**Presidential Advisory Council on HIV/AIDS (PACHA)**

**Thirty-third Council Meeting**

**Hubert Humphrey Building**

**200 Independence Avenue, S.W.**

**Washington, DC 20201**

# June 12--13, 2007

# Council Members Present

Marilyn A. Maxwell, M.D., PACHA Chair

Troy Benavidez

Cheryll Bowers-Stephens, M.D., M.B.A.

Freda McKissic Bush, M.D., FACOG

Shenequa Flucas

Raymond V. Gilmartin, M.B.A.

Edward C. Green, Ph.D.

Franklyn N. Judson, M.D., M.P.H.

Robert Kabel, J.D.

David J. Malebranche, M.D., M.P.H.

John C. Martin, Ph.D.

Jose A. Montero, M.D., FACP

Beny J. Primm, M.D.

Robert R. Redfield, M.D.

Carl Schmid II

Barbara Wise, B.S.

Ram Yogev, M.D.

# 

# Council Staff Present

Marty McGeein, M.B.A., B.S.N., R.N.C., R.N., Executive Director, PACHA

Nancy Barnes, Program Assistant

## Guest Speakers

John O. Agwunobi, M.D., M.P.H., M.B.A., Assistant Secretary of Health,
U.S. Department of Health and Human Services

Timothy P. Condon, Ph.D., Deputy Director, National Institute on Drug
Abuse, National Institutes of Health, U.S. Department of Health and
Human Services

Capt. Hilda Douglas, M.P.H., Deputy Director, Division of Service
Systems, HIV/AIDS Bureau, Health Resources and Services Administration,
U.S. Department of Health and Human Services

Hon. Mark R. Dybul, Ambassador, U.S. Global AIDS Coordinator

Timothy H. Holtz, M.D., M.P.H., FACP, Commander, U.S. Public Health
Service, International Research and Programs Branch, Centers for Disease
Control and Prevention, U.S. Department of Health and Human Services

Miguel Gomez, Director, The Leadership Campaign on AIDS, Office of
HIV/AIDS Policy, U.S. Department of Health and Human Services

**DAY ONE**

### Welcome Remarks and Introductions

Council Chair Marilyn Maxwell welcomed the members and guests and
officially opened the thirty-third meeting of the Presidential Advisory
Council on HIV/AIDS (PACHA).

Dr. Maxwell introduced Marty McGeein, the Executive Director of PACHA,
and Nancy Barnes, a PACHA staff member. Ms. McGeein offered information
about her background and thanked the members for their service to the
public. "I am here as a human being, a woman, a nurse, an entrepreneur,
a grandmother, and interested in the very vulnerable. My motto is to
leave it better than you found it." Ms. McGeein said she anticipated
that the years ahead would be the most successful period in PACHA's
history.

Dr. Maxwell asked the members to introduce themselves and to briefly
explain their passion and interests in the field of HIV/AIDS.

Cheryll Bowers-Stephens, M.D., is a child and adolescent psychiatrist in
New Orleans, Louisiana. Her interests are in the role that mental health
plays in the epidemic, particularly with regard to medication adherence
and disease continuation.

Freda McKissic Bush, M.D., practices obstetrics and gynecology in
Jackson, Mississippi. Her passion is to help women raise awareness of
their own sexual behavior, to obtain jobs, and to take care of their
families.

Shenequa Flucas lives with HIV, is an outreach educator, and is a mother
of three from Port Arthur, Texas. Her passion is making more people
become aware of the risks of contracting HIV. She encourages other
individuals living with HIV to live positive lives despite their
infection and to prevent others from contracting HIV.

Raymond Gilmartin, M.B.A., is Professor of Management Practices at
Harvard Business School, in Boston, Massachusetts, and former Chairman
and Chief Executive Officer of Merck & Co. His passion is developing new
medicines and vaccines to treat HIV and AIDS.

Edward Green, Ph.D., is a Senior Research Scientist at the Harvard
Center for Population and Development Studies, in Cambridge,
Massachusetts. His passion is promoting primary behavior change, which
includes fidelity, partner reduction, and delay in sexual debut to
prevent HIV infection, particularly in Africa and the Caribbean.

Franklyn Judson, M.D., practices medicine at the University of Colorado
in Denver, where his work entails examining the biology and behavior of
sexually transmitted diseases. His passion is to thoroughly understand
the behavioral determinants of HIV in the United States and in
developing countries.

Robert Kabel, J.D., is of counsel with Baker & Daniels, LLP, in
Washington, D.C. Mr. Kabel was Board Chairman of Log Cabin Republicans
and currently serves as Chairman of Liberty Education Forum. His passion
is to promote HIV prevention issues both domestically and
internationally.

David Malebranche, M.D., practices internal medicine at Emory University
in Atlanta, Georgia. He is interested in how the HIV epidemic affects
black men.

John Martin, M.D., is President and Chief Executive Officer of Gilead
Sciences, in Foster City, California. His passion is to devise new drug
treatment options for treating HIV and to ensure that people living with
HIV have access to antiretroviral medications and medical care.

Marilyn Maxwell, M.D., is Professor of Internal Medicine & Pediatrics at
St. Louis University, in St. Louis, Missouri. Her passions are educating
and empowering teenagers to make the right decisions, and to ensure that
African American women and men and incarcerated individuals are not
disproportionately affected by the epidemic.

Jose Montero, M.D., is Associate Professor of Medicine at the University
of South Florida, in Tampa. His passion is to ensure that all people
have access to routine tests and that incarcerated individuals or those
living with mental illness are not disenfranchised.

Beny Primm, M.D., is the Executive Director of the Addiction Research
and Treatment Corporation in Brooklyn, New York. His interests are
making sure that HIV stays on the public's radar screen and to mitigate
the devastating effects that HIV/AIDS is having in the African American
community.

Carl Schmid II is Director of Federal Affairs at The AIDS Institute, in
Washington, D.C. His passion is to promote HIV prevention, particularly
among the gay and African American communities in the United States.

Robert Redfield, M.D., has worked as a clinician at the University of
Maryland in Baltimore since 1983. He is committed to promoting
prevention and treatment options for individuals. One of his passions is
to ensure that everyone has access to HIV treatment; another is
exploring novel targets to exploit the host-cell pathway and to reduce
infectivity levels.

Barbara Wise lives with HIV. She cofounded WiseChoices, in Littleton,
Colorado. Her interests are in showing people the reality of living with
HIV/AIDS and demonstrating that a person's outcome in life depends on
the choices he or she makes.

Ram Yogev, M.D., is Professor of Pediatrics at Northwestern University
Medical School in Chicago, Illinois. His passion is to ensure that
children affected by the HIV/AIDS epidemic receive care, treatment, and
compassion.

**International Issues: Robert Redfield, M.D., Chair of the
International Subcommittee**

Dr. Redfield spoke of President Bush's commitment to seek
reauthorization of the President's Emergency Plan for AIDS Relief
(PEPFAR), noting that the President has asked Congress to approve \$30
billion for the next phase of PEPFAR, and that the Group of Eight (G-8)
leaders have also committed approximately \$30 billion in new
international AIDS funding. "Clearly, the United States is taking the
lead to invest resources in malaria, tuberculosis, and AIDS." Dr.
Redfield noted that he has been informed that strong bipartisan support
exists in the Congress to reauthorize PEPFAR and spoke of the program's
successes thus far: more than 1 million patients are receiving
antiretroviral therapy (ART) (from an initial baseline of 52,000
patients), nearly 102,000 infant infections have been averted, and more
than 2 million orphans and vulnerable children are receiving care. Dr.
Redfield expressed great confidence in the program, but also some
concern: "In 5--10 years, ARTs will be different, and we need a
long-term strategy. We haven't addressed a sustainable, long-term plan
to work with the pharmaceutical firms to develop new drugs, especially
for pediatric populations. If new pharmaceuticals are developed, we will
need new \[care\] models."

### Remarks and Swearing-in Ceremony: John Agwunobi, M.D., M.P.H., M.B.A., Assistant Secretary for Health, U.S. Department of Health and Human Services

Dr. Agwunobi was appointed Assistant Secretary of Health in the U.S.
Public Health Service in 2005, and serves as the Department of Health
and Human Services representative to the World Health Organization.

Dr. Agwunobi thanked the panel members for their service and noted that
PACHA is one of the President's most important advisory councils, adding
that the Council has more work ahead of it than behind. "The epidemic is
still a scourge. Your work is probably more important than mine. I have
a job description. You, on the other hand, can go wherever you think
you're needed and say whatever you think needs to be said. Your job is
to lead, and I look forward to hearing the results of your work in the
future. I serve you." Dr. Agwunobi thanked Ms. McGeein for agreeing to
serve as the PACHA Executive Director, noting her extensive experience
in fighting the HIV/AIDS epidemic.

Dr. Agwunobi swore in the Council's two newest members, Mr. Gilmartin
and Mr. Schmid.

***Questions and Comments Addressed to Dr. Agwunobi:***

-   Dr. Primm expressed great concern that domestic spending on HIV/AIDS
    is not keeping up with international spending. "It concerns me and
    the community greatly that the domestic focus seems to be waning.
    It's bad for the African American community, because HIV is still
    spreading." He asked Dr. Agwunobi to comment. Dr. Agwunobi said he
    took Dr. Primm's comments with great respect and understanding and
    asked the Council members to recognize that the United States had
    committed itself to being a global leader in the fight against
    HIV/AIDS. He said the epidemic should not be an Us/Them dilemma,
    that the global epidemic is the United States' epidemic. "The larger
    fight is our fight. That we've declared our international interest
    does not diminish our domestic fight." Dr. Agwunobi acknowledged
    that the spread of HIV is beginning to insidiously undermine the
    African American community. "I'm heartened that African American
    leaders are taking this on; I'm confident we can take on both global
    and domestic \[aspects of the epidemic\]."

-   Dr. Judson asked what Dr. Agwunobi saw as important changes and
    priorities that might be expected or might not occur in the next 18
    months in light of the 2008 Presidential election. Dr. Agwunobi
    urged the Council members not to be distracted by the political
    pundits and opinion makers and assured them the President is
    committed to the epidemic. "We aren't coasting; we have a lot to do,
    and we intend to do it in the time that is left. I do know that what
    we've committed to do, we will do, \[regardless of\] whether it's
    PEPFAR, Ryan White funding, or testing."

-   Dr. Redfield commented that nearly 40 percent of the persons with
    HIV in his program are uninsured, 40 percent are underinsured. And,
    in Maryland, about 30 percent of those living with HIV are
    undiagnosed. He noted there is reluctance in urban areas, the rural
    south, and in disaffected African American communities to expand
    case loads by 30 to 50 percent when resources appear to be
    restricted. "We should not have undiagnosed HIV infections, but we
    need dollars \[to care for\] noninsured and underinsured
    individuals." He asked what discussions have occurred to ensure that
    HIV diagnosis occurs early and becomes routine. Dr. Agwunobi
    responded that no one's health care needs should be unmet because a
    patient or a care provider is worried about not being able to meet
    patients' needs. "Testing is not just about treatment, it's also
    about prevention. We know that those who know their status change
    their behavior. . . . \[Testing\] is one strategy to start slowing
    the spread of HIV." He expressed his confidence that if a large
    segment of the population is identified as needing care and
    treatment, it will become a compelling reason to find the means to
    provide these services.

**National HIV Testing Day: Miguel Gomez, Director, The Leadership
Campaign on AIDS, Office of HIV/AIDS Policy, U.S. Department of Health
and Human Services**

Mr. Gomez spoke to the Council about National HIV Testing Days (NHTDs).
He said there are now nine HIV/AIDS Observance Days, such as Caribbean
American HIV/AIDS Awareness Day, HIV Vaccine Awareness Day, and World
AIDS Day. Mr. Gomez spoke at length about Caribbean American HIV/AIDS
Awareness Day, in part to use it as an example of how to promote
successful awareness and testing options. He noted that his Office
encourages organizations to not just declare an awareness day, but to
devise a sustainable plan that involves fact sheets, posters, event
locations, and involvement by local officials such as a mayor, an imam,
or the head of a local health department. Mr. Gomez's Office encourages
those who run testing days to compile personal stories and to get the
event publicized in the local press. "We must advertise what the message
is and why it is important that people learn about the epidemic, take
the test, and learn about care." Mr. Gomez spoke of the importance of
those being tested having a support network, such as friends, siblings,
or a parent. He spoke of new recommendations that were compiled recently
by the Centers for Disease Control and Prevention (CDC) (i.e., HIV tests
should be a routine part of medical care, patients should have the
choice to opt out of testing, those at high risk for contracting HIV
infection should seek annual screening, and all pregnant women should be
screened for HIV) and new posters that were being endorsed by the
National Association of People with AIDS (NAPWA), which has as its
slogan "Take the Test, Take Control." Mr. Gomez said that in previous
years, HIV/AIDS used to be among the top 5 news stories, but now the
issue is rarely considered to be among the top10.

Mr. Gomez explained that the Department of Health and Human Services
(DHHS) is committed to promoting NHTDs because it gives the Department
the opportunity to promote HIV testing; to educate the public about the
change in HIV testing recommendations; to promote domestic HIV/AIDS
policies, programs, and resources; and to have senior DHHS officials
publicly support HIV testing. Mr. Gomez noted that DHHS has 67,000
employees, many of whom have not been tested. "If we're not committed to
employee testing, how can we ask the public to do it?" He provided
extensive details on how DHHS works internally and with groups around
the United States to promote NHTDs.

Mr. Gomez spoke of various Web and other mass media activities to
promote the 2007 NHTD, and showed a video that First Lady Laura Bush
made to promote NHTDs via podcast media. Mr. Gomez explained in detail
the importance of using podcasts to reach young people (particularly
those aged 13--24 years), many of whom prefer to receive their news and
general information through the Internet and other new media. Mr. Gomez
displayed the new DHHS National Testing Day Web site (www.HIVtest.org)
and explained its new features to the Council members. He also
introduced the www.aids.gov Web site and explained its goals to Council
members.

***Questions and Comments Addressed to Mr. Gomez:***

-   Dr. Malebranche noted that an inherent barrier in promoting HIV
    testing is that many medical providers will not seek an HIV test
    unless the patient is homosexual or a woman planning a pregnancy. He
    pointed out the paternalism inherent in health care providers
    promoting HIV testing: "Do as I say, not as I do," and noted the
    powerful image that was evident when the Reverend Jesse Jackson
    agreed to be tested at a church.

-   Mr. Schmid asked why the testing that HHS is doing for its employees
    takes an hour. He noted that many people may be put off if it takes
    that much time.

-   Dr. Green noted how the Internet has been implicated as a risk
    factor in HIV transmission in recent years and noted that it is good
    to see it being used for prevention purposes rather than for
    purposes of promoting sexual encounters.

-   Dr. Maxwell noted a sample, one-page promotional advertisement that
    had been included in Council members' meeting packets about NHTDs
    and encouraged her colleagues to share it with local media outlets.
    \[Ms. McGeein said the document is in the public domain and could be
    used as Council members saw fit as long as they removed or modified
    the sentence in the first paragraph of the handout that reads "As a
    member of the Presidential Advisory Council on HIV/AIDS (PACHA), I
    encourage you to adopt that motto and take an HIV test."\]

-   Dr. Yogev noted that pretest and posttest counseling is a barrier to
    people seeking HIV tests, adding that one can receive test results
    in 20 minutes, but that counseling adds thousands of hours and labor
    to the process. He also discussed the absence of adolescents in the
    media samples that Mr. Gomez displayed and asked whether DHHS is
    making any attempt to find a teenage idol to serve as the U.S. HIV
    testing ambassador.

**Implementation Update on the Ryan White HIV/AIDS Treatment
Modernization Act of 2006: Capt. Hilda Douglas, M.P.H., Deputy Director,
Division of Service Systems, HIV/AIDS Bureau, Health Resources and
Services Administration, U.S. Department of Health and Human Services**

Capt. Hilda P. Douglas offered a brief overview of the current status of
procedures for implementing the Ryan White HIV/AIDS Treatment
Modernization Act of 2006. The Act became effective in December 2006.

Capt. Douglas noted that her Office had until March 2007 to review the
new law and to devise new application guidelines for awarding Part A
(the part of the Act that provides emergency assistance to localities
disproportionately affected by the HIV/AIDS epidemic) grants by March 1,
2007, and to communicate those implementation changes to other
Departments within DHHS and to the Congress. Her staff held several
conference calls with grantees to notify them of changes that would
occur in the application and grant process. The Bureau staff learned
that several communities (Baton Rouge, Charlotte, and Indianapolis among
others) that used to be considered Part B (the part of the Act that
provides grants to States and territories for primary health care
\[including the AIDS Drug Assistance Program\] and support services that
enhance access to care for people living with HIV and their families)
grantees are now eligible for Part A funding.

Capt. Douglas said that her staff was given the responsibility of
interpreting the new Act and, as a result, they had answers to some
questions but not all questions. Bureau project officers gathered
questions, created a question-and-answer document, and posted the
document on the Bureau Web site so that everyone would have access to
clear and concise answers.

The Bureau staff wrote letters to all grantees providing definitions of
status and interpretations of the new requirements. Letters to Part A
grantees provided a definition and status of a Transitional Grant Area
(TGA), an outline of acceptable administrative costs, and new
requirements for serving on the planning council. Letters to Part B
grantees provided new guidance for the AIDS Drug Assistance Program
(ADAP) and new classes of drugs. Letters to Part C grantees delineated
budget categories and services. Letters to all Part A, B, and C grantees
explained interim waiver requirements for core services. Under the new
Part B regulations, all drugs approved by the Food and Drug
Administration for the treatment of HIV and AIDS were placed in the ADAP
formulary. Previously, States could decide on their own which drugs they
would provide to patients on the basis of how much the State could
afford to pay.

Grant awards were issued January 1 and April 1, 2007, to Part C grantees
for early intervention services. The formula for calculating Eligible
Metropolitan Area (EMA) grants and new TGAs (i.e., those that were
formerly considered EMAs) was issued March 1, 2007. The formula for
calculating Part B ADAP funds was issued April 1, 2007. On April 4,
2007, the HIV/AIDS Bureau released its formula for calculating new TGA
grants. Part A supplemental funds were issued May 23, 2007.

Part C grantees did not have to provide significant paperwork other than
recalculating their budgets.

Capt. Douglas noted that 60 reviewers are currently screening Part A and
Part B applications in anticipation of awarding Part B ADAP supplemental
funds on July 29, 2007, and Parts A and B Minority AIDS Initiative funds
by August 1, 2007.

Capt. Douglas told the Council members that the Act was passed without a
management statement, and the DHHS General Counsel was engaged to
interpret the law and to provide legal opinions on new definitions for
EMAs, TGAs, emerging communities, grandfathering, and other issues. She
noted that the profile of the 20 project officers has changed;
previously, project officers managed specific issues of the Act. Now,
project officers are assigned to manage specific geographical areas.

***Questions and Comments Addressed to Capt. Douglas:***

-   Mr. Schmid: Some jurisdictions that were previously considered EMAs
    are now reclassified as TGAs, and several communities took a
    financial cut more than 5 percent. How were the awards calculated?
    How much money did your Office hold back for emergencies, and how
    will it be distributed? \[Capt. Douglas: Previous funding formulae
    depended on estimates of HIV/AIDS case data, whereas new formulae
    used actual case data. She noted the HIV/AIDS Bureau has retained
    \$1 million for emergency needs.\]

-   Dr. Judson: What is the year-per-year dollar increase and the dollar
    percentage increase for the new authorization versus the prior
    appropriation? What is the maximum amount by which any EMA would
    have had its funding reduced? \[Capt. Douglas said she would need to
    review data to respond to Dr. Judson's first question. She said that
    funding for ADAP remained flat, at \$2.9 billion.\]

-   Dr. Martin: Are the new TGAs \[that were previously considered
    EMAs\] not required to have planning councils? \[Capt. Douglas: My
    Office invited health officials from those areas to Washington for a
    4-day consultation to help them understand how Parts A and B
    differ.\]

-   Dr. Redfield: Without Ryan White funding it would be impossible to
    practice AIDS medicine in Baltimore. Has the Health Resources and
    Services Administration held meetings to calculate what the funding
    implications are from \[previously\] estimated case data to now
    using actual HIV data? If we encourage national HIV testing and find
    that an estimated 25--50 percent of HIV cases are truly undiagnosed,
    how will we find the significant resources that will be required to
    provide care and treatment to those individuals? Dr. Redfield also
    asked Capt. Douglas to examine the discrepancy between \$2.9 billion
    for domestic HIV funding versus a proposed \$30 billion for
    international expenditures. \[Capt. Douglas responded that the needs
    of all patients living with HIV/AIDS are probably unmet. She also
    noted that Ryan White funding is not the definitive or only program
    that provides care and treatment to people living with HIV/AIDS.
    "The Medicare and Medicaid programs contribute a large percentage of
    AIDS care."\]

-   Dr. Maxwell noted that States that chose not to report names of
    individuals who had tested positive for HIV are now at a financial
    disadvantage. She said those States had blatantly ignored Federal
    law, and although they were not being punished, they were being
    "disincentivized."

-   Dr. Malebranche said he understands that names-based reporting is an
    incentive for receiving more Federal money, but that flat-line
    funding means dead funding. For patients with a diagnosis of AIDS,
    and with more patients seeking an HIV test, he asked whether Capt.
    Douglas was planning to take the same pot of money and shift it
    accordingly. \[Capt. Douglas responded that it was up to individuals
    affected by HIV/AIDS and their care providers to seek greater
    funding from elected representatives if they believe that funding is
    insufficient.\]

**Open Discussion**

PACHA members held a 2-hour open forum. The first questions and comments
were directed to Mr. Miguel Gomez.

-   Dr. Martin: For testing to be routine, it must not cost a fortune.
    People in South Carolina who were diagnosed with having HIV had four
    intersections with the health care system before they were tested.
    How can we ensure that testing is adequately reimbursed or covered
    by health insurance providers? \[Mr. Gomez: I would reemphasize what
    Dr. Agwunobi said this morning, that resources should be available
    for testing. Behavioral studies have shown that when individuals
    learn they are HIV-positive, they change their behavior. The Centers
    for Medicare & Medicaid Services provides the largest reimbursement
    for National Testing Day.\]

-   Dr. Judson: Once we achieve a certain standard-of-care status in
    this country, it will be paid for. Whether or not it benefits
    society, it'll be paid for. If this works the way we hope it will
    (people seek testing) and we don't have the funds to pay for tests,
    we will go to city councils, to the States, to the Federal
    Government, and say we have people with HIV for whom we do not have
    the budget resources to provide treatment. There are extremely few
    places in the United States where someone cannot receive treatment.
    I like one of your mottos ("Take Control, Get Tested") but not the
    other ("Love Is Fleeting, Knowledge Lasts"). In most countries love
    is enduring; knowledge is something we often forget, or it changes.
    I'd propose that sex or making love is fleeting; love lasts and
    knowledge is fleeting. \[Mr. Gomez: That comes from a public
    relations firm in Boulder, Colorado, and from the Kaiser Family
    Foundation. I'm not familiar with flash mob behavior. I'll ask what
    the focus groups thought of it. I'll review the research and bring
    it to Marty's attention so that she can distribute it.\]

-   Dr. Judson: In 1987, at the Stockholm conference, I started
    promoting the wider use of HIV testing. I insisted this was one of
    the best HIV tests we had, and to not use it widely was unethical.
    Everyone in my department was tested. There's no stigma. It's become
    such a normal, common thing to do for what has become a treatable
    disease. Every new case that we wouldn't have known about previously
    can be quickly moved upstream to the source and downstream to
    potential spreaders through partner notification. Then begins the
    covenant between the health care provider and the patient: HIV stops
    with me and with my patients. Ryan White and CDC funding will
    encourage States to use epidemiological data to test for earlier,
    undiscovered infections, and thus promote better prevention efforts.

-   Mr. Schmid: I suggest that we have CDC here for our next meeting to
    determine how testing is going. For reimbursement, you could bring
    in some large insurance companies. I think the reimbursement issue
    is so important.

-   Ms. McGeein: When CDC first announced this, we put representatives
    of CDC and the Centers for Medicare & Medicaid Services (CMS) in a
    room together and suggested how CMS would pay for it. I was assured
    by CDC that it was successful. But apparently, the policy is not in
    place.

-   Mr. Schmid: It is my understanding that the group that is critical
    for reimbursement did not issue a positive opinion on whether or not
    routine medical testing should occur.

-   Dr. Martin: We should ask the companies that supply the tests what
    their policy should be.

-   Dr. Yogev: You're talking about reimbursement for underinsured
    people, but a much higher proportion of those infected are
    unofficial immigrants. Medicaid will not pay for testing in
    Illinois. There's no reimbursement. You have to offer tests from the
    kindness of your heart. An interesting \[testing gap\] exists in the
    adolescent population. How do emergency rooms do it? We need a
    safety net. \[Mr. Gomez: I appreciate the recommendation that John
    \[Martin\] made. We need an update from emergency rooms and one
    from CDC. What's happening with the promotion of more HIV testing in
    emergency departments? I don't have those data yet.\]

-   Dr. Judson: CDC has no responsibility for medical care payment. The
    agency recommends guidelines, but CDC has no control over how people
    should follow or pay for those guidelines.

-   Ms. McGeein: In my mind, the testing and care payment issues are
    different questions.

-   Dr. Yogev: The Advisory Committee on Immunization Practices
    recommended that the Government find funding to vaccinate all
    children. Can we learn how this mechanism works?

-   Ms. McGeein: There is a Federal program that provides vaccines for
    children who are unable to get them anywhere else; that almost
    always implies children whose families live at or below the poverty
    level and are uninsured. It's a unique category of people.

-   Dr. Yogev: With flat funding and the recommendation that we test 100
    million people, this can't be covered through Ryan White.

-   Ms. McGeein: Eighty percent of the American people have access to
    some kind of insurance. Ryan White provides care to 150,000 people.
    As a speaker rather than an executive, it was \[my intention\] to
    force some efficiencies into the Ryan White program and to ensure
    that money was used more productively. Even if Ryan White funding
    stays flat, the money will go further through efficiencies. It's an
    economically sound principle. We will never be responsible for
    providing care to 100 million people.

-   Dr. Yogev: Seventy-five percent of Ryan White funding is for
    treatment, for groups of people already infected; it is not meant to
    be used to identify new cases. Maybe we should consider recommending
    this.

-   Dr. Judson: Even without a law in 1996, we began testing all
    pregnant women at the Denver Center. As the inner city health care
    provider, we convinced ourselves we had to pay for it. Now with the
    new CDC protocols, DHHS is following this recommendation. I'm a
    member of Kaiser \[Permanente\] with 460,000 patients in Colorado.
    They've begun to implement HIV testing at the point of care
    according to the CDC recommendations. They're competing and
    comparing themselves with other health care providers; that's
    already happening. It's expensive, but it will work.

-   Dr. Redfield: When you have a blank slate it's easy to learn
    something, but it's complicated to unlearn something. I'm trying to
    understand how we're proactively engaging the medical community.
    Let's get individual citizens to understand the importance of
    testing. I'd also say maybe there's still a need for a proactive
    medical program. \[Mr. Gomez: Our partners are the American Medical
    Association, the American Nurses Association, and others. Their
    governing bodies need to discuss this. You are a powerful entity and
    can be declarative with those you serve.\]

-   Ms. Wise: If I was \[a young person\] at a testing event and
    considering that I might be at risk, and I'm with my friends, and
    we'll know our results in 20 minutes, I might \[re-evaluate\]
    whether I want to go through such a devastating event in the middle
    of a big party. Suppose all my friends test negative and I test
    positive? How are people counseled? \[Mr. Gomez: We try to make sure
    that a person receives counseling along with his or her test; that
    occurs 90 percent of the time. We offer people options, so that if
    they don't want to take the test that day, they receive clear
    information on where they can find a test at another time. At least
    we can begin the dialogue. It sounds obvious, but the challenge is
    to keep it simple. The public health message is that we want people
    to get tested in routine settings. Not all Americans need to be
    tested, but those who think they might be at risk \[must be
    encouraged to do so\]. Testers must be skilled and have solid
    counseling skills. That's the rare opportunity to begin an HIV
    dialogue. We want to create behavior change.\]

-   Ms. Wise: What do you do to train someone to counsel? \[Mr. Gomez:
    That's not my domain; I work with grantee communities to make sure
    appropriate training occurs.\]

-   Ms. Flucas: How do you get people to return for their test results?
    \[Mr. Gomez: At DHHS, 25 percent of the people who took the test
    didn't show up for their results. We let people know where they can
    take the test or find additional information, and it's the fastest
    moving paper in the entire clinic. When someone leaves, they have a
    Web address so they can find additional information.\]

-   Dr. Judson: With name-based testing, it's now our responsibility to
    follow up with those who tested. That's why people do or don't get
    tested. In the 1980s, I made it a habit to ask my students what was
    the Number One reason they hadn't been tested. Overwhelmingly, they
    said they didn't want to know the results; they didn't want to deal
    with it; they didn't want to change their behavior. \[Mr. Gomez:
    People must be given alternatives.\]

-   Dr. Redfield: The early 1980s was a complicated time, and the
    American medical community didn't promote testing as a smart thing
    to do. Now we try to link it with medicine. I'd like to think that
    in 2009, we won't need national testing days. The environment in
    which you should be diagnosed would be in a medical center. The end
    goal is not to have more testing days, but to have HIV testing be
    integrated into overall medical care.

-   Dr. Bush: The latest American Medical Association newsletter has an
    article about universal testing. It says that 100 percent of
    patients in emergency departments are offered HIV tests, but only 60
    percent agree to be tested, and 40 percent opt out. Of the 60
    percent who agree to the test, around 1 percent test positive. The
    snag is weaving the test \[and counseling\] into the overall flow of
    care in an emergency department, because the objective in emergency
    care is to get a patient in and out as quickly as possible.

-   Dr. Malebranche: Why is there a focus on the emergency department as
    the place to test? If it's supposed to be a screening process
    similar to that for hypertension or breast cancer, it should be the
    focus in outpatient clinics.

-   Dr. Judson: In inner cities, the emergency department population has
    disproportionately high risk factors for HIV. An emergency
    department by its very nature is the ideal setting for implementing
    an HIV program. \[Mr. Gomez: Some people use the emergency
    department as their only source of medical care, and for some,
    emergency care may be the first contact they've had with a medical
    provider in 5 years.\]

-   Dr. Redfield: We don't have a comprehensive, effective health
    program for many Americans. The Global Fund and PEPFAR are asking
    how general health care can be integrated with HIV clinics. We need
    to strengthen access to the health system for all Americans.

**Comments Not Directly Associated with HIV Testing**

-   Dr. Martin: I would like to have a hard copy of domestic resolutions
    in the premeeting agenda.

-   Dr. Redfield: I would like to know the true cost of providing care
    to HIV-infected individuals. It would be useful to learn the status
    of previous resolutions we adopted. \[Ms. McGeein: We had asked CDC
    what the yield would be if 100,000 people were tested and to
    delineate that population on the basis of their being uninsured,
    underinsured, etc.\]

-   Dr. Redfield: There is a significant gap in resources required to
    provide services to underinsured individuals and the reality that
    will unfold in the next several years. We need to review whether
    funding is adequate or whether a gap in funding exists. People want
    to be helpful, but without accurate information, we go on our
    biases, which is wrong. \[Ms. McGeein: This is a market-based health
    system. I'm not sure what you're seeking. Describe "program."\]

-   Dr. Redfield: The contribution the Federal Government makes to HIV
    health care through Ryan White, Medicare, and Medicaid. My concern
    is that in my district, we will show disproportionately fewer people
    are infected versus those who are uninfected. I agree that
    ultimately we need to bring an HIV diagnosis into clinical medicine
    and not influence providers.

-   Mr. Schmid: CDC put out a program announcement last week for
    increased testing and they estimate they will find 20,000 new
    positives. Since 70 percent of the population living with HIV/AIDS
    rely on the public health system, that's a lot of people for whom we
    must provide care.

-   Dr. Bush: I don't know the difference between a generalized and a
    concentrated epidemic, but I know we have a heightened crisis in the
    African American community. Has it been declared an epidemic, and
    what difference would it make in the community? We should be ringing
    alarm bells and putting the news on CNN. What would be the public
    health response?

-   Dr. Green: In most of the world, HIV is concentrated in three
    populations, particularly commercial sex workers and injecting drug
    users. Most HIV in Africa and the Caribbean occurs in the general
    population, not in high-risk groups. Thailand declared a 100 percent
    condom use policy, and it seemed to work well there and in Cambodia
    as a first-line defense, but condoms don't work well in a
    generalized epidemic. Africans have been depicted in the West as
    being polygamous and promiscuous, but that's not true. By standard
    measures, Americans and Europeans are more promiscuous. Africans
    have more regular outside relationships and fewer outside partners.
    What has worked in Thailand, Cambodia, and the United States has not
    worked in Africa. People are afraid to admit this. HIV is spreading
    rapidly among heterosexuals in the African American and Hispanic
    communities. A lack of circumcision could be exacerbating higher
    prevalence. When I came on PACHA, we didn't have the circumcision
    data. HIV is spreading rapidly among heterosexuals in the United
    States.

-   Dr. Bush: What is the threshold for declaring an epidemic?

-   Dr. Green: Any national prevalence greater than 1 percent. But that
    ignores transmission dynamics, and Joint United Nations Programme on
    HIV/AIDS (UNAIDS) estimates have been acknowledged to be too high.
    Before, Rwanda had 30 percent prevalence, but it's been revised to 3
    percent. David Wilson of the World Bank has suggested better
    definitions. There's not a magical cutoff point; it has to do with
    whether or not infections are occurring in the general population.

-   Dr. Redfield: CDC announced years ago that 1 in every 52 African
    American women was infected with HIV, and Representative Maxine
    Waters (D-CA) called it a public health emergency. I was saddened to
    learn a couple of weeks ago that 5 percent of the population living
    in ZIP code 20210 (Washington, D.C.) has HIV. That's 1 in 20 people.
    I don't think all new infections can be traced to behavioral issues.
    I think one of the most important research questions is to explore
    nutritional, socioeconomic, and biological bases for new infections.
    The issue is critical and it needs leadership. What should be our
    course of action to curtail the epidemic?

-   Dr. Primm: I was just in a consulting group to examine sexually
    transmitted diseases (STDs) and bacterially transmitted STDs. Social
    determinants are important in the transmission of bacterial
    infections. A sense of intimacy seems to be lacking. In 2002, at age
    15, more than 30 percent of boys have already had oral sex and 29
    percent have had vaginal sex; the figures for women are similar. We
    should be talking to youngsters at ages 10 and 12 years about sex.
    \[Dr. Primm showed three slides to demonstrate the effects of HIV on
    the African American community in the United States.\] We should be
    focusing on this in the United States. It is shocking that HIV is
    affecting poor whites, blacks, Latinos, and Indians. We don't say
    much about the prison system and its role in HIV transmission. We
    need to talk about this.

-   Dr. Bowers-Stephens: That's provocative. I've heard many statements
    today that are culturally and racially insensitive. Based on your
    three slides, what is your response regarding transmission
    determinants in the African American community?

-   Dr. Redfield: If you look at transmission of HIV from one human to
    another, it is the CCR5 receptor that uses HIV as a coreceptor to
    gain entry to macrophages. As a person gets sicker, the virus
    evolves to use CCR6 or CCRX4. In couples who carry two different
    viruses, the virus still uses the same CCR5 for macrophage entry.
    How much virus does a person have? The average viral load among
    armed forces personnel is about 10,000 copies, but in Africa it is
    100,000. The ability to transmit HIV from one human to another has
    an infectious dose threshold. In Africa, people have a higher
    threshold level. The average cell might have 3,000 to 6,000
    molecules per cell, and if I can reduce that to 23 molecules, the
    cell doesn't get infected. We're now trying to do clinical research
    on vitamin A deficiency. Another good way to downregulate CCR5 is to
    give people methadone. We may not be as aggressive in treating
    vaginosis or other complicating infections that have immune
    activation; we may be doing things proactively. One of the most
    promising antiretroviral medicines is one that blocks CCR5.

-   Dr. Bowers-Stephens: I'm a social scientist. I think HIV/AIDS has a
    biopsychosocial aspect to it.

-   Dr. Redfield: How do we show how a person responds? People with a
    Type C personality are generally passive in dealing with their
    illness; we could examine chemokine expression biology and relate it
    to how a person responds to an illness.

-   Dr. Bowers-Stephens: Environment can affect biology.

-   Dr. Primm: There are 10 African American women for every 7 men; 3 or
    4 of these 7 are in jail, and 1 of those is bisexual or gay. This
    disproportion creates many problems in the community. There's
    nothing worse than the way we approach prevention, such as through
    circumcision, where a white-gloved hand is ready to circumcise a
    black penis \[Dr. Primm showed a slide\]. That turns my community
    against circumcision; we don't have cultural sensitivity. We need to
    make some recommendations in this country to get people to think in
    completely different ways about HIV transmission. Bob, I agree with
    you about CCR5, but when we test we perform an antibody test. We
    need to do RNA and antigen tests.

-   Mr. Gilmartin: In Botswana, the approach to HIV/AIDS was led from a
    national perspective, and it was comprehensive. They distribute
    condoms and antiretrovirals. They had to learn what was and what was
    not effective. Community-based organizations became engaged in
    counseling and orphan care. It strikes me that an opportunity exists
    to attack this problem in the United States through a community-led,
    comprehensive approach. I think that's the only way it can be done.
    Merck used statistics to promote the human papillomavirus (HPV)
    vaccine.

-   Dr. Green \[to Dr. Primm\]: The broad trend in the past 15 or 20
    years among teenagers is less teen pregnancy and less sexual
    activity; to understand the special dynamics, we have to look beyond
    teenage behavior. Conservatives are passionate about abstinence.
    You've touched on many of the major factors: disproportionate
    African American men in prison, down-low behavior, drugs and
    alcohol, high rates of drug use, lack of circumcision. I think the
    behavioral factors need to be explored further.

-   Dr. Malebranche: There was a great review by Millett et al. in the
    *American Journal* *of Public Health* (Millett GA, Peterson JL,
    Wolitski RJ, Stall R.Greater Risk for HIV Infection of Black Men Who
    Have Sex With Men: A Critical Literature Review. *Am J Public
    Health.* 2006;96(6):1007--19). Why is there disparity among black
    men who have sex with men (MSM) versus MSM of other ethnicities? It
    can be applied to the general African American community.
    Coinfection and late testing are factors. Down-low behavior is not
    predictive of anal STD rates or HIV infection. MSM of other
    ethnicities were more or as likely to have infections. Sexual
    networking, circumcision, bacterial vaginosis, behavioral practices
    of African American women who were more likely to engage in
    douching---these are factors. This is a social disease. It's about
    poverty and poor access to medical care. We can be just as
    promiscuous as other populations, but because of other things,
    that's where it becomes a bomb ready to explode. This epidemic
    didn't become a racial disparity overnight. We keep talking about
    testing and treatment, and personal responsibility. At the end of
    the day, I don't know whether this group is qualified or competent
    to discuss this; nor perhaps are the higher-ups. I hate to say it,
    but many people don't care about overcrowding in prisons. We have
    more people in prison than any other nation.

-   Dr. Primm: 700,000 men were discharged from prison last year. It's a
    constant seeding mechanism. It's a rite of passage now \[for a young
    black man to go to prison\]. If we don't do anything about it now,
    it'll become a genocidal plot. Just a high school education is
    enough to promote prevention.

-   Dr. Yogev: We avoid the issue and become depressed. For years I
    tried to get nurses to work with this population. You represent the
    few. We recommend an infrastructure to work with all populations. We
    talk about circumcision. We need to have the community leaders pick
    up the baton of prevention, and we as a community need to ask for
    the resources. The Hispanic community has the same problem. It's a
    different culture, a different approach.

-   Ms. Wise: I agree about working with teens. Latina and black women
    are getting HIV at ages 15 to 24. They need hope. They engage in
    risky behaviors because they're trying to get their needs met;
    they're looking for either a sense of security or a sense of being
    worthy and loved. I think we need to get information to young people
    beforehand.

-   Dr. Green: The data in Africa are quite clear that poverty and lack
    of education are not risk factors. Rather, it's just the opposite:
    Greater education and greater wealth tend to lead to greater
    mobility and more sex partners.

-   Dr. Judson: No one disputes that if you don't deal with multiple
    partners you won't get very far. We should be examining how to
    change exposure behavior. Diseases that are coprevalent will be
    cotransmitted. As gonorrhea rates go higher, so do HIV rates. You
    have to reduce the number of sexual partners. Poverty is not
    associated with prevalence. Better educated/wealthier men and women
    command more than one partner. There is no direct correlation in
    Africa with economic levels and HIV. When 90 percent of HIV cases
    occurred among white, educated gay men, they had the highest
    disposable income levels, and they had rates 20 to 40 to 60 times
    higher than heterosexual men. They had more sexual partners. I don't
    think there's evidence that if people had more discretionary income
    \[HIV rates would come down\]. I don't have an answer for
    controlling HIV rates in penal institutions; it's appalling. There
    are disproportionate sentencing practices.

-   Dr. Bowers-Stephens: Besides the oversimplification of issues, more
    important, I think, when we talk about HIV/AIDS policies, we have to
    take them in the context of larger policy issues in this country:
    eradication of poverty and resolving our national health care
    crisis. Perhaps we need a more rounded committee that can examine
    these issues.

-   Mr. Gilmartin: Botswana followed comprehensive, community-led
    principles. We can't spend \$100 million over 5 years. The
    partnership began in primary schools; it was training. It was a
    national policy to have opt-out testing.

**Summary of Public Comments**

**James Sykes, Global Advocacy Coordinator, The AIDS Institute:**
Malaria is the most important parasitic disease in the world. It kills
3,000 children every day and more than 1 million each year. That is one
death every 30 seconds. The President's Malaria Initiative (PMI) targets
15 of the countries hardest hit by malaria. Seven of these countries are
also PEPFAR countries. Studies have shown that malaria also increases
HIV viral replication and viral load, which may hasten HIV disease
progression. The AIDS Institute recognizes the President's commitment to
reduce deaths due to malaria, but we are concerned that more funding is
needed to keep the promise of universal access to HIV/AIDS care and
treatment. We are committed to ensuring access to care and treatment for
those most vulnerable in the world. It is our hope that the United
States will maintain its commitments to fighting both HIV/AIDS and
malaria in resource-constrained countries and will work with Congress
and the Administration to fulfill these efforts.

**Ronald Johnson, Deputy Executive Director, AIDS Action Council:** A
few days ago, President Bush announced the nomination of Dr. James
Holsinger as his choice to be our Nation's next Surgeon General. After
reviewing Dr. Holsinger's record, AIDS Action Council expresses its
opposition to the confirmation of Dr. Holsinger as Surgeon General. We
call on PACHA to also express its opposition to the nomination. Sadly,
Dr. Holsinger has a long record of prejudice toward and bias against
lesbians and gay men. The record shows his support for reparative
therapy to "cure" homosexuals. Such therapy has been discredited widely
by mainstream medical, psychiatric, and psychological organizations,
including the American Medical Association. The notion that gay people
need to be cured adds to the stigma and discrimination facing gay and
bisexual people. AIDS Action believes that Dr. Holsinger will not
inspire the confidence of people living with HIV/AIDS or of people at
risk for HIV infection and therefore will not be a credible leader in
the efforts to end the HIV/AIDS epidemic here in the United States. The
commitment to combating the domestic HIV epidemic needs to be
strengthened with public health leadership that commands respect. We
feel that Dr. Holsinger will be unable to fulfill this important duty of
the Surgeon General.

**Suzanne Miller, Public Policy Director, The AIDS Institute:** We
understand that CDC will soon announce that the number of new HIV
infections is substantially higher than the current 40,000 annual
number---it may be as much as 50 percent higher. The AIDS Institute is
pleased that CDC is about to finalize an addendum to the HIV Prevention
Strategy. We are deeply disappointed that we did not make progress in
decreasing HIV rates. Now with a strategy in place of decreasing new
infections each year by 5 percent or at least 10 percent by the end of
2010, we hope leadership and resources will be directed toward
comprehensive HIV prevention, including a concerted effort to promote
evidence-based prevention. Over the past 5 years, CDC's HIV prevention
budget has been cut. CDC was able to stem the tide of cuts by
transferring \$45 million to the HIV prevention center for testing
programs. This year, the President has proposed increases for testing
and the House has recommended a \$64 million increase for testing. A
plan to reach national prevention goals must include comprehensive
educational programs and programs that target specific populations. We
congratulate CDC for adding a focus on men who have sex with men,
African Americans, and other disproportionately affected groups for
addressing the issue of comorbidities such as mental health and
substance abuse. Syringe access programs must be part of a comprehensive
plan to prevent HIV infections. We also strongly support comprehensive
sex education. We are disappointed in the proposed increases in funding
for abstinence-only-until-marriage programs. We support current efforts
to create a Federal funding stream for comprehensive sex education.

**James Albino, Government Relations and Public Policy Manager, National
Minority AIDS Council:** The HIV/AIDS crisis in Puerto Rico is
deepening, and the service delivery system that provides life-extending
care and treatment to more than 30,000 persons living with HIV/AIDS on
the island is in danger of collapsing. The 2007--2008 Ryan White grant
awards for Puerto Rico were reduced, and Caguas and Ponce, which were
classified as Eligible Metropolitan Areas, have been redesignated as
Transitional Grant Areas. The two agencies charged with the
administration of nearly 75 percent of the funds designated to help
Puerto Rico's HIV/AIDS community continue to be hampered by internal
bickering, mismanagement/misappropriations, and ongoing FBI and IRS
investigations on charges of possible corruption. The San Juan municipal
government is under a criminal investigation on charges of
misappropriations; this affects 32 municipalities in eastern Puerto Rico
and 22 community-based organizations (CBOs), many of which have been
forced to close. Since the last PACHA meeting, the ADAP waiting list has
grown and more than a dozen CBOs have been unpaid since December 2006.
Much of northeastern Puerto Rico, Vieques, and Culebra have little or no
services. I implore PACHA to reach out to DHHS Secretary Michael Leavitt
to take immediate and effective action to offer technical and financial
assistance to the HIV/AIDS community in Puerto Rico.

**DAY 2**

**PEPFAR Reauthorization: The Honorable Mark R. Dybul, Ambassador, U.S.
Global AIDS Coordinator**

Ambassador Dybul spoke to Council members by telephone from Kigali,
Rwanda, where he was attending the 2007 HIV/AIDS Implementers Meeting.

The Ambassador reminded Council members that President Bush requested
that Congress reauthorize PEPFAR at \$30 billion, and that the Group of
Eight Nations had committed to spending an additional \$30 billion on
HIV/AIDS. The goal is to have the law passed and signed by December 8
(World AIDS Day) so that countries would not have to be concerned about
the availability of resources in 2009, but also to continue and expand
the novel concept of partnership compacts with recipient countries.
Services will continue in the 15 focus countries, which will cost
approximately \$26--\$27 billion. Services will be expanded to other
countries that demonstrate a commitment to fighting the epidemic through
appropriate policies and workforce efforts, orphan protection, gender
protection, rapid testing, and mandatory (i.e., opt-out) testing.
Partnership compacts between the United States and donor countries will
determine which countries will receive PEPFAR funds. A new, major
component of PEPFAR will be to connect HIV with the larger goals of
development such as agricultural projects, clean water, food security,
gender equality, and efforts to combat tuberculosis and malaria.

Ambassador Dybul reminded Council members that PEPFAR has seen great
success: 2.5 million people are receiving treatment, 12 million new
infections have been prevented, and 12 million orphans have been
protected. Through PEPFAR reauthorization, the goal will be to provide
treatment to 5 million individuals, prevent 24 million new infections,
and protect and care for 24 million orphans.

***Questions and Comments Addressed to Ambassador Dybul:***

-   Dr. Yogev: With the exception of two or three countries, pediatric
    drugs are not available in appropriate formulations. Is the
    Government working on a process to have drug companies commit to
    making such pediatric formulations? \[Ambassador Dybul: Yes. We are
    working with the World Health Organization and pediatric AIDS groups
    to identify appropriate formulations. There's a limit to what the
    U.S. Government can do to press companies to make these
    formulations, but we take every opportunity to do so at public and
    private partnership meetings.\]

-   Dr. Judson: How much flexibility will the new law have to allow you
    to move money from countries that either cannot or will not achieve
    their performance goals to other countries that are more likely to
    have success in achieving their goals? \[Ambassador Dybul: We have
    that flexibility now. Every year, we set country allocations on the
    basis of performance. Countries that perform well get greater
    increases than those that do not. A similar structure will be built
    into the partnership compact, although for humanitarian reasons we
    cannot remove people from treatment and children out of care. Some
    countries stipulate that a physician rather a nurse must see every
    patient with HIV and some require long tests rather than rapid tests
    and they don't offer opt-out testing. That is an inefficient use of
    resources. Even \$60 billion is not enough to do everything.
    Countries that perform well will receive better resources; for
    example, South Africa will receive \$500 million.\]

-   Dr. Green: There's a move underway in Congress to remove earmarks
    for antiretrovirals. Has the issue of promoting abstinence only come
    up at the implementers meeting? \[Ambassador Dybul: The *National
    Review* published an article on this recently. Even people who are
    not normally kind to the Administration are praising the G-8 and the
    President. I believe we need to hold on to the directive that
    promotes abstinence only. There may come a time when we don't need a
    directive, but it's not now. Perhaps we can come up with language
    that includes abstinence, fidelity, and correct and consistent
    condom use. It'll be a tough fight. There's legislation afoot to
    remove it. We will strongly advocate retaining the directive related
    to abstinence.\]

-   Mr. Schmid: Since the dollar amount for PEPFAR will be doubled, will
    the goals for treatment be doubled? \[Ambassador Dybul: We cannot
    withdraw what we will have achieved. By the end of 2008, we will be
    ahead of the original 2010 goals. It will cost the 2008 budget times
    five to maintain the number of people on treatment (about \$27
    million). While it doubles the commitment, it's not a doubling of
    the goal. These are lifetime commitments. We want to double the
    number of infections averted. This is why the G-8 commitment is so
    important. Currently, 7 million people need care and treatment. The
    current estimate is that 10 million people will need treatment, or 5
    million will need universal access to care.\]

-   Ms. McGeein: What do you want PACHA to do to help you? \[Ambassador
    Dybul: I think education is important. Council members have
    influence around this issue. Understand the goals and how the vision
    was developed. Congress will have many questions. This isn't a
    political issue; it's a programmatic issue. If the law isn't passed,
    we will not achieve the 2008 goals. We must work through optimizing
    the resources. It will take many voices to push this. We want your
    insight and advice. I need your individual and collective thoughts,
    and please get the message out about why it's important to do this
    and to do it now. We will try to keep the law relatively clean and
    to turn it around quickly.\]

**Addressing the Linkages Between Drug Abuse and HIV/AIDS: Timothy
Condon, Ph.D., Deputy Director, National Institute on Drug Abuse,
National Institutes of Health**

Drug abuse and HIV are cooccurring and intertwined epidemics. In 2001,
nearly 40 percent of all AIDS deaths were linked to injecting drug use,
whereas in 2005, 36 percent of all AIDS deaths were linked to injecting
drug use. Drugs of abuse have had a major effect on the HIV/AIDS
epidemic. The proportion of AIDS cases in adults and adolescents has
dropped steadily among men who have sex with men (MSM), among injecting
drug users, and among MSM who also use injection drugs, although the
proportion of AIDS cases has increased among heterosexuals.

Drug use promotes the acquisition and transmission of HIV through
high-risk sexual behaviors that result from drug use inhibition and
other physiological factors. Drug use also affects HIV disease
progression.

In 2005, an estimated 19.7 million people in the United States, or 8.1
percent of the population aged 12 or older, were current illicit drug
users.

Advances in science in the past 10 years have revolutionized our
fundamental views of drug abuse and addiction. We now understand that
drug abuse is a biobehavioral disorder. In 1987, the Partnership for a
Drug-Free America used a commercial that showed an egg sizzling in a
frying pan and the slogan "This Is Your Brain on Drugs." Ten years
later, we are able to depict the changes in brain chemistry using
magnetic resonance imaging (MRI). The bottom line is that addiction is a
brain disease. We have come to know a lot about the pleasure/reward/

reinforcement pathways in the brain, and drugs of abuse work on these
pathways. In people who abuse drugs, memory and learning are also
affected, as are cues and behaviors that affect craving, motivation,
drive, and decisionmaking. Drugs of abuse (especially amphetamines)
release tremendous amounts of dopamine, which leads to euphoria.

The science of drug abuse has generated a lot of new information. We
know that any physiological system that is driven to extremes becomes
habituated, leading to long-term sequelae, including fundamental,
long-lasting changes in the brain. Dr. Condon showed several positron
emission tomography (PET) scans to demonstrate metabolic activity in a
normal brain and in the brain of a cocaine user after 10 days and after
100 days of drug use.

Dr. Condon explained that addicts cannot stop, because addiction changes
the brain circuitry. He noted that drug abuse treatment must encompass
pharmacological, behavioral, medical, and social services so that all
the needs of an individual are met (i.e., a whole-person approach to
treatment).

The National Institute on Drug Abuse (NIDA) uses the following
principles of treatment:

1.  No single treatment is appropriate for all individuals.

2.  Treatment needs to be readily available.

3.  Treatment must attend to multiple needs of the individual, not just
    drug use.

4.  Multiple courses of treatment may be needed for treatment success
    (i.e., drug abuse is a chronic, relapsing disease).

5.  Remaining in treatment for an adequate period of time is critical
    for treatment effectiveness.

Apart from obvious public health impacts, drug abuse and addiction
treatment is also important for preventing and treating HIV/AIDS. In
fact, drug abuse treatment *is* HIV prevention because treatment
decreases levels of seroconversion, it decreases HIV risk behaviors, it
increases HIV treatment adherence, and it decreases disease progression.

The NIDA strategy in treating drug abuse involves blending research and
practice, and bringing science-based technologies into ongoing community
practice. The NIDA Clinical Trials Network (CTN) has dual missions: to
conduct multisite clinical trials to determine the effectiveness of drug
abuse treatment interventions in diverse community-based treatment
settings and diverse patient populations, and to transfer research
results to treatment programs, clinicians, and their patients to improve
the quality of drug abuse treatment throughout the Nation. The network
consists of academic institutions and 240 community treatment programs
in 34 States and Puerto Rico that perform real-life, real-time clinical
trials.

NIDA is working with CDC to expand access to rapid HIV tests and
counseling through the CTN 0032 study. The test has been approved for
use by the Food and Drug Administration. It requires a finger stick for
a drop of blood or a mouth swab, results are available in 20 minutes, it
does not require laboratory facilities, and the test can be performed by
drug counselors.

Dr. Condon explained that treatment strategies and clinical practice
must have practical applications in communities and does so using a
blending initiative in which CTN and other NIDA research are combined to
assess how treatment research can be applied in practical settings. Dr.
Condon explained how NIDA worked with the Substance Abuse and Mental
Health Services Administration (SAMHSA) to devise a blending initiative
that used buprenorphine in the short-term treatment of opioid
withdrawal. The point of such an initiative, he noted, is to decrease
the usual 17 years it takes to translate scientific findings into
practical drug addiction treatment strategies and protocols.

Dr. Condon explained NIDA's work in reducing drug abuse in the criminal
justice system, where 60--80 percent of people either have a problem
with drugs or are incarcerated as the result of a drug issue. Again
noting that drug abuse is a chronic, relapsing disease, Dr. Condon noted
that with treatment, more people remain drug-free and arrest-free. He
presented data from a recent study that examined relapsing trends among
inmates who were started on methadone before they were released into the
community.

***Questions and Comments Addressed to Dr. Condon:***

-   Dr. Green: Has anyone come up with something akin to a 12-step
    program similar to Alcoholics Anonymous? \[Dr. Condon: I don't think
    a 12-step program provides treatment, but it serves a critically
    important role after care. That's why Weight Watchers works. People
    need behavior reinforcement.\]

-   Dr. Primm: I want you to mention your partnering with the American
    Psychiatric Association (APA) and mental health---the bench to the
    trench program. The minority fellowship program is being dropped
    because of a lack of funding at NIDA and SAMHSA. \[Dr. Condon: Our
    partnership with APA was wildly successful, but the NIDA budget is
    not growing. All programs are getting cut. Eventually, the tide will
    turn and we will establish a new commitment for minority
    fellowships.\]

-   Ms. McGeein: When will you have results on your cooperative study
    with CDC? \[Dr. Condon: I hope by the end of this year or early next
    year.\]

-   Mr. Schmid: Collaboration with CDC is important, and so is the
    ability to translate science into practical application. What work
    is NIDA doing on the crystal methamphetamine epidemic? \[Dr. Condon:
    That would be another entire presentation. We started doing research
    on crystal meth 10 or 15 years ago, but only in the past 5 years has
    it been getting press attention. Midwestern cities---places like
    Omaha and Des Moines---are awash with crystal meth, but they didn't
    go through the crack cocaine epidemic and they don't have the
    addiction infrastructure to deal with such an epidemic. We're just
    beginning to talk more with CDC about methamphetamine prevention,
    and the Office of the Drug Czar is rising to the occasion because it
    is such an important issue.\]

**HIV and Multidrug-Resistant/Extremely Drug-Resistant Tuberculosis: The
Perfect Storm: Timothy H. Holtz, M.D., M.P.H., FACP, Commander, U.S.
Public Health Service, International Research and Programs Branch,
Division of TB Elimination, Centers for Disease Control and Prevention**

Dr. Holtz reviewed what is known about the interaction between HIV and
tuberculosis (TB), particularly extremely drug-resistant TB (XDR-TB).

TB is one of the world's most prevalent diseases. An estimated 8.8
million new cases of TB cases are confirmed annually. TB claims
approximately 4,400 lives per day, or 1.6 million lives per year.
Twenty-two countries with a high burden of TB account for approximately
80 percent of all TB cases. India and China account for one-third of all
cases of TB. Approximately 700,000 people newly diagnosed with TB are
also believed to have HIV infection. The World Health Organization (WHO)
estimates that approximately 420,000 new cases of multidrug-resistant TB
(MDR-TB) occur each year; these are considered to be TB caused by an
isolate that is resistant to at least isoniazid and rifampin. MDR-TB is
a problem predominantly in Eastern Europe and Asia, but all areas of the
world report some cases of MDR-TB.

Dr. Holtz showed a slide that compared the incidence of TB in 1990 and
in 2005. In that period the incidence of TB had tripled in countries of
the former Soviet Union, and it had increased by 2.5-fold in sub-Saharan
Africa. Uganda, for example, has made great strides in reducing HIV
prevalence, but the incidence of TB has risen dramatically.

MDR-TB results from poor TB control programs, low drug regimen
completion rates and poor clinical practices, and erratic drug supply
and poor quality of drugs. MDR-TB results in longer treatment (6--24
months); toxic, complicated regimens (4--6 months using injectable
drugs); and increases in the number of cases and costs by 10-fold to
100-fold. It leads to lower cure rates (i.e., \<75 percent) and higher
death rates, particularly in individuals with HIV coinfection.

Where HIV appears to be linked with high mortality, studies of treatment
show similar findings. For example, one study from New York City in the
mid-1990s found that 62 percent of patients with HIV and MDR-TB died,
whereas 26 percent of those with HIV but without MDR-TB died. Another
study from New York City in 1996 found that 72 percent of patients with
concurrent MDR-TB and HIV infections died versus 20 percent of those
without HIV. A study from South Africa in 2002 showed that 20 percent of
patients with MDR-TB died, but 41 percent of those with MDR-TB and HIV
coinfection died.

TB and HIV have been called the "cursed duet" because each infection
worsens the other. HIV is the most potent risk factor for developing TB,
both through an increase in the reactivation of latent TB infection and
through an accelerated progression from infection to disease. The risk
of progressing to active TB in individuals who are not HIV-infected is
5--10 percent in a person's lifetime. In individuals with HIV infection,
50--60 percent will develop TB in their lifetime.

Multiple associations between HIV and drug-resistant TB are converging
for what could be "the perfect storm": poorly performing TB control
programs in settings with high HIV burden may lead to the emergence of
anti-TB drug resistance; excessive global TB burden is largely due to
HIV; overwhelmed health services will result in a deterioration in the
performance of TB control programs; patient adherence to TB treatment
suffers, which results in increased treatment default rates; acquired
rifamycin resistance will occur among HIV-infected TB patients under
treatment; and malabsorption of anti-TB drugs among HIV-infected TB
patients will be associated with poor treatment outcomes.

A definite link has been identified between HIV and acquired rifamycin
resistance among patients with TB under treatment. Multiple studies have
demonstrated that poor treatment adherence, advanced immune suppression,
concomitant treatment of other opportunistic infections, cotreatment
with antiretroviral (ARV) medication, and treatment with intermittent TB
treatment regimens play a role in the development of rifamycin
resistance among those with HIV.

China, India, and Russia have the highest estimated annual burden of
MDR-TB with 135,000, 90,000, and 35,000 cases, respectively. In
contrast, fewer than 150 cases of MDR-TB are reported in the United
States each year. HIV prevalence among patients with TB is well in
excess of 20 percent throughout sub-Saharan Africa, and well over 50
percent in southern Africa.

The emerging worldwide epidemic of drug-resistant tuberculosis is a
byproduct of ineffective or poorly organized systems for TB control. It
is entirely a human-made problem. The natural selection of rare
drug-resistant strains inside the human body occurs when inconsistent or
interrupted treatment occurs, when the wrong drugs are prescribed for
the wrong amount of time, when drugs of inferior quality are given, or
when the supply of drugs is interrupted. CDC first defined extremely
drug-resistant TB (XDR-TB) in the March 2006 issue of *Morbidity and
Mortality Weekly Report.* XDR-TB is widely distributed geographically
and appears to be more present in countries that already have high rates
of MDR-TB. Its development is likely due to the poorly controlled use of
second-line drugs for MDR-TB treatment, something that CDC and other
agencies are attempting to control through a mechanism known as the
Green Light Committee.

XDR-TB is defined as MDR-TB that is also resistant to any
fluoroquinolone and one of the three second-line injectable drugs.
Inadequate treatment of MDR-TB will predictably result in the emergence
of *Mycobacterium tuberculosis* strains with resistance to second-line
drugs. If a patient with MDR-TB develops resistance to second-line
drugs, that person may be virtually untreatable, because both
flouroquinolones and injectable agents are critical to the successful
treatment of MDR-TB. An analysis of XDR-TB treatment in Latvia has shown
that treatment success is at best 35 percent; patients with HIV and
XDR-TB may be virtually untreatable.

In KwaZulu-Natal Province, South Africa, in 2005--2006, 119 patients
were enrolled in a TB/ARV integration study. Fourteen patients (12
percent) died (all from TB), and 10 (71 percent) were found to have had
MDR-TB. Six of the 10 were subsequently found to have had resistance to
all first- and second-line anti-TB drugs. This suggested that XDR-TB was
present in the local hospital and possibly in the community. In a survey
that followed, 1,539 consecutive patients presenting at the local
hospital and clinic with symptoms suggestive of TB were fully evaluated
with MDR-TB culture and drug susceptibility testing. Among those, 542
patients (35 percent) had culture-confirmed TB. Of those, 221 (41
percent) had MDR-TB confirmed. Of the 221, 53 were identified as XDR-TB,
representing 10 percent of the culture-confirmed cases and one-fourth of
the MDR-TB cases.

XDR-TB has now been reported in at least 390 provincial hospitals and
elsewhere in South Africa. More than 30 new cases are reported monthly
in KwaZulu-Natal Province. Other cases of XDR-TB have been reported in
Iran, Spain, Italy, and Germany. To date, WHO has documented XDR-TB
cases in 35 countries.

How is the world going to combat XDR-TB? A seven-point action plan
emphasizes the essentials of proper TB control:

1.  Conduct rapid surveys of XDR-TB (determine the burden).

2.  Enhance laboratory capacity (with an emphasis on drug susceptibility
    testing).

3.  Improve the technical capacity of practitioners to respond to XDR-TB
    outbreaks and to manage patients.

4.  Implement infection control precautions with a focus on people
    living with HIV/AIDS.

5.  Increase research support for new anti-TB drugs.

6.  Increase research support for rapid diagnostics.

7.  Promote universal access to ARVs under joint TB/HIV activities.

***Questions and Comments Addressed to Dr. Holtz:***

-   Dr. Bush: Is the wearing of masks part of the goal to reduce the
    spread of TB? Are people restricted from traveling? What are simple
    measures we can take to reduce the spread of TB that is not
    drug-related? \[Dr. Holtz: The surgical mask you often see in
    pictures is not protective against inhaling droplets that contain
    *M. tuberculosis*. They are not to be worn by anyone entering an
    infection control unit, but those who have TB can wear them because
    it prevents their sputum from being aerosolized. The masks you hear
    about in the media for health care workers are N95 respirators, but
    they are expensive; they prevent inhalation of sputum droplets and
    they filter air. They must fit, and they don't last forever.
    Providers such as nurses are most susceptible because they spend
    time on wards where patients are coughing. CDC now recommends that
    patients with TB should be isolated in separate rooms and not housed
    together in a ward, but that might lead to stigma. The best thing is
    to put people outside in the open air where there is ventilation.
    People should not be sitting together in hospital corridors waiting
    to be seen by a health care provider.\]

-   Dr. Judson: Is there evidence that MDR-TB or XDR-TB is associated
    with a decrease in infectiousness or pathogenicity? \[Dr. Holtz: For
    many years the conventional thinking was that MDR-TB isolates are
    less competent or less hardy. I have heard that patients with MDR-TB
    are just as infectious as other patients with TB.\]

-   Dr. Redfield: The linkage between HIV and TB is real, and it is one
    of the reasons we focus on the first principle of *do no harm*. In a
    public hospital in Rwanda, I saw the first eight bays filled with
    women dying of AIDS, five or six of whom had active TB. One was
    holding her 1-year-old granddaughter, who was being exposed to TB.
    Infection control is not rocket science. Individuals who have HIV
    coinfection with XDR-TB need to have their immune systems
    reconstituted, which means that ARVs need to be effective. It is
    fundamental to use your experience with TB and to help educate smart
    organizations like WHO to preserve the integrity of ARVs. It's our
    only weapon against XDR-TB in HIV-infected patients for the next
    several years.

-   Dr. Yogev: In places I visit, people are unaware that using ARV
    drugs is helping develop TB resistance. Is CDC considering
    encouraging a specialty in TB? \[Dr. Holtz: Many countries are
    switching to favarones. The Global AIDS Program is working with
    this, and there's a specific HIV/TB team, especially in clinical
    management. It's recognized in sub-Saharan Africa. The standard
    regimens are changing to add favarones or other drugs that have less
    interaction.

-   Dr. Malebranche: At my clinic, when we admit a severely
    immunocompromised patient, unless the patient has Kaposi's sarcoma
    or cryptosporidium, our first approach is to treat the TB. Do you
    have experience with that? \[Dr. Holtz: In the past couple of years,
    when we first started working with PEPFAR, the recommendations were
    to wait and start ARVs when patients were well enough. But the trend
    now is to become more aggressive. Start TB therapy first, because
    it's life-threatening. If a patient has a very low CD4 count, you
    start within a month or two. There are not good studies or published
    data on this.

-   Dr. Redfield: In some parts of the world, there is a trend to delay
    HIV therapy and to treat TB first; that keeps patients with TB from
    transmitting it to other people. HIV therapy is not an emergency. It
    is important to first obtain an accurate diagnosis of underlying
    infections.

-   Dr. Judson: In Denver, our HIV experts are also the TB experts. If a
    patient doesn't have a desperately low CD4 count, we start treating
    that person for TB. As rates of MDR-TB and XDR-TB rise and people
    present with very low CD4 counts, that will create a different set
    of recommendations.

Motions and Voting

The following motion was proposed by the International Subcommittee. The
motion was passed by the Council with one abstention.

## International Subcommittee Resolution

WHEREAS, The President's Emergency Plan for AIDS Relief (PEPFAR) is the
largest commitment of an international health initiative dedicated to a
single disease by any nation;

WHEREAS, PEPFAR is in the 4th year of an initial 5-year program that has
rapidly expanded access to essential, life-saving HIV prevention,
treatment, and care services in 15 focus countries that constitute more
than 50 percent of the global HIV epidemic;

WHEREAS, the PEPFAR program was begun as a humanitarian program designed
to dramatically improve the health of, and provide hope to, millions of
citizens in these focus countries;

WHEREAS, the PEPFAR program also has importance for long-term global
economic development, stabilization of societies, and the strategic
interest of the United States;

WHEREAS, the PEPFAR program is also a reflection of the U.S.
Government's commitment to global health as an important component of
U.S. foreign policy;

BE IT RESOLVED that the Presidential Advisory Council on HIV/AIDS
(PACHA) recommends that the PEPFAR program be reauthorized before the
end of Calendar Year 2007 and expanded for the purpose of maintaining
the momentum of this unprecedented demonstration of the commitment of
the American people to addressing one of the most pressing global health
challenges of our time.

**Public Comments**

**Larry Bryant, National Field Organizer, Housing Works; Member, Board
of Directors, National Association of People with AIDS, Washington,
D.C.:** I am disappointed that PACHA doesn't seem to follow a model of
leadership of being a collective voice of people living with HIV/AIDS
with the goal to develop, encourage, and empower individuals to
articulate their concerns, their issues, their fears, and their passions
on local, State, and Federal levels. Even local planning councils and
other advisory or planning bodies that provide input and insight do not
accurately represent those affected by the epidemic. It is my belief
that this body be more fully representative of the epidemic we are
facing. Black and Latino men and women, youth, transgender, and other
marginalized people are sorely underrepresented at the table. With all
due respect to the experience and expertise of the members around this
table today, not one person comes close to speaking to me and my 21
years of living HIV-positive. It seems that repeatedly, the seats
available for leadership in discussing, planning, and implementing
strategies to end this disease are filled with the same minds that have
steered us to a plateau of 40,000 new infections each year and the
hardest hit areas just keep getting hit. Rather than just talk the talk,
perhaps PACHA should pass the baton to the current and next generation
of brilliant minds to further close the gap toward no new infections and
ending AIDS in this country and around the world. It is true that the
collective face of AIDS has changed. It should also be true of its
leadership.

**Robert Carroll, Ph.D., Director, Northwest AIDS Education and Training
Center, Seattle, Washington:** I speak on behalf of the National
Association of AIDS Education and Training Centers (AETCs), the clinical
training and education arm of the Ryan White HIV Treatment Modernization
Act. We have asked Senators to provide an additional \$15 million for
AETCs for a total of \$50 million in FY 2008. AETCs have received
decreased levels of funding for the past 4 years; however, the important
work of training medical professionals continues and is urgently needed
in this rapidly changing field. Providing comprehensive primary care to
patients with HIV, incorporating new medication combinations, meeting
the challenge of drug resistance among those receiving combination ARV
therapy, and intervening to prevent new infections are just a few
examples of the training that AETCs provide in the complex field of HIV
care and treatment for the entire range of health care professionals.
Moreover, all our trainings are unbiased and evidence-based, with
measurable outcomes. In the newly reauthorized Ryan White CARE Act, the
AETCs have been given the additional tasks of providing education and
training on hepatitis B and ensuring culturally competent care for
Native Americans and Alaskan Natives. In addition, CDC has recently
released recommendations for all patients to be offered HIV testing in
all primary care settings. Additional training will be needed for
clinicians in emergency rooms, clinics, and other primary care settings
on how to test persons for HIV and link them to HIV services if needed.
Ensuring quality HIV health care and meeting these increased
responsibilities will require the ongoing excellence of the AETC
program. I ask that PACHA recognize the importance of maintaining the
successful achievements of the AETCs. We hope that as the national
experts in HIV and AIDS, you will support efforts in both the executive
and legislative branches to build on our training successes as we work
together to meet the changing clinical dimensions of HIV care and
treatment.

**Donna Crews, Director of Government Affairs, AIDS Action, Washington,
D.C.:** I found the conversation held during yesterday's PACHA open
discussion period to be disturbing. The views expressed by members that
education, poverty, access to care, and racism do not play a role in the
unprecedented spread of HIV throughout the African American community is
startling. The African American community cannot be compared with
African communities where the HIV epidemic is so generalized that
everyone is at risk for HIV. Many African Americans who are living with
HIV have never been to Africa, and more important, over five generations
ago, their ancestors were brought to the United States in shackles to
build this country. For a statement to be said for the record that
"there are more blacks in jail, since they commit more crimes"
disregards the sentencing disparities that have been the norm in this
country for more years than anyone would care to remember. The clearest
example is the Anti-Drug Abuse Act of 1986. The law's mandatory
penalties for crack offenses were the harshest ever adopted for
low-level drug offenses and established drastically different penalty
structures for crack and powder, under the belief that crack cocaine was
more dangerous than powder cocaine and posed a greater threat. The
result is that defendants convicted with just 5 grams of crack
cocaine---the weight of less than two sugar packets and a quantity that
yields about 10 to 50 doses---are subject to a 5-year mandatory minimum
sentence. The same 5-year penalty is triggered for the sale of powder
cocaine only when an offense involves 500 grams, 100 times the minimum
quantity for crack, which yields between 2,500 and 5,000 doses. The
mandatory sentencing structure that continues today results in average
sentences for crack cocaine offenses that are 3-1/2 years longer than
for offenses involving powder cocaine. Crack is the only drug that
carries a mandatory prison sentence for a first-time possession offense.
It is my hope that PACHA members will come up with culturally competent
suggestions to take to the President, without the racially insensitive
and demeaning conversations that were heard yesterday, to begin to
address the state of emergency in African American communities. Action
must be taken, and as the Presidential Advisory Council on HIV/AIDS, you
have been sworn to take action.

**Adjourn**

Dr. Maxwell thanked members for their participation and adjourned the
meeting.

**Future meeting dates**

Domestic Subcommittee: September 10, 2007

International Subcommittee: September 17, 2007

Full Council: October 15--16, 2007