Presidential Advisory Council on HIV/AIDS

**23rd Meeting**

**Hubert Humphrey Building**

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

**Washington, DC**

August 7--8, 2003

**MINUTES**

Contents

**WELCOMING REMARKS** [5](#welcoming-remarks)

Louis Sullivan, MD, Co-Chair [5](#louis-sullivan-m.d.-co-chair)

Josephine Robinson, Acting Executive Director
[5](#josephine-robinson-acting-executive-director)

Joseph O'Neill, MD, Director, White House Office of National AIDS Policy
[5](#joseph-oneill-m.d.-director-white-house-office-of-national-aids-policy)

**PREVENTION SUBCOMMITTEE---Anita Smith, Chair**
[6](#prevention-subcommitteeanita-smith-chair)

Advancing HIV Prevention: New Strategies for a Changing Epidemic, US
2003---Ronald O. Valdiserri, MD, MPH (CDC)
[6](#advancing-hiv-prevention-new-strategies-for-a-changing-epidemic-u.s.-2003ronald-o.-valdiserri-m.d.-m.p.h.-cdc)

Discussion [7](#discussion)

How Can We Become More Effective in Preventing HIV Infection among Young
People---Lloyd Kolbe, PhD (CDC)
[9](#how-can-we-become-more-effective-in-preventing-hiv-infection-among-young-peoplelloyd-kolbe-ph.d.-cdc)

*Discussion* [10](#discussion-1)

How Drug Use Exacerbates the Risk for HIV/AIDS---Donal Vereen, MD (NIDA)
[11](#how-drug-use-exacerbates-the-risk-for-hivaidsdonald-vereen-m.d.-nida)

How Substance Abuse Exacerbates Risk Behaviors for HIV/AIDS---H. Westley
Clark, MD, JD, MPH (SAMHSA)
[12](#how-substance-abuse-exacerbates-risk-behaviors-for-hivaidsh.-westley-clark-m.d.-j.d.-m.p.h.-samhsa)

*Discussion* [13](#discussion-2)

**PUBLIC COMMENT** [14](#public-comment)

Gene Copello---Florida AIDS Action/Southern AIDS Council
[14](#gene-copelloflorida-aids-actionsouthern-aids-council)

Murray Penner---NASTAD [15](#murray-pennernastad)

Jesse Milan, Jr.---CDC AIDS Advisory Committee
[15](#jesse-milan-jr.cdc-aids-advisory-committee)

Camron Craig---New York City AIDS Housing Network
[15](#camron-craignew-york-city-aids-housing-network)

Shirine Mohagheghpour---Planned Parenthood Federation of American
[15](#shirine-mohagheghpourplanned-parenthood-federation-of-american)

Lavern Holley---New York City AIDS Housing Network
[15](#lavern-holleynew-york-city-aids-housing-network)

Ronald Johnson---Public Affairs and Education Officer, National Minority
AIDS Council
[15](#ronald-johnsonpublic-affairs-and-education-officer-national-minority-aids-council)

Shana Doucette---Senior Student at Santa Clara University
[16](#shana-doucettesenior-student-at-santa-clara-university)

Mary Schmidt---Student at Marquette University
[16](#mary-schmidtstudent-at-marquette-university)

Bonnie Marshall---Sisters for Life and the Global Initiative on AIDS
[16](#bonnie-marshallsisters-for-life-and-the-global-initiative-on-aids)

Jennifer Flynn---New York City AIDS Housing Network
[16](#jennifer-flynnnew-york-city-aids-housing-network)

**TREATMENT AND CARE SUBCOMMITTEE---Brent Minor, Chair**
[16](#treatment-and-care-subcommitteebrent-minor-chair)

HIV and Hepatitis C Co-Infection--Victoria Cargill, MD (OAR)
[16](#hiv-and-hepatitis-c-co-infectionvictoria-cargill-m.d.-oar)

*Discussion* [17](#discussion-3)

An Assessment of the Ryan White CARE Act---Patricia Bass, RN, MA (CAEAR
Coalition)
[19](#an-assessment-of-the-ryan-white-care-actpatricia-bass-r.n.-m.a.-caear-coalition)

*Discussion* [19](#discussion-4)

Condom Promotion for AIDS Prevention in the Developing World: Is It
Working---Norman G. Hearst, MD (University of California--San Francisco)
[20](#condom-promotion-for-aids-prevention-in-the-developing-world-is-it-workingnorman-g.-hearst-m.d.-university-of-california-san-francisco)

*Discussion* [21](#discussion-5)

**INTERNATIONAL SUBCOMMITTEE---Abner Mason, Chair**
[22](#international-subcommitteeabner-mason-chair)

Socio-political Assessment of Emergency Plan for AIDS Relief (EPAR)
Recipient Countries---George Ayittey, Ph.D. (American University, Free
Africa Foundation)
[22](#socio-political-assessment-of-emergency-plan-for-aids-relief-epar-recipient-countriesgeorge-ayittey-ph.d.-american-university-free-africa-foundation)

Discussion [23](#discussion-6)

**RESOLUTIONS** [24](#resolutions)

Prevention---Council Discussion [24](#preventioncouncil-discussion)

Local Involvement [24](#local-involvement)

Treatment and Support Services for Substance and Drug Users
[25](#treatment-and-support-services-for-substance-and-drug-users)

Prevention Subcommittee [26](#prevention-subcommittee)

Treatment and Care---Council Discussion
[27](#treatment-and-carecouncil-discussion)

Hepatitis C [27](#hepatitis-c)

AIDS funding [28](#aids-funding)

International Resolutions---Council Discussion
[29](#international--council-discussion)

Emerging Epidemic in China, India, and Other Countries
[29](#emerging-epidemic-in-china-india-and-other-countries)

Trade-Related Intellectual Property Agreement
[29](#trade-related-intellectual-property-agreement)

**CONCLUDING REMARKS** [31](#concluding-remarks)

**FINAL RESOLUTIONS** [**Error! Bookmark not
defined.**](#__RefHeading___Toc48544058)

Prevention Subcommittee Motion #1: [**Error! Bookmark not
defined.**](#__RefHeading___Toc48544059)

Prevention Subcommittee Motion #2: [**Error! Bookmark not
defined.**](#__RefHeading___Toc48544060)

Prevention Subcommittee Motion #3: [**Error! Bookmark not
defined.**](#__RefHeading___Toc48544061)

Treatment and Care Subcommittee Motion #1: [**Error! Bookmark not
defined.**](#__RefHeading___Toc48544062)

Treatment and Care Subcommittee Motion #2: [**Error! Bookmark not
defined.**](#__RefHeading___Toc48544063)

International Subcommittee Motion #1: [**Error! Bookmark not
defined.**](#__RefHeading___Toc48544064)

International Subcommittee Motion #2: [**Error! Bookmark not
defined.**](#__RefHeading___Toc48544065)

International Subcommittee Motion #3: [**Error! Bookmark not
defined.**](#__RefHeading___Toc48544066)

**AGENDA** [34](#agenda)

**MATERIALS PRESENTED AT THE MEETING**
[36](#materials-presented-at-the-meeting)

***Meeting Report Prepared by:***

***Winfield Swanson, ConsultantSocial & Scientific Systems, Inc.***

*August 7, 2003*

# **WELCOMING REMARKS**

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

Dr. Sullivan thanked former members---Caya Lewis, John Perez, and Ingrid
Duran---and introduced three new members:

-   Dr. Edward C. Green, medical anthropologist and senior research
    scientist at Harvard School of Public Health;

-   Dr. Franklin Judson, director, Public Health Department for the City
    of Denver, and president of the International Union against Sexually
    Transmitted Diseases; and

-   Dr. Beny J. Primm, president, The Addiction Research and Treatment
    Corporation in New York (one of the largest minority substance abuse
    treatment programs).

## Josephine Robinson, Acting Executive Director

This was the first PACHA meeting Ms. Robinson organized for the
34-member Council. She thanked everyone for the opportunity to serve,
gave logistical directions, and announced the arrival of a program
assistant for PACHA, Dana Ceasar.

## Joseph O'Neill, M.D., Director, White House Office of National AIDS Policy

Three areas are the most important: domestic agenda, global agenda, and
prognostications. Strides made in the last year have changed existing
policy, namely, with the Food and Drug Administration (FDA)'s approval
of the rapid test for HIV, and with the Centers for Disease Control and
Prevention (CDC)'s new HIV testing guidelines, which incorporate HIV
testing into the mainstream of medical care. To prevent losing ground in
minority communities, the White House needs PACHA's ongoing guidance and
thought.

On the domestic front, implementation and refinement of new testing
approaches is a hugely important step for public health in this country.
There is also a huge problem with access to medical treatment and
pharmaceuticals, which will only get worse. But a number of changes are
in motion in health care financing, all of which will be important to
people living with AIDS (PLWAs). At the same time, tough structural
issues need to be dealt with in a time of tough budget constraints
(Joshua Bolton is in charge of budget), and every organization will have
to determine what is less important. These decisions require PACHA's
input. Ryan White reauthorization will come up, and this Administration
will take strong policy positions. It is very important that this
Council hear from a wide variety of people and issues. The President
wants the best advice he can get and is not afraid of hearing things he
disagrees with.

On the global front, Randy Tobias (Eli Lilly CEO) has been nominated to
be the Global AIDS Ambassador and, to implement the new initiative, a
skeleton crew is setting up an office at the State Department. For the
President's Maternal--Child Transmission initiative, resources have been
quickly deployed to 14 countries. This is also one of the first times an
Administration is poised to release RFAs jointly from the Department of
Health and Human Services (DHHS) and the U.S. Agency for International
Development (USAID); this action will bring the development world and
the health world together. The President has promised that the Global
AIDS Program would have the money needed, and he wants to see results
and accountability.

# **PREVENTION SUBCOMMITTEE---Anita Smith, Chair**

This subcommittee tackled three topics: the new CDC guidelines, youth,
and substance abuse and HIV. Each of the speakers had also spoken at the
last subcommittee meeting.

## Advancing HIV Prevention: New Strategies for a Changing Epidemic, U.S. 2003---Ronald O. Valdiserri, M.D., M.P.H. (CDC)

CDC and the Health Resources and Services Administration (HRSA) each had
an advisory committee to look at HIV/AIDS; the two merged in September.

Dr. Valdiserri reviewed the epidemiological science behind the new
initiative: Between 1981 and 2002 in the United States there were
859,000 cases of HIV/AIDS and 487,672 deaths. In the mid-1990s the
incidence dropped because of better treatment, meaning that the period
between infection and symptoms lengthened; deaths dropped a few years
later but are beginning to level off. However, the number of PLWAs is
steadily increasing, and consequently opportunities for transmission are
also increasing.

For the third year in a row, diagnoses among men who have sex with men
(MSM) have increased. Concurrently, there have been three outbreaks of
syphilis among MSMs---in Miami, New York City, and Los Angeles. This is
a matter of concern because of what it might imply about HIV/AIDS. Of
the people who know they're HIV+, 40 percent engage in vaginal or anal
intercourse but use condoms correctly; 27 percent abstain; 15 percent
have sex with one HIV+ partner; and 14 percent have unprotected sex. We
need to do a better job of delivering ongoing prevention messages among
sexually active persons. Of the 850,000 to 950,000 PLWAs in the United
States, an estimated 180,000 to 280,000 do not know they're infected.
Too many get tested late in the infection when treatment won't be
maximally effective. As for perinatal transmission, 300 babies are
infected annually.

The goal of CDC's new initiative is to reduce HIV transmission by
reducing barriers to testing, increasing access to and utilization of
quality medical care and treatment, and continuing ongoing prevention
services. These are not new policy issues.

At the end of 2002, the Institute of Medicine (IOM) advocated
strengthening programs to help PLWAs, namely:

-   Make voluntary HIV testing a routine part of medical care,

-   Implement new models for diagnosing HIV infection outside medical
    settings,

-   Prevent new infections by working with persons diagnosed with HIV
    and their partners, and

-   Further decrease perinatal HIV transmission.

Health care delivery people need consultation with PLWAs to recognize
the reality that they are sexually active and some have multiple
partners.

In the perinatal component, HIV testing is now being offered to pregnant
women with opt-out provision, the same way other tests are offered.

CDC has not clearly communicated what the guidelines are about. CDC
will:

-   continue to support efforts to keep HIV-negative people healthy;

-   continue to fund community-based organizations (CBOs), especially
    those serving minorities;

-   continue to rely on behavioral prevention approaches;

-   continue to support community planning; and

-   continue to support voluntary testing.

Several specific activities were mentioned. In mid-July, CDC published
(with HRSA) *Incorporating HIV Prevention into the Medical Care of
Persons Living with HIV.* Also in July, CDC hosted a meeting of medical
and nursing associations. Health departments are required to make PLWAs
their highest priority for prevention services. Demonstration projects
were recently solicited. In August CDC plans a consultation with PLWAs,
who are inadvertently stigmatized. The new OraQuick test kit provides
diagnosis within 20 minutes; people are now being trained to use it. CDC
also plans to monitor how well the initiative is working.

### *Discussion*

[Ms. Robinson:]{.underline} A breakdown of the budget will be available
tomorrow.

[Ms. Ivantic-Doucette:]{.underline} There are legal considerations. For
example, in Milwaukee, a pregnant, HIV-positive woman went to a clinic
for perinatal testing and did not consent to HIV testing. (She knew she
was HIV-positive but didn't want her partner to know.) She was
accidentally tested and sued the OB-GYN, who is closing his practice.

[Dr. Valdiserri:]{.underline} The State can make laws about testing, and
CDC is trying to become better informed to know what the State laws are.
No one is suggesting that informed consent be done away with, but that
an opt-out provision be available.

[Mr. Sneed:]{.underline} Mr. Sneed has seen some past failures. Of the
some 180,000 to 280,000 who don't know they're HIV-positive, how many
are MSM and how many African American? What about the 41 percent who
were diagnosed late in the disease? What are ongoing prevention
services?

[Dr. Valdiserri:]{.underline} We can assume that racial and ethnic
minorities are overrepresented and also that MSM are a significant
component. The highest incidence occurs among young African American
MSM. Ongoing prevention, for the private sector, means understanding
what's happening with your patient's sexual behavior and it means
screening for other sexually transmitted diseases (STDs). For
nongovernmental organizations (NGOs), it may mean more in-depth
counseling sessions. Studies have shown that stress reduction is helpful
to PLWAs.

[Mr. Sneed:]{.underline} Psychosocial support issues are important and
will have to be incorporated.

[Dr. Sweeney]{.underline}: She is concerned about testing without
pre-test counseling, which gets into issues of telling partners.

[Dr. Valdiserri]{.underline}: Once people learn they're HIV-positive,
they increasingly engage in safer sex. Most people are very motivated
not to spread the virus. Pre-test counseling is very important in the
private sector, but CBOs have other issues such as quality assurance and
privacy rights. In some settings, pre-test counseling was seen as a
barrier to testing; post-test counseling could be effected by referral
to resources in the community. This would address the time limitations.
We need to develop models so other resources in the community can pick
up the slack (as was done with prevention of smoking).

[Ms. Rock]{.underline}: What about at-risk prevention in directly funded
communities? Increased diagnosis will increase incidence, which will
increase reliance on Ryan White CARE.

[Dr. Valdiserri]{.underline}: Having CBOs apply directly to CDC for
resources is under discussion. The initiative's focus is on counseling
and testing, but a third domain focuses on ongoing prevention support to
stay safe and to work with partners (especially if they are
seronegative). The announcement will probably be published in November
and will indicate dollar amounts for various activities. CDC and HRSA
still think early diagnosis is important, but it is true that funding
for care is an issue.

[Dr. Reznik]{.underline}: People recently diagnosed will be coming into
care in 2004 and 2005 in both the public and private sectors. What work
is being done to translate these numbers of incidence into realistic
budget projections for treatment and support?

[Dr. Valdiserri]{.underline}: Some information we have; some we don't.
Everyone identified will not seek care through Ryan White money. More
resources will be needed, an issue PACHA might want to take up.

[Dr. Primm]{.underline}: How will consultation with the HIV-positive
community be done? At point-of-care testing, doctors must have a clear
waiver. With rapid testing, the additional confirmatory test should also
be done.

[Dr. Valdiserri]{.underline}: CDC has a history of consulting with PLWAs
and has rapport with NAPLWA. It would be a consultation with the
HIV-positive community in Atlanta working closely with CBOs to get the
information. Rapid testing is not The Answer (for one thing, it is much
more expensive), but it is helpful. CDC intends to move slowly and with
purpose and foresight. So, we need to find out how to work with the best
public health community for the best outcome to patients.

[Mr. Minor]{.underline}: Mandatory partner notification might keep
people from being tested and it also has legal aspects. Many liaisons
occur through the Internet. How aggressive is CDC in tracking people?
How does community planning balance with prevention programs that have
been cut or reduced?

[Dr. Valdiserri]{.underline}: The Internet is a very important risk
venue. CDC is involved in research activities to find how to best reach
out to high-risk persons. Partner notification has been a required
activity of State health departments since the early 1990s, but the
reality is that some States do a better job than others. CDC would
consider an appropriate level of tracking activity. To prevent
criminalization and stigmatization, CDC will have to work more closely
with PLWAs.

The Stop AIDS Program is still receiving CDC funds, but CDC sent the
group a letter saying that some materials they had developed appeared to
encourage sexual promiscuity. CDC will continue to work with sexually
active people; their main concern is preventing transmission of STDs,
and sex is the usual way they are transmitted.

[Dr. Judson]{.underline}: CDC and HHS are getting together, but to
really make progress, prevention has to go well beyond CDC's guidelines.
It has to be a regular practice with its own funding mechanism. The
obvious place is to have Ryan White incorporate HIV testing as a regular
practice.

[Dr. Valdiserri]{.underline}: Of the \$35 million earmarked for AIDS,
about \$13 million is new funding; the rest is renewed. Developing
infrastructure is expensive. With small health staff, it's about
training and awareness of current developments in the field. Community
planning involves looking at what is happening in the epidemic in your
area, what's happening in treatment development, what's happening with
PLWAs. Government alone cannot stop this epidemic. We have to do a
better job of working with the private sector.

## How Can We Become More Effective in Preventing HIV Infection among Young People?---Lloyd Kolbe, Ph.D. (CDC)

The number of 15- to 19-year-old females who engaged in sexual
intercourse doubled in the 1980s and 1990s. The 13- to 24-year-old
population is a 10-year age group, whereas all the other age groups span
20 years. These young people will age through the older cohorts, so
being effective at age 13 implies being effective at the older ages.
There were 3 million other newly diagnosed STDs/year. This age group
suffers from other STD epidemics, e.g., gonorrhea, chlamydia, and
herpes. They also experienced nearly 1 million pregnancies.

Prevention programs can only be effective if they work with the social
institutions that most influence young people, namely, parents, schools,
etc.

CDC's goal is to decrease the incidence of HIV infection by 25 percent
by 2005. To do this, they will work with CBOs and NGOs like the National
Commission on Correctional Health Care, and they will implement
school-based strategies. Now almost 90 percent of schools give HIV
education; in 1991 few did. In that decade we have seen a major increase
in abstinent young people, a major decrease in pregnancies, a major
increase in condom use, and a decrease in multiple partners. However, as
a Nation we need to do a better job of preventing high-school
intercourse. Despite these improvements, the use of drugs and alcohol
has increased (from 22 percent to 26 percent).

Gay, lesbian, and bisexual youth remain a concern. Some 20 percent
missed school because they didn't feel safe; 36 percent had attempted
suicide; 24 percent of the girls had been pregnant at least twice. Youth
in high-risk situations are those who sell or barter sex; those who live
in juvenile justice facilities or in runaway and homeless shelters;
those who use STD clinics, mental health facilities, alcohol and drug
abuse treatment; those who are members of gangs or are migrants.

Efforts to prevent HIV infection should be integrated with efforts to
prevent other STDs and unintended pregnancy. Likewise, State education
associations should integrate prevention activities with health
departments.

Sex in the media has adverse effects and we need to learn how to reduce
those effects. The new initiative is a major issue for young people. For
instance, we need to understand the extent to which children receive
age-appropriate counseling. Risk reduction should be integrated with
youth development efforts. Clustering phenomena potentiates the
opportunity. In order to focus adequate attention on young people,
people with different perspectives must find the will and the means.

### *Discussion*

[Ms. Clements]{.underline}: How young should children be tested?

[Dr. Kolbe]{.underline}: In the early elementary grades children need to
understand the concept of infection. Toward the middle grades and high
school grades we should provide more information about how HIV/AIDS is
acquired. What they learn in school depends on their community.

[Ms. Ivantic-Doucette]{.underline}: Values and attitudes begin
developing by age 6; after that, it's a matter of refining them. The
greatest influence is the family. What recommendations do you have for
prevention?

[Dr. Kolbe]{.underline}: We must help children to develop competence,
confidence, caring, connections, contributions, and character. It's
important to provide infrastructure and support to address HIV/AIDS and
other epidemics, e.g., violence and substance abuse.

[Dr. McIlhaney]{.underline}: Some would refer to peer-based education.
Regardless, we need to give kids a vision of what life can be. We should
deliver the STD risk message, incorporating a vision of possibilities.

[Dr. Kolbe]{.underline}: We need to be honest with young people as to
what we know and don't know about the efficacy of condoms. We must do a
better job of helping them understand and of motivating them to use
condoms. The HIV epidemic was responsible for building the adolescent
and school health program at CDC; Congress provided the money. We need
to deal with a wide range of other illnesses, so we should build
infrastructure in a way to address other illnesses in addition to
HIV/AIDS. We should give young people the opportunity to be risk-free
and prepared for life.

[Mr. Sneed]{.underline}: Many organizations are primarily for
heterosexual youth. What about gay, lesbian, bisexual youth? They're
prisoners of psychic isolation and have to learn on the street.
Renaissance III (Mr. Sneed's organization) opened a center for gay,
lesbian, bisexual youth, the first in Texas.

[Dr. Kolbe]{.underline}: It's far more controversial to do the same
things among these youth, although the data are very clear about the
wide range of public health needs. The problems are further compounded
when you cross these people with communities of color. We need specific
focused attention to address these young people.

[Ms. Shoemaker]{.underline}: What guidelines can we use when we speak in
the schools in this age of budget decreases?

[Dr. Kolbe]{.underline}: This Council can address the budget issue to
recall our Nation's focus to the needs of young people. The controversy
is not insignificant, but PACHA could call people together to ask them
to state their concerns.

## How Drug Use Exacerbates the Risk for HIV/AIDS---Donald Vereen, M.D. (NIDA)

Drug abuse is a huge but hidden problem. Drug use relates to AIDS in
actual transmission of HIV and also in its direct effect on the
progression of the disease. The disease is transmitted through shared
needles, worsened by the poor decision-making of the drug-influenced
mind. HIV incidence among MSM has increased as incidence from
heterosexual contact has increased, while incidence among injecting drug
users (IDUs) has remained the same. All three are related to drug use,
which accounts for about half the cases of AIDS. Heterosexual male IDUs
are most commonly implicated in disease transmission, followed by female
IDUs, and then MSM IDUs. Since 1990 we have seen increases in the number
of: children infected by their mother (from 4 percent to 17 percent);
women infected by their husband (from 8 percent to 29 percent); men
sharing needles (from 5 percent to 30 percent); and MSM (7--8 percent to
9 percent).

Drugs can interfere with judgment and reduce inhibitions, both of which
are related to risk-taking behavior. Drug-addicted people often sell sex
to obtain drugs. In addition, accumulating evidence indicates that some
drugs (methadone or morphine, cocaine, methamphetamine) exacerbate AIDS
progression by enhancing viral replication and infectivity. They also
exacerbate changes in the brain relating to dementia. Lastly, drugs
release dopamine, which gives the drug user excessive feelings of
pleasure, so that users might substitute drugs for other pleasurable
experiences.

Therefore, the most effective HIV/AIDS prevention strategy is drug abuse
treatment. Any type of treatment slows seroconversion. This is
science-based behavioral treatment. A national drug abuse treatment
clinical trials network is underway.

*Principles of Prevention* (known as the "Red Book") and other
information are available on the Web (\<www.nida.gov\>).

## How Substance Abuse Exacerbates Risk Behaviors for HIV/AIDS---H. Westley Clark, M.D., J.D., M.P.H. (SAMHSA)

The Substance Abuse and Mental Health Services Administration (SAMHSA)'s
mission is to build resilience and to facilitate recovery. SAMHSA's
programs (e.g., co-occurring disorders, substance abuse treatment,
HIV/AIDS and hepatitis, criminal justice) are all treated in light of
crosscutting principles (e.g., data and evidence-based outcomes,
collaboration with public and private partners, cultural competency,
recovery, reducing stigma and barriers to service). Mr. Curry wants to
focus on a few major programs rather than on many smaller ones.

IDUs represent the largest HIV-infected substance-using population in
the United States. Sexual contact among IDUs is characterized by
multiple partners, unprotected intercourse, and exchange of sex for
drugs.

Of reported AIDS cases, IDU is involved in 57 percent of cases among
women, 52 percent of reported pediatric AIDS cases, and 31 percent of
all male AIDS cases. Treatment Improvement Protocol #37 outlines
substance abuse treatment for persons with HIV/AIDS and includes medical
assessment, mental health needs, counseling, integration of services,
use of case managers, legal, ethical and privacy issues, and funding and
policy considerations. Addiction is a treatable disease, but we must
improve service delivery. Recovery Month (*see*
\<www.recoverymonth.gov\>) was initiated to induce all levels of society
to work toward enhancing addiction treatment access, availability, and
quality.

For more information on SAMHSA's and the Center for Substance Abuse
Treatment (CSAT)'s programs, see \<www.samhsa.gov\>.

### *Discussion*

[Mr. Sneed]{.underline}: In the South, care providers say crack cocaine
is the #1 drug connected with HIV transmission. Is SAMHSA refocusing any
of its programs? Have CBO contracts been audited?

[Dr. Clark]{.underline}: Crack cocaine is associated with sexual
activity, but in some areas there's no cocaine and the real question is
sexual behavior fueled by psycho-active drugs. You must know the
epidemiology of your community. SAMHSA has tried to work with the CDC to
get the latest information. As for auditing, SAMHSA operates under a
Government Performance Act that requires a task force to look at how
money in block grants is being spent. Under set-asides, States are the
responsible entities, so we work with them so they can spend the money
wisely.

[Dr. Vereen]{.underline}: A State-based household survey is emerging,
but the Government hasn't started to compare States. States will be able
to use the survey to customize their programs. The natural tendency is
to develop programs geared to a specific drug, but we should intensify
comprehensive anti-drug activities. For example, while public health
people focused on treating heroine addiction, cocaine came in "the back
door."

[Ms. Ivantic-Doucette]{.underline}: At Marquette University they're
trying to work with the positives around risk behavior. What about the
drug-using population that is infected? Clinicians don't understand drug
treatment or drug use---in studying the behavior of health care workers,
they find that it takes 17 years to incorporate a new treatment method.
An example is the finding that over time people with HIV/AIDS develop
pain. Pain is poorly understood and treated, so these people return to a
methodone program to take care of pain. If they can't manage their pain
sufficiently, they return to the community and to substance abuse. The
flip side is that if you reduce pain, you reduce substance abuse. Is
anyone thinking about this? What about the linkages for the positives?

[Dr. Vereen]{.underline}: The National Institutes of Health (NIH) are
engaged in a number of exercises to re-tool to focus on real-world
entities. At the National Institute on Drug Abuse (NIDA), often the
kinds of issues you raise come from clinicians who are not involved in
research. Researchers need to develop more on how knowledge gets
transferred and translated. There is no national institute on pain;
instead we have to organize five, six, or seven Institutes to deal with
pain. The National Institute of Dental and Craniofacial Research works
on pain more than any other Institute.

[Dr. Primm]{.underline}: Both Dr. Clark and Dr. Vereen are
psychiatrists, but neither talked about the mental health issues. The
Office of AIDS Policy and the Office of National Drug Control Policy
need to talk about this as well as about IDU and paraphernalia.

[Dr. Vereen]{.underline}: It has been frustrating as the only physician
in the Office of the National Drug Control Policy working on issues
related to AIDS and also on other mental health issues, e.g.,
co-occurring disorders. The top level isn't addressing mental health,
but in Government agencies there's a lot of discussion under the top
level.

[Dr. Clark]{.underline}: We are dependent on groups like PACHA for input
to be sure these issues aren't forgotten in times of limited resources.

[Mr. Nickerson]{.underline}: Substance abuse treatment is effective in
preventing HIV. Is this self-selecting? Sixty-one percent of people have
never sought treatment---how can we reach them?

[Dr. Vereen]{.underline}: The slide included people in coerced treatment
(there was still a delaying effect with seroconversion). Some States
don't spend all of their block grant money for treatment. Needle
exchange, as part of a comprehensive drug program, acts like an outreach
program. Increasing the number of relationships an addict has with other
persons or institutions drives the treatment program.

[Rev. Sanders]{.underline}: Do you use research from other institutions,
specifically regarding the decline in IDU? To what degree have SAMHSA
and NIDA looked at the new CDC initiative, and how does it relate to
your own new initiatives?

[Dr. Vereen]{.underline}: As a research agency, NIDA's approach would be
to determine what research questions have to be asked to address the
initiative. NIDA also works on the findings with the people in place to
actually use the research results in new publication, for example.

[Dr. Clark]{.underline}: SAMHSA is working with CDC, HRSA, and the
National Institute of Mental Health (NIMH) to align SAMHSA's new efforts
to translate them into service-driven, service-delivery systems. Part of
our task is education. But there will be a lag time while we figure out
the strategy. We use input from groups like PACHA.

# **PUBLIC COMMENT**

## Gene Copello---Florida AIDS Action/Southern AIDS Council

At the last PACHA meeting concerns for the southern region were
distributed, namely, that the South is heavily affected (a third of
PLWAs live there), but it is underfunded. Three policy positions will be
presented in New Orleans this winter:

-   All persons must have access to prevention.

-   All PLWAs must have access to care.

-   Support for all regions is needed, but the South must have support
    in proportion to its infected population.

Mr. Copello has not heard from PACHA or the Administration.

## Murray Penner---NASTAD

NASTAD represents HIV/AIDS directors throughout the States and
Territories. States intend to implement restrictions as shortfalls occur
in ADAP, which serves more than 2 million people annually. NASTAD
requests that PACHA request the President to request increased funding
from Congress.

## Jesse Milan, Jr.---CDC AIDS Advisory Committee

The CDC AIDS Advisory Committee recommends that PACHA and CDC/HRSA
committees have mutual liaisons. Mr. Milan urges PACHA to act on that
recommendation at this meeting. The CDC committee recommended the
formation of a national plan.

## Camron Craig---New York City AIDS Housing Network

Mr. Craig, infected since 1996, gave testimony to Congressman Velasquez
and now he's giving testimony again. We know that education and
prevention work and that abstinence hasn't worked since Adam and Eve.
When the epidemic first occurred, faith-based organizations wanted
nothing to do about it. Now the President wants to give these
organizations money to do something they never wanted to be involved
with in the first place!

## Shirine Mohagheghpour---Planned Parenthood Federation of American

Combating the spread of HIV/AIDS is a national priority. Nevertheless,
infection among some groups is increasing. Young people need sex
education that will prevent STDs and unintended pregnancy. Despite the
evidence, Congress has committed funds for abstinence-only programs and
prevents groups from mentioning condoms, except to say they don't work.
Federally funded programs continually discount the benefits of condoms.
Abstinence must be included, but not at the expense of facts.

## Lavern Holley---New York City AIDS Housing Network

Prevention works. Faith works only when combined with prevention. You
can't tell kids not to have sex. This can be done only by CBOs, not
faith-based organizations, because faith-based organizations only want
to say "no."

## Ronald Johnson---Public Affairs and Education Officer, National Minority AIDS Council

Gay PLWAs are continually confronted with stigmatization of being gay or
having AIDS. Prejudice and stigma are prevalent in our community. Mr.
Johnson is concerned about unintentional stigmatization that may result
from CDC's new initiative. He asks PACHA to ask the Administration to
form a broader study. New strategies should be subjected to rigorous
peer review before they are implemented.

## Shana Doucette---Senior Student at Santa Clara University

Ms. Doucette would like to underscore the importance of educating our
youth. Because of normal cervical development, delaying sex by 1 year
makes a difference in the likelihood of HIV transmission, but girls
don't know this. They also don't know there is medication to prevent
infection from date rape. Ms. Doucette has witnessed the impact this
lack of education has had on her peers. Youth need information to be
able to make informed decisions.

## Mary Schmidt---Student at Marquette University

Ms. Schmidt strongly supports youth involvement in PACHA. Engaging
children at a young age makes sense because children are often the
experts in making plans for policies that affect them. Children and
youth have a real need for information and support, and have something
to offer in return.

## Bonnie Marshall---Sisters for Life and the Global Initiative on AIDS

President Bush chose not to release a bundle of money on the AIDS bill
right now. This was the right decision because there's no infrastructure
for accountability. Secondly, black women have not been mentioned even
though they are on the front lines. Abstinence works, so you can't say
abstinence has no place. Ms. Marshall's challenge to PACHA is, why black
women, who have the highest rate of AIDS, aren't on the agenda.

## Jennifer Flynn---New York City AIDS Housing Network

Ms. Flynn spends hours finding housing, getting Medicaid "turned on,"
and other tasks. All of these other issues are intertwined with AIDS.
Science says, "Programs that talk openly and frankly about AIDS in their
community's language are the only ones that work." Condoms save lives.
Ms. Flynn hopes programs that talk openly about sex and drugs will be
funded.

# **TREATMENT AND CARE SUBCOMMITTEE---Brent Minor, Chair**

The Treatment and Care Subcommittee dealt with two specific issues:
hepatitis C and funding of HIV/AIDS care. The impact of co-infection is
too dramatic to be ignored. In addition to Dr. Cargill, Jody Rich (Brown
University) and Jules Levin (MCAP) also spoke at the Committee's meeting
3 weeks ago.

## HIV and Hepatitis C Co-Infection--Victoria Cargill, M.D. (OAR)

HIV and HCV produce about the same number of virions per day. Of some 4
million people infected with HCV (30,000 new infections/year), about 10
percent are co-infected with HIV; of about 450,000 infected with HIV,
half are co-infected with HCV. But Dr. Cargill's work in a Southeast
D.C. clinic shows that its clients have gone from being half co-infected
to 98 percent co-infected. At the Johns Hopkins University clinic,
nearly 90 percent of IDUs are co-infected. People are living longer now,
so they tend to die of end-stage liver disease. In 1998, a third of
patients had to stop highly active antiretroviral therapy (HAART)
because of liver toxicity.

HIV co-infection accelerates the progression of HCV fibrosis and causes
death from liver disease while preventing the afflicted from taking
HAART. HCV accelerates HIV disease progression and may blunt the CD4
response to HAART. As HIV progresses, so does HCV. There is a racial
difference in HCV; type 1 most often affects African Americans.
Sustained virological response in HCV type 1 is 50 to 60 percent; in
type 2 it is 80 percent.

### *Discussion*

[Mr. Sneed]{.underline}: The material Mr. Sneed has read about HCV
protease inhibitors makes them seem promising without side effects.
Should we fast-track some of these medications, as we did with ARV?

[Dr. Cargill]{.underline}: There are other drugs in clinical trials.
Some data suggest significant toxicity. We know a lot about HIV, but
there are a lot of questions about the HCV virion we can't answer. Some
data suggest that even persons treated with drugs with side effects, on
liver biopsy, show that change was made. You can't fast-track something
you don't have. We do have prevention. It takes up to 18 months to get
infected with HIV, but only about 2 to get infected with HCV.

[Dr. McKinnell]{.underline}: Drug discovery to the marketplace is a 6-
to 8-year process; if any drugs show promise, drug companies will go to
the FDA to get them fast-tracked. Can we say early treatment with HCV
will make a difference?

[Dr. Cargill]{.underline}: There's no reason to suggest that early
intervention would not make a difference. With HCV, people may think
they have a cold or mild flu, so they don't get diagnosed.

[Ms. Ivantic-Doucette]{.underline}: Who in the health care provider team
will be managing the patients? From HIV studies we know that without a
significant number of patients in your practice, you can do harm. What
recommendations do you have about credentialing or competency?

[Dr. Cargill]{.underline}: There's already a looming debate among those
who care for HIV patients. HIV care is not something anyone takes on
easily. The challenges are formidable because it requires a
multidisciplinary staff---liver biopsies, psychological support, etc.,
in addition to pharmaceuticals and substance abuse treatment. There has
been no clinical trial, but we may not need one. Dr. Cargill would
recommend guidelines; but to require certification in areas like
this---one that has 12 times the incidence as the national average, or a
rural area that links with urban learning---could mean that those
patients have no care at all.

[Ms. Rock]{.underline}: When you have a 15-year-old who's pregnant and
HIV-positive, it is the girl's right not to have the mother present, but
the mother is responsible for her and whether she takes her treatment.

[Dr. Cargill]{.underline}: There's no one-blanket solution. We have to
trust that as human beings we'll make the right decision in these
complex situations. Nothing in medical school prepared Dr. Cargill to
deal with 14-year-olds having sex in alleys to avoid their mothers'
boyfriends' advances.

[Mr. Nickerson]{.underline}: What is your experience in treating people
in conjunction with substance abuse?

[Dr. Cargill]{.underline}: The Consensus Conference changed many
policies; people used to have to abstain for 2 years. However, people
who drink have active APC replication different from people who don't
drink. It's not ethical to treat people who come to the office drunk or
high because they can't understand the treatment. The clinician has to
come to some kind of middle ground.

[Ms. Clements]{.underline}: What about cost and treatment for poor
people?

[Dr. Cargill]{.underline}: Cost is not insignificant. There are some
treatment slots if they're part of a protocol. Dr. Cargill's clinic
provides transportation to ensure that people continue treatment. It
requires creativity.

[Dr. Primm]{.underline}: What is the efficacy of interferon in type 1
HCV?

[Dr. Cargill]{.underline}: Pegasus is sustained much higher (to the 60th
percentile), so they can stop over the weekend; the mental health side
effects are not so severe. The longer you can get people through
therapy, the longer you can stave off hepatocellular carcinoma.

[Dr. Sweeney]{.underline}: She knew of a patient who was doing well on
interferon but discontinued, because she was losing weight and didn't
want people to think she had HIV.

[Dr. Cargill]{.underline}: Weight loss is a side effect. You can try to
adjust therapies, but you're working on a physiological goal.

[Ms. McDonald]{.underline}: OUTREACH, Inc., has a staff of 20; 18 are
HIV-positive and 16 are co-infected. They see about 1,000 clients a
month. Ms. McDonald is afraid to start testing because they have no
access to care.

[Dr. Cargill]{.underline}: Women appear to have a great chance of
clearing HCV infection. If we don't test, we miss an opportunity to
counsel, we miss opportunities to intervene. The client's distress
cannot dissuade us from giving the information we have.

## An Assessment of the Ryan White CARE Act---Patricia Bass, R.N., M.A. (CAEAR Coalition)

The Ryan White CARE Act was authorized in 1990, reauthorized in 1995 and
2000, and will be considered for reauthorization in 2005. The CARE Act
is flexible and responsive. It has evolved along with new technologies,
is responsive to the changing epidemic, and will be able to address
emerging trends through change, development, and refinement. Ryan White
is working and is a safety net for the under- and uninsured. It helps us
to move from a sick-care system to a health-care system by involving
local control---essential and successful; by empowering and involving
PLWAs in decision making; and by enabling community planning and
collaboration among multiple agencies and providers.

Also important is its comprehensive range of services, which support the
public health infrastructure and strengthen other systems of care
including community-based programs. However, ADAP has become a crisis
because there's now an 18-month waiting list; what will happen with the
CDC initiative is unknown.

Issues for 2005 are: distribution of funds; local control and planning
councils (which should include the homeless); support services (which
mean that people will continue to take their HAART); funding for women,
children and youth; quality; and early intervention. However, funding is
for systems, not individuals, and shrinking Medicaid programs will leave
gaps. Meanwhile, we need to talk about a continuum of care, not
segmented services.

### *Discussion*

[Dr. McKinnell]{.underline}: Early treatment saves money in the long
run. What about undocumented residents?

[Ms. Bass]{.underline}: Accountability is very important. Certainly
undocumented people are in Philadelphia's system, but we can't tell how
many.

[Ms. Rock]{.underline}: How can we invite other entities (e.g., the
Department of Social Services) to close some of the gaps and provide a
continuum of care?

[Ms. Bass]{.underline}: Health care providers in the HIV-world are
territorial. Nevertheless, we kept inviting the medical directors of all
managed care organizations in Philadelphia to our meetings and finally
we got them to join in helping to solve the problems.

[Dr. Driscoll]{.underline}: Because new treatments emerge as the
epidemic changes, ADAP is also changing. But, to have accountability,
you have to prioritize.

[Ms. Bass]{.underline}: We're seeing evolving core priorities. This is
the importance of local control.

[Ms. Clements]{.underline}: How can we be sure the dollars keep pace
with the geographic flow (e.g., the difficulties in the South) across
the United States?

[Ms. Bass]{.underline}: The dollars follow the number of clients. But,
we do need to address what's going on in the South.

[Dr. Sweeney]{.underline}: There are people who get diagnosed and
treated in New York, but go home to their family in the South, where
they may not be able to get treated. There must be a way to do this
better.

[Dr. Judson]{.underline}: The best way would be to move forward with
standards of care within Ryan White. Abstinence and drug use behavior
can change, so this should include periodic assessment of the risk of
transmitting to other patients. When the provider accepts a patient,
s/he accepts responsibility to be sure their patient doesn't become the
source of another case.

[Ms. Bass]{.underline}: Our public health perspective should include
primary, secondary, and tertiary care. It's not so much a matter of best
practice---bringing people into care must be connected to keeping them
in care.

[Dr. Green]{.underline}: How is Title 1 funding determined from the EMA?
We need credibility when we ask for more funding.

[Ms. Bass]{.underline}: There's a 10-year band. It's based on a formula
of the number of people living with AIDS, which is reviewed every 5
years.

[Rev. Sanders]{.underline}: Our recommendation is faithful to making the
formula follow the disease.

*August 8, 2003*

## Condom Promotion for AIDS Prevention in the Developing World: Is It Working?---Norman G. Hearst, M.D. (University of California, San Francisco)

Efficacy is the theoretical effect of a treatment used under ideal
conditions. We don't know the efficacy of condoms---no such study has
ever been done and would be unethical. Effectiveness is what happens in
actual practice. For condoms, this can be determined by following
discordant couples and comparing over time. (Meta-analyses show 94
percent effectiveness.)

Condom use in Africa has increased to about 70 percent in some
countries, but HIV prevalence has also risen (e.g., 35--40 percent in
Botswana). However, these numbers don't tell what would have happened if
people weren't using condoms.

Success stories are Thailand and Uganda. In Thailand, the main
transmission involved the commercial sex industry; the health department
focused on this and mandated that brothel owners require condom usage.
They achieved about 95 percent condom use among commercial sex workers,
and with that increase, HIV incidence decreased. But, it wasn't just
condoms: during this period, Thai men decreased use of brothels by about
half.

In the mid to late 1980s, Uganda had one of the highest infection rates.
They responded and brought down HIV prevalence from about 30 percent to
about 5 percent. They did it by abstinence and an advertising campaign
that encouraged remaining faithful to your partner(s). Condoms were not
a big part of the message, but lately they've been a more important part
of the campaign. There's an inherent conflict between a message that sex
is safe as long as you use a condom; and the message that you can't have
casual sex when you live in a country where 20 percent of the people are
HIV-positive. Questions about condom use remain, e.g.: How consistent
does condom use have to be? How high must rates of condom use be to
protect the community? Can a generalized HIV epidemic be overcome
primarily through condoms? How can condom promotion best be integrated
into multifaceted prevention?

We know that:

-   When condoms are used consistently, they are effective but not 100
    percent effective.

-   Condom promotion is proven effective in certain settings (commercial
    sex workers, MSM, etc.).

-   Condom promotion for the general population has not yet produced the
    expected benefits.

-   Sexual behavior change is possible and can make a big difference in
    the epidemic.

Condoms are an important part of any HIV/AIDS program and should be
promoted. But, we can't look at outcomes in terms of condoms only. As
for the ABC program, A and B worked in Uganda, but we don't know if it
would work elsewhere; successful programs must be endogenous. We need to
know how to do A and B and not discourage C; how to do C and not
discourage A and B.

### *Discussion*

[Ms. Freeman]{.underline}: What ages were used in the control group?

[Dr. Hearst]{.underline}: 18- to 25-year-old young men were the only
people we looked at.

[Dr Green]{.underline}: Two A and B programs have been promoted by USAID
in Zambia.

As for condom use with a non-cohabiting partner, 57 percent means 57
percent of the 10 percent of the population that has a non-cohabiting
partner. Most Ugandans don't have casual partners, but among those who
do, condom use is high.

[Dr. Judson]{.underline}: In the 1990s, Dr. Judson worked in Uganda with
pregnant women and military recruits. The general knowledge about HIV
infection has changed enormously, and this change can be attributed to
the culture, religion, and common sense. Feeling at risk is also
important; many of the women knew someone who was sick or had died.
Rates of gonorrhea serve as a surrogate. Before we knew what was causing
HIV, rates had decreased by 50 percent between 1981 and 1982. By 1986,
when government programs began, decreases were already occurring among
gay men. The point is that any intervention must be accompanied by
changes in exposure behavior, which Uganda illustrates.

[Dr. Hearst]{.underline}: Knowing somebody with AIDS is a big part, and
everybody in Uganda knows someone with AIDS. Stigma is also very
important, and in Botswana no one talks about it.

[Mr. Sneed]{.underline}: ABC programs might work in certain populations
and situations in the United States. Information to clarify this might
come from the STD transmission rates during the 1930s and 1950s, and
experience with the A and B then.

[Dr. Hearst]{.underline}: We can't assume that what works in the United
States will work in Africa, nor vice versa.

[Rev. Sanders]{.underline}: We can never talk about the data like that
from Thailand and Uganda without talking about the leadership in those
countries, and the psychosocial attitudes and response. Our message our
President must be clear, and it must be grounded in science. There are
also issues that arise from private conversation versus public and open
conversation. With religious leaders, conversation flows easily when
discussing A and B, but not C. The myths that continue to this day must
also be dealt with (e.g., condoms are the ways the West is actively
spreading AIDS in Africa; condoms are a way to take control from
Africans). We need to give our leadership a voice that is sound
scientifically.

# **INTERNATIONAL SUBCOMMITTEE---Abner Mason, Chair**

We have three resolutions: sociopolitical assessment for the countries,
the emerging epidemic in India and China, and improved AIDS drugs.

## Socio-political Assessment of Emergency Plan for AIDS Relief (EPAR) Recipient Countries---George Ayittey, Ph.D. (American University, Free Africa Foundation)

Various initiatives have been started in Africa but got nowhere, and the
reason had to do not with lack of U.S. political will, but with the type
of government the United States was dealing with.

With a disease with no known cure, the emphasis is on making life for
the victim more comfortable, and on prevention. Treating those already
infected involves enormous costs, beyond the means of poor people.
Modern health care infrastructure in Africa has collapsed in many
countries---only 20 percent of the people have access to modern health
care---so, we must also find a way of delivering the drugs. The vast
majority of Africans rely on traditional medicine and live in rural
areas under the authority of traditional rulers (more than under the
national rulers who live in the capital city). Therefore we must involve
the traditional rulers and traditional healers, because if we don't
involve them they can cause problems (e.g., one, by saying sex with a
virgin would cure AIDS, set off an explosion of rapes in South Africa).

Leaders in Africa have shown no political will or commitment to confront
the disease. They have been in denial. Senegal, Ghana, and Uganda have
been the only countries that made credible efforts to educate their
people. The others did not because they felt uncomfortable talking about
condoms in public. South Africa (which has one of the highest rates of
HIV infection) won a court battle to produce less expensive AIDS drugs;
then it refused to distribute the drugs. Their priorities are
skewed---they claim not to have money for AIDS drugs, but intended to
spend money on weapons at a time when South Africa has no enemies.

### *Discussion*

[Dr. Hu]{.underline}: Without health care infrastructure and
transportation, even if drugs are available, they are not accessible.
The lack of political will is evident in other countries, not just in
Africa. We also need to be sure patients can take the drugs correctly,
e.g., with water and a meal. Without this, the drugs are useless.

[Dr. Ayittey]{.underline}: Behavioral change depends on endogenous
factors, and African leadership has not launched a public awareness
campaign against AIDS. Many feel uncomfortable talking about sex in
public. In Zimbabwe and Namibia, there is the bizarre belief that
homosexuality caused AIDS, so they launched a vicious assault against
homosexuals.

[Dr. Driscoll]{.underline}: The President's initiative aims to put 2
million people into treatment in 14 countries. To do that we have to
take advantage of the one country that has extensive
infrastructure---South Africa. There seems to be no consensus about the
reasons for Mr. Mbecki's behavior. How can we get the South African
Government to change its policy? There's widespread support for a big
change.

[Dr. Ayittey]{.underline}: This is one of the tragic instances in AIDS.
South Africans also have a relatively much higher income than residents
of other African countries. South Africa has far better capacity, even
than Uganda, to launch an effective campaign against AIDS, but Mr.
Mbecki has not shown the leadership. People speculate about why---maybe
to prevent a high-profile campaign that would focus on AIDS and deter
foreign investment. It may also be a response to medical experiments
during the days of apartheid. The dilemma is how you persuade
recalcitrant African leaders to become more committed. This cannot be
dictated from the outside; but traditional leadership might be useful.
Also, the churches have been very effective. Since 1960, there have been
more than 180 African heads of state; fewer than 20 stepped down
voluntarily; fewer than 10 live in their own country. But in all the
states that have collapsed, two institutions have always
remained---national traditions and the churches. We need to involve both
of these time-tested and durable institutions.

[Dr. Reznik]{.underline}: Will traditional leaders and healers be able
to overcome the lack of political will?

[Dr. Ayittey]{.underline}: Previous initiatives were crafted in
"partnership" with African governments, but Westerners have the naïve
belief that there is a government as they know it in any African
country. What exists is a Mafia-type group that holds the state hostage
and doesn't care about the people. Therefore the people in the rural
areas (most of the people) relate to the traditional chiefs. The formal
(Western-type) governments lack legitimacy for the people who are
infected with AIDS because the government is dysfunctional. However,
it's diplomatically tricky to go into an African country and bypass the
government in place and deal with other groups. For instance, if you
provide food aid, the government will insist upon distributing the food
and then distribute the food to their supporters only. Somehow we have
to find a way to reach the people.

[Dr. McIlhaney]{.underline}: How do you account for high usage rates of
condoms in African countries? We could use the same means to encourage
the A and B parts of the program.

[Dr. Ayittey]{.underline}: Radio is the most effective means of reaching
the African people. This means was used in Uganda and Senegal. But you
can only get so far in changing attitudes about condoms. There has been
a cultural resistance to using condoms. The African chief is the keeper
of tradition, so if you want to change behavior you have to have the
chief play a role (e.g., if an HIV-positive man dies, his brother
inherits his wife---it's another means of transmission). The churches
also could play an important role.

# **RESOLUTIONS**

## Prevention---Council Discussion

### *Local Involvement*

[Mr. Nickerson]{.underline}: The resolution should ask the
Administration to project the number of people this initiative is likely
to bring into care and to plan for that number.

[Dr. McKinnell]{.underline}: We should not focus on the shortfall this
year---it doesn't make sense to save a penny this year and pay a dollar
next.

[Mr. Sneed]{.underline}: The shortfall is disproportionate for people of
color.

[Ms. Ivantic-Doucette]{.underline}: Paragraph 3: "greater their risk of
what"?

[Rev. Sanders]{.underline}: A slide yesterday spoke to the concern that
this CDC initiative does not exclude behavior modification that had been
in place. Somehow the motion needs to reference that. Make it clear that
this initiative is a part of what we have and is not excluding it.

[Dr. Judson]{.underline}: Dr. Judson finds not helpful the term "people
of color," "community of color," etc. It's a meaningless PC term (i.e.,
it offends nobody and communicates nothing). Are the others colorless?
Indians and many Asians may be classed as people of color but are in the
lowest risk group. In Colorado black communities have no larger
incidence than whites in the same socioeconomic group. We should be
focusing on socioeconomic group, not color group. The problem is where
we're trying to direct funds.

[Dr. Sullivan]{.underline}: Dr. Sullivan has no objection to changing
it, but to what? This can be discussed in the Prevention Subcommittee;
otherwise we'll never get to the end of our agenda.

[Rev. Sanders]{.underline}: How we effectively identify people who are
disproportionately impacted without stigmatizing them cuts across all of
our committees.

[Ms. Robinson]{.underline}: PACHA's language should be consistent with
the guidelines this represents, and this is CDC's term.

[Dr. Sweeney]{.underline}: The last paragraph sounds like the focus is
being moved; we're broadening, not transitioning.

[Ms. Clements & Mr. Sneed]{.underline}: Paragraph 6, last sentence:
Could we add something about support services?

[Mr. Sneed]{.underline}: Paragraph 7: add "and community leaders."

[Dr. Sullivan]{.underline}: This is a resolution on prevention services;
we have other resolutions, so this resolution doesn't have to cover
everything. That will defeat our purpose and they won't be taken
seriously.

[Mr. Minor]{.underline}: It's important to include confidentiality and
the integrity of public health information.

[Dr. Green]{.underline}: Last paragraph: PLWA is not a change but an
emphasis.

[Dr. Reznik]{.underline}: Paragraph 6: change medical care to primary
care.

[Mr. Minor]{.underline}: We need to recognize that there is still a
stigma attached to an HIV diagnosis.

### *Treatment and Support Services for Substance and Drug Users*

[Ms. Ivantic-Doucette]{.underline}: Add something about the impact of
media.

[Ms. Clements]{.underline}: The role of parents must be recognized, but
many high-risk youth don't have parental associations.

[Mr. Sneed]{.underline}: Last paragraph: include community.

[Ms. Rock]{.underline}: Last paragraph: Ms. Rock suggested new language,
which she will bring to the subcommittee meeting.

### *Prevention Subcommittee*

[Mr. Sneed]{.underline}: The SAMHSA representatives didn't answer his
questions; maybe this will help.

[Mr. Nickerson]{.underline}: Although supporting the gist of it, Mr.
Nickerson worries about the 9 of 10 people not seeking treatment. Best
practices should be recognized.

[Rev. Sanders & Mr. Nickerson]{.underline}: Some of the science supports
prevention initiatives that are so politically unpopular that we do not
have a climate that allows them to be supported. Where can we find the
language that at least recognizes the fact that we know the science is
there.

[Dr. McKinnell]{.underline}: We're missing an opportunity if we err on
the side of political correctness and unpopularity. It's hard to
criticize PACHA; we're the ideal forum to be blunt. Let's make sure we
communicate clearly and break through these language issues; that's
what's tying the hands of public health workers.

[Ms. Smith]{.underline}: We aren't prepared as a committee to move
forward on the language changes.

[Dr. McIlhaney]{.underline}: If there is strong evidence that something
doesn't work, we should get a scientist in here to discuss it.

[Dr. Primm]{.underline}: We should all commit ourselves to being frank
and honest. I saw two friends speak here yesterday who could not speak
in the manner in which they would have liked. We need to ensure that
those who come to us are not hog-tied.

[Ms. Smith]{.underline}: Should we move forward on the motion on
treatment, and consider the other separately?

[Dr. Sweeney]{.underline}: We can't move forward until we have the
science to support or not support our position. With the impact and
number on IDU, an important part of our recommendation involves needle
exchange if it works. We need to be conclusive about our
recommendations.

[Rev. Sanders]{.underline}: PACHA has a history, which we need to
revisit. What we have seen in some of the decreases is caused by an
initiative that is invisible and underground. We need to bring the
Government to bear on what works. I support Dr. Sweeney in that IDU is
so important, we must somehow address the issue. At least. we can give
them some language to study it further.

[Ms. Freeman, Dr. Primm, Mr. Sneed]{.underline}: We should not just
ignore the "down low" issue even if all the data are not in. This is too
important to African American women.

[Dr. Reznik]{.underline}: Change the first to last word to: "all HIV
treatment program." That would address the issue and allow us to discuss
it later.

## Treatment and Care---Council Discussion

### *Hepatitis C* 

[Dr. McKinnell]{.underline}: This is a model for what we as a group
should be doing. It's specific and far-reaching. We need to be more
aggressive in what we're recommending.

[Mr. Nickerson]{.underline}: Not a third, but half (as we saw yesterday)
are co-infected. HCV infection is largely driven by IDU and we need to
talk about substance abuse. Substance abuse should be one of the
"whereases."

[Dr. Driscoll]{.underline}: The motion is specific; it gives a standard
by which we can measure and follow up. If we say something vague, we
can't later determine whether we're being listened to.

[Dr. Judson]{.underline}: Two important talks we heard yesterday dealt
with our growing understanding of the psychoneurological basis of drug
use, and with mental illness. And, we can't talk about HCV without
talking about drug use and mental illness. We're getting closer to the
mental effects. HCV treatments aren't that good, have serious side
effects, and cost a lot. We can't say that if we treat everyone,
everything will be fine.

[Mr. Sneed]{.underline}: In addition to what Dr. Judson said, our effort
would be better placed on research and development, and working with the
pharmaceutical companies to develop more effective drugs. The third to
last paragraph that requests an expanded effort on research doesn't
satisfy because we have the cart before the horse: you can test, but
there's no money to treat even if the treatments were good. So the
emphasis should be on research to find good drugs.

[Dr. McKinnell]{.underline}: The Treatment and Care Committee could
undertake a project to think through how to do pharmaceutical research
(classic high-risk, high-reward). Drug discovery is a very expensive,
long-term project, which leads to FDA approval. Having to test a new
drug against the best currently available is preventing a lot of
research on HIV drugs.

[Dr. Driscoll]{.underline}: Last paragraph in resolution: "add to the
formularies." The best way to ensure new developments in drug research
is to ensure the companies' incentive through reimbursement. The FDA
seems to have picked up the idea that the "me too" drugs are worthless.
But their profiles of efficacy, toxicity, and tolerance are also
different, so a person who cannot take a mainstream drug may be able to
tolerate a "me too." Also, they are usually cheaper. We need the
flexibility they offer.

[Mr. Nickerson]{.underline}: Why would people want to be tested if they
couldn't be treated? Co-infection with another hepatitis increases liver
failure, although other factors go into determining the outcome, e.g.,
alcohol consumption. Testing should be encouraged.

[Dr. Primm]{.underline}: Of drug abusers who go to the Addiction
Research and Treatment Corporation, 65 percent are HCV-positive and
about 20 percent are HIV-positive. While we have to do more research and
development, some things can be done, e.g., ensuring good diet,
exercise. We need to inform the public that these behavior changes will
help.

### *AIDS Funding*

[Dr. McKinnell]{.underline}: We need to be high-reaching and specific
and we need to facilitate a national discussion.

[Mr. Sneed]{.underline}: National discussion is needed, but another
discussion is also needed. How much do we at the Federal level spend on
all HIV activities and programs? \[Budget table completed and committees
will have for discussion.\] Is the money being spent as effectively as
possible? You have to account for the money and make sure it's spent
wisely before you ask for more.

[Dr. Driscoll]{.underline}: Second to last paragraph: Consider changing
to "future of AIDS funding priorities." We have to talk about priorities
and maybe also accountability. We (PACHA) are the highest-level panel to
discuss AIDS policy and we should be far-reaching and specific.

[Ms. Smith]{.underline}: Can we call special meetings?

[Dr. Sullivan]{.underline}: There's no restriction on what we can
discuss; budget is the only restriction.

[Ms. Robinson]{.underline}: The current budget doesn't allow for
anything outside the Council meetings, but they're considering it. The
purpose of the dialogue is to inform the President and the Secretary, so
we need to be sure the vehicle will feed into a dialogue with them.

[Rev. Sanders]{.underline}: What other ways can we achieve this
conversation, perhaps with broader participation? For example, a few
months ago, there was a 12-hour radio discussion about church matters,
which is now being made into a video. This might not be immediately
translatable, but it could inspire us.

[Mr. Minor]{.underline}: We acknowledge Pat Ware for her previous work.

## International\--Council Discussion 

### *Emerging Epidemic in China, India, and Other Countries*

[Dr. Sullivan]{.underline}: A task force was convened at the request of
the Chinese Minister of Health who asked the United States for help in
addressing the epidemic. The task force found that: Less than 50 percent
of the Chinese population know there is an epidemic. There is great
stigma against the disease, homosexuality, and sex workers. The
infrastructure is weak to nonexistent. The Minister of Health sees the
situation as a powder keg, but he doesn't have much support from
provincial leaders in the government. He said it would help if our
leadership encouraged their leadership to address this. They estimate
that they have 1 million infected, but they have no data. Other
countries face a similar situation, e.g., India, Pakistan, Russia. They
are at the beginning of an epidemic. This resolution focuses on China,
but acknowledges other countries and encourages our leadership to
encourage their leadership to confront the epidemic at a time when the
effect could prevent the situation we see in Africa.

[Dr. Sharma]{.underline}: The problems in Africa are similar to those in
many Asian countries---growing population, weak infrastructure, lack of
access to medical care, and, most important, denial. The United States
should take the lead and offer to go into these countries to offer
assistance. Burma, which has been under a military dictatorship for
years and which is denying an exploding epidemic, should be added

[Dr. Hu]{.underline}: It is timely to include countries other than
China. Actually India and Russia have received CDC and USAID assistance
for years, and China has recently begun to receive such assistance. So
we should include the technical support, because they already receive
resources from the United States.

[Dr. McIlhaney]{.underline}: We want to encourage programs that will
result in the decline of HIV; other humanitarian concerns are
commendable but we are here because we want HIV to decline.

[Ms. Rock]{.underline}: In India they're becoming infected from
unscreened blood transfusions.

[Dr. Sullivan]{.underline}: Chinese peasants also sell blood and have
become infected that way. But if we can get the leadership to focus, a
number of these layers will come off.

### *Trade-Related Intellectual Property Agreement*

[Mr. Mason]{.underline}: PACHA thought it was important to go on record
to achieve two objectives, namely, to balance commitment to access to
drugs, with having worthy drugs. These drugs are life-saving and we have
an obligation to make them available to as many people as possible.
Almost half the people in the world who are infected live in the 14
countries the President targeted. Drug resistance is an increasing
problem, so we need to continue developing new drugs. It's important to
balance access and availability.

[Mr. Sneed]{.underline}: The spirit of the motion is good, but the bulk
addresses treatment and care issues as well as international issues and
costs. In the future, if an issue relates to two committees, the
committees should discuss the issue jointly.

[Dr. Driscoll]{.underline}: In the early 1990s, drug companies had a
"Manhattan Project" for AIDS. The private sector can deal with risk; the
Government is risk-averse (or we throw them out). To develop drugs you
have to be able to take risks and to be rewarded for that. People don't
seem to understand that. We need risk-taking, incentives, and rewards or
we will have no new drugs. Countries that remove incentives and rewards
have developed no drugs. And the drug companies need protection of
intellectual property.

[Dr. Reznik]{.underline}: When you lose a partner, you lose a part of
yourself; to prevent such sorrow, we must give pharmaceutical companies
the freedom to discover drugs.

[Rev. Sanders]{.underline}: Giving freedom to develop drugs is
important, but so is having the political will to deliver these drugs
wherever they are needed (e.g., drugs to prevent mother-child
transmission). Even in the most remote areas, you can get a Coca Cola.
We have to ensure that the will of Government, manifested by the
proposed appropriation, is combined with the will of industry to
distribute drugs as effectively as Coca Cola does. There must be a
passionate commitment to extending life all over the globe. In some
instances, there have been efforts to influence how these drugs are made
available. It would be naïve of us not to realize that people infected
with this disease will not use every means possible. We need to balance
the interests of intellectual property rights against the will by dying
people.

[Dr. McKinnell]{.underline}: This discussion is like a group of people
describing a coin. What you describe depends on which side you're
looking at. Everything drug companies do to develop drugs isn't helpful
if the drugs are never used. It's the tyranny of the "or"---it's not A
[or]{.underline} B; we need to do both. Within the World Trade
Organization now, there is emerging consensus that may solve this
dilemma. If the return on the investment can be earned from those who
can afford to pay for the drugs, then the drugs can be offered nearly
free because the greatest cost is in discovery; the cost of
manufacturing is low. If we can get a consensus to do both, we can solve
this problem.

[Dr. Judson]{.underline}: The system of free enterprise requires
international trade protection. Most of the costs of the development of
these new drugs are being paid for by consumers in the developed
countries. This will be a problem to come back to.

[Rev. Sanders]{.underline}: The recommendation must speak to both sides
of the coin.

[Dr. Sullivan]{.underline}: When you get a Coke in a remote area, you
only have to drink it. For HIV/AIDS drugs, you have to know what you're
doing to take them so they will be effective. We have to stimulate
development of health care delivery people.

[Dr. Judson]{.underline}: Combination therapies are difficult even with
a strong infrastructure with support services. A year after initiation,
only half of the patients can continue because of mental illness, the
home situation, or compliance problems. Taking combination therapies is
incredibly daunting at the village level. There's potential to throw
away huge amounts of money on programs that do actual harm. We've seen
this with food for the poor: We give food and people continue to starve.

[Dr. McKinnell]{.underline}: NIH data from Uganda show that compliance
in Africa is higher than here.

[Dr. Judson]{.underline}: There's also the issue of theoretical efficacy
versus effectiveness of actual use when you broaden an application.

[Mr. Nickerson]{.underline}: Nevirapine may be administered in one dose,
but it's not simple. We don't want to repeat the American experience
where we used the weakest drugs until resistance developed (treat to
fail). Even though Africans may not have modern buildings, they have
infrastructure that can be developed and that we can work with.

Discussion of Resolutions

Subcommittees discussed their resolutions, then presented the revised
draft to the whole committee to vote on (pages 31--41 below).

# **CONCLUDING REMARKS**

[Mr. Minor]{.underline}: The Council's draft letter to the President
(distributed to the group) lays out some guiding principles that stay
above politics.

[Dr. McKinnell]{.underline}: The public comments are helpful, but it may
be more useful to hold public comments to the end so the public will
have a chance to react to the meeting discussions and presentations.

[Dr. Driscoll]{.underline}: Some interested organizations were not
represented. Should we publicize PACHA meetings more widely?

[Ms. Robinson]{.underline}: Public comments are mandated, but they can
be held at any point during the meeting. This meeting was posted on the
PACHA and CDC Web sites.

[Ms. McDonald]{.underline}: At CDC there was great interest in PACHA.
Maybe we could get a listserv. Has someone been chosen to serve as
liaison between PACHA and CDC?

[Ms. Robinson]{.underline}: The process of setting up a listserv has
been begun.

[Dr. Sullivan]{.underline}: The letter suggesting PACHA--CDC liaison was
just received, so we will think about it before we decide. Should there
be interaction between the public and ourselves?

[Dr. Driscoll]{.underline}: Last year we had trouble with the rapid
testing resolution because the public had no information.

[Ms. Robinson]{.underline}: All resolutions, once confirmed, will be
posted on the PACHA Web site, so the public will have all the
information used to make the decisions.

Minutes from PACHA's January meeting were approved.

*Adjourned at 3:55.*

**COMMITTEE MEMBERS**

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

Jacqueline S. Clements

Thomas A. Coburn, M.D.

James P. Driscoll, Ph.D.

Mary Fisher

Vera Franklin

Mildred Freeman

John F. Galbraith

Katryna Gholston

Edward C. Green, Ph.D.

David Greer

Cheryl-Anne Hall

Jane Hu, Ph.D.

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

Joseph Jennings

Rashida Jolley

Franklyn Judson, M.D.

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.

Beny J. Primm, M.D.

David Reznik, D.D.S.

Debbie Rock

Reverend Edwin Sanders II

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

Lisa Mai Shoemaker

Anita Smith

Don Sneed

Louis W. Sullivan, M.D.

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

# **AGENDA**

***Thursday, August 7, 2003***

8:30 a.m. **Continental Breakfast**

9:00 a.m. **Welcome Remarks**

> Tom Coburn, M.D., Co-Chair
>
> Louis Sullivan, M.D., Co-Chair

9:10: a.m. **Remarks**

> **Josephine Robinson,** Executive Director (Acting)

9:20 a.m. **Remarks**

> **Speaker To Be Confirmed,** The White House

9:30 a.m. **PREVENTION**

Anita Smith, Chair, Prevention Committee, PACHA

9:35 a.m. **Advancing HIV Prevention: New Strategies for a Changing
Epidemic**

> **US 2003**
>
> **Ronald O. Valdiserri**, MD., Deputy Director, National Center for
> HIV, STD, and TB Prevention, Centers for Disease Control and
> Prevention (CDC)

**10:05 am** Questions and Council Discussion

10:50 am **Break**

11:00 a.m. **Targeting Prevention Messages to Youth**

> **Lloyd Kolbe**, Ph.D. Director, Division of Adolescent and School
> Health, Centers for Disease Control and Prevention (CDC).

12:00 noon **LUNCH**

1:00 p.m. **Substance Abuse and HIV Prevention: How Substance Abuse
Exacerbates Risk Behavior for HIV/AIDS**

**Donald Vereen, MD**, Medical Officer and Special Assistant for Medical
Affairs, National Institute on Drug Abuse

**H. Westley Clark**, M.D., J.D., M.P.H., Director, Center for Substance
Abuse Treatment, SAMHSA

2:30 p.m. **Public Comments**

3:30 p.m. **TREATMENT AND CARE**

**Brent Minor**, Chair, Treatment and Care Committee, PACHA

3:35 p.m. **Hepatitis C Co-Infections**

**Victoria Cargill**, **MD**., Director of Minority Research and
Director of

> Clinical Research, Office of AIDS Research, NIH

4:20 p.m. **Break**

4:30 p.m. **Funding of HIV/AIDS Care**

**Patricia Bass, R.N., M.A., Chair,** CAEAR Coalition

5:30 p.m. **ADJOURN**

####### Friday, August 8, 2003

8:30 a.m. **Continental Breakfast**

8:50 am **Welcome Remarks**

> Tom Coburn, M.D., Co-Chair
>
> Louis Sullivan, M.D., Co-Chair

9:00 am **The ABC Model and Its Application to HIV/AIDS Prevention**

**Norman G. Hearst, M.D., MPH,** Professor, Family and Community
Medicine, University of California, San Francisco

9:50 a.m. **INTERNATIONAL**

Abner Mason, Chair, International Committee, PACHA

9:55 a.m. **Socio-political Assessment of Emergency Plan for AIDS Relief
(EPAR) Recipient Countries**

> Speaker To Be Confirmed

10:50 a.m. **Break**

11:00 a.m. **Emerging Epidemic in China, India and Other Countries**

Council Discussion

11:30 a.m. **Trade-Related Intellectual Property Agreement**

Council Discussion

12:30 p.m. **Council Adjourns for Preparatory Work**

12:30 p.m. **WORKING** **LUNCH**

2:30 p.m. **Council Reconvenes for Motions and Voting**

4:00 p.m. **A[D]{.smallcaps}JOURN**

# **MATERIALS PRESENTED AT THE MEETING**

Advancing HIV Prevention: New Strategies for a Changing Epidemic (Dr.
Valdiserri, CDC)

Questions & Answers on CDC's New HIV Initiative, "Advancing HIV
Prevention: New Strategies for a Changing Epidemic---United States"
(CDC)

How Can We Become More Effective in Preventing HIV Infection among Young
People (Dr. Kolbe, CDC)

Advancing HIV Prevention: New Strategies for a Changing Epidemic
(NASTAD)

Reducing the Risk: Connections that Make a Difference in the Lives of
Youth (NICHHD et al.)

How Drug Use Exacerbates the Risk for HIV/AIDS (Dr. Vereen, NIDA)

HIV and Hepatitis C Co-Infection---A Very Present and Growing Health
Challenge (Dr. Cargill, OAR)

An Assessment of the Ryan White CARE Act of 2000 (Ms. Bass, CAEAR
Coalition)

Overview of the Ryan White CARE Act AIDS Drug Assistance Program (ADAP)

AIDS Drug Assistance Programs: An Overview of Current and Future Issues
(NASTAD)

Condoms for AIDS Prevention in the Developing World. A Review of the
Scientific Literature

Leadership in the Campaign to Fight AIDS in Africa (Dr. Ayittey)

Averting a Full-blown HIV/AIDS Epidemic in China. A Report of the CSIS
HIV/AIDS Delegation to China, January 13--17, 2003

The White House Initiative to Combat AIDS---Learning from Uganda (The
Heritage Foundation)

Morbidity ad Mortality Weekly Report. Advancing HIV Prevention: New
Strategies for a Changing Epidemic---United States, 2003 (CDC)

Public Comments; Murray Penner, National Alliance of State and
Territorial AIDS Directors; To the Presidential Advisory Committee on
HIV/AIDS (August 7, 2003)

2003 HIV/AIDS Resource Guide (Pfizer)

Presidential Advisory Committee on HIV/AIDS, Prevention Committee, draft
resolutions

Presidential Advisory Committee on HIV/AIDS, Treatment and Care
Committee, draft resolutions

Presidential Advisory Committee on HIV/AIDS, International Committee,
draft resolutions