**Presidential Advisory Council on HIV/AIDS**

December 7-8, 1995

Marriott at Metro Center

Washington, DC

**MINUTES**

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

December 7

Chairman Dr. R. Scott Hitt opened the meeting by thanking Ms. Patricia
Fleming, Mr. Jeff Levi, Mr. Richard Sorian, and the other staff of the
Office of National AIDS Policy (ONAP) for their work in organizing the
first White House Conference on AIDS held the preceding day.

ONAP Director Ms. Fleming said she was almost speechless after the
conference and was exceedingly grateful to President Clinton for his
speech. She welcomed new members to the Council and advised them that
they have a very important job ahead, particularly after the conference.
She also announced the Food and Drug Administration\'s (FDA) approval of
Sinequir, the first protease inhibitor, which was approved in the
shortest period of time of any drug in FDA history, 90 days.

Council members then introduced themselves and discussed the
implications of, and new opportunities presented by, the White House
Conference the day before. Members echoed Dr. Hitt\'s thanks to ONAP
staff in putting together the conference and acknowledged the Chair\'s
work in organizing the meeting as well. Members uniformly praised the
conference and President Clinton\'s commitment to HIV/AIDS but raised
concerns about maintaining the momentum established at the conference,
the need for an immediate focus on Black and Latino communities,
discrimination, and what many saw as a lack of emphasis on prevention,
particularly needle-exchange programs.

Dr. Hitt said he believed the conference accomplished its goals of
raising awareness of both the President\'s commitment and AIDS as an
issue. He said that the interaction of staff members and Cabinet level
people with conference participants has helped increase faith in the
Council. He said he was very impressed by the demographics of the
Council members chosen by the Administration. Over one-third of members
are living with HIV; one-third are people of color; more than one-half
are gay or lesbian; and almost one-half are women. Noting that he has
also heard comments about what persons are missing from the Council, he
said it is the Council\'s job to reach out twice as hard to communities
and experts in fields that might not be represented on the Council, such
as housing experts or high-level treatment advocates.

The Council then broke into meetings of its Services, Prevention, and
Research Subcommittees (see attachments).

**Alternative Medicine and HIV/AIDS**

Dr. Wayne Jonas, Director of the National Institutes of Health (NIH)
Office of Alternative Medicine (OAM), spoke before the Council about the
Office\'s activities in alternative medicine and AIDS.

Dr. Jonas described the brief history of OAM, from its inception in
1992-93 at a budgetary level of \$2 million to its estimated \$5 million
budget in FY 1995. The Office is mandated to facilitate the evaluation
of alternative medical treatment modalities, investigate and validate
the efficacy of alternative treatments, and support research training in
alternative medical practices. It is also charged with establishing an
information clearinghouse to exchange information with the public about
alternative medicine.

OAM receives approximately 1,200 information requests each month, the
vast majority of which (78 percent) are related to alternative therapies
for cancer, Dr. Jonas said. Requests for information about AIDS come in
a distant second at 7 percent, a figure that Dr. Jonas said he believes
is relatively low because people with HIV infection and AIDS are
accessing other resources for information about alternative therapies.

Clinical trials of conventional Western medical interventions outnumber
those of alternative therapies 300 times. The issue of research in these
areas is not one of quality, but of quantity, Dr. Jonas said. The lack
of regulation and quality assurance for many alternative therapies leads
to a higher risk that many treatments offered may be fraudulent.

The first grants awarded by OAM were for small exploratory studies of
alternative therapies. Of 42 such pilot grants, 3 are related to HIV.
Because the grants are funded at a level of \$30,000, however, many of
the studies lack the number of patients and the statistical power
necessary to answer the research questions posed. Small, simple studies
such as one examining the effect of massage on weight and other health
measures of HIV-exposed infants have been able to demonstrate positive
results.

Another problem faced by OAM-supported investigators involves receiving
Institutional Review Board (IRB) approval for studies when the
participating institution has no IRB or any faculty on an IRB at another
institution. Receiving FDA approval for Investigational New Drug (IND)
use for formulations used in alternative medicine can prove costly and
time-consuming. For example, in a study investigating acupuncture and a
combination of 15 herbs with a long history of use in patients with
chronic sinusitis, it was necessary for investigators to use a formula
containing fewer herbs because of the high cost of chemistry, laboratory
toxicology, and pharmacodynamic studies required by the FDA. Even with
the less complicated combination, the cost of the IND drug was three
times more than the amount of the grant received to study the
formulation.

In addition, many alternative therapies have been developed and are
widely used in foreign countries, where the problems encountered in
prospective analyses may be even more pronounced than in the United
States. Dr. Jonas said one field investigation on chiropractic treatment
found that diagnoses were recorded on only 24 percent of patient
records. OAM does have a Research Development and Investigation Section,
which pro-actively screens, prioritizes, and provides technical support
to the most promising research opportunities from around the world.

Last year, OAM awarded 10 clinical research center grants, including 1
to Bastyr University in Seattle to study alternative therapies for AIDS
and HIV infection and provide mechanisms for supporting collaborative
research efforts in complementary and alternative medical practices. The
Bastyr University center\'s \$920,000 grant will support an assessment
and evaluation of research opportunities and the development of a
prioritized research agenda.

Subjects of research proposals received by the Bastyr University center
include glutamine treatment for overall improvement in AIDS, neuropathy
and acupuncture, and the impact of therapeutic touch on the immune
system.

Dr. Hitt commented that there is a feeling that Government is not doing
enough research in this field. \"Short of saying that we need to
increase the budget by 200 percent or by 1,000 percent, what is it that
we can we do to get the word back to the community that the Government
is concerned about this, they are doing their best to get outreach about
this?\" He asked whether OAM\'s Advisory Council has provided
AIDS-related advice to OAM.

Dr. Jonas said the Advisory Council has focused on a general discussion
of the field, which has included AIDS, and that a report to Congress
from experts in the field also contains information on AIDS. He said OAM
hopes that its AIDS research center at Bastyr University will come up
with an organized AIDS research agenda.

Members also discussed the difficulties in compiling a directory of
alternative therapies for AIDS. Dr. Hitt noted that an alternative
therapies manifesto published by the Gay Men\'s Health Crisis provides a
good review of alternative therapies. Government\'s outreach could
include such a listing, he suggested.

Dr. Jonas said such an effort falls under OAM\'s agenda to develop an
information clearinghouse, which may take the form of an online service,
a directory, and/or an 800 number. (OAM already has an 800 number, but
it has not yet advertised it.) The clearinghouse will have general
information about, and descriptions of, therapies as well as reports of
quality research. Dr. Jonas asked the Council what kinds of information
it would like in such a directory. He said he hopes a full clearinghouse
will be up and running in a year.

Council members said a year is too long to wait for a clearinghouse and
asked what recommendations it can make to the HHS Secretary to help
expedite the effort.

Dr. Jonas said OAM is developing an evaluation system for clearing
information and its Database and Evaluation Section is starting to
download existing online medical information and will try to develop
bibliographies. OAM is also evaluating other information resources.

He also hopes to work with other Institutes at the NIH to fund more
research in specific areas of alternative medicine.

Dr. Hitt asked whether there is an overall plan related to AIDS, and if
so, whether it was developed with community input. Dr. Jonas said that
next week he will have the first meeting with primary investigators from
the OAM centers. Council members also discussed the need to develop such
an AIDS plan with community input and to speed the establishment of an
800 number or information clearinghouse. Dr. Jonas said it would be very
helpful for Council members to provide names of experts in the field.

**Discussion of Services Subcommittee Recommendations**

Council members began their discussion of recommendations from the
Services Subcommittee with a proposed recommendation to \"rescind
mandatory testing and/or discriminatory policies currently in place in
the U.S. Foreign Service, the Peace Corps, the Job Corps, the State
Department, and the military.\"

Asked whether there is consensus in the military that there is no public
health need to continue mandatory HIV testing, Mr. Benjamin Schatz said
the primary concerns are related to autologous transfusions, expenses,
and sending personnel overseas. Dr. Michael Rankin said that battlefield
blood transfusions are probably the only legitimate public health
concern.

Council members voted unanimously to endorse the recommendation with the
addition of the phrase \"where there is no compelling public health
justification.\"

Members next discussed a proposed recommendation that the Centers for
Disease Control and Prevention (CDC) review its guidelines for voluntary
disclosure of HIV status by health professionals who perform
\"exposure-prone\" procedures. Issued in July 1991, the guidelines have
been used by courts to justify discrimination against a wide range of
health care workers, which in turn makes it harder to recruit health
care workers to work in the field of HIV, said Mr. Schatz.

The CDC has never defined \"exposure-prone\" procedures. The guidelines
were issued when there was not much information on transmission from
health care workers and were promulgated at a time of high emotion in
the aftermath of reports of HIV transmission from a Florida dentist to
some of his patients, Dr. Jerry Cade said.

The Council unanimously approved the recommendation that the President
\"instruct the U.S. Centers for Disease Control and Prevention (CDC) to
review its guidelines that arbitrarily restrict HIV-infected health care
workers and that lead to discrimination against them and to ensure that
these guidelines are consistent with prevailing scientific and public
health knowledge on the issue.\"

A further recommendation discussed and endorsed by the Council was that
President Clinton \"oppose any congressional efforts to require that
otherwise qualified service personnel who test positive for HIV be
discharged, including a veto of the Department of Defense
Reauthorization Act if such a provision is included. In his veto
message, we recommend that the President state that the veto is in part
due to the inclusion of this provision.\"

Members next approved a recommendation that the President \"Direct the
CDC, Immigration and Naturalization Service (INS), and Department of
State to monitor and coordinate the HIV testing of immigrants to ensure
informed consent, pre‑ and posttest counseling, and appropriate legal
and health referrals and to ensure that waivers of the HIV exclusion are
granted on a priority basis when permitted by statute. Also, when
permitted by statute, the INS and the Executive Office of Immigration
Review (EOIR) should grant stays of deportation, suspension of
deportations, extended voluntary departure, deferred action, and asylum
based on the social group category of HIV‑positive individuals.\"

The Council also approved four recommendations related to Medicaid and
Medicare programs. The first calls for the President to \"Continue to
support and defend the [entitlement status]{.underline} and
[funding]{.underline} for Medicaid and Medicare; and continue to oppose
any efforts to restrict [eligibility]{.underline} and
[services]{.underline} for people living with HIV/AIDS.\"

The second is to \"Direct that any waivers granted to States under the
Medicaid program ensure access to a comprehensive continuum of care for
people living with HIV/AIDS. To implement this policy, you should direct
the Health Care Financing Administration (HCFA) to establish national
criteria by which to assess State waiver applications and to ensure that
these criteria be consistent with current health care knowledge. These
criteria also should be consistent with the provisions of the Americans
with Disabilities Act (ADA), and State plans should be reviewed for this
purpose by the Department of Health and Human Services (DHHS) Office of
Civil Rights.\"

The third is that the President \"Direct HCFA to ensure that State
Medicaid programs cover HIV testing and counseling.\"

A fourth recommendation was discussed that would require HCFA to ensure
that all FDA-approved drugs are covered under State plans, even when
prescribed for \"off-label\" indications.

Noting that the FDA is holding hearings on this topic, Ms. Phyllis
Greenberger said the issue may be too complicated for President Clinton
to endorse a recommendation at this time. Members agreed with
Mr. Nicholas Bollman\'s assertion that the refusal to reimburse for
off‑label uses of drugs is a medically inappropriate effort at cost
containment. The problem is especially severe in pediatrics because 75
percent of drugs are not labeled for use in children, said Ms. Mary
Boland.

Although Mr. Steve Lew pointed out that Medicaid can decide to reimburse
for drugs in a specific compendium, other members said that the rapidly
evolving standard of therapy for HIV/AIDS makes such a measure
impractical.

Members voted to ask the President to \"direct HCFA to report to the
Council at its next meeting possible strategies to address the need to
ensure that all Food and Drug Administration (FDA)‑approved drugs are
covered under State plans, even when prescribed for off‑label
indications. These strategies should address both policies and vigorous
enforcement mechanisms.\"

The impact of managed care on persons living with HIV/AIDS and the need
for comprehensive HIV health care systems were also addressed. Although
some members said that legislation is needed before services can be
regulated, others said that, even if guidelines are developed by the
Government, they could be used by States and private insurers to
establish a minimum standard of services. Services Subcommittee Chair
Mr. Edward Gould said the issue of managed care needs to be addressed
and that the managed-care standard does not take into account that, in
people with HIV disease, treatment tends to occur in hills and valleys.
Mr. Bollman suggested that the Council at least identify the creation of
standards for the provision of primary care for HIV-infected persons as
an issue and ask HCFA to present its ideas on how to solve the problem.

Members agreed to table discussion on the recommendation until the
Subcommittee returned with a rewritten version.

In a general discussion with ONAP staff about how best to direct its
recommendations, Mr. Terje Anderson argued very strongly to maintain the
recommendations directed to the President in the language of the report.

The Council then endorsed a recommendation that the President \"Direct
all appropriate agencies to support the investigation of the efficacy of
complementary treatment therapies and provide increased financial
support for this effort, and that therapies shown to have benefit should
be reimbursed under Medicaid.\"

Specific directives to the NIH\'s OAM may be developed at a future
meeting.

Members next discussed recommendations related to education and
training. Noting that funding for AIDS Education and Training Centers
(AETCs) was cut from \$16 million to \$0 and then increased back to \$8
million, Council member Dr. Stephen Abel said full funding should be
reinstated. Although some problems existed in the program, the new
centers will be working more closely with councils and primary care
providers, he said. Because President Clinton recently wrote a letter to
Congress requesting full funding for the centers, members agreed to be
on record as stating the Council encourages full funding.

Members voted to recommend that the President \"Continue to support full
funding to a national network of AIDS Education and Training Centers
(AETCs) and direct the Health Resources and Services Administration
(HRSA) to ensure that the work of AETCs is coordinated with community
providers and planning groups\" and \"direct HRSA to review and report
to the Council at its next meeting the effectiveness of the Bureau of
Health Professions\' education activities specific to HIV/AIDS.\"

Members next discussed a draft letter to President Clinton thanking him
for the White House conference and including the Council\'s
recommendations as part of the letter.

**CDC Public Service Announcements**

Council members then heard from Ms. Melissa Shepherd of the CDC, who
described and then showed videotapes of the agency\'s new public service
announcements (PSAs) for HIV/AIDS. Introduced the previous week, the
PSAs are part of a prevention campaign entitled \"Respect Yourself,
Protect Yourself.\" Their release retires the \"America Responds to
AIDS\" campaign, an announcement that was greeted with applause from
Council members.

The TV and radio spots were developed after multiple airing of a
television program, \"Smart Sex,\" and a phone survey of 500 viewers who
identified the messages with the most resonance. Youth were then brought
in for a 2-day meeting at which they viewed the messages and prioritized
them. The youth also provided advice on music and graphics.

The resulting PSAs were tested in mall intercepts in Los Angeles,
Seattle, Houston, and Atlanta. Following CDC approval, more testing,
particularly of one video targeted to young gay men, was conducted among
gay men in street intercepts in San Francisco and New York.

The PSAs range from 10 to 60 seconds in duration, with some available in
both Spanish and English. Titles include \"How Do You Know?\" (about HIV
status), \"Buying Condoms,\" \"Alcohol---Stay in Control,\" and
\"Abstinence.\"

Ms. Shepherd said the spots cost less than \$400,000 to develop and test
and that within the first week the CDC had already recouped its
investment through network broadcasts. When asked about the PSAs\'
exclusion of Asian and Native Americans, Ms. Shepherd said the CDC was
aware of the need for greater representation but that the spots were
made from existing video clips. She urged members to forward any footage
that might be useful in future PSAs.

Asked about efforts to gain prime-time coverage, Ms. Shepherd said more
than 30 percent of PSAs used in the 1994 campaign were aired during
prime time and that some networks air the announcements during
late-night talk shows popular with young audiences. The CDC has asked
networks to air the PSAs during shows targeted at persons 18 to 24 years
old.

Noting that in the past he has complained about the lack of PSAs showing
men having sex with men, member Mr. Schatz said the new PSAs represent a
very important step. He also applauded the announcements for their use
of non-gender-specific language when discussing sex.

The Council then adjourned for the day, with ad hoc meetings of its
three Subcommittees scheduled for the evening.

December 8

**HHS Secretary Donna Shalala**

HHS Secretary Donna Shalala addressed the Council and began by thanking
Ms. Fleming for her leadership in organizing the White House conference.
She told the Council that the Administration sees the conference \"as
part of a longer strategic effort in this area.\" She said that the
President\'s budget announced December 7 protects spending priorities on
AIDS and its prevention investments. Although it is not a detailed
budget, Secretary Shalala said, \"Let me assure you that it repeats what
the President said on Medicaid and our determination to stand firm on
Medicaid. It actually, I believe, adds some resources on Ryan White, and
the whole prevention package continues to be there.\"

Secretary Shalala did concede that decreases in the discretionary budget
will affect many programs; nevertheless, the core of prevention,
treatment, and research investments is protected as part of this overall
budget, she added.

Next, Secretary Shalala, administering the oath, swore in the Council
members as advisors to the President, and a group photo was taken.

Secretary Shalala continued to address members on the current budget
debate with Congress. The only budget on the table now, she said, is the
7-year budget based on the Administration\'s assumptions. The
Republicans have rejected that approach, arguing that the Administration
must use the Congressional Budget Office (CBO) assumptions, she said.
The Secretary then asserted that there were no CBO assumptions; they are
still under development.

The Administration\'s decisions concerning what is left within the
discretionary budget have not yet been determined, she said. She noted
that priorities would need to be set with HHS but assured the Council
that AIDS programs would be protected. She continued, however, that
\"obviously, this is a very tough budget, and we are in a very different
era.\"

Asked whether prevention is an investment priority, Secretary Shalala
said it has not traditionally been a priority, but the Administration
will try to protect prevention investments.

Asked about Medicaid regulation of managed care by States and the
possibility of exceptions for people with HIV/AIDS, Secretary Shalala
said, \"It has been our strategy all along to work with the States to
develop those kinds of options.\" She stressed the \"need to develop a
set of managed care organizations and other kinds of alternatives to fee
for service¼ that have experience with AIDS patients and provide high
quality of care.\" Whether or not HHS gives States more or less
flexibility, she said, our focus will be \"on the quality of care and
the appropriateness of care and not simply on the nature of the
organization and the delivery system.\"

Mr. Robert Fogel asked about block grants combining sexually transmitted
disease (STD), TB, and HIV/AIDS funding as Performance Partnerships
grants instead of providing direct funding. Secretary Shalala responded
by stressing the attempt of HHS through Performance Partnerships to deal
with outcomes rather than regulate the inputs. \"We do not consider
Performance Partnerships a traditional block grant,\" she said, \"in
which we turn over responsibility to the States as opposed to a
partnership under which the Federal government and the States agree upon
a set of outcomes\" that can be regularly measured. The Administration,
she continued, is attempting to develop a concept, a true partnership,
in the Government\'s relationship with the States. In addition, the
Secretary added, she herself is attempting to change HHS from being
overly oriented toward tight regulation to actually measuring whether
programs have an impact. She suggested that Dr. Philip Lee could meet
with the Council at its next meeting to discuss in more detail what she
is describing.

Asked about the receptiveness of the current Congress to the argument of
the cost-effectiveness of prevention, Secretary Shalala said, \"As far
as I can tell, there are no substantive policy discussions taking place
as part of these budget negotiations. Perhaps the term that was used in
the session I did at the White House conference is most appropriate;
that is, we are now sitting across the table from mad bookkeepers.\"

**Prevention Subcommittee Recommendations**

The general Council meeting resumed at 8:45 a.m. with a reading of the
recommendations from the Prevention Subcommittee, followed by a
discussion.

The recommendations begin with a statement, directed toward the
President, that \"We are delighted you have committed to set a goal of
reducing the number of new infections every year until there are no more
new infections.\"

It continues that \"You should direct the Centers for Disease Control
and Prevention (CDC) to develop a behavioral surveillance mechanism that
will provide an analysis of patterns in risk-taking behavior. To assist
in accomplishing this goal, we ask you to \`Direct the CDC to join with
the National Institute on Drug Abuse (NIDA) and other relevant agencies
to institute surveillance methods for detecting patterns of risk-taking
behaviors in populations that show a continuing disproportionate
increase in AIDS cases.\'\"

Council members then voted to recommend that the President \"Direct the
Secretary of Health and Human Services (HHS) to coordinate the planning
of an early warning system and ensure its ongoing use.\"

Members also discussed a proposal that the CDC issue an annual estimate
of HIV incidence. Stating that the Subcommittee does not believe such
efforts will require the collection of additional data, Mr. H. Alexander
Robinson said, \"What we don\'t get from the CDC is an analysis of the
data. We get a lot of number reporting.\"

Although the information is necessary, testing and information
collection could be intrusive, said Ms. Boland. Noting the previous
discussions about managed care and capitation, Mr. Bollman said that
without this kind of data, the level and range of services required for
people living with HIV will likely be severely underestimated.

The Council agreed to postpone voting on the recommendations until a
rewritten recommendation was prepared and presented.

The Council then discussed a series of recommendations intended to
reduce the spread of HIV through injection and other drug use. Some
Council members questioned the observation that at least 50 percent of
new HIV infection is related to injection drug use. Subcommittee members
said the figure is conservative and that at least five significant
studies have corroborated the estimate. Members agreed that the
recommendations should be broadened to include all substance abuse.

Members also discussed the need to revise the Department of Justice
Model Drug Paraphernalia Act, which serves as a model for some 40
States. Developed in the 1970s, the law is outdated and does not reflect
current knowledge about the effectiveness of access to sterile needles
in reducing HIV transmission, they said.

While acknowledging that drug paraphernalia laws are within the purview
of the States, Council members agreed that the model developed by the
Justice Department should no longer be used and that its revision would
send a message to States that they should consider revising their laws
to reflect current knowledge about public health.

Echoing comments made earlier by Mr. Robinson, Mr. Anderson expressed
concern about what he called mixed signals from HHS Secretary Shalala
about needle exchange. \"There is no question in the National Academy of
Sciences report that needle exchange is effective and that needle
exchange does not increase drug use in the community,\" he said. Needle
exchange remains a controversial political issue, however, he
acknowledged. \"What we are asking the Secretary to do, what we are
asking the Federal government to do, is to follow up to allow selected
use of waivers, to allow Federal funds to be used in some circumstances
when necessary to meet local conditions,\" he said. \"We do not
anticipate that this will lead to a general lifting of the ban. We wish
we could go that far, but we are trying to provide a politically
acceptable solution.\"

The Council unanimously approved the following statement and
accompanying recommendations:

\"The Administration should pursue a comprehensive strategy to decrease
HIV transmission related to injection drug use, which accounts for at
least 50 percent of new HIV infections. Additional infections occur
through sexual contact with injection drug users. Injection drug use is
directly or indirectly responsible for the overwhelming majority of HIV
infections among women and infants. Strategies must explicitly address
the sharing of injection drug paraphernalia as well as the high-risk
sexual behavior associated with drug and/or alcohol use.

\"We ask the Administration to do the following: Increase the access to
effective substance abuse prevention and treatment research programs by
opposing congressional efforts to cut Substance Abuse and Mental Health
Services Administration (SAMHSA) and other Federal funding for drug
abuse treatment and prevention programs in FY 1996 appropriations,
restoring budget requests for SAMHSA and other Federal funding for drug
abuse treatment and prevention programs to at least the FY 1995 levels,
and supporting the continuation of specific funding for AIDS
demonstration projects of the National Institute on Drug Abuse (NIDA).

\"Revise the Department of Justice Model Drug Paraphernalia Act, which
serves as a model for State drug paraphernalia laws, to make it
consistent with current reports, studies, and data relating to the
access to sterile syringes as an effective intervention to counter HIV
transmission among injection drug users.

\"Direct the Secretary of Health and Human Services to provide a
recommendation (within 90 days) regarding the impact of needle-exchange
programs on HIV infection and substance abuse. The recommendation should
be based upon current reports, studies, and data on needle-exchange
programs and should include specific recommendations for programs and
demonstration projects to implement needle exchange. The Secretary shall
develop and execute a plan to carry out the recommendations and indicate
what programs and demonstration projects will be started or expanded.\"

Discussion next moved to a recommendation that the Administration
maintain independent HIV prevention programs and avoid consolidated
grant programs, including Prevention Partnership grants and other block
grants. Mr. Robinson expressed concern about the lack of evidence that
the grants will improve services.

Mr. Levi outlined the Administration\'s view of the Prevention
Partnership program. The Administration is trying to reaffirm its
commitment to community planning, and the President has put out the
performance measure of reducing the number of new infections each year,
he said. The CDC and SAMHSA have agreed in writing to pursue development
of the performance measures with input from the AIDS community, he
added. Performance Partnership grants would bring together three funding
screens with one community planning process and one set of performance
measures, a proposal that has generated controversy, he acknowledged.

Mr. Robinson said that the Council did not object to the performance
measures; rather, the objection lay in the combination of HIV, STD, and
TB funding into one planning process. \"There is no evidence that that
will actually have a benefit in this area,\" he said.

Council members remained unconvinced by Mr. Levi\'s and Secretary
Shalala\'s defense of the Prevention Partnership grants and voted to
advise that the President \"should reaffirm support for community-based
planning for prevention activities. Your administration has begun to
plan for the combining of HIV/STD and TB funding. The current proposal
does not adequately safeguard the community planning process. This
proposal does not take into consideration the need for measures that are
relevant to communities of color, gay and bisexual men, substance users,
youth, women, and/or other communities and groups that have not been
captured by existing data.\"

The Council specifically recommended that the President \"Direct the CDC
to maintain HIV prevention programs independent of any consolidated
grants programs including the currently proposed Performance
Partnerships grants.\"

In its discussion of community-based planning and other activities,
Council members voted to recommend that the President \"Direct the CDC
to continue direct funding to community‑based organizations\" and
\"Direct the CDC with the assistance of existing national minority
organizations and other appropriate partners to structure its technical
assistance programs to address the prevention program development and
infrastructure needs of populations that are currently experiencing
continued disproportionate increase in new infections.\"

Members also discussed a proposal calling for the Indian Health Service
(IHS) to develop a comprehensive AIDS prevention and care program.
Although some Council members expressed concern that the recommendation
would exclude other populations, Mr. Jeremy Landau said there has been a
significant negative change in IHS policy recently and that Native
Americans are under purview separate from other population groups.

The Council endorsed a statement that \"HIV/AIDS is established and
growing throughout Indian Country and threatening a population already
reduced to 1.4 million from war, disease, and poverty. Since the Indian
Health Service (IHS) is the only health service provider for Native
Americans on reservations, there is a need for prevention services
specifically directed to Native Americans.\" The Council also
recommended that the President \"Direct the Director of the IHS to
develop a comprehensive AIDS prevention and care plan for Indian Country
within 90 days with the input of consumers of services.\"

The Council also approved a rewritten recommendation that the CDC
conduct an annual estimate of HIV incidence based on geographic and
demographic analysis. It voted to request that the CDC issue an annual
estimate of HIV incidence based on seroprevalence studies that provides
a geographic and demographic analysis of the populations where there is
a continuing disproportionate increase in new HIV infections. This
report will give the Public Health Service, the business community, and
countless volunteer organizations the ability to focus on the most
severely impacted HIV/AIDS populations. In addition, the Council
requested that the President \"Direct the Secretary of Health and Human
Services to ensure that resources are allocated to accomplish the task
stated above.\" The Council also recommended that the President \"Ensure
that funding is adequate and responsive to the epidemiological trends,
needs, and prevention infrastructure of affected communities.\"

The Council then endorsed the following revised recommendations from the
Services Subcommittee concerning the development by Government agencies
of oversight guidelines for HIV managed-care programs:

\"Direct those Federal agencies that either finance or administer health
care services (including but not necessarily limited to the Health Care
Financing Administration \[HCFA\], the Department of Veterans Affairs,
the Department of Defense, and the Bureau of Prisons) to develop
oversight guidelines for HIV managed-care programs. This will also
require effective regulatory enforcement mechanisms.

**\"**Direct the Health Resources and Services Administration (HRSA) to
develop a coordinated agency‑wide approach that provides effective
education, training, and technical assistance to HIV/AIDS providers and
AIDS service organizations on health care management issues. Such an
approach should include active participation by the private sector.\"

Members also discussed the need for additional staffing for the Council.
Mr. Robinson said the staffing should be from within ONAP. He also
expressed concern that the Council has not provided in an effective
manner for persons with AIDS.

**Research Subcommittee Recommendations**

Research Subcommittee Chair Dr. Alexandra Mary Levine said the first
recommendations came from workshops held at the December 6 White House
conference. One issue is the need for partnerships between the private
sector, Government, advocates, and others in order to move forward in
vaccine and other prevention research efforts. She noted that President
Clinton had said Vice President Gore would be asked to organize these
kinds of groups.

Council members unanimously approved background information stating that
\"A vaccine to prevent AIDS and an anti‑HIV topical microbicide to
prevent infection are feasible technologies that [can]{.underline} be
developed. Such technologies represent the most promising ultimate
solutions for control of the global pandemic. These technologies will
require the cooperation and collaboration of Government, community
representatives, private industry, and academia, in the United States
and other nations, to overcome current obstacles and to develop these
products as rapidly as possible.\"

The Council approved the recommendation that the Vice President lead a
Government initiative to promote partnerships: \"The Vice President\'s
leadership and technological expertise should be sought to bring
together the resources and expertise of various Government agencies, the
private sector, community groups, and other nations in the effort to
develop HIV vaccines and microbicides, and to \`reinvent\' the
Government\'s involvement in the development of these products.\"

Another set of recommendations related to the development of
microbicides was developed after a workshop held by the Subcommittee
with representatives from the National Institute of Child Health and
Human Development (NICHD).

Dr. Levine began by describing microbicides as either spermicidal or
nonspermicidal topical agents, in foam, gel, or suppository form, that a
woman controls and can use to prevent HIV/STD infection.

Dr. Levine told the meeting that microbicidal research is currently an
extraordinarily small field---condoms and nonoxynol‑9 have been the only
methods for prevention of STDs for the last 25 years---but that
production of a effective microbicide is both feasible and cheap. She
also noted the importance of empowering women to prevent infection
instead of relying on a sexual partner to use a condom, a practice that
is not possible in many parts of the world and the United States.
Development of an effective microbicide has tremendous implications for
controlling the world epidemic, she said.

Important subissues in microbicidal research include the vehicle in
which the microbicide is dissolved, such as film or foam, and the safety
of its use on the vaginal mucosa. Dr. Levine cited an uncontrolled study
of the contraceptive sponge with nonoxynol‑9. The study was poorly done
and showed increased transmission. The disruption of normal vaginal
tissue is another issue that must be studied, she said.

Proceeding as quickly as possible \"to organize the appropriate science
behind the microbicides\" is another important issue, Dr. Levine said.
Millions of women will continue to be infected until these products are
available.

She added that other means, such as nonoxynol-9, other vehicles, such as
diaphragms, and substances such as chlorhexidine that have potential as
anti-HIV drugs have not been studied very well.

Clinicians need to be able to explain to a female patient her options
for reducing her risk of infection, Dr.  Levine said. She then asked for
the Council\'s advice. The group recommended that the NIH hold a
Consensus Development Conference.

Dr. Bruce Weniger noted that the recommendation intentionally calls for
the development of a topical rather than a vaginal microbicide. Products
should also be tested rectally so they can be used not only in vaginal
intercourse but also in receptive anal intercourse. This product could
be of great value to gay and bisexual men as well, he said.

Dr. Weniger compared the role of microbicides in a harm-reduction
algorithm with that of drug use: that it is best not to use drugs; the
next best thing is not to share a needle; if one is still going to share
needles, bleach should be used to clean them; and if no bleach is
available, they should be rinsed with water.

The Council then discussed whether it was appropriate for such a
politically appointed body as the Council to make research
recommendations. Concerning the issue of microbicides, Council members
remarked that research is understaffed and that microbicides are
probably the most cost-effective preventive measure.

The Council unanimously endorsed the following background statement:
\"Women infected heterosexually by HIV represent the fastest growing
group diagnosed with AIDS in the United States and account for half of
all cases in Africa and an increasing proportion of cases in Asia. Since
women may not be able to demand the use of condoms by their partners,
female‑controlled methods such as anti‑HIV topical microbicides to
prevent sexual transmission of HIV are urgently needed.\"

The Council endorsed the recommendation that \"The priority for funding
by the OAR for microbicide research and development as well as funding
within the CDC must be increased substantially, with a concomitant
increase of FTEs allocated for this priority.\" The Council also
recommended that \"The Government should develop mechanisms to increase
the pool of investigators in microbicide research and development,
especially those involved in biomedical and behavioral aspects.\"

Members also approved the background statement that \"While the results
of ongoing microbicide research are awaited, it is urgent to promulgate
public health recommendations for preventing sexual transmission of HIV
by using existing, licensed pharmaceutical products for off-label
indications, based on the best information currently available.\"

The Council approved the accompanying recommendation that \"A public
health policy consensus panel should be convened by the Public Health
Service by the end of April 1996 to assess the possible efficacy of
available spermicides (e.g., nonoxynol‑9) and other licensed products
(e.g., chlorhexidine, benzalkonium chloride, diaphragms) to be used in
\"harm reduction\" algorithms to decrease sexual transmission of HIV.
The panel should include senior public health policy officials (CDC,
FDA, HHS Secretary\'s Office), research agencies (NIH), community groups
(women\'s health research advocates, commercial sex workers, interested
foundations), academia, and industry. The meeting should also feature a
review of the entire status of anti‑HIV microbicide research.\"

The group also approved a recommendation that \"The FDA comment by
January 31, 1996, upon the proposed FDA regulations that require
\`inclusion of women in all clinical trials of drugs for treatment of
HIV/AIDS in which there is no known evidence of reproductive toxicity.
When such toxicity has been documented, alternatives that allow the
inclusion of women should be provided.\'\"

Another recommendation would require drug sponsors to provide whatever
data they have on gender-specific toxicities, although concern was
expressed that some clinical trials, such as one focused on Kaposi\'s
sarcoma, do not include enough women to be statistically significant.
Nevertheless, Dr. Levine argued for the provision of all current,
relevant data, especially for gender-specific toxicity.

Members approved the recommendation that \"The final version of the
proposed regulations published in the *Federal Register*, Vol. 60, No.
174 at 46794, must require a sponsor to file gender accrual analysis in
the annual Investigational New Drug (IND) report. In addition, for the
New Drug Application (NDA) and the product licensing application (PLA),
the regulations must require sponsors to analyze clinical data by gender
and assess potential differences, including reporting on side effects
between genders.\"

Another issue discussed was the current regulation that pregnant women
must obtain consent from the father of the fetus in order to participate
in clinical trials, regardless of individual circumstances. Council
members approved a recommendation that \"The Secretary of HHS should
publish for public comment by March 1, 1996, the proposed regulations
regarding participation of pregnant women in clinical trials, with the
following revision: A pregnant woman\'s inability to obtain a written
consent from the father of the fetus should not disqualify her from
participation in a federally funded clinical trial. This fact should be
so stated in the protocol consent form.\"

Council members then discussed a series of recommendations intended to
ensure that therapies developed are acceptable to target populations and
that advances in treatment are rapidly disseminated to the community.
Noting that six drugs are now licensed for use in treatment of HIV
infection, Dr. Levine said it is important to determine how to mandate
postlicensing studies in order to ensure that combinations are studied.

Ms. Boland stressed the importance of ensuring that advances make it
into the HIV service community, noting that it took 2 years to get out
the message about ACTG 076, the study of AZT in pregnant women. Members
also noted the difficulty in adapting drugs to formulations that are
appropriate for pediatric populations, with Mr. Bollman saying that
private industry is not developing pediatric formulations.

Members approved a statement that \"Advances in HIV/AIDS therapies,
vaccines, and microbicides require the dissemination, acceptance, and
use of these products by the populations that can benefit from them.
Such applications of biomedical discoveries require the expertise of the
social and behavioral sciences.\"

The Council voted to recommend that \"In HIV/AIDS clinical research, the
NIH must ensure the early and fundamental involvement of behavioral and
social scientists in the process of initial study development, design,
and implementation\" and that \"HHS should develop ongoing mechanisms to
ensure the rapid translation of breakthrough research findings into
clinical practice.\"

**Leadership Recommendations**

Members then discussed a set of recommendations in the area of
leadership, asking that President Clinton discuss AIDS during his State
of the Union Address and release the Administration\'s updated plan on
AIDS.

Council members rejected the idea of setting a date by which the
epidemic can be ended. Although all agreed that with proper prevention
tools the epidemic can be ended even in the absence of a cure or a
vaccine, Mr. Levi warned that setting a date by which it should be ended
would be politically dangerous and reminded members of former HHS
Secretary Margaret Heckler\'s overly optimistic setting of a date for a
vaccine when the discovery of HIV was announced.

Mr. Robinson suggested the Council\'s commitment to the President\'s
current goal, which is decreasing new infections every year, requires a
numerical target. Without that, he said, prevention is not a priority.

The Council voted to approve the recommendation that President Clinton
include the issue of AIDS in his State of the Union Address without
establishing a date by which the epidemic can be ended. The approved
recommendation states that \"Much of America has lapsed into a
complacency about AIDS even while the epidemic continues to expand its
path of devastation. We would like to ask you during the State of the
Union Address to renew your commitment to ending the AIDS epidemic and
to committing our Nation\'s resources to preventing new infections,
caring for people now living with HIV/AIDS, and finding a cure, vaccine,
and effective treatments for HIV. Also during this address, announce the
immediate release of an updated National Plan on AIDS.\"

The Council also approved a recommendation that \"To accomplish further
the goals outlined at the White House Conference on HIV/AIDS, the
Administration should ensure that key Cabinet Secretaries initiate and
maintain regular, face‑to‑face meetings with HIV service providers and
advocates to ensure consistent and ongoing communication and partnership
with community members on the frontlines of the AIDS epidemic.\"

**Assistant to the President for Domestic Policy, Ms. Carol Rasco**

Ms. Carol Rasco, Assistant to the President for Domestic Policy, met
with the Council and expressed gratitude for its report and its
recommendation to hold the White House Conference.

Ms. Debra Fraser-Howze said that the sustained and visible leadership of
the President is very important and it will be mentioned frequently in
the Council\'s recommendations. Ms. Rasco thanked the Council for its
support and noted that it would be helpful if members could work with
the Governors on Medicaid issues.

Mr. Gould suggested that there is a need to help educate and raise the
awareness of corporate leaders. Ms. Rasco said Council members can help
the Administration look for opportunities to reach out to the business
community and others. Dr. Levine noted that she had spoken with a
consortia of industry in Sao Paulo, Brazil, and that their knowledge of
the number of persons with AIDS, the costs of the disease, and the need
for AIDS programs far surpasses ours.

Ms. Rasco\'s response was that corporate America needs to be educated on
the subjects of HIV infection and AIDS. She then related an anecdote
concerning the manager of a Sunbeam plant in Louisiana whose insurance
premiums had skyrocketed because of the increased numbers of female
workers at the plant giving birth prematurely. After finding that the
numbers of premature births could be decreased by simple measures such
as directing the factory nurse to monitor pregnant women and providing
healthy snacks and cots for naps, he became an advocate for simple,
cost-effective health interventions.

Dr. Levine asked whether there was a way to increase staff support for
the Council. She said her own secretary has been spending 2½ hours each
day photocopying, collating, and mailing Council-related materials.
Ms. Rasco, noting financial constraints, said she would see what she
could do.

Mr. Schatz also called for increased support, saying that \"we simply
cannot carry out a meaningful national plan\" without a significant
increase in office support. Ms. Rasco suggested that foundations or
other organizations may be able to provide volunteers to help in the
office.

Finally, Mr. Richard W. Stafford suggested that the Administration
encourage its most visible Cabinet officials to visit pediatric AIDS
wards or group homes when they visit other cities. Such visits will
reinforce the Administration\'s message on AIDS.

**General Discussion of Council**

Members then returned to a discussion of recommendations that had been
previously tabled.

Ms. Fraser-Howze suggested the Council urge the President to hold a
White House briefing and update with congressional Black, Latino, and
Women\'s caucuses in order to solicit their support in the fight against
AIDS. While supportive of the concept, Council members agreed it would
be best to propose a detailed plan for ways to increase partnerships
with congressional leaders.

In general Council business, members discussed the need for payment in
advance for travel expenses of members, particularly those with HIV/AIDS
who may be living on a limited income. Mr. Schatz asked that members
improve their preparation for these meetings and suggested that
deadlines be set for recommendations submitted to the Subcommittees.
Mr. Landau added that members should prepare in advance for the meeting
so as to avoid 12‑hour days, which are stressful for persons living with
HIV/AIDS.

Ms. Greenberger suggested the Subcommittees meet in person more often,
perhaps using private funds for such efforts.

Members also discussed a number of process issues, such as the
introduction of new recommendations, particularly leadership
initiatives, that do not fall under the purview of a specific
Subcommittee.

All agreed that a number of important issues raised at the White House
conference should be addressed at future meetings. In addition, members
suggested that outside persons should continue to be invited to meetings
to provide information and make the process more inclusive. Members
discussed how best to build on the momentum established at the
conference. It was suggested that each participant at the conference be
sent a document indicating the Council\'s previous recommendations and
the Administration\'s responses as well as a copy of the Council\'s new
recommendations.

Ms. Fraser-Howze suggested that a few members form a committee to meet
with Dr. Hitt via conference call in order to develop recommendations on
how best to work as a Council and that time be set aside at the next
meeting for discussion. Members agreed that an ad hoc committee should
be formed to develop mechanisms and guidelines for process as well as a
set of strategic functions, strategic goals, and associated resources in
AIDS.

Stating that he was concerned that it has not yet determined its role,
Mr. Anderson suggested that the Council needs to develop a long-term
vision, including what it wants to accomplish, and how.

Dr. Abel stressed the importance of reaching out to communities not at
the meeting and suggested that the Council set aside time at its next
meeting to discuss its long-term plans.

Dr. Hitt informed members that travel advances are available but must be
requested 30 days in advance. He thanked ONAP staff for their hard work
despite the Government shutdown.

Noting that they did not have sufficient time to devote to the issue of
housing, members voted to include a recommendation that \"The Advisory
Council recognizes the critical and growing need for housing services
for persons living with HIV and AIDS. We also wish to acknowledge and
thank Housing and Urban Development Secretary Henry Cisneros for his
outstanding leadership and unprecedented willingness to work in
collaboration with AIDS housing providers and advocates. In July 1995,
the Council recommended to President Clinton that he make AIDS housing
an investment priority in FY 1997. We underscore the importance of this
earlier recommendation and commit to preparing a more detailed set of
housing recommendations at our next Council meeting.\"

Members thanked ONAP and Social & Scientific Systems staff for their
support for the meeting. Mr. Landau provided an outline suggesting how
the meeting should be conducted and asked members for comment.

**Presidential Advisory Council on HIV/AIDS**

**Services, Prevention and Research**\
**Committee Breakout Sessions**

**Breakout Session: Services Subcommittee**

December 7, 1995

9:30 a.m. to 1:30 p.m.

Grand Ballroom Sections A/B, Marriott at Metro Center

**MINUTES**

**Members Present:** Mr. Edward Gould, Chair; Dr. Stephen Abel;
Ms. Regina Aragon; Ms. Mary Boland; Mr. Nicholas Bollman; Mr. B. Thomas
Henderson; Ms. Carole laFavor; Mr. Steve Lew; Dr. Michael Rankin;
Mr. Benjamin Schatz; Mr. Richard W. Stafford.

Also present: Mr. Jeff Levi, Deputy Director, Office of National AIDS
Policy (ONAP)

**Recommendations on Discrimination**

Mr. Benjamin Schatz read the Committee\'s November 28, 1995, draft of
recommendations for discussion only. They included recommendations that
the President should, by Executive Order, oppose mandatory testing
currently in place in the U.S. Foreign Service, the Peace Corps, the Job
Corps, the State Department, and the military and instruct the U.S.
Centers for Disease Control and Prevention (CDC) to review its
scientifically discredited guidelines that arbitrarily restrict
HIV-infected health care workers and lead to discrimination against them
and to make these guidelines consistent with the prevailing scientific
and public health knowledge on the issue.

The Committee agreed that the President should veto the Department of
Defense (DoD) Reauthorization Bill and state that the veto is in part a
result of the inclusion in the Bill of a requirement that service
personnel who test positive for HIV be immediately discharged.
Mr. Edward Gould supported the recommendation because there is no place
for mandatory testing. The Federal agencies included in the
recommendation are the only agencies that now have mandatory testing.

Ms. Carole laFavor mentioned the opposition by the DoD, and Dr. Stephen
Abel noted that currently people who are HIV positive are not allowed
into the military. Those who test positive after joining the military
are supposed to be granted all rights when under care and treatment;
however, Ms. Mary Boland mentioned two friends in the military who were
not legally discharged but were forced out after testing positive.
Mr. Gould reiterated that the Committee recommends that the President
veto the reauthorization bill because it requires service personnel who
test positive for HIV to be immediately discharged.

The Committee discussed the language of the recommendation on
discrimination and mandatory testing. Dr. Abel objected to the word
\"encourage\" in the recommendation that the CDC review its guidelines
because it denoted intention; it was changed to \"leads to
discrimination.\"

The Committee then discussed the degree to which the President can
instruct the CDC to ensure its guidelines are in accordance with sound
public health practices. The leadership should defer to the public
health community on that, Mr. Jeff Levi said. He also cautioned that the
guidelines should be consistent because a precedent of asking the
President of the United States to determine what is sound public health
policy should not be made.

Mr. Gould agreed that the President should state the above-mentioned
reasons for the veto, eliminating the phrase \"highly cynical.\"
Mr. Levi added that background information or an explanation should be
attached to the recommendations; for example, that DoD studies show that
those with HIV are serving well and effectively or a statement that they
should serve.

**Medicare and Medicaid**

The Committee next discussed action regarding Medicare and Medicaid.
Mr. B. Thomas Henderson pointed out that because of the President\'s
December 6 veto, the recommendation for the President to oppose the
proposed changes for Medicare and Medicaid had been accomplished.
Mr. Nicholas Bollman added that the Committee recommend that the
President continue to support and defend entitlement status and funding
for Medicare and Medicaid, to which recommendation Ms. Regina Aragon
suggested adding that the President continue to oppose any efforts to
restrict eligibility or services for persons living with HIV/AIDS. The
Committee should establish a set of principles by which to judge the
President\'s actions, Mr. Bollman said.

The Committee than examined the recommendation regarding State waivers.
Mr. Gould said that the language should read that the President should
direct that waivers sought or granted to States be consistent with or
measured by Health Care Financing Administration (HCFA) criteria.
Mr. Bollman added that these criteria should be consistent with the
provisions of the Americans with Disabilities Act, should be reviewed
for this purpose by the Department of Health and Human Services (HHS)
Office of Civil Rights, and should be continually revised to reflect
state-of-the-art scientific and health care knowledge. HCFA also should
ensure that State Medicaid programs cover anonymous HIV counseling and
testing and that all drugs approved by the Food and Drug Administration
(FDA) for treatment of persons living with HIV/AIDs are covered under
these State plans.

Mr. Henderson suggested that any waivers granted be consistent with
appropriate standards. He said he wanted to ensure that any plan a State
presents is not automatically deemed acceptable. There should be minimum
standards that States must meet to qualify, and he emphasized that the
Committee should ensure that at least minimal standards are in place for
States to obtain a waiver. If the goal is to encourage optimum services,
he said, there must be a minimum beyond which States cannot obtain a
waiver and that ensures the floor is high enough to adequately protect
those with HIV and AIDS.

Dr. Abel pointed out that in the New York City strategic plan a list of
minimum services were designated as core HIV/AIDS services in programs
and development. They include HIV testing and counseling, primary care,
acute care, dental and oral care, pharmacy services, home care, adult
day care, case-management services, nutrition and food services, alcohol
and drug abuse services, and transportation assistance. Mr. Gould said
that in New York many HMO-type plans did not allow for the fact that HIV
tends to be a disease with alternating peaks of good and bad health.

Ms. Boland clarified the language in the provision to say that waivers
granted to States under Medicaid ensure access to a comprehensive
continuum of care for persons living with HIV. Mr. Gould said that at
the minimum these waivers must ensure access to care.

The Committee then discussed the inclusion of \"off label\" drugs and
agreed that HCFA should ensure that all drugs approved by the FDA are
covered under the State plans, even if used for \"off label\"
indications. Mr. Bollman suggested that within the recommendation, the
language should include a comment that this policy will require HCFA\'s
diligent enforcement.

**Alternative Therapies**

The Committee then discussed alternative therapies. Mr. Gould suggested
that the Committee add more specific recommendations or kinds of
alternative therapies at the next Council meeting. Dr. Abel asked the
Committee how it would respond if asked how to investigate thoroughly
the efficacy of alternative treatment. Ms. laFavor specifically
mentioned HIV-related research in Seattle and Minneapolis. In
Minneapolis, the research is in acupuncture and therapeutic massage. She
thought that the Office of Alternative Medicine (OAM) has funded the
research for \$850,000, and she was concerned about what she viewed as
tokenism on the part of Government concerning alternative or holistic
therapies because very little money is going into the research.

The Committee then discussed the language of the recommendation and
agreed to use the words \"review\" instead of \"research\" and
\"complementary\" instead of \"alternative\" therapies. Mr. Gould then
read the revised provision: \"Because complementary therapies are widely
used and show benefit, the President should direct all appropriate
agencies to support the investigation of the efficacy of complementary
treatment therapies and provide increased financial support for this
effort. Therapies shown to have benefit should be included as
FDA-approved and reimbursed under Medicaid. The President should also
direct the NIH Office of Alternative Medicine to review such therapies
and compile and publish a resource directory and guide on alternative
complementary forms of treatment for HIV/AIDs as well as all
life-threatening illnesses.\"

Mr. Henderson asked that the phrase \"all life-threatening illnesses\"
be removed, and the Committee agreed that the recommendations should
specify HIV/AIDS.

**Managed Care**

Ms. Boland expressed concern that providers of medical care and
community-based organizations that need to be included in the
recommendation will be lost in the changes occurring in Medicaid and
private health care.

Mr. Gould noted that the Committee must decide what is important, and
Mr. Henderson suggested that the Committee deal with action items that
can be dealt with in a relatively short time and then look at the
broader issues. Mr. Gould suggested that, if the Committee wants to make
managed care a priority, it must recognize that some other issues will
be shortchanged.

Mr. Bollman then read the preamble to the Managed Care section, and
Mr. Gould listed the issues the Committee would bring forward at the 3
p.m. meeting, such as discrimination, Medicaid, alternative or
complementary therapies, managed care, and housing. Some of the
discrimination recommendations, the housing recommendation, and the
issue of substance abuse would be postponed. The Committee agreed to
include the Bureau of Prisons as another agency that should be directed
by the President to develop national oversight criteria for managed
care.

Mr. Steve Lew said that the original intent of the recommendation on
managed care was twofold: to prepare as much as possible the Ryan White
CARE Act-funded community-based models for adapting to the changes in
managed care and to clarify the objective of Health Resources and
Services Administration (HRSA)-provided education---otherwise, the
recommendation will be confused with the separate category of education
and training. Mr. Bollman responded that, if the recommendation is seen
as concerned only with community-based providers, there will be
competition with other effective care models that are not community
based. He suggested that the wording read \"clinically effective care
models.\"

**Education and Training**

Mr. Gould mentioned the need for public and private sector collaboration
to ensure a knowledgeable work force. Ms. Aragon noted that community
providers are not effectively linked to the communities and that there
are no ties between planning councils or other bodies. She said that
HRSA should ensure that the work of AIDS Education and Training Centers
is coordinated with community providers and planning groups.

**Housing and Substance Abuse**

Ms. Aragon suggested that the President make AIDS housing a priority in
the 1997 budget, including an increase in funding not only for HOPWA but
also for the housing assistance grants, a section within the Housing and
Urban Development Administration (HUD) that deals with HOPWA, and the
McKinney Act. She said that certain issues, such as housing for people
who are substance users or have a history of substance abuse, the
difficulty of providing care, and regulations that have strict
eligibility criteria for housing services, are more complicated and
require further research.

Mr. Lew proposed that the Committee recognize that extra time would be
needed for discussing the issues on housing and substance abuse and
drafting the wording on the budget. Mr. Gould ended the meeting with a
statement that the Committee had determined that substance abuse in
connection with HIV is a significant issue that should be fully
developed and that the Committee was not prepared to make a
recommendation at this time.

**Presidential Advisory Council on HIV/AIDS**

**Breakout Session: Prevention Subcommittee**

December 7, 1995

10:30 a.m. to 2:30 p.m.

Washington Room, Marriott at Metro Center

**MINUTES**

Subcommittee members discussed how best to present its agenda in a
dynamic and positive way and the importance of reminding the President
and the American public that prevention works.

Its working draft report called for reinvigorating the fight against
AIDS and \"getting ahead\" by aiming prevention efforts at the growing
edge of the epidemic and focusing efforts on the most vulnerable
communities. An annual report from the CDC could show where infection is
increasing most rapidly, and that is where prevention efforts should be
targeted.

Mr. Mario Solis, a health information specialist who helped the
Subcommittee prepare its draft report, outlined key recommendations for
a number of areas.

He noted that the Subcommittee had received a number of new
recommendations within the previous 48 hours, including one that HHS
should review all regulations to be certain that they do not restrict
the content of prevention materials, and that the NIH and OAR should
research sexual behavior and sexuality as indicators of high risk for
HIV transmission---specifically, efforts to assess accurately the risk
of oral sex.

Belief that prevention does not work is widespread, Mr. Solis said,
despite evidence indicating that health prevention and promotion work.
Also, we need to ensure that our goals are possible, that we do not have
too many things on the list, and that we will have the desired impact,
Mr. Solis said.

Mr. Anderson said he felt the draft report reflected the Subcommittee\'s
discussion and is a good start. He was concerned, however, that the
draft report did not focus enough on action and lacked a prevention plan
on a national level. \"The Federal government,\" he said, \"does not
have a coherent structured set of goals and objectives for bringing this
epidemic to an end through prevention. I want to see us instruct the
Federal government that they need to have a comprehensive, complete,
working plan on bringing this epidemic to an end; that the efforts are
united, coordinated, and collaborative.\"

Agreeing with Mr. Anderson, Mr. Schatz said he felt the Subcommittee
should set aside time to examine the Administration\'s responses to
specific recommendations, including instances in which the Council
believes those responses have been inadequate.

There was discussion that inclusion of the word \"plan\" in any
recommendation risked involving the Council in bureaucratic inertia. Mr.
Anderson said he remained concerned about the lack of coherence in the
national prevention effort. The Council\'s recommendations should impose
on the various agencies \"the obligation to work collaboratively; the
obligation to think strategically about what they are doing.\"

Ms. Altagracia Perez stressed the need for the Government to make
publicly available such information as the effectiveness of
needle-exchange programs and the recent report on youth, and she
endorsed the need for a \"date certain\" for ending the epidemic through
prevention efforts.

Members then described their own priorities in the area of prevention.

Ms. Debbie Runions indicated that because 75 percent of new infections
are drug related, her priorities are in prevention programs. She also
cited a recommendation for joint efforts by the Secretaries of HHS and
Education to address HIV education and prevention among youth. Such
efforts are measurable and can be done quickly, she said.

Ms. Perez rated taking HIV prevention out of Prevention Performance
Partnership grants as her first priority, followed by the need for
national models for youth prevention programs and a revised model for
State drug paraphernalia laws.

Mr. Landau indicated behavioral surveillance as his top priority,
followed by needle exchange and a recommendation for development of an
AIDS prevention and care plan by the Indian Health Service, which he
said recently fired three of its AIDS coordinators and is not filling
those positions.

Mr. Robinson said measures to reduce transmission related to injection
drug use was his highest priority but that a comprehensive set of
prevention applications \"much larger than needle-exchange\" programs is
needed. His second priority was prevention for people with HIV,
including early prevention and secondary prevention. The third would
look at the Federal structure around prevention, especially as it
relates to community planning.

Mr. Schatz proposed a new recommendation for research to assess
accurately the risk of oral sex and said he wanted surveillance to be
linked with funding. He listed limiting content restrictions as his
third priority.

Mr. Fogel suggested that the group ask the President and appropriate
agencies within HHS to report to the Council by January 1 about what the
Administration is doing in specific areas of research. Needle exchange
obviously \"can dramatically affect the epidemic aspects of the
disease,\" he said. Noting that the national networks still refuse to
accept condom advertisements, he suggested the Subcommittee in the
future consider recommending steps the Administration might undertake,
such as a meeting with the Vice President in which network executives
are encouraged to air condom advertisements that are tasteful, accurate,
and educational.

Ms. Kathleen Gerus said she agreed with Ms. Runions\' priorities of
ending the epidemic among injection drug users and increasing efforts
targeted to youth.

Ms. Denise Stokes called for education and prevention programs targeted
to youth but suggested they be more specific and directed, particularly
in their content. Her second priority was research and models for
minority communities, followed by needle-exchange programs.

Mr. Robinson cited prevention education for youth as his highest
priority and cited a point raised at the White House conference that the
CDC provide technical assistance directly to school boards that are
developing programs. He listed behavioral surveillance and a demographic
and geographic survey as his second and third priorities.

Ms. Stokes again emphasized the need for research on successful models
for encouraging behavior change in minority communities. Ms. Perez
suggested that prevention strategies targeted toward minorities be
specific to the communities being targeted and that information targeted
to youth should be \"explicit and honest.\" Other members suggested
substituting the word \"frank\" or \"comprehensive\" for \"explicit.\"

Because there is no Federal mandate for AIDS education, members
discussed how best to encourage collaboration between the Federal
government and States in school education efforts.

Mr. Anderson said the Federal government\'s primary involvement in
school education is through the CDC\'s Division of Adolescent School
Health (DASH), which provides HIV education and prevention. There are
two model curricula, both of which have been tested and found fairly
effective. Funds are given to departments of education, which are
responsible for providing training and technical assistance to school
boards, school districts, and individual schools on how to provide AIDS
education.

Mr. Robinson said the draft education recommendation was intended to
bring the Secretaries of HHS and Education together. Mr. Fogel suggested
that the CDC needs to provide more information to boards of education
about where the epidemic is occurring and the effectiveness of
prevention measures.

Ms. Stokes recounted difficulties in addressing school boards even when
armed with surveys about teenage sex. Mr. Fogel suggested the group ask
for more information on current programs and then consider asking the
CDC to be more aggressive in its prevention efforts targeted at youth.
Mr. Robinson said that by the March meeting of the Council, there will
be a presentation on current programs. Mr. Schatz suggested that the
group ask Mr. Levi of ONAP to provide the information to the group by
January.

In discussing the group\'s desire to lift the ban on Federal funding for
needle-exchange programs, Mr. Landau pointed out that the conference
committees of Congress can amend anything they want, such as Ryan White,
so the Council should move with caution.

Members agreed that a scientific panel is not necessary to assess the
effectiveness of needle-exchange programs because of the unequivocal
nature of the recent National Academy of Sciences report.

Mr. Anderson stressed the need for needle-exchange programs to be
conducted within the context of substance abuse treatment and other
programs. He said that the recommendation would allow local and State
governments to use Federal funds for needle-exchange programs and that
the Federal government would not mandate such programs. The Government
would need to establish a process to decide how to release funds for
such programs.

Members agreed to ask the President to direct the HHS Secretary to
provide a recommendation within 90 days regarding the efficacy of
needle-exchange programs.

Discussion about the public\'s perception of needle-exchange programs
continued. Ms. Perez said that until the general public realizes that
such programs do not increase drug use, people will continue to oppose
needle-exchange programs.

\"At the very least, I want the Secretary to say that the evidence shows
that this will not increase drug use, and that in fact there is some
validity in it, and we are not going to do it anyway,\" said
Mr. Robinson. \"If that is the bottom line, that is what I want to know,
that is what I want to be able to take back to the community and say we
asked for it, here\'s an answer, here\'s where they are, they know the
evidence, they reviewed it, and they are not going to do it.

\"The Secretary said,\" Mr. Robinson continued, \"when asked about this
after the conference, that there is controversy over the research. It is
not acceptable for the Secretary to continue to put forth that myth;
that is not the science. There is controversy within communities about
whether this is the right thing to do, but to say that there is
controversy in the science is inaccurate,\" he said.

Ms. Perez, citing concerns in the Black community about genocide and the
argument that AIDS was developed intentionally, said that nonetheless,
condoms do prevent transmission. And while communities of color have
legitimate concerns about drug use, she added, and may feel concerned
that the measures will allow people to use drugs, needle-exchange
programs do reduce transmission.

Needle exchange needs to be taken out of a moral context, agreed
Mr. Landau, who suggested that the group preface its recommendation with
language about how such efforts can reduce the epidemic by 50 percent.

Although needle-exchange programs are one of the tools we have for
dealing with AIDS, Mr. Anderson said, they are probably not the most
effective tool. The amendment of State drug paraphernalia laws will
probably have a more extensive impact on the spread of this epidemic
than anything else, he said.

Members agreed to work on the language of the recommendation and
background information.

**Presidential Advisory Council on HIV/AIDS**

**Breakout Session: Research Subcommittee**

December 7, 1995

10:00 a.m. to 2:00 p.m.

Montreal Room, Marriott at Metro Center

**MINUTES**

**Members Present:** Dr. Alexandra M. Levine (Chair), Dr. Jerry Cade,
Ms. Debra Fraser-Howze, Ms. Phyllis Greenberger, Dr. R. Scott Hitt,
Ms. Helen Miramontes, Ms. Sandra Thurman, Dr. Bruce Weniger.

**Presentation on the AIDS Drug Development Task Force**

The meeting of the Research Subcommittee began with introductions by
members of the Presidential Advisory Council on HIV/AIDS and the
following members of the National Task Force on AIDS Drug Development:
Dr. Arthur Ammann, Director of Research, Pediatric AIDS Foundation, and
Ms. Theresa McGovern, Esq., Director of the HIV Law Project in New York
City. Dr. Ammann referred to the document entitled \"The National Task
Force on AIDS Drug Development: A Status Report in Response to the Task
Force Recommendations.\" He said that one recommendation was that the
Task Force concept continue, but not in its current form, which must
operate under Government regulations that require the meetings to be
open to the public and that restrict sharing of confidential
information. If the Task Force were set up as a working group that is a
kind of think tank, information about drugs in the pipeline could be
shared freely among representatives from industry, the AIDS community,
the Federal Government, and research scientists. Such sharing could
result in faster development of AIDS drugs, Dr. Ammann said. The
Research Subcommittee suggested that the proposed working group be
supported by private funds or that the Government be consulted to
identify a specific legal structure to allow it to be free of some
Government restrictions. The President could delegate Vice President
Gore to implement this recommendation (former Vice President Dan
Quayle\'s Competitive Council might serve as a model).

Dr. Ammann also noted that he had made 14 recommendations for drug
development relative to pregnant women and infants. He said that four
drugs to be approved within 6 months will not have safety and
pharmacokinetics (PK) evaluation for infants and pregnant women, thus
precluding them from being used to prevent perinatal transmission.

Dr. Levine read the Task Force\'s draft recommendation on this issue:

**The President must mandate that all federally sponsored drug trials
must enroll women in numbers sufficient for valid interpretation of
results. While the FDA issued guidelines for such access in 1993, there
was no assessment of the impact of these guidelines or actual adherence
to these guidelines. The President should mandate a review of the
current status of women and infants in federally sponsored
antiretroviral therapy trials.**

Ms. McGovern noted that her agenda is to eliminate restrictions on women
with life-threatening disease in early clinical trials and to ensure
that drug side effects in women are studied. She said that she has
developed recommendations that were approved by the Task Force at its
January 1994 meeting, but these recommendations are on hold because of
FDA opposition. She referred to the recommendation B.21 in the Task
Force draft report:

**DHHS must amend its Regulations Governing Human Subject Research which
limits research on fetuses and pregnant women. In particular, DHHS must
eliminate the requirement that the father of the fetus must consent
before a woman may participate in a clinical trial.**

The DHHS Office of Protection from Research Risks (OPRR) has forwarded a
rule consistent with this recommendation to Assistant Secretary for
Health Dr. Philip Lee, and the FDA has drafted a proposed rule
responsive to this recommendation. The Council could make the following
recommendation to the President:

**The President should direct the Secretary, DHHS, to immediately
release the review of the proposed recommendation by the OPRR so it can
be published for comment in the *Federal Register*.**

Ms. McGovern pointed out recommendation A.5.c in the Task Force report:

**The FDA must amend the regulations defining circumstances under which
it is appropriate to issue a clinical hold or terminate an IND to
include instances where a trial sponsor imposes restrictions on the
inclusion of women of childbearing potential in any phase of any
clinical trial for life threatening illnesses where there is no evidence
of reproductive toxicities\....**

A second recommendation to the President will be formulated to ensure
that this recommendation is implemented. (Ms. McGovern will fax further
input to Dr. Levine to allow drafting of this recommendation.)

An additional recommendation might be to ask the President to direct the
NIH Director to evaluate each Institute\'s analyses conducted in
response to FDA\'s 1993 guideline to assess gender differences related
to drug effects. This might be broadened to recommend that the FDA
review the gender analysis of all clinical trials (since FDA guidelines
apply to more than NIH trials). The following two options for wording
were suggested:

**Direct the FDA to mandate side effect profiles of drug effects in
women as part of safety and efficacy reporting**. [OR]{.underline} **The
FDA should ensure that applications for new drugs include data on all
populations likely to use such drugs**.

Other points made during the discussion included the following:

· Ms. Heidi LeShan? of NIH said that NIH research cannot be funded
without a plan for including women and children in studies; if study
sections find that this plan is inadequate, the study is not approved.
She will find out how implementation of the plans are monitored.

· There has never been a lawsuit for harm caused by Phase I studies, so
this should not be a deterrent to industry.

· The Subcommittee questioned why FDA is holding up implementation of
the Task Force recommendations and why pregnant women must obtain the
consent of the fetus\' father to participate in trials.

· Dr. Levine noted that requiring gender analysis might hold up research
while the large numbers of women needed to allow statistical analysis
are recruited. Therefore, the recommendation might state that data on
side effects and toxicity need not be statistically oriented.

Mr. Tim Westmoreland of Georgetown University Law School (who has worked
with the Pediatric AIDS Foundation) reviewed issues related to drugs for
pediatric patients, noting that 75 percent of drugs have no indications
for pediatric use. Although the Foundation does not want to hold adult
drugs hostage, it would like FDA to encourage manufacturers to develop
oral formulations of adult HIV/AIDS drugs and to conduct simultaneous PK
studies of these drugs in adults and children. It was noted that FDA
Director Dr. David Kessler has identified this as a failure at the FDA
level. The Council will press FDA on this issue and request more
information from Dr. Kessler.

Mr. Westmoreland reviewed proposed legislation by Senator Nancy
Kassebaum that would provide an incentive to industry by extending
market exclusivity for 6 months against generic copies of the drug if a
company conducts PK studies. He said that there is no obvious opposition
to the bill; however, it was noted that the health care industry might
object to increased drug costs that might ultimately result from such
legislation.

The following recommendation was proposed:

**The Administration should submit legislation to provide incentives to
develop oral formulations of AIDS drugs for children and PK data. Other
proposed legislation (e.g., involving tax credits) might also achieve
this end.**

Another issue raised was the recommendation involving conflict of
interest disclosure for members of NIH study sections. Dr. Levine said
that this is part of a large document (Name of document? from ACT UP?)
that she will review.

**Discussion of Other Issues**

Dr. Levine then reviewed some of the issues that had been raised
yesterday at the meeting of the Research and Treatment Subcommittee of
the National Conference on AIDS. Some of these issues that the Research
Subcommittee should consider are the following:

· The President should include mention of HIV/AID issues in his speeches
on other topics.

· Presidential scholars in HIV research should be funded by NIH or
through private donations.

· The President should direct DHHS to convene a consensus meeting to
determine how to ensure Phase IV studies of drug combinations after
drugs are licensed. (This might be part of the Vice President\'s role;
Ms. Thurman will develop this point.)

· Ways of recruiting private investment in the drug development process
should be explored. (This also might be part of the Vice President\'s
mandate.)

· A national standard of care should be developed for the off-label use
of drugs as standard of care, because many health maintenance
organizations (HMOs) will not pay for off-label drugs. Feedback will be
sought on the status of FDA guidelines being developed in this area.

· Ways of increasing the number of minority researchers should be
explored. (Ms. Fraser-Howze will develop this point.)

· NIH funding mechanisms should be restructured to allow more creative
research.

Dr. Weniger noted several messages from yesterday\'s meeting: (1)
vaccines/microbicides for prevention are technically possible; (2) such
products are highly cost-effective and justify the money invested in
them; (3) a public/private partnership and international effort will be
needed; Vice President Gore should oversee ways of energizing the
private sector. Ms. Jane Sanville of the Office of National AIDS Policy
said she will write up the notes from yesterday\'s meeting.

Before lunch, Dr. Levine reviewed two of the recommendations in the
draft list \"Important Issues in the Area of AIDS Research with
Recommendations for Presidential Action (the third recommendation is
found on page 2 of these minutes).

**1. The Federal Government must make the development of an
antimicrobial agent against HIV and other sexually transmitted diseases
(STDs) an urgent research priority, with significant expansion and
acceleration of the current federally funded research effort in this
area.**

**2. The President should veto any bill which weakens the budget
authority of the Office of AIDS Research (OAR) at the NIH, or which
fails to set a fixed funding level for AIDS research.**

These recommendations would be revised as necessary later during the
Council\'s meeting. Dr. Weniger suggested adding a recommendation on
behavioral research.

**Panels on Microbicides**

The afternoon session, led by Dr. Phyllis Greenberger, focused on
presentations on the need to support research on microbicides. The first
panel focused on public/private research efforts. To begin, Dr. Penny
Hitchcock, Chief of the STD Branch, National Institute of Allergy and
Infectious Diseases (NIAID), described NIAID\'s three parallel tracks in
basic, applied, and clinical research. The basic science agenda includes
studies of early steps of HIV infection; inactivation of pathogens;
toxicity of spermicides/microbicides; and the ecology of the
reproductive tract. Applied research includes *in vitro* assays of
microbicides, studies in animal models, and studies of microbicide
formulations. Clinical evaluations include Phase I to Phase III studies
(a Phase III study of vaginal film containing nonoxynol-9 \[N-9\] is
being conducted in Cameroon) as well as behavioral research on product
acceptance and compliance. Dr. Hitchcock said that microbicides should
be colorless, odorless, and tasteless so that women at greatest risk,
who are often involved in nonconsensual sex, have control over the
method. The products should also be cheap, safe, and stable. She
mentioned other NIAID studies, including those of antimicrobial peptides
called defensins, which may inactivate various pathogens.

Dr. Sharon Hillyer, an NIAID grantee at the University of Pittsburgh,
noted that microbicide research is in its infancy---condoms and N-9
remain the only methods for preventing STDs in the last 25 years. She
pointed out that heterosexual transmission of STDs occurs within the
vaginal ecosystem and that any microbicide for use in the vagina must
not disrupt or destroy the vaginal epithelium, kill beneficial vaginal
bacteria that produce compounds that inhibit infectious agents (acidic
conditions decrease STDs), or cause overgrowth of harmful organisms such
as yeast or *E. coli*. She noted that a vaginal microbicide should be a
woman-controlled method and that most effective microbobicides will
probably by \"cocktails\" of compounds with different activities.
Dr. Hillyer\'s laboratory is testing three existing products: (1)
chlorhexidine, a nontoxic agent effective against HIV and other STDs *in
vitro*; (2) N-9, which is active against many STDs but somewhat toxic
with repeated use; and (3) benzalkonium chloride, a spermicidal
detergent-like compound active against many STD agents but toxic in the
monkey model. The research is also developing two new products based on
compounds found in a healthy vagina: (1) a lactobacillus suppository
with myeloperoxidase that kills HIV *in vitro* (it will be tested in
high-risk adolescents to determine whether it inhibits HIV transmission)
and (2) a product based on synthetic milk lipids. Dr. Hillyer noted the
limited resources for these studies and the need for a commitment from
leadership to develop these important weapons against heterosexual
transmission of HIV.

Dr. Pam Stratton, an obstetrician-gynecologist in the Contraceptive
Branch of the National Institute of Child Health and Human Development
(NICHD), described studies designed to evaluate spermicidal microbicides
and to understand the effect of these products on the intravaginal
system. Optimal characteristics of such products include activity
against multiple viral targets; suitability for topical, vaginal, or
rectal use; and being nonirritating with regular use. Dr. Stratton also
reviewed the good and bad aspects of N-9, noting as its main drawback
that multiple use (four times daily) is irritating and that daily use of
the N-9 sponge leads to ulcers and vulvitis, which may increase the risk
of HIV infection. She stressed that new products must be compatible with
condoms.

Ms. Anne-Marie Corner, President and CEO of Biosyn, a small
biotechnology company concerned with AIDS and female health, described
studies of the Prevecon suppository, a vaginal microbicide now in a
Phase I trial in 20 women. This product is a synthetic organic molecule
active against HIV and other STDs. Prevecon is spermicidal, active at pH
4 to 7.5, and will be available in several other formulations. The
Investigational New Drug (IND) application was submitted in 1994, Phase
II/III trials are planned for 1997, and the product is expected to be
ready in 2000. NICHD has funded preclinical and Phase I trials, and the
product has been tested in a NIAID program project grant for studies of
STD prevention in animal models. The World Health Organization is
expected to collaborate in the Phase III trial. Ms. Corner\'s
recommendations for expediting the availability of microbicides include
the following: (1) change product liability laws; (2) have a
Presidential directive for increasing microbicide awareness; (3) have
equal emphasis on contraceptive microbicides and HIV microbicides (to
address the needs of different groups); (4) increase research support
for the clinical development of products, and (5) speed up the Request
for Proposal (RFP) process. In response to questions, Ms. Corner noted
that about one-half of the women in the Phase I trial are members of
minority groups; that all women in this trial are compensated for their
time and child care expenses; and that the women are required to have
had tubal ligation and be monogamous and free of STDs.

The second panel on microbicides consisted of Dr. Malcolm Potts of the
University of California, Berkeley; Dr. Zena Stein affiliation?; and
Dr. Lori Heise of the Center for Women\'s Global Leadership at Rutgers
University. Speaking from the perspective of his 30 years of work with
contraceptives, Dr. Potts noted that microbicides are a low-tech
solution not currently attractive to industry. He said that FDA must
speed up the development of these preventive agents and that NIH must
support the development of cheap and simple products by giving contracts
to small, low-tech companies. The NIH should assemble a panel that would
decide the requirements for products, which must kill virus *in vitro*,
not harm the vagina, and slow the spread of HIV (the latter is harder to
prove).

The need for a consensus conference to resolve practical and ethical
issues was raised. Participants disagreed about whether microbicides
should be promoted at this time or whether more research is needed. (N-9
is currently the only FDA-approved product.) Ms. Patricia Fleming noted
that if people think a product will protect them, their risk of
acquiring HIV infection might increase. Dr. Hitchcock added that *in
vitro* data are not applicable to humans and that more research is
needed before microbicides can be promoted; she believed that women
should be given information on STD prevention. On the other hand,
Dr. Potts countered that microbicides are better than nothing for
high-risk women, such as sex workers or women who use crack. It was
noted that a trial using the N-9 sponge in African women was not a
success but that the study was uncontrolled and used a dose four times
higher than normal.

Dr. Stein\'s handout discussed the need for research on the
acceptability and effectiveness of various barrier methods, including
the female condom, diaphragm plus N-9, and cervical cap. She noted the
need for methods that are woman controlled and compatible with
conception, and she called for research on the role of the cervix and
the phase of the menstrual cycle in HIV transmission and the role of
sperm as vectors. She stated that the female condom is safe and reusable
and allows women to use it without the knowledge of their partners.
However, Dr. Hitchcock noted the lack of data on this product (Dr. Stein
noted that there have been no studies of the male condom). Dr. Stein
suggested that the President appoint a blue-ribbon panel to develop
short-term recommendations and immediate steps to protect women using
existing barrier products.

Dr. Heise summarized her written testimony, which stressed the need to
increase funds for research to develop female-controlled methods of
HIV/STD prevention, especially vaginal microbicides. She called for
studies of multiple products, because many will \"drop out\" as testing
proceeds, and for multicenter trials, with Phase III trials in
developing countries. She noted that only \$15 million of the FY 1995
PHS \$2.7 million budget for HIV prevention and care is devoted to
female-controlled methods. Her recommendations included the following:

· Resources should be shifted to increase investment in studies of
heterosexual transmission and vaginal physiology.

· The President should direct agencies to develop a network of clinical
trial sites.

· The Government should test available methods as well as other methods,
such as Germany\'s cervical cap and the N-9 contraceptive film being
used in Cameroon.

· The OAR should sponsor a consensus conference to develop guidance for
street-level prevention workers on how to counsel women using existing
products such as N-9. The Government should consider promoting a
hierarchial prevention message that takes into consideration that some
method is better than no method.

During the discussion of microbicides, the following points were made:

· Approximately \$11.8 million is spent on microbicide research at
NIAID. About 50 percent of STD research comes from AIDS funds. The
Women\'s Interagency HIV Study (WIHS) involves a cohort of 3,000 women.

· Two types of microbicides must be developed: those that are
spermicidal and those that are not (women must have the choice of
getting pregnant without risk of infection).

· A public information campaign is needed to inform the public about
microbicides. The scientific community also should be made aware that
microbicides are not marginal products. Greater knowledge about
microbicides would lead to increased private investment.

· An infrastructure is needed for testing microbicides. The
infrastructure of the HIV Vaccine Efficacy Trials Network (HIVNET) could
be used.

· The leaders who control the Federal funds (e.g., the Directors of the
NIH, OAR, CDC) should be targeted.

· The NIH lacks the staff to oversee contracts.

Before the meeting ended, Mr. Jeff Blum of the Patients\' Coalition
(which includes representatives of people with AIDS, cancer, epilepsy
and other serious illnesses) presented a handout listing the
Coalition\'s Principles of FDA Reform: The Patients\' Perspective. He
asked meeting participants to endorse these principles by signing and
returning the form on the first page of the handout. The Coalition\'s
principles include support for special FDA treatment of drugs for
serious and life-threatening diseases; pre-approval access to
experimental drugs that show reasonable safety and efficacy;
post-marketing approval of such drugs; validation of third-party
reimbursement of off-label uses of drugs; FDA regulatory flexibility;
FDA requirement of data for all populations likely to use new drugs; FDA
responsiveness to public concerns; communication between FDA and
industry; and incentives to encourage research.