# Presidential Advisory Council on HIV/AIDS

# 23rd Meeting

**Hubert Humphrey Building**

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

**Room 800**

**Washington, DC 20201**

**Monday, March 29, 2004, and Tuesday, March 30, 2004**

**Council Members---**

**Present March 29**

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

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

Jacqueline S. Clements

James P. Driscoll, Ph.D.

John F. Galbraith

Edward C. Green, Ph.D.

David Greer

Cheryl-Anne Hall

Jane Hu, Ph.D.

Karen Ivantic-Doucette, M.S.N., FNP., ACRN

Rashida Jolley

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

Abner Mason

Sandra McDonald

Joe McIlhaney, M.D.

Henry McKinnell, Jr., Ph.D., M.B.A.

Brent Tucker Minor

Dandrick Moton

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

Beny Primm, M.D.

David Reznik, D.D.S.

Deborah Rock

Rev. Edwin Sanders

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

Lisa Mai Shoemaker

Anita Smith

Don Sneed

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

# Council Members--- 

# Present March 30

Same as above, plus Joseph Jennings

# Council Members--- 

# Absent March 29

Co-chair, Louis Sullivan, M.D.

Mary Fisher, Ph.D.

Vera Franklin

Mildred Freeman

Katryna Gholston

Joseph Jennings

# Council Members--- 

# Absent March 30

Same as above except Joseph Jennings

# Staff---

# Present March 29, 30

Josephine Bias Robinson, Executive Director (Acting), PACHA

Elizabeth Onjoro, Ph.D.

Dana Ceasar

Miguel Gomez

# *DAY 1*

**MORNING SESSION**

PACHA Co-chair Dr. Thomas Coburn welcomed Council members, members of
the public, and staff at 8:30 a.m. He asked Council members to forgive
his missed meetings due to health problems. He said his prognosis is
good. He said he will give everyone a chance to speak but will also run
a tight schedule.

Dr. Coburn introduced Josephine Bias Robinson and congratulated her for
her excellent and timely work.

# *Remarks*

Ms. Robinson said that members should look to the briefing book and an
additional packet for information about the meeting. She said that each
of the three Subcommittees of the Council---Prevention, Treatment and
Care, and International---planned to present draft motions for the
Council's consideration. She explained that the motions will be
introduced today, commented on, and further worked out in breakout
sessions the next day. The plan at present is for the Council to then
consider and possibly vote on motions brought forward from the sessions.
The breakout sessions will be open to the public.

## Prevention Subcommittee Report

Anita Smith, Chair of the Prevention Subcommittee, said Subcommittee
members had worked hard and accomplished a lot through monthly phone
calls between meetings. The Subcommittee has two motions, one on
prevention of HIV in youth and one on the ABC prevention strategy.

Ms. Smith said the youth motion reflects the members' thoughts on how to
address the very complex topic of youth, risk behavior, and prevention.
The Subcommittee's January meeting was devoted to this subject, and
members heard from experts as well as young people themselves and what
they do with member Debbie Rock's group, the Baltimore Pediatric HIV
Program, Inc.

Alcohol, drugs, and other risky behaviors put youth at risk. The
protective factors are the same for all these and are rooted in
connections with parents, schools, setting goals, and so on. This
morning, the Council will hear from a representative of the Centers for
Disease Control and Prevention (CDC) about data on behaviors, and
another presentation on sexually transmitted diseases (STDs) and
clustering of risk behaviors among young people.

Citations have been provided for the motion on youth. The second motion,
on the ABC strategy, is a joint motion of the Prevention and
International Subcommittees.

The **first motion** is in the meeting briefing book. It was moved and
seconded that it be presented, read, and placed in the record. It reads
as follows:

**Presidential Advisory Council on HIV/AIDS**

#### Prevention Subcommittee 

#### Motion

WHEREAS, an estimated 15,000 of the estimated new 40,000 HIV infections
in the United States in 2000 were among youth aged 15 to 24^1^, and

WHEREAS, evidence also shows that among this same age group there were
9.1 million new STD infections (48 percent of the approximately 18.9
million new cases of STDs in 2000)^1^ , and

WHEREAS, research shows that the earlier young people begin to
participate in unhealthy risk behaviors, the greater their overall and
long-term risk, for example:

-   Young people who participate in first intercourse before age 14 are
    significantly more likely to have more lifetime sexual partners.
    Fifty-seven percent of girls who initiate sex before age 14 report
    six or more lifetime partners compared to 10 percent of girls who
    initiate sex at age 17 or older. Likewise, 74 percent of boys who
    initiate sex before age 14 report six or more lifetime partners
    compared to 10 percent of boys who initiate sex at age 17 or older.
    The number of new sexual partners over time is a key factor in the
    spread of STDs, including HIV/AIDS^2^;

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-   Young people who begin drinking before age 15 are more than twice as
    likely to develop alcohol abuse and are four times more likely to
    develop alcohol dependence than those who began drinking after age
    21^3^;

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-   Epidemiological and clinical studies suggest that adolescents who
    begin drug use at early ages not only use drugs more frequently, but
    also escalate to high levels more quickly and are less likely to
    stop using^4^;

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-   Experts agree and studies show that age of initiation is a powerful
    predictor of tobacco consequences and dependence. The vast majority
    of people who become addicted smokers started smoking regularly
    before 18 years of age and will be addicted for an average of 16 to
    20 years^5^;

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-   The earlier the onset of a delinquent career, the greater the number
    of delinquent offenses juveniles are likely to commit before their
    18th birthday^6^; and

WHEREAS, studies reveal interconnections between unhealthy risk
behaviors, for example, linking alcohol and/or substance abuse with
early and unplanned sexual activity among youth, putting them at
increased risk for acquiring HIV^7^, and

WHEREAS, evidence also shows that a child\'s connections with parents,
family, and school are the strongest protective factors for early onset
of multiple unhealthy risk behaviors, including those that put youth at
risk for HIV^8^,

BE IT RESOLVED that PACHA commends the President of the United States
for his focus on helping youth make right and healthy choices in his
2004 State of the Union address, and

BE IT FURTHER RESOLVED that PACHA urges the President to implement a
strategy that will help ensure that America\'s youth are encouraged to
make right and healthy choices by establishing an office or designating
a staff person at the White House who is responsible for making sure
that all youth risk behavior prevention messages generated by and
disseminated through the Federal Government are cogent, comprehensive
and coordinated, focused on risk avoidance (i.e., consistent with
Uganda\'s ABC prevention model for HIV/AIDS) for all youth from
behaviors that put their health and well-being at risk.

***Citations***

1.  Weinstock H, Berman S, Cates Jr. W. "Sexually Transmitted Diseases
    among American Youth: Incidence and Prevalence Estimates, 2000."
    Perspectives on Sexual and Reproductive Health (2004) 36(1): 6-10.

2.  "Trends in the Well-being of America\'s Children and Youth: 1996."
    U.S. Department of Health and Human Services, Office of the
    Assistant Secretary for Planning and Evaluation.

3.  Grant BF, Dawson DA. "Age at Onset of Alcohol Use and its
    Association with DSM-IV Alcohol Abuse and Dependence: Results from
    the National Longitudinal Alcohol Epidemiologic Survey." Journal of
    Substance Abuse (1997); 9:103-110.

4.  Johnson RA, Gerstein DR. "Initiation of Use of Alcohol, Cigarettes,
    Marijuana, Cocaine and Other Substances in U.S. Birth Cohorts since
    1919." American Journal of Public Health (1998); 88:27-33.

5.  Choi WS, Pierce JP, Gilpin EA, Farkas AJ, Berry CC. "Which
    Adolescent Experimenters Progress to Established Smoking in the
    United States?" American Journal of Preventive Medicine (1997);
    13(5):359-364.

6.  Snyder HN, Sickmund M. "Juvenile Offenders and Victims: a National
    Report." Washington: National Center for Juvenile Justice (1996).

7.  Willard JC, Schoenborn CA. Relationship between cigarette smoking
    and other unhealthy behaviors among our nation\'s youth: United
    States, 1992. Advance Data (April 24, 1995) (263).

8.  Blum RW, Rinehard PM. "Reducing the Risk: Connections that Make a
    Difference in the Lives of Youth." Division of General Pediatrics
    and Adolescent Health, University of Minnesota, Minneapolis, MN.

In introducing the second motion, on the ABC strategy, Ms. Smith
explained that she and other Subcommittee members wanted to be on record
as supporting President Bush's global initiative. The motion itself
deals with the Uganda model. It advocates that this model be examined to
see if there are elements that can inform other nations and "our own
domestic prevention. Our own numbers in this country are not going
down."

The **second motion** is in the meeting briefing book. It was moved and
seconded that it be presented, read, and placed in the record. It reads
as follows:

##### 

##### Presidential Advisory Council on HIV/AIDS

**Prevention and International Subcommittees**

**Draft Motion**

WHEREAS, President Bush has heralded the Uganda ABC prevention model as
the most effective worldwide and has made it the centerpiece of the
President\'s Emergency Plan for AIDS Relief (PEPFAR), and

WHEREAS, the data shows that between 1991 and 2001 prevalence of HIV
infection in Uganda declined by 66 percent, from 15 percent to 5
percent[^1], and

WHEREAS, by 1995 fully 95 percent of Ugandans were reporting A or B
behaviors in the preceding 6 months, meaning they were having sex with
only one partner or they were abstaining, or they were faithful within
the minority of polygamous marriages found in Uganda,^2^ and

WHEREAS, there was a highly significant decline in young males and
females reporting premarital sex between 1989 and 1995[^2], and

WHEREAS, the ABC prevention model developed by Ugandan leadership in
1986 contained clear and targeted messages: (1) be Abstinent outside of
marriage, (2) Be faithful in marriage, and (3) use Condoms 100 percent
of the time if you are married to an infected partner or engage in
casual sex,

BE IT RESOLVED that PACHA applauds and supports the President\'s
commitment to the one prevention model that has shown to be most
effective prevention strategy for generalized epidemics around the
world; and

BE IT FURTHER RESOLVED that PACHA recommends to the President of the
United States that a key part of PEPFAR include technical assistance to
the Ministries of Health and NGOs in targeted countries on how to
implement effective ABC programs and intervention strategies, that
include ABC Best Practices as well as implementation timelines and
milestones, and

BE IT FURTHER RESOLVED that PACHA urges the President of the United
States to request an earmark in future PEPFAR funding for the "B"
portion of the ABC message, since data shows that a reduction in number
of partners played a crucial role in Uganda\'s prevalence decline[^3]
and many PEPFAR target countries do not currently focus on the \"B\"
message; and

Be it further resolved that PACHA urges the President of the United
States and U.S. Department of Health and Human Services Secretary Tommy
Thompson to evaluate the United States\' domestic prevention strategy
outcomes compared to the Uganda ABC prevention model outcomes with a
goal of identifying strategies whereby the United States would realize
an annual reduction in numbers of new HIV infections.

***Citations***

1.  Low-Beer, D. and Stoneburner, R. "Behaviour and Communication Change
    in Reducing HIV: Is Uganda Unique?" African Journal of AIDS
    Research (2003) 2(1): 9--21. Using weighting for rural-urban
    population distribution, HIV prevalence fell from 15 percent to 5
    percent in the same time period.

> Hogle, J., editor, Green, E.C., Nantulya, V., Stoneburner, R., Stover,
> J. "The ABCs of HIV Prevention." USAID, Office of HIV/AIDS.
>
> "What Happened in Uganda? Declining HIV Prevalence, Behavior Change
> and the National Response." USAID/Washington and The Synergy Project,
> TvT Associates, Washington, D.C. (Sept. 2002).

2.  From unpublished Demographic and Health Survey data, Uganda (1995).
    Cf. table on p. 157, Green, E.C., "Rethinking AIDS Prevention."
    Praeger Press, Greenwood Publishers, Westport, CT (2003).

3.  From both World Health Organization and U.S. Department of Health
    and Human Services data. Bessinger, R, Akwara, P., and Halperin, D.
    "Trends in Sexual and Fertility Related Behavior: Cameroon, Kenya,
    Uganda, Zambia, and Thailand." Calverton, MD: ORC Macro, the Measure
    Project. Report to USAID (Feb. 20, 2003)**.**

4.  Bessinger, et al., op. cit.; Green, op. cit.; Low-Beer and
    Stoneburner, op. cit.

Dr. Coburn said discussion of the motion would take place following the
presentations.

***Presentation topic:*** Update on Youth, HIV/STDs Statistics, and Risk
Behavior Participation

***Presenters:*** Janet Collins, Ph.D., Acting Director, Division of
Adolescent and School Health, Centers for Disease Control and
Prevention; Franklyn N. Judson, M.D., M.P.H., Professor and Director,
Denver Public Health Department, PACHA member.

**"Health Risk Behaviors Among Adolescents**" ---Dr. Janet Collins

Dr. Collins reported on CDC data collected over a decade among American
youth. The leading causes of death among 10- to 24-year-olds in the
United States as of 2001 were primarily injuries suffered, for example,
in auto accidents.

However, the Nation should also be concerned about the following
statistics:

-   870,000 pregnancies occur each year among 15- to 19-year-olds.

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-   490,000 live births occur each year to teen mothers aged 15 to 19
    years.

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-   Three million sexually transmitted disease (STD) infections occur
    each year among 13- to 19-year-olds.

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-   Since 1988, 13 percent of those diagnosed with HIV were 13 to 24
    years old at diagnosis, and 37 percent were 15- to 34-year-olds.

Behaviors that contribute to the leading causes of morbidity and
mortality in people 25 years and older include:

-   Behaviors that contribute to unintentional injuries and violence

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-   Alcohol and other drug use

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-   Sexual behaviors

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-   Tobacco use

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-   Unhealthy diets

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-   Inadequate physical activity.

The CDC's Youth Risk Behavior Surveillance Systems (YRBSS):

-   Focus the Nation on behaviors causing the most important health
    problems

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-   Assess how risk behaviors change over time

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-   Provide comparable data among subpopulations of youth.

Thirty-five States and 18 cities participate, helping with State and
local school-based surveys. Other components of the YRBSS include
college surveys, alternative school surveys, household surveys, specific
population school-based surveys, and methodological studies.
Importantly, the data help analysts look at the patterns among youth who
are in school as well as those who are out of school.

The surveys are:

-   Done on 9th- through 12th-grade students

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-   Based on probability samples of schools and students

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-   Anonymous

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-   Self-administered

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-   Completed in one class period

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-   Conducted biennially during the spring.

Response rates over the 10-year period of 1991--2001 have been stable.

Data from the survey show:

-   Fourteen percent of youth surveyed rarely or never wore seat belts,
    although that percentage is lower than in 1991.

-   Nearly 31 percent had ridden with a driver who had been drinking
    alcohol.

-   Seventeen percent carried a weapon, gun, knife, or club, although
    the differences between males and females were vast, and the numbers
    are shrinking from 1991.

-   The rate of those who had attempted suicide has remained at a fairly
    flat rate---nearly 9 percent in 2001.

-   Nearly one-half report current alcohol use, with the percentage
    among whites and Hispanics much higher than among African American
    youth.

-   Nearly one-third reported episodic heavy drinking, with the
    percentage, again, among whites and Hispanics much higher than among
    African American youth.

-   Almost one-quarter reported in the previous 30 days having used
    marijuana, about 9 percent more than in 1991.

-   Nearly one-half reported having had sexual intercourse: about 44
    percent of whites, 48 percent of Hispanics, and 61 percent of
    African Americans, but that is a decline from 54 percent in 1991,
    the first year of the survey.

-   Some 14 percent had had more than four partners in their lifetime,
    with that percentage varying among racial and ethnic groups: 12
    percent for whites, 26.6 percent for African Americans, and nearly
    15 percent for Hispanics.

-   The multiple-partners statistic has declined over the 10 years of
    the survey: 14.2 percent in 2001 against 18.7 percent in 1991.

-   More than half of those surveyed had used a condom during their last
    sexual intercourse, with African Americans reporting the highest
    use, at 67 percent.

-   Condom use is on the rise among the age ranges surveyed.

-   More than a quarter of those surveyed smoked cigarettes and,
    although this percentage seems to be on the decline, the rates are
    too high.

-   Self-reported height and weight indicated that some 14 percent
    consider themselves at risk of becoming overweight, and only
    one-fifth eat five or more servings of fruits and vegetables every
    day.

-   Vigorous physical activity has declined and, in particular, there
    has been a decided drop in physical activity rates by girls over
    their high school careers.

Dr. Collins also reported that although we tend to think of youth as
engaging in many risk behaviors, being enrolled in school makes a
difference: for example, among 14- to 17-year-olds in school, 42 percent
were not engaged in a single risky behavior, against 21 percent among
those out of school. Of great concern is that, over time, 10 percent of
those in school engaged in four or more risky behaviors, but that
percentage climbed to 30 percent for those not in school.

**"STDs in the U.S. 2003: An Update on National Epidemiology and
Considerations for National STD Control" ---**Dr. Franklyn Judson

Dr. Judson said that the data he was about to review are primarily from
the CDC.

Facts about sexually transmitted diseases in the United States:

-   More than 65 million people currently live with an incurable STD,
    and most of those STDs are viruses.

-   An additional 18 million become infected with one or more STDs each
    year.

-   There is no single STD epidemic, but, rather, multiple epidemics,
    and many diseases are difficult to track.

In general, STDs are most common in women between the ages of 15 and 19
and in men between the ages of 20 and 24. Dr. Judson reported the
following preliminary incidence figures:

-   Chlamydia---2.8 million

-   Gonorrhea---718,000

-   Syphilis---37,000

-   Hepatitis B---81,000

-   HIV (sexually transmitted only)---30,000

-   Trichomoniasis---7.4 million (and the "least serious" of the STDs)

-   Herpes simplex virus (HSV-2)---1.6 million

-   Human papillomavirus (HPV)---6.18 million

Discussing single STDs, Dr. Judson showed that although rates of
chlamydia have risen, better diagnostic tests are also available. In
terms of gonorrhea, although it seemed nearly eradicated, it is again on
the rise, and the number of afflicted women is closing in on the number
of afflicted men. Gonococcal rates among gay men are rising
disturbingly. In addition, there is an uptick in rates of pelvic
inflammatory disease hospitalization among women ages 15 to 44 that may
be attributable to gonorrhea and/or chlamydia infections.

Syphilis, "which we ought to be able to eradicate," said Dr. Judson, is
mostly down in men and women, although data in 2002 showed an uptick
among men in general and a very large upswing among gay men, especially
recently. In Denver, Dr. Judson said, the public health department went
18 months without a single case of syphilis, but now the situation has
deteriorated, with 3,256 cases estimated in 2002 alone among men who
have sex with men (MSM). Dr. Judson showed recent data possibly
implicating sex between MSM who meet over the Internet for some of this
increase, particularly in major urban areas such as San Francisco.

More complicated are the rates of genital herpes over time, although
it's clear that both men and women tend to progressively acquire the
infection over a period of sexual activity in their most sexually active
years. Finally, HPV, the most common STD, is "often the cause of
cervical cancer in women," and is "incredibly prevalent in the
populations studied," Dr. Judson said.

# *Discussion* 

Viral hepatitis does not appear in the statistics because, until
recently, it was rarely transmitted sexually. In gay men, HCV infection
is usually the result of injecting drug use and, in earlier years, from
a less-than-secure blood supply.

The CDC survey of youth doesn't request information about rationales, so
it can offer no data on whether there is a decline or an upswing in
abstention or delay in having sex. It was said that HIV instruction has
improved in the schools, as well as instruction on risk, including of
pregnancy.

Concern was expressed that because of a change in the metabolic index
about 10 years ago, the obesity curve among young people might actually
be higher. Dr. Collins responded that CDC is holding to reference rates
in the early 1980s and identification is not just of the heaviest few.

In response to a question, Dr. Collins said the survey doesn't provide
information about the usual use of condoms. "Our data are sketchy at
best in understanding multiple behaviors," she added. Asked if condom
use is higher among African Americans because condoms are more available
to them, Dr. Collins said such use "may be a cultural more." She added
that interviewing youth would be a good idea, and said that qualitative
data on cigarette smoking have been very informative. Those data seem to
indicate that cigarette smoking is not part of African American
cultures.

Drs. Judson and Collins were asked about the effect of incarceration on
youth behavior, and also about the possibility that the data do not show
those who seek treatment with private physicians, for example. Dr.
Judson agreed that there is a possibility that gonorrhea is being
underrepresented by private physicians, but added that most States
require physicians and both in-State and out-of-State labs to report
positive cultures, so his impression is that it is not differentially
underrepresented.

Dr. Collins explained that the geographical range of the CDC survey was
nationally representative and represented 9th- through 12th-graders in
this country. She added that when a State has lower rates, the CDC looks
at what drives that in order to help other States. She said that the
behavioral risk/behavior surveillance system is "an important part of
our effort" in which all States participate.

It was observed that over the past 5 to 7 years, most of the trends in
youth are favorable. Dr. Judson said that the easiest STDs to measure
and the ones that most likely reflect behavior are gonorrhea and
syphilis, and for young people, that trend has improved. Where the trend
has worsened is among gay men. "The most readily definable group where
trends are going the wrong way is among gay men," he said.

In answer to a question about the debut of sexual activity and infection
in gay males, Dr. Judson stated that there are "real deficiencies in our
data collection there." Dr. Collins said that question is not asked on a
national basis, in part because schools are not interested in taking
risks in asking about the sexual behavior of their youth. Some State and
city surveys can, however, ask any questions they would like. And in
States such as Massachusetts, the data gathered are very revealing. Dr.
Collins noted a steady decline in teenage pregnancy rates and a decline
in abortion rates.

***Presentation:*** "Youth: Interconnections that Risk, Interconnections
that Protect"

***Presenter:*** Dr. Alma L. Golden, Deputy Assistant Secretary of
Population Affairs, Office of Public Health and Science, DHHS.

Dr. Golden said our teens are at risk for HIV due to:

-   Drug use and sexual involvement

-   An interplay of both risk and protective factors

-   Risk occurrence in interconnected clusters---although protective
    patterns also occur in interconnected clusters.

Dr. Golden provided demographic information about American youth and
provided statistics about the behavior of 7th- to 12th-graders:

-   11 percent of males and 5 percent of females perpetuated violence in
    the past year.

-   10 percent of males and 9 percent of females smoke six or more
    cigarettes a day.

-   20 percent of males and 16 percent of females drink alcohol 2 or
    more days a month.

-   14 percent of males and 12 percent of females use marijuana at least
    once a month.

-   40 percent of males and 37 percent of females have had sexual
    intercourse.

Risks are interconnected because:

-   Behaviors tend to cluster.

-   Decision pathways are similar.

-   One risk may disinhibit for another risk.

-   Personal management or self-control may not be well developed.

-   There is no clear advantage for avoiding risks.

-   Most risky behaviors have common risk factors.

In the age ranges studied, 46 percent have no risk behaviors, 26 percent
have one risk behavior, 24 percent have two to four risk behaviors, and
4 percent have five or more risk behaviors.

Corisks with substance use include the following factors:

-   Using one substance significantly increases the chance of using
    others.

-   Violent and delinquent acts are associated with regular or binge
    use.

-   Vulnerability to sexual risks increases.

-   Behavioral patterns and personal health consequences can be
    lifelong.

Sexually active teens have higher rates of most other risk behaviors,
particularly those who initiate sex at a young age. For example, males
ages 12 to 16 who were not virgins were three times more likely to drink
alcohol and twice as likely to smoke cigarettes. Females aged 12 to 16
who were not virgins were more than twice as likely to drink alcohol and
to smoke cigarettes.

Decisionmaking about whether to remain virgin was measured, and the
results show heavy influence by individual peers and peer groups. Fear
of STDs and pregnancy as well as religion, morals, and values played
high-level roles in the decision as well.

The younger teens are when they initiate sex, the more partners they
will have by age 20, and the number of partners they have is a risk
factor for STDs and HIV/AIDS. Statistics from 1992 indicate that of
sexually active male teens who began sexual intercourse at age 14 or
younger, some 75 percent had had six or more partners by age 20. The
percentage was about 20 percent lower for female teens.

Connections for protection include family, faith, friends, future, and
school.

Statistics from the period 1980 to 2000 show that among white, African
American, and Hispanic children, white children are most likely to live
with two parents and African American children are least likely. Most
teens say that parents have the most influence on their decisions about
sex and that their parents are their role models. Key points of
influence include:

-   Parent/child connections

-   Shared parent/adolescent activities

-   Parental presence

-   Household access to substances

-   Parent disapproval of sex

-   Parent disapproval of contraception

-   Parental expectations

-   Parental academic expectations.

After parents, teens say their friends have the most influence on their
decisions about sex. In addition:

-   Peer influence can be both positive and negative, depending on the
    friends.

-   Friends model behaviors and set norms.

-   Having older friends is a risk factor.

-   Parents can influence a teen's choice of friends.

In addition, teens said morals, values, and religious beliefs most
affect their decisions about whether to have sex, and 83 percent of
teens said that religion is important in their lives. In the winter of
2000, one survey showed that approximately 59 percent of teens believed
their life belongs to God or a higher power, 29 percent believed their
life belongs to them, 9 percent believed their life belongs to their
family, and 4 percent believed their life belongs to the community
around them.

Schools are also influential. Teens who feel connected to their schools
are less likely to engage in risky behaviors; to be violent; to smoke,
drink, and use marijuana; and are more likely to delay sexual activity.

Factors influencing school connectedness include:

-   Perceived lack of prejudice

-   Perceived fair treatment by teachers

-   Feeling part of the school

-   Feeling closeness with others

-   Average daily attendance.

Dr. Golden concluded that:

-   Teens who have a positive vision for their future are less likely to
    engage in risky behaviors.

-   Perception of hopelessness and lack of goals are powerful risk
    factors.

-   Parents and other adults can help teens identify and work toward
    goals.

-   Youth who engage in multiple risk behaviors tend to be those who
    lack "clusters" of protective factors.

-   The challenge is to increase the number of protective factors in the
    lives of at-risk youth.

Strategies for increasing protection factors include:

-   Parental and family involvement

-   Positive examples and role models

-   Respect for self, others, and the law

-   Self-management

-   Decisionmaking

-   Healthy relationships

-   Established expectations.

Dr. Golden provided hand-outs: "This Is My Reality: The Price of Sex: An
inside look at black urban youth sexuality and the role of the media,"
cosponsored by MEE Productions and the National Campaign to Prevent Teen
Pregnancy, and a fact sheet from the National Campaign to Prevent Teen
Pregnancy's study "Teen Sexual Activity, Pregnancy, and Childbearing
Among Black Teens."

She said that some of the data she had used came from surveys conducted
by the National Campaign to Prevent Teen Pregnancy.

## Discussion

Dr. Golden was asked whether she has looked at the impact of media on
young people. She pointed to the "Reality" study she had provided to
Council members.

Another question was asked about the risk behaviors of
same-gender-loving males and females.

Presentations earlier in the morning indicated African American youth
engage in fewer risky behaviors than white and Hispanic youth, but "when
we look at the HIV majority, it's African American youth," so how are
these cofactors working? Dr. Golden said researchers haven't been
monitoring risks the right way and that she would like to see more
protective and supportive activities and nurturing environments for
inner-city youth. More affluent youth are also engaging in more risky
behaviors, for some of the same reasons, she said. It was reiterated
that two important factors are age of sexual debut and number of
partners.

The influence of youth incarceration, particularly of African American
youth, was raised, along with whether the school data from the CDC study
include private and public schools and whether a breakdown of data
between the two categories is available. Dr. Collins said the sampling
frame includes both types of schools, but there are so few private
schools included that the data are not split out. Dr. Judson said that
in some inner-city schools, by senior year, 30 percent to 40 percent of
the youth are no longer available to take the survey because they are no
longer in school.

## Discussion on Prevention Subcommittee Motions

Dr. Henry McKinnell suggested that the Prevention Subcommittee ask for
better data, ask for strong leadership in the area of youth prevention,
and broaden its request for proposed use of the Ugandan ABC model. Dr.
Golden agreed.

The Council did not take up the matter at this time.

***Continued Discussion of Presentations***

The impact of curriculum content on youth making choices was raised. Dr.
Collins said the Government is working on a consumer guide to
educational products in this area.

Presenters were asked why the word "self-esteem" had not been used. Dr.
Golden said she's cautious about how to use such a term. She agreed that
the media have a powerful effect on how people think of themselves, and
would welcome more insights and data on that. She added that sometimes
we convey to our teens that we expect them to do something, but then we
ourselves act differently.

Presenters were asked whether coeducational settings make a difference.
Dr. Golden said only anecdotal evidence is available, not data.

Presenters were asked whether anyone should assume parents have the
skills necessary to be good parents. Dr. Golden observed that we do have
parents who don't understand what's important---for example, families
eating meals together. This kind of challenge is difficult to address
through policy, but it does present opportunities, she added.

It was said that our Nation is composed of a diversity of cultures and
that, across cultural lines, there is a lack of good parenting.
Presenters were asked why there hasn't been better leadership on this on
a national, spiritual, or racial level. Dr. Coburn said that in his
African American patients he sees all kinds of families, parents, and
effects of parenting and skills, and "how the Government tries to
elevate that won't be one key that fits all. It's really about
leadership and standing up and having someone say this is a problem."

Discussion continued about the effect of the media on youth behaviors,
specifically of MTV's effect. It was said that the norm in dress is to
look provocative. Dr. Golden commented that, even if we know of the
media's effect, "What can we do about it, in light of free speech?" She
advocated that the faith community and health professionals get together
and say the same things at the same time.

It was observed that the media does a lot of good and also a tremendous
amount of harm. It was proposed that the Council emphasize the negative
influences of such media and recommend that all measures be taken to
make media executives more conscious of their responsibilities to
society and youth.

The question was raised about how public the positive statistics are on
African American youth behavior. Dr. Golden responded that the "This Is
My Reality" study is useful in this regard, as is a brochure entitled
"Faith Matters." Rev. Edwin Sanders responded that we have to get that
information to the justice system so they stop targeting our people. Dr.
Coburn commented that as a Nation we are spending more trying to cut the
flow of drugs in Colombia than treating our own people.

**AFTERNOON SESSION**

Dr. Coburn reconvened the Council after lunch at 12:30 p.m.

Prevention Subcommittee Chair Anita Smith said that part of the
Prevention Subcommittee's intention in its youth prevention motion is to
motivate high-level Administration staff to coordinate messages and
activities in preventing STDs in youth and to address some of the issues
raised in discussion, such as the influence of the media and need for
better parenting. Prevention Subcommittee presentations then continued.

***Presentation topic:*** The ABC Model and Its Application to HIV/AIDS
Prevention

**"A Summary of ABC Evidence"** ---Dr. Edward C. Green, Harvard Center
for Population and Development Studies and PACHA member

Dr. Green said that he first went to Uganda, where the ABC strategy has
been such a success, in 1993. Most HIV is transmitted through sexual
intercourse, and having multiple sexual partners drives AIDS epidemics.
He said there are two basic ways to prevent the disease, through risk
reduction and risk avoidance. AIDS prevention programs often do not
address this, he added. Most funding has gone to risk reduction, not
also risk avoidance.

In Uganda, the three-pronged ABC Strategy consists of avoiding exposure
through abstinence (A), reducing exposure through being (B) faithful,
and blocking exposure by using condoms (C).

AIDS prevention strategies were developed in the United States, with the
American epidemic in mind. That is, when HIV infections are concentrated
in high-risk groups, such as men who have sex with men (MSM), commercial
sex workers (CSW), and injecting drug users (IDU), it "may make sense to
focus ... on risk reduction, such as use of condoms, treatment of STIs,
and provision of clean syringes." But Africa is a different matter, in
both culture and affected populations.

Risk-reduction strategies focused on condom use or fear of death have
not proven very effective in Africa. A principal reason is that most
condom use in general populations is inconsistent, in part due to
relative lack of availability. Even when more condoms are made
available, rates of infection have not declined in many countries and
have actually risen in some.

In 1993, researchers found that HIV infection rates had started to
decline, and that condom use rates were too low to have had any
significant impact. The focus of the Ugandan strategy had been on
abstaining from sex, being faithful, or using condoms. The country
strongly emphasized fidelity, abstinence, and delay of sexual debut
among youth. Behavior changed to the greatest degree among 15- to
19-year-olds, and this age group also experienced the greatest decline
in HIV prevalence.

Uganda's President Yoweri Museveni started the national response in
1986. By 1991, he was making speeches about how condom use was not
enough. He emphasized instead delaying sex until one is married, and
being faithful to one partner. He also said that death awaited those who
became infected.

Dr. Green said that this was a deliberate use of fear, but that people
were also given the choice of the ABCs. Distinguishing features of the
Uganda campaign, in addition to the ABC Strategy, were:

-   Bold leadership at the highest level

-   AIDS preventive education in primary schools

-   Involvement of religious leaders

-   Involvement of persons living with HIV/AIDS (PLWHAs) in AIDS
    prevention

-   Fear arousal, meant to engender risk perception and behavioral
    change

-   Face-to-face, open discussion about AIDS, and community involvement

-   Major involvement by and advancement of women and youth

-   Fighting AIDS-associated stigma.

Dr. Green showed slides that illustrated marked changes in sexual
behavior among men and women in Uganda between 1989 and 1995, according
to World Health Organization and Global Programme on AIDS surveys.

Dr. Green also provided some data on Thailand's policy, which began in
1989. Abstinence/delay also became part of the message, but it is not
clear when and to what degree. Early national response:

-   Targeted adolescents, CSWs (with a 100-percent condom-use policy in
    effect in brothels), clients of CSWs, and wives of men with multiple
    partners

-   Used fear arousal messages to attract attention and to convey the
    core information that AIDS is fatal but can be prevented

-   Used primary change messages that emphasized condom use and partner
    reduction.

Further, in Thailand, the then-new prime minister in 1991 became
directly involved in AIDS control, chaired the national AIDS committee,
and helped develop a 5-year plan. The country's

health officials:

-   Rapidly disseminated information through leadership structures, down
    to the grass roots

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```
-   Incorporated AIDS education into the school curricula in 1990

-   Mobilized religious leaders.

Early results in Thailand showed a drop in men reporting premarital or
extramarital sex, including with CSWs, and more consistent condom use.
By 1996, condom use had risen to 97 percent in brothels in Bangkok.

Dr. Green emphasized that the Ugandan and Thai strategies were
indigenous responses, and there seems no reason why this approach
couldn't work in the United States.

**"Evidence that Demands Action: Comparing Risk Avoidance and Risk
Reduction Strategies for HIV Prevention" ---**Dr. Joe McIlhaney,
President and Chief Executive Officer of the Medical Institute for
Sexual Health and PACHA member.

Dr. McIlhaney characterized his presentation as an introduction to the
monograph "Evidence that Demands Action: Comparing Risk Avoidance and
Risk Reduction Strategies for HIV Prevention," by Dr. Green, Dr. Rand L.
Stoneburner, Dr. Daniel Low-Beer, Dr. Norman Hearst, and Sanny Chen,
M.H.S., which was provided to Council members.

Dr. McIlhaney stated that 8,000 people die of AIDS every day worldwide.
Several HIV prevention programs have been implemented throughout the
world. The bulk of UNAIDS' 100 countries had strategic AIDS plans by
December 2002.

Abstinence effectively eliminates risk, Dr. McIlhaney said. Condoms are,
if used correctly and consistently, about 90 percent effective. A
vaccine, according to UNAIDS, will not exist for another 10 years. The
question is not whether you are conservative or liberal or rich or poor,
he said, or whether we have a stake other than ending or limiting the
epidemic. The question, Dr. McIlhaney said, is, "Is there a place that
has reversed this? If there is, we have an obligation to support it."

Dr. McIlhaney said the Ugandan HIV prevention approach succeeds because
of communication about HIV/AIDS and people with AIDS through, in part,
social networks.

Also, HIV prevention in pregnant women in Uganda decreased from
approximately 30 percent to less than 6 percent from 1990 to 2000.

Despite the data, there appears to be confusion about Uganda's success,
but Dr. McIlhaney reminded the Council of Dr. Norman Hearst's briefing
of the Prevention Subcommittee's last meeting and the evidence presented
in the "Evidence that Demands Action" monograph. The more than 13
million people in sub-Saharan Africa who have been infected since 1994
might not have been if a Uganda-like policy had been adopted elsewhere.

Dr. McIlhaney added that President Bush has said that Uganda "has given
us a successful model."

**"ABC in the U.S.: Applicability to MSM" ---**Dr. Mark Thrun, Assistant
Professor of Medicine, University of Colorado Health Science Center, and
Medical Director, HIV Prevention, Denver Public Health

Dr. Thrun said that his clinic is the largest in Colorado for HIV/AIDS.
He said the problem is obvious: Rates of infection are flat or declining
among IDUs and MSM/IDUs, but they are increasing among MSMs.

Rates of risky behaviors are going up, including more multiple sex
partners and more anal sex.

The number of sexual contacts can be decreased either by delaying sexual
debut or by reducing the number of partners. The infectiousness of
contacts can be decreased by reducing the rate of anal/vaginal sex, the
use of barriers and microbicides, obtaining treatment to decrease viral
load, and by serosorting or limiting partners to those with the same
serostatus.

Serosorting requires disclosing serostatus to one's sexual partner
and/or life partner (they are not always the same).

Gay men can change their behaviors, Dr. Thrun stated, and showed data
that reveal a steady decline in infection rates over 4 years in the
mid-1980s, and increases in the use of condoms during anal sex,
especially after seroconversion. Testing, he said, is the best
intervention there is. "Most HIV-positives who know it keep their
partners safe."

AIDS has been around for some time now, and people "know better. So why
are rates going up at present?" Dr. Thrun asked. Possible answers
include apathy, a lost sense of urgency, the availability of medication
that makes the disease seem no longer fatal, young people thinking they
don't know anyone who is positive, and unwillingness to disclose.

There is also, Dr. Thrun said, a lack of fear. "People in the U.S. just
aren't afraid anymore, and fear works---especially with youth."

The key problem is lack of communication, Dr. Thrun said. There is a
"lack of meaningful discussion about HIV and AIDS outside of small
groups of 'in the know' people."

He recommended discussions with youth that stress or acknowledge:

-   That abstinence is a reasonable goal, but it isn't the only way

-   Sensitivity and awareness in talking with MSM/gay or
    MSM/gay-questioning youth

-   The realities of the MSM/gay lifestyle

-   That is not okay to ostracize HIV-positive people.

MSM youth are at a high risk for AIDS, Dr. Thrun said, and yet health
care workers don't usually address them in their homes, churches, or
schools. They should be hearing prevention messages everywhere that
include risk data and that dispel the assumption that HIV is an easily
managed disease.

By individualized risk assessment and counseling, health professionals
can encourage reducing the number of sexual partners. The medical
provider must be fully knowledgeable about HIV risk and must be
comfortable testing for and counseling about HIV.

At present, however, medical providers don't talk enough about ongoing
risk. Dr. Thrun then pointed to four projects that help providers learn
to assess risk and to provide counseling that emphasizes personal
responsibility.

Partner reduction can also be encouraged through destigmatizing HIV and
persons at risk for HIV. "Fight the disease, not the person" programs
are important but do not go far enough. Also, HIV sufferers will remain
stigmatized until they are no longer ostracized or alienated.

Discussions about HIV and populations at risk need to occur at home, at
school, at church, in the community, in bed, with family, with partners,
with peers, with educators, and with providers who:

### 

### Encourage partner reduction through social constructs that support monogamy

### Value committed relationships 

### Avoid the hypocrisy of encouraging and opposing long-term relationships at the same time.

Condoms need to be encouraged in all high-risk settings:

-   100 percent abstinence outside of relationships is not a realistic
    goal.

-   It is poor public health policy not to educate people about
    potentially life-saving intervention.

-   Correct and consistent use of condoms should be recommended outside
    of long-term monogamous relationships in which both partners are
    HIV-negative.

Gay men/MSM need to accept responsibility for their actions:

-   To knowingly expose someone to HIV is inexcusable.

-   An individual is ultimately responsible for his or her own health.

Dr. Thrun said he is a firm believer in the Ugandan ABC approach. He
emphasized:

-   Abstinence for all youth should be discussed, and limiting the
    discussion to only male-female sexual acts alienates the population
    at the highest risk of infection.

-   We may need to find a new word for abstinence.

-   Partner reduction and personal responsibility are cornerstones.

-   Condoms cannot be dismissed.

Finally,

-   Society needs to decide if MSM/gay populations are a priority.

-   Only when public institutions lead the way in destigmatizing HIV and
    populations at risk for HIV will meaningful change occur.

## Discussion

There was concern that serosorting may not help destigmatize AIDS. Dr.
Thrun said he thinks serosorting shouldn't be emphasized; rather, it is
a means to reduce harm. There was concern, also, about politicization of
the A and B parts of the ABC strategy. Dr. Thrun stressed that the needs
of all populations are important, and we should not gloss over the
differences between some of them.

Further discussion on the ABC model indicated some hesitation about
expecting the same result elsewhere as in Uganda. "The fear factor may
not work as well here," Dr. Thrun said. He was asked if the model needs
to be tweaked in the United States. Dr. McIlhaney responded that he does
not advocate a "simplistic imposition" of one program or on one group.
He said he thinks that until someone can show why the United States
shouldn't use such a successful program, Americans should try it. He
added that the key in Uganda was leadership at the highest level. Dr.
Green added that he feels the Western world is operating now on a
simplistic model based on risk reduction, and that anything we can do to
broaden risk reduction would be good. How that would be done should be
"left to the countries themselves. They know their people."

The funding aspect of the program was mentioned. Dr. McKinnell said
anyone on the Council who feels the program should be AB and not C
should "come to grips" with the fact that if we spend one-third of our
money on A (abstinence) and another third on B (being faithful), "we
will have no money left to run programs."

Karen Ivantic-Doucette said that the ABC model teaches us that through a
behavioral focus, HIV infection is 100-percent preventable. It broadens
people's options through risk avoidance and risk reduction. "To lower
the standard because it's too hard is not correct." It was stated that
there were reasons other than ABC that Uganda experienced infection
reduction, including the fact that it was a country at peace and that
health services availability increased.

Dr. Coburn advocated that the Council stay focused on educational
leadership, delay of sexual debut, and monogamy. "We've not had any
leadership in this area until now. What if every person in a position of
leadership said the same thing? What our kids are getting is a mixed
message. The fact is, AIDS is not treatable and prevention is our best
tool. We need to be very honest about what it's like out there. We have
wonderful drugs, but we haven't cured anybody."

## Treatment and Care Subcommittee Report

Brent Tucker Minor, Chair of the Treatment and Care Subcommittee, was
acknowledged to discuss the Subcommittee's work and motions.

Mr. Minor said the Subcommittee has been meeting monthly, including
through conference calls, and has three motions that he would like to
introduce and have accepted as written, knowing they can be amended
later. The first motion asks for the appointment of a permanent director
of the Office of National AIDS Policy (ONAP).

Dr. Coburn said the motion is considered read and discussion delayed
until tomorrow. It reads as follows:

**Presidential Advisory Council on HIV/AIDS**

## Treatment and Care Subcommittee

**Draft Motion**

WHEREAS, it is the responsibility of the Presidential Advisory Council
on HIV/AIDS (PACHA) to advise the President on AIDS-related issues, and

WHEREAS, the members of PACHA acknowledge and thank President Bush for
his vision and leadership on this important issue, and

WHEREAS, the President continues to make HIV/AIDS a high priority for
his Administration, and

WHEREAS, the Office of National AIDS Policy was created and funded to
serve as the focal point of AIDS-related policies for the White House,
and

WHEREAS, the Office of National AIDS Policy has been without a permanent
Director for a significant period of time, and

WHEREAS, the absence of a permanent Director of the Office of National
AIDS Policy limits the Administration's opportunities to advance
AIDS-related issues on a regular and consistent basis, and

WHEREAS, the visibility of AIDS issues and the successful implementation
of AIDS-related policies is lessened by this lack of regular and
consistent messages,

BE IT RESOLVED that PACHA requests President Bush to appoint immediately
a permanent Director of the Office of National AIDS Policy.

Minor said that the **second motion** is on the AIDS Drug Assistance
Program (ADAP).

Dr. Coburn stated that the motion is considered read and discussion
delayed until tomorrow. It reads as follows:

**Presidential Advisory Council on HIV/AIDS**

## Treatment and Care Subcommittee

**Draft Motion**

WHEREAS, AIDS-related medications have been universally accepted as an
essential component of medical therapy for a person living with
HIV/AIDS, and

WHEREAS, the AIDS Drug Assistance Program (ADAP) has provided thousands
of Americans living with HIV/AIDS access to live-sustaining medications,
and

WHEREAS, thousands of Americans are currently denied access to ADAP
programs because of funding shortfalls, and

WHEREAS, the Presidential Advisory Council on HIV/AIDS (PACHA) wrote a
letter to President Bush in June of 2002 describing the dire
circumstances of the ADAP funding crisis and the need to bring together
a broad coalition to address this problem effectively,

BE IT RESOLVED that PACHA requests that the Secretary of Health and
Human Services gather information from a variety of sources, such as
representatives of the Administration, Congress, State health
departments, AIDS advocacy groups, and the pharmaceutical industry in
order to make future recommendations, and

BE IT FURTHER RESOLVED that the Secretary be willing to consider all
practical solutions to the ADAP crisis, including structural reform to
encourage the more efficient and effective use of public funds, and

BE IT FURTHER RESOLVED that because of the emergency nature of this
situation that the Secretary report his findings and recommendations to
PACHA within 90 days.

Minor said the **third motion** calls for a domestic AIDS summit.

Dr. Coburn stated that the motion is considered read and discussion
delayed until tomorrow. It reads as follows:

**Presidential Advisory Council on HIV/AIDS**

## Treatment and Care Subcommittee

**Draft Motion**

WHEREAS, it is the responsibility of the Presidential Advisory Council
on HIV/AIDS to advise the President on HIV/AIDS related issues and
policy, and

WHEREAS, a White House Summit on HIV/AIDS in 1995 was successful in
focusing the Nation's attention on prevention and treatment responses to
the epidemic, and

WHEREAS, in the ensuing years since the first White House Summit, the
epidemic has dramatically changed both in terms of those who are
affected and the treatments available, and

WHEREAS, the President has made HIV/AIDS, both domestically and
internationally, a high priority for his administration,

BE IT RESOLVED that PACHA request the President to convene a White House
Summit on HIV/AIDS in 2005,

BE IT FURTHER RESOLVED that PACHA request President Bush continue to
highlight the current state of domestic HIV/AIDS in 2004.

Mr. Minor then introduced the Subcommittee's Guiding Principles and Core
Values, which are meant to be a foundation for all of PACHA's work. Mr.
Minor asked that the Council adopt these and use them as a guiding
force.

Dr. Coburn said these principles and values may need to go back to each
Subcommittee, adding that the Council will consider it, time permitting.

## 

## Guiding Principles and Core Values

**No matter where someone lives, how they became infected, what their
race, gender, age, or sexual orientation, he or she should have access
to the best medical options available.**

Standards of care must be clearly understood, rigorously enforced, and
maintained at the highest level. Care and treatment options should be
determined by the decisions of the client and their medical provider.

**Our work in HIV/AIDS should be guided by proven public health
strategies and based on current scientific knowledge.**

AIDS is a public health crisis and should be treated as such. The needs
and concerns of people living with HIV/AIDS should always be our most
urgent concern.

# We must work to reduce the stigma that continues to be associated with being HIV-positive.

Stigma keeps people from being tested, seeking care, maintaining their
treatment regimens, and adds to the tremendous burden of living with
this disease. Only through greater openness and acceptance of people
living with HIV/AIDS, including their full integration into mainstream
care and services, can we hope to achieve this.

# 

# Access to care and early treatment should be a top priority because it is cost-effective, limits disease progression, reduces new infections, and because it is the proper and humane response to this epidemic.

Efforts to increase testing are laudable and must be matched with an
increase in service availability so clients are not lost to care.

**Support services are an integral part of helping clients get care and
stay in care.**

We must not fail to recognize the impact of long-term issues such as
substance abuse, mental health, poverty, and homelessness, among others,
on the overall ability of a client to respond effectively to treatment.
Failure to support clients with such services can lead to noncompliance
to treatment regimens, drug resistance, and ineffective care.

Care and treatment is ultimately delivered at the local level and input
from the local community is essential to making good decisions about
priorities and service needs.

We must respect the differences in how and where care is provided.
Engaging the local community in such decisions is appropriate to ensure
the cultural competency of the services we provide.

**Our services and dollars must follow the epidemic.**

We must alter how services are provided as the needs and demographics of
the community change.

**We must maximize every single resource we have to battle this
disease.**

We must be willing to expand funding sources, improve purchasing
programs for drugs and services, and eliminate waste and duplication
whenever possible.

***Treatment and Care Subcommittee Presentations***

Mr. Minor then introduced a presentation by the Institute of Medicine
(IOM) on "Measuring What Matters." The Subcommittee was briefed earlier
on the report and found it energizing.

**"Measuring What Matters: Allocation, Planning, and Quality Assessment
for the Ryan White CARE Act" ---**Dr. A. David Paltiel, Associate
Professor, Division of Health Policy and Administration, School of
Public Health, Yale University, and Institute of Medicine (IOM)
Committee Member, and Dr. Paul D. Cleary, Professor, Department of
Health Care Policy, Harvard Medical School, and IOM Committee Chair

Dr. Paltiel quoted Congress' charges to the IOM committee tasked with
the report:

1.  To assess whether reported HIV cases are adequate, reliable, and
    sufficiently accurate for inclusion in formula grants for the CARE
    Act, Title I and II, and to make recommendations for improving HIV
    reporting systems

2.  To identify data and tools for assessing a community's severity of
    need and how that information can be used in allocation decisions

3.  To identify available health outcome and other data that can be used
    to measure the quality of and access to CARE Act-funded services.

Dr. Paltiel then outlined the motivation for the study, and also said
that the committee had seen data "showing that disparities in access to
and quality of care" exist. He detailed the first charge---relating to
HIV data and formulas. He said that formulas based on estimated living
AIDS cases (ELCs) can be counted with some degree of accuracy, but
counting HIV cases is more difficult. He emphasized that IOM interpreted
its charge as looking at HIV reporting only for purposes of resource
allocation, but that the IOM committee thinks CDC should accept all data
and help States improve their systems.

Dr. Paltiel said that when the committee considered the sufficiency,
adequacy, and reliability of data, it came up with four evaluation
criteria:

-   All States should be capable of providing data.

-   Data should be of comparable quality across jurisdictions.

-   HIV data should produce more accurate assessments of the relative
    disease burden and resource needs.

-   Including HIV data should result in significant variation in the
    relative size of awards to States and EMAs.

Dr. Paltiel outlined key findings related to Charge 1:

-   Areas are not capable of providing comparable data.

-   It's not clear that inclusion of HIV case reports in formulas would
    produce fairer allocations.

-   Formula features "dampen" any change that would result from using
    HIV data---double counting of EMA cases, hold harmless, minimum
    awards, and so on.

Key recommendations stemming from Charge 1 findings are:

-   Continue using ELCs in the formulas for the next few years but also
    take simultaneous steps to improve HIV reporting

-   Consider developing alternative estimates of HIV (survey or
    model-based estimation)

-   Propose congressional reconsideration of the formula, including the
    match between intent and results.

Dr. Cleary then presented Charge 2 resource needs, conceptual framework,
key findings, and key recommendations.

Dr. Cleary said that the IOM committee's analysis focused on Title I
supplemental awards and that such awards---which can be half of the
total award---are determined by a competitive grant application process.
He said that resource needs are determined by disease burden and cost of
care minus available resources.

Key findings for Charge 2 including the following:

-   Title I supplemental award process relies on nonstandard measures of
    local need.

-   The application process is mostly burdensome for grantees, and given
    a high correlation between supplemental and base awards, the effort
    seems unjustified.

Key recommendations for Charge 2 are:

-   Title I supplemental awards should be streamlined and based on two
    components:

    -   a quantitatively defined need based on a small number of
        standardized measure

    -   a locally defined need described in short narrative by grantees.

-   Predominance of weight for determining such awards should be given
    to quantitative measures.

-   Two approaches for estimating resources needs are direct measures
    and indirect measures.

-   The Secretary should evaluate the cost and utility of redesigning
    and coordinating studies conducted by HRSA and CDC to assess the
    needs of people living with HIV (and such efforts are underway).

Dr. Cleary said the IOM committee was "constantly reminded in our review
of Title I applications of the level of challenge faced by applicants."
He said that what HRSA and CDC are already doing is impressive and if it
were coordinated, that would be even better.

Dr. Cleary then outlined Charge 3: Quality of Care. Here, the IOM
committee found:

-   HRSA, grantees, and others expend considerable effort to assess the
    quality of HIV/AIDS care.

-   Many systems and approaches can be used to measure quality of
    HIV/AIDS care.

-   But the problem is that measures are not standardized.

The IOM committee also found very little data on outcomes, structure,
and overall population, so it tried to inventory what does exist and
suggest processes.

Key recommendations, under Charge 3, are to adopt:

-   A specified initial set of standardized quality measures (a list of
    which is provided in the IOM report)

-   Specifications for a process for defining and putting into operation
    suggested measures

-   Additional resources to develop infrastructure for monitoring
    quality (the committee does not favor unfounded mandates).

The full report is available at [www.nap.edu](http://www.nap.edu/).
Further information about committee members and the project is available
from [www.iom.edu/ryanwhite.com](http://www.iom.edu/ryanwhite.com).

## Discussion 

Dr. Coburn began the discussion by stating that the epidemic has changed
and now involves higher numbers of women of color, yet there is a marked
disparity in the resources available to them. He said he was
disappointed in the IOM report because it delays addressing that
disparity. He said he hoped that when the CARE Act is reauthorized, it
will be amended so that a greater proportion of funds are available to
African American and Hispanic women. He asked Drs. Paltiel and Cleary if
it is possible to avoid having the CDC return to surveillance data.

Dr. Cleary said he, Dr. Paltiel, and the entire committee agree with Dr.
Coburn's emphasis and the hope is that the report's impact will "be more
positive than you are implying. We agree there are huge disparities. The
issue here is not whether there are such disparities or whether they are
problematic, the question is whether switching over will address the
problem you've identified. If we were to switch tomorrow from reports
based on AIDS cases to reports based on HIV-positive cases, that would
not, much to our surprise, move the numbers that much. Second, the
disparities are probably affected more by the formula currently in place
under the CARE Act than the characteristics of HIV. The question is,
what should Congress do to fix this?"

Dr. Paltiel said that the report addresses disparities and makes the
point that addressing them is a formula, not a data issue.

It was mentioned that Congress could carve out more of a greater
percentage of funds than it does at present to address these
disparities, particularly in rural areas. Dr. Coburn stated very
strongly that everyone should report HIV and if they don't, suffer the
consequences.

Dr. Cleary said the question posed to the committee was how to improve
the formula as quickly and as completely as possible.

Dr. Coburn said that the committee's data will be valuable in rewriting
the CARE Act amendments.

Dr. Judson congratulated the IOM committee for doing a good job of
responding to narrow questions in a narrow way. He added he's convinced
that allocation of resources might not change if one used the current
"defective" HIV reporting system. He said he's concerned that States are
still being provided incentives to allow cases to advance to AIDS and
not to prevent further transmission. So any reauthorization has to
require a credible way to detect and report all HIV infections
confidentially by name into treatment and include a strong prevention
component. This would bring the act into conformance with CDC efforts,
and "I think States would find a way." Second, Dr. Judson said,
providers need to regularly assess ongoing risk behavior. "Both
providers and patients have need to have incentives and responsibility
not to further transmit HIV."

Dr. Cleary said the IOM committee does not disagree, and thinks
HIV-positive cases will be included in the formula by mandate of
Congress. The IOM said that the committee is not ready to do that today,
but provided suggestions for how to get those data up and running as
soon as possible.

Dr. Judson said Colorado was ready in 6 months in 1986.

Dr. Cleary said that the report also addressed the fact that those
diagnosed and in care constitute a small proportion of the epidemic.

Dr. Coburn said that there are regional pockets of higher incidence of
HIV/AIDS and also regionalization in the U.S. House of Representatives.
"Our country is letting down minority women on this issue right now,
period."

It was said that over the last 2 years, several large cities have lost
supplemental funding or experienced a variance against their base
funding. If HIV reporting is instituted, it might take several years to
make it accurate.

Dr. Cleary explained that the problem is one of duplication, i.e.,
wanting to make sure that some patients are not represented multiple
times.

Dr. Cleary was asked whether the IOM committee examined EMA Planning
Councils and their domination by "certain groups." Dr. Cleary said the
committee did not look at that, but HRSA has begun to improve assessment
and the quality of process within Title I.

Dr. Cleary was asked if the committee gathered information on the impact
of ADAP allocations. The answer was no.

Dr. Coburn recommended that the Treatment and Care Subcommittee
reexamine the IOM report and make recommendations on changes PACHA could
support.

In answer to a question about how disparities in the South should be
addressed, Dr. Paltiel said some members of the IOM committee were very
eager to make suggestions about structural changes; however, this is not
the mandate of the report. He suggested that if one wanted to address
this issue quickly, one should look to the degree that funds can be
carved out for non-EMAs under Title II. Dr. Cleary added that the IOM
committee suggested that Congress do the rewrites of the formula.

Dr. Coburn said that the biggest battle in past amendments has been on
the carve out, and that he anticipates the same this next time because
"when you increase carve outs, you take away from the large EMAs."

It was observed that the United States isn't making as much progress
domestically as internationally, and that the current system isn't
working for hundreds of thousands of people in this country. It was
suggested, therefore, that the Treatment and Care Subcommittee's motion
on ADAP "go well beyond 2004."

Mr. Minor said the Subcommittee is moving in that direction, and when a
second IOM report on the subject is released, the Subcommittee may make
a recommendation.

It was said that as HIV/AIDS patients get sicker, they relocate from
were they were diagnosed to where their families are. Dr. Paltiel said
this is of concern, and nothing in the funding formula addresses this
dilemma.

After a break, Treatment and Care Subcommittee Chair Minor referred to
the AIDS Drug Assistance Program (ADAP) motion in introducing Dr.
Deborah Parham Hopson

**"Funding of HIV/AIDS Care/ADAP" ---**Deborah Parham Hopson, R.N.,
Ph.D., Associate Administrator, HIV/AIDS Bureau, HRSA/DHHS

Dr. Hopson started her presentation by saying that medical health care
professionals experience daily frustration with the CARE Act, and it
helps to realize "we are on the right track in trying to improve it in
the 2005 reauthorization."

The CARE Act is not the largest program available for HIV/AIDS Care.
Federal and State dollars break down as follows:

-   In addition to the CARE Act, Medicaid and Medicare are the three
    largest payers of HIV/AIDS care in the United States.

-   Total Federal HIV/AIDS domestic spending was \$15.3 billion in FY
    2003 and will be an estimated \$16.3 billion in FY 2004. It
    comprises .7 percent of the total Federal budget.

-   In 2003, Federal and State governments spent approximately \$8.5
    billion on HIV/AIDS care and assistance alone (Medicaid).

-   Medicaid, a Federal and State program that covers more than 50
    million low-income individuals, will spend an estimated \$5.4
    billion in 2004 on HIV/AIDS health care.

-   States' share of Medicaid amounted to \$3.7 billion in FY 2003.

-   Medicare, a federally funded health insurance program that provides
    health care services for an estimated 34 million Americans over the
    age of 65 and nearly 6 million nonelderly adults with permanent
    disabilities, spent \$2.1 billion in 2002 on HIV/AIDS health care.

-   The new Medicare prescription drug bill will add new prescription
    drug benefits that will substantially increase HIV/AIDS drug
    expenditures from 2006 on.

The CARE Act:

-   Was first authorized by Congress in 1990, and reauthorized in 1996
    and 2000

-   Is meant to improve the quality and availability of care for
    individuals and families with HIV disease

-   Is the third largest funding source for critical therapeutics,
    health care, and support services

-   Through it, an estimated 533,000 uninsured and underinsured persons
    living with HIV/AIDS receive care at the cost in FY 2004 of more
    than \$2 billion.

Appropriations in 2004 for the Act broke down as follows:

-   Title I, which provides formula grants to EMAs: 30 percent

-   Title II base, which provides formula grants to States, D.C., and
    the territories, and includes ADAP: 17 percent

-   Title II ADAP: 36 percent

-   Title III, which provides discretionary grants to community-based
    organizations: 10 percent

-   Title IV, which provides discretionary grants to support care for
    women, infants, and youth and for programs that include AIDS
    Education and Training Centers, Dental Reimbursement Program,
    Community Based Dental Partnership Program, and Special Projects of
    National Significance: 4 percent

-   AETC: 2 percent

-   Dental: 1 percent.

Through discretionary grants, CARE Act administrators are able to
address some of the disparities. Dr. Hopson said when her program asks
HIV patients what they need and don't get, the answer is mental and
dental health services.

Dr. Hopson then proceeded to answer the following questions posed to her
by the Subcommittee:

1\. Why did 40 EMAs receive less funding in FY 2004?

-   Distribution of estimated living cases of AIDS

-   Decrease in available funding from FY 2003 to FY 2004

-   Effects of the "hold harmless" provision in the statute

-   EMAs demonstrated need for supplemental funds

-   Amount of funds designated by Congress for the Minority AIDS.

Dr. Hopson's department is using the IOM report to help get better data
and to make funding as equal across EMAs as possible, but last year New
York lost funding due to a decrease in demonstrated need. Dr. Hopson
also said that less money is now available to support the Act.

2\. What is the status of ADAP?

-   ADAP accounts for the largest CARE Act expenditure with a budget of
    \$748.9 million in FY 2004.

-   For the 16 municipalities that participated, more than \$23 million
    in Title I funding was earmarked for HIV/AIDS drugs through local
    AIDS Pharmaceutical Assistance Program (APAP) in the CARE Act in FY
    2003.

-   Less than or equal to 3 percent is reserved for areas with severe
    need.

Providing a national overview of ADAPs, Dr. Hopson said that there are
57 ADAPs, including the District of Columbia, Puerto Rico, the Virgin
Islands, Guam, Marshall Islands, Northern Mariana Islands, and the
American Samoa Islands. There is wide variation in program
characteristics due to individual State administration of each ADAP and
HIV/AIDS prevalence in each State. Differences are most pronounced in
areas of funding, eligibility criteria, formulary size, and cost-saving
strategies.

ADAP is the most rapidly growing CARE Act program, with \$749 million
earmarked for it, up from \$52 million in 1996.

Financial challenges for ADAPs are:

-   As persons with HIV/AIDS live longer, there is an increase in the
    demand, utilization, and cost of care, especially for AIDS drugs.

-   Increases in the number of new HIV cases (estimated 40,000 annually)
    increase the numbers of persons seeking care.

-   Medicaid is caught between the downturn in State revenue and
    increased health care spending. As a result, all 50 States and the
    District of Columbia implemented Medicaid cost containment measures
    in FY 2003 and plan to put in additional spending caps in FY 2004.

-   ADAP is the payor of last resort for PLWHA who are poor and
    uninsured---some of whom have lost Medicaid and other local benefits
    as those programs tightened their enrollment and eligibility.

Financial challenges for ADAPs include the costliness of HIV/AIDS drugs:

-   An HIV/AIDS drug regimen costs between \$11,000 and \$15,000
    annually.

-   A new class of drugs called fusion inhibitors, released last March,
    costs more than \$20,000 annually.

-   In addition, highly active antiretroviral therapy (HAART) often
    requires expensive laboratory diagnostic tests to identify drug
    resistance early on in treatment.

Nine State ADAPS have waiting lists: Alabama, Alaska, Colorado, Idaho,
Kentucky, Montana, North Carolina, South Dakota, and West Virginia. The
total number on those waiting lists is 1,214 persons. Dr. Hopson said
that up to 3 percent of ADAP can be set aside for severe need, and it
will be applied here, as it can be.

Cost containment strategies include direct purchase, rebates, mandated
rebates, voluntary rebates, and use of the Federal Supply Service
(permitted for the District of Columbia). In the States, cost
containment measures include capped enrollment, capped expenditures, and
medical criteria for participations.

3\. How is the CARE Act responding to the Southern Manifesto?

-   All CARE Act programs provide services in manifesto States, and
    although there is some uneven distribution, Congress tried to
    correct that by setting aside \$10 million or so.

-   Identifying emerging communities (ECs), where 3 of 4 Tier I ECs are
    in Baton Rouge, LA, Memphis, TN, and Nashville, TN, and 13 of 25
    Tier II ECs are in southern States.

-   New Title III Early Intervention Service (EIS), 44 of which (out
    of 111) were established in southern States.

> 4\. How is HRSA responding to the new CDC Advancing HIV Prevention
> Initiative?
>
> In addition to CARE Act programs in place, the main program at HRSA is
> working to make sure the most critical aspects are targeted so that
> new people are identified. Dr. Hopson recommends creating a capacity
> for outreach, very much in sync with the CDC, that extends to
> community and migrant health centers, rural health programs, maternal
> and child health programs, and a program where HRSA works with
> providers and medical schools to train people in caregiving for HIV
> patients.
>
> Dr. Hopson concluded by saying that domestic AIDS funding in general,
> and not just the CARE Act, has "responsibility to address the new wave
> of people who will be coming for care."

## Discussion

Dr. Hopson was asked to comment on the observation that Title I
supplemental and other funding streams seem to be drying up. Dr. Hopson
said there has been a decrease in overall funds available. Her
assistant, Doug Morgan, said one should note that only half of the CARE
Act Title I funds actually go to the formula. A structural factor in the
status is the "hold harmless" provision. This year that meant that when
20 EMAs were held harmless, the makeup money had to come out of the
supplemental side. That has had an overall impact, as well as the
Minority AIDS Initiative. Although New York City didn't do well with
supplemental last year, this year, it did. The money New York City
didn't get last year was not available for redistribution this year. Mr.
Morgan said that from now on, the review process will be an objective
one.

Clarification was sought on the Minority AIDS Initiative, and Dr. Hopson
confirmed that that money goes to areas in need.

Subcommittee members indicated interest in more information about the
effect of the new Medicare prescription drug bill. Staff will work with
Dr. Hopson to obtain the information.

In answering the question of whether preferred drug lists are a way to
respond to costs, Mr. Morgan said he hasn't seen that; rather, States
are looking at what's on their formularies and are making hard choices.
He is seeing some keep only vital drugs on and leave others off. These
are tough decisions to make, and some States are making every effort to
try to provide as much as they can, he added.

In answer to the question of whether States with waiting lists can
expect supplemental funds, Dr. Hopson said she is preparing to provide
supplemental awards over the next few weeks. "I hope they would use some
of those funds to clear their waiting lists," she added.

In terms of the southern States and immediate assistance, seven of the
nine States with ADAP waiting lists---many of them southern---will
receive supplemental funds. Within the boundaries of the law, and within
Title II, HRSA has been able to target some discretionary funds to the
southern States. Within the DHHS as a whole, there is still internal
discussion about how to deal with reauthorization.

Dr. Coburn then showed three slides that demonstrate "the tremendous
disparity in the South where we are seeing the problems."

## International Subcommittee Report

Dr. Coburn then asked International Subcommittee Chair Abner Mason to
address the Council.

Mr. Mason thanked the Subcommittee members for participating in several
conference calls since the last Council meeting. He announced that the
members have two motions that were not in the binder. He asked Dr.
Coburn if the Subcommittee could put them forth tomorrow.

Dr. Coburn asked about the content of the motions.

Mr. Mason said that the **first motion** involves an Asian focus.

Dr. Coburn asked for and received a motion and a second that the motion
be considered read. The motion reads as follows:

# Presidential Advisory Council on HIV/AIDS

# International Subcommittee

### **Draft Motion**

**WHEREAS, the Asian AIDS epidemic, with more than 10 million cases, is
second only to the Sub-Saharan epidemic and may be expanding faster,**

 

WHEREAS, in Asia, as in Africa, the AIDS epidemic, if unchecked,
threatens to destabilize important countries and is currently a major
factor in destabilizing Myanmar. The AIDS destabilization threat to Asia
is as real as it is to Africa, the major difference being the timeframe.

 

WHEREAS, Asia is and has long been the most populous continent, is one
of the cradles of human civilization, and is becoming the most
economically dynamic region on the planet,

WHEREAS, Asia is politically less stable and has less health care
infrastructure than other developed areas such as Europe and North
America,

 

WHEREAS, the worldwide economic and geopolitical consequences of
destabilization in China, the Indian Subcontinent, or Southeast Asia
would be exceedingly grave,

WHEREAS, the United States has long involvement in Asian countries, and
our recent history is importantly linked with theirs,

 

WHEREAS, the Asian countries have recognized the implications and extent
of their AIDS epidemics and want to act,

 

WHEREAS, the Asian countries with severe HIV/AIDS epidemic need more
than just technical assistance to institute treatment, as well as
prevention, and lack resources to do treatment by themselves,

WHEREAS, PEPFAR has no Asian countries among the 14 designated focus
countries,

 

WHEREAS, Congress recognized this limitation by requiring the addition
of a 15th country outside of Africa and the Caribbean in last year\'s
appropriation,

 

WHEREAS, more AIDS treatment and prevention programs must be implemented
quickly in Asia to prevent a devastating tragedy which will affect the
U.S. national interest and world economy and health,

 

BE IT THEREFORE RESOLVED that PACHA recommends to the President that
PEPFAR be expanded to include Asian focus countries and to allocate a
significant portion of PEPFAR funding to Asia in the near future.

Mr. Mason then brought up the **second motion**, on the safety, quality,
and effectiveness of drugs procured by PEPFAR funds. He said that an
editorial written by him on this subject appeared in the *San Francisco
Chronicle* today.

Dr. Coburn said the Chair will consider a motion and a second to
consider the second motion read. Such was received. The motion reads as
follows:

# Presidential Advisory Council on HIV/AIDS

# International Subcommittee

### **Draft Motion**

Ensuring the Safety, Quality and Effectiveness of Drugs Procured by
PEPFAR Funds

WHEREAS, the President's Emergency Plan for AIDS Relief (PEPFAR) has as
its major goal the implementation of a plan to provide lifesaving drug
treatment to 2 million people infected with HIV in the 14 targeted
countries, and

WHEREAS, the Office of the Global AIDS Coordinator has been given the
responsibility and authority to fund the purchase of drugs, and to
determine what drugs will be procured either directly or indirectly with
PEPFAR funds, and

WHEREAS, the people of Africa and the Caribbean who will receive drugs
procured directly or indirectly with PEPFAR funds deserve drugs that
meet the high standards for safety, quality, and effectiveness, at least
equal to those standards required for drugs to be approved for use by
Americans in the United States, and

WHEREAS, even with the best of intentions, allowing a different standard
of drug safety, quality, and effectiveness for PEPFAR drug procurements
will allow, if not ultimately encourage, a lower standard of care for
African and Caribbean drug recipients, and

WHEREAS, FDA-approved antiretroviral drugs and their generic equivalents
have demonstrated their capacity to effectively manage HIV disease, and

WHEREAS, poor quality, counterfeit, mismeasured, or ineffective drugs
can speed development of resistant virus, sicken or kill patients, or
simply fail to help them, thus undermining support for PEPFAR and
spawning cynicism about American motives where there had been respect
and hope,

BE IT RESOLVED that PACHA recommends that the President direct the
Office of the Global AIDS Coordinator to require that any drug procured
directly or indirectly with PEPFAR funds must meet the same or equal
standards for safety, quality, and effectiveness as would be necessary
for drug approval in the United States.

BE IT FURTHER RESOLVED that PACHA recommends that the Secretary of the
U.S. Department of Health and Human Services take all necessary steps to
expedite clinical trials on new drugs and formulations, including
fixed-dose combinations (FDCs) that hold promise for simplifying
treatment regimens, decreasing treatment costs, and thereby expanding
safe effective treatment.

***Presentation topic:*** The Partnership between Global Fund and PEPFAR
in Implementing HIV/AIDS Programs

***Presenter:*** Dr. Vinand M. Nantulya, Senior Advisor to the Executive
Director, Global Fund

Dr. Nantulya said the question is not whether the ABC strategy worked in
Uganda. It did. The question is, what are the critical components for
other circumstances?

Dr. Nantulya said there is extensive complementarity in focus countries,
PEPFAR, and the Global Fund in the

-   Scale-up of prevention, care, and support

-   Scale-up of antiretroviral (ARV) treatment

-   Provision of support and care to orphans and other vulnerable
    children

-   Investment in strengthening countries' health systems.

For example, PEPFAR is going to provide Kenya with ARVs worth \$40
million to scale up treatment at 30 centers, among other interventions;
the 30 centers have been established and staff trained using resources
from the Kenyan government and the Global Fund; and there is
consultation and coordination at country level. Other examples include
Uganda.

PEPFAR is a financial contributor to the Global Fund. More than 121
countries are supported indirectly by PEPFAR through the Global Fund.
The approved proposals are consistent with PEPFAR's mission.

Most of the proposals to the Global Fund target prevention. All
proposals are reviewed by a Technical Review Panel. One hundred percent
of the proposals deal with behavior change communication; 84 percent
with condom promotion and distribution; 81 percent with voluntary
counseling and testing; 74 percent with treatment of STIs; 68 percent
with mother-to-child transmission; 38 percent with safe medical
practices; 32 percent with blood safety; and 19 percent with
postexposure prophylaxis.

Population groups targeted by prevention include, in order of
percentage, youth out of school, commercial sex workers, schoolchildren,
women, mobile populations, prisoners, MSM, military personnel, and
workers in the workplace.

Most proposals integrate treatment with care and support, and this
includes strengthening HAART programs and providing HAART medications.

Dr. Nantulya then listed the countries that have received some 225
Global Fund grants worth \$2 billion. The region receiving the most
grants is Africa, following by Asia and the Americas.

The Fund's disbursement target by the end of this year is \$1 billion.
At present, half of the funds are going to the public sector and half to
private-sector entities. The Fund plans to increase the share going to
faith-based organizations.

The Fund has strong support from the U.S. delegation, which is a major
player in the Global Fund. The Fund's critical challenges are:

-   A need for continuity of Global Fund's Board-approved policies on
    drug procurements implemented in many countries since October 2002.
    These policies are based on four criteria:

    -   lowest price

    -   assured quality

    -   competitive tendering

    -   conformity with national and international law.

-   Securing further U.S. contributions to the fight against HIV/AIDS in
    the 100-plus other countries through contributions to the Global
    Fund

-   Letting countries and communities take charge of their own destiny
    so that they can prioritize and implement what works best in their
    social contexts

-   Building a culture of research evidence based on policy and
    practice.

***Presenter:*** Dr. William Steiger, Special Assistant to the Secretary
for International Affairs, Office of Global Health Affairs/DHHS

Dr. Steiger explained that there is no bigger supporter of the Global
Fund than the United States, which provides at least three times as much
money as any other donor, and DHHS Secretary Tommy Thompson is chairing
the Global Fund Board until early 2005.

In partnership with the Global Fund, all 14 countries identified in
President Bush's plan have received Global Fund monies. The first
competitions in certain program areas were held in December. Awards,
principally for antiretroviral therapy and abstinence, have been made.
Several hundred million dollars have been committed, some to faith-based
groups. A comprehensive plan is underway now to encourage national
Government and nongovernmental partners to provide one unified U.S.
Government strategy for countries to be assisted. Global AIDS
Coordinator Ambassador Randall L. Tobias is reviewing specific proposals
now, then awards will be made.

Ambassador Tobias asked in this process that Global Fund colleagues be
taken into account, in part to prevent duplications. Technical experts
have been working with the Secretary also, to develop standard
indicators to make sure we can compare what the Fund is spending its
money on and what the President's initiative is spending its money on.
Everything is linked to the President's goals and that means drawing a
line between investments and results in terms of risky behavior
avoidance. At present, one focus is faith-based groups, particularly
those in the countries involved.

Dr. Steiger said the future holds a fourth round of grants from the
Global Fund, in June. The Fund and the 14 countries already identified
are almost like a beta test for the President's Emergency Plan, he
explained, insofar as the programs that are funded are based on
competitive review. The Fund's emphasis on quality and performance will
help the U.S. Government and the President's plan in the future.

## Discussion

A request was made for a copy of Mr. Mason's editorial in the *San
Francisco Chronicle*. Staff provided copies of it, "The False Promise of
Untested AIDS Drugs," as well as copies of "Beyond Slogans: Lessons from
Uganda's Experience with ABC and HIV/AIDS," by Susan A. Cohen, in the
Issues and Implications section of the December 2003 Guttmacher Report
on Public Policy, and a PowerPoint presentation on Recommendations of
the Ryan White CARE Act Reauthorization Workgroup to the CDC/HRSA
Advisory Committee (CHAC), which was given to Treatment and Care
Subcommittee members last February.

Haiti was mentioned as a priority country, but how can the Fund foresee
doing something there given the governmental chaos?

Dr. Steiger answered that both Guyana and Haiti are focus countries.
Other Caribbean members are Belize, the Dominican Republic, and the
Bahamas, all of which have also received separate grants from the Fund.
There is a major need for coordination in the Caribbean. On paper, there
is some overlap and major challenges. The Secretary's challenge is to
make sure that things are done in the most efficient way possible.

With some exceptions, Fund work has gone on in Haiti despite the crisis.
So far, all sides have been willing to work with the Fund.

Council members still wondered whether Global Fund and the President's
Emergency Plan will duplicate one another. An explicit question was, how
will the President's plan be implemented?

Dr. Steiger responded that the Global Fund is independently incorporated
under Swiss law. The United States is a major player and donor. The
President's Emergency Plan is administered by Ambassador Tobias,
coordinator of all HIV/AIDS programs around the world. The President's
plan will be implemented through a multiplicity of partners, such as
faith-based groups, local NGOs, and so on. The Fund is working to wring
any duplication out of the two activities. In most areas, there's enough
work to go around.

It was said that the delivery infrastructure still remains the major
challenge in Africa, and the question was asked, what's the standard
format to ensure baseline will be equitably evaluated?

Dr. Steiger said that, in the U.S. Government, the thinking is that
there are two potentially major ways to start up very quickly: using
local faith-based organizations on the ground, with clear lines of
accountability, doing a lot with very little; and leveraging the assets
of private companies. Dr. Steiger gave the example of a brewery that has
a plant and a clinic in that plant and that clinic is only running at
50-percent capacity. That, he said, is a wonderful use of underutilized
infrastructure.

Dr. Steiger said that, on the data question, data are very soft in many
places, for most countries have never done a full baseline survey. He
added that there are major plans to help with this in Fund and the
President's plans.

It was said that one of the countries chosen for funding is Myanmar,
which is under the leadership of a brutal military regime. There is no
private enterprise there or private or public NGOs so, the question was,
will the funds go where they are intended? How?

Dr. Nantulya responded that Myanmar is one of the countries "we call
difficult. We have not signed a grant yet. If we are to sign it, it
would not be with the government of Myanmar but, rather, with UNDP or an
NGO."

Dr. Steiger responded that Congress and the Administration say that
money should not go directly to these countries. Congress has mandated
that if the Fund signs agreements and provides money to any of a certain
named set of countries, the United States will discount its
contributions to the Fund.

The question was posed about which behavioral change would be most
effective in bringing down HIV rates in our country. Also, what is the
Fund's policy on ABC?

Dr. Nantulya said that an article is coming out in a British medical
journal that analyzes the relative contributions of different
interventions within ABC, and it states that B was the most important
component accounting for a decline in HIV prevalence and incidence.
Statistics for Uganda, Kenya, Zambia, and Zimbabwe were examined, and
when one looked at all age groups, the most significant decline in
responses related to multiple partners or sex with nonregular partners.
The HIV decline in Uganda was pronounced against rates in the other
countries.

Dr. Nantulya added that the Fund in its mandate and in its modus
operandi does not tell countries what interventions to implement, but
when it analyzes proposals coming in, it finds that nearly all address
ABC in different combinations of the A, B, and C.

Dr. Nantulya explained: In a sexually transmitted epidemic, the only way
to bring that epidemic down is to apply ABC. For an epidemic that is
confined in specific groups, the best way to bring that epidemic down is
C. This technical information is available, and when countries submit
proposals, these proposals are analyzed in light of available evidence.
Proposals that show what is known not to work are not approved. The
Secretary of the Fund retains the right subsequently to inspect and
evaluate a project at any point during implementation.

The relationship of the World Health Organization's 3 x 5 Initiative,
the Global Fund, and the President's Emergency Plan, Dr. Nantulya
explained, is that the 3 x 5 is an independent program with independent
sources of funds. Dr. Steiger said that the 3 x 5 is a framework that
the United States has helped WHO formulate, that includes technical
recommendations.

In discussing the application or acceptance of the ABC model, one has to
consider dynamics that are responsive to the various target populations.
It was suggested that organizations avoid developing a model that is
then superimposed on populations.

It was suggested that smaller faith-based organizations might be
particularly helpful in sustained efforts. Dr. Steiger responded that a
pillar of the President's programs is to link with such organizations,
and later this spring, there will be a "twinning center" designed to
identify potential partnerships that will be funded initially through
HHS and HRSA.

Do brand name drugs need to be used in programs abroad? Because if so,
that can cause difficulties, including cost overruns, it was observed.
Dr. Steiger said that this week regulatory and medical experts from
around the world are meeting to judge the quality of non-brand-name
drugs for HIV/AIDS patients. He said the Administration strongly feels
that it can't compromise on quality, and that low price and high quality
are the goal.

Ms. Robinson reminded participants that tomorrow's meeting will take
place in the same room. She asked Council members to read all motions
before tomorrow. She said that public comment is tomorrow at 10:25 a.m.,
and that speakers must preregister at the registration desk outside the
door. The per speaker time allotment is 3 minutes.

Dr. Coburn ***adjourned Day 1 of the 23rd Meeting of PACHA***.

## DAY 2

# 

# MORNING SESSION

Co-chair Dr. Thomas Coburn called the meeting to order at 8:30 a.m. with
a revised agenda and announced that Secretary Tommy Thompson was
expected. He said International Subcommittee Chair Abner Mason would
introduce two presentations on drug safety and efficacy, one by Dr.
Jeffrey Murray from the U.S. Food and Drug Administration (FDA), and
possibly another by Dr. Mary Pendergast, formerly of FDA.

## International Subcommittee Presentations

Dr. Judson asked if the Subcommittee's motion dealing with drug
procurement attempts to change or support something already written in
law. Mr. Mason responded that there are many different opinions on the
situation for procurements under the President's Emergency Plan. The
Subcommittee took up the issue to send a clear message on what members
thought should be the case. Mr. Mason reminded the Council that a panel
of experts meeting in Botswana is trying to come up with an approach to
the issue, and that group will have the benefit of the Council's motion,
if it chooses to pass it.

***Presentation topic***: Safety and Efficacy of Drugs Used in PEPFAR
Recipient Countries

***Presenter***: Jeffrey Murray, M.D., M.P.H., Deputy Director, Division
of Antiviral Drug Products, U.S. Food and Drug Administration

Dr. Murray explained that his presentation would be on the "Drug
Approval Processes: Antiretroviral Drugs," specifically:

-   New drug application (NDA): definitions

-   NDA life cycle

-   Antiretroviral approval (new molecules): accelerated approval and
    endpoints

-   NDA versus ANDA (generic)

-   New formulations from innovators.

NDA is a new drug application. It might be a new molecular entity or new
dosage form or fixed-drug combination. It could be supplements, such as
new indications or new populations (pediatric, for example). It could be
abbreviated NDA or ANDA, for generics.

When a new molecule is involved:

-   There must be sufficient data to permit approval, and data must
    include risk versus

> benefit assessment.

-   Information must include chemistry, manufacturing and controls,
    nonclinical

> pharmacology and toxicology, human pharmacokinetics and
> bioavailability, microbiology, clinical, and statistical data.

For a new antiretroviral, NDA information is required on:

-   Chemistry, manufacturing, and controls

-   Animal toxicology (9-12 month study, usually dog and rat)

-   Clinical pharmacology (15-40 studies)---PK, bioavailability, drug
    interactions

> (very relevant to HIV/AIDS), mass balance

-   Clinical studies (2-5) Phase 2 dose-ranging as well as Phase 3

-   Virologic data---*in vitro* and clinical data on
    resistance/susceptibility.

Dr. Murray noted that sometimes an advisory committee is appointed for
an NDA, particularly if the application is for a controversial drug or a
new drug in a class.

In the life cycle of a New Drug Approval, an application is considered
filed by the 60th day if all the pieces of the application are in place.
A review is then performed and issues identified, including risk
management. Multidisciplinary meetings are held. The advisory committee,
if any, votes. Labels, reviews, risk management plans, and Phase 4
commitments are discussed and commitments are made. A decision letter
stating approve, approvable, or not approvable is then posted within
6--10 months.

Dr. Murray showed a chart of AIDS drugs and noted that four were
approved in 2003, a record.

Accelerated approval regulations exist for:

-   Serious or life-threatening illnesses such as HIV and cancer

-   Meaningful therapeutic benefit over existing treatments.

Accelerated approval is based on:

-   Surrogate endpoints other than survival or irreversible morbidity

-   The sponsor's conduct of postapproval studies to confirm clinical
    benefit (after validation of HIV RNA this was changed to durable
    virologic suppression)

-   Prereview of promotional materials

-   Withdrawal procedures.

The basic difference between accelerated and traditional approval is
that changes in HIV RNA are allowed to be observed 24 weeks in an
accelerated approval and 48 in a traditional. In addition, 6 versus 12
months of safety data gathered on fewer patients are allowed in an
accelerated approval.

Antiretroviral approval is for:

-   Approval of a new drug, NOT a regimen (in combination with other
    antiretrovirals, for example).

-   When the indication is for use in combination with other
    antiretrovirals.

-   Trizivir (ZDV plus 3TC plus ABC) is one of the approved
    combinations, but each drug was approved individually first.

-   Not all three drug combinations make appropriate HAART.

Brand name versus generic drug requirements are the same up to animal
studies, clinical studies, and bioavailability. Instead of these, a
generic must show bioequivalence. It must show the same active
ingredients, the same route of administration, the same dosage form, the
same strength, the same conditions of use, and the brand name it is
making generic must be off patent or nearly off patent.

Retrovir will come off patent in 2005; Zerit, late in 2008; and Viramune
and Crixivan, in 2012.

Approved generics, Dr. Murray summarized, are bioequivalent to innovator
drugs. Bioequivalence is based on two drug concentration exposure
measures---Cmax and AUC (area under the time-concentration curve). In
short, "the standards are pretty strict."

Innovators can develop new formulations, such as a new dose or new
strength. Dr. Murray explained that bioequivalency is not required if
supported by previous clinical data. For example, in the old
formulation, Viracept was given in five 250 mg. caplets twice daily. Now
it is available as two 625 mg. caplets twice daily. Further, the new
size "increased bioavailability."

Dr. Murray noted that there can be a new innovator formula on the market
that is not bioequivalent, but generics must be bioequivalent. At
present, there is no ANDA pending for a generic version of the HIV
antiretrovirals because nothing is off patent until next year.

## Discussion

Dr. Murray named the four antiretrovirals approved in 2003: Fusion,
Rayataz, Emtriva, and Fuzeon. Fuzeon was approved in 5 months.

## Presenter: Dr. Mary Pendergast, former Deputy Commissioner, U.S. Food and Drug Administration 

Dr. Pendergast spent 20 years at FDA and has also worked with WHO and
other world agencies as well as smaller regulatory agencies on how to
regulate drugs in a market economy. Dr. Pendergast said her talk would
address in part "How the WHO process works and compares and contrasts
with FDA."

Dr. Pendergast emphasized she will not criticize WHO, for it is a
well-meaning and hard-working organization. However, there are
structural limits to its ability to ensure safe, effective, and
high-quality drugs. Dr. Pendergast explained that:

1.  WHO is not a regulatory agency. It was not created by structure of
    laws. It can't compel solid information or punish people who don't
    give it to them. What has been learned here is that, left unchecked,
    pharmaceutical companies provide inadequate information.

```{=html}
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1.  WHO does have trained professionals to review applications, but they
    are voluntary workers from WHO's member nations. Some of these
    volunteers have a lot of experience; some don't.

2.  Unlike in the United States, with the FDA, WHO both advocates for
    particular drugs or regimens and also is supposed to act as an
    impartial assessor. That would be a challenge for anyone.

3.  WHO does not have all the resources it needs. For example, it lacks
    an office of scientific investigations. It doesn't have a
    postmarketing reporting system---no feedback loop. That's left to
    the local countries where the drugs are used.

4.  WHO has other types of resource problems that prevent inspections
    and reviews such as those conducted by FDA.

5.  When a company submits to WHO approval, the review process is
    entirely secret. WHO can't share data with anyone. The FDA is the
    most open, transparent regulatory agency in the world, by contrast.
    FDA can be held accountable in this way. The same is true of
    manufacturing inspections.

6.  There is no legal construct to keep WHO accountable.

Dr. Pendergast said the standard for U.S. domestic programs is for
purchase of approved drugs. The circumstances for U.S. international
programs, at least in connection with USAID, is that when a manufacturer
has a drug but has not sought FDA approval, there is an opportunity for
a waiver of that standard. So, she concluded, the debate about drugs to
purchase for international AIDS programs may be one that focuses on when
to grant a waiver.

## Discussion

The question was asked, what's wrong with purchasing for international
programs three-drug combinations from, for example, a pharmaceutical
company in India and making them available at low cost. The question,
Dr. Murray responded, is whether the drug quality is the same. Even
companies trying to make formulations of their own drugs have trouble
doing that. Are you getting what you're paying for? With HIV, you are
exposing yourself to the risk of developing drug resistance and/or
spreading that drug resistance.

Dr. Pendergast observed that two triple-drug formulations have been put
on WHO's prequalification list, and everyone hopes they work. No one
knows they work. The data on which they were approved are not public.
Once the three generics are put together, they are no longer just a
generic. They constitute a new drug that needs new levels of study and
assessment.

Addressing the quality of generics, Dr. Murray said they are the same as
the original drugs if they are judged bioequivalent. Most drugs are
close to being 100 percent bioequivalent. In his presentation, he showed
an 80 percent--125 percent range, but he said that accounts for
statistical variability. He said FDA is particularly aware of the narrow
range for toxicity in HIV drugs, and that it is vigilant in looking for
tolerability and/or safety problems.

Dr. Murray and Dr. Pendergast confirmed that FDA does not have any
oversight for procurement of drugs to be used in Africa or anywhere
else. The agency reviews only what it is given. One way for the United
States to feel more comfortable about non-U.S.-manufactured drugs is to
encourage those manufacturers to submit requests for accelerated
approval to FDA. If FDA then said, "you're approvable," and therefore
can be approved once the U.S. patent is lifted from these drugs, that
would be sufficient "in my view" to allow a decision to purchase that
drug.

In answer to a question about quality control and plant inspections in
India, Dr. Pendergast observed that there are many Indian drug
manufacturers, and some are very good, and some that are less good. They
can get and do have FDA approval for their drugs. Dr. Murray noted that
there are differences in quality in companies in the United States.

In response to a question about what are the essential aspects of
obtaining a waiver, Dr. Pendergast said, as she understands it, the
question boils down to, when we spend taxpayers' dollars, who
decides---the State Department and/or grantees, for example--- and under
what standards.

It was noted that the Subcommittee's motion calls for some high-quality
level of approval, and the question was asked about the possibility of
FDA approving generic drugs.

Dr. Pendergast noted that she is no longer at FDA. She agreed that FDA
is the gold standard of drug regulatory agencies in the world, but added
that there are other countries with standards in which we could have
confidence---Canada and Japan, for example. She added that it is not
uncommon for a manufacturer who has proposed generic manufacture and
sale to approach the FDA for approvability while waiting for a U.S.
patent to lift. Dr. Pendergast said she does not know if that's the case
at present for any of the HIV drugs.

Dr. Coburn asked if innovator drug companies are buying rights to
manufacture generics so that they don't face competition from others
when HIV drug patents lift. He added that this is fairly common
practice.

Dr. Pendergast said the Federal Trade Commission (FTC) is the one to
ask.

## Public Comment Period

Dr. Coburn announced that the Council would take 25 minutes of public
comment, then break for Secretary Thompson at 10 a.m.

Dr. Coburn noted that public speakers who have registered who are not
present will be allowed to make comments later.

## Public Comment Rules

Ms. Robinson noted that public comment time is an opportunity to speak
before Council. It was moved to Day 2 (March 30) to give the public an
opportunity to hear all the presentations and all the motions presented
to the Council. She reminded speakers they were required to register.
The names were taken by her office, and will be read in the order in
which they were received. There are approximately 18 speakers. The time
limit for each is 3 minutes. Staff will provide a reminder of 1 minute
remaining.

## Written Submissions 

Written comments needed to be received by March 24 and not exceed five
pages in length so that members of the Council could receive and read
them in advance. Ms. Robinson asked that members remain in the room for
the period.

Deborah Rock asked that the peer counselors from the Baltimore Pediatric
HIV Program be allowed to go last, as they are still en route.

# Public Speaker #1

**Carl Schmid, AIDS Institute**

Mr. Schmid identified himself as Director of Federal Affairs for the
AIDS Institute. He noted that the Council would hear later from Gene
Copello, executive director of the Institute.

Mr. Schmid said the Institute applauds the ABC strategy's successful
implementation in Uganda, which included strong leadership by the
government. The Institute agrees that the strategy, however appropriate
it is made for different populations, must be comprehensive in
nature---with a focus on A, B, C, and strong leadership by the
government. Mr. Schmid said earmarking among these strategies will not
work.

Mr. Schmid said in presentations given March 29 there was little said or
discussed about why certain groups, such as adolescents, do what they
do. He congratulated Dr. Thrun for his candid remarks on gay youth. He
said the startling level of new infections, especially in minority
communities, cannot be ignored, as it has been. As the Council considers
prevention approaches, please remember, he asked, to address mental
health aspects and needs of individuals.

**Public Speaker #2**

**Marsha Martin, AIDS Action**

Ms. Martin asked for creation of a Council subcommittee on the domestic
AIDS epidemic "because in the discussion, it's difficult to understand
what is being addressed." She suggested the Council consider publishing
an update or report on the domestic AIDS epidemic. She also asked that
risk categories and their utility be reviewed. Be careful, she said,
about use of the term "MSM." Sometimes it's about gay, and sometimes
it's about behavior. She also wondered about the definition of
"generalized populations."

Ms. Martin advocated running the numbers and asking "how we're doing."
With no real increases in money, how are we going to take care of newly
identified patients? Dollars are shrinking from all sectors, not just
Federal programs and policies. Where are we going to make up the
shortfall in dollars? She brought and handed out copies of a report
entitled "Connecting to Care," about successful efforts in programs that
help connect those who know their status and care. It is based on 17
case studies in cities range from Gallup to Hartford to Nashville to
D.C. to West Palm Beach.

**Public Speaker #3**

**Hank Wilson, Committee to Monitor Poppers**

Mr. Wilson stated that he is HIV-positive. He said he was going to talk
about poppers. Poppers is a sex drug. Internet ads still sell it, even
though it was banned in 1991. It is an important issue for prevention.
Poppers have an adverse effect on HIV drugs. It's a risk factor for
unsafe sex and seroconversion. It is now confirmed that if you take
three sniffs of poppers, you immediately lower the immune system by 30
percent. Mr. Wilson wants every young gay man to make an informed
choice. His challenge to the CDC is: are we arming our young people with
information? The Sexual Health Survey did not assess popper use. Please
put this back on the radar screen, he said.

**Public Speaker #4**

**Bernadette Marriott, RTI International**

Dr. Marriott is a scientist at RTI International in Research Triangle
Park, NC. Her statement has been officially endorsed by the American
Society for Clinical Nutrition of which she is a member.

Dr. Marriott discussed malnutrition and its devastating effects on the
immune system, thereby exacerbating HIV/AIDS and increasing the risk of
opportunistic infections. Specific supplemental nutrients can enhance
the effectiveness of HIV drug treatment by addressing malnutrition and
helping to rebuild the immune system. All HIV treatment programs should
include nutritional assessment, dietary counseling, and provision of
specific nutrient supplements. More research should also be conducted in
this area.

Malnutrition is a typical backdrop to HIV/AIDS throughout the world. The
malnourished are more likely to contract HIV. Data show that
identification and treatment of micronutrient deficiencies can play a
critical role in prolonging life for HIV-positive patients.

> *Dr. Coburn called for a break in anticipation of Secretary Thompson's
> arrival. The Council will resume Public Comment after the Secretary's
> speech.*

## Secretary Tommy Thompson

At 10 a.m., Dr. Coburn introduced Health and Human Services Secretary
Tommy Thompson. Dr. Coburn thanked Secretary Thompson for his leadership
and hard work.

Secretary Thompson thanked Dr. Coburn for his leadership and passion on
this subject and wished him good luck in his election race in Oklahoma.
He noted that when he was Governor of Wisconsin, whenever he asked
individuals to help him, they did, just as they have come to serve on
the Council. He said he was lucky to have such dedicated publicly minded
individuals helping in the development of policy to help people around
the world.

Secretary Thompson recalled his trip to Africa in the first week of
December (2003), in the company of some members of the Council. He
called it a "transforming experience." He visited a small village
outside the capital of Uganda, where people use motorcycles to deliver
drugs in the bush. Secretary Thompson and others had an opportunity to
visit with families in mud huts where there was nothing but necessities,
and family members were HIV-positive. He met Rosemary, whose husband
died in 1994, leaving her HIV-positive with four children. Then her
brother died, leaving three more children in her care. She was on her
deathbed when we started delivering drugs to her village, and now she's
raising crops on two acres of land. She makes \$70 a year to support
her, her children, and her mother.

Secretary Thompson said he expected Rosemary to be depressed, but she
was just the opposite: positive, full of life, and happy to raise her
children. She would not have had that opportunity without the generosity
of the American taxpayer and the expertise of the staff in this
Department.

In another village, Secretary Thompson met a carpenter named Samson,
whose wife had died 3 years ago and was buried outside his hut so his
children could be reminded every day that they had a mother and that
this HIV/AIDS is a deadly disease. Samson goes to the swamps every day
for wood, from which he makes chairs and tables. He has never seen a TV,
never heard a radio, and can't read, but he had the presence of mind to
tell me to go back to America and thank George Bush for believing in us
and giving us hope and a chance to live, and also to thank Americans and
HHS. Secretary Thompson said that tears started rolling down his eyes.
They had nothing but hope and optimism. And that's why you're here. We
want to win this war. At present, we're losing it, so we just have to be
rededicated.

The Secretary noted he had just returned from chairing a Global Fund
Board meeting, where member nations reached agreement on \$5.5 billion
in pledges, in 30 months. This Fund and the President's initiative are
providing hope and optimism. He has now met the health ministers in
Africa and has been transformed from pessimism to optimism for the
future.

We're all in agreement, too, that this is a war that we have to fight
right here in the United States, the Secretary said. Our first
responsibility is here, he added, and in this regard, the new quick
test, using saliva, will be helpful.

Secretary Thompson concluded his remarks, and Dr. Coburn resumed public
comment.

## Public Comment Period Resumed

**Public Speaker #5**

**Genevieve Clavel, Private Individual**

Clavel stated that AIDS money is being spent where it shouldn't be. We
are experiencing a severe financial crisis in the United States, yet
money is going to pay for the expenses of certain people instead of
patients. Clavel stated she had flown on her dime from Los Angeles. She
said she wants personally to speak to Donald Morgan about cover ups
after audits by the CDC and HRSA in Los Angeles. She said she supports a
Federal audit of where AIDS money is really going, for example, to
faith-based organizations or for lobbying.

**Public Speaker #6**

# Arnitra Bannister, Baltimore Pediatric HIV Program 

Bannister is a peer educator in Baltimore. She said one-half of all new
HIV/AIDS cases are from youth. In the United States, the primary route
of transmission is sexual intercourse. There is a need not for
traditional education of youth, but more peer and comprehensive
education. We must also teach abstinence. If a young person does have
sex, they need to know how to have safe sex and make good conscious
decisions. We need more support and peer groups because it's easier for
young people to talk to a peer than to a teacher or parents. If I'm a
young person with STD, will I more easily talk to my parents or a peer?

**Public Speaker #7**

**Angela Williams,** **Baltimore Pediatric HIV Program**

Ms. Williams, HIV-positive, contracted the infection at birth. She is a
peer counselor. She noted that youth are sexually active. One indicator
is the pregnancy rate, now at 1 million each year in the United States.
Through sex, one can also get STDs and HIV. Ms. Williams said when she
talks to youth, she tells them the best way to be safe is not to have
sex. She tells those who do, have safe sex. As a teenager, she feels she
would much rather have a peer talk to her about HIV and STDs than
someone twice her age because then she can relate to that person. That's
why peer educators are important in the communities. If we lose our
youth, we lose our future.

# Public Speaker #8

**Tillman White,** **Baltimore Pediatric HIV Program**

Mr. White was diagnosed as HIV-positive at the age of 22. He may have
contracted the infection earlier, at age 17, from an older woman he met
in church. Now he's following his heart and stressing the importance of
peer counseling and advocacy one on one.

# 

# Public Speaker #9

**Helen Higgins, Baltimore Pediatric HIV Program**

Ms. Higgins is a mother and a counselor. She is HIV-positive and became
pregnant by an older man. As a peer educator, she visits schools,
churches, and other places in the communities. She counsels. Examples of
the positive effects of peer counseling include the fact that young
people have revealed things to her that they could not to others, such
as multiple abortions, anal sex with a father, and severe STD infection
that had gone untreated.

**Public Speaker #10**

**Tiare Letman, Baltimore Pediatric HIV Program**

Ms. Letman has been HIV-positive since birth. She is a peer counselor.

**Public Speaker #11**

# Patricia Hawkins, Whitman-Walker Clinic

Ms. Hawkins said the statistics of incidence are rising, yet funds
remain flat. She knows of two patients who died in West Virginia last
year waiting for drugs. Forty cities have lost Title I funding, and
these same cities are absorbing the costs of the CDC initiative. Flat
funding means death in America.

**Public Speaker #12**

**Christina Edwards, Private Individual**

Ms. Edwards said she flew in with her own money from Los Angeles. She
said an audit is needed of how HIV funds are spent, from the biggest to
the smallest entities. She suggested that the audit not by conducted by
HRSA or CDC because "some people there are in bed with the bad guys."
She also stated that there is waste in HIV programs.

# Public Speaker #13

**Peg Willingham, International AIDS Vaccine Initiative**

Ms. Willingham said her organization's mission is development of a safe
vaccine for AIDS. AIDS has exploded into a worldwide disaster, so we
need an AIDS vaccine. We need more resources and research for this and
also on microbicides. Current options for treatment do not work for
everyone. Private industry needs more incentives to develop vaccines and
microbicides. Although it will take a few years, eventually there will
be a vaccine.

**Public Speaker #14**

**Noemi Nagy, Mother of Jonathan Rizzario**

Ms. Nagy and her son, Jonathan, are from New York. They listened to the
Prevention discussion. She said she noticed that the discussion didn't
mention prenatally infected children, who face a life of need for
support but limited resources are available.

Also, women are 40 percent of new cases, and they can't be
ignored---women are heads of households. HIV is often the last thing on
their minds. Unless their needs are met, the country will face a new
task of dealing with orphans. There has been a great deal of emphasis on
Uganda. We can learn a lot from that by improving cultural competency in
the United States. Proceed with caution, she said, and do not to create
barriers for our most vulnerable population.

**Public Speaker #15**

**Godfrey Sikipa, RTI International**

Mr. Sikipa said international AIDS councils need to build capacity,
especially now at a time of massive financial inflows. As observed at
this meeting, this Council could play an important role in building that
capacity, especially in the targeted nations, to encourage use of
scientific evidence and data and public participation. Mr. Sikipa
suggested that PACHA, through its International Subcommittee, create
linkages with national AIDS Council, with a view toward building
international AIDS Council capacity.

**Public Speaker #16**

# Donald Oxley, OraQuick

Mr. Oxley congratulated the Council for playing a part in OraQuick's
announcement of the availability of a new quick test for HIV. He
reminded the Council that "what you do impacts this disease in a
positive way." He announced that his company is ready to discount the
test, based on saliva, by 70 percent for Africa because "we know it's
the right thing to do." Keep up your push because we in the private
sector will respond, he concluded.

**Public Speaker #17**

**Dion Richetti, NY-NJ AIDS Educating Training Center**

New Jersey is a microcosm of the status of funding of the epidemic.
Newark lost its EMA. Others lost funding or portions of their funding
this year. New Jersey is at risk of losing its current capacity relating
to the epidemic at the very time that outreach efforts are bringing more
into systems of care. At present, he said, his organization is
scrambling just to keep up most basic services. It is important that
funding be distributed based on need, not politics. Richetti concluded,
saying he supports additional money for Title I for FY 2005.

**Public Speaker #18**

**David Shippee, Chase-Brexton Health Services**

One problem with the Title I process is that it causes a see-saw
planning process. Having to reapply each year causes fluctuations in
staff at the same time the clinic is dealing with 1,500 patients now and
2,500 patients who are expected to come. STD infection rates are the
leading edge of HIV disease, and Baltimore has the off-and-on
distinction of being first in the Nation in syphilis. To help clinics
like Chase-Brexton, the Title I process needs to be redesigned to
acknowledge need for continuity of care.

**Public Speaker #19**

# Gene Copello, AIDS Institute

The Council needs to convene a meeting on domestic financing and
structure that would include discussion of the Ryan White CARE Act as
well as larger components. This meeting should address care and
treatment as a system. It should occur after the next Institute of
Medicine report comes out on HIV financing. There should also be
discussion of mental health and substance abuse as well as all the
components of the ABC strategy.

## Reconvening and Announcement About Motions

Dr. Coburn reconvened the Council shortly after 11 a.m. noting that the
Council would now have a brief discussion on the Subcommittee motions.
Dr. Coburn announced that the International Subcommittee had made
revisions to its two motions, one on drug procurement, and one on
providing assistance to Asia. Changes were also presented to the joint
motion of the Prevention and International Subcommittees.

## Revisions to Three International Subcommittee Motions Allowed

Dr. Coburn said he would allow the revisions to the three motions to be
presented, but that he would not allow this in the future because "it's
not fair for those who have studied the earlier product."

Mr. Mason made a motion to amend the three motions that were read into
the record yesterday.

Discussion of Revision to Prevention and International Subcommittee
Motion on the ABC Strategy

Dr. Coburn asked the Council to direct its attention first to changes in
the Prevention and International Subcommittees' joint motion on the ABC
strategy.

Prevention Subcommittee Chair Smith introduced the motion on screen. Dr.
Coburn asked if there were any additional changes.

Dr. Judson advocated guidelines for resolutions. For example, he said,
they should always have a clear-cut title and be less than one page. To
whom the resolution is addressed and what action or follow through is
needed needs to be clear.

## 

## Discussion of Prevention Subcommittee Motion on Youth Prevention

Emphasis on Risk Avoidance---

Sandra McDonald asked for clarification on the Subcommittee's other
motion, on youth prevention, which uses the term "risk avoidance," in
the last paragraph, adding that it doesn't consider all the barriers and
social contexts in which youth are making decisions.

Ms. Smith asked for responses.

Monica Sweeney concurred with the need to spell out more than just risk
avoidance.

The Council returned to discussion of the ABC strategy motion.

## Discussion on Prevention and International Subcommittees' ABC Strategy Motion, Continued

Earmarking---

Dr. David Reznik said he is concerned about language indicating an
earmarking of funds for the B part of the strategy.

Dr. Edward Green said the International Subcommittee decided to urge the
President to say that the B of ABC (the "Be faithful" or partner
reduction message) not be neglected. Ms. Smith added, "to ensure that
adequate resources be provided."

Dr. Reznik said Ms. Smith's concept is fine.

Karen Ivantic-Doucette suggested using "in concept and resources" as
well as attention. Ms. Smith accepted the suggestion.

Dr. Henry McKinnell asked that priority be given to programs that
include all three parts of the strategy. Ms. Smith responded that it
would be difficult because PEPFAR will fund many different programs. It
was noted that the ABC approach might not yet be very well spelled out
in PEPFAR.

Ms. Robinson said her staff is looking for a fact sheet on the law and
how it is set up for ABC to be accomplished.

Dr. Coburn reminded the Council that what is happening now is that
Subcommittees are supposed to listen to members' concerns about their
motions before the breakout sessions.

Dr. Sweeney suggested that Chairs reiterate what they are hearing in
terms of remaining issues.

Ms. Smith said earmarking is an issue and reduction of stigma. Rev.
Edwin Sanders indicated he would help her with language to address the
stigma issue.

The Council returned to discussion of the Subcommittee's motion on youth
prevention.

## Discussion of Prevention Subcommittee Motion on Youth Prevention 

Risk avoidance and risk reduction---

Nathan Nickerson said he perceives an emphasis on abstinence in the
language on risk avoidance and suggested that because the epidemic in
the United States is different than in Uganda, those differences should
be addressed.

No other comments were made on the Prevention Subcommittee motions.

## Discussion of Treatment and Care Subcommittee Motions

ONAP Director Motion--

Subcommittee Chair Minor asked for comments on the ONAP Director Motion
first.

Dr. Joe McIlhaney asked what efforts have been made to fill the position
to date.

Ms. Robinson said there has been an active search for a director. Carol
Thompson is acting director.

Dr. McIlhaney suggested new language about encouraging attempts to fill
the office.

Dr. Judson asked that there be a title and that the motion be shortened.

ADAP Motion--

Mr. Minor asked for comment on the ADAP Motion.

Ms. Smith suggested that a 90-day limit on a report by the Secretary
seems a bit unfair. She suggested requesting a report on this at the
next meeting in June.

Dr. Coburn said structural reform of ADAP is critical. A cover letter to
the Secretary should address this.

Dr. Judson said he has looked at Colorado's waiting list and there's no
one on that list who was not receiving treatment; rather, they were just
waiting for ADAP. We may use that to drive the funding process, but we
may be doing a better job than we think we are.

Dr. McIlhaney asked if there has been a good evaluation of how people
are using ADAP, in the interests of making sure the drugs are being used
as effectively as possible.

Dr. McKinnell added that early treatment legislation is a good idea
because it saves lives as well as money.

Dr. Sweeney advocated adherence treatment programs for the most
vulnerable people because that's an efficient way of using money.

Summit Motion---

Mr. Minor asked for comment on the summit motion.

Dr. Sweeney said members should have some idea of what they hope to
accomplish.

Ms. Smith said it should read that the committee hopes this would bring
about domestic policy on HIV that doesn't exist today.

Dr. Beny Primm observed that we may have to wait until 2005 because of
the elections, so perhaps someone needs to address domestic issues in
another way, before a summit.

Mr. Nickerson seconded the idea of identifying special summit goals.

Mr. Minor explained that the Subcommittee wanted to see if the Council
wants to go ahead with this idea and, if so, whether there should be a
separate committee to work on it---at the June meeting, to announce
dates and goals.

Dr. McKinnell asked for clarification that the collection of programs
already developed aren't meeting the needs. He agreed there is a need to
look at structural change in ADAP, particularly in favor of early
treatment.

Guiding Principles and Core Values---

Mr. Minor was wondering if those would be adopted.

Dr. Coburn suggested that discussion move on to the International
Subcommittee's motions. Mr. Mason provided the new draft, as follows:

**Presidential Advisory Council on HIV/AIDS**

**International Subcommittee**

### 

### Draft Motion

WHEREAS, the Asian AIDS epidemic, with more than 10 million cases, is
second only to the sub-Saharan epidemic and may be expanding faster.

WHEREAS, in Asia, as in Africa, the AIDS epidemic, if unchecked,
threatens to destabilize important countries. The AIDS destabilization
threat to Asia is as real as it is to Africa, the major difference being
the timeframe.

WHEREAS, Asia is and has long been the most populous continent, is one
of the cradles of human civilization, and is becoming the most
economically dynamic region on the planet.

 

WHEREAS, Asia is politically less stable and has less healthcare
infrastructure than other developed areas such as Europe and North
America.

 

WHEREAS, the worldwide economic and geopolitical consequences of
destabilization in China, the Indian Subcontinent, or Southeast Asia
would be exceedingly grave.

WHEREAS, the United States has long involvement in Asian countries, and
our recent history is importantly linked with theirs.

WHEREAS, the Asian countries have recognized the implications and extent
of their AIDS epidemics and want to act.

WHEREAS, the Asian countries with severe HIV/AIDS epidemic need more
than just technical assistance to institute treatment as well as
prevention and lack resources to do treatment by themselves.

WHEREAS, PEPFAR has no Asian countries among the 14 designated focus
countries.

 

WHEREAS, Congress recognized this limitation by requiring the addition
of a 15th country outside of Africa and the Caribbean in last year\'s
appropriation.

 

WHEREAS, more AIDS treatment and prevention programs need to be
implemented quickly in Asia to prevent a devastating tragedy which will
impact the U.S. national interest and world economy and health.

 

BE IT THERFORE RESOLVED that PACHA recommends to the President that
PEPFAR allocate a significant portion of funding to Asia and that PEPFAR
be expanded to include Asian focus countries particularly those willing
to provide high-level leadership and to share costs. Moreover, PACHA
recommends that discussions be initiated in the near future with India
and China on establishing cost sharing programs to facilitate access to
American expertise on AIDS prevention and treatment.

## Discussion

Dr. James Driscoll suggested that the language read "expansion of PEPFAR
to include Asia."

Dr. Coburn said while the United States has leading expertise and
treatment in HIV, it is arrogant to say that when the country's own
domestic rate is rising. He advised finding another way to express it.

Dr. Judson said he's not sure the United States can be more useful in
Asia until more is known.

Dr. Janet Hu said she often travels in China, and the situation in Asia
is very different; that is, no one really knows how to deal with it on
the ground. A lot of advice and expertise are needed. ABC will work
perfectly in Asia because the culture is more conservative.

Dr. Judson said he spent 2 weeks reviewing the HIV program in China last
year. ABC is already part of the culture there and already part of the
law. China is increasingly accessing expertise on this to the extent it
will be useful. They're learning, and, in fact, they may have more to
offer us than we to them in terms of a prevention environment, he said.

Ms. Ivantic-Doucette agreed with Dr. Judson and that the Subcommittee
may mean simply to include one country in Asia.

Dr. Judson said he's not adverse to solidarity with Asia through PEPFAR;
it's just that we should be discrete.

*International Subcommittee's Revised Motion on Drug Procurement under
PEPFAR*

Mr. Mason asked for comments on the **second motion**, as revised. It
reads as follows:

# 

**Presidential Advisory Council on HIV/AIDS**

**International Subcommittee**

### 

### Draft Motion

**On funds to ensure the safety, quality, and effectiveness of drugs
procured by PEPFAR**

WHEREAS, the President's Emergency Plan for AIDS Relief (PEPFAR) has as
its major goal the implementation of a plan to provide lifesaving drug
treatment to 2 million people infected with HIV in the 14 targeted
countries, and

WHEREAS, the Office of the Global AIDS Coordinator has been given the
responsibility and authority to fund the purchase of drugs, and to
determine what drugs will be procured either directly or indirectly with
PEPFAR funds, and

WHEREAS, the people of Africa and the Caribbean who will receive drugs
procured directly or indirectly with PEPFAR funds deserve drugs that
meet a high standards for safety, quality, and effectiveness, and

WHEREAS, FDA-approved ARV drugs and their generic equivalents have
demonstrated their capacity to effectively manage HIV diseases, and

WHEREAS, poor quality, counterfeit, mismeasured, or ineffective drugs
can speed development of resistant virus, sicken or kill patients, or
simply fail to help them, thus undermining support for PEPFAR and
spawning cynicism about American motives where there had been respect
and hope,

BE IT RESOLVED that the Presidential Advisory Council on HIV/AIDS
recommends that the President direct the Office of the Global AIDS
Coordinator to require that any drug procured directly or indirectly
with PEPFAR funds must meet comparable standards for safety, quality,
and effectiveness as would be necessary for drug approval in the United
States or any other country with drug approval standards of comparable
scientific rigor.

In addition, the Office of the Global AIDS Coordinator should be
directed to create an outside technical advisory panel to advise the
Office on clinical outcomes, quality standards and drug treatment
guidelines.

BE IT FURTHER RESOLVED that PACHA recommends that the Secretary of DHHS
take all necessary steps to expedite clinical trials on new drugs and
formulations, including fixed-dose combinations (FDCs) that hold promise
for simplifying treatment regimens, decreasing treatment costs, and
thereby expanding safe effective treatment.

## Discussion

Mr. Minor observed that the second to last paragraph is new and good.
But he hopes we do not impede quick access to effective drugs. Is that
the role of the new advisory panel, he asked?

Mr. Mason said it would advise the Global AIDS Office on a standing
basis.

Dr. Judson asked, Can the emergency fund be used that way?

Mr. Mason responded that he thinks the coordinator has authority to
purchase in any way he sees appropriate.

Dr. Primm said that it must be ensured that the drugs and everything
else are of the first quality.

Dr. Coburn asked the Council to finish this discussion then proceed into
breakout groups for a working lunch.

Final Pre-Breakout Discussion on the Prevention and International
Subcommittee's ABC Strategy Motion

ABC Strategy and Appropriateness for the United States---

Rev. Sanders indicated hesitancy about the appropriateness and
completeness of the ABC strategy.

Dr. Coburn responded that we should avoid polarizing the debate between
condom versus abstinence. There is one common purpose---to lesson the
impact of the epidemic and as advisors, to give the President the very
best advice in both treatment and intervention.

Rev. Sanders advocated sensitivity to the breadth of the ways this
disease is manifested in this country and in American society. He wants
the Council to consider talking about ABC in terms of principle because
as a concrete application, it still needs to be refined for use in the
United States. The new CDC initiative has been framed in light of ABC,
so there is nothing problematic. Application of ABC in Uganda is very
different because it's being driven by a culture, by experiences, that
are different from those in the United States.

Ms. Smith said her Subcommittee's intention in the last paragraph of the
motion was to do what is being advocated and if it doesn't work, it will
be changed.

Marriage versus Relationships and Faithfulness---

Ms. Smith promised the Subcommittee would take up concerns about this
language in the motion.

Delay in Sexual Debut---

Dr. Sweeney said delay in debut is an important issue that everyone can
engage in, regardless of sexual orientation.

Personal Responsibility---

Lisa Mai Shoemaker asked for language in the motion on personal
responsibility.

Dr. Judson said the ABC model hasn't been well defined, and it doesn't
have much to offer the United States in its most simplistic form,
especially when infection by drug injection is a large part of the U.S.
epidemic.

Ms. Robinson informed the Council that she now has the fact sheet on how
funding is directed for the President's Emergency Plan.

## Locations, Staff, and Rules for Breakout Sessions

Ms. Robinson announced that the public may sit in on the Subcommittee
breakout sessions but must chose one to attend. She announced the room
numbers and staff for each.

Dr. Coburn adjourned the Council for Preparatory Work by the Prevention,
Treatment and Care, and International Subcommittees.

**AFTERNOON SESSION**

Dr. Coburn reconvened the Council for Motions and Voting at 2:20 p.m.

## Prevention Subcommittee Motions: Revisions Presented

Dr. Coburn asked Prevention Subcommittee Chair Smith to display the
Subcommittee's two motions.

The **first motion**, informally known as the youth prevention motion,
now reads as follows:

**Presidential Advisory Council on HIV/AIDS**

**Prevention Subcommittee**

**Call for the Establishment of an Office or Designation of Staff at
the**

**White House to Address**

**HIV Prevention and Interrelatedness of Risk Factors for Youth**

*WHEREAS, an estimated 15,000 of the estimated new 40,000 HIV infections
in the United States in 2000 were among youth aged 15 to 24 and (1),
and*

WHEREAS, evidence also shows that among this same age group there were
9.1 million new STD infections (48 percent of the approximately 18.9
million new cases of STD in 2000) ^1^, and

*WHEREAS, research shows that the earlier young people begin to
participate in unhealthy risk behaviors, the greater their overall and
long-term risk, for example:*

-   Young people who participate in first intercourse before age 14 are
    significantly more

> likely to have more lifetime sexual partners. Fifty-seven percent of
> girls who initiate sex before age 14 report six or more lifetime
> partners compared to 10 percent of girls who initiate sex at age 17 or
> older. Likewise, 74 percent of boys who initiate sex before age 14
> report six or more lifetime partners compared to 10 percent of boys
> who initiate sex at age 17 or older. The number of new sexual partners
> over time is a key factor in the spread of STDs, including HIV/AIDS
> ^2^;

-   Young people who begin drinking before age 15 are more than twice as
    likely to

> develop alcohol abuse and are four times more likely to develop
> alcohol dependence than those who began drinking after age 21 ^3^;

-   Epidemiological and clinical studies suggest that adolescents who
    begin drug use at early ages not only use drugs more frequently, but
    also escalate to high levels more quickly and are less likely to
    stop using ^4^;

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-   Experts agree and studies show that age of initiation is a powerful
    predictor of tobacco consequences and dependence. The vast majority
    of people who become addicted smokers started smoking regularly
    before 18 years of age and will be addicted for an average of 16 to
    20 years ^5^;

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```
-   The earlier the onset of a delinquent career, the greater the number
    of delinquent offences juveniles are likely to commit before their
    18th birthday ^6^; and

WHEREAS, studies reveal interconnections between unhealthy risk
behaviors, for example linking alcohol and/or substance abuse with early
and unplanned sexual activity among youth putting them at increased risk
for acquiring HIV ^7^, and

WHEREAS, evidence also shows that a child\'s connections with parents,
family, and school are the strongest protective factors for early onset
of multiple unhealthy risk behaviors, including those that put youth at
risk for HIV ^8^,

BE IT RESOLVED that PACHA commends the President of the United States
for his focus on helping youth make right and healthy choices in his
2004 State of the Union address, and

BE IT FURTHER RESOLVED that PACHA urges the President to implement a
strategy that will help ensure that America\'s youth are encouraged to
make right and healthy choices by establishing an office or designating
a staff person at the White House who is responsible for making sure
that all youth risk behavior prevention messages generated by and
disseminated through the federal government are cogent, comprehensive
and coordinated, focused on risk avoidance and risk reduction (i.e.,
consistent with Uganda\'s ABC prevention model for HIV/AIDS) for all
youth, with special attention to those at higher risk.

Citations

1.  Weinstock H, Berman S, Cates Jr. W. "Sexually transmitted diseases
    among American youth: incidence and prevalence estimates, 2000."
    Perspectives on Sexual and Reproductive Health 36(1): 6-10 (2004).

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```
9.  "Trends in the Well-being of America\'s Children and Youth: 1996."
    U.S. Department of Health and Human Services, Office of the
    Assistant Secretary for Planning and Evaluation.

10. Grant BF, Dawson DA. "Age at Onset of Alcohol Use and its
    Association with DSM-IV Alcohol Abuse and Dependence: Results from
    the National Longitudinal Alcohol Epidemiologic Survey." Journal of
    Substance Abuse, 9:103-110 (1997).

11. Johnson RA, Gerstein DR. "Initiation of Use of Alcohol, Cigarettes,
    Marijuana, Cocaine and Other Substances in U.S. Birth Cohorts since
    1919." American Journal of Public Health, 88:27-33, (1998).

12. Choi WS, Pierce JP, Gilpin EA, Farkas AJ, Berry CC. "Which
    Adolescent Experimenters Progress to Established Smoking in the
    United States?" American Journal of Preventive Medicine,
    13(5):359-364 (1997).

13. Snyder HN, Sickmund M. "Juvenile Offenders and Victims: a National
    Report." Washington: National Center for Juvenile Justice, (1996).

14. Willard JC, Schoenborn CA. "Relationship Between Cigarette Smoking
    and Other Unhealthy Behaviors among our nation\'s youth: United
    States, 1992." Advance Data, April 24; (263), (April 24, 1995).

15. Blum RW, Rinehard PM. "Reducing the Risk: Connections that Make a
    Difference in the Lives of Youth." Division of General Pediatrics
    and Adolescent Health, University of Minnesota, Minneapolis, MN.

## Discussion

Ms. Smith characterized the discussion during the Subcommittee's
breakout, including the systematic taking up of all issues, one by one.
She noted the principal changes are in the last paragraph. She asked for
a motion to adopt and second.

Deborah Rock made the motion to adopt; Cheryl Anne Hall seconded it.

There was no further discussion.

## Motion Carries

Dr. Coburn asked for a show of hands in favor and announced that the
motion carries.

The second Prevention and International Subcommittee motion, on the ABC
strategy, was presented by Prevention Subcommittee Chair Smith. It now
reads as follows:

**Presidential Advisory Council on HIV/AIDS**

**Prevention and International Subcommittee**

**Call for Bold Leadership in Raising Domestic HIV Prevention
Awareness**

WHEREAS, President Bush has heralded the Uganda ABC prevention model as
the most effective worldwide for sexual transmission of HIV and has made
it the centerpiece of the President\'s Emergency Plan for AIDS Relief
(PEPFAR), and

WHEREAS, the data shows that between 1991 and 2001 prevalence of HIV
infection in Uganda declined by 66 percent, from 15 to 5 percent, and

WHEREAS, by 1995 fully 95 percent of Ugandans were reporting A or B
behaviors in the preceding 6 months, meaning they were having sex with
only one partner or they were abstaining, or they were faithful within
the minority of polygamous marriages found in Uganda, and

WHEREAS, there was a highly significant decline in young males and
females reporting premarital sex between 1989 and 1995, and

WHEREAS, the ABC prevention model developed by Ugandan leadership in
1986 contained clear and targeted messages: (1) be Abstinent, (2) Be
faithful, and (3) use Condoms 100 percent of the time if you have
relations with an infected partner or engage in casual sex,

BE IT RESOLVED that PACHA applauds and supports the President\'s
commitment to the one prevention model that has shown to be most
effective prevention strategy for generalized epidemics around the
world; and

BE IT FURTHER RESOLVED that PACHA urges the President of the United
States to give the "B" portion of the ABC message increased attention,
emphasizing personal responsibility since data shows that a reduction in
number of partners played a crucial role in Uganda\'s prevalence decline
and many PEPFAR target countries do not currently focus on the \"B\"
message; and

BE IT FURTHER RESOLVED that PACHA urges the President of the United
States and Secretary Tommy Thompson to evaluate the United States\'
domestic prevention strategy outcomes compared to the Uganda ABC
prevention model outcomes to identify strategies whereby the United
States would realize a short-term goal of annual reduction in numbers of
new HIV infections and a long-term goal of no new infections; and

BE IT FURTHER RESOLVED that PACHA urges the President of the United
States and Secretary Tommy Thompson to exercise bold leadership in
raising domestic HIV prevention awareness as a part of the strategy to
reduce new HIV infections, again with a long-term goal of no new
infections.

## Motion

Ms. Smith noted all changes, including the deletion of a technical
assistance paragraph and the addition of a paragraph calling for bold
leadership. She asked for a motion.

Dr. Coburn moved that the motion be adopted, and Dr. Green seconded it.
The motion was then opened for discussion.

Dr. Green noted the absence of the technical assistance paragraph. He
said PEPFAR countries may still need some help. Dr. Sweeney explained
that it's not possible to give assistance on ABC intervention because
Council members don't have any experience with outcomes. Dr. Green
wondered using technical experience from Ugandan AIDS experts who have
first-hand experience with implementing ABC prevention strategies.

## Amendment Proposed

Dr. Green then proposed an amendment, that "it be resolved that the
scientific findings of the Uganda ABC strategy be disseminated to PEPFAR
countries."

## Discussion on the Amendment 

Dr. Green refined his amendment: "BE IT RESOLVED that PACHA recommend to
the President of the United States that the most substantial scientific
data underlying the President's adoption of the Uganda ABC model be
disseminated to PEPFAR countries."

## Amendment Carries

Dr. Coburn asked for all in favor to say aye. The amendment carried.

## Discussion

Dr. Reznik asked for clarification on references for levels of condom
use in 1995. Dr. Green said the best source is the DHS (Demographic and
Health Surveys of 2001, which in fact showed a significant rise in
condom use for casual sex between those years).

Don Sneed said he welcomes the emphasis on Part B, adding he thinks it
will lead to a psychosocial and a "moral revolution" in minority and
other communities in America.

## Amendment Proposed

Mr. Nickerson said the first paragraph of the motion would read better
if the language were changed to: "...the Uganda ABC model as the most
effective worldwide for prevention of sexual transmission of HIV..."

## Discussion on the Amendment

None.

## Amendment Carries

Dr. Coburn asked for all in favor to say aye. The amendment carried.

## Request for Statements of Opposition to the Motions as Adopted and Amended

Dr. Coburn asked for any opposition to the motions as adopted and
amended. There was none.

## Treatment and Care Subcommittee Motions: Revisions Presented

Dr. Coburn asked Treatment and Care Subcommittee Chair Minor to display
the Subcommittee's three motions.

The **first motion,** informally known as the ONAP Director motion, now
reads as follows:

**Presidential Advisory Council on HIV/AIDS**

## Treatment and Care Subcommittee

**Draft Motion**

**Appointment of Permanent ONAP Director**

WHEREAS, it is the responsibility of the Presidential Advisory Council
on HIV/AIDS (PACHA) to advise the President on AIDS-related issues, and

WHEREAS, the members of PACHA acknowledge and thank President Bush for
his vision and leadership on this important issue, and

WHEREAS, the President continues to make HIV/AIDS a high priority for
his Administration, and

WHEREAS, the Office of National AIDS Policy was created and funded to
serve as the focal point of AIDS-related policies for the White House,
and

WHEREAS, despite attempts to fill the position the Office of National
AIDS Policy has been without a permanent Director for a significant
period of time, and

WHEREAS, the absence of a permanent Director of the Office of National
AIDS Policy limits the Administration's opportunities to advance
AIDS-related issues on a regular and consistent basis, and

WHEREAS, the visibility of AIDS issues and the successful implementation
of AIDS-related policies is lessened by this lack of regular and
consistent messages,

BE IT RESOLVED that PACHA requests President Bush to appoint immediately
a permanent Director of the Office of National AIDS Policy.

Mr. Minor noted the Subcommittee's addition of a title, and the movement
of some language from the fourth paragraph to the fifth.

## Motion 

Dr. Coburn asked for a motion to adopt and a second. Dr. Reznik provided
the motion and Don Sneed the second.

## Discussion of Motion

John Galbraith said since there is a director at present, we might want
to invite her to a Subcommittee or Council meeting.

Dr. Coburn noted that she attended the PACHA meeting on Day 1 (March
29).

Ms. Ivantic-Doucette wondered if the motion needed to be so formal and
that she'd have to vote no at present because there is an acting
director. Also, she believed it might embarrass the President. She
recommended that the Subcommittee withdraw the motion and handle it
differently.

## Tabling of Motion Proposed

Dr. Coburn observed that no one will take this job permanently because
it's an election year. He proposed tabling the motion until June and
having Secretary Thompson address the Council.

## Motion to Adopt Tabling Motion

Dr. Sweeney moved to support tabling, and Ms. Rock supported with a
second.

## Discussion on the Motion

Dr. Coburn asked for discussion.

Dr. McIlhaney said the Subcommittee motion seemed like a criticism. Rev.
Sanders explained that the position has not been filled permanently for
a very long time, which suggests the issues it tackles are not at an
appropriate priority level. That, he added, is the most important
message.

Dr. Reznik noted that Ms. Robinson is acting, Christopher Bates is
acting, Carol Thompson is acting. Those are all key AIDS offices.

Mr. Minor said the motion was not meant to embarrass the President. It
is tough to find people, and this is a tough job, he said.

## Motion to Table Carries

Dr. Coburn asked for all in favor of tabling, and that carried, with one
vote against.

Mr. Minor brought up the **second motion**, informally known as the ADAP
motion. It now reads as follows:

**Presidential Advisory Council on HIV/AIDS**

## Treatment and Care Subcommittee

**Draft Motion**

**ADAP Funding Crisis**

WHEREAS, AIDS-related medications have been universally accepted as an
essential component of medical therapy for a person living with
HIV/AIDS, and

WHEREAS, the AIDS Drug Assistance Program (ADAP) has provided thousands
of Americans living with HIV/AIDS access to life-sustaining medications,
and

WHEREAS, thousands of Americans are currently denied access to ADAP
programs because of funding shortfalls, and

WHEREAS, the Presidential Advisory Council on HIV/AIDS (PACHA) wrote a
letter to President Bush in June of 2002 describing the dire
circumstances of the ADAP funding crisis and the need to bring together
a broad coalition to address this problem effectively,

BE IT RESOLVED that PACHA requests that the Secretary of Health and
Human Services take appropriate immediate action to resolve the ADAP
funding crisis through FY 2004 and to gather information from a variety
of sources, such as representatives of the Administration, Congress,
state health departments, AIDS advocacy groups, and the pharmaceutical
industry in order to make future recommendations, and

BE IT FURTHER RESOLVED that the Secretary be willing to consider all
practical solutions to the ADAP crisis, including structural reform to
encourage the more efficient and effective use of public funds, and

BE IT FURTHER RESOLVED that because of the emergency nature of this
situation that the Secretary report his findings and recommendations to
PACHA within 90 days.

Mr. Minor characterized the changes as a flip-flop and a deletion.

## Motion to Adopt

Ms. McDonald moved to adopt, and David Greer seconded.

***Discussion***

Dr. Driscoll observed that the motion seems similar to things done in
the past and not sufficiently strong or sufficient. There is no way the
President's budget will be adequate for the States, much less troubled
States. Maybe this resolution could be a step toward something stronger
if there is no change in the situation between now and June.

Mr. Minor said that was the Subcommittee's intention.

## Call for the Question

Dr. Coburn called for the question, and asked for all in favor.

## Motion Carries

The motion carried unanimously.

Mr. Minor brought up the **third motion**, on a summit. It now reads as
follows:

**Presidential Advisory Council on HIV/AIDS**

## Treatment and Care Subcommittee

**Draft Motion**

**White House Summit on Domestic HIV/AIDS**

WHEREAS, it is the responsibility of the Presidential Advisory Council
on HIV/AIDS to advise the President on HIV/AIDS-related issues and
policy, and

WHEREAS, a White House Summit on HIV/AIDS in 1995 was successful in
focusing the Nation's attention on prevention and treatment responses to
the epidemic, and

WHEREAS, in the ensuing years since the first White House Summit, the
epidemic has dramatically changed both in terms of those who are
affected and the treatments available, and

WHEREAS, the President has made HIV/AIDS, both domestically and
internationally, a high priority for his administration,

BE IT RESOLVED that PACHA requests the President to convene a White
House Summit on HIV/AIDS in 2005 that would primarily focus on domestic
issues, and

BE IT FURTHER RESOLVED that the Secretary of Health and Human Services
appoint a committee to identify and engage key participants to develop
goals and a timeline for the Summit to present at the June PACHA
meeting, and

BE IT FURTHER RESOLVED that PACHA requests President Bush continue to
highlight the current state of domestic HIV/AIDS in 2004.

Mr. Minor characterized the changes as adding a clearer focus on
domestic issues and adding a new paragraph and title.

## Motion to Adopt

Dr. Coburn asked for a motion to adopt.

Dr. Prem Sharma made the motion, and Ms. Rock seconded.

## Discussion 

Dr. Coburn said he has trouble every time we ask for a committee, and he
thinks the Secretary will handle it. "What we really want is his
response." Mr. Minor agreed.

## Amendment Proposed, Moved, and Seconded

Dr. Coburn proposed that the second to last paragraph be deleted.

Dr. Reznik so moved and Rev. Sanders seconded.

## Amendment Accepted

Dr. Coburn asked for all in favor of the amendment, and it was accepted
unanimously.

## Guiding Principles and Core Values Status

Mr. Minor reported that there is not so much disagreement on this
document as a need to flesh it out and pick it up again in June as PACHA
moves forward with discussions on the CARE Act reauthorization and
related matters. Dr. Coburn agreed, and asked that all three
Subcommittees take it up and come back with a consensus in June.

## International Subcommittee Motions Presented

Dr. Coburn asked International Subcommittee Chair Mason to display the
Subcommittee's two motions.

Mr. Mason said the **first motion**, which expands the President's
Emergency Plan, is as follows:

# 

# Presidential Advisory Council on HIV/AIDS

# International Subcommittee

# Revised March 30, 2004

**Draft Resolution**

## *Expanding the President's Emergency Plan for AIDS Relief to Include Asia*

***WHEREAS, the Asian AIDS epidemic, with more than 10 million cases, is
second only to the sub-Saharan epidemic and may be expanding faster,
and***

 

WHEREAS, in Asia, as in Africa, the AIDS epidemic, if unchecked,
threatens to destabilize the region---the AIDS destabilization threat to
Asia is as real as it is to Africa, the major difference being the
timeframe, and

WHEREAS, Asia is and has long been the most populous continent, is one
of the cradles of human civilization, and is becoming the most
economically dynamic region on the planet, and

 

WHEREAS, Asia is politically less stable and has less healthcare
infrastructure than other developed areas such as Europe and North
America, and

 

WHEREAS, the worldwide economic and geopolitical consequences of
destabilization in China, the Indian Subcontinent, or Southeast Asia
would be exceedingly grave, and

 

WHEREAS, the United States has long involvement in Asian countries, and
our recent history is importantly linked with theirs, and

 

WHEREAS, the Asian countries are recognizing the implications and extent
of their AIDS epidemics and want to act, and

 

WHEREAS, the Asian countries with severe HIV/AIDS epidemic need more
than just technical assistance to institute treatment as well as
prevention and lack resources to do treatment by themselves, and

WHEREAS, PEPFAR has no Asian countries among the 14 designated focus
countries, and

 

WHEREAS, Congress recognized this limitation by requiring the addition
of a 15th country outside of Africa and the Caribbean in last year\'s
appropriation, and

 

WHEREAS, more AIDS treatment and prevention programs need to be
implemented quickly in Asia to prevent a devastating tragedy, which will
impact the U.S. national interest and world economy and health,

 

BE IT THEREFORE RESOLVED that PACHA recommends to the President that
PEPFAR be expanded to include Asian focus countries particularly those
willing to provide high level leadership.

In addition, PACHA recommends that discussions be initiated in the near
future with India and China on establishing cost-sharing programs to
facilitate access to American expertise on AIDS public health measures
and treatment.

Mr. Mason characterized changes as using the word "region" in Paragraph
2, and changing the last two paragraphs to leave out the concepts of
cost sharing and prevention.

## Discussion of the Motion

Dr. Coburn said although he doesn't question the intent of the motion,
he does question whether the United States can pay for it. If the United
States can offer expertise instead of money, maybe it can be done.
Subcommittee member Driscoll said that was the Subcommittee's intent.
More expensive items in a cost-sharing program with India and China
would be paid for by India and China, and only one Asian country would
be added to PEPFAR.

Dr. Reznik said the motion doesn't specify that so now he has a problem
with it.

Mr. Mason explained that the President's plan allows for a 15th country,
and it can't be in Africa. We're suggesting that there not be additional
funding, but, rather, that the 15th country be added, an Asian country.
It's not our job to decide which country. You provided for this, there's
a need, name the country, let's get started, he said.

Dr. Hu said, this doesn't have to happen now. And it's up to the
Administration to decide which country. However, cost sharing with China
and India was added.

Ms. Ivantic-Doucette said she thinks it is confusing that cost sharing
was added. Would it be helpful if it were eliminated now and revisited
in June?

## Amendments Proposed

Dr. Reznik said that's part of his issue. And he proposed that the last
few paragraphs be reordered. He also proposed that the last paragraph be
dropped and included in a separate resolution.

Dr. Coburn asked if there was further discussion on what Dr. Reznik
proposed, which he characterized as elimination of the last paragraph
for consideration as a separate resolution and rearranging the last few
paragraphs on the first page.

## 

## Amendment Moved

Ms. Ivantic-Doucette made a motion to delete the last paragraph, and Dr.
Reznik seconded it.

Discussion

Dr. Sharma asked about the status of the second motion.

Dr. Coburn clarified that, in June, the Council would take up another
resolution to address the deleted last paragraph. Dr. Driscoll agreed.

Dr. Coburn asked for further discussion.

## Amendment Carries

The Council voted unanimously in favor of Ms. Ivantic-Doucette's motion.

## Resolution Motion Made

Mr. Nickerson asked that the new resolution refer to a specific Asian
country.

## Resolution Motion Carries 

A motion was made to support Mr. Nickerson's motion, and was then
seconded.

Dr. Coburn asked for a vote, and it was unanimous.

## Other Amendments

Dr. Coburn asked for other amendments.

## Vote on the Motion 

Dr. Coburn called for a vote on the International Subcommittee's first
motion as revised and amended. The vote was unanimous.

## The International Subcommittee's Second Motion Regarding Drug Procurement 

Mr. Mason introduced the Subcommittee's **second motion** as revised. It
now reads as follows:

**Presidential Advisory Council on HIV/AIDS**

**International Subcommittee**

**March 30, 2004**

Draft Resolution

Ensuring the Safety, Quality and Effectiveness of Drugs Procured by the
President's Emergency Plan for AIDS Relief Funds

WHEREAS, the President's Emergency Plan for AIDS Relief (PEPFAR) has as
its major goal the implementation of a plan to provide lifesaving drug
treatment to 2 million people infected with HIV in the 14 targeted
countries, and

WHEREAS, the Office of the Global AIDS Coordinator has been given the
responsibility and authority to fund the purchase of drugs, and to
determine what drugs will be procured either directly or indirectly with
Emergency Plan funds, and

WHEREAS, the people of Africa and the Caribbean who will receive drugs
procured directly or indirectly with Emergency Plan funds deserve drugs
that meet a high standard for safety, quality and effectiveness, and

WHEREAS, even with the best of intentions, allowing a compromised
standard of drug safety, quality and effectiveness for Emergency Plan
drug procurements will allow, if not ultimately encourage a lower
standard of care for African and Caribbean drug recipients, and

WHEREAS, FDA approved ARV drugs and their generic equivalents have
demonstrated their capacity to effectively manage HIV disease, and

WHEREAS, poor quality, counterfeit, mismeasured, or ineffective drugs
can speed development of resistant virus, sicken or harm patients or
simply fail to help them, thus jeopardizing the success of the Emergency
Plan,

BE IT RESOLVED that the Presidential Advisory Council on HIV/AIDS
recommends that the President direct the Office of the Global AIDS
Coordinator to require that any drug procured directly or indirectly
with Emergency Plan funds must meet comparable standards for safety,
quality and effectiveness as would be necessary for drug approval in the
United States or any other country with drug approval standards of
comparable scientific rigor.

In addition, the Office of the Global AIDS Coordinator should be
directed to create an outside technical advisory panel to advise the
Office on clinical outcomes, quality standards and diagnostic and drug
treatment guidelines.

BE IT FURTHER RESOLVED that PACHA recommends that the Secretary of HHS
take all necessary steps to expedite clinical trials on new drugs and
formulations, including fixed-dose combinations (FDCs) that hold promise
for simplifying treatment regimens, decreasing treatment costs, and
thereby expanding safe effective treatment.

## Mr. Mason characterized changes made by the Subcommittee as having deleted parts of Paragraph 6. 

## Call for General Discussion

Dr. Coburn called for general discussion on the motion.

## Amendment Proposed

Dr. Reznik proposed that the word "kill" be replaced with the word
"harm."

## General Discussion Continued 

Mr. Minor said PACHA should monitor this to make sure it doesn't impede
development of drugs, generic or not.

## Request for a Motion Made 

Dr. Coburn asked for a motion.

## General Discussion Continued

Ms. Ivantic-Doucette said PACHA needs to look at pricing and procurement
issues in June for some discussions and recommendations.

## Discussion and Call for the Question

Dr. Coburn asked if there was discussion. Hearing none, he called for
the question.

He then asked for a motion to support Dr. Reznik's amendment to change
"kill" to "harm." Dr. Reznik so moved, and Dr. Green seconded it.

## 

## Amendment Carries

Dr. Coburn asked for a vote on the amendment, and it passed unanimously.

## Motion Made

Dr. Sharma, with a second by Ms. Hall, moved to send the last paragraph
involving China and India back to the International Subcommittee for
reconsideration at PACHA's June meeting.

## Housekeeping Chores and Adjournment 

Dr. Coburn and Ms. Robinson then noted some housekeeping chores,
including that all motions approved will be revised in the minutes.
Chairs and Subchairs will review the minutes, then send them to other
Council members. All resolutions and motions will be posted on the Web
site 45 days after the meeting. All materials will be posted as well, if
they were made available electronically.

Dr. Coburn thanked Council members for their time, adding that Dr.
Sullivan thanks them as well.

Ms. Rock thanked Ms. Smith on behalf of the Prevention Subcommittee. Mr.
Minor thanked Dr. Coburn for his devotion to the cause.

Ms. McDonald said she would forward through Ms. Robinson some recent
documents from CDC.

Dr. Coburn ***adjourned the 23rd meeting of PACHA.***

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