Presidential Advisory Council on HIV/AIDS

Twenty-first Meeting

January 30-31, 2003

Hubert H. Humphrey Building

Washington, DC

# Minutes

*Members Present:*

Thomas A. Coburn, M.D., Co-Chair

Louis W. Sullivan, M.D., Co-Chair

Rosa M. Biaggi, M.P.H., M.P.A.

Jacqueline Clements

James P. Driscoll, Ph.D.

Mildred Freeman

David Greer

Cheryl-Anne Hall

Janice Hu, Ph.D.

Karen Ivantic-Doucette, M.S.N., F.N.P., ACRN

Joseph Jennings

Rashida Jolley

Caya B. Lewis, M.P.H.

Abner Mason

Sandra S. McDonald

Joe S. McIlhaney, M.D.

Hank McKinnell, Ph.D.

Brent Tucker Minor

Dandrick Moton

Nathan M. Nickerson, R.N., M.S.N.

John A. Perez

David Reznik, D.D.S., M.S.

Debbie Rock

Rev. Edwin Sanders II

Prem Sharma, D.D.S., M.S.

Anita Smith

Don Sneed

M. Monica Sweeney, M.D., M.P.H.

*Members Not Present:*

Ingrid M. Duran

Mary Fisher

Vera Franklin

John F. Galbraith

Katryna Gholston

Lisa Mai Shoemaker

# 

# Thursday, January 30, 2003

# Morning Session

## Opening Remarks

Co-Chair, Dr. Louis Sullivan welcomed all Council members and
representatives of the press to the meeting. He noted that he would be
leaving the session for 3 hours to participate in a March of Dimes
event, but that his co-chair would preside during that time.

Co-Chair, Dr. Tom Coburn welcomed past and new Council members and
forecast an active Council meeting. He expressed hope that this Council
would accomplish what has not been accomplished to date.

Dr. Joseph O'Neil, Director of the White House Office on National AIDS
Policy (ONAP), greeted the Council for the first time in this capacity.
He said that he wanted to put the Council's work in context and help
members realize that they are advising the Administration at a historic
time in the HIV/AIDS epidemic. President Bush takes the Council's work
very seriously, he continued, and has expressed the desire to meet with
members tomorrow to voice this commitment. The Council will be present
also at the President's address to a larger group concerning AIDS here
and abroad. Although some see the State of the Union endorsement for
AIDS funding as amazing, Dr. O'Neil stated that the President's remarks
were wonderful but not surprising, and consistent with the
Administration's attitude.

The Council's job is several-fold. The Government needs to be kept
honest, and the Council can accomplish this task as it is best done: in
the spirit of good will. Members must be visionary, must keep their eyes
on the forest but see the horizon. Members need to ask the important
questions: Why are infections not decreasing? Why are people still
waiting for medications? This is a truly historic time in the epidemic,
and the Administration is passionately seeking new answers.

Ms. Rock applauded the commitment to global AIDS funding but questioned
delays in funding of domestic programs, specifically, the Omnibus Bill
and Health Resources and Services Administration (HRSA) funds for client
services. Dr. O'Neil acknowledged that funding is only a piece of what
is essentially a political matter. The Council will not be doing its job
if it says only "more money"; everyone needs to be accountable. Dr.
Coburn added that this year there are 19,900 matters and \$280 billion
worth of "pork" to help members of Congress and having nothing to do
with health, included in the Omnibus Bill. The cynical view, he said, is
to see this as "members acting like politicians instead of like
statesmen."

## Remarks: Claude A. Allen, Deputy Secretary of Health and Human Services

Dr. Allen welcomed the Council to the Department of Health and Human
Services (HHS) on behalf of Secretary Tommy Thompson and the Department.
He thanked members for their roles in fighting against HIV/AIDS and paid
special tribute to the co-chairs and to Pat Ware, Executive Director of
the Council. He stated that he is honored to fulfill the charge he has
been given by the President and the Secretary to pay close attention to
this issue, which has critical personal significance for him as the
father, brother, and uncle of African American women, the population
group with the fastest growing rate of new infections.

Dr. Allen proceeded with a brief update on the Department's activities
since the last Council meeting. Making sure that people know their HIV
status is critical. To help in this part of the battle, Secretary
Thompson has approved use of the rapid HIV diagnostic test kit, which
gives results with close to 99.6 percent accuracy in 20 minutes. With
the short time needed for results, clients can seek counseling and
treatment immediately.

The President has led the fight to double the research budget at the
National Institutes of Health (NIH), and the Administration is focused
on the issue of health disparities among minority populations here in
the United States. The President plans to double the capacity of the
Community and Migrant Health Centers, which provide HIV/AIDS care to the
poorest and most vulnerable populations. The current network of 3,300
sites serving 11 million low-income clients will expand by 260 new and
improved centers serving an additional 1.25 million persons. A 5-year
initiative to expand access to health services for rural and inner-city
areas will ultimately fund 1,200 sites serving 22 million people each
year.

Dr. Allen reflected on the 20-year fight against HIV/AIDS at the
Department and observed that HHS officials need to step back and take a
look at where they are and where they need to go to end this disease. If
the Department were a country, with its more than 300 programs and a
\$450 billion budget, it would rank as the sixth largest in the world.
In order to deal with the magnitude of the situation, the Secretary has
put together an HIV/AIDS Management Coordination Team, comprised of
senior officials from all agencies that deal with HIV/AIDS. The team's
purpose is to ensure that resources are being spent wisely and grants
are being used to fight the disease and not to support bureaucracy; it
does not have an audit function.

The Deputy Secretary reviewed the specific provisions for HIV/AIDS made
in the State of the Union address and marveled at the amount of time
given to the issue. (Details of the President's plan appear in Dr.
Allen's written remarks, which were made available to Council members.)

Dr. Allen described his own journeys to Africa and the "shining example"
he found in Uganda, where the spread of HIV is dropping and coming under
control, thanks largely to the tireless efforts of the First Lady of
Uganda and her message to youth of ABC. Abstinence until marriage is the
best policy for youth, Being faithful in a mutually monogamous
relationship is key, and Condoms, used consistently and correctly, can
reduce the risk of HIV/AIDS for those who engage in risky behavior.
Uganda is the only nation in Africa with a growing rate of life
expectancy.

Dr. Allen urged Council members and all others in the United States who
labor in the HIV/AIDS field to keep Uganda and its success in mind.
International programs must always respect the cultures and traditions
of other countries and not just provide the "American" solution, which
has not even been very successful here. At the same time, much can be
learned from other nations. HIV/AIDS is a tough issue, the speaker
concluded, and the Department appreciates the courage of Council members
who have chosen to participate in finding solutions and developing ideas
to deal with it.

Dr. Sweeney questioned why this country has no way for best practices to
receive national exposure and implementation. She gave as an example the
success of New York State in reducing vertical transmission of HIV. Dr.
Allen cited three possible explanations. First, certain system problems
have existed in the Department, which basically is many systems (HRSA,
NIH, etc.) that rarely communicate with each other. These barriers are
being torn down, he stated, and agencies are being forced to talk across
their boundaries. A demonstration program will model the process.
Second, a national forum has not been provided to show how best
practices can be replicated and translated into application. Third,
agencies with best practices often have not kept track records of how
they conceived and developed their best practices, which would be
extremely helpful. Dr. O'Neil added that some States are taking
unorthodox means to get the word out on their successes; Dr. Antonia
Novello, who will speak on Friday, will discuss the situation in her
State of New York.

Dr. McIlhaney asked if data are available on how Uganda is accomplishing
its success and how this approach can be replicated. Dr. Allen
remembered seeing posters in Ethiopia that mentioned condoms but also
conveyed the ABC message. In Uganda, the effort decreased the number of
partners and increased the age of sexual debut for girls. We must be
willing to take these steps, he stated.

Dr. Sharma queried how U.S. interests can be sure that money is not
misused, in faith-based projects, for example. In Africa, Dr. Allen
said, the Department is working with the U.S. Agency for International
Development (USAID) to ensure respect and level the playing field.
Smaller faith-based players will be involved through the Compassionate
Capital Fund, which will be extended internationally.

## Update of PACHA Activities

*International Conference on HIV/AIDS---Barcelona, Spain*

Dr. Driscoll reported that the HIV/AIDS community seems to be moving
toward reconciliation since the protests in Barcelona. Rapid testing has
been a major success; in talking with Secretary Thompson and Deputy
Secretary Allen, he found that the consensus is that people came
together. Regarding the issue of treatment versus prevention, people are
moving beyond conflict here and realizing that the two are symbiotic:
one cannot be addressed without addressing the other. Pilot programs in
resource-poor countries *are* possible and feasible, and the best
intelligence and resources need to be applied to the job. Generics are
more available, and not-for-profits are working. An annual cost of \$300
per person for HIV treatment is becoming possible.

Ms. Ivantic-Doucette commented that she sensed a divisive advocacy in
the beginning in Barcelona, rather than a feeling of unity. During the
International Committee's meeting with Secretary Thompson, he was
incredibly compassionate in "owning" U.S. leadership in the effort. He
was going to outline steps for U.S. participation before he was booed
off stage. Her perception is that there is a fundamental tiredness in
the HIV/AIDS community that has been working at this for so long; its
members need to be reenergized.

Dr. McKinnell agreed that there is a basic fatigue in the activist
community, but international and Government participants now "get it."
Fifty percent of patients on antiretroviral therapy (ART) now will
exhaust their options in 5 years, and new compounds will be needed. If
virus loads are suppressed to zero, it could take 70 years to eradicate
HIV. This is a tricky situation.

With regard to the multisectoral "getting it," Ms. Ivantic-Doucette
counseled that it may be wise to start thinking along the lines of ABCD,
with D for Development. All the poverties that drive the epidemic need
to be looked at: economic, access, mental health, and others.

Mr. Mason noted "lots of support" for the Global Fund, which is "the
group that will make the difference." The Fund had expected more money
from President Bush.

*United States Conference on AIDS (USCA)*

Mr. Sneed found USCA helpful, especially as a means for new staff to
learn skills and gain exposure. Affinity groups profited as well. Noting
the booing of people who disagreed with each other, he advocated
maintaining respect in sorting out differences.

Ms. McDonald, a charter member of the National Minority AIDS Council
(NMAC), said she has attended many USCA gatherings and always comes away
with the experience of seeing "little bitty people doing *huge* things."

*New Members of Presidential Advisory Council on HIV/AIDS*

Ms. Ware asked the seven newly sworn members of the Council to introduce
themselves. Rosa Biaggi, Jacqueline Clements, David Greer, Janice Hu,
Brent Minor, David Reznik, and Don Sneed reviewed their backgrounds and
current experiences as members of the HIV/AIDS community.

## Discussion of PACHA's Vision and Goals

Dr. Coburn began the discussion by characterizing the Council's vision
as being so successful that it is not needed. Its goal is to limit and
destroy this disease. A subgoal is to leave politics outside. Dr. Coburn
has been very pleased with his meetings with President Bush and senior
staff at CDC and other agencies. Nevertheless, the bureaucracy has to
"crank it out," and doctors and other professionals do not want the
rapid test. In China, a 10-minute urine test is 99 percent accurate; in
Africa (Benin), a staged rapid test is 100 percent accurate. Neither
test is allowed in the United States.

Dr. Coburn affirmed that the Council's job is to advise Secretary
Thompson. He expressed his extreme pleasure in Dr. O'Neil, who took a 50
percent pay cut to take the position of ONAP Director, and advised
Council members that only he and Co-Chair Sullivan speak for the
Council. If individual members are questioned by the press, they speak
only for themselves and must stress that point.

Mr. Minor responded to Dr. Coburn's request for suggestions on how to
approach the issues with the view that the Council should be the eyes
and ears of the Administration in helping to address today's issues in a
more effective manner. When the Ryan White CARE Act was funded in 1990,
a different group of patients was being treated. Our delivery systems
and funding mechanisms need to be adjusted to meet current needs. We
need to evolve with the epidemic, be more nimble in delivering services,
and listen "outside the Beltway."

Mr. Sneed called for a serious look at how medications are being
prescribed for AIDS patients. The AIDS Drug Assistance Program (ADAP) is
basically bankrupt, he said, because of overuse. All patients don't need
highly active antiretroviral treatment (HAART) or all the other drugs
that doctors keep changing them to. Dr. Coburn suggested that Mr. Sneed
might want to change from the Prevention Committee to the Care and
Treatment Committee.

Ms. Freeman proposed endorsing the ABC program used in Uganda. Dr.
Coburn replied: "I teach abstinence" and went on to state that CDC will
be releasing some horrible data on the prevalence of HIV/AIDS in this
country. His own personal experience includes delivering 290 babies last
year, 270 of them to indigent patients, one of whom was an 11-year-old
girl. These mothers basically had no knowledge, no praise, no
self-worth, and no alternative.

Dr. McKinnell suggested four categories of Council activity: (1) set a
goal (e.g., an AIDS-free generation by 2020); (2) prevention (bring on
the fight, and make a recommendation); (3) treatment (specifically, the
crisis in funding); and (4) research (the ultimate answer is technology,
but the Food and Drug Administration \[FDA\] won't allow the research to
get the answers).

Dr. Driscoll urged going where consensus exists but nothing is being
done (e.g., rapid testing, delay of sexual debut, or limiting partners
and teaching monogamy).

Dr. Sweeney asked members to consider a few matters. HIV/AIDS is
surrounded by complacency; people think they can take a pill and they'll
be all right. Why aren't successful models being replicated? Examples
include testing in prisons and lessons from abroad, such as the
10-minute urine test. Spending 90 percent of time and effort on
treatment and 10 percent on prevention doesn't make sense. Everyone
talks about a vaccine, but consider the records for other vaccines. Only
20 percent of at-risk teens have received the hepatitis-B vaccine, and
influenza vaccine has a dismal pattern of use. People won't come to get
a vaccine.

Rev. Sanders offered two points. First, he is always amazed that the
HIV/AIDS community doesn't go beyond the biomedical into the
socioeconomic issues that influence and are the backdrop for HIV and
AIDS. It has been found that the people who don't take their HIV/AIDS
medications don't take any other prescribed medications either. Problems
would still exist even if all the medications that are needed were
available. Second, the Council wants to follow the position of being
faithful to what the scientists tell us about this disease, and not take
a political position.

Discussion moved to future meetings of the Council. Dr. Coburn reported
that the Council operates on a limited budget of about \$400,000,
including staff expenses. The next meeting should be protracted;
Committees could go away and then come back together. He prefers weekend
meetings, so that he doesn't have to leave his practice. Dr. Sweeney
spoke to the Council's losing momentum when members stay apart too long.
Ms. McDonald asked about requesting more money, and Dr. Coburn said that
he had asked repeatedly for an accounting of how the money in the
Council budget is spent, but no one will give him that accounting.

Dr. McIlhaney urged the Council to think in terms of advocating, to
*not* accept the current situation and to look everywhere to see how it
can be changed, to follow it to death and *do it*. Dr. Coburn added that
if contact tracing and partner notification are not instituted in the
U.S. public health system, the problem of HIV/AIDS will never be solved.
He implored members to "do everything we know how to do"---with
courageous leadership based on love, and reported being moved to tears
by President Bush's description of how initiatives will have an impact
on real lives.

# Afternoon Session

## Public Comments and Council Response

Before hearing from the seven representatives of the public, Ms. Ware
asked Council members to be sure to enter the names of any other
organizations they may have joined on form 450 and to complete the
foreign activities questionnaire as well.

Dr. Sullivan welcomed members of the public and invited speakers to
begin.

## Jackie Walker, ACLU Prison Project

Ms. Walker found it encouraging to see an ex-offender, Mr. Sneed, on the
Council. She noted that 17 percent of people with AIDS go through the
prison system and that 2 percent of all the people in prison have HIV.
The annual report on hepatitis-C, HIV/AIDS, and the prison system is now
available at the Web site of the National Criminal Justice Reference
Service: \<www.ncjrs.org\>. Regarding testing, 20 States do mandatory
testing, 3 States do voluntary testing, and the Federal prisons test
only on release. Ms. Walker offered her view that education and
prevention are more important than testing. She stated that she is
available to the Council as a resource on HIV/AIDS, tuberculosis, and
the prison system.

Mr. Sneed asked Ms. Walker if she thinks mandatory testing 6 months out
of prison is a good idea. She replied that she doesn't think such
testing is necessarily a good use of resources. A more worthy expense
would be the video produced by a California group that addresses women
partnering with men coming out of prison and provides honest talk about
what they did in prison.

Dr. Sweeney asked if any State has developed an effective model for
quarantining prisoners until their HIV status is known. Ms. Walker said
that this kind of reporting is not done, so that she doesn't know.
Alabama has entry and exit testing and segregates HIV-positive
prisoners, but 48 States have abandoned the practice. New York has a
great system, as do Louisiana and California, but this type of research
is not done.

## David Oxley, Orasure Technologies

Mr. Oxley spoke briefly, expressing his small-business firm's
appreciation for the Council's efforts in behalf of rapid testing.
Orasure has submitted its CLIA waiver to the FDA and awaits a positive
response.

## Gene Copello, Florida AIDS Action

Dr. Copello spoke as a member of the Steering Committee of the Southern
AIDS Coalition. He provided Council members with copies of the November
2002 draft *Southern States Manifesto on HIV/AIDS and STDs in the South:
A Call to Action*, a document that led to two regional conferences and
to the formation of the Coalition. He summarized the key points of the
*Manifesto*:

-   The changing face of HIV/AIDS as an epidemic that is increasingly
    rural, female, African American, and heterosexual is strongly
    affecting the South, which has the largest proportion of persons
    living with AIDS when compared with other geographic regions of the
    United States.

-   The health care infrastructure in the South is inadequate to support
    HIV/AIDS prevention and care programs. Growing waiting lists for
    ADAP programs across the region complicate the situation.

-   Evidence shows that people living with AIDS often return to their
    southern hometowns for family support, but much of the Federal
    funding is distributed based on where they were diagnosed. This has
    a tremendous impact on communities already lacking access to basic
    health care.

The *Manifesto* recommends that current Federal funding streams and
appropriations levels for HIV/AIDS and STD programs be increased and
that Federal resources be distributed in such a manner as to ensure all
at-risk individuals in the South---and across the Nation---access to at
least minimal prevention, diagnosis, and treatment services.

Considerable discussion followed Dr. Copello's presentation. Rev.
Sanders noted that the points made in the *Southern Manifesto* have been
seen over and over, but reallocation or restructuring to make resources
follow the epidemic has not happened. Institutional forces have been
built around this epidemic that don't make the best use of resources.
Dr. Coburn stated that the last Ryan White legislation provides funding
based on prevalence, but that CDC did not trace the epidemic. Where the
infection is going is important, not where it has been. The resource
problem is true in the South because of low income and long history, but
Uganda addressed the problem through leadership, even without
infrastructure and without resources. Rev. Sanders added that perhaps a
nontraditional infrastructure can be used if a traditional one is not
available.

Dr. Coburn revealed that CDC does blind testing, unethically, without
telling the infected patients they are infected, similar to the
notorious Tuskegee syphilis tests. As of last month, he stated, two
blind tests were still running. CDC has historically traced this
epidemic through blind tests, random blood tests. When he was a Member
of Congress and Chair of the Health Committee 2 years ago, Dr. Coburn
put a halt to blind tests on newborns, but two other blind tests
continue.

Dr. McKinnell stated that this matter should go to the Secretary
immediately as a serious ethical problem. Dr. Sullivan suggested a
request to the Secretary about what response has been made to the
*Southern Manifesto* and what plans exist for the future. Dr. Sullivan
then summarized the issues of CDC testing and notification and declared
that the Council needs some resolution on this: the Council needs to
have a CDC representative come before the Council to present its
justification for these practices, ideally at its next meeting.

Thena Durham, Deputy Director of CDC's National Center for HIV, STD, and
TB Prevention, spoke from the audience. HIV/AIDS is different, she
stated; this is a State-based surveillance issue. Blinded testing is an
epidemiological tactic developed where no treatment is available. CDC
does not collect identifiers for any testing; all its information is
blinded. The most recent example is West Nile virus, which indicates
only palliative care. Ms. Durham offered to relay the Council's concern
to Dr. Jaffe at CDC.

Dr. Sullivan expressed his appreciation but stated that the Council
would like to have Dr. Jaffe or Dr. Gerberding appear before the Council
to explain their reasons for blinding. Dr. McKinnell noted that this
really gets to the politics of HIV; if we were doing random screening of
brains and one had a brain tumor, he said, I would want to find that
person. Dr. Coburn added that infected individuals can be identified
without jeopardizing their families; the real reason CDC is doing this
is because they don't have good numbers. Ms. Ivantic-Doucette
contributed her experience as a provider for 450 patients. Many of these
women continue risky behavior without telling their partners, and
sometimes she needs blind tests to see what is happening in her client
base. It is the patient's right to inform the partner, she stated.

Dr. Sullivan urged Council members to reserve this discussion until they
hear from CDC. He also cautioned that the Council's concern should be
couched in terms suggesting that CDC procedures "would *appear* to be
unethical." Ms. Lewis added that members should always consider ethical
issues regarding testing as they deliberate. Mr. Nickerson put in a last
word as a local health provider. "HIV exceptionalism" has pertained to
other diseases as well, he said, and blind surveillance can be the key
to seeing where pockets of disease exist.

Dr. Coburn ended the discussion with his view that "once you have a
treatment, you *cannot* do blind testing."

## Michael Harris, MF Harris Research

Mr. Harris, president of a small biotech start-up company, presented his
research on the Dark Horse Project, a study of immune response using air
and mixed gases under hyperbaric conditions. He stated that his findings
warrant further investigation of the method in relation to HIV and AIDS.

## Ann Pozen, National Association for Victims of Transfusion-Acquired AIDS

Dr. Pozen addressed the absence of any financial relief for victims of
transfusion-acquired AIDS, while the Ricky Ray Hemophilia Relief Fund of
1998 has provided one-time payments of \$100,000 to hemophiliacs who
have contracted AIDS or their families. A bill supporting Dr. Pozen's
concern was introduced in the House and Senate during the 107^th^
Congress, and she would like it reintroduced and passed.

Dr. Sullivan asked how many transfusion-infected individuals this
involves. Dr. Pozen replied that no surveillance was done on this
patient group, but a math model prepared by CDC estimates that about
12,000 persons were infected between 1981 and 1985. Most of them have
died or their heirs are not eligible, but those eligible under the Steve
Grissom Act would be compensated at \$100,000 per infection for medical
bills and lost income of both the infected patient and the breadwinner
who had to take care of the patient. The final cost of the Ricky Ray
Fund was \$750 million, which might be comparable to the cost of the
proposed compensation.

## Bill Arnold, ADAP Working Group

Mr. Arnold testified that the greatest weakness in the AIDS treatment
situation is access to ADAPs. If ADAPs are not funded, this
last-resource source will be lost. Drug companies represent the only
additional resource, but the paperwork involved can be prohibitive. The
speaker pleaded with the Council to consider the plight of the 7,000 or
8,000 individuals who need this funding.

Ms. Ivantic-Doucette noted the formulary limitations in some States as a
problem, but asked what ADAP has done regarding nonmedical issues. Mr.
Arnold replied that every ADAP is reviewing its procedures with its
board, medical officers, and other relevant entities. Prescription
issues exist within the medical community, and formularies depend on
funding and budgets, particularly State budgets.

Dr. Driscoll reported that at the Fair Pricing Coalition Act meeting,
some drug companies had taken price cuts back by lowering the rebates
they had offered to ADAP in New York. Drug companies had been asked to
freeze prices to all public payers, but then the Consumer Price Index
(CPI) kicks in and there is little net advantage. The CPI will adjust
the rebate advantage in New York and Texas.

Dr. Coburn stated that he manages but does not treat HIV patients
because of the strict protocols now in effect. Money can be wasted if
doctors don't know what they're doing. Dr. Sweeney commented on the
strict protocols on treating with cocktails and that a provider needs a
certain volume of patients before being eligible for consideration as an
"expert." Experts can be nurse practitioners, physician assistants, and
other non-M.D. providers. When protocols are followed and experts
provide treatment, much better results are accomplished.

Mr. Sneed noted that patients are often put on drugs that they do not
understand or know how to adhere to. Pharmaceutical firms spend a
fortune trying to get doctors to put patients on their brands, and
patients need to educate themselves to be able to turn down medications.
The structural problems of ADAP also need to be studied.

## Father Edward Phillips, Diocese of Nairobi

Father Phillips sought to share some key points from his experiences in
Africa. First, AIDS is destroying the entire family system in Africa.
Second, in the English-speaking countries, health care for AIDS is
provided primarily by faith-based organizations (FBOs), but these groups
are not invited to the government table. In Kenya, FBOs provide 71
percent of such health care; in Nigeria, 60 percent; and in South
Africa, 64 percent. Third, the family system and good governance
constitute the basics of success in the AIDS war. Mother-to-child
transmission must be prevented, and antiretroviral therapy must be
provided for mother, child, husband, friend, every element of the family
system. Then good governance must ensure that funds for ART are going to
that purpose and not out of the country through corruption into Swiss
banking systems.

## Report on Visit of CSIS Task Force on HIV/AIDS to China, January 13-17, 2003

Dr. Sullivan introduced fellow members of the Center for Strategic and
International Studies (CSIS) who participated in a visit to China to
meet with senior health officials. These officials have are about where
U.S. health officials were in the early 1990s regarding HIV/AIDS. Former
U.S. Ambassador to China J. Stapleton Roy and Dr. Sullivan led the
delegation to Beijing. Dr. Bates Gill, the CSIS Freeman Chair in China
Studies, and Dr. J. Stephen Morrison, Executive Director of the CSIS
Task Force on HIV/AIDS and Director of the CSIS Africa Program,
organized the group's work with the Chinese Ministry of Health.

**Ambassador Roy** acknowledged that his participation in the delegation
was based on his China connection rather than on any technological
expertise. The Chinese are aware of their limitations in this area of
public health, and the Minister of Health not only spent several hours
with the group but also accepted Senator Bill Frist's (R-TN) invitation
to come back to the United States to study nongovernmental organizations
(NGOs) and other approaches to dealing with HIV/AIDS. China had no NGOs
in 1995 but is now forming such groups.

China is at risk of a generalized HIV/AIDS epidemic that could mirror
the situation in sub-Saharan Africa. By 2010 the virus could infect
between 10 and 20 million Chinese. Because the blood supply all across
China is contaminated, HIV could spread to 1.3 billion people. The
United States has strong humanitarian and national security interests
for keeping the situation in China from reaching catastrophic levels.
Chinese officials have taken moves to confront the looming catastrophe
that they are not equipped to handle, and U.S. officials plan to advise
them on how public-private partnerships and other mechanisms can be
utilized.

**Dr. Morrison** specified the threat in China as an HIV breakout from
affected clusters to the general population. China and India comprise
the front line of suppressing a major HIV/AIDS breakout globally. Action
must be taken to preempt this potential crisis.

The speaker sounded a few cautionary notes regarding China's ability to
act in its own behalf in the face of a generalized HIV/AIDS epidemic.

-   Insufficient political will and financial commitment to deal with it
    are found at senior and provincial levels.

-   The country lacks public health care capacity. China has only 50 to
    100 doctors trained in HIV.

-   Poor baseline data and assessment capacity are found. Probably 1 to
    1.5 million infections exist, but only 30,000 have been diagnosed.

-   Lack of awareness is critical; only 55 percent of the population
    know about HIV.

-   Bureaucratic and political obstacles exist; little communication is
    seen between bureaus and offices.

-   The national budgetary commitment is \$62 million annually.

**Dr. Gill** enumerated several issue areas that the United States can
bring forward and that he hopes the Council will support:

-   The importance of senior-level contact and leadership dialogue
    between China and the United States (Chinese Government levels above
    the Ministry of Health have difficulty committing);

-   Funding and expansion of technical assistance on the ground in China
    by agencies such as NIH, CDC, USAID, and the Department of Labor
    (training, planning, and budgeting are needed for the rural
    populations most affected in China; 120 million "floating
    population" are cut off from systems);

-   Assistance to China regarding a trans-bureaucratic coordinating
    mechanism (the Global AIDS Fund turned down such a proposal this
    week); and

-   Increased diplomatic energy directed toward relations with China in
    order to assist the country more effectively.

Finally, the United States should be at least doubling its current \$5
million financial commitment to China.

In response to questions from Council members, Dr. Sullivan and his
associates further described the situation in China. Fully 80 percent of
the population in China is in rural areas rather than in cities, which
presents a very different scenario than in the United States. The lack
of infrastructure is thus critical. The HIV-infected population is
mostly male, 70 percent are injection drug users (IDUs), and the fastest
growing mode of infection is heterosexual contact. China's statistical
base is woefully inadequate in this matter. No national blood-testing
program exists, and stigmas are the same as experienced in the United
States. The United States has a strong health system. China's is flimsy
at best, and its infrastructure is comparable to that of Africa. Health
professionals in this country have developed incredible experience in
the past 10 years. China is right at the point where an epidemic could
be stopped if intervention is implemented, but if the top levels don't
respond, a crisis is imminent.

Dr. Jane Hu, founder and chair of the China Foundation and a member of
the Presidential Advisory Council, gave additional insights. The China
Foundation has been working in the densely populated and extremely poor
rural areas with blood sellers, IDUs, and sex workers. The group
estimates that 20 million persons may be infected. AIDS in China will
affect the United States in more ways than AIDS in Africa does, because
the United States and China are major trade partners. Dr. Hu believes
that the window of opportunity for averting the impending crisis is only
3 or 4 years. She believes that President Bush would be the most
powerful person to convince the Chinese leadership, from the top down,
that China needs a national movement to stem the spread of AIDS.

Ms. McDonald proposed that the Council make a recommendation to the
Secretary and to the President that these matters in China receive
immediate attention. After referring the study of China as well as
Russia, India, and Burma/Myanmar (all highly volatile areas for epidemic
explosion, per Dr. Sharma) to the International Committee, Dr. Sullivan
called for a vote. The China recommendation received unanimous approval.

Dr. Sullivan then stated that he had to return to Atlanta and that Dr.
Coburn would preside over the remainder of the Council meeting.

## Wrap-up

Ms. Ware announced that the Council will be able to have three meetings
a year, and that she has suggested planning them over Friday-Monday
periods. She asked Council members to check their calendars and send her
available dates in June/July and in October. She noted that the
co-chairs will need to be more effective in communicating with members.

Regarding Council funding, Ms. Ware explained that the ONAP budget is
handled through NIH and that its consulting firm does not give her a
running total of what they have spent, although she keeps trying to get
this information. "Maybe we need to change consulting firms," she
stated. PACHA funding goes through Health and Human Services.

Mr. Minor stated that he wanted to thank Pat Ware and the co-chairs for
handling the public comments so well.

Minutes of the last Council meeting were unanimously approved.

The meeting adjourned at 5:20 p.m.

Friday, January 31, 2003

Morning Session

# Opening Remarks

Dr. Coburn called the meeting to order and introduced the first speaker.

# Disparities in HIV/AIDS Health Care

*Health Resources and Services Administration (HRSA)*

**Deborah Parham, Ph.D., R.N.**

# Associate Administrator, HIV/AIDS Bureau

Dr. Parham proposed to focus on three aspects of disparities in HIV/AIDS
health care: how disparities came to be such a central issue, how these
disparities are reflected in the people served through the Ryan White
programs, and how disparities can be reduced both in access to care and
in the health status of people being served.

In the early days, when AIDS progressed rapidly and unchecked among
white gay men in urban areas, it caused poverty and dependency. People
lost their jobs and thus their health insurance. Disenfranchisement from
the health care system *because* of poverty and its associated problems
was not the primary force separating people from services. This has all
changed. Over the past decade, AIDS has spread most rapidly among people
least able to fight it: injection drug users, minorities and minority
subpopulations (women, gay men), homeless individuals, and persons in
prisons and jails. When these populations came into care, they suffered
from the stigma of race, ethnicity, and sexual orientation. Many did not
have health insurance, many were living in poverty before they became
HIV-positive, and many presented with high rates of comorbidities like
mental illness and addiction.

One survey reported that people living with HIV in care over a 6-month
period in 1996 were *half* as likely to be employed as the general
population, *half* as likely to have household income above the 25^th^
percentile, and *half* as likely to have private insurance. More recent
data show that almost 70 percent of AIDS cases reported in 2001 were
among minorities, and more than 81 percent of cases among women were
among minorities. Even with the vast resources that the United States
has mobilized, every 13 minutes, someone in this country is infected
with HIV. Every 13 minutes, someone else is diagnosed with AIDS. Every
34 minutes, another person dies from it. Based on 2001 data, one in four
of those contracting HIV this year with be under age 21. Seven in 10 of
AIDS diagnoses and deaths will be among racial or ethnic minorities.

The Ryan White CARE Act community of providers sees about 533,000 people
each year. The proportion of clients who are racial and ethnic
minorities continues to increase; today 70 percent fall within this
group. The CARE Act is the payer of last resort (i.e., Ryan White funds
can be used when people without private insurance and personal resources
have essential needs that are not met by Medicaid, SSI, and other
components of the public "safety net"). Disparities in access to health
care are often reflected in the health status of people entering care at
Ryan White-funded sites. Among new Title III clients in 2001 (funding
for early intervention services), only 51 percent had no symptoms of HIV
disease, 25 percent were already living with an AIDS-defining condition,
and another 24 percent had conditions symptomatic of HIV disease.

To the huge question for the Ryan White community---and for all
providers---of whether disparities in access to care and in health
status can be corrected, Dr. Parham answered a resounding Yes. To do so,
energies need to be focused in two areas: people must get into care as
soon as possible after they become HIV positive, and providers must work
toward reducing disparities in health status once people have entered
care. This is really what the Ryan White program is all about. On
average, patients are better off receiving care at a Ryan White-funded
site than elsewhere. Providers improve patient chances by taking care of
the whole person, meaning shelter, treatment for comorbidities, proper
diet, and other aspects of life that threaten compliance with a
complicated regimen of treatment. When providers address the multiple
problems associated with AIDS and when they look at people's needs as
they relate to staying in care over time, they can stop disparities in
health care. This reality is reflected in the lives of hundreds of
thousands of people who are alive and thriving because they have
received access to the services to make it all possible.

The text of Dr. Parham's remarks was made available to Council members.

*Office of Minority Health*

**Nathan Stinson, Jr., Ph.D., M.D., M.P.H.**

**Deputy Assistant Secretary for Health (Minority Health)**

Dr. Stinson outlined the five strategies that his Office employs in its
focus on AIDS, which was chosen as a priority because the science exists
and money was already being spent on the disease. The strategic
approaches reflect how the Department of Health and Human Services does
its work.

1.  Policy: the always important foundation.

2.  Enhancing the science base: The Office collects racial and ethnic
    data and finds that the cost of doing surveys, questionnaires, and
    other data-gathering tasks is a hard sell. New clinical programs and
    treatment approaches are easily marketed.

3.  Partnerships: This strategy receives much lip service, but real
    partners are needed to work in unison for the common goal. The
    Office is seeking to establish partnerships with State Minority
    Health Offices. In South Carolina, all migrant health camps have
    been identified, and the State has conducted HIV assessments of all
    clients.

4.  Linkage to services: The Office acknowledges that people who get
    sick will need services from beginning to end, and thus it gives
    grants to community organizations that provide services and do
    prevention work.

5.  Strategic communications: To enable the replication of approaches
    that the Office knows will work, culled-out examples must be shared
    with communities. Here the Office walks a fine line. Some messages
    convey things the individual can do, but they must be presented in
    such a way that they don't blame the individual for the problem but
    instead encourage that person to be receptive to the message.

Dr. Stinson revealed that the Office of Minority Health receives free
radio time from the ABC Radio Urban Network in exchange for public
service messages that are broadcast over the network's 200-odd stations.
The current focus is on the "Take a Loved One to the Doctor" message,
which it is hoped will help establish a day in September when listeners
will do just that. The Office also is working with Hispanic radio
stations.

Regarding best practices, Dr. Stinson avowed that *equal care equals
equal outcome*. The best must be replicated once people enter the health
system. (Note: Later in the meeting, Dr. McKinnell stated that *equal
equals equal* is only half right: doctor and patient behaviors determine
outcomes.)

*Community Representative*

**Deborah Dimon, R.N., B.S.N., M.P.H.**

# Alexandria, Virginia, Health Department

Ms. Dimon has been involved in the planning and delivery of HIV/AIDS
services for low-income under- and uninsured persons living in
Alexandria City for the past 12 years. She spoke of the challenges
inherent in connecting with clients and supporting their adherence to
primary HIV medical care, treatment regimens, and other services.
Several factors contribute to the lack or irregularity of client
connection to care. In addition to the denial and distancing that may
characterize the client's initial reaction to receiving an HIV-positive
diagnosis, a litany of fears also comes into play: fear of death, of
being reported, of becoming a statistic, of becoming labeled, of facing
discrimination, of losing employment, of being deported, of losing or
damaging relationships with family and friends. Some people lack trust
in the Western medical model of care and/or public services. Others
believe that HIV was manufactured by the "powers that be" and
subsequently mistrust the treatment developed by the same. Younger
persons are receiving a diagnosis that demands consistent and routine
medical care during a stage of life when one normally enjoys good
health. Adolescents have expressed feelings of being misunderstood by an
older generation of providers. Families may have so many priorities to
juggle that health care takes a back seat. Persons from racial
minorities have found it difficult to relate to providers from different
backgrounds, and others living with HIV do not always feel an uninfected
provider can meet them on common ground. Persons living with HIV in
prison often choose not to disclose their status for fear of having
their confidentiality compromised and experiencing the subsequent
fallout. Language and cultural barriers present new challenges in
connecting and providing services for a growing number of multicultural
residents living with HIV.

Clients sometimes perceive the treatment prescribed in long-term
management of the infection as too difficult to follow, requiring too
many pills, demanding too much consistency, causing unwanted side
effects, possibly exposing one's status to household members or
coworkers, and providing a daily reminder of an infection that has no
cure. There are misunderstandings that treatment controls infectiousness
and that being infected means only having to take a few pills a day.
Significant psychosocial conditions also diminish the ability to connect
and remain adherent to care.

In an attempt to meet these challenges, facilitate access, and support
adherence, in 1992 the Alexandria Health Department implemented a case
management model. Public health nurse case management, enhanced by close
collaboration with a consumer advocate, was tied to the existing primary
HIV care services. Collaborations were developed with a minority
community-based service organization and with the Alexandria Detention
Center, Alexandria Mental Health/Mental Retardation and Substance Abuse
Services, INOVA Alexandria Hospital, and other nonprofit AIDS and social
service organizations.

The Department has provided primary medical care at one of its four
sites, the Flora Krause Casey Health Center, since the beginning of the
epidemic. HIV pre- and posttest counseling services are provided at all
the sites, and persons testing positive for HIV receive partner
counseling and referral services. They are then directly linked to the
Casey Health Center for comprehensive primary HIV medical care, case
management, dental care, drug assistance, nutrition counseling, and
supplements. Health counselors also work with inmates at the Detention
Center prior to their release.

Adding an adjunctive consumer advocate to medical care and case
management providers has served as a bridge to enhance connection to
services and peer support for adherence to medical monitoring and
treatment. The groundwork laid by the Department's first consumer
advocate, Eddie Ross, was instrumental in developing the consumer
advocate role and in exemplifying the key qualities needed in this role.
Eddie Ross was from the community and was living with HIV; through his
understanding, communication, education, and simple caring for fellow
consumers, he maintained the human element in the system of care.

Despite the dedicated team of physicians, nurses, and consumer
advocates, however, challenges outside of the Department's control
continue to impede connections and adherence to care. The original
minority community-based organization (CBO) that provided the consumer
advocate services withdrew from its role as the sole minority HIV
service provider in Alexandria. The absence of organizations willing to
adopt this responsibility led to direct employment of consumer advocates
by the Department. Positive Livin' has emerged as an exciting
alternative, but concerns exist that competition for limited funding may
diminish collaborative efforts. Funding changes for mental health and
substance abuse services, housing and residential treatment facility
shortages, increased unemployment, and the general economic downturn
have all complicated social stability for consumers. Nevertheless, the
team continues its efforts, and there are still many success stories to
share.

*Community Representative*

**Mari Parr**

# Positive Livin'

Ms. Parr, the new Executive Director of Positive Livin', a minority
community-based organization in southeast Fairfax County (Alexandria
City), served as a case supervisor and project manager with black
populations for 6 years. In seeking to determine how her organization
can reach out to minorities and get them to help get the message on
HIV/AIDS out, she spoke with consumer clients. Three major concerns were
revealed: (1) distrust of the system after incarceration; (2) the issue
of being accepted, particularly if one is still drinking and not taking
care of him/herself; and (3) upset and amazement that people still don't
know about "the bug": the HIV virus. The third client stated that he
wanted to be a part of it, that he would make a difference because he
could say, "Look at me!" This would represent his first chance to be
connected. Many blacks can't trust the system and consequently seek
comfort in a nonjudgmental environment. Consumer advocates can provide
this security.

Ms. Parr acknowledged that new minority CBOs face problems, too, among
them funding and proving themselves to seasoned providers. These small
minority groups are also part of this puzzle along with their potential
clients.

Dr. Coburn ended this portion by quoting Martin Luther King, Jr.: "To
change someone, you need to love them." Not just say it, Dr. Coburn
added, but show it by actions.

Members of the Council departed at 9:30 a.m. to meet with President Bush
and returned to the Humphrey Building at approximately 12:30 p.m.

## Afternoon Session

Discussion of Committee recommendations continued after lunch; they are
summarized in the Committee reports. Dr. Coburn interrupted this
discussion when Dr. Joseph O'Neil and Dr. Claude Allen arrived. He
thanked Dr. O'Neil for the confidence the President has in his work; Dr.
Coburn has known him since the Co-Chair has been at the White House and
is happy to have others see what a wonderful human being he is.

Dr. Allen reported that the Department of Health and Human Services
(HHS) has received the application for the rapid-test CLIA waiver, an
event that can triple if not quadruple testing stations. His chief
concern is that HHS have the manpower to do all it is charged to do.
Secretary Tommy Thompson's role as chair of the Global AIDS Fund will
also add to the responsibilities of HHS. Consequently, Patricia Ware,
Executive Director for PACHA, has been asked to come to HHS to be
Special Assistant to Deputy Secretary for Health Allen, working in the
areas of women's health and minority health. Josephine Robinson will
take over immediately as Acting Director of the Presidential Advisory
Council.

Dr. O'Neil cited the "great time" he and Ms. Ware had working together
at Jackson Place, and termed losing her to HHS as the "cloud" on this
whole situation. Ms. Ware then addressed the group, stating that she had
enjoyed working with all the members of the Council and that she is
pleased the group is so diverse. The Co-Chairs had worked hard behind
the scenes to make that happen. Discussion of Committee recommendations
was delayed until scheduled speakers had completed their remarks.

# Public Health Model: New York State

**Antonia C. Novello, M.D., M.P.H., Dr.P.H.**

# New York State Commissioner of Health

Dr. Novello expressed her pleasure at being back in Washington and with
the Council and her eagerness to show members "how to do it right." If
it can work in New York, she stated, it can work anywhere.

New York State has a population of 19 million (2.3 million of whom were
not born there) and citizens who speak 167 languages. The State has 18
percent of AIDS cases nationwide. Of the 149,341 cases reported through
December 2001, 43 percent are in the black community, 29 percent in the
Hispanic community, and 27 percent among whites.

New York spends \$2.2 billion in Federal and State funding on its
response to HIV/AIDS. This response includes prevention (education,
counseling, and testing), the continuum of health care (primary care,
hospital, home care, nursing care, case management, medications
\[ADAP\], and managed care under HIV Special Needs Plans), support
services (housing, transportation, nutrition, permanency planning, and
peer support), and harm reduction: syringe access and exchange, partner
notification, prenatal and newborn testing and treatment, and focus on
communities of color. This focus includes partnerships with CBOs serving
persons of color. Two programs focus exclusively on developing
leadership and providing services within communities of color: the
Community Development Initiative (CDI) and Multiple Service Agencies
(MSAs). The State builds partnerships among CBOs and faith-based
organizations (FBOs) and provides financial support to FBOs to provide
HIV education and services. Under Project WAVE (War Against the Virus
Escalating), minority radio stations provide free air time to promote
HIV counseling and testing events.

Since 1985, New York has provided free, anonymous HIV pre- and posttest
counseling and HIV antibody testing. The 66 State-operated sites in 24
counties include walk-in and evening clinics in high-risk areas.
Individuals who test positive are given partner notification assistance
and referrals to medical and support services. The State is developing
HIV Special Needs Plans (SNPs) as a unique feature of its Medicaid
managed care program. SNPs will be comprehensive networks of primary
care physicians specializing in HIV as well as enhanced managed care
services such as treatment adherence support, HIV case management, and
linkages to other support services. The first SNP, HealthFirst, will
begin voluntary enrollment in April 2003. Initially the six SNPs now
working toward certification will serve Medicaid-eligible, HIV-positive
persons in New York City, Long Island, and Westchester County.

The HIV Reporting and Partner Notification Law that took effect in New
York on June 1, 2000, seeks to develop a highly secure and confidential
reporting system that collects and maintains complete, accurate,
unduplicated information on all HIV/AIDS cases in the State. This system
monitors recent trends in AIDS cases, new HIV infections, and emerging
subepidemics. Physicians and others authorized to order HIV-related
tests, including nurse practitioners, physician assistants, nurse
midwives, coroners, and medical examiners, report these data along with
laboratories and blood and tissue banks that conduct testing. Data
reported include initial cases of HIV diagnosis, HIV illness, and AIDS;
names of known contacts and others the patient wishes to notify, and
status of such notifications; and results of domestic violence
screening. Sensitivity here is crucial: notification is delayed if a
threat of domestic violence exists. New York is the only State that has
had no breach of confidentiality.

New York State has had notable success in reducing perinatal
transmission of HIV. By emphasizing prenatal HIV counseling and testing,
newborn testing as a safety net, training of physicians, and technical
assistance to hospitals, the public health system has dramatically
reduced the number of HIV-positive women delivering and the number of
cases of mother-to-child transmission when women delivering are
HIV-positive. The percentage of women aware of their HIV status before
delivery has increased exponentially. (These and other aspects of New
York State's approach are explored in fuller detail in Dr. Novello's
PowerPoint presentation, which is available to Council members.)

The State's harm reduction initiatives include a syringe exchange
program begun in 1992 and offered in 13 individual programs across the
State. More than 100,000 clients have been served in the past 10 years
at sites ranging from storefronts, mobile vans, and street sites to
hospital-based locations. An independent evaluation conducted by Beth
Israel Medical Center found that new infections had been reduced by at
least 50 percent.

A second primary prevention program, the Expanded Syringe Access
Demonstration Program, allows syringes to be sold or furnished to
persons age 18 and over without a prescription. More than 2,400
pharmacies are registered to distribute such syringes, with the
provision that they must offer information on the closest substance
abuse treatment center and instructions on safe disposal of syringes. An
independent evaluation was due to the State Legislature in January 2003.

Dr. Novello encouraged Council members to learn more about HIV/AIDS
statistics, programs, and services in New York State by accessing the
State Web site
([www.health.state.ny.us](http://www.health.state.ny.us/)) and clicking
on the HIV/AIDS icon on the home page.

# International Model: Haiti

**Jim Yong Kim, M.D., Ph.D.**

# Partners in Health, Harvard Medical School

In the absence of Dr. Joia Mukherjee, who was attending the Global AIDS
Fund meeting in Geneva, Dr. Kim presented an overview of the Haiti
Model. An infectious disease physician and anthropologist, he began by
asking a common question: Why introduce antiretrovirals (ARVs) into
resource-poor settings? "Because they are effective and they will reduce
suffering, mortality, and transmission," began his answer. The
conventional wisdom argues against this position: ARVs in poor countries
fall victim to lack of infrastructure and prohibitive costs of drugs.
But the language of sustainable programs, endorsed by President Bush,
suggests options. Prevention and treatment go hand in hand. Operational
research cannot be conducted if there are no operations.

Haiti is the poorest country in the Western Hemisphere and the highest
in HIV prevalence. Its public health care system has collapsed. Landless
peasants travel to Port-au-Prince in search of work and return to their
villages with HIV infection. Since 1998, highly active antiretroviral
treatment (HAART) has been offered in Haiti, thanks to recycling and
donations. The directly observed therapy (DOT) approach has been coupled
with HAART, serving as a safeguard on the money invested in treatment.
DOT originated in Tanzania and was instituted by doctors treating
patients with tuberculosis, who would observe the patients taking their
medications. It has had an extremely successful record, particularly in
prison systems, and basically pays for social systems support.

Drug procurement has to be front and center of any HIV/AIDS work in
Haiti. The biggest challenges to scale-up there include creation of
coalitions to expand and harmonize prevention and care services. The
goal of new initiatives such as the Global AIDS Fund is to adopt the
CHIPS (complex health intervention in poor settings) strategy that will
allow providers to confront challenges appropriately. Basic health
services must be provided before individual diseases can be attacked. By
focusing on HIV, providers create the focus on developing health
systems, which has never been done before.

As President Bush has stated, saying that because someone is poor, he
won't get treated is part of our primitive past.

**Historical Overview on Research, Care, Treatment, and Prevention**

**Robert R. Redfield, M.D.**

**Director of Clinical Care and Research**

# Institute of Human Virology, University of Maryland at Baltimore

Dr. Redfield recalled his 20-year, career-long involvement in HIV/AIDS
work. During that time, he has seen unparalleled advancement that has
changed AIDS from a devastating illness with a 10-month survival rate to
a chronic disease whose sufferers are often able to have a normal,
natural lifetime. Nevertheless, many in the United States still fail
therapy, and sub-Saharan Africa still has decreasing life expectancy.

Today the HIV epidemic is treatable and preventable, yet despite
remarkable advancements in treatment and the prevention of complications
associated with HIV infection, the epidemic continues. Despite
unprecedented scientific advancement (largely by the U.S. Public Health
Service), HIV has transitioned from a local infection in the late 1970s
to a global pandemic whose impact on the world will soon be measured by
its causation of global economic and political instability.

Dr. Redfield posed an opening thought to Council members: If an
efficacious preventive HIV vaccine could be deployed today worldwide,
would this prevent the economic and social destabilization of
sub-Saharan Africa? If not, what would?

Six areas of focus are indicated:

1.  Durable treatment is a primary prevention strategy.

2.  Antiretroviral (ARV) resistance has critical consequences.

3.  Sustainable success requires resources to develop, implement, and
    evaluate new treatment strategies.

4.  An unchecked HIV epidemic in our Nation has the potential to
    increase racial health care disparity.

5.  Our Nation should aggressively and successfully empower
    resource-limited countries to implement sustainable HIV
    antiretroviral treatment (ART) programs and reverse the widening
    health care gap and its economic and security consequences.

6.  Developing new treatment priorities for resource-poor and
    resource-limited areas should be a U.S. scientific priority.

The impact of ART in the United States has several elements:

-   Major impact on mortality of advanced HIV infection

-   Major impact of morbidity secondary to HIV infection

-   Evidence of health care disparity related to mortality among blacks

-   Significant treatment failure in experienced clinics secondary to
    the development of drug resistance

-   Significant "swings" in consensus recommendation related to use of
    ART

-   Increased morbidity and mortality secondary to drug-induced
    toxicities

-   Increased transmission of ARV drug-resistant virus.

Dr. Redfield traced the evolution of HIV/AIDS treatment through multiple
mainstream approaches, noting that he has many patients who have lost
all treatment options. The current mainstream treatment strategy
includes these elements:

-   Sequential combination chemotherapy (rational ART sequencing based
    on concerns of cross-resistance)

-   Preservation of future treatment options

-   Maximized adherence via reducing pill burden and dosing interval

-   Expanded use of viral load monitoring

-   Use of resistance testing in selected clinical settings (viral
    rebound, new infection) to steer drug selection

-   Delayed use of ART (due to high risk of viral failure and toxicity).

The consequences of implementing this strategy include the following:

-   Greater than 30 percent of patients in treatment with drug
    resistance

-   Increase in patients requiring deep salvage regimen

-   Increase in primary infection with resistance virus

-   Recognition of significant toxicity, particularly of principal
    investigators (PIs)

-   Increase in morbidity and mortality from drug toxicity

-   Changes in consensus treatment recommendation: delay treatment.

Dr. Redfield advised that the United States has provided the learning
curve for the world. No other Nation need do the same.

The lack of durability in clinical cohort studies is shown in certain
1-year ART failure rates: Baltimore, 63 percent; Cleveland, 53 percent;
San Francisco, 50 percent; and Amsterdam, 40 percent. The transmission
of HIV-resistant virus has changed from 3.4 percent in the 1995-98
period to 12.4 percent in 1999-2000. There is a growing population of
treatment-experienced patients with multidrug-resistant virus.

Impatience for progress is a driving factor in the search for successful
treatment. This impatience has many faces:

-   Desire of HIV-infected population to be treated

-   Desire of biomedical community to treat

-   Lack of significant debate about consensus treatment recommendations

-   Poor understanding of *in vivo* HIV replication treatment goals
    despite decision to use ART

-   Lack of significant public health debate on the impact of premature
    use of ART on future control of the HIV epidemic.

Progress toward sustainable therapy can be made by acknowledging the
reasons for viral failure. These include premature wide-scale
introduction of suboptimal ART, limited public health debate about
long-term implications for both patients treated and future patients,
the high adherence threshold (90-percent adherence equals 50-percent
treatment failure in 1 year), and limited development of adequate
treatment support systems prior to introduction of treatment. A
portfolio of treatment support structure choices is needed; this is a
critical funding issue that the Presidential Advisory Council can
influence. Knowledge, skills, and equipment need to be imported to deal
with this situation.

Dr. Redfield acknowledged that many in the gay community developed drug
resistance because they volunteered to help researchers in the
beginning. Two epidemics are possible: one that is treatable, and one
that is less treatable because of lower drug adherence in poor
communities. There is real concern about the potential for drug
resistance to have a disproportional impact on the urban poor and the
potential, if unchecked, to lead to increased racial health care
disparity. HIV infection could become biologically entrenched in one
population.

The HIV/AIDS community needs to reevaluate risk reduction and prevention
messages in light of increased ARV resistance. It needs to emphasize the
development and implementation of successful secondary prevention
programs. It needs to develop and implement new treatment support
systems that enable patients to be successfully treated for the long
term. All the system's financial flexibility is being sucked into drugs;
there is reluctance to invest in treatment support, yet long-term
durable therapy is critical.

Dr. Redfield expanded on the potential for growing health care disparity
at home. In Maryland, 85 percent of HIV clients are black, and 2 percent
of all blacks are infected. In his own clinic, not one black has been
cured. He sees women in their 40s with lung cancer; one-third of those
infected don't know they're infected. New acute infections need to be
diagnosed; infrastructures need to be strengthened. Dr. Redfield
specified some of the characteristics of the domestic health care
disparity:

-   Differential penetration of the HIV epidemic in the U.S. population

-   Differential impact of ART on mortality

-   Potential for increased comorbidity and disease outcome (renal
    disease, hepatic disease)

-   Potential to increase current cancer disparity

-   Potential for differential penetration of multidrug-resistant virus

-   Potential for disparity to become biologically entrenched

-   Potential for increased racial tension over outcome of AIDS epidemic
    in sub-Saharan Africa.

Treatment must be embraced as a key component of the overall prevention
effort. Early diagnosis must be enhanced to include acute HIV infection
(i.e., high viral load). Increasing evidence shows that treatment during
acute infection is of benefit to the patient. The North Carolina STAT
program found that 10 percent of new diagnoses were seronegative acute
infection. Public health capacity must be increased to provide greater
opportunity for early diagnosis, especially during acute infection, and
the effectiveness of the public health system in actively engaging and
retaining persons living with HIV into care and treatment must be
improved. Increased standard-of-care thresholds are indicated for
long-term durable viral suppression via the development and
implementation of improved treatment support systems for care delivery.
Resources and new initiatives must be targeted that are designed to
address and revert the potential impact of HIV infection on increasing
health care disparity in the United States.

Leadership and proportional response are what was missing, stated Dr.
Redfield. This week, he concluded, President Bush supplied them both.

Dr. Redfield moved on to a discussion of ART in Africa and the growing
health care disparity abroad, evidenced and caused by the following
factors:

-   Accelerated natural history

-   Declining life expectancy

-   Unilateral access to specific ARV drugs

-   Western biomedical research priorities

-   U.S. and European "experts" driving local therapeutic guidelines

-   Limited local leadership

-   Transition of HIV epidemic from health crisis to cause of economic
    and political instability.

Western researchers and health care providers need to be humble in
Africa and to avoid transferring U.S. methods and strategy to African
Nations. An African strategy is needed, not a transplanted U.S.
strategy. Translating the current Western approach on sequential
combination drug treatment is the wrong approach. Instead, the optimal
profile of ARV drugs to be used in Africa must be defined. Next steps
include the following:

-   Define a realistic role for diagnostic testing in management

-   Develop an African ART strategy

-   Focus on operational therapeutic research in resource-poor and
    resource-limited countries and validate success before wide-scale
    application

-   Make development of products with proper profile for use in
    resource-limited countries a priority

-   Recognize that we have one chance to get it right. If significant
    viral resistance emerges (as in the United States and Brazil), this
    is a signal for ART; if the reverse, the course of events unfolding
    in Africa will be lost.

Finally, global health will be the defining issue of U.S. foreign policy
in the next century. We don't need to solve every world health problem,
but certain goals for ART are inescapable:

-   Reverse the impact of the HIV epidemic on declining life expectancy
    in affected countries

-   Reverse the tragic trends of increasing numbers of HIV-related
    orphans

-   Reverse the trend of loss of key members of work forces of local
    industry and teachers

-   Minimize the impact on local government and global economics

-   Avert the development of economic and political instability in
    sub-Saharan Africa and avert the spread of instability to other
    regions of the world.

Dr. Redfield offered some closing thoughts on the subjects under
discussion. What will be our Nation's legacy related to the HIV
epidemic? Will we close or widen the world's health care gap? (His)
belief is that greater success will come for all if the power of science
can be refocused to the development of treatments capable of causing
sustainable improvements in health worldwide.

Now is a time of great opportunity to affect the transition of the HIV
epidemic from a health pandemic to a factor critical to global economic
and political stability. Whatever course of action is taken will have
historical consequences and shape our world and the 21^st^ century. If
successful, the introduction of ART in sub-Saharan Africa could be the
beginning of an era of better global health with broad economic and
political stability consequences. If unsuccessful, progressive widening
of the health and economic gaps and growing global political instability
should be anticipated.

Council members welcomed Dr. Redfield's remarks, and he said that a copy
would be made available to the Council.

Discussion focused on the need for a treatment support system. Ms.
Ivantic-Doucette noted that Western love of technology/drugs is
outspending available funds, and people are reluctant to spend money on
interrelationships with patients. She asked if funding direct treatment
should be considered. Dr. Redfield stated that funding should come
through Ryan White funds. Providers need to "get it"; patients used to
be blamed if drugs (given too soon) failed. Now a new paradigm is
needed: a new treatment support system, perhaps intensive at first and
then eased up. This is now a chronic disease model, and patients always
have to be given a chance to change.

Dr. Coburn noted that giving people a drug and sending them out the door
is not treating patients; they need support to be adherent. Regarding
whether the best drugs should be given first, Dr. Redfield observed that
certain alternatives can be durable and that high-mutation-threshold
drugs are being developed. In his practice, he said, providers are
aggressive and treat early but not before establishing "friendships"
with the patients.

# Update on Global AIDS Fund

# Terrell Halaska 

# Deputy Chief of Staff for Policy 

Ms. Halaska reported on the meeting of the Global Fund to Fight AIDS,
Tuberculosis, and Malaria just completed in Geneva. As the elected Chair
of the Fund, Secretary Tommy Thompson, representing the U.S. Government,
will direct meetings and focus on the efficiency of the Fund. The Board
elected Dr. Suwit Wibulpolprasert of Thailand as Vice Chair. The United
States has provided 48 percent of the Fund's funding to date. Projects
in Africa received 60 percent of the Fund's grant awards, with 10
percent each going to proposals from India and other countries.
AIDS-specific projects received 60 percent of funding, malaria-specific
20 percent, tuberculosis-specific 15 percent, and a combination about 2
percent. The Fund's next meeting in June will take place in Geneva, and
an October meeting will be held in Thailand.

# Update on USAID Programs

**Connie Carrino**

# Division Director on HIV/AIDS

Ms. Carrino briefed Council members on the activities of the U.S. Agency
for International Development (USAID) program on HIV/AIDS. Last year's
budget totaled \$510 million, with \$75 million going to the Global Fund
and \$435 million toward bilateral spending in 50 countries. Her work in
HIV/AIDS began in 1991, when there was no targeted funding and she went
to New Delhi as a diplomatic courier in order to work in the field.
Tremendous progress has been made since then, and USAID funds programs
from prevention through care that seek to prevent infections, provide
care, and provide support to families and communities.

Programs in Africa are often work-based. USAID provides "food for AIDS,"
\$10 million directed toward AIDS-related famine. Tuberculosis is the
leading cause of death in countries with USAID support, and prevention
*is* critical in controlling AIDS. USAID endorses the ABC combined
program for prevention. Sexual transmission accounts for 80 percent of
AIDS worldwide, and even girls at sexual debut do not control their
agreement. ABC is important. Another prevention program supported by the
Bush Administration focuses on mother-to-child transmission.

*Children on the Brink*, a 1997 report, introduced the subject of AIDS
orphans, another target of concern. Children do best when they are
reared within a family and within a community. Working in the community
is an important part of USAID efforts. Scaling up means scaling out into
the community, enlisting the support especially of FBOs; to encourage
this support, USAID is providing small grants for small groups under the
Administration's faith-based initiative. USAID Administrator Andrew
Natzios is keen on this initiative, and projects are being pursued in
Uganda, Ghana, and Cambodia, among others. Ms. Carrino thanked the
Council for its support of the Administration on the FBO initiative; Mr.
Nickerson clarified that the Council had included FBOs as one of several
categories of partners.

Dr. McIlhaney spoke to the issue of women's rights, noting that a USAID
report states that young men are as moved by this issue as are young
women. Nevertheless, replied Ms. Carrino, in countries like Chad girls
are married off at the age of 12 or 13, often to much older men.

Ms. Lewis asked how USAID women's health and reproductive health
programs are conducted in partnership with FBOs. In mother-to-child
prevention efforts, programs promote understanding of family planning
after the baby is born, and STD prevention and treatment are included as
well in community programs. Regarding the mother-to-child initiative,
Ms. Carrino reported that all 14 countries have done assessments and set
up team structures at the top. They will then prepare proposals for
3-year plans, some starting with mother-to-child transmission and others
continuing efforts already in place. Each government is basically doing
its country's program.

Ms. Ivantic-Doucette questioned whether USAID funds for infrastructure
can be used to purchase drugs. Ms. Carrino noted that her agency is
working closely with other agencies, and that all are looking at
trade-offs, using generics overseas, for example. Dr. McKinnell offered
that no patents apply to the 14 countries involved, so there would be no
problem with generic drugs. The Accelerated Access Initiative addresses
this situation.

# Wrap-up

Dr. Coburn stated that Council members will receive a letter asking
about available dates in late spring/early summer and in early fall for
the next two Council meetings. He noted that it is important for Dr.
Sullivan, who has a particularly demanding schedule, to be able to be
present.

In the Council's work in advising on policy, it is important to present
both sides of an argument. Dr. Coburn asked that if members wish to
communicate a position to other members, they should first send their
position to Dr. Coburn and Dr. Sullivan, along with opposing views on
their argument. For example, he cited, Dr. Kim and Dr. Redfield were on
opposite sides of their issue.

Mr. Mason questioned whether a press release on the Council's work
during this meeting would be appropriate. Dr. Coburn replied that he had
found that in Washington, if you talk about what you do, you get a lot
less done. He thinks that the Council should walk quietly and give its
best advice to the President. Talking about oneself is what D.C. does,
but it is not a good policy.

Both Dr. Coburn and Ms. Ware addressed the issue of contact of Council
members with the press. Council members are private individuals, not
representatives of the Council. They speak only for themselves.
Regarding AIDS, however, this will never come through. The press will
connect members with the Council, no matter what they say. It is
therefore wise to say only what the Council has completely endorsed. The
press is not interested in what happened; they want only members'
reactions and thoughts about issues and to provoke controversy. Council
members are only advisors, not news makers, but the Council hit two home
runs today: the CLIA waiver is as important as anything the Council has
done in the past 2 years. Members are accountable only to the President.

Dr. Driscoll suggested that the Council formally thank the President for
meeting with its members. Dr. Coburn stated that he would prepare such a
message and post it for members' review.

Ms. McDonald proposed that the Council thank Pat Ware for all her hard
work on behalf of members, meeting arrangements, and other matters. She
stated that the group would like to offer flowers to Ms. Ware, but few
seemed aware of the changes about to happen.

The meeting adjourned at 5:05 p.m.