**Presidential Advisory Council on HIV/AIDS**

**Full Council Meeting**

March 15--18, 1998

Madison Hotel

Washington, D.C.

**MINUTES**

**Present**: R. Scott Hitt, M.D., Chair; Stephen N. Abel, D.D.S.; Terje
Anderson; Regina Aragon; Judith Billings; Charles Blackwell, J.D.;
Nicholas Bollman; Jerry Cade, M.D.; Lynne M. Cooper; Rabbi Joseph A.
Edelheit; Robert Fogel; Debra Fraser-Howse; Kathleen Gerus; Phyllis
Greenberger; Robert Hattoy; B. Thomas Henderson; Michael T. Isbell;
Ronald Johnson; Jeremy Landau; Alexandra Mary Levine, M.D.; Miguel
Milanes, M.P.A.; Helen H. Miramontes; Rev. Altagracia Perez; Robert
Michael Rankin, M.D.; H. Alexander Robinson; Debbie Runions; Sean
Sasser; Benjamin Schatz, J.D.; Richard W. Stafford; Denise Stokes; Bruce
Weniger, M.D.; and Daniel Montoya, Executive Director for PACHA within
the Office of National AIDS Policy (ONAP). **Present from ONAP**: Sandra
Thurman, Director; Todd Summers, Deputy Director; Brad Austin,
representative from Substance Abuse and Mental Health Services
Administration (SAMHSA); Matthew Murguia, Office on Minority Health
(OMH); Robert Soliz, Health Resources and Services Administration
(HRSA); Todd Weber, Centers for Disease Control and Prevention (CDC);
and staff members Sarah Holewinski and Jeff Kamen.

**Absent**: Nilsa Gutierrez, M.D., M.P.H.; Steve Lew; and Charles Quincy
Troupe.

**March 15**

**Opening and General Council Business**

Dr. Hitt, Chair, opened the Ninth Meeting of the Presidential Advisory
Council on HIV/AIDS (PACHA) with a review of interim activities and
meeting goals. He thanked members and ONAP staff for their ongoing
efforts on behalf of PACHA and HIV/AIDS issues and welcomed all guest
speakers slated to address the Council during this meeting.

**New Members**

Three new members were welcomed to the Council: Charles Blackwell, J.D.,
President of Native Affairs and Development Group, Washington, D.C., and
Ambassador to the United States of America from the Chickasaw Nation;
Ms. Lynne M. Cooper, President of DOORWAYS, St. Louis, Missouri; and
Miguel Milanes, M.P.A., Coordinator of HIV/AIDS Programs, Dade/Monroe
Counties, Florida Department of Health. Two new agency representatives
to ONAP---Mr. Brad Austin, SAMHSA, and Mr. Todd Weber, CDC---also were
introduced.

Ms. Mary Boland has resigned to fulfill other professional commitments,
leaving a vacant Council seat and a gap in coverage of pediatric issues.
Dr. Hitt said that Ms. Boland had provided suggestions for her
replacement and recommendations for all PACHA issues she was covering,
and he asked members to submit additional names of potential candidates
to fill this vacancy.

**Interim PACHA Activities**

· PACHA's Second Progress Report was issued directly following the
December meeting, garnering a large amount of press coverage, with
overall balanced reporting.

· Following its issuance, Dr. Hitt met with Mr. Erskine B. Bowles, Chief
of Staff to the President, who promised to schedule a meeting for PACHA
with President William J. Clinton this year.

· Council members have been involved with 1998 appropriations, and
budget increases have been realized across the board, although
allocations for prevention were lower than anticipated.

· Subcommittees have had exponentially increased workloads over recent
months, with major issues coming to mature recommendations. Dr. Hitt
encouraged members to cross-visit during breakout sessions to study
other Subcommittee issues in depth. He said that perspectives of those
outside of PACHA were helpful in formulating recommendations, citing
recent involvement by Mr. Henderson, Mr. Lew, and Dr. Rankin with the
Research Subcommittee in finalizing the forthcoming vaccine report.

**The Council's Role and Ongoing Tasks**

Dr. Hitt restated the Council's role of providing frank and informed
advice to the President regarding global prevention and treatment for
HIV/AIDS. PACHA, he said, has received positive feedback from the
Administration and the HIV/AIDS community on its fulfillment of this
role. Now, the Council should revisit its mission statement and
long-range planning to determine its primary focus during the remainder
of this administrative period and what form, if any, a final PACHA
report should take. The Process Committee was asked to develop a
procedure for this planning, and adequate time will be allotted for
full-Council discussion during the June meeting.

**ONAP Update**

Ms. Thurman, ONAP Director, thanked her staff and PACHA members for
their work and support, welcomed new Council members, and presented an
update on agency activities and the global status of HIV/AIDS. Overall,
there has been some great news, she said; however, incredible challenges
continue to exist as well. Successes include:

**· Budget increases**. This year's appropriations show the largest
percentage increases ever, including \$165 million for Ryan White
programs (with help from the Office of Management and Budget \[OMB\]
leaders); \$21 million for Housing Opportunities for People With AIDS
(HOPWA); and \$124 million for National Institutes of Health (NIH)
research. The most disappointing allotment was the \$5 million increase
in prevention funds involving the "race and health initiative."

**· International leadership**. ONAP is taking a more visible leadership
role on the international front, working with Vice President Albert
Gore, Jr., and his staff and visiting health ministers on issues such as
technology transfer and access to treatment. ONAP also briefed President
Clinton on the global status of AIDS prior to his recent visit to
Africa. In addition, the Office has initiated several small programs
through the White House, including (1) facilitation of an HIV training
program for African chemical plant workers, cosponsored by the America
Federation of Labor and Congress of Industrial Organizations (AFL/CIO)
and the U.S. Agency for International Development (USAID), an example of
building public/private partnerships; (2) site visits to Russia and,
possibly, India; and (3) use of recent findings on zidovudine (AZT) and
neonatal transmission to help formulate programs for providing drugs to
pregnant women in developing countries.

**· PACHA recommendations database**. The database of all PACHA
recommendations and Administration responses made to date is complete;
Dr. Hitt thanked Mr. Summers for developing this useful and thorough
compilation.

· **ONAP offices**. New, expanded offices for ONAP on Lafayette Square
and for Ms. Thurman in the Old Executive Office Building (OEOB) indicate
that ONAP has moved ahead in its inclusion within the White House
complex.

· **Confirmation of Surgeon General**. Dr. David Satcher's confirmation
as Surgeon General is good news for the AIDS community and a positive
sign for future progress.

Ongoing ONAP activities include the following:

· **President's youth directive**. Mr. Summers reported that President
Clinton's directive has given ONAP an opportunity to make connections
for HIV prevention within all the Department of Health and Human
Services (HHS) programs involving 13- to 21-year-old youths. Mr. Soliz
is leading the effort to inventory HHS programs and focus on HIV
prevention and health care services for young people with HIV/AIDS. ONAP
set up a task force, comprising representatives from CDC, HRSA, and
other agencies, to integrate youth concerns and will make
recommendations to the President within the next 2 months.

· **Indian Health Service (IHS)**. Ms. Thurman met with IHS to
reinvigorate a program on HIV in Native Americans, with the agency
agreeing to co-chair an interagency working group on this significant
issue. Mr. Blackwell is assisting ONAP in the process.

· **Names reporting and surveillance**. Although the CDC is moving
forward on names reporting, neither the White House nor HHS is currently
in support of this form of data collection, Ms. Thurman said. There is
agreement that a better collection method is needed; however, the
Administration must be convinced that there is no better way to collect
the data. ONAP is monitoring the issue closely.

· **Medicaid expansion**. Efforts to date have been unsuccessful. In
response, Vice President Gore was adamant that money be added to the
AIDS Drug Assistance Program (ADAP) as a stopgap method of providing new
drug treatments to persons with AIDS. ONAP continues to try to determine
feasible methods for delivering full health care services and
integrating current vertical programs into the larger context. An
internal task force of senior staff personnel has been established,
including Ms. Thurman; Mr. Christopher C. Jennings, Special Assistant to
the President for Health Policy Development; Mr. Donald Gips, Domestic
Policy Advisor to the Vice President; Dr. Eric Goosby, Director, Office
of HIV/AIDS Policy, HHS; Dr. Marsha Martin, Special Assistant to the
Secretary of HHS; Ms. Nancy-Ann Min DeParle, Administrator, Health Care
Financing Administration (HCFA); and Mr. Earl Fox, Director, HRSA. On a
positive note, HCFA is enthusiastic about working with States to obtain
Medicaid waivers for local programs as interim or long-term measures.

· **Interdepartmental AIDS task force**. A task force established
several years ago has been revived, with ONAP bringing together 40 to 50
representatives involved in the epidemic to discuss back-to-work issues
(including Federal personnel policy). The Services Subcommittee asked
for notes from this and future meetings, and ONAP agreed to provide
them.

· **Leadership meetings**. A series of leadership meetings are being
co-chaired by ONAP, with the first---on women and AIDS---scheduled for
April 9. Women political leaders and women's organizations, as well as
the media, will be briefed by ONAP and asked to include epidemic issues
on their broader agendas in the future. ONAP has formed a strong
alliance with the White House Office for Women's Initiatives and
Outreach, co-sponsor of the upcoming leadership session, and future
leadership meetings will cover the race and health initiative and other
such areas.

· **Prisons issues**. Mr. Summers reported that ONAP met with
Dr. Kathleen M. Hawk, Director of the Federal Bureau of Prisons (FBP),
along with the head of the FBP Infectious Diseases Program and other
personnel from the Department of Justice, to address PACHA's concerns.
The FBP has agreed to meet with ONAP, HRSA, and HCFA to find ways to
cover gaps in entitlement services for persons on parole and discharged.

· **Vaccines**. The AIDS vaccine initiative is not moving as quickly as
hoped, although ONAP had a good meeting with Dr. Harold Varmus, Director
of NIH, and a building site has been identified for the new AIDS Vaccine
Center. Members of the PACHA Research Committee were thanked for their
help with the overall process. ONAP will co-chair an internal working
group of all Federal agencies involved and is keeping the White House
apprized of vaccine development progress.

· **Needle exchange**. Progress on needle exchange funding is the bad
news. Ms. Thurman restated her personal commitment to having the
moratorium on Federal funds for needle exchange programs lifted and said
that this issue has become "a symbol of politics, rather than science,
driving policy." The President remains firmly committed to achieving his
prevention goals, and she is optimistic that progress will be made. In
answer to member queries, Ms. Thurman said she did not believe that HHS
Secretary Donna E. Shalala has met with the President on this issue, nor
is a meeting planned. She could not say what the Secretary's stance and
strategies concerning needle exchange might be.

**Council Response to ONAP on Needle Exchange** **and Other Issues**

The lack of progress on needle exchange brought a strong response from
Council members, who indicated that Secretary Shalala's failure to
address the issue is not acceptable and that this brings into serious
question the Administration's commitment to prevention. It is becoming
increasingly difficult to support and defend the President and his goal
of stopping the spread of the epidemic within a decade, Mr. Anderson
said. Council members are frustrated with the continuing silence from
the Administration, and Mr. Robinson called for a moratorium on meetings
and working groups and the beginning of real action. It was agreed that
science has proved that needle exchange prevents the spread of infection
without increasing drug use, but that the issue is being driven by
politics. Although the Council appreciates ONAP's views on the
difficulties of dealing with the twin epidemics of HIV and drug
addiction, Rabbi Edelheit said the American public is open to dealing
honestly with these issues now.

Whereas ONAP and General Barry R. McCaffrey, Director, Office of
National Drug Control Policy (ONDCP), have made their opinions clear, it
is not known what the beliefs or strategies are at HHS, which has
working responsibility for the program. Additionally, conflicting views
have been coming from different areas of HHS. Although Ms. Thurman has
not communicated with Secretary Shalala directly, she has discussed
needle exchange with Mr. Kevin Thurm, Deputy Director of HHS, and
believes that the agency understands the significance of making a
decision on this issue in the near future.

Ms. Aragon noted that the National Organizations Responding to AIDS
(NORA) has asked the Council to issue publicly a strong statement about
needle exchange during this meeting, and members concurred that
immediate action is warranted. It was decided to address Secretary
Shalala and President Clinton and to hold a press conference denouncing
the Administration's lack of leadership if responses were not
forthcoming.

Ms. Miramontes pointed out that the lack of commitment by the
Administration is also seen in the slow progress in vaccine and
microbicide development and the insignificant appropriations for the
race and health initiative and for prevention education. Dr. Hitt
reminded ONAP that a similar issue with HHS---on Medicaid
expansion---had arisen during the December PACHA meeting and that
seemingly little has happened on that subject to date.

Ms. Thurman noted that discussions are taking place, and Mr. Summers
reminded the Council that progress has been made, citing HCFA's
commitment to States' Medicaid options. Mr. Henderson also noted that
Medicaid models are being developed between HCFA and other entities,
such as the Kaiser Foundation. The Council, however, called for a more
concrete plan of action, with specific deadlines, and asked that HCFA
take a greater leadership role. Ms. Thurman promised that any progress
would be conveyed immediately to the Council.

**Subcommittee Meetings**

**Communities for African and Latino Descent**. Members present were
Ms. Aragon, acting Chair; Mr. Milanes; Reverend Perez; Mr. Robinson;
Mr. Sasser; and Mr. Stafford. Also present were Mr. Murguia; Mr. Ryan
LaLonde, assistant to Mr. Blackwell; and Mr. George Roberts, Dr. Dawn
Smith, and Dr. Imani Thompson, CDC.

**Discrimination**. Members present were Mr. Schatz, Chair; Ms. Gerus;
Mr. Henderson; and Mr. Johnson.

**International Issues**. Members present were Mr. Fogel, Chair;
Mr. Anderson; Ms. Cooper; Rabbi Edelheit; Ms. Greenberger;
Ms. Miramontes; Ms. Runions; and Dr. Weniger. Also present were
Mr. Andrew Barrer, The World Bank; Dr. Mary Lou Clements-Mann, Johns
Hopkins School of Public Health; Ms. Patsy Fleming, Joint United Nations
Programme on HIV/AIDS (UNAIDS); Mr. Jerry Gottlick,* U.S. Medicine*;
Mr. Jeff Morley, Agouron Pharmaceuticals, Inc.; Mr. H.R. Shepherd and
Mr. Alfred Rabow, Sabin Vaccine Institute; Mr. Bob Rohr, *Bay Area
Reporter*; Mr. Soliz; Ms. Patricia Thomas, independent journalist; and
Mr. Mike Tobin, Ortho Biotech. Invited speakers were Ms. Thurman, who
gave a briefing on the global status of HIV/AIDS, and Dr. Jonathan Mann,
Dean of the School of Public Health, Allegheny University of the Health
Sciences, who discussed ethics and human rights issues in AIDS vaccine
trials.

**Prisons Issues**. Members present were Mr. Landau, Chair; Dr. Abel;
Mr. Blackwell; Dr. Cade; and Mr. Rankin. Others present were Mr. Austin;
Ms. Rebecca Helem, National Minority AIDS Council (NMAC) and NORA; and
Mr. Summers, who reviewed the PACHA Prison Assessment and provided an
update on Federal brigs and prisons.

**Prevention**. Members present were Mr. Robinson, Chair; Mr. Anderson;
Ms. Aragon; Ms. Billings; Mr. Fogel; Ms. Gerus; Dr. Hitt; Mr. Isbell;
Reverend Perez; Ms. Runions; and Mr. Schatz. Also present were
Mr. Austin; Ms. Heidi Ecker, *AIDS/STD News Report*; Mr. Bill Haworth,
Bentley Health Care; Mr. Ernest Hopkins, San Francisco AIDS Foundation;
Mr. LaLonde; Ms. Miguelina Maldonado, NMAC/NORA; Mr. Rohr, Ms. Eva
Seiler, CDC; Ms. Thurman; and Mr. Weber. Ms. Jane Silver, NORA/AmFAR
(American Foundation for AIDS Research), briefed the Subcommittee on the
Federal funding for a needle exchange moratorium.

**Research**. Members present were Dr. Levine, Chair; Ms. Greenberger;
Mr. Hattoy; Ms. Miramontes; and Dr. Weniger. Mr. Claude Kamenga, FHI,
was also present. The primary focus was the Subcommittee's forthcoming
report to the Council.

**Services**. Members present were Mr. Henderson, acting Chair;
Dr. Abel; Ms. Aragon; Mr. Blackwell; Ms. Cooper; Rabbi Edelheit;
Mr. Milanes; Dr. Rankin; Mr. Sasser; and Mr. Stafford. Also present were
Ms. Fleming; Mr. Montoya; Dr. Smith; Mr. Soliz; and Mr. Summers. Outside
panelists were invited to brief the Subcommittee on the major issues
being considered by the Council:

**· National policy dialogue on early medical intervention
services/regional meetings**. Panelists were Dr. Goosby, Dr. Martin, and
Mr. Joseph Kelly, National Alliance of State and Territorial AIDS
Directors (NASTAD).

· **Access to treatment and Medicaid waiver process**. Panelists were
Dr. Martin and Ms. Kathy King and Mr. Gary Claxton, HCFA.

· **Drug pricing update**. Mr. Kelly discussed pharmaceutical company
issues (e.g., liability, antitrust, profitability) and presented a
strategy based on a study at the University of California, San Francisco
(UCSF), showing that Medicaid expansion could be achieved with an
18-percent reduction in drug costs.

**Emergency Full-Council Meeting**

After informally polling members, Dr. Hitt convened an unscheduled,
full-Council session to discuss details of the proposed press conference
to address the needle exchange issue. Discussion covered timing,
substance of the PACHA message, possible civil disobedience in
conjunction with the conference, and what action to take regarding
Secretary Shalala. It was recommended that Secretary Shalala be informed
of the Council's intention to make a public statement and to give HHS an
opportunity to meet with PACHA regarding its plans for the needle
exchange issue, with the hope of forestalling the public action.
Concerns were raised as to whether the Council could reach a consensus
on the text of a public statement in time for a public conference on
March 17 and whether this event would interfere with other scheduled
activities that day, including a public comment period and an address to
the Council by Dr. Satcher. The consensus was that the matter should not
be delayed.

Dr. Martin and Dr. Goosby, who attended the emergency session, had been
apprized of the Council's concerns during the Services Subcommittee
meeting earlier in the day, and both committed to take PACHA's message
back to HHS. They did note that this issue is being reviewed at the
highest levels in the Administration and that action will be
forthcoming, although no date or strategy could be given at this time.
Dr. Martin said that Secretary Shalala is very concerned. She assured
the Council that HHS was trying to stick with the science. Dr. Goosby
indicated that PACHA would not be unhappy with the final outcome on this
matter; however, he urged the Council to continue to articulate its
frustration.

**March 16**

**Full Council Session---General Business**

Dr. Hitt announced that the White House had been informed of the
Council's proposed public actions and that Ms. Thurman was currently at
HHS to discuss needle exchange and the vaccine initiative. Options for
the press conference were discussed, including whether to use civil
disobedience and whether to hold the conference in front of the White
House or at the Madison Hotel. The latter option was chosen, in view of
current restrictions on visits to the White House associated with
potential terrorist activities. Actions considered were a vote of no
confidence in the Administration's commitment to end the epidemic; a
public letter to the President; demand for a meeting with Secretary
Shalala; demand for the Secretary's immediate resignation; demand for
the Secretary's resignation if a negative opinion on needle exchange is
forthcoming; and/or Council members' resignations if inaction continues.

A statement drafted by Mr. Henderson became the core of the message to
be delivered to the public: "That . . . it is time for leadership on the
part of Secretary Shalala. The science is clear; and it is time for her
to get out in front of this parade. . . . Clearly, General McCaffrey is
marshaling his forces quite effectively. We do not have a general on our
side, and this Council feels that it is time for Secretary Shalala to
take that role, if this battle is going to be won with the President." A
letter to Secretary Shalala was drafted, calling for an unequivocal
public statement on the scientific evidence of needle exchange and its
role in HIV prevention and further action on needle exchange. The letter
was approved and hand-delivered to the Secretary. (A copy is included in
the Addenda to the Minutes.)

**Full-Council Panel Presentation:**

**HIV/AIDS in African-American and Latino Populations**

A panel discussion was convened by the Communities for African and
Latino Descent Subcommittee to inform the Council on the unique aspects
and issues of the epidemic within these communities. Ms. Fraser-Howse,
Chair, opened the session by thanking the Subcommittee and Mr. Montoya
for developing the presentation. Pointing out that these communities
have the fastest growing percentage of infection, she described the
current national environment as "ready for the issues."

Mr. Robinson reported on a meeting March 3--4 (referred to by panelists)
between 33 leading African-American AIDS advocates and top officials of
the CDC. The outcome was a set of formal demands from the advocates
concerning the need to find strategies and funding to fight HIV/AIDS in
this community (full text is in the Addenda to Minutes). The demands
also called for action by Secretary Shalala and the President and the
declaration of a state of AIDS emergency within the community. As a
result, a core group of public and private entities are taking a
critical look at what the epidemic is doing to this community, and how
it can be stopped.

Ms. Aragon introduced the panel presentation and guest speakers:

**Monina Klevens**, D.D.S., M.P.H., HIV Surveillance Unit of the CDC,
discussed the epidemiology of AIDS among Hispanics in the United States,
characteristics of the infected population, trends in the disease, and
the complex issues surrounding the Latino community. She also described
CDC surveillance, which occurs within all States and U.S. dependencies:
a standard case definition, without name and address reported to the
CDC, with strict security and confidentiality measures to ensure that
information is protected.

The Hispanic population, Dr. Klevens said, is overrepresented among
people with HIV/AIDS, with the ratio of Latino men, women, and children
becoming infected far higher than that of white, non-Hispanics; and
these ratios are increasing. Additionally, the current decline in deaths
from AIDS is less among Hispanics than in the white population. The
highest rates of Hispanics with AIDS are found in the Northeast,
Florida, and Puerto Rico. Unique issues that must be faced in HIV
prevention among Hispanics include ancestry, place of birth, primary
language, access to health care, socioeconomic status, acculturation,
and determination of what interventions can be effective in this
context. Further study and more prevention activities, including earlier
monitoring, appropriate for each subgroup affected, are needed.

**Dawn Smith**, M.D., M.P.H., M.S., Division of HIV/AIDS Prevention,
Surveillance, and Epidemiology, CDC, focused on the impact of HIV and
AIDS-related deaths in the African-American community and presented
"ideas about where CDC is going with its data." The increase in the
proportion of cases among African Americans in the United States began
in 1987, affecting all parts of the community. Primary risk groups are
injecting drug users (IDUs), representing 44 percent of new infections;
men who have sex with men (MSM), 29 percent; and heterosexual men and
women, 23 percent. By gender and age groups, the highest rate of AIDS
cases is among African-American men. Among African-American women,
numbers are rising; but among children, especially with new treatments
to reduce neonatal transmission, rates are falling.

Although infections and deaths are declining overall, the rate of
decline is much lower among African Americans than in any other ethnic
group, and the epidemic disproportionately impacts this community, in
both urban and rural settings. The implication is that quality care is
not as accessible within minority communities as it is in white
communities. The mortality rate continues to be higher among
African-American men than in any other group, with AIDS being the
leading cause of death. Problems exist in estimating the true impact
because HIV reporting is more consistent in States where the black
population is lower, and because African Americans are less likely to
report HIV infections.

The numbers indicate that things are bad and getting worse, and the
impact is particularly severe because of multiple risks and
interrelationships among the risk groups, in both youths and older
people. To deal with this crisis, resources---people and money---are
needed to match the urgency, severity, and epidemiology of the epidemic.
Resources must be used to address known facilitators of infection, such
as injection drug use and socioeconomic status factors, and to provide
services---including improved counseling and testing---that increase
intervention strategies and disseminate those that have proven
effective.

**Imani Thompson**, Ph.D., HIV Prevention Unit, CDC, discussed the
African-American Initiative developed by the Community Assistance
Planning and National Partnerships Branch, National Center for HIV, STD,
and TB Prevention. This is the first leg of an overall people-of-color
initiative that ultimately will include Hispanics, Native Americans, and
Asian/Pacific Islanders. The initiative was developed to review the
targeted CDC spending for programs that do not seem to reflect the true
nature of this epidemiology. A budget analysis for the advocate leaders
showed that appropriate correlations within the targeted programs do not
exist. For example, two of the largest funding categories for State
health departments are health education/risk reduction (HERR) and
counseling and partner notification programs. Of this, about 33 percent
in HERR and 24 percent of counseling/notification funds are targeted to
African Americans, who represent 43 percent of all AIDS cases and 54
percent of new infections.

As a result of the meeting with African-American leaders, the internal
working group and others at CDC have been reenergized, Dr. Thompson
said. With an overarching goal of reducing the impact of HIV/AIDS among
African Americans, the strategy is to utilize effective, evidence-based
HIV prevention approaches. Four critical steps have been identified by
CDC: define the problems, assess current programs, design new
strategies, and implement strategies. Focus groups of targeted
populations (youths, women, MSMs, and substance abusers as well as
workers, laborers, and Haitians in Miami) have already begun to meet. A
review of programs that focus on the epidemic in the community has
begun, and an assessment of national and regional minority organizations
and the technical assistance network among community planning groups is
nearing completion. Short- and long-term recommendations have been made
for potential action steps by the CDC in five categories: health
communications and social marketing, partnerships and advocacy, program
development and evaluation, technology transfer, and research. Since the
meeting, the CDC has communicated with Secretary Shalala and the Surgeon
General, Dr. Satcher, about the emergency status of the epidemic in the
community, forwarded budget analysis data to the advocates, held a
telephone consultation among the internal working group and an ad hoc
committee of 11 outside consultants, and set up a planning meeting in
April for a leadership summit to be held in June to review HIV/AIDS
prevention implementation strategies for African-American communities.

Still needed are enhanced partnerships between CDC and community
organizations, more money, more creative strategies, and assessment of
recommendations by the outside consultants. As long as the epidemic
continues to spread in the African-American communities, these programs
must continue, and even more must be done. It is clear that the public
sector alone cannot successfully combat HIV/AIDS; overcoming the current
barriers to HIV prevention and treatment in this community requires that
leaders in the community themselves acknowledge the severity of the
epidemic and play an even greater role in combating HIV/AIDS.

Questions from Council members concerned prison issues (to be addressed
at the June summit); intervention strategies that have proven successful
in these communities (for example, provision of skills for women in
negotiating use of condoms in sex); differences in transmission factors
within geographical areas; detailed accounting of the CDC budget;
results of a study among African-American youths; trends in death rates
among young adults 18 through 25 years of age; and the effects of
language and literacy in prevention programs. Mr. Milanes suggested the
need to review the community planning process and to revisit cooperative
agreements with States to rectify such gaps as are found in Miami, the
largest metropolitan area without CDC funding.

**Mindy Fullilove**, M.D., New York State Psychiatric Institute,
discussed community infrastructures and environments and how they affect
health care and public health strategies. Community collapse, such as
has happened in Harlem, is a "spiraling process," resulting in a loose
collection of individuals not working together, not taking care of each
other, and without viable lines of communications. This leads to
increased incidence of epidemics. In these communities, people "medicate
dysphoria"---e.g., rootlessness and confusion---with such things as sex
and drugs, which become their only means of identification with others.

Dr. Fullilove spoke not only of the differences, but also of the
similarities among the various AIDS communities. In all communities
(ethnic groups, gays, IDUs, etc.), there is a history of upheaval and
sense of displacement; all experience discrimination, abandonment, and
usually a loss of housing. In most urban renewal, there is little
planning as to where the displaced will go, a particularly critical
issue for IDUs, as no one wants these people around. Where housing is
lost, the greatest number of drug-related deaths occur, and AIDS is
where the drugs are; AIDS is "where the displaced people went."
Prevention efforts must be carried out in these areas, and more money
and resources must be used for social science research that will explain
the unique issues of the African-American and Hispanic communities.

Ms. Fraser-Howse thanked the panel and summarized the information,
including the alarming state of emergency within these communities, the
need for more realistic strategies and resources targeting them, and the
need to get people to the table who understand the full story. Many
Council members expressed anger and concern at the situation, and all
agreed that PACHA should take strong and specific stands on this issue.
Several asked what the Council can do to help, and Ms. Fraser-Howse said
that the Subcommittee would come back with recommendations. One
suggestion was that PACHA respond to the insignificant appropriation for
the race and health initiative; another was to strongly urge that the
CDC critically assess its programs and shift priorities and funds for
both research and intervention programs, based on the percentages of
infections. It was agreed that the Council, as an interim action, would
issue a resolution in support of the demands of the African-American
leaders (see Subcommittee Report, March 18).

**General Business/Services Subcommittee Initial Report**

The Council met to finalize details of the press conference, the letter
to the President, and the PACHA resolution. Dr. Hitt announced that a
press release on needle exchange had already gone out with a statement
from ONAP and that the Council's letter to Secretary Shalala had been
delivered.

**Subcommittee Meetings**

**Communities for African and Latino Descent**. Members present were
Ms. Aragon, Mr. Milanes, Reverend Perez, Mr. Robinson, Mr. Sasser, and
Mr. Stafford.

**International Issues**. Members present were Mr. Fogel, Mr. Anderson,
Ms. Cooper, Rabbi Edelheit, Ms. Greenberger, Ms. Miramontes,
Ms. Runions, and Dr. Weniger. Others present included Mr. Mochine Alami,
Ms. Martina S. Awoke, Mr. Gillette Conner, and Ms. Sheila Mudhani,
National Council for International Health (NCIH); Ms. Alice Blair and
Ms. Karen Peterson, American Red Cross (ARC); Ms. Dominique DeSantis,
UNAIDS; Ms. Keirsten Giles, World Vision; Ms. Chris Heash, Episcopal
Caring Response to AIDS (ECRA); and Ms. Seiler. AZT efficacy in clinical
trials was discussed by panelists Dr. Helen Cornman, AIDS Program
Director, NCIH; Ms. Fleming; Dr. Paul DeLay, USAID; Dr. Timothy Dondero,
CDC; and Ms. Maldonado.

**Prisons Issues**. Members present were Mr. Landau, Dr. Abel,
Mr. Anderson, Mr. Blackwell, Dr. Cade, Ms. Cooper, and Dr. Rankin. Also
present were Mr. Austin and Mr. Eric L. Turner, HIV Community Coalition
(HCC). Mr. John Miles, CDC, reviewed surveillance methods currently
being used and others being considered for use in the future.

**Prevention**. Members present were Mr. Robinson, Mr. Anderson,
Ms. Billings, Mr. Blackwell, Ms. Gerus, Mr. Henderson, Mr. Isbell,
Mr. Landau, Reverend Perez, Ms. Runions, Mr. Sasser, and Mr. Schatz.
Also present were Mr. Austin, Ms. Seiler, and Mr. Weber. Guest speakers
Dr. Patricia Fleming, CDC, and Professors Lawrence O. Goftin and James
G. Hodge, Jr., Georgetown University Law Center, discussed the current
status of HIV surveillance.

**Services**. Members Mr. Blackwell, Ms. Cooper, and Rabbi Edelheit,
with guest speakers Mr. David Harvey and Ms. Maldonado of NORA,
Ms. Chris Collins of Congresswoman Nancy Pelosi's office, and
Ms. Christine Lubinski, AIDS Action Council (AAC), discussed
return-to-work issues and the HIV Treatment Improvement Act of 1997.

**Research**. Members present were Dr. Levine, Dr. Cade, Mr. Johnson,
Mr. Miramontes, and Dr. Weniger.

**March 17**

**Press Conference**

A formal press conference was held on Tuesday, March 17, at the Madison
Hotel. With the full Council in attendance, Dr. Hitt introduced the
issues of needle exchange to local, national and international media:
the Administration's lack of action and commitment, evidence from the
scientific community showing that needle exchange can play a crucial
role in prevention, the vote of "no confidence" in the Administration,
and a call for President Clinton to take action. Following this
introduction, Mr. Johnson, Ms. Aragon, Mr. Anderson, and Ms. Stokes made
personal statements to the media, and copies of the Council's letter to
the President and the Resolution on Needle Exchange Programs were made
available. (Text of the press conference statements, letter, and
resolution are included in the Addenda to Minutes.)

The consensus of the Council was that the session was well attended by
the press and that followup coverage was widespread and beneficial to
the interests of PACHA and the AIDS community. (A list of media in
attendance is included in the Addenda to Minutes.) Dr. Hitt expressed
his appreciation for the Council members' participation and to
consultant Mr. Bill Hayworth for his help in getting the message to the
press.

**Full-Council Panel Presentation: Research Subcommittee Vaccine
Update**

Dr. Hitt opened by saying that the Research Subcommittee has worked for
more than 2 years and taken dozens of hours of testimony from the best
sources in the world to bring this vaccine development update and
proposed recommendations to the Council. The recommendations have been
reviewed by outside sources and contain input from all of the diverse
interests involved. He thanked the Subcommittee for its exhaustive work.

Dr. Levine also thanked the Subcommittee, in particular Ms. Miramontes
and Dr. Weniger, who worked with the Chair on every draft of the
recommendations. She then reviewed the major questions and problems that
face the development of an AIDS vaccine:

· Is there such a thing as a protective immune response? Positive
indications have been seen through use of a chimpanzee model. This, in
turn, leads to another complication: there may be a vaccine that either
prevents initial infection (as in the polio vaccine) or does not prevent
infection, but does prevent progression to disease (as in rabies).

· If there is a protective immune response, is it antibody-related? If
so, is antibody the whole answer? Or, is it a cell-mediated response?

· What, if any, adjuvants should be used to make the vaccine even more
effective? The problem is that manufacturers of the vaccine(s) must work
from the start of development with the producers of the adjuvant(s), and
this is not a standard procedure in the pharmaceutical industry.

· The lack of an effective animal model for HIV promulgates the
controversial issue of human testing and has slowed the development
process significantly.

Other, practical issues that have arisen include the following:

· Although the Administration seems to believe that the answer lies
solely within NIH, there are other entities with much experience in
making vaccine, in both the Government (CDC, Department of Defense
\[DoD\], and others) and private industry, that have not been involved.
Since private industry traditionally has brought new products from
development to implementation, these companies have to be involved in
the early stages of developing and making both vaccines and adjuvants.

· Major problems exist in testing the products. For phase I and II
(toxicity and side effects), initial safety testing can be done in the
United States. For phase III (efficacy), however, the normal procedure
is to study subjects in large numbers with placebo controls, but the
incidence in the United States is not large enough to answer these
questions in a timely fashion. Going outside the United States, where
the prevalence is much higher, questions could be answered faster;
however, this raises ethical implications.

· Issues related to industry include the extremely high cost involved in
the development of a vaccine that will be used largely in poor,
developing countries and the vast liability implications. The usual
funding sources may not be available, which is a further complication.

Overall, there are tremendous issues, from the basic science to the very
complicated ethical, practical, and financial issues, both in this
country and worldwide. Even the administrative structure limits the
development of an AIDS vaccine in this country. Dr. Levine presented the
draft recommendations, including alternative verbiage, which was
reviewed by the Council and approved on a paragraph-by-paragraph basis.
Major disagreements centered around leadership of the new NIH AIDS
vaccine program, ONAP's authority vis-à-vis the vaccine initiative, and
the strength of the wording in calling for a plan of action coordinated
among very high-level personnel. Most of the document was approved
unanimously, except for paragraph one, to which one member was opposed,
with the final revised paragraph and details being approved in a later
session. The adopted text is included in the Addenda to Minutes under
New PACHA Recommendations. The Council applauded the passage of the
long-awaited vaccine policy recommendation.

**Public Comment**

Several organizations had asked to make public comments, primarily on
needle exchange; however, with the advent of the PACHA press conference,
it was noted that the Council is complying with the requests of the
community, and most representatives canceled their comments.

**Miguelina Maldonado**, Executive Director of Public Policy and
Government Relations for NMAC, commented on several other issues brought
up in Subcommittee discussions. On perinatal transmission trials
conducted in Africa and Asia (as discussed by the International Issues
Subcommittee), she said that the budget for USAID has been level-funded
since 1993 at \$120 million, and because of funding shortfalls, trials
have been stopped. She urged the Council to consider making a
recommendation that USAID's budget for HIV/AIDS be increased. She also
suggested that the Subcommittee study the issue of whether the
institution of these short-course therapies can be advocated and
supported in developing nations. In addition to increased funding for
programs to reduce perinatal transmission in the most hard-hit areas,
sub-Saharan Africa, Asia, and Southeast Asia, it is important to study
what can be done in prevention and treatment of the mothers of the
children.

Regarding the report on African-American and Latino communities, she
said, we must emphasize the point of the connection between substance
abuse and HIV/AIDS. More focus should be given to the differences in
modes of transmission within minority groups and the difference in
impact on substance abusers by population. We must look at comprehensive
strategies in these communities and study how SAMHSA and CDC can
collaborate to address the problems.

**Helen Cornman**, NCIH, concurred with Ms. Maldonado's recommendations
on the USAID budget. NCIH has been working with NORA to get this budget
increased, and now PACHA's help is needed. She applauded what the
Council has done with the needle exchange issue.

Mr. Hattoy recommended that PACHA consider establishing a formal working
group to monitor the appropriations process, focusing on specific areas
such as USAID funding. Dr. Hitt asked him to put together an ad hoc
working group that would watch these issues.

**Discrimination Subcommittee Report**

Mr. Schatz briefed the Council on areas of concentration by the
Discrimination Subcommittee:

**HIV-positive health care workers**. Progress in this area has been
made, apparently because of the Subcommittee's interest. In February, a
meeting was convened to brief CDC advisory committees, and as a result,
CDC agreed to revise its guidelines on HIV-positive health care workers:
eliminating the so-called "informed consent" provision and the concept
of "exposure from procedures" and moving toward a statement that a
meaningful risk does not exist and that there is no need for a special
set of rules for these workers. Quelling a long-held fear of enormous
vocal backlash, only five people testified against the proposed
revisions at the last open meeting at the CDC. This is a very important
first step; however, the Subcommittee must continue to push for a
commitment for a deadline for CDC recommendations and action.

**Assessment of military policy**. In December, the Subcommittee
assessed the written military policy on HIV-positive personnel as
exemplary; however, concerns exist that the policy is not necessarily
translated into reality. The Subcommittee, therefore, is continuing to
monitor the issue, and Dr. Rankin volunteered to work with the group. A
question has arisen regarding the mandate of the Subcommittee---that is,
to find HIV-specific discrimination in policy. Should this mandate be
broadened? For example, even if the exclusion policy toward HIV-positive
personnel is consistent with exclusions for people with other
disabilities, are these fair and valid overall? HIV has been in the
forefront in making inequities known on a broader basis, and the
Subcommittee welcomes other member opinions as they try to resolve this
question.

**Recommendation on medical privacy**. A recommendation on strengthening
medical privacy as concerns law enforcement, which was tabled in
December, was submitted for Council review. Discussion focused on
upcoming and competing legislation involving police access to medical
records. The Subcommittee recommendation, in support of legislation that
does not include a broader exemption for police agencies, was approved
unanimously. (See Addenda to Minutes, New PACHA Recommendations, for
full text.)

**Communities for African and Latino Descent Subcommittee Report**

Mr. Robinson reported that, as a followup to the panel presentation, the
Subcommittee is drafting a resolution in support of the demands of the
African-American activist group that met with the CDC. Reverend Perez
asked that PACHA agree to adopt such a resolution, and it was accepted
unanimously. Subsequently, the Council voted on the wording of the text,
as follows:

The Presidential Advisory Council on HIV/AIDS endorses the \[following\]
demands of the African-American Consultants to the Centers for Disease
Control and Prevention African-American Initiative. These demands, along
with the Council endorsement, will be transmitted to the President and
the Secretary of Health and Human Services. (See Addenda to Minutes for
list of demands.)

Mr. Robinson discussed process issues concerning the Subcommittee,
including a definition of its primary role: to assist the larger PACHA
Subcommittees (i.e., Services, Prevention, etc.) in addressing issues
that have to do with all communities of color, with particular focus now
on African-American and Latino populations. Under this redefinition, a
checklist is being developed covering related issues which each of the
broader Subcommittees should address. Further, it is being ascertained
whether the interests of this Subcommittee have proper representation on
each of the Subcommittees, and the suggestion has been made that
Subcommittees meet jointly with the Communities Subcommittee to ensure
inclusion of the interests of African Americans and Latinos in all
coverage. In line with this philosophy, the Subcommittee will not have a
large number of independent actions or recommendations; however, it
suggests that future PACHA recommendations, whenever feasible, address
the need for targeted services and prevention strategies for these
communities.

Mr. Blackwell expressed the opinion that the Council should also
consider the inclusion of Native American issues in all recommendations
and actions in the future, and Dr. Levine added that consideration be
given to the inclusion of other populations such as adolescents, women,
and IDUs as often as possible to keep a focus on the needs of all
affected groups.

**International Issues Subcommittee Report**

Mr. Fogel briefed the Council on Subcommittee activities during its
breakout sessions:

**Findings in recent perinatal transmission studies**. These findings in
Africa were described by representatives from CDC, NMAC, NCIH, and
UNAIDS. In line with this, a major conference will be held in Atlanta,
Georgia, to develop an outline of action that is sensitive to cultural
and economic issues of the different countries. The Subcommittee will
bring results and any appropriate recommendations to the June PACHA
meeting.

**Other international issues**. These issues were addressed: (1) India
has become the number one country worldwide in new infections. (2)
During the President's visit to Africa, HIV site visits were planned for
congressional and cabinet members, and Mr. Clinton was to mention AIDS
issues in some of his speeches. (3) USAID has offered to detail a person
to staff an international position in ONAP, and the Subcommittee called
on ONAP to agree to this as soon as possible.

Mr. Robinson noted the disparity in the fact that the President was to
make comments about AIDS during his visit to Africa, but had not
addressed the issue of AIDS in African Americans in the United States.

**Prison Issues Subcommittee Report**

Mr. Landau reported that the Subcommittee continues to work with the FBP
and CDC to document the burden of disease in the incarcerated
population. Issues of concern now and in the near future include (1)
privatization in prisons, with more than 27,000 HIV-positive inmates in
prisons (representing more than 2 percent of the total prison
population) and (2) surveillance and safety of information in Federal
prisons and how it translates into the State systems (with 16 States now
doing mandatory testing). He welcomed Ms. Billings and Mr. Blackwell to
the Subcommittee.

Proposed activities prior to the June meeting include continuing the
ongoing study of surveillance, visiting one or more prison facilities
with ONAP, continuing the review of the assessment document from ONAP,
and studying model program issues. Following up on a recommendation
approved in December, the Subcommittee is pursuing a national meeting on
prison issues. Work is complete on the study of brigs and prisons within
the DoD systems, and Mr. Landau said that the 10 to 15 inmates with HIV
currently in that system are receiving good treatment.

**Address by Surgeon General David Satcher**

David Satcher, M.D., Ph.D., newly appointed Assistant Secretary for
Health and Surgeon General of the United States, was introduced by
Dr. Hitt to the Council. The former Director of the CDC, Dr. Satcher
also has worked in private community health, concentrating on women's
and children's health issues that include immunization and development
of viral microbicides, and has been involved with the HIV/AIDS epidemic
since 1981 when it was first defined by the CDC.

Dr. Satcher expressed deep appreciation for the work of the Council and
stated his strong commitment to community participation in prevention
planning, local programs with local control, and the early involvement
of affected communities in formulating policy. This is an era of
controversy and change, he said, and progress has been made; and much
more is known about the disease, including how the virus moves through
populations, which allows the targeting of resources in a proactive
manner through behavioral studies. Unfortunately, there is no vaccine,
and new antiviral therapies and health care services are not universally
available to all populations, especially high-risk groups. Although
there has been a dramatic decline in AIDS-related deaths and infections
overall, the impact is growing in such populations as women and
minorities, and there is much to be done in this area.

Coordinated effort is needed to move such programs as vaccine
development and access to treatment forward. Dr. Satcher called for
aggressive development of strategies that will increase our ability to
(1) identify and target populations with high-risk behaviors; (2) bring
HIV-positive individuals into care and services; (3) embrace individuals
with nonjudgmental services that are designed to retain these
individuals in care; and (4) work within each high-risk population to
identify specific points of access into medical care and essential
services that are acceptable and available. This means changing the
delivery systems to afford affected populations an opportunity to regain
control over their lives.

Of concern to Dr. Satcher is the risk that the controversy surrounding
these issues will divide or delay the Nation in making significant
progress in the fight to end the epidemic. Issues of specific immediate
concern include access-to-treatment by all persons, efficacy trials of
short-course therapy and perinatal transmission, and needle exchange. In
his new roles, he will look to all of these as major public health
issues and will work to "ensure that science informs the assumptions on
which policy discussion occurs, in every aspect of the HIV/AIDS
epidemic, from surveillance to research and care." The basis for
speaking out on issues, he said, will be the public health science. In
addition, positive communications among all communities is important as
is maintaining a balance between public health science and the concerns
of the people in the country. It is also essential to have cooperation
among prevention programs and to find creative ways for businesses and
foundations to form partnerships.

In discussion that followed, Mr. Anderson and other Council members
expressed PACHA's loss of confidence in the Administration's commitment
to HIV prevention. Dr. Satcher reminded the group of the progress that
has occurred, including the establishment of ONAP, the NIH vaccine
program, changes in CDC, and ongoing funding increases in the past 5
years even with overall budget cuts, and asked that the Council not lose
sight of these areas of progress. There are, however, some real concerns
about the balancing of funding for programs.

Concerning substance abuse and mental health services, Dr. Satcher
agreed that there are major problems, particularly the judgmental
attitudes in this country. As to needle exchange, he understands the
frustration and assured the Council that the Administration is very
concerned and is looking critically at the science; the struggle is with
the issue and attitudes toward substance abuse. The Surgeon General was
reminded that it is difficult to reconcile the numbers of infections
that are occurring while waiting for the Administration to reach a
decision.

In answer to questions about the insignificant budget for the race and
health initiative, Dr. Satcher said that the sole purpose of the
initiative is to provide funds to select cities to set up models to try
to close the gaps in access to treatment. The outcome will determine how
to spend more money in the future. He asked the Council not to think of
this as "token money," but rather the beginning of a much larger
coordinated community effort.

Mr. Johnson asked Dr. Satcher about the controversies surrounding
reporting and surveillance and asked for an update on where the
decision-making responsibility is within HHS and his office on issuing
Federal guidelines and setting up new methods of reporting at the CDC.
Dr. Satcher mentioned the difficult challenge of monitoring the
epidemic, and the need to know the status of the epidemic at any time.
He asked the Council if it had looked at the science of this issue, the
approximately 30 States that currently have a name-reporting system, and
how this experience is shaping the Council's thinking. HHS wants to know
what the States' experiences have been and to make a decision based on
that experience. Dr. Hitt offered the Council to give the Surgeon
General a briefing on their findings in such matters in the near future.

Mr. Isbell said that the Council is inspired by Dr. Satcher's life-long
commitment to public health and is aware of the contributions this
President and Administration have made in the fight against AIDS. On the
issue of prevention, however, members are concerned that the infections
continue. In addition, the Council believes that, given the current
situation with States creating policy without guidance, it is very
critical that there be movement on surveillance. Dr. Satcher said that
he will take these messages to the Secretary.

Concerning the limited access to treatment for many groups, Mr. Bollman
asked how the Council can help Dr. Satcher's office move this issue
forward. Dr. Satcher agreed that there is limited access and asked the
Council to provide all ideas and information to his office.

Dr. Levine mentioned specific mechanisms of prevention, such as the
importance of providing a place for IDUs to go for needle exchange. She
also apprised Dr. Satcher of the Council's recommendations on vaccine
development and the Administration's perceived belief that NIH is the
only answer to vaccine development. All private and public entities
involved in vaccine development must be included from the outset, and a
mechanism for doing this must be handled at the highest level of the
Administration.

Regarding the current Supreme Court case on the Americans With
Disabilities Act (ADA) and its impact on asymptomatic HIV-positive
individuals, Mr. Henderson suggested that Dr. Satcher make certain that
this Administration is taking an active role in defending the coverage
of the ADA for these individuals, and if that fails, it should actively
support legislative solutions within HHS, CDC, and other agencies to
remedy the problem.

Dr. Hitt and other members thanked Dr. Satcher and said that the Council
looks forward to his efforts at making changes in the CDC that will
regain the community's confidence in the commitment to prevention.

**Subcommittee Meetings**

**Prevention**. Members present were Mr. Robinson, Ms. Gerus,
Mr. Isbell, Mr. Landau, Mr. Milanes, Reverend Perez, and Mr. Schatz.
Also present were Mr. Monsanto Als, assistant to Ms. Fraser-Howse;
Mr. Austin; Ms. Ecker; Ms. Maldonado; Ms. Seiler; and Mr. Weber.
Dr. David Holtgrave, CDC, discussed specific CDC budget issues and
tracking of funding.

**Services**. Members present were Mr. Bollman, Chair; Dr. Abel;
Ms. Aragon; Mr. Blackwell; Ms. Cooper; Rabbi Edelheit; Mr. Hattoy;
Mr. Henderson; Dr. Rankin; Mr. Sasser; and Mr. Stafford. Also present
were Dr. Cornman; Mr. Heash; Dr. Allen Huff, ARC; Mr. Seth Kilbourn,
NORA; Mr. LaLonde; Mr. Rohr; and Mr. Mike Shiver, National Association
of People With AIDS (NAPWA). Guest panelists were invited to provide
briefings on the following issues:

· **FY 1999 Budget/FY 2000 Appropriations**---Mr. Summers, Mr. Harvey,
and Ms. Maldonado.

· **Reauthorization of HOPWA**---Mr. David Vos, Department of Housing
and Urban Development (HUD).

· **Native American Issues---**Mr. Murguia.

· **Youth Directive/June Panel Presentation Update**---Mr. Soliz and
Mr. Harvey. Mr. Sasser provided an outline of the proposed full-Council
briefing session planned for the next PACHA meeting.

· **National Drug Control Strategy, 1998--A Ten-Year Plan**---Mr. John
Gregrich, ONDCP.

· **HIV+ Healthcare Worker Guidelines**---Dr. Robert Janssen, CDC, by
conference call.

**Research**. Present were Dr. Levine, Mr. Johnson, Mr. Miramontes, and
Mr. Murguia.

**March 18**

**Prevention Subcommittee Report**

Mr. Isbell, Co-Chair, said that the Subcommittee had focused on three
areas:

**Needle exchange**. Discussions included nongovernmental organizations
to help formulate a strategy, with the result that the outcome of the
press conference is positive.

**Surveillance**. Dr. Fleming briefed the Subcommittee on the background
and current views at CDC of what surveillance should provide and
discussed such issues as possible negative legislative action in the
event of HIV reporting, feasibility of using unique identifiers, timing,
and the problems involved in the States' implementing different systems
and collecting data that cannot be compared. A followup conference call
schedule has been set to work on these issues and related
recommendations. The Council, Mr. Isbell said, needs to encourage CDC in
devising new ways of obtaining information while maintaining security.
Dr. Goftin and Dr. Hodge discussed the development of a model
confidentiality law with respect to public health information, with
target dates for the first draft in June and a complete model in
November 1998. Changes in the epidemic make the need for reporting even
more important in finding areas of risk; concurrently, there is an
increasingly significant need for greater protection. It was suggested
that someone approach Microsoft^®^ to see if there are any new
developments in computer security.

**Funding for prevention**. Dr. Holtgrave discussed the CDC's \$250
million budget for State and local organizations in education and
promotion of risk-reduction programs. The Council has long been
frustrated by the lack of information at CDC as to how this money is
spent; however, these data are now being compiled. Findings to date are
of limited use, but additional information will be sent through
Mr. Montoya to Council members as it is received. What is evident is
that groups at highest risk seem to be undertargeted by CDC, although
one group---heterosexual contact---seems to be overtargeted. A very
large "other" category must be enumerated and carefully defined.
Mr. Isbell thanked Dr. Holtgrave for starting the process of budget
analysis.

**Prevention conference**. Mr. Summers said that ONAP will host a
conference at the White House for prevention research personnel within
both NIH and CDC to determine the status of this research and to help
build a better coordinated network through more effective communications
channels. Ms. Miramontes noted that better communications are also
needed among these groups and the AIDS community.

**Services Subcommittee Report**

Mr. Bollman and Mr. Henderson reported on a number of areas covered in
the Subcommittee's breakout sessions, including:

**National policy dialogue**. The proposed dialogue was addressed by
Dr. Martin, Dr. Goosby, and Mr. Kelly. The important news is that HHS is
moving forward with plans for the dialogue, including regional meetings.
The Subcommittee's greatest concern is that this movement leads to
implementation of a real program within a feasible time frame and within
this budget cycle.

**Medicaid expansion update**. An update was provided by Ms. King and
Mr. Claxon from HCFA, and Dr. Martin, and included actuarial information
on cost analysis to show budget neutrality. Mr. Henderson, Mr. Bollman,
Dr. Hitt, and Mr. Montoya had had a conference call with Dr. Sophia
Chang of the Kaiser Foundation, which has developed a model, working
with HCFA actuarial information.

**Drug pricing**. Models are also being developed by Kaiser Foundation
to provide the pharmaceutical companies with clear information as to
what changes in drug pricing would do to expand their sales bases.
Discussions will be held between the Subcommittee and Vice President
Gore's office as to where talks with the pharmaceutical companies stand.
Progress is being made, but much more must be done. Mr. Summers said
that the internal task force set up by ONAP will study short- and
long-term strategy in this area. It was noted that the Subcommittee had
started looking at these issues almost 2 years ago and it appears that
these developments will lead to some action on universal access to the
new treatments. HCFA has had meetings with States about the waiver
process, and actual programs are close to being put into place, the
first being in Massachusetts.

**Return-to-work issues**. There may be an opportunity for the Council
to bring these issues, particularly in terms of Social Security
disability coverage, through the Social Security reform process. The
Social Security Administration has a staffed task force for the reform
process. This also could lead to specific Subcommittee recommendations
which would be reviewed by the Social Security task force.

**Access to drug abuse treatment**. Mr. Bollman said that the
Subcommittee was unable to meet with anyone from the ONDCP. He pledged
that the Subcommittee would come in June with specific thoughts or
recommendations on access to high-quality drug abuse treatment services.

**Reauthorization of HOPWA**. Reauthorization is controversial, with
many people believing that it should not be taken up this year. Because
of the importance of the subject, however, the Subcommittee continues to
monitor its status. As background, a draft paper addressing technical
and policy issues on reauthorization and improvement of HOPWA was made
available to Council members.

**Native American issues**. Mr. Blackwell, a new member of the
Subcommittee, discussed these issues and suggested topics for a
full-Council presentation in November. Mr. Bollman said that the
Subcommittee would proceed to develop the presentation and
recommendations.

**Youth issues**. These issues are seen as an area that the Subcommittee
was not able to track closely until Mr. Sasser joined the group. A
proposed outline of a full-Council presentation to be given in June was
provided to the Council by Mr. Sasser, who will work with each of the
Subcommittees to get recommendations associated with that presentation.

**Budget process**. The budget process was discussed with Mr. Summers
and NORA personnel, and it became clear that there is a great deal of
work to be done in order to obtain increased funding in currently
underfunded areas. A budget recommendation was drafted asking the White
House to get involved in negotiating for higher funds within Congress.
Following discussion, the Subcommittee redrafted the recommendation, and
it was adopted with changes. (The full text is in Addenda to Minutes,
New PACHA Recommendations.)

**Followup on Needle Exchange**

Dr. Hitt reviewed the activities of the past 2 days and said that the
"President has heard the message." The danger now is that, with the
Council leaving town, the pressure will be lessened. In order to
maintain momentum, the Council will ask NORA to keep pressure on the
Administration. It still is necessary to ascertain who is at fault for
the Administration's apathy and where the Secretary of HHS stands on
this issue and push for action. Conflicting messages from HHS appearing
in the press must be clarified. One story indicated that the agency is
now waiting for additional studies to prove the science. The
Government's own studies already prove the efficacy of needle exchange.

Dr. Goosby volunteered to appear before the Council that morning to
discuss these conflicts; however, at this point, members believed that
answers need to come directly from Secretary Shalala or someone in her
office who can speak for the Secretary. It was agreed that the Council
would talk to Mr. Thurm by conference call during this final session of
the meeting, and a set of questions and strategies was developed for the
call.

Future action will include a followup full-Council conference call
(subsequently set for March 31) to review what has transpired, with a
message to be sent to Secretary Shalala asking specifically what she
thinks, what she needs to know, and when she is going to act on this, if
those questions have not already been answered. Some members urged a
call for Secretary Shalala's resignation; others asked that a meeting
with the President be demanded. Mr. Bollman pointed out that there are
many issues for which he should be updated as to the Council's view.
Dr. Hitt said that the request for the meeting is with the President's
staff.

Ms. Thurman reported that Mr. Thurm at HHS said that the department is
not waiting for additional studies---although they are still analyzing
those that they have---and that the source for the story has been told
by the Secretary that this is not true.

**Discussion and Adoption of Leadership Recommendation**

After much discussion, it was agreed that a recommendation on funding
and the current state of emergency within the African-American and
Latino communities proposed by the Services Subcommittee should be
listed as a Leadership Recommendation. One area of controversy was that
the recommendation could be seen as excluding Native Americans and other
minorities. Mr. Blackwell said that it is his impression that the
Council does not have integrated knowledge about the impact of the
disease on Native Americans, Alaskan Natives, and Pacific Islanders and
that these groups should be included in all recommendations regarding
budget issues and other support. Members agreed that these groups should
not be excluded; however, it was also pointed out that the Council, to
be effective, must be relatively specific in its recommendations and not
dilute them with too many generalities. In addition, the emergency at
hand, in terms of numbers of new infections, lies specifically within
the African-American and Latino communities.

It was agreed to include the four groups of color within the general
statement of the recommendation, while reserving the context of an
emergency state for the communities of African and Latino descent. The
leadership recommendation was adopted with one member opposed.

**Conference Call with Deputy Director of HHS Kevin Thurm**

Mr. Thurm, speaking for Secretary Shalala, addressed PACHA through a
full-Council conference call. Dr. Hitt began by reviewing what has
happened in the past 24 hours and asked Mr. Thurm for clarification of
the conflicting statements in the press about the need for "additional
studies."

Mr. Thurm apologized for the misleading stories and said that the press
had already been called to clarify that HHS is not waiting for results
of any other particular studies to prove the science of needle exchange,
nor is there any specific time frame set for analysis of the existing
studies. He said that HHS "continually looks at results of any study
that comes into the office." Mr. Thurm went on to say that "everyone in
the Administration is working to resolve these issues" and to provide a
realistic time frame. He said that PACHA had been appropriately clear
and direct and that the significance of this concern is appreciated.

Mr. Anderson asked who was speaking for the Secretary on this issue. A
clear, single-point message is needed. In the case of the recent article
in the press, a statement signed by the Secretary, saying that HHS is
not looking at any other studies, should be submitted within 24 hours to
clarify the misconceptions in the media.

Mr. Thurm said that a number of people were authorized to speak for the
department, including Dr. Goosby and Dr. Martin; however, the point is
well taken and future messages coming from the HHS need to be clearer
and, if possible, in writing. Regarding a time frame for a needle
exchange decision, Mr. Thurm said the agency is not in a position to
provide this.

Council members asked again if a written clarification on the article in
the press was forthcoming, and Mr. Thurm said that the department is
"probably prepared to clarify" the conflicting statements about the
studies.

Mr. Robinson reminded Mr. Thurm that 13 months ago the department
promised a resolution on needle exchange within 6 months. Mr. Hattoy
also noted that Dr. Goosby and Dr. Martin had laid out a relatively
short time frame for something to happen during the Council meeting and
asked whether Mr. Thurm would stand by those statements.

Asked what the problem was in analyzing the results of the Federal
studies that have been completed, Mr. Thurm said that he is not a part
of the research community and, therefore, cannot answer that question.
Dr. Levine said that she assumed that this expertise does exist in the
department and that she wanted to pose these questions to those experts:
What are the flaws in the current research? What are the issues that
create such difficulty in analyzing these completed, federally funded
studies?

Mr. Thurm said he understood how the answers he was giving today are
unacceptable to the Council; however, he assured the Council that the
Secretary does follow the science.

Mr. Bollman noted that the Secretary has always been known as a leader
in progressive causes and has made extraordinary leadership advances,
which makes it even more difficult for us to understand why these
issues---including many other than needle exchange---are not being
resolved. New treatment protocols suggest that early intervention is an
effective solution, and yet there are tens of thousands of people who
cannot get access to them; and HHS is not taking a leadership role in
making this happen.

Mr. Thurm said that his office is not happy to have these conversations
and not happy to be unable to report resolution; however, the department
wants to move cautiously and lay out an effective, longer term strategy.

Ms. Stokes asked Mr. Thurm to relay to Secretary Shalala that she has
broken the promises she made personally 4 years ago, when she said that
we have the knowledge and the technology and the strength to end
unnecessary deaths now. Mr. Schatz noted that the Council is wasting its
time, venting at the wrong person, and called for an immediate meeting
with the Secretary. Mr. Thurm said that he cannot guarantee a meeting
with the Secretary, but that he would check her schedule and get back to
Dr. Hitt.

Dr. Hitt summarized by saying that the Council wants to know who is
speaking for HHS and the Secretary, that it wants this and a retraction
of the news story in writing almost immediately; further, the Council
wants a meeting with Secretary Shalala as soon as possible. He thanked
Mr. Thurm, and he hoped that the Deputy Secretary could get a real sense
of the anger and frustration among the Council members and that he would
take this back to the Secretary so that these issues can be addressed.
The conference call was then ended.

Mr. Aragon noted that NORA's recent request for an urgent meeting with
the Secretary had been denied and that even Mr. Thurm did not meet with
the group. A number of members, including Mr. Isbell, Mr. Hattoy, and
Mr. Henderson, said that they would be comfortable with calling for the
Secretary's resignation if no word is received today.

**New Business**

**Long-term planning**. Dr. Hitt reminded the Council that PACHA has a
finite term---about a year to complete this process. The last long-term
planning exercise was done in December 1996, during which the Council
tried to focus its efforts into a concise 4-year goal. (Copies of that
document were made available to the members.) It is time to come back to
that process, he said, and talk about what the Council should focus on
in its limited time left and what the final PACHA product should be---a
Progress Report or a set of Recommendations to the next Administration.
Time will be set aside for planning at the next meeting, and
Subcommittees were asked to limit their agendas for the breakout
sessions accordingly.

**Next Council meeting**. The next Council meeting will be held June
15--18, 1998, at the Madison Hotel in Washington, D.C. Dr. Hitt asked
members to contact Mr. Montoya if they wished to be included in any of
the scheduled Subcommittee conference calls.

**Closing**

Dr. Hitt thanked Council members, Ms. Thurman and the ONAP staff, the
PACHA meeting staff, and guests for their participation; the Ninth
Meeting of PACHA was adjourned at 12:15 p.m. March 18, 1998.