDC) and the NIH.

ONAP is trying to focus attention on people most vulnerable for HIV
infection, such as women, communities of color, and young people,
especially young gay and bisexual men, Ms. Fleming said. The recent
report to the President on youth and AIDS has sparked discussion
throughout the country. More than 30,000 copies of the report have been
requested.

Ms. Fleming said that, despite its recent victories in Congress, the
Administration did not achieve all of its goals and that much remains to
be done. The Administration believes that funding for AIDS prevention
should be increased and will fight for such increases in the FY 1997
budget. Other priorities include full budget authority for the OAR and
protection of the Medicaid program. She noted that The President has
withstood tremendous pressure from the Republicans in Washington and in
the States who want to dismantle Medicaid. While grateful for the
support of Council members and others throughout the country for their
efforts to preserve Medicaid, she warned that they must continue to
oppose the efforts of the Republican leadership in Congress to destroy
Medicaid.

Ms. Fleming concluded her presentation by outlining the following major
challenges facing the Council:

· How to provide quality care and services in a changing delivery
system---not only by protecting Medicaid and increasing Ryan White CARE
Act funding but also by addressing a host of issues associated with the
trend toward managed care.

· How to address more effectively the dual epidemics of HIV and
substance abuse.

· How to slow the epidemic among young people---especially young gay men
of color.

· How to further strengthen AIDS research efforts by implementing the
report of the NIH AIDS Program Evaluation Working Group, by
reauthorizing OAR, and by compelling Congress to restore OAR\'s budget
authority.

· How to ensure that housing needs are addressed so that housing
programs keep pace with the epidemic.

· How, in a climate increasingly hostile toward international aid
cooperation, to maintain support for the international effort against
AIDS.

**Council Discussion**

Council members expressed thanks to the ONAP staff for their hard work
and their appreciation to the Administration for its efforts to repeal
successfully the Department of Defense amendment that would have
resulted in HIV-infected military personnel being forced out of the
armed services. They also noted that, for the first time in the AIDS
epidemic, there has been a rapid response to AIDS policy recommendations
from the Administration.

Council members then discussed its role and relationship to previous
advisory bodies on AIDS, such as the National Commission on AIDS (NCOA).
Dr. Hitt noted that, so far, the Council has made 37 recommendations.
Unlike previous groups that have made recommendations for action, the
Council has asked for and incorporated the Administration\'s response to
the recommendations and provided assessments and action plans that are
continually updated. He then outlined the recommendations and steps
taken by other advisory groups and efforts to determine which of these
recommendations remain relevant to the Council\'s work today. NCOA, for
example, made 210 recommendations, many of which were not directed
toward the Executive branch, he said. Many of these recommendations are
no longer timely, such as those written before the implementation of the
Housing Opportunities for Persons with AIDS (HOPWA) program or passage
of the Ryan White CARE Act.

Council members discussed how best to proceed with their
recommendations, such as how to distribute them in order to obtain
feedback. Dr. Hitt said that the set of recommendations developed at the
Council\'s December meeting has been distributed to the 300 participants
at the White House Conference on AIDS and that feedback has been very
positive. Others suggested that the Council focus on its action plan in
order to avoid the impression that it is simply repeating what previous
commissions have done.

Members then discussed and voted on a series of proposed new
recommendations to the President before breaking into meetings of the
Council\'s Services, Prevention, and Research Subcommittees. The
Prevention and Research Subcommittees had met the previous evening to
review recommendations. The Services Subcommittee held a day-long
meeting April 24 to hear from a variety of speakers on issues such as
epidemiology, housing, substance abuse treatment, and managed care.

When the meeting resumed on April 26, Jeff Levi, Deputy Director of
ONAP, noted that one of the issues to emerge from Vice President Gore\'s
meeting with representatives from the pharmaceutical industry was how to
conduct good post-marketing trials of new drugs. Vice President Gore has
suggested that this issue should be addressed by a dialogue among
Government officials, researchers, pharmaceutical companies, third party
payers, and consumers. He has asked the Keystone Center to convene such
a group to conduct a dialogue on this process. The group, slated to
begin meeting the end of April 1996, is charged with issuing a report by
August 1.

**Presentation from the Research Subcommittee**

**NIH AIDS Research**

Dr. Alexandra Levine, chair of the Council\'s Research Subcommittee,
reported that it had met the previous afternoon with representatives
from OAR and participants in the recently completed external review of
NIH AIDS activities. She noted that OAR was established in 1988 but had
no authority until 1993 and that the NIH budget for AIDS research totals
\$1.4 billion per year and is spread out over its 24 Institutes,
Centers, and Divisions.

A summary report of the extensive review by outside scientists and
activists of all NIH-supported AIDS research activities was released in
March. The report of the NIH AIDS Research Program Evaluation Working
Group is also known as the Levine report, named after the Working
Group\'s chair Dr. Arnold Levine, a respected researcher who was chosen
because he is not involved in AIDS research. Dr. Alexandra Levine
reported that the Working Group made 14 major recommendations on how NIH
should conduct and support AIDS research:

1\. Increase support for investigator-initiated research to double that
of the current level.

2\. Establish a trans-Institute vaccine development effort, with more
funding and an increased emphasis on basic research.

3\. Increase funding for studies of basic human immunology.

4\. Develop a comprehensive HIV prevention agenda that includes
behavioral, biomedical, and social components.

5\. Integrate all NIH-supported adult clinical trials into one network.
The NIH\'s current support of a variety of clinical trials networks,
each with its own data bases, is inefficient.

6\. Refocus and restructure of the National Cancer Institute\'s \$53
million per year AIDS drug screening program.

7\. Increase basic research on opportunistic infections, such as
cryptosporidiosis, and disseminate research findings for early clinical
evaluation.

8\. Strengthen the scientific base for the assessment of complementary
and alternative therapies for AIDS. Establish an ad hoc advisory group
to catalog studies currently being conducted with therapies and sponsor
workshops on issues such as methodology.

9\. Open NIH-supported Regional Primate Research Centers to the outside
scientific community.

10\. Increase funding by 50 percent for the NIH\'s 16 AIDS Research
Centers to promote multidisciplinary research including psychosocial,
behavioral, virology, and immunology research. Increase access by
outside scientists to these centers.

11\. Establish, coordinate, and make accessible national tissue banks
and data bases.

12\. Upgrade NIH AIDS information systems in order to track research
activities and projects accurately.

13\. Develop and implement a clear and uniform definition of AIDS and
AIDS-related research to ensure that monies for AIDS research are being
spent on such research.

14\. Preserve a strong OAR.

Dr. Levine noted that the Research Subcommittee\'s final comments on the
report will await the final reports from the six Area Review Panels of
the Working Group, which will provide more detailed recommendations in
specific areas of AIDS research as well as input from constituents.

Asked about the responsiveness of OAR to recommendations in the report,
Dr. Levine said OAR appears to be very receptive but it still lacks the
budget authority needed to implement the recommendations. Congress has
not supported Administration efforts to consolidate the AIDS budget
within OAR but instead gave OAR a 3 percent transfer authority to move
funds. She said that congressional recognition of OAR\'s authority is
very important, adding that the Subcommittee supports the Council\'s
recommendation for budget authority for OAR. OAR cannot coordinate AIDS
research activities unless it has the authority to determine where the
money should be spent, she emphasized.

**Vaccine Development**

Dr. Levine also reported on a recent conference call between
Subcommittee members, participants in the NIH review, vaccine
researchers, and advocates to discuss the status of AIDS vaccine
research. She noted that extensive gaps remain in the research to date
and that, for each year\'s delay in developing an effective vaccine,
more than 50,000 people are lost. An ongoing controversy in the
development of an effective AIDS vaccine continues to be the debate over
the balance between basic and applied research and whether to proceed
with large-scale testing of existing vaccines.

Dr. Levine also reported on a new international vaccine development
initiative being headed by Dr. Peggy Johnston, a former official with
the Division of AIDS at the National Institute of Allergy and Infectious
Diseases. Funded with money from sources such as the Rockefeller
Foundation and other countries, the initiative will distribute research
funding to institutions and researchers throughout the world in an
effort to accelerate vaccine development. Dr. Levine said the
Subcommittee finds the new initiative to be an excellent model for
collaboration and cooperation and supports it.

**Council Discussion**

No formal presentations were made by the Services and Prevention
Subcommittees.

Dr. Hitt discussed the need for an executive summary to accompany the
Council\'s recommendations. The summary will contain an overview of the
Administration\'s progress and explain the Council\'s response. The
summary and recommendations could be distributed both in print and
electronically, by placement on a World Wide Web site such as the
CDC\'s, he suggested.

Council members suggested the executive summary acknowledge the
Administration\'s high degree of responsiveness but point out that much
more needs to be done. They also suggested that the Council focus on
listening to the community and seeking input from across the country.
The Council will need to emphasize that this executive summary, and the
recommendations, is an ongoing progress report and that the Council has
only just begun to examine some areas, such as AIDS in adolescents and
housing and services issues. Members advised that the executive summary
state that prevention efforts have been difficult due to political
pressures.

Dr. Hitt noted the importance of distinguishing between what the Council
has done and its role in relation to NCOA and previous commissions.
While the latter conducted hearings and fact-finding visits, this
Council is focusing on a more fundamental and practical action plan, he
said. Members added that the Council must assess the Administration\'s
response to the previous recommendations, and decided to designate a
person from each Subcommittee to carefully review the previous
recommendations and identify which are still relevant and/or have not
yet been addressed.

Council members then discussed the continuing need for additional
staffing for ONAP and measures to relieve the overworked staff. They
agreed that the lack of staffing has diminished the Council\'s
effectiveness.

Members also considered how best to address crosscutting issues such as
chemical dependency and substance abuse, Medicare and Medicaid funding
and managed care, and the international dimension of the AIDS epidemic.
Dr. Hitt asked Council members to send suggested topics for future
meetings to him in writing.

Members suggested that the Council include community and other
appropriate representatives at its September meeting. It was also
suggested that regular conference calls between Subcommittee chairs
could facilitate the development of recommendations in crosscutting
areas.

**ONAP Town Hall Meetings**

Mr. Richard Sorian told the Council about the regional \"town hall\"
meetings that ONAP is holding across the country. To date, the office
has held meetings in New York City and Texas, attended by ONAP staff,
Council members, and Administration officials such as Health and Human
Services Secretary Donna Shalala and Assistant to the President for
Domestic Policy Carol Rakso. The meetings include discussions with
representatives from the local communities as well as talks with local
media and business representatives.

Council members applauded this effort but expressed concern about the
apparent focus on urban areas and the exclusion of visits planned to the
Plains and Mountain States as well as the Pacific Northwest and New
England. Ms. Fleming noted that she has visited Vermont and that ONAP
staff have been to rural areas. She and Mr. Sorian emphasized that the
visits will continue beyond those projected through August and that
additional sites can be added. Mr. Sorian added that the meetings are
based on funding assistance from outside organizations. Dr. Hitt asked
Council members to be proactive and suggest ideas for locations for such
meetings.

Council member Dr. Stephen Abel, who participated in the meeting in the
South Bronx, said that the meetings represent a commitment on the part
of the Council to act as the community\'s conduit to the White House.
Members appeared to agree with Dr. Hitt\'s recommendation that the
meetings remain open to the community, even though they may become
\"rough.\" Mr. Sorian noted that ONAP asks community members in the
locations what type of meeting is best suited for that locale and that
such meetings provide a needed opportunity for affected persons and
communities to express their anger.

**Other Business**

In other Council business, members voted to approve a recommendation
that the Council ask for the Administration\'s position on proposed
legislation that would address product liability issues for persons who
have become HIV infected through blood products.

They also approved a new recommendation from the leadership Subcommittee
that President Clinton and Vice President Gore accept an invitation to
co-chair and attend the display of the AIDS Quilt in Washington, DC, in
October.

Members also discussed gaps in representation on the Council,
particularly the proportionally small representation of African
Americans and youth, and ways to reach out to those communities in order
to make their voices heard.

The Council adjourned at 3:30 p.m.