Twenty-third Meeting

Hubert Humphrey Building
200 Independence Avenue, S.W.
Room 800
Washington, DC 20201

Minutes

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 241, 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/AIDS2;
• 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 213;
• 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 using4;
• 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 years5;
• The earlier the onset of a delinquent career, the greater the number of delinquent offenses juveniles are likely to commit before their 18th birthday6; 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 HIV7, 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 HIV8,

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 percent1, 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 19953, 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 decline4 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.
• 490,000 live births occur each year to teen mothers aged 15 to 19 years.
• Three million sexually transmitted disease (STD) infections occur each year among 13- to 19-year-olds.
• 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
• Alcohol and other drug use
• Sexual behaviors
• Tobacco use
• Unhealthy diets
• Inadequate physical activity.

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

• Focus the Nation on behaviors causing the most important health problems
• Assess how risk behaviors change over time
• 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
• Based on probability samples of schools and students
• Anonymous
• Self-administered
• Completed in one class period
• 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
• 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. Further information about committee members and the project is available from 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.
2. 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.
3. 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.
4. 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.
5. WHO has other types of resource problems that prevent inspections and reviews such as those conducted by FDA.
6. 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.
7. 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;
• 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;
• 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).
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, 9:103-110 (1997).
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, 88:27-33, (1998).
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, 13(5):359-364 (1997).
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; (263), (April 24, 1995).
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.

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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