**Presidential Advisory Council on HIV/AIDS**

April 5-8, 1997

Madison Hotel

Washington, DC

**MINUTES**

**Present:** R. Scott Hitt, M.D., Chair; Stephen N. Abel, D.D.S.; Terje
Anderson; Judith Billings; Tonio Burgos; Jerry Cade, M.D.; Rabbi Joseph
A. Edelheit; Robert Fogel; Debra Fraser-Howze; Kathleen Gerus; Phyllis
Greenberger; Robert Hattoy; B. Thomas Henderson; Michael Isbell; Ronald
Johnson; Jeremy Landau; Alexandra Mary Levine, M.D.; Steve Lew; Helen M.
Miramontes; Rev. Altagracia Perez; Robert Michael Rankin, M.D.;
H. Alexander Robinson; Debbie Runions; Benjamin Schatz; Richard W.
Stafford; Denise Stokes; Sandra Thurman; and Bruce Weniger, M.D. Also
present from the Office of National AIDS Policy (ONAP): Eric P. Goosby,
M.D., Acting Director; Daniel Montoya, Executive Director; Tiffany
Bronson; and Jason Wright.

**Absent:** Regina Aragon, Mary Boland, Nicholas Bollman (participated
in Committee meetings via conference call), and Charles Quincy Troupe.

**Opening and General Council Business**

Dr. Hitt, Chair, opened the sixth meeting of the Presidential Advisory
Council on HIV/AIDS (PACHA) with a review of the agenda and report on
interim activities. A number of significant issues and actions were
addressed during the 4-day meeting, including the following:

**New ONAP Director and Staff:** On April 7, members attended a press
conference at the White House during which the President named the new
Director for the Office of National AIDS Policy (ONAP)---Ms. Sandra
(Sandy) Thurman, PACHA member and former Executive Director of AID
Atlanta. Dr. Eric Goosby, Director of the Office of AIDS in the
Department of Health and Human Services (HHS) was named Deputy Director,
having served as ONAP's Acting Director since Patsy Fleming left the
position in February. Daniel Montoya was named Executive Director,
serving as liaison with PACHA. Other new ONAP staffers introduced at the
Council meeting were Jason Wright and Tiffany Bronson. Dr. Hitt said
that PACHA expects important changes in ONAP, including better
coordination between HHS and the White House, and ONAP pledged to
continue to support the Council and to work "more aggressively with the
Administration." A reception in the Indian Treaty Room of the Old
Executive Office Building that night honored Ms. Thurman, Dr. Goosby,
Mr. Montoya, Ms. Fleming, and Jeff Levi, former Deputy Director.

**Responses to Recommendations:** Responses from the last PACHA meeting
have been provided by HHS (collated by Dr. Goosby), the Office of the
Under Secretary of Defense, the Department of Housing and Urban
Development (HUD), the United States Agency for International
Development (USAID), and the Department of State. The Council agreed
that a new evaluation of Administration responses to all Recommendations
should be conducted before the next meeting (see New Business, below).

**PACHA Charter:** The Council has been rechartered automatically for
another term.

**ONAP Update**

Dr. Goosby, thanked by the Council for his help during a "difficult
transition," discussed HIV/AIDS-related issues and activities, including
his recent experience working with the White House. Describing "high
levels of activity and anxiety" surrounding White House staff and the
number of opportunities for mistakes that can impact HIV/AIDS programs,
he stressed the ongoing need for PACHA to have a "clear and constant
dialogue" with the Administration, especially regarding domestic policy.
ONAP's continuing mission is to foster this dialogue and to work across
all agencies and organizations dedicated to HIV/AIDS research. He said
"this is an extraordinary time" when a convergence of unique forces,
long in evolution, are impacting the epidemic. Difficulties exist
because of the differences in treatment and delivery systems and in
patient populations; however, infrastructures are being augmented,
protease inhibitors (PIs) seem to be decreasing death rates, risk
behaviors are being considered more in prevention, and HIV transmissions
are lessening in this country, including a 27-percent drop in the number
of children acquiring the virus through vertical transmission. The
possibility of immunopotentiators and their roles are very promising,
and collaborative efforts to look at indirect evidence support the idea
that a drop in viral load is in correlation with one's ability to infect
another individual.

Gaps are seen in technology and in determining and delivering effective
therapeutic interventions, and filling service capability holes must be
a priority of every budgetary consideration. Other important converging
issues include Welfare Reform, Medicaid eligibility, definition of
disability, and the role and evolution of managed care. Of great impact
are the diametrically opposed concepts of providing adequate response to
the needs of diverse populations and maintaining efforts to contain
costs. The Federal Government is less effective than it should be, in
large part because the leadership lacks the experience and understanding
of the issues. The AIDS community must monitor and stress quality of
care with sensitivity to population differences as the country moves
from Federal to State and local programs, with the potential for people
to become lost in or hurt by the system. Knowledgeable health care
providers with the ability to design effective programs for individual
patients and manage multiple therapy protocols are needed, and the
knowledge base must be distributed across all populations. Additionally,
a better mechanism is needed for allocation decisions that correlate
with the demographics of the epidemic. The potential for effective and
meaningful work is available within the White House.

**Survey/Questionnaire Review**

Dr. Hitt thanked Ms. Billings for help in developing the questionnaire
for PACHA's "HIV/AIDS Federal Support Survey" and Mr. Wright for
compiling the responses. Ms. Billings said that more than 30 responses
were received out of 300 surveys sent to White House conferees, local
organizers of community briefings, and AIDS organizations around the
country. Respondents included health care workers, academics,
politicians, researchers, and persons with HIV/AIDS, most representing
community-based organizations (CBOs) and health services. A "fair amount
of agreement" with Council priorities and its role was found, and common
themes included the need for more emphasis on new high-risk populations,
realism about prevention efforts, affirmative action on approving needle
exchange, and strong congressional and Presidential leadership and
response to controversial issues.

Mr. Fogel believed that the response base was too low for statistical
use, but Ms. Billings said that answers were consistent enough to offer
broad guidelines. Dr. Hitt noted that most responses reflected the
opinions of large organizations, and Mr. Henderson called this "sound
input from effective people" and an important evaluation. Dr. Hitt,
Dr. Levine, and Rev. Perez asked participants in a recent Los Angeles
meeting of CBOs the survey questions and found that their answers
corresponded with the written responses. He encouraged all members to go
back to their communities to get input about "what we are doing and
where we should be going."

Mr. Wright will perform a further breakdown of respondents by ethnicity
and other factors for Council use, and ONAP will furnish copies of all
responses to committee chairs and other members who want them.
Committee-specific recommendations will be highlighted, if requested by
Chairs.

**Needle Exchange and Substance Abuse Updates**

Dr. Goosby provided the Council with a report---*Needle Exchange
Programs in America: Review of Published Studies and Ongoing
Research---*made to the Committee on Appropriations for the Departments
of Labor, HHS, Education, and other agencies in February by HHS
Secretary Donna E. Shalala. Other background was provided, including a
national survey on needle exchange programs in the United States in the
*Journal of the American Medical Associatio*n (*JAMA*) and an overview
of vaccines and politics in the *Wall Street Journal*.

During meetings of the Prevention and Research Committees, outside
panelists discussed the need for a national HIV/AIDS and substance abuse
prevention strategy, particularly through lifting Federal bans on
funding and modification of State and local regulations on purchase and
possession of clean syringes. Studies indicate that clean needles save
lives, and integration of needle exchange into a comprehensive strategy
to reduce HIV infection related to injection drug use can produce
significant savings.

**Coburn Bill Update**

The Coburn Bill---the HIV Prevention Act of 1997---has been submitted to
Congress, and a resolution may be forthcoming, Dr. Hitt said. A
Statement of Policy on HIV/AIDS by the National Governors' Association
regarding the bill was provided to PACHA, which developed a
Recommendation regarding the HIV Prevention Act conference (see New
Council Recommendations, below).

**New Assistant to HHS Secretary**

Ms. Fleming introduced Marsha Martin, D.S.W., recently appointed Special
Assistant to Secretary Shalala. The former director of homeless
activities under HUD and at the Department of Veterans Affairs (VA) was
commended by Dr. Rankin for "a superb job with homeless veterans," and
Dr. Martin thanked ONAP for helping her get up to speed in her new job.
Calling homelessness "unacceptable" and funds from the Federal budget
"too small for such a big problem," she admonished government to face
its responsibility in this arena. The VA, the single largest provider of
HIV treatment because of the number of veterans with the disease, is
developing a care plan that will be open to the total community and will
include sharing agreements and bartering for services such as clinical
and hospital facilities. Dr. Martin asked PACHA to provide input to her
office and to call on her for assistance (212-690-5400).

**Discussion of Domestic Policy**

Dr. Hitt said that the AIDS community is finding that it has good access
to and response from Bruce Reed, recently named Assistant to the
President for Domestic Policy. Dr. Hitt thanked Mr. Reed for his
advocacy and help, including facilitating a meeting between the National
Organization Responding to AIDS (NORA) and the Deputy Chief of Staff to
the President, speeding the appointment of the ONAP Director, and
meeting with PACHA prior to the Council session to discuss major issues,
Recommendations, and Welfare Reform.

Mr. Reed addressed the Council on new ONAP leadership, the state of
HIV/AIDS programs, and the Administration's commitment to finding a cure
and a vaccine. He thanked the Council for its contributions and
Dr. Goosby for an "outstanding job in a tough situation." He said that
Ms. Thurman is a "tribute to the Council," with both proven experience
and the support of the President to make a success of the Director's
job. For the first time, the ONAP Director will have an office in the
White House and meet regularly with the President's staff.

Mr. Reed described the progress made in HIV/AIDS research over the past
4 years, calling the advances a "sign for us to do more, not less." The
Administration has an ambitious AIDS agenda, a good budget, and a
commitment to continue fighting for increases in funding for National
Institutes of Health (NIH) research, Ryan White programs, and the
Centers for Disease Control and Prevention (CDC) programs. Battles ahead
include needle exchange, restoring Medicaid cuts for immigrants, and
monitoring Welfare Reform; the Council's help is needed in tracking
these issues. It is encouraging to see that many States are using their
own money to extend Medicaid to legal immigrants, and a coalition of
Governors and mayors is being built to try to put this money back into
the budget.

Major issues brought up by Council members in discussion with Mr. Reed
included the following:

· Concerning ONAP, Mr. Burgos suggested empowering Ms. Thurman by giving
her an appropriate title and staff and better recognizing Dr. Goosby for
his efforts as well as giving him more opportunities to contribute.
Mr. Reed concurred.

· Mr. Reed said that the Administration will try to incorporate new
Public Health Service (PHS) standards of care guidelines into the prison
system.

· Mr. Schatz asked how the President's efforts to respond to PACHA
Recommendations on discrimination manifest in mandatory testing in
Government entities could be increased, saying that nothing has happened
in more than 2 years. Mr. Reed responded that PACHA has a good case on
this, and the Council should "hold our feet to the fire."

· Mr. Isbell said that, in order to reach the President's goal of zero
seroconversion, the Federal ban on needle exchange programs must be
lifted. Mr. Reed acknowledged that this is an important and highly
charged issue that the Administration is "committed to review"; however,
the office does not want to do something that will backfire.

· It was noted that the "national prevention strategy" is inadequate and
in need of an implementation plan. The Council asked Mr. Reed to work
with PACHA in its efforts with the CDC and the Substance Abuse and
Mental Health Services Administration (SAMHSA) to develop a real
strategy. SAMHSA has not been as accountable as necessary for spending
resources and responding to the problem, and the Council is particularly
concerned that the position of Associate Director for AIDS Programs
might not be filled.

· Dr. Hitt noted that the Council feels a sense of frustration, having
spent 2½ years developing Recommendations at the President's request
only to have many of them go unaddressed. More high-level leadership is
needed to address difficult issues.

**AIDS Vaccine Panel Presentation**

Introducing a full-Council panel briefing on AIDS vaccines, Dr. Hitt
noted that this is one of the most difficult issues of the epidemic and
that the Council has spent 2 years becoming educated on the subject to
develop appropriate Recommendations to the Administration. "The time
seems right now," he said, and the community mandate is clear---that the
Administration must put more emphasis, effort, and direction into the
development of an effective vaccine against HIV/AIDS. Dr. Levine, Chair
of the Research Committee, introduced speakers, who were asked to
discuss their organization's vaccine activities as well as proposed
PACHA Recommendations on vaccine development. The general agreement was
that an effective vaccine can be developed, and it offers the only
reasonable hope for controlling the epidemic of AIDS.

**John G. McNeil, M.D., M.P.H.,** Director of the Department of Defense
(DOD) HIV-1/AIDS vaccine development program, Walter Reed Army Institute
of Research, said that the research and development of candidate
vaccines by DOD was initiated to deal with problems within the U.S.
Armed Forces worldwide. Through collaborative partnerships, the program
has had successes with such diseases as hepatitis A and meningitis. Its
small annual budget (\$20 million from the President's request, with
about \$15 million from Congressional "plus-ups") is devoted mostly (57
percent) to HIV vaccine development. The strategy is to use basic
research to build trials based on plausible immune effectors of
virologic control, select candidates that induce indicated immune
responses, and conduct proof-of-concept efficacy trials. Searching for
an AIDS vaccine has problems similar to those of malaria: Protective
immunity and pathogen--host interactions are not clearly understood,
good animal models do not exist, and the diseases cause catastrophic
pandemics. The process is long, and a problem exists in the advancement
of products from Phase II to Phase III clinical trials; the "pipeline is
seriously constricted at the end."

**William E. Paul, M.D.,** Director, Office of AIDS Research (OAR), NIH,
and Chief of the Laboratory of Immunology of the National Institute of
Allergy and Infectious Diseases (NIAID), said that the OAR Advisory
Council (OARAC) considers vaccine development among its leading
mandates. NIH funding for vaccine research will have increased in FY
1998 by 33 percent over FY 1996, from \$110 million to approximately
\$150 million, even as other HIV research budgets have remained rather
flat. Adding to this large investment in fundamental research (on issues
of the structure of, immune response to, and mechanisms of the virus
that cause disease) makes the actual funding for AIDS research much
greater. Congress may accord an even greater increase in the overall
HIV/AIDS budget than what has been requested, and the OAR pledges to see
that increases are sustained annually. Money needs to be stockpiled for
efficacy trials, which will be substantially more expensive than those
for many other vaccines, and a funding screen is needed for planning
over the next few years.

For progress to be made, a combined effort of targeted vaccine research
and increased input into the "pipeline" is needed. To this end, the OAR
is stressing investigator-initiated research, with the number of grants
increasing 50 percent from 1994 to 1998. Tremendous advances have been
made in understanding the mechanisms of the immune response, and the NIH
is moving into Phase II trials on the prime/boost strategy to determine
whether it warrants advance into Phase III. Opportunities exist for a
close collaboration among NIH, DOD, CDC, and others, and Dr. Paul
advocates using the OAR's new AIDS Vaccine Research Committee (AVRC) as
the facilitator.

**Jerald C. Sadoff, M.D.,** Executive Director of Vaccine Research,
Merck Research Laboratories,

said that an HIV vaccine can be developed, based on epidemiological
clues such as the existence of long-term nonprogressors and certain
persons who seem to be immune. One major hurdle is the lack of an
acceptable surrogate marker that can guide the choice and quantity of
antigens in the vaccine, permit rational experiments with termination of
dose and regimens, and guide assays to determine vaccine stability and
reproducibility. Current debate concerns whether cellular immunity alone
is enough, and there are several promising approaches using live
vectors, the so-called "naked DNA." Development of clues to the nature
of surrogate markers through investigation of animal models and
epidemiologic leads, therefore, should be the highest priority. Another
hurdle is the definition of success: The ideal vaccine would provide
long-term sterile immunity, while an acceptable one might prevent
progression. The market size has been seen as a barrier in terms of
industry incentive; however, although development of vaccines is
dependent on Government- and foundation-sponsored research, the sooner
industry becomes involved, the sooner a transferable process yielding
similar results will be developed. At least several hundred million
dollars per year are needed even for a narrow approach.

**Margaret Johnston, Ph.D.,** Scientific Director, International AIDS
Vaccine Initiative (IAVI) and former Director of the Division of AIDS
for NIAID, said that insufficient attention is being paid to HIV vaccine
development, private sector talents are not being used appropriately,
and development of vaccines appropriate for use in developing countries
is being ignored. IAVI's mission is to ensure development of safe,
effective, preventive vaccines suitable worldwide, using advocacy in
both industrialized and developing countries, working with other
organizations to create a better environment for increased investment in
HIV vaccine development, and raising funds to fill gaps in the current
research and development effort. Success in HIV vaccine development
requires that the United States increase its leadership and
participation in international efforts and work to attract additional
involvement of the private sector, especially in designing promising new
candidate vaccines for human testing. IAVI supports NIAID's two-pronged
strategy of both fundamental and empirical research and urged that this
direction not be lost in the effort to beef up the knowledge base. The
NIH should go beyond its traditional role and help apply fundamental
knowledge to vaccine strategies, provide additional funds for targeted
vaccine development, and take responsibility for immunogen design and
product production. Obstacles include its move toward more
investigator-initiated basic research and cumbersome Government
regulations and budget process.

**Yichen Lu, Ph.D.,** Senior Scientist and Manager of the HIV program,
Virus Research Institute, Inc., said that 5 years ago there were 40
companies looking for a vaccine; now there are fewer than 10, with no
newcomers. Large drug companies are not collaborating with biotechnology
companies, which do the basic research but cannot afford to advance on
their own. Private investors have been intimidated by the high price of
developing an HIV vaccine candidate into Phase III trials. (Although the
average vaccine development program takes \$100 million and 10 years,
some HIV vaccine programs have spent 15 years and \$700 million without
reaching Phase III trials.) The pipeline is dangerously empty, and the
Government needs to rescue this effort. Dr. Lu is working on producing a
prototype vaccine in Thailand (in 3 years) because the local government
is supportive and because funding has come from an industrialized
source, the Japanese Government. The local and Japanese governments will
take the program to Phase II and III trials.

**Anthony S. Fauci, M.D.,** Director and Chief of the Laboratory of
Immunoregulation, NIAID, agrees that a firm and passionate commitment to
the development of a vaccine is needed but that the ability to predict
what will be successful is not now available. There must be a
combination of basic science to understand mechanisms, immunological
correlates, and the best candidates (the NIH has a major mandate to
continue a steady stream of science) and an empirical approach to
determine the right paths. To develop a vaccine successfully, an
infrastructure has to be available; NIAID has that in its assayed
populations and its data on rates of infection, mechanisms to determine
immunological response, HIVNET, commitment in resources, and manpower
available both domestically and internationally to take a proven
candidate to advanced phases. Currently, the prime/boost approach is
farthest along, but multiple candidates are studied constantly. The NIH
also recognizes the need to forge partnerships between industry and
Government to bring vaccines to final phases.

**David M. Gold, J.D.,** Cofounder of the AIDS Vaccine Advocacy
Coalition (AVAC), emphasized the need to increase support for vaccine
research among CBOs and investment by industry. Additional resources are
needed, but they should be used more efficiently than in the past. Since
industry researchers say the leading barrier to private sector
investment is the scientific feasibility of developing an HIV vaccine at
this time, Government advancement of the science will drive investment
capital. He applauded the early efforts of the AVRC, and believes it
must be supported widely. He noted that PACHA's Recommendations "barely
mentioned" the committee, which risks weakening the NIH's efforts and
the impact of its own report. The NIH should continue to lead the
country's AIDS vaccine research program, and there is no need to spend
valuable research dollars to expand Food and Drug Administration (FDA)
and CDC programs, although DOD's program should be supported.
Significant gaps in AIDS research can be filled through
investigator-initiated research, targeted research, and effective
scientific leadership. The following areas need attention: useful,
comparative animal and Phase I human studies; a focus on broad-based
outreach to fill the studies; dissemination of information on immune
responses seen in trial participants; and a broad range of vaccine
approaches and combinations. Large pharmaceutical and vaccine
manufacturers must increase investment in vaccine development; the
actual private investment is relatively minuscule.

**Philip K. Russell, M.D.,** President, Albert B. Sabin Vaccine
Foundation, Professor, Johns Hopkins University Center for Immunization
Research, and former head of military and World Health Organization
vaccine development programs, said that an AIDS vaccine is the most
important public health issue of our time. He is in general agreement
with much of the PACHA report and many issues discussed in this meeting.
There are common elements in all successful vaccine programs: a strong
research program underpinning product development, based on both basic
and empiric science; effective collaborations between Government
agencies and industrial development, with a commitment by both parties
to a common goal and an involved leadership capable of directing a very
complex program; and recognition of the value of conducting early
efficacy trials. Information gathered in field trials, whether
candidates are successful or not, is extremely valuable in guiding
future efforts. Animal studies have limited value in predicting the
immunogenicity or protective efficacy of a vaccine for humans, but
clinical trials are essential.

Supported actions include parallel, multiple vaccine development and a
coordinated national strategy, drawing on the strengths of Government
agencies and fully utilizing the potential of technology and immunology
industries. All elements needed for success---a powerful academic
research community, a vigorous publicly funded research effort, and an
immensely powerful vaccine development industry---exist. Lacking are
leadership, sufficient financial commitment in both private and public
sectors, and a mechanism for bringing the sectors together effectively,
as has been done in space, defense, and SEMATECH consortia.

**David Baltimore, Ph.D.,** Cochair, Professor of Molecular Biology and
Immunology, Massachusetts Institute of Technology, Nobel Prize laureate,
and Chair of the NIH AVRC, described the new group as a coordinating and
advisory body for the overall NIH vaccine effort. The Committee's major
focus is to identify opportunities for moving vaccine development
forward and arranging for these research directions to receive increased
attention. The first vehicle is a fast, simple grant program that
supplies funds for targeted areas of research, particularly to recruit
new scientists for HIV studies, and is available to individuals as well
as through the Small Business Innovative Research (SBIR) program.
Initial funding is \$6 million for \$150,000 direct-cost-maximum grants
for 2 years, but additional sources are available. The total amount to
be spent depends on the number of deserving grants reviewed. Targeted
areas are animal models, envelope protein structure as it relates to
immunogenicity, and optimization of antigen presentation for the
development of cytotoxic T lymphocytes (CTLs). In the future, AVRC will
focus on other areas, particularly on DNA and live-attenuated vaccine
approaches. The grant deadline is May 23, 1997; applications will be
reviewed by an internal panel in the Division of AIDS with the advice of
a grant specialist.

An active program of vaccine testing in humans does exist, focused on
the prime/boost strategy, and it is important to continue this and gain
as much scientific knowledge as possible, even if it is not efficacious.
AVRC sees as its major tasks ensuring that opportunities for clinical
testing are being generated and that the United States has as broad and
deep a program as possible so the full range of opportunities can be
investigated, including study of viral pathogenesis, structure, and
function; examination of modes of immune response; and evaluation of
modes of eliciting immunity such as through proteins, peptides, DNA,
vectors, and whole virus. It is known that vaccines work mainly by
stimulating immunologic memory---most have worked through
antibody-mediated responses---and that the control of CTLs may be
important but generally has not been studied. Antibodies can play an
important role in the development of HIV immunity, but there is a likely
need for a strong CTL-based response. Furthermore, other possible
protective modes of response need to be studied, with significant
concentration on how the body responds to an HIV infection.
Historically, the best vaccines have been live-attenuated and
whole-killed viruses; however, the differences between HIV, the first
human lentivirus challenge, and other viruses cannot be minimized.

**Issues and Answers:** Council members brought up a number of issues,
as follows:

· Asked how to pull in DOD and other agencies so there is mandated
coordination, Dr. Paul suggested that AVRC could act as a nucleating
factor.

· Ms. Miramontes raised a concern about the balance between basic and
empirical research in study sections. Dr. Fauci said that this is a
troubling problem and that the NIH is developing special emphasis panels
to look at relative priorities in protocol applications.

· As to ethical issues, Dr. Fauci said that formal ethicists are used in
the design of any institutional review board (IRB) or other safety group
so that safety and ethical issues are being addressed before the fact.
If there are international implications, the ethicists must have
experience working with the World Health Organization (WHO) and The
Joint United Nations Programme on HIV/AIDS (UNAIDS). IAVI has addressed
some of these issues and will provide the Council with a report.

· Regarding Government agencies working on multiple vaccine approaches
other than the prime/boost, Dr. Fauci said that the NIH does not have
only "one egg in the basket" and it would not try to prohibit work on
other candidates.

· Asked to describe the "pipeline," Dr. Baltimore said AVRC believes it
understands the concept but "we don't know all of what private industry
is doing, and probably shouldn't."

· Dr. Levine asked how to get more funds, but no answer was forthcoming.
Dr. Fauci suggested that the Council support the NIH by emphasizing the
need for new money, not moving funds from one area to another.

· Regarding implementation of the "Levine Committee" recommendations,
Dr. Paul said that OAR has responded to all recommendations and that a
plan has been written and reviewed by the OARAC and should be ready for
public distribution shortly.

· On the issue of liability, Dr. Paul said that work at the NIH is
limited to research and development and that liability should be left to
other entities in the Government that are better equipped to handle
these concerns. Ms. Greenberger pointed out that it is one of the top
three impediments to vaccine development, and Dr. Sadoff agreed, but
said it does not need to be addressed until the kind of vaccine to be
used and its risks are known. Dr. Fauci also agreed that liability can
impede vaccine development but that these matters are out of the
scientists' scope.

· Since industry ultimately must manufacture the vaccine, the Council
questioned whether a group like ONAP could feed seed money to industry
where it is needed to expand the pipeline rather than have it all go
through the NIH. Dr. Paul said that the present spending process is
designed to limit duplication and ensure that HIV money is spent fairly
in both private and public sectors. The NIH has a good record in leading
the development of vaccines. Dr. Fauci pointed out that national vaccine
cooperative groups, which include consortia with industry, do exist and
that the grant system factors in both industry and academia in its
review. Dr. Lu called the SBIR award funding program "more generous"
than NIH R01 grants, but limited. For Phase I trials, a small company
can be granted \$75,000 in funds for 6 months; if successful, it can
request Phase II funding---\$750,000 for 3 years, not nearly enough to
move a product into human testing.

**Responses to PACHA Recommendations:**

· Most speakers agreed that a public commitment from the President to
develop a successful vaccine is very important but setting a time line
is problematic. It is impossible to predict an actual time to
development, and having an unrealistic deadline can lead to
disappointment if it is not met. Most agreed, however, that 7 to 10
years was not out of the question and that setting some kind of
reference lends to the urgency. The term "within a decade" can be
depressing, especially in developing countries. Dr. McNeil believes that
three first-generation vaccine strategies could be fully evaluated by
the year 2005.

· More funding can always be used; however, it should be staged
carefully. Dr. Baltimore suggested that any increased funding should
take into consideration the importance of developing a stronger
intramural vaccine program within the NIH. Dr. McNeil suggested that
funding is not the primary issue keeping products out of the distal end
of the pipeline; rather, it is a philosophical issue. A model can be
driven for \$360 million per year---a sum that is available---based on
preventing 30 percent of new infections in the United States, but much
of this amount should be earmarked to underwrite leverage of contract
with private industry.

· A full-time AIDS coordinator in the White House is not needed; there
are already too many advisors and chiefs. No one person is capable of
doing this; two would be better---one a basic scientist and the other a
developer with an appreciation of basic science, working as a team. One
suggestion was to have a Chief Executive Officer rather than a
coordinator. Leave coordination at the agency level (within the NIH),
and empower agencies and individuals by giving them sufficient
resources. The Council asked how efforts can be coordinated and
private/public sectors held accountable without a national coordinator.
Dr. Baltimore's view is that information moves fast enough on the
scientific level and that coordination becomes more important as the
vaccine moves forward into Phase III trials. Ethical and legal concerns
then come into play. In actual development of candidates, however, there
is no extensive coordination problem with industry. There already are
too many meetings and too much time spent on airplanes. Dr. Lu said that
the "Baltimore Committee" has the best scientists in the world, so there
is no need for parallel coordination; rather, someone should pursue the
business side.

· Having the Vice President lead a consortium of high-level
private/public sector individuals through a dialog on HIV/AIDS subjects
might be effective, but adding another level of organizational structure
would not. To be productive, such an arrangement should involve
informal, face-to-face meetings where serious discussions can take
place, and it also needs an international scope. Some believed that
industry might not respond openly at a table with Mr. Gore and the
competition; others suggested leaving it to industry to decide how
Government can help.

**Committee Meetings, Actions, and Reports**

Following are summaries of Committee and Subcommittee activities during
the PACHA meeting and their reports to the Council.

**Research Committee**

The Committee met April 5, 6, and 7, with Dr. Levine, Chair and
Dr. Cade, Mr. Fogel, Ms. Greenberger, Mr. Hattoy, Dr. Hitt, Mr. Johnson,
Ms. Miramontes, Dr. Weniger, and ONAP staff present. Primary actions
included finalization of new vaccine Recommendations (see New Council
Recommendations, below) and facilitation of a presentation panel on
vaccine development for the full Council (see AIDS Vaccine Panel
Presentation, above). Following a lengthy discussion on the
Recommendations and the presentations of the vaccine panel,
Ms. Greenberger suggested that the Committee establish a list of major
issue questions for the AVRC, and the Committee agreed.

**Services Committee**

The Committee met April 5, 6, and 7, with Mr. Bollman (via conference
call), Chair; Mr. Henderson, facilitator; and Dr. Abel, Mr. Anderson,
Mr. Lew, Dr. Rankin, and Mr. Stafford present. Mr. Henderson reported on
Committee activities during the meeting:

**Responses to Recommendations:** Most Recommendations from the last
meeting covering Ryan White programs and Housing Opportunities for
People with AIDS (HOPWA) have produced responses.

**Ryan White Update:** During a Committee meeting, **Dr. Joe O'Neill,**
Acting Director of the Bureau of Health Resources and Development,
Health Resources and Services Administration (HRSA), reported on
reorganization of Ryan White programs and introduced **Dr. Michael
Kaiser,** new Director of Title IV. Consolidation of Titles I through V
into one entity, headed by Dr. O'Neill, will allow HRSA to be more
responsive, reduce costs and duplications, standardize technical
strategies, coordinate resources, and improve grant applications and
data collection. Administrative changes will be made within 6 months;
the overall consolidation will take 3 to 5 years. Reorganization issues
include developing a consistent policy and more aggressively determining
the impact of Ryan White on the American public. Two recent HRSA
appointments with positive impact on HIV/AIDS programs are Dr. Earl Fox,
Administrator, and Joan Holloway, liaison to the Ryan White group for
contact with groups such as PACHA. A permanent Director for the Title V
AIDS Educational Training Program (AETP) should be appointed soon. The
Committee applauded the changes and asked that the Ryan White group
reevaluate Council Recommendations.

**HOPWA Update:** **Fred Karnas,** Director, Office of HIV/AIDS Housing,
HUD, updated the Committee on the HOPWA program. Major problems include
an inadequate budget (\$136 million for FY 1997, with no increases seen
in the near future); realignment of funding among 80 jurisdictions,
causing smaller communities to lose eligibility; and new definitions of
eligibility that could result in people with HIV losing support. The
Committee's main concern was loss of housing for patients whose health
improves to the point of their being able to work part time (the "cost
of getting well"). HUD is undergoing a General Accounting Office (GAO)
evaluation, and the Office of AIDS is analyzing its own program impact.
Mr. Karnas asked PACHA to keep him informed of the needs of people with
AIDS and housing.

**Meeting with New HUD Secretary:** The Committee met with the newly
appointed HUD Secretary, Mr. Andrew Cuomo, to address housing issues.
The most important concept expressed by the Secretary is that this is
not just a programmatic issue in regard to HOPWA but a mindset that
needs to be changed within all HUD programs.  The Committee believes
that PACHA will have good support from the new leadership.

**Native American Issues:** Mr. Landau reported that Recommendations on
Native American issues have been partially addressed, although related
Ryan White questions have not. Both Mr. Landau and Dr. Goosby noted that
the Indian Health Service (IHS) is not responding to either PACHA
Recommendations or Native American needs in the HIV/AIDS arena. It is a
politically and logistically difficult area to cover in that IHS has
different types of health care programs and funding methods than HRSA.
IHS also does not designate funds for HIV prevention and treatment
because it does not see HIV as a major problem in this population.
Dr. O'Neill said that the Ryan White group is trying to develop joint
"technical-assist" strategies with IHS because Ryan White group has no
mechanism for funding the Indian Nations. HIV-related funding comes
through States, although the Nations have a better relationship overall
with the Federal Government. Dr. Goosby is instituting a working group,
including IHS, CDC, the NIH, and American Foundation for AIDS Research
(AmFAR), within the HHS AIDS Office to develop documentation on programs
and health care issues of this population. The current modus of IHS is
to move responsibility to tribes and provide technical assistance and
block resources, which Dr. Goosby considers a shedding of
responsibilities and fears that individuals will receive less than
optimal care.

To cover this critical area better, the Services Committee needs a
Native American on the Committee to replace Ms. laFavor, and the Council
and ONAP were asked to help address this issue with the President.

**Pharmaceutical Cost Reduction:** To address the high cost of PIs,
Dr. Goosby said that HRSA tries to lower the overall prices through 340B
programs, which make funds available to seek the best prices, and to
have Medicaid pick up more of the costs. This is difficult because
States do not want to deal with these processes. HRSA is trying both to
persuade States to tighten eligibility requirements and to obtain a
formulation from the AIDS Drug Assistance Program (ADAP) on pricing and
listing of drug categories. To date, prices have decreased minimally.

Pharmaceutical companies earn about six times their projections of
profit on PIs, and Dr. Goosby calls them "powerful, extremely effective,
and subtle," with "very deep pockets and excellent legal and lobbying
minds." Approximately 9,000 indigents are being treated in
company-sponsored compassionate care programs now, and many cities are
trying to use this system. The Government, which makes up about 65
percent of the market share for PIs, does have some leverage, and the
pharmaceutical companies are finally beginning to look at lowering the
prices. These issues are difficult to address because legal and
financial matters keep the companies from openly discussing pricing, a
subject not covered in the Keystone Conference. Dr. Goosby encouraged
the Services Committee to frame a Recommendation on creating more
pressure on pharmaceutical companies to lower prices. On the other hand,
the AIDS community needs to provide good substantiating data on drug
usage at funded centers. HRSA hopes to have statistics on increased
utilization of multiple therapy in time for budget development.

**Medical Marijuana:** A Recommendation developed by the Services
Committee with the Prevention Committee was finalized and approved (see
New Council Recommendations, below).

**Military Clinical Research:** Mr. Henderson and Dr. Rankin will follow
up on this issue, which now appears to be more than a programmatic
difference between the Army and the Navy. It is believed that the
military may be moving away from the clinical arena, and the issue bears
monitoring.

**Youth Issues:** Most youth issues have been moved to the Prevention
Committee because they primarily involve intervention, and the Services
Committee does not have a member with experience in this area, although
one Recommendation is being formulated in the Office of Alternative
Medicine (OAM) by Mr. Lew. Rev. Perez said that the Prevention Committee
also has a problem with adequate representation and is worried that
youth issues will be lost. It is strongly recommended that a new Council
member with youth experience be found to address these issues.

**White House Advisory Council on Consumer Protection and Quality in
Health:** The "good news" is that Richard Sorian has been named Deputy
Executive Director and that two members of the new council have direct
HIV/AIDS experience---Nan Hunter and Sandra Hernandez.

**Standards of Care:** The final document will be called the "PHS
Guidelines," and it will complement the "NIH Principles." The main
difference is that the PHS document is drug specific. Dr. Goosby, who
has been responsible for much of the development of the so-called
Standards of Care, explained that it is a basic guideline for all
HIV/AIDS-related entities, developed by panels from the HHS and HRSA,
with input from the NIH, CDC, and representatives from managed care and
payer organizations. HRSA has a 3-year commitment on this project to
publish the guidelines (within 6 months) and develop conduits for
providers. Dr. O'Neill said that PACHA and ONAP can contribute
significantly by providing the guidelines with a level of prestige and
influence that the Agency cannot achieve.

**Standards of Care Assessment/Facilitation Process:** The possibility
of having a reassessment dialog similar to the Keystone Conference on
pharmaceuticals among a "creditable group of participants with
broad-based interests" around care and services was raised, and
Dr. O'Neill pledged \$20,000 to \$30,000 from HRSA to study the
feasibility of such a meeting. This would include the issues around the
PHS Guidelines and their implications on programs of all levels,
disability and returning to work, Medicaid/Medicare, changing
populations, new treatment regimes, support service systems, funding,
vaccines, and collaborative opportunities. The goal would be to develop
a broad policy consensus on these critical issues. A panel consisting of
Dr. O'Neill, Mr. Levi, Dr. Goosby, and Abby Dilley, Vice President of
the Keystone Center, spoke about the process with the Services
Committee. They described it as "comfortable, informal, and
off-the-record," with a neutral mediator (Keystone). Panelists agreed
that the current state of change in HIV/AIDS treatment is forcing the
reexamination of populations, paradigms, and definition of such terms as
"early intervention." Major questions asked by the Council concerned the
public role in the changing systems and how to educate the HIV/AIDS
populations about the new guidelines. The Council agreed that it should
focus on the possibility of a Keystone Conference and to choose a
delegation of two to three members to work with HRSA to determine scope
and budget. Mr. Henderson, Dr. Bollman, Dr. Hitt, Mr. Levi, and
Dr. O'Neill will meet to further discuss the possibilities.

**Back-to-Work Issues/Medicaid Coverage:** Rabbi Edelheit reported on a
followup to the presentation by Susan Daniels of the Social Security
Administration (SSA) at the last PACHA meeting. **Diana Fortuna,**
Senior Policy Analyst, Domestic Policy Council, discussed with the
Committee barriers to employment for people with disabilities and
problems involved with Social Security Disability Insurance (SSDI) and
Supplemental Security Income (SSI) eligibility. The Government, she
said, has an "old-fashioned notion" of equating disability with
inability to work; however, the SSA is trying to redefine the term.
Currently, people with disabilities who become well enough to work
part-time are in jeopardy of losing SSDI/SSI health care coverage. The
President's current budget request may help fill the gaps through State
options on Medicaid, a proposed Medicare demonstration program allowing
SSDI beneficiaries to return to work with 4 additional years of
premium-free Part A coverage, and a pilot program that proposes expanded
financial encouragement to rehabilitation providers to help SSDI and SSI
beneficiaries return to work. At this point, all AIDS patients are
facing reevaluation. Some have been given time eligibility and some are
permanently eligible; substance abusers and alcoholics are no longer
eligible under these programs. Ms. Fortuna said she would try to obtain
statistics on how many people living with HIV/AIDS are affected. No
funding exists to educate the public about the new programs, and
Ms. Fortuna encouraged organizations like PACHA to spread the word. In
Council discussions, Mr. Lew suggested that PACHA ask Ms. Daniels for
names of other advocacy groups concerned with these issues so that
HIV/AIDS organizations can join forces in dealing with them. There was a
great deal of discussion of disability, with the conclusion that PACHA
needs more input. Mr. Henderson said that the Keystone process could
address the issues, and Dr. Hitt said that the Council will put together
a presentation panel for the next meeting.

**Prevention Committee**

The Prevention Committee met April 5 and 6, with Mr. Robinson, Chair,
and Mr. Anderson, Ms. Billings, Mr. Fogel, Ms. Fraser-Howze, Ms. Gerus,
Dr. Hitt, Mr. Isbell, Mr. Johnson, Mr. Landau, Ms. Miramontes,
Ms. Runions, Mr. Schatz, and Ms. Stokes present. The Committee received
updates on needle exchange and substance abuse from outside panels and
developed a long-term work plan. Mr. Robinson reported on major issues,
including:

**Needle Exchange:** Much national attention is being focused in this
area, with the most urgent needs being the lifting of bans on use of
Federal funding for needle exchange programs and modification of State
laws and regulations on sale and use of clean syringes. Speakers
presenting an update to the Committee on these issues were**:**

**· Christine Lubinski,** Deputy Executive Director, AIDS Action Council
(AAC).

· **Miguelina Maldonado,** National Minority AIDS Council (NMAC), who
described the devastation caused by the twin epidemics of HIV and
substance abuse in communities of color.

· **Jane Silver,** AmFAR, who covered Federal prohibitions in specific
Acts; Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA)
reorganization; and the Departments of Labor and HHS.

**Substance Abuse:** Concerned that other substance abuse issues are not
being sufficiently addressed at this time because of the current high
level of interest in syringe exchange, the Committee called in speakers
to present an update on various issues. The Prevention Committee is
developing a panel presentation on all aspects of substance abuse to be
given to the full Council at the next meeting. The major needs described
are for more treatment slots and funds for every area of prevention and
care. Panelists were:

· **T. Stephen Jones, M.D.,** Special Assistant for Substance Abuse and
HIV Prevention, Division of HIV/AIDS Prevention-Intervention Research
and Support at the National Center for HIV, STD, and TB Prevention at
the CDC, who called for syringe exchange and educated primary care
physicians who can help patients reduce HIV risk.

· **Beth Weinstein,** Connecticut Department of Health, who described
the positive effects of a State law passed in 1992 allowing the sale of
up to 10 syringes without a prescription and possession of 10 clean
syringes without legal penalty. The Connecticut State action caused a
drop in on-the-street syringe purchases from 71 percent to 28 percent
and a decrease from 52 percent to 32 percent in injection drug users
(IDUs) who reported sharing syringes, a "remarkable indicator of
behavior change" from a program without Federal, State, or local
funding.

· **Ellen Weber,** Legal Action Center, who discussed the inadequate
funding in substance abuse prevention, including SAMHSA block grants.

**CDC Briefing:** Mr. Levi joined the Committee in planning the content
and format for its briefing by CDC the week of July 21. A letter to
Dr. Helene Gayle, head of the new, consolidated HIV/AIDS group at CDC,
outlining areas for discussion was drafted and submitted to the Council
for suggestions. Dr. Hitt will help formulate the final draft, which
will address CDC's overall HIV/AIDS strategy and the gaps that exist.
The Committee believes that the prevention section is the weakest and
does not constitute a true strategy. The Committee also will focus on
working with the Administration and CDC to develop a mutual strategy and
implementation plan.

**Presidential Recommendations:** These Recommendations were submitted
to the Council (see New Council Recommendations, below) on the Coburn
Bill, content of prevention materials, and needle exchange. Discussion
of the Coburn Bill centered on whether the Recommendation should
specifically ask the President to veto the bill. The Council agreed that
this would be "micromanaging" and decided that it should alert the
President to the need for a veto strategy.

**Prison Subcommittee**

The Subcommittee met on April 5, 6, and 7, with Mr. Landau, Chair, and
Dr. Cade, Ms. Gerus, and Dr. Rankin present. Mr. Landau reported to the
Council:

**New Recommendations:** Mr. Landau presented background on the issues
of compassionate release, discharge planning, standards of care,
protective barriers, and substance use in prisons (see New Council
Recommendations, below).

**Followup on Issues:** Letters to Dr. Kenneth Moritsugu of the Federal
Bureau of Prisons, Jeanne B. Fites, Deputy Under Secretary of Defense on
HIV/AIDS programs in DOD correction facilities, and HHS Secretary
Shalala regarding oversight language for discharge planning were
submitted for PACHA and ONAP approval and coordination.

**NORA:** During a joint meeting with the NORA Working Group on
Incarcerated Individuals on April 6, the Prison Subcommittee continued
to gather background information on relevant issues. Guests included
NORA participants Lin Hagood, CURE; J. Homar Perez and Tommy Reeder-Bey,
National Association of People with AIDS (NAPWA); Cochise Robertson-El,
Blind Faith; Jennifer Smith, Center for Women Policy Studies; Jonathan
Smith, DC Prisoner's Legal Services Project; Marilyn Torres; and Jackie
Walker, ACLU National Prisons Project.

**International Subcommittee**

The Subcommittee met April 5 and 6, with Mr. Fogel, Chair, and Mr. Lew,
Ms. Miramontes, Ms. Runions, and Dr. Weniger present. Dr. Fogel provided
responses given to international Recommendations from the Department of
State and USAID.

**Discrimination Subcommittee**

The Subcommittee met on April 5 and 6, with Mr. Schatz, Chair, and
Mr. Johnson, and Mr. Montoya present. Mr. Henderson, Ms. Gerus
Mr. Schatz reviewed Subcommittee activities:

**Recommendation Followup:** Regarding Recommendation II.E.1
(elimination of discriminatory policies, including mandatory HIV
testing, in Federal agencies), little has been done except by the Job
Corps, which was the President's focus during presentation of the
original Recommendation. Mr. Johnson noted that the DOD, Peace Corps,
and USAID must follow State Department guidelines and that it will take
very forceful, high-level leadership to change these practices.
Mr. Fogel suggested omitting the military. Dr. Rankin said that the
military actually does allow people with HIV to remain in service, but
when they get out with a pension they must go into a test program. This
represents a clear discriminatory practice. Rabbi Edelheit said that the
policy inconsistency between this group of Federal entities and other
agencies that do not have mandatory testing should be noted.
Recommendation II.E.2. (review of HHS and CDC HIV/AIDS guidelines) is
the "most egregiously ignored." HHS has not replied, and although CDC
has made some commitment to bring its guidelines up to standards,
nothing has happened. This problem should be revisited with Secretary
Shalala and Dr. Gayle. A number of suggestions/recommendations sent to
Secretary Shalala's office have not been answered or complied with, and
Dr. Goosby said this was partially because of a reduction of HHS staff.
He will help facilitate responses. On the issue of asylum, no response
has been received from the Immigration and Naturalization Service (INS),
and Mr. Montoya is drafting a followup letter.

**Discrimination Letter:** A letter to the President following up on
Recommendation II.E.1, drafted by Mr. Schatz and Rabbi Edelheit, was
approved unanimously. The letter will be circulated throughout the
Administration, to Cabinet members, all of the listed agencies, and
others concerned, such as Mr. Reed. (Dr. Hitt will provide the
distribution list and any responses to members.) Mr. Henderson said that
Mr. Reed was receptive to the idea of bringing the issue up at a Cabinet
meeting or other such forum so that the President can stress its
importance. The Council will follow up with Ms. Thurman every week until
a written response comes from the President.

**Communities of African and Latino Descent Subcommittee**

The Subcommittee met April 6, with Ms. Fraser-Howze, Chair; Mr. Burgos,
Rabbi Edelheit, Rev. Perez, and Dr. Goosby; and Mr. Montoya of ONAP
present. A written report on the initial activities of the new
Subcommittee was submitted to the Council, including its agenda (which
will focus on disproportionately impacted populations.) A list of
population-specific needs include, but are not limited to, AIDS orphans,
women and children in communities of color, IDUs and drug abuse,
immigrants, cultural and language barriers, inadequate health care and
infrastructures, and minority CBOs. Other immediate process issues
include the formation of a small advisory group and broadening the
involvement of communities of color in the decision-making and
information process of PACHA. Two issues of immediate concern are the
requirement of military personnel with HIV/AIDS to participate as
research subjects as a condition of their pension, which will be studied
by Mr. Burgos, and the decision by individual physicians to withhold
life-prolonging medications from patients determined to be noncompliant.

The Subcommittee discussed prioritization of the issues and limits to
what can be covered adequately. The need for better demographic
information on the epidemiology and the trends and impact on the
communities requires immediate attention, as does the need for the
President to demonstrate through action that he is aware of the changes
in trends in the epidemic. Funding allocation commensurate with the
areas of new infections is also advocated. A White House summit should
be held to bring attention to the impact on and special needs of the
targeted infected and affected populations. In addition, PACHA should be
represented at the Presidential summit on Volunteerism in America, which
will be held in Philadelphia. Dr. Goosby will explore these issues.

**Dale Anthony,** a community advocate from Long Island, attended the
Subcommittee meeting to present concerns about the lack of support for
the African-American community and discuss the difficulty in gaining
access to lifesaving medications, the fear of discovering their
serostatus that dominates this community, and the lack of will to comply
with medical regimens.

Assignments for followup include information gathering on AIDS orphans,
Mr. Fraser-Howze; medical determination and noncompliance and
Presidential summits, Dr. Goosby; and compilation of names for an
advisory group to the Subcommittee, Mr. Burgos and Rabbi Edelheit.

**New Council Recommendations**

New Recommendations to the Administration that were approved by the
Council during the meeting are:

**Medical Marijuana** (Services Committee, with Prevention; passed
unanimously)

Discussion by the Council included the fact that there is no mention of
"physicians prescribing" marijuana for patients, an intentional
omission.

Background: On November 5, 1996, voters in California and Arizona
approved the use of marijuana for medical purposes. In 1994, Ohio
approved the use of medical marijuana, though its legislature is
currently considering reversing that stand. Virginia and Louisiana have
decriminalized possession of marijuana in certain medical cases. Today,
26 States and the District of Columbia have existing laws and
resolutions establishing therapeutic research programs, allowing doctors
to prescribe marijuana, or asking the Federal Government to lift the ban
on its medical use. In 10 States, similar laws have either been repealed
or have expired.

Proponents of the use of medical marijuana cite anecdotal evidence of
beneficial effects from its use, while opponents claim no convincing
scientific evidence of such benefits and cite potential dangers.
Research on the potential health benefits and/or risks associated with
medical marijuana use is clearly needed.

· The President should direct appropriate agencies to take all steps
necessary to encourage scientific research, including clinical trials,
to gauge the potential benefits and/or risks of medical marijuana use
(including smoked marijuana) on chronic pain, nausea, glaucoma, and
other conditions due to illnesses such as HIV/AIDS, cancer, and other
chronic diseases.

Further, the President should direct that, pending the results of such
research, the Government refrain from any efforts to prosecute doctors
who, in good faith, discuss the use of medical marijuana or recommend it
for their patients.

**Content of Prevention Materials** (Prevention Committee; passed
unanimously)

· The Secretary of Health and Human Services should eliminate all
regulations and requirements for mandated reviews by citizen review
panels of the content of HIV prevention materials. HIV prevention
materials produced or distributed with Federal funding should be free of
restrictions on content, subject to review only for scientific accuracy
and cultural appropriateness for the targeted population. Grantees
should be given great flexibility in utilizing the least burdensome
methods of conducting these reviews.

**Coburn Bill** (Prevention Committee; passed, with one opposed)

· The President should forcefully oppose the HIV Prevention Act of 1997.
Many provisions of this bill, including enforced mandates, interference
with State and local control over health care policies, and the
potential for institutional discrimination against people living with
HIV/AIDS, will undermine rather than enhance our Nation's HIV prevention
strategy.

**Needle Exchange** (Prevention Committee; passed unanimously)

The PACHA commends the Secretary of Health and Human Services and the
Department of Health and Human Services on the *Report to Congress on
Appropriation for the Department of Labor, Health and Human Services
Agencies: Needle Exchange Programs in America: Review of Published
Studies and Ongoing Research*, which acknowledges the efficacy of
syringe exchange programs to reduce the transmission of HIV.

**WHEREAS,** this report to the Congress confirms that syringe exchange
programs reduce the rate of new HIV infections among injection drug
users, and further confirms that such programs constitute a sound public
health practice as part of an overall effort to reduce the incidence of
new HIV; and

**WHEREAS,** the Secretary's report found no evidence that established
that syringe exchange programs increase drug use; and

**WHEREAS,** a panel of nongovernmental public health experts convened
by the National Institutes of Health found no scientific or medical
evidence that syringe exchange programs increase drug use; and

**WHEREAS,** the President has set a goal of reducing the number of new
infections each year until there are none; and

**WHEREAS,** the President has established a drug policy seeking to
reduce the prevalence and incidence of drug abuse through prevention,
counseling, and treatment; and

**WHEREAS,** syringe exchange programs and appropriate and effective
substance abuse treatment and counseling efforts provide a unique
opportunity to reduce the incidence of substance abuse and the number of
injection drug users;

· **THEREFORE,** we strongly recommend that the President ensure that
the Secretary of Health and Human Services take all necessary steps to
promptly certify syringe exchange programs as effective in reducing the
incidence of new HIV infections while not increasing substance abuse;
thus, the use of Federal funds for syringe exchange and substance abuse
counseling and treatment programs must be permitted in those communities
that determine such programs to be appropriate.

**Vaccine Development** (Prevention Committee; passed unanimously)

Background: The following recommendations are the result of 2½ years of
development by the Research Committee, with input from the entire
Council and more than 50 other sources. The final critique came during
the panel presentation (see AIDS Vaccine Panel Presentation, above) when
a group of outside experts commented on the draft Recommendations.

Dr. Levine noted several changes that arose out of the panel
presentation. The term "within a decade" remains in the first
Recommendation, despite a consensus of the presentation panel that it is
not appropriate to set a date for the vaccine development goal. Some
Council members wanted to put a specific date; others believed that it
was more appropriate to leave out even "decade" in deference to
Dr. Baltimore's request. A majority of members believed that "decade"
should be maintained to highlight a sense of urgency without putting
unrealistic aspirations forward, and most panelists had agreed that this
was a realistic time frame. Other major changes included the addition of
emphasis on an international perspective and recognition of the AVRC.

Preamble: *Development of a successful HIV/AIDS vaccine is clearly
feasible and should be considered of the highest priority by our
Government. In order to succeed, we suggest the following
recommendations:*

1\. The President must declare an urgent goal of developing a vaccine to
prevent HIV/AIDS within a decade in order to mobilize public opinion,
political will, and international collaboration, and to assign high
priority to this effort within each of the governmental agencies
involved in HIV/AIDS vaccine research and development. As the HIV/AIDS
epidemic has no borders and a successful vaccine will require
international collaboration, the President should work with the leaders
of other nations in a global effort to achieve an HIV/AIDS vaccine for
all nations.

2\. A significant and sustained increase in funds must be made available
for HIV/AIDS vaccine research and development. These funds must be
derived from NEW sources from both Government and industry and must not
be taken from existing programs aimed at prevention, research, care,
services, and/or treatment for persons with HIV/AIDS. Innovative use of
such funds is essential, as seed money to initiate new and creative
hypotheses in vaccine research; to support product development; to
expand the proportion of successfully funded grant applications; and to
bring additional entities into the HIV/AIDS vaccine field.

3\. Development of an effective HIV/AIDS vaccine will require expertise
in many areas, including basic science, applied research, public health
policy, and legal, ethical, industrial, and international issues.
Dr. David Baltimore has recently been chosen to provide advice and
leadership for the NIH HIV/AIDS vaccine effort, and the Council is
highly supportive of this appointment. Additionally:

· Participation by nongovernmental sectors and organizations is also
essential to achieve the goal of expedited vaccine research, product
development, and use. The Vice President should convene a
public--private HIV/AIDS vaccine consultative forum, composed of senior
representatives, to encourage communication between sectors, to address
gaps in the field, and to speed progress toward the President's goal.
Participation on this HIV/AIDS vaccine forum should include
representation from U.S. Government agencies, industry, the
international community, academia, the World Bank and other funding
agencies, the insurance industry, ethicists, and communities most
affected by the epidemic.

· To achieve the goal of a more comprehensive vaccine development effort
within the government, ALL relevant agencies within the U.S.
Government---including NIH, CDC, DOD, DVA, FDA, USAID, and relevant
offices within these agencies, especially those relating to minority and
women's health---must be substantively involved in the vaccine effort.
The agencies must regularly communicate with one another and share
information.

**Prisons Recommendations** (Prison Issues Subcommittee)

Following discussion and revisions, all Recommendations were passed:
numbers 1 and 2 unanimously, number 3 with two abstentions, and number 4
with one abstention.

Background: Since the 1970s, when the war on crime became a war on drugs
and drug users, the rate of incarceration has skyrocketed in this
country. If we are seriously opposed to a war on drug users, then we
also must stop this cycle where it does significant and far-reaching
damage---in prisons among incarcerated persons.

If self-destructive behaviors are modified and prison clients are
encouraged to adopt healthier, more productive lives, the rehabilitation
process is enhanced, and thereby, the rate of recidivism among
ex-offenders may be reduced.

Prisons are rehabilitory institutions. That the system is "broke" is
neither the responsibility of inmates nor the justification for a
punitive or inadequate health care delivery system within prisons.
Health care is guaranteed to prisoners in the United States, and access
to AIDS health care within prisons should be commensurate with the
standards of care established for all Americans.

That the disproportionately high rate of HIV infection among African
Americans and Latinos is discriminatory is reflected in the
disproportionate number of African Americans and Latinos in the Nation's
prisons. It is impossible to separate access to care from institutional
racism, and we must, therefore, be guided by a commitment to ensure the
highest possible standards of care and access for all Americans,
including prison inmates.

We therefore must place AIDS health care for inmates and ex-offenders in
the context of national standards of care *and* prison reform, not in
the context of judgments placed upon inmates, sentencing offenders,
racism, classism, or anticipated recidivism. We must anticipate
successful release of these individuals into a society where the
mainstreaming of inmates works safely and effectively for all involved.
The goal of no new infections and good health care among all of those
previously infected must guide our activities within the discussion of
AIDS among inmates and ex-offenders.

The issues facing inmates with AIDS are the same as the issues facing
most Americans with AIDS. The risks of infection through injection drug
use and sexual---consensual and forced---transmission may be even higher
among incarcerated individuals than the general population as a result
of the lack of adequate protection within this restricted living
environment. The necessity of effectively addressing this urgent need
without prejudgment, therefore, cannot be underestimated.

1\. **Compassionate Release:** The President should direct the
Department of Justice and the Director of the Federal Bureau of Prisons
to revise administrative and judicial standards of compassionate release
for use in all Federal and federally funded prisons. Prisons will do
this in accordance with American Bar Association (ABA) standards.
Furthermore, equivalent compassionate release programs should be
required in State and local prisons as a condition of these institutions
receiving Federal funds. The Federal Bureau of Prisons also should be
directed to maintain statistical and evaluative records concerning the
compassionate release policy and file an annual report to the President,
Secretary of Health and Human Services, and the Office of National AIDS
Policy.

2\. **Discharge Planning:** The President should direct the Secretary of
Health and Human Services to develop standards of care to ensure that,
prior to release, ex-offenders with HIV/AIDS are provided timely,
thorough, and appropriate case management/discharge planning. These
standards should address behavioral and social service needs; continuity
of care; and appropriate linkages to local community services, medical
services, social service benefits, appropriate case management, and
housing assistance programs to ensure against homelessness.

3\. **Standards of Care:** The President should direct the Federal
Bureau of Prisons to incorporate the upcoming *Report from the HHS Panel
on Clinical Practices for the Treatment of HIV Infections* in all
correctional medical facilities. It should be required that care
providers be adequately trained to implement these standards and all
appropriate therapeutic options associated with the management of HIV
disease be available.

4\. **Protective Barriers:** The President shall direct the Attorney
General to direct the Federal Bureau of Prisons to ensure that condoms
and dental dams are made readily available for all prisoners within
correctional facilities to prevent transmission of HIV/AIDS.

5\. **Substance Use:** The President shall direct the Attorney General
to direct the Federal Bureau of Prisons to investigate and report within
90 days on the feasibility of and various options for providing
comprehensive substance abuse treatment for incarcerated individuals
with a dual diagnosis of chemical dependency and HIV disease.

**Process Issues**

The Process Committee, consisting of all Committee and Subcommittee
Chairs, will continue to meet by conference calls to discuss Council
process issues and monitor Recommendations that need to be "pushed."
Process issues discussed during the meeting were:

**Recommendations to the President:** The strength of Administrative
Recommendations can be weakened if they are not action-specific or are
too lengthy. Council Recommendations should identify actions that can be
taken by the President and/or Vice President and can be monitored by the
Council. New Recommendations should follow the format of the original
set---one or two sentences that can stand alone---and be as succinct as
possible for the purpose of alerting the Administration that there are
new data available. If a Recommendation cannot stand alone, a brief
explanation can be included. It is not PACHA's role to provide
background for the White House as to why a certain action should be
taken, although members individually may draft background letters to the
President. Broad language is sufficient until the Council knows the
specifics of the issue, at which point Committees should convene by
conference call to monitor and follow up with specifics to the
Administration in letters or further Recommendations. Recommendations,
responses, and followup should be coordinated through Dr. Hitt and the
ONAP office. Another process suggestion is to trust Committees to
develop effective Recommendations and thereby not spend so much time
"wordsmithing" in full-Council meetings.

**Letters to the Administration and Other Government Entities:** Letters
to the President, normally sent either as followup to Recommendations
that have not been addressed or notification of new and pressing
matters, should signify urgency and importance. Care must be taken to
avoid sending too many messages, or by duplication diluting the strength
of the letters. The process for sending letters to any Government entity
is as follows: a Committee drafts a letter through conference calls,
submits it to Dr. Hitt for suggestions and approval, and sends the final
draft to Mr. Montoya, who will keep ONAP and other Council members
informed, collect additional suggestions from ONAP, and give advance
notification to the appropriate recipients. Committees should monitor
responses and keep the Council and ONAP advised; the ONAP Director, in
turn, can help in followup. Letters do not have to be approved by the
whole Council, whereas Recommendations and resolutions do.

**ONAP Authority over PACHA:** Concern was expressed by Council members
that ONAP should not have final say on PACHA letters and actions. Since
the ONAP/PACHA relationship is not clearly defined, Rabbi Edelheit urged
Dr. Hitt to discuss the limit of ONAP's control at the next meeting. It
was agreed that ONAP should not have veto power over PACHA letters or
Recommendations, but that the Office, especially the Director, should be
given opportunity for input before any message is sent to the White
House.

**Holding "Feet to the Fire":** Holding Government groups accountable
should be a function of the Council as a whole, with assistance from
Ms. Thurman at ONAP.

**Committee/Subcommittee Meetings:** Members noted that there are so
many Committees and Subcommittees on the Council that major efforts may
be diluted. Subcommittee meetings should start on time, times should be
set so that they do not interfere with attendance at Committee sessions,
and all meeting times should be announced to the full Council. Meetings
also should start on time. Members should be notified of interim
meetings and conference calls, through Mr. Montoya, and background
information and agendas should be distributed to members at least 14
days in advance. More work, such as formulation of Recommendations,
should be done through conference calls prior to full-Council meetings.
It was suggested that members use e-mail more and make sure that
Mr. Montoya has current contact information, including an emergency
contact number.

**New Business**

**Reevaluation of Recommendations:** The process of reassessing
responses to existing Recommendations was discussed, and the Assessment
Committee formed to set up the process and conduct the evaluation.
Assessment Committee membership, which represents all PACHA Committees
and Subcommittees, includes Dr. Abel, Ms. Billings, Dr. Cade, Rabbi
Edelheit, Mr. Henderson, Mr. Isbell, Mr. Johnson, Dr. Levine, Mr. Lew,
Ms. Miramontes, Dr. Rankin, and Mr. Schatz. The previous evaluation
included a request for agencies to respond to relevant recommendations,
assessment of the responses in a written report, revision of the report
by the full Council, and presentation of the report to appropriate
agencies. It was agreed to shorten the process of assessment, without
losing the input of the full Council. Dr. Hitt asked that Committees and
Subcommittees keep this issue on their agenda for the next few months
and that a report be given at the next meeting by the Assessment
Committee.

**Council Vacancies:** With the resignation of Ms. Carole laFavor, two
vacancies exist on the Council, with other openings possible in the near
future. Ms. laFavor nominated her own replacement, and Dr. Hitt asked
members to submit other suggestions as soon as possible. For a better
balance on the Council, consideration should be given to ethnic descent
(especially African and Native Americans); geographic factors (e.g.,
persons from Florida and rural areas); and experience in working with
international issues, primary care, CBOs, and/or youth and HIV (or a
young person).

**The CDC Briefing in Atlanta:** The Briefing (week of July 21) for the
Prevention Committee may be extended to include a meeting of PACHA
Committee and Subcommittee Chairs, if the budget allows, to cover
interim Council business. A final date will be set as soon as possible.

**Next Meeting and Closing**

A date was not set, but the Council decided to hold a 4-day meeting in
Washington, D.C., later this year, and members were to be polled for
date preference. Three full-Council presentation panels covering
disability and return-to-work issues, impacts on people of color, and
substance abuse are proposed for the meeting. Dr. Hitt thanked Council
Members, ONAP staff, and guests for their participation, and the sixth
meeting of PACHA was adjourned at 2:00 p.m., April 8, 1997.