**Presidential Advisory Council on HIV/AIDS**

September 8-10, 1996

Bethesda Marriott Hotel

Bethesda, Maryland

**Members Present**: R. Scott Hitt, M.D., Chair; Stephen N. Abel,
D.D.S.; Terje Anderson; Judith Billings; Nicholas Bollman; Tonio Burgos;
Jerry Cade, M.D.; Robert Fogel; Kathleen Gerus; Edward Gould; Phyllis
Greenberger; Robert Hattoy; B. Thomas Henderson; Michael Isbell; Ronald
Johnson; Jeremy Landau; Alexandra Mary Levine, M.D.; Steve Lew; Helen H.
Miramontes; Altagracia Perez; Michael Rankin, M.D.; H. Alexander
Robinson; Debbie Runions; Benjamin Schatz; Denise Stokes; and Bruce
Weniger, M.D. Also present: Patricia Fleming, Jeffrey Levi, Daniel
Montoya, and Jane Sanville, Office of National AIDS Policy (ONAP).

**Members Absent**: Regina Aragon, Mary Boland, Debra Fraser-Howze,
Carole laFavor, Richard W. Stafford, Sandra Thurman, Charles Quincy
Troupe.

Dr. Hitt opened the fourth meeting of the Presidential Advisory Council
on HIV/AIDS (PACHA) by welcoming new members, Ms. Billings, Mr. Isbell,
and Mr. Johnson, and reviewing Council actions since the April meeting.

He thanked Mr. Anderson, Ms. Aragon, Dr. Cade, Mr. Gould, Dr. Levine,
Mr. Henderson, Ms. Miramontes, Mr. Robinson, and Mr. Schatz for their
contributions to the Assessment and Executive Reports, which were
distributed to community-based AIDS Service Organizations (ASOs), State
and Territorial associations, and attendees at the White House
Conference on AIDS. Other activities included the International AIDS
Conference and Vice President Gore\'s Keystone Conference, which
resulted in a plan for collaboration between the pharmaceutical industry
and Government on development of optimal AIDS drugs. Council members
Runions and Perez were noted for their participation at the Democratic
National Convention.

** ONAP Report**

Ms. Fleming thanked the Council for its help to ONAP and the President,
whom she described as \"optimistic\" about a national goal of giving
people with HIV/AIDS (PWAs) a normal life span. The Administration,
aware of the concerns of PWAs and other adversely affected groups, is
working to save Medicaid benefits. The Administration\'s recent
legislative agenda include the Kennedy-Kassebaum bill and the Welfare
Reform bill, and ONAP is working to ensure that AIDS issues are included
in all immigrant programs. The Health Care Finance Administration (HCFA)
is working with New York on a landmark waiver on Medicaid managed care
and has been very responsive to housing concerns of people with
long-term illnesses.

The major unfinished business of Congress remains in the area of
appropriations, which affect AIDS issues such as labor and housing. The
President has submitted two add-on budget resolutions of concern: (1)
redirection of \$25 million from other programs in Housing and Urban
Development (HUD) to its Housing Opportunities for People with AIDS
(HOPWA) program, which Ms. Fleming called \"the result of a new level of
visibility,\" and (2) increases in funding of the Ryan White Title II
AIDS Drug Assistance Program (ADAP) by \$65 million. This is an
indication of the Administration\'s intent to meet needs as they arise.
Council members emphasized that stable housing and living environments
are significant in both treatment and prevention of AIDS. ONAP hopes to
obtain a single budget appropriation this year for the Office of AIDS
Research (OAR) to give it more budget authority and urged PACHA to
contact Congress on this issue.

The ONAP meeting in Tampa on substance abuse and AIDS prevention and
treatment, during which Mr. Anderson represented PACHA, and a session
with the Deputy Director of the Office of National Control Policy are
seen as significant in formulating greater collaboration on these twin
epidemics. The main message in Tampa was that the Government creates
many obstacles to the integration of both HIV and substance abuse
programs at the community level.

Results of the Vancouver Conference were mixed. More hope is seen for
the future through new protease inhibitors, but major questions arise
about their durability. Approval of these expensive drugs creates other
public policy needs: (1) more ADAP funding; (2) an adjustment in the
Medicaid/Centers for Disease Control and Prevention (CDC) definition of
HIV/AIDS to ensure the earliest possible treatment for infected persons;
(3) a restructuring of care systems to provide more flexibility in
allowing patients to go on and off disability as needed; and (4) a way
to convince vulnerable populations to seek early testing and counseling
voluntarily.

The newly created Forum for Collaborative HIV Research resulting from
the Keystone Conference may help answer questions arising over the
potential long-term effects of new AIDS drugs. The inclusion of
third-party payers such as programs under HCFA, Medicaid, Medicare, and
private insurers will extend the reach of clinical trials to heretofore
unaccessed populations. Dr. Levine represented PACHA in this effort.

Other issues include the President\'s request for full-prevention
programs within the CDC and the microbicide initiative, a \"giant step\"
toward prevention through empowerment. The ONAP regional briefings were
productive and informative, and Ms. Fleming thanked Council members for
participating in these meetings.

** National AIDS Strategy**

ONAP\'s long-promised national plan was introduced by Ms. Fleming as
\"The National AIDS Strategy.\" The term \"strategy\" was used to
signify that this is a \"living document\" that can be updated
periodically rather than an implementation plan. It is \"historic\"
because it is the first Government-wide strategy involving an
Interdepartmental Task Force (IDTF) representing every agency that
supports AIDS activities in the Executive Branch and the first time
goals have been linked with budget levels. Ms. Fleming asked for Council
input and recommendations but did not guarantee that suggestions would
be included in the final draft.

Ms. Sanville reviewed the draft Strategy policy areas: prevention,
research, care and services, civil rights (including discrimination
issues), international activities, and translation of research advances
into practice. Objectives and recommendations of other groups, including
PACHA,

are represented. Highlights are the following: major
Presidential/national goals, recent Administration accomplishments, and
areas requiring special attention or proposed future actions. No time
lines are included, so it is incumbent upon the Council and ONAP to work
with agencies to determine how goals can be met. The Appendices describe
recent and ongoing agency goals and actions.

The process for finalizing the Strategy is to obtain suggestions and
comments from the Council during this meeting and through conference
calls with Committees over the next few days, followed by release of a
draft National AIDS Strategy to the AIDS community and private sectors
for review and comment. ONAP hopes to present the final draft at the
December PACHA meeting.

During subsequent discussions, the Council raised concerns and made
suggestions about the release and content of the document: It needs much
work; it may be ill-timed; and it must be made clear to all concerned,
including the media, that this is not an implementation plan to end the
epidemic but that a second process is required to identify
implementation steps. Also, the community must understand its ability to
affect the Strategy. It was also suggested that more attention be given
to funding and implementation of prevention programs and that the
relevant activities of such agencies as the Office of Civil Rights of
Health and Human Services (HHS), Housing and Urban Development (HUD),
Veterans Affairs (VA), the State Department, the military, and the Civil
Rights Commission be included.

Dr. Hitt asked what further information was needed from the Council, and
Ms. Fleming and

Mr. Levi said that ONAP would crosswalk the PACHA Recommendations
against the Strategy to see whether anything has been omitted. Comments
and suggestions for implementation of the Strategy should be made in
writing by individuals or Committees by November 1. Committees were
asked to discuss this in their next conference calls and to draft
responses to ONAP. ONAP will not circulate the Strategy to the public
before the Council suggestions are made and the document has been
revised accordingly. Volunteers to help in revising and planning release
are Ms. Miramontes, Mr. Landau, Dr. Rankin, Mr. Johnson, and
Mr. Anderson.

** Four-Year Plan**

During several discussions, the Council developed a \"Four-Year Plan\"
to show the White House and the AIDS community what it hopes to
accomplish in the future. Major issues were the following:

** Should the Council\'s Charter be extended past July 1997? ** Yes---to
address issues that have not been covered (e.g., managed care, drug
abuse, new medications) and new ones that arise, and to ensure
implementation of strategies and recommendations.

** What do we want the legacy of this Council to be?** To be seen as an
outspoken voice of the community; a moral conscience holding the
Administration accountable; an aid to restructuring Administrative
structures as needed; the initiator of actions that led to changes in
the epidemic and decreases in infections; and as a force in increasing
the visibility of AIDS within the Government, bringing together creative
thinking of many groups, and helping the Administration grapple with
changes in the epidemic.

** How are we different from other groups?** We provide diversity and
effective cross-communication; the President listens and responds to us;
we can talk to all groups involved; and the community comes directly to
us with input and we respond.

** What are our long-term goals?**

** Four-year outcome goals:** to be a catalyst for bringing the epidemic
to an end---by decreasing the rate of infection by at least
one-half---by the end of the century, and to ensure universal access to
optimal AIDS treatment and care.

** Strategies for achieving these goals** involve developing proactive
plans and community involvement/support (e.g., needle-exchange
programs), making prevention a higher Government priority, protecting
and following up on current programs and recommendations, facilitating
the National Strategy, finding new strategies to respond to epidemic
changes, and continuing high-level discussions.

** Longer term/wider scope goals:** to develop strategies for more
effective international collaboration and to develop a structure for
dealing expeditiously with future epidemics.

** What are our roles?** Identify recommendations; advisory;
prioritization; continued evaluation and assessment and Executive Branch
oversight and monitoring; bidirectional communications in consensus
building, consciousness-raising, and personalizing HIV; conduit for
information and recommendations; and constituency building in outreach,
mobilization, and education.

The Council agreed that it should act as a facilitator for the Executive
Branch in AIDS-related efforts, advise the President on domestic and
foreign issues of the pandemic, stay in touch with all contingencies and
interest groups, and gain better access to the private sector.

** Short-Term Goals**

An action plan through December includes scenarios for either election
outcome:

** All-case goals:** Committees to identify recommendations needing
updated responses, follow up on timed recommendations, continue
high-level meetings with the Administration to discuss strategies, and
identify what can be signed and implemented (\"stroke of the pen\"
strategy) by January 15 (before a White House transition). The Council
will start immediately on transition plans to educate new legislators,
implement \"friendly\" appointments, target allies for the Council, and
formalize its resources request.

** \"Scenario 1\" goals **(President re-elected): Write the President
and Vice President requesting they interpret the election results
vis-à-vis AIDS efforts, report on Council activities and resources to
new Congressional members, and invite Congressional leadership to the
next Council meeting.

** \"Scenario 2\" goals **(President not re-elected): Discuss immediate
strategy by conference call, finalize a \"stroke-of-the-pen\" strategy,
and draft an Exit Document.

Other issues for consideration in the short term include continuing
resolutions, international concerns, prisons, substance abuse, and youth
and HIV. New Council Committees were established for discrimination and
prison issues, and members volunteered to work on international concerns
with Mr. Fogel. In addition, Dr. Cade and Mr. Anderson will draft a
preliminary plan for covering substance abuse for the December meeting.
The Council discussed Quilt activities and will make recommendations to
the White House regarding Administration participation.

A questionnaire drafted by Mr. Henderson and Dr. Hitt was proposed for
surveying AIDS service organizations (ASOs) and White House Conference
participants by the end of the year to continue a dialogue with the AIDS
community, evaluate the Council\'s work to date, and seek input on
prioritization of AIDS issues. The Council could not decide on timing,
circulation, wording of the questionnaire, or uses and value of the
results, and the issue was tabled until the December meeting.
Ms. Billings will redraft the questionnaire with Dr. Hitt.

** Staffing and Budget Issues**

Support staff and funding are needed to continue Council work, even on
an interim basis, as volunteer burnout is inevitable and communications
must be improved. Funding is needed for staff, consultation with outside
experts, member travel to other meetings, communications, and research.
Staff---one full-time employee (FTE), requested through HHS, and a
person capable of performing analytical, organizational, and other
substantive work---are needed to handle administrative work,
communications, community outreach, coordination and documentation of
meetings and conference calls, action reminders, research, and
information gathering. ONAP can provide office space for Council staff
but cannot share personnel. Ms. Fleming suggested that a Government
Fellow possibly could be assigned to PACHA. The Council will draft an
interim working plan, with long-term needs to be delineated if PACHA is
to continue. Dr. Hitt asked Committees to prepare 6-month plans for
staffing and resource needs.

** Process Issues**

** Information production and dissemination processes** need to be
improved through better staffing and funding.

** Communications protocols and proper coordination** must be developed.
Council communications should not be duplicative or burdensome to
members, outside agencies, or ONAP, and a mechanism for followup is
needed. On an interim basis, Council communications with Government
entities, especially those concerning information or meetings and
requiring followup, will go through Mr. Montoya, excluding conference
calls that involve other ONAP personnel.

** A new Discrimination Committee** was established to help identify and
keep up with related issues. Members are Mr. Schatz, Chair, and liaisons
from existing Committees---Ms. Gerus, Mr. Henderson, and Mr. Johnson.

** Interim action plan**. A non-urgent issue, such as a resolution or a
letter, can be put in the *Federal Register*; however, if urgent, it
should be handled by conference call.

** Committee participation and structure**. Problems have arisen with
members who are absent from meetings and conference calls and do not
respond to urgent communications. Members were urged to change or drop
out of Committee assignments if they are not able to complete tasks and
follow up on action items. Committees agreed to send advance information
on the topics and participants of conference calls.

** Absentee policy**. Suggested ways of dealing with absenteeism include
using an attendance chart for meetings and conference calls; creating an
environment wherein members feel safe to say \"I can\'t do it\"; asking
those who have missed meetings not to revisit issues that have already
been resolved; having Chairs self-police their meetings; setting a limit
on the number of times a Council member can miss for other than excused
absences and/or in case of illness (two should be the maximum); and
replacing non-participating members with others who can participate.
Dr. Hitt will develop a device for tracking attendance and a guideline
for participation and absenteeism. ONAP will research the legalities of
removing Presidential Council members, and Dr. Hitt will check policy
with the White House.

** Lobbying**. Members were reminded that they cannot lobby while on
Government-paid travel; if members choose not to accept Government
funding, they can do as they please.

** International issues**. Mr. Fogel asked for help in researching the
issues surrounding U.S. leadership and AIDS in the international
community, and Mr. Rankin and Dr. Weniger volunteered. The Council
deferred a decision whether this will be a full or ad hoc committee or
remain a cross-cutting issue with Mr. Fogel as the point person.

** International Issues Update Panel**

A panel representing 14 AIDS-related organizations discussed major
issues in the international arena and made recommendations for actions
by PACHA and the Administration. Mr. Fogel chaired the panel and noted
that the AIDS pandemic is not only a matter of numbers of people
infected and orphans created, but also of the economic disasters it
causes in emerging economies. In addition, it affects issues of civil
rights, gender, and social justice. Speakers were the following:

**Victor Barnes**, Acting Director of the Division of HIV/AIDS of the
U.S. Agency for International Development (USAID), presented an overview
of the global epidemic and the USAID\'s past and future response to it.
He also summarized the AIDSCAP Satellite Symposium at the Vancouver
Conference, covering the status and trends of the epidemic outside the
United States: From 1990 through the present, HIV infections worldwide
doubled, with 94 percent in developing countries, where HIV/AIDS is
spreading rapidly even as it declines in the United States. Heterosexual
transmission is the major route of infection; the average age of newly
infected persons is declining; rates of newly infected women and youth
in urban settings are disproportionately high; economic impact is high;
available resources for care and treatment are much smaller than in the
United States; and morbidity and mortality have forced the growth of a
community-based infrastructure that is missing from the United States.

**Eric L. Sawyer**, ACT UP/New York, discussed human rights abuses,
which continue to kill millions of impoverished PWAs. These include drug
company profiteering, government isolation of the rich from the poor and
the uninfected from the infected with immigration barriers and
quarantines, and hatred of the poor and disenfranchised communities.

**Stuart Burden**, MacArthur Foundation, gave a private sector
perspective, focusing on

U.S. leadership in worldwide collaboration; resources, including new
funding and equipment donations; and development of ideas through new
methods of exchange.

**Lori Heise**, Health and Development Policy Project, addressed
integration of gender and social justice issues into international
health policy and practices and suggested that increased funding could
come from foreign-aid budgets.

**Cynthia Mariel**, National Council for International Health, discussed
the roles of private voluntary organizations (PVOs) and nongovernmental
organizations (NGOs) in the fight against AIDS. More than 100
organizations in the United States are involved in international AIDS
programs, and she stressed the need for funding for these
community-based groups.

**Paul Boneberg**, Global AIDS Action Network (GAAN), addressed U.S.
global AIDS programs and gave recommendations for USAID, the Department
of State, the President, and PACHA.

**Jairo Pedraza**, Global Network of People Living with HIV/AIDS (GNP+),
discussed international access to treatment and the mission of GNP+ in
World Health Organization (WHO) regions.

**Harold Phillips**, National Minority AIDS Council (NMAC), spoke on the
exchange between domestic and international NGOs, the Joint South
Africa/U.S. Collaboration Conference, and the mission of NMAC in
providing technical assistance to AIDS-related organizations.

**Patricia Fleming**, Director of ONAP and a delegate to the joint
United Nations Programme on HIV/AIDS (UNAIDS), discussed the creation
and mission of UNAIDS: to amplify national programs, help eliminate the
tangle of programs, and reduce overlapping among government
organizations globally. With a total budget of \$60 million, UNAIDS
provides technical assistance to governments, promotes research and
exchange of prevention ideas, coordinates AIDS programs within
companies, and promotes strong AIDS programs in foreign countries.

**John Y. Killen, Jr., M.D**., National Institute of Allergy and
Infectious Diseases (NIAID), gave an international perspective to the
issue of prevention research and vaccine development. Finding an
effective HIV/AIDS vaccine is an enormously challenging but feasible
goal, with scientific, logistic, social, and economic issues that are
different in other parts of the world. He provided a copy of NIAID\'s
strategic plan for vaccine research and development and described the
Institute\'s infrastructure for worldwide vaccine efficacy trials,
HIVNET.

**Deborah L. Birx, M.D.**, Department of HIV Vaccine Development of the
Department of Defense (DoD) and the Walter Reed Institute of Research,
described the Army\'s vaccine research and development program and its
coordinated efforts with the Navy and other countries.

**Phillip K. Russell, M.D.**, The Johns Hopkins University, School of
Public Health, talked about International AIDS Vaccine Initiative
efforts to create a more favorable environment for development of a safe
and effective vaccine around the world. The Initiative will help
strategic planning and funding for underfunded research in conjunction
with the private sector.

**Elaine Daniels, M.D., Ph.D.**, U.S. Department of Health and Human
Services (HHS), discussed the Trinational Joint Declaration on HIV/AIDS,
a meeting of high-level Administration personnel from the United States,
Mexico, and Canada, and the U.S./Canada Initiative on Palliative Care.
She focused on incorporation of input of PWAs in all phases of the AIDS
epidemic and partnerships between PWAs and health care workers.

**Nancy Carter-Foster**, Director of Emerging Infectious Diseases and
HIV/AIDS Office of the Department of State (DOS), discussed the changing
attitudes and status of the disease at high levels. The DOS educates
high-level personnel such as ambassadors and all of its Foreign Service
personnel on AIDS in international populations and human rights issues.
She described the establishment of the Global Surveillance and Response
Network and the U.S. International Strategy on HIV/AIDS, which includes
prevention of new infections, reduction of personal and social impacts,
and mobilization and unification of national and international efforts.

The following were common themes and recommendations:

Because the disease is an issue of development, poverty, and power
dynamics, USAID is the heart of the response to global AIDS. It should
be strong, well funded, and fully staffed, and its agenda should be
expanded to include care and treatment with prevention efforts and
protection of human rights. Vacancies in the Office of AIDS must be
filled with people with global HIV/AIDS experience.

Collaboration among all National Governments and NGOs is necessary to
provide effective exchange of ideas and techniques, to develop
preventions and treatments, and to eliminate costly overlapping.

Money is the critical factor in halting the spread of AIDS; the
international effort needs five to ten times more funding than it
currently has. The President should seek a huge increase in global AIDS
funds for both prevention and care. The United States also needs a
vehicle to manage its AIDS funding.

The United States must increase its leadership in linking worldwide
efforts and information. The President and Vice President must become
more involved in leadership, such as working with the private sector to
increase resources for the worldwide fight against AIDS.

In order to stop the pandemic, the United States must have a global
perspective. We have a moral obligation to help other countries, as AIDS
can destroy emerging economies in such areas as Africa, Asia, and the
former Soviet Union.

Access for all people to prevention and care is of greatest importance.

Drug pricing must be curbed; the Administration can help by asking for
cooperation from pharmaceutical companies to increase access and promote
public health worldwide.

The ratio of global research investment in treatments versus prevention
is five to one; the development of vaccines and other preventive
measures needs to be emphasized.

NGOs, PVOs, and other community-based programs around the world need
support.

Human rights and social justice must be considered, and the development
of a human rights protection program for PWAs must be developed.

Gender issues, such as female microbicides and empowerment, must be
addressed.

All travel restrictions against PWAs should be removed. Unrestricted
travel is a basic human right and allows people with important messages
to enter this country.

This Update is seen as a \"first step\" in the development of U.S.
international collaborative efforts; however, PACHA needs to continue to
educate members on the global pandemic, include the international agenda
in all meetings, and add members with international experience.

In summary, Mr. Barnes said that prevention cannot be provided in
isolation. He outlined some of USAID\'s responses to these issues:
adding discrimination to its agenda; seeking to fund small,
community-based programs by involving NGOs and PVOs in implementing its
programs locally; and fully staffing the Office of AIDS by the end of
this year.

Dr. Hitt thanked the Panel and asked each of the speakers to select
three to five major recom-mendations, reformatting them to match PACHA
recommendations, including both actions that the Executive Branch can
take alone and those that need cooperative effort. PACHA will use these
to develop international Council recommendations to the Administration.

**Committee Meetings**

** Research and Prevention Committees**

** Joint Meeting**

**Committee Attendees**

**Research Committee: **Alexandra Mary Levine, M.D.; Jerry Cade, M.D.;**
**Ms. Phyllis Greenberger;** **Scott Hitt, M.D.; Mr. Ronald Johnson;**
**Ms. Helen H. Miramontes**.**

**Prevention Committee: **Mr. Terje Anderson, Mr. Robert Fogel,
Ms. Kathleen Gerus, Mr. Mike Isbell, Mr. Jeremy Landau, Mr. Steve Lew,
Rev. Altagracia Perez, Ms. Debbie Runions,

Mr. Benjamin Schatz.

**Presenters/Panelists**: Judith D. Auerbach, Ph.D., Behavioral and
Social Science Coordinator,

Office of AIDS Research, NIH; Don Des Jarlais, Ph.D., Director of
Research, Chemical Dependency Institute, NDRI; Margaret Chesney, Ph.D.,
Co-Director of the Center for AIDS Prevention Studies, University of
California, San Francisco.

Dr. Levine opened the meeting with an overview of the joint committee
panel meeting. She introduced the guest presenters and thanked them for
sharing their expertise with the Council. She noted that Dr. Hortensia
Amaro from the School of Public Health, Boston University, who was to
speak on social issues of behavior, race, and ethnicity, was unable to
attend the conference.

She briefly outlined the research priorities developed in the NIH Plan
for HIV-Related Research, considered to be the consensus document of
where the field should be going. Dr. Auerbach went on to discuss the
genesis and mission of the Evaluation Working Group Area Review Panels,
which, after a year-long review of AIDS research at the NIH, developed
the recommendations incorporated in the \"Report of the NIH AIDS
Research Program Evaluation Task Force.\" The mission of the Panels, she
said, was to look critically at the NIH Plan and determine how to
develop specific recommendations that address the priorities.

Dr. Auerbach emphasized the focus of the science and the themes imbedded
in each of the four priorities.

The first priority is primary prevention through intervention research.

The second is to support the basic social sciences and behavioral
research underlying interventions: neurobiological and the
neuropsychological factors.

The third is to address the consequences of HIV from the individual to
the societal level.

The fourth is to advance innovative methodologies to enhance behavioral
research.

The key issues for OAR, she said, are better representation across the
range of behavioral and social sciences disciplines; integration of
disciplines such as anthropology, sociolology, and political science
(impact of policy decisions); augmentation of the units of analysis to
include couples, families, communities; clarification of the basic
science of HIV prevention and intervention; greater knowledge of the
mechanics of sexuality, sexual behavior, addiction, individual behavior
change; more attempts to integrate behavioral and biomedical approaches
where appropriate; attention to populations that have been
underrepresented to date; recognition of the individuals and communities
affected and created by HIV/AIDS.

Dr.  Des Jarlais' presentation dealt with the worldwide spread of HIV
disease among injection drug users (IDUs) and the need to implement an
effective, preventive needle-exchange program. Recent studies point to
the rapid and widespread increase in drug use and HIV disease over the
past 10 years. In cities where there was an explosive rise in HIV,
studies found that IDUs were not aware of the connection between needle
sharing and HIV; there were strong restrictions on access to sterile
equipment; and IDUs were sharing needles with strangers. Conversely,
cities with a stable, low-HIV seroincidence among IDUs showed that
prevention efforts were begun early (before the disease grew out of
hand), and there was early access through syringe-exchange programs and
community outreach. Data show that there are very effective
interventions for IDUs to reduce risk behavior and HIV transmission.
However, although the National Commission on AIDS in 1991 recommended
treatment upon request for IDUs and removing legal barriers to syringe
exchange in pharmacies, neither of these recommendations has been
implemented.

Dr. Chesney discussed the challenges facing the research and prevention
community that will affect issues of adherence for IDUs. The latest
clinical trials show that protease and reverse transcriptase inhibitors
have achieved sustained reduction of plasma HIV RNA; that triple
therapy, including antiretrovirals and protease inhibitors, has led to
significant decreases in viral load. The issues that need to be
addressed are the extent to which (1) reductions in viral load will lead
to survival and (2) noncompliance with therapy will lead to resistance,
cross-resistance strains of the virus, and multidrug resistance strains
to the virus.

Recent studies have raised some challenging issues for behavior and
social science research: (1) identifying and recruiting persons into
triple-therapy care as early as possible during the acute infection
stage to lower the virus levels; (2) maintaining compliance to new
triple-therapy regimens; (3) focusing prevention intervention (early
counseling, access to care, making compliance a life priority) on
HIV-positive individuals; (4) testing the effects of primary prevention
intervention on HIV seroincidence.

**Discussion**

Dr. Levine opened the floor for questions from the Committee. An
intensive question and answer period followed, and the following are
some of the points made:

Certification of needle-exchange efficacy must come from the Surgeon
General before an effective Federally funded needle-exchange program can
be put in place.

There are no data to show an increase in drug use as a result of a
needle-exchange program.

Mandatory testing will not work; there is no way to determine how often
a person should be tested. What should be considered is targeted testing
and targeted intervention. Substantial evidence exists that links needle
exchange with getting IDUs into treatment; however, most cities do not
have sufficient treatment centers.

The NIH is working on a multidisciplinary approach, bringing together
the various ICDs to develop an AIDS prevention science agenda and
linking it to the CDC and other agencies with similar agendas.

Accessibility to clinical trials is necessary to increase enrollment and
ensure participation and retention.

NIDA is conducting studies on such issues as how to make the local
syringe-exchange programs more effective and how to reach the most
people.

There are questions that remain unanswered concerning early intervention
and the proposed three-drug treatment. How long should the treatment
last? When should treatment be stopped? Should it be stopped?

Adherence counseling (maintaining correct dosage, staying on therapy
regimen, knowledge of what the drugs are and how they work, etc.) is
very important for therapy to be effective.

Questions that still remain unanswered: Why is risk behavior occurring?
What underlying cause of risk behavior are we trying to determine? Are
randomized trials worthwhile?

Societal problems need to be solved if HIV/AIDS prevention problems are
to be solved.

**Conclusion**

Dr. Levine and the Committee members thanked the speakers for their
contributions to a most interesting and informative meeting, and
adjourned the meeting.

**Services Committee Meeting**

**Members Present:** Mr. Gould, Chair; Dr. Abel; Mr. Bollman;
Mr. Burgos; Ms. Fleming;

Mr. Henderson; Dr. Hitt; Mr. Levi; Mr. Lew; and Dr. Rankin. Mr. Gould
introduced the Committee and guest speakers, who briefed the Committee
on various aspects of health care services.

**Drug Pricing**: John Coster, National Association of Chain Pharmacies;
Paul Kim, American Foundation for AIDS Research (AMFAR); and Steve
Schondelmeyer, University of Minnesota, gave an overview of drug-pricing
methods, trends, problems, and abuses.

**Housing**: Jacquie Lawing, Deputy Assistant Secretary for Economic
Development, HUD; and David Vos, HUD Office of HIV/AIDS, discussed the
HOPWA program and HUD\'s plans and commitment to increase its budget and
provide housing for PWAs.

**AIDS Drug Assistant Program (ADAP)**: Joseph O\'Neill, Associate
Administrator for AIDS, and Anita Eichler, Head of AIDS Services, HRSA,
gave an overview of ADAP, its current financial crisis, and cost-savings
and monitoring programs it is initiating. Annette Burn, Director, and
Robert Stealey, Office of Drug Pricing, described the drug-pricing
program and voluntary discounting practices under the 602 pricing
program. Joe Kelley, National Alliance of State and Territorial AIDS
Directors, presented a \"Fiscal Status Update of State ADAPs,\"
discussing gaps in coverage and challenges facing these programs. These
include large shortfalls created by rapidly increasing patient
enrollments and escalating drug costs, especially in programs that cover
protease inhibitors.

From the ADAP Working Group, Gary Rose, AIDS Action Council, and Kara
Lindeman, Director of Public Affairs, Merck & Co., gave an advocacy
perspective on the need for interim solutions to the escalating costs of
medications and the shortfalls and gaps in States\' funding.

**Ryan White CARE Act Reauthorization Implementation Issues:**
Mr. O\'Neill reviewed the Act and the issues of implementing the
significant changes being made in it under the Reauthorization of 1995.
Other HRSA officials described activities and changes in individual
funding programs.

Title I, funding for cities, and Title II, States, were described by
Ms. Eichler.

Title IIIB, community and individual health care providers, described by
Dr. Deborah Parham, Chief of the HIV and Substance Abuse Service Branch,
now specifies that 50 percent of funding is to go to primary care for
HIV.

Title IV, pediatric care providers, discussed by Lauren Deigh, Deputy
Chief for the Pediatric AIDS Program Branch, puts new emphasis on women
and pediatric research.

Significant Programs of National Significance (SPNS), research and
development of new models of care, reported Kathy Marconi, Director of
Science and Epidemiology, Bureau of Health Resources Development, is now
linked more closely to other programs.

The AIDS Education Training Centers (AETCs) program for health care
workers, discussed by Bruce Martell, Acting Director of the program, is
shifting patients into managed care.

The new AIDS Dental Reimbursement Program, giving support to dental
schools and hospitals, was described by Stuart Bernstein, Bureau of
Health Professions.

Other business included a discussion with Nancy-Ann Min, Associate
Director, Office of Management and Budget (OMB), who discussed the
commitment of the OMB and the Executive Branch to increase budgets for
AIDS programs.

**Committee Reports to the Council**

**Joint Research Prevention Committees Report**

Dr. Levine, Chair, reviewed a new OAR portfolio, which responds to PACHA
Recommendation II.D.4 on HIV/AIDS clinical research. The portfolio,
\"Prevention Science,\" relates to behavioral and social sciences issues
and delineates the following goals: researching interventions that are
effective, as measured in the community; studying reasons why persons
continue risk behaviors after education; evaluating research methods;
and finding ways to minimize social consequences of HIV infection.
Dr. Paul is establishing an Advisory Committee to help the NIH develop a
coordinated prevention science agenda, and Dr. Auerbach asked PACHA to
recommend a coordinated behavioral and social sciences program at the
NIH.

Studies on injection drug users (IDUs) presented by Dr. Des Jarlais may
clear the way for Federal- or State-funded needle-exchange programs.
Several of the studies show that in cities with the highest incidence of
IDU seroconversions, IDUs were not educated to the association of
sharing equipment and HIV seroconversion; users had many opportunities
to share equipment with others, including strangers; and there was no
needle-exchange program. Cities with lower rates of infection began
prevention strategies early, had tremendous community outreach, made
education a priority, and had practical needle-exchange programs.

Under a current Labor/HHS bill affecting CDC and other funding, Federal
money cannot be spent on syringe-exchange programs until the Surgeon
General can prove the following: (1) that they are effective in
preventing or decreasing HIV transmission and (2) that they do not lead
to increased drug use. Another bill, affecting only NIDA funds, adds a
requirement for associated decreased drug use. The studies quoted above
prove points 1 and 2; another study, in Tacoma, Washington, also showed
decreased drug usage, because exchange sites have become drug treatment
centers as well.

Research and Prevention Committees will draft a recommendation for the
Surgeon General to state that these requirements have been met and ask
for Federal money for a syringe-exchange program. Even if the Government
does not comply, this will allow States to set up their own programs.
This recommendation should be ready to go to the President in December,
before any White House transition. Committee members will meet with
personnel from the office of Secretary Shalala for assistance with the
recommendation.

Dr. Chesney\'s key issues were compliance and early detection and
treatment of potential HIV infections, which dramatically affect
survival and transmission rates. Of particular concern is compliance
with protease inhibitor treatments, which are extremely difficult. Also,
it was found that health care workers who receive needle sticks do not
seroconvert if given AZT within

72 hours. Although using this method for sexual exposure might prove
successful, it would remain problematic.

**Research Committee Report**

Dr. Paul has set up six groups to plan methods and set a timetable for
implementing the recommendations made by the OAR Area Review Panels, to
be submitted by December 16. A consolidated OAR budget has not been
established yet, perhaps because it is believed that the current
Congress would not respond well to the fact that 12 percent of NIH money
is already directed to AIDS.

Although Dr. Paul does not favor microbicide development, Dr. Levine
pointed out that PACHA should continue to recommend it because it is
easy and practical to develop and effective as prevention. She will meet
with Dr. Fauci on this subject after the Council meeting.

Suggested Council Recommendation followup concerns II.D.1. on the Vice
President\'s efforts on drug development. The focus of the Keystone
Group has been on treatment; microbicides and vaccines should now be
added.

The Committee\'s short-term plans are to meet with the Prevention
Committee to draft a recommendation on needle exchange and arrange for
speakers for the next meeting on social issues. In the future, it will
develop a vaccine agenda. Conference calls will be made September 24
(external vaccine briefing), October 9 (general research), and October
25 (external vaccine briefing) at 10 a.m. EST, and December 6 (with
Prevention on syringe exchange) at 11 a.m. EST.

**Prevention Committee Report**

Mr. Anderson made the report in Mr. Robinson\'s absence, saying that the
integration between the Research and Prevention Committees was very
helpful. Recent actions by the Committee included a meeting with the
Office of National Drug Control Policy (ONDCP) that was \"open and
honest,\" and it was recommended to ONDCP that someone with HIV
expertise be added to their staff. Council members are invited to submit
recommendations and resumes. A conference call with the head of the HIV
Office of the CDC resulted in the Committee\'s belief that CDC\'s AIDS
programs are \"underdeveloped, unfocused, and overly timid.\" The
Committee will request a full-day meeting with the CDC in December to
obtain a better understanding of the CDC\'s AIDS programs so that more
targeted recommendations can be made.

Followup is needed for: (1) Recommendation I.C.1, asking that prevention
be designated by the President as an investment priority (The Committee
feels that clarification is needed for the term \"investment
priorities\"), and (2) the Recommendation specifying how to address the
issue on research of the safety of oral sex relative to transmission.
Followup is requested on surveillance and prevalence, testing, and
training, particularly by the CDC.

On the Defense of Marriage Act (DOMA), the Committee drafted a letter
asking the President to support the Act as a prevention measure.
Conference calls were scheduled for October 7 (review National
Strategy), November 19 (preparation for CDC meeting), and December 6
(syringe exchange); all are at 11 a.m. EST.

**Services Committee Report**

Mr. Gould, Chair, distributed the final draft of a letter on welfare
reform (the Personal Responsibility and Work Opportunity Reconciliation
Act of 1966) as concerns PWAs, and the Council voted unanimously to send
it to the President immediately.

Mr. Bollman reviewed reports on the economics of drug development,
marketing, and sales, and the current status of the AIDS Drug Assistance
Program (ADAP). Drug prices continue to escalate, especially for
protease inhibitors, and there is great need to seek government
assistance in monitoring and controlling these prices. ADAP\'s financial
crisis began before the advent of protease inhibitors, whose costs have
escalated the problem; no State can meet the demand for these expensive
drugs at the present levels of funding and vary in their coverage, from
none to that of a limited number of drugs and/or patients. Program
advocates say \$140 million is needed next year but find it difficult to
justify because the demand and need are not truly known. New finance
strategies are needed, and the Committee will look at issues for future
recommendations: (1) actual costs of drugs and whether they can be
reduced through cooperative efforts between the Government and drug
companies by cost reduction or leverage in bulk purchasing, (2) pricing
issues, and (3) who will pay for these drugs. Services should stay
abreast of ADAP advocate activities to see whether a national consensus
develops. An emergent problem is that AIDS service funds in all or most
States are being diverted to ADAP to pay for drug costs. The Committee
was urged not to let this happen, since other service delivery system
needs are increasing. Dr. Hitt noted that the Council report had omitted
the status of ADAP; however, there seems to be no clear-cut consensus on
which to base a recommendation.

Regarding HOPWA, Mr. Gould said that, although the Council has raised
HUD\'s conscious-

ness about housing needs, money is very difficult to find. A request for
reprogramming of

\$15 million into HOPWA from other HUD programs was turned down, but HUD
staff are hopeful that the \$25 million reprogramming supplement to this
year\'s budget will be accepted.

Dr. Abel reported on significant modifications to the Ryan White CARE
program, among them that SPNS now includes Native Americans. A new
Dental Reimbursement Act provides

\$6 million to dental schools and hospital residency programs to train
dentists in working with patients with HIV disease; however, larger
dental centers, which treat the greatest number of AIDS patients, are
not eligible for these funds. The AETC program has a 25 percent budget
cut, necessitating revision of training and standardization across the
country to reduce costs. Title IV is linking 20,000 women, youth, and
children into research protocols for the first time, and Title IIIB has
changed from intervention into a primary care program. Discussion of
Titles I and II raised issues of where money is best spent and whether
outcome measures can be developed to answer this. Should it be left to
the Federal Government, the States, the advocates, or the ethicists? The
Service Committee votes for the ethicists.

Conference calls were set for October 3 (review of National Strategy)
and October 24 (update) at 10 a.m. EST. Reports will be given in
December on issues under review, including youth and alternative
therapies. Regarding existing Service recommendations, the Committee
agreed that all or most are in progress; if shortfalls are perceived,
the Committee will contact Mr. Levi. Services hopes to have additional
recommendations on drug pricing and ADAP by December.

**Discrimination Committee Report**

Mr. Schatz reported that the Committee found the following areas of the
National Strategy needed expanded coverage: discrimination issues other
than employment, such as education, housing, and denial of care; a
broader role of Government in fighting discrimination even in
nontraditional areas such as family law; a more systemic agency approach
toward education; and the list of agencies responding to discrimination
issues in the Appendices.

\"Stroke-of-the-pen\" items for immediate Administration response
include Recommendations II.E.1. (discrimination in Government agencies)
and II.E.2. (health care workers). The Committee proposed to meet with
the Domestic Policy Council regarding II.E.1. and the CDC and the
Prevention Committee on II.E.2. Ms. Fleming said ONAP briefed the
President on discriminatory practices in the Peace Corps and other
agencies and met with the Job Corps, which has agreed to remove
restrictions such as mandatory HIV testing. ONAP will follow up with
other agencies, and Mr. Henderson said that contact was being made with
the Department of State.

For the December meeting, the Committee will put together information
from outside sources, including the Discrimination Subcommittee of the
White House Conference. Mr. Lew will assess immigration discrimination
issues. Conference calls were set for September 26 and November 18 at 12
noon EST.

**Prison Committee Report**

Mr. Landau, Chair, introduced the new Committee members---Dr. Abel,
Ms. Gerus, Mr. Cade, Dr. Ranking, and Patricia Milon, HRSA Liaison---and
said they will send an information packet and proposed recommendations
to the Council prior to the December meeting. The Committee will put
together a panel with three or four speakers to review the material;
discuss legal, prison, international, and inmate issues; and make
recommendations for 1997. Conference planning calls are set for October
31 and November 21 at 11 a.m. EST, through Ms. Milon\'s office.

**International Update Review**

The Council viewed the International Update Panel as a good format for
future information sessions; however, speakers and material should be
limited, reasonable time limits imposed, and time reserved for
questions. Speakers should answer the question, \"What do you want the
Council to do for you?\" and give specific recommendations. Background
material and recommendations, if possible, should be sent to Council
members in advance. Dr. Hitt asked Mr. Fogel to collect, assess, and put
recommendations from the speakers into proper format for Council
consideration. Two proposed \"urgent-message\" international
recommendations were put before the Council; one was approved as
follows:

Because of the extraordinary number of vacancies in the Agency for
International Development (USAID) HIV/AIDS program and the potential
impact of these vacancies on its effectiveness, the President should
direct USAID immediately to fill the existing vacancies in the Division
of HIV/AIDS with personnel expert in global AIDS issues. USAID should
incorporate in its future AIDS programs greater emphasis on skills
exchange between domestic AIDS groups and their counterparts in other
nations and expand its AIDS efforts to include issues relative to care,
treatment, and the protection of the human rights of those infected.

A recommendation for a meeting between the President and the Director of
USAID was tabled for additional consideration. A second recommendation,
to fill a current vacancy on the Council with someone with international
experience, will be made to the Administration.

**Other Business**

**National Strategy Resolution**

A resolution on the National AIDS Strategy was reviewed and approved by
Council members:

The Council is appreciative that ONAP has sought our feedback on the
internal working draft of the National AIDS Strategy and requests an
opportunity to review the document and provide our responses no later
than November 15 \[or November 1 as requested by Ms. Fleming\], 1996. It
is our understanding that ONAP will take our comments under
consideration, report back to the Council, and circulate the subsequent
draft for community comment by the time of the Advisory Council\'s
December 1996 meeting.

**DOMA**

The Discrimination Committee stated that DOMA should be covered in the
Prevention Committee, since it is not being targeted as a Civil Rights
issue, but rather for the impact of homophobia on HIV research.
Prevention stated that a public ban on same-sex marriage will establish
\"a phobia that makes it difficult to send the message to high-risk gay
men that their lives are worth protecting.\" The Committee\'s letter
would put the Council on record as considering this a prevention issue.
Unanimously approved, it was to be sent to the President immediately.

**Gramm Amendment/SSDI Issues**

Mr. Anderson reviewed these issues and asked that the Council send an
information request to the Administration before the next meeting
concerning what HHS is doing to implement the Gramm Amendment to the
Welfare Reform bill to provide access to certain public benefits to
people convicted of drug felonies. Additionally, an imminent change in
the determination of Social Security Disability Insurance (SSDI)
benefits based on substance abuse will separate PWAs in need of public
assistance (Medicaid) from health care. The Council should ask the
Social Services Administration (SSA) what is happening and how they will
ensure access to services for HIV/AIDS patients. These issues should be
addressed in December, and the Service Committee should monitor them as
well as any response from the President to the letter regarding the
welfare bill.

**Long-Range and Short-Term Goals**

Possible public uses of the Four-Year Plan are to reference the two main
objectives in a survey to White House Conference attendees and as
background for a meeting with the Administration to discuss staffing and
funding needs. Members were asked to review the Plan and send changes to
Dr. Hitt for further refinement at the next meeting. Short-term action
goals include the following:

Committees submit new followup action plans for appropriate
recommendations.

Members look for suggested action items in the transition phase.

Interim staffing and budget requests finalized, and during Quilt weekend
a meeting set with Kevin Thurm\[?\] to discuss resource needs.

The Administration advised regarding possible Quilt activities.

A letter to the President and Vice President interpreting election
results drafted by

Mr. Anderson, Mr. Fogel, and Dr. Hitt.

The Process Committee develops a legislative agenda and invitee list to
send with Council reports to new and old Congressional leaders after the
election, along with an invitation to the December Council meeting.

\"Stroke-of-the-pen\" strategy finalized and an Exit Document written by
the Process Committee.

**Town Hall Meetings**

Richard Sorian, ONAP, reported on the regional \"Town Hall Meetings\"
held to brief community leaders and organizations. He thanked the
Council for the idea and the direct participation of 17 members. The
project, which took 24 weeks and covered 39 ASOs and 3,500 to 4,000
people in 11 cities, was highly successful and provided many benefits,
including the opportunity to contact local philanthropists and develop a
list of community-based organizations (in Appendix to Report).

Conclusions were as follows: (1) Communities value and publicly support
programs like the Ryan White CARE Act, HOPWA, and prevention programs
supported by the CDC and other agencies. (2) Individuals, especially
PWAs, and local organizations appreciate the contact with Council
members and Government officials and having a public forum. (3)
Increased funding over the last few years is appreciated, but there are
rising needs and competition for funds. Some emerging populations, such
as youth and women, are struggling to get funds and learn skills needed
to gain them. ADAP is very popular, but people do not know how to get
into it, or how much and what it will cover.

ONAP found many successful community models for working with
under-covered populations (e.g., peer counseling programs work well with
youth) and is working with the CDC to set up a consortium to study and
replicate some of them. Conflict between the advocates of HIV prevention
and some community entities such as city councils and school boards
exists, but ASOs are finding innovative ways to avoid the conflicts.

Followup is essential and ONAP staff and the 21 participants from other
agencies are working on issues such as Social Security eligibility
problems. The draft report will be refined and sent to agency
participants and White House conferees, who inspired this program.

No more trips are planned between now and December, and Mr. Sorian asked
the Council to consider whether this process should be continued.
Dr. Hitt said it will be on the December agenda and a thank-you letter
will be sent from the Council to agency participants.

**Members Representing the Council**

Two issues surround Council representation in outside meetings: funding
and participation. Currently, there is no formal process for raising
funds and determining which meetings should be attended and by whom. The
current Council budget covers only the PACHA meetings and conference
calls. If a Council member is invited by a group to attend and expenses
are paid, there is no problem. Mr. Levi said it is legal for the Council
to accept private and agency funds for this, but there is no Government
agency to administer these funds. He will research regulations about
traveling abroad for members. Also needed are processes for obtaining
information from meetings that the Council does not attend and inviting
outside advisory council members and others to PACHA meetings. This will
be addressed in the staffing and funding requests; for now, members
should coordinate with Dr. Hitt when representing the Council.

Regarding the current staffing crunch, an agency representative from the
CDC, Ms. Sherry Darden, and Ms. Milon from HRSA are available to help
the Council. Mr. Levi will write a protocol for communications between
Council members and ONAP for this purpose.

Ms. Fleming thanked her staff for working with the Council, and Dr. Hitt
thanked Council members, Assessment and Process Ad Hoc Committees, and
ONAP for their participation. The meeting was adjourned at 1:30 p.m.
September 10, 1996.