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Issue #226: April 23, 1999
fastfax is available by fax in the 215 and 610 area codes at no cost, or by mail anywhere for $20.00 per year, by calling 215-545-6868, and by E-mail by contacting and type the message SUBSCRIBE in the message section. Sources for some articles in this issue include AIDS, Kaiser Daily HIV/AIDS Report, Philadelphia Gay News, Reuters, St. Petersburg Times.
In This Issue:
GOP leaders seek 'audit' of federal AIDS $$
HAART failure is "common: after a year: study
FDA approves new protease drug
Florida: Viagra linked to unsafe sex?
Commission schedules public hearings
WISDOM seeks risk reduction workers
MANNA sponsors "Feeding Your Kids"
U.S. Representative Tom Coburn (R-OK), House Majority Leader Dick Armey (R-TX) and Commerce Committee Chairman Tom Bliley (R-VA) have sent a letter to the United States General Accounting Office requesting a "performance audit and evaluation of all federal AIDS/HIV programs and services."
"Congress has a moral obligation to those suffering with AIDS/HIV to ensure that the nearly $9 billion directed to federal AIDS programs is spent for purposes for which it is intended," Coburn, a practicing physician, said in a statement. "Over the past five years I have encountered too many instances where federal AIDS/HIV funds have been misused. There have been instances in which AIDS dollars have been used for political campaigns, programs that condone illegal drug use, and programs that fail to fairly distribute funds to women and minorities," he said.
Coburn's statement cited a number of recent news reports as the basis for his concern.
In a story reported this month in U.S. News and World Report and the New York Blade, the head of an AIDS group in Puerto Rico testified that more than $2 million of U.S. funds for AIDS services were diverted to the political campaigns of Puerto Rico governor Pedro Rossello and other officials. A trial is underway and several individuals involved in the case have already pleaded guilty. Governor Rosello denies any knowledge of the embezzlement.
In May 1998, the Associated Press reported that the head of a North Carolina program "Drug and AIDS Prevention Among African-Americans" wrote checks to himself and kept books that were "unauditable". Similar charges have been levied against several Philadelphia-area AIDS service organizations; two former AIDS agency heads, Fran Stoffa and Carmen Bolden, were convicted of embezzlement several years ago.
Coburn also cited an October 1996 Washington Post article which he said described a program that "condoned illegal drug use in a housing facility funded with federal AIDS dollars."
"I am concerned that these examples may represent a widespread pattern of abuse." Coburn said. "This audit is designed to spotlight lapses in accountability and restore integrity and compassion to federal AIDS/HIV programs. As a practicing physician, I have seen first-hand the effects of this horrible disease. As a congressman, I am dedicated to guaranteeing that AIDS/HIV dollars are spent to alleviate that suffering."
Coburn has come under fire from AIDS advocates in the past for proposing federal legislation which would mandate HIV testing for prisoners and other populations, and aggressively seek out partners of HIV-positive people.
Specifically, the GOP leaders requested an update from the GAO on its report, initially issued in January of 1995, which examined the allocation of federal AIDS funding in terms of whether it was being fairly distributed in terms of "race, gender and/or other demographics." The congressmen also asked the GAO to determine the "average cost per client served nationally, regionally and in urban versus rural settings" of Ryan White CARE Act-funded programs.
They have also asked the GAO to determine what criteria determine federal AIDS Drug Assistance Program (ADAP) distributions and whether these criteria "advantage or disadvantage" any state or region.
Coburn and his colleagues also asked if the Department of Health and Human Services routinely requests from grantees information pertaining to what percentage of the funds directed towards care and prevention programs are spent on overhead or other non-care related activities, and if so, what that information dhows. The also want to know if there is "evidence of abuses or misuses of federal AIDS funds."
Recognizing growing complaints that Ryan White funds are supporting a wide variety of social support services rather than primary medical care, the congressmen asked the GAO to "provide an estimate of the percentage of CARE program funding which directly supports treatment and medical care for HIV/AIDS patients." The also asked for an estimate of the percentage of Ryan White funding which supports "services and welfare not directly related to treatment, such as housing, counseling and other services, with a special request to determine how much is estimated to be spent "directly or indirectly on housing."
The GOP leaders also want to know the salary levels of top administrators in AIDS service organizations that administer substantial federal grants, which they define as $250,000 per year or more, and how they compare with state and federal civil service compensation in their regions.
Linking their request to Coburn's partner notification agenda, the Republicans also ask, "Are funds routinely being spent to ensure that those who test positively are made aware of their treatment options and how to access them and their personal responsibility to notify past, present and perspective partners of their HIV status? Is there any evidence of a failure to enforce federal laws- such as spousa1 notification or tolerating drug abuse in housing programs- within any of the programs?"
The GOP request immediately generated an angry response from Daniel Zingale, executive director of AIDS Action, the lead Washington AIDS lobbying group.
The legislators' request is "nothing less than a politically motivated attempt to raise doubts about the fight against AIDS and the community-based service organizations leading that fight," Zingale said. He said he hoped that if the audit is conducted, "we expect the [GAO] will conduct it fairly, equitably and free of the political influences of those who are beginning the process."
In the clinical setting, many HIV-infected people who receive highly active antiretroviral therapy (HAART) containing a protease inhibitor will experience virologic failure by 1 year. However, the majority of patients will also maintain CD4 cell levels above baseline for at least 1 year, according to a San Francisco team.
In the April 16th issue of AIDS, Dr. Steven G. Deeks and colleagues at San Francisco General Hospital and the University of California describe the findings of an observational study, in which they evaluated 337 patients. All of the patients received at least 16 continuous weeks of HAART that included a protease inhibitor.
After 48 weeks of follow-up, they found that 50.2% had plasma HIV RNA loads below 500 copies/mL. "Protease inhibitor therapy in a patient population that is relatively advanced clinically and heavily pretreated with nucleoside analogues...is not likely to achieve durable viral suppression," Dr. Deeks said in an interview with Reuters Health Information Service.
The predictors of virologic failure are becoming increasingly clear, he continued. These include a low CD4 cell count, delay in therapy initiation, a high viral load, and "most importantly, prior therapy with nucleoside analogues."
"Even though virologic failure was relatively common, immunologic failure, as defined as a drop in CD4 count, was exceedingly rare through 1 year of follow-up," Dr. Deeks said. Since the paper was published, "further work that we've done suggests that this phenomena persists through 2 years of follow-up."
"One of the more novel contributions of this study was the surprising lack of efficacy with
salvage therapy," he continued. In only 22 of 99 patients (22%) who experienced virologic failure and switched regimens were HIV RNA levels undetectable at 24 weeks.
For heavily pretreated patients, there are still few treatment options. Most drugs "have largely been developed for the treatment of antiretroviral-naive patients, and because of tremendous cross-resistance within each of the classes of drugs we currently have, successful salvage therapy is going to remain exceedingly uncommon."
One exception may be for patients in whom virologic failure is detected relatively early. For those patients who were protease inhibitor-naive prior to the HAART regimen and are quickly switched to a regimen containing an NNRTI, "successful salvage therapy is possible."
The other clinical issue is that because each HIV-infected patient tends to be unique, and the virus is so variable from person to person, it has become difficult to study effective interventions in a prospective manner, he added. "It almost comes down to do the best you can on a case-by-case basis," he said.
FDA approves new protease drug
The U.S. Food and Drug Administration has approved another treatment choice for patients with HIV, a protease inhibitor called amprenavir.
Amprenavir, sold under the brand name Agenerase, is taken in combination with other AIDS medications. It comes in capsule form for adults - eight capsules twice a day - and a liquid formulation for children 4 and older.
It can be taken with or without food, but should never be taken with a high-fat meal because the fat content can decrease absorption of the drug, the FDA said.
Protease inhibitors are a class of AIDS medicines that, when taken with other types of AIDS drugs, can significantly improve patients' health. Amprenavir is the fifth protease inhibitor on the market.
In six-month studies, amprenavir lowered levels of HIV in patients' blood and increased their levels of T-cells.
Common side effects include nausea, diarrhea, vomiting and rash. The FDA warned that in about 1 percent of patients, amprenavir also can cause severe and life-threatening skin reactions, including Stevens-Johnson syndrome, in which painful blisters line the mouth, genital region and eyes. As with similar AIDS drugs, doctors also must be careful to avoid dangerous interactions when prescribing amprenavir with other medications.
Discovered by Vertex Pharmaceuticals but manufactured by Glaxo Wellcome Inc., the wholesale price will be $6,132 a year.
Agenerase is the first protease inhibitor to be approved in more than two years.
"There is a great need for dosing flexibility with antiretroviral therapy. Agenerase has a long half- life and can be dosed twice a day. This aspect of the drug, and the fact that it is generally well-tolerated, make Agenerase an important new treatment for HIV," said Jeff Goodgame, M.D., Principal Investigator, Central Florida Research Initiative, in a press release from Glaxo. "Agenerase increases the options for naive and treatment-experienced HIV patients and may help to simplify combination therapy by offering less restrictive dosing patterns."
Florida: Viagra linked to unsafe sex?
y Jo Becker
© St. Petersburg Time
From the moment the sexual potency drug Viagra hit the market, Jerry Wells was worried. Wells, who manages the state's pharmacy program for the poor, called a meeting of the state's top AIDS health officials last year to ask this question: Should the state pay to give HIV-positive men a drug that promotes sexual activity, even as state health officials were promoting abstinence as the best method to prevent the spread of HIV?
"I felt like there was a public health question," Wells recalled.
"They felt that it would be controversial either way we did it, and that if we denied coverage it would create an outcry."
The state did nothing.
Last year, Florida spent nearly $1.1-million on sexual potency drugs -- most of it on Viagra - through the Medicaid program for the poor. Of that total, 14.6 percent -- or about $159,000 -- went to sexual potency drugs for 930 HIV-positive men.
At least three states have refused to cover Viagra at all - despite a federal law requiring Medicaid coverage of the drug. Now, as Florida lawmakers debate a proposal to curb spending on Medicaid prescription drugs, state officials are looking at spending on Viagra as one thing they would like to cut.
"If it were up to me, the state wouldn't pay for it at all," said Donna Arduin, the budget director for Gov. Jeb Bush and the chief architect of the new policy.
Bush and Arduin want to cut Medicaid spending for many drugs by forcing doctors to get the state's permission to prescribe them. A politically appointed panel of doctors, pharmacists and others would decide which drugs require prior authorization.
The governor's drug policy proposal is controversial enough on its own -- social services advocates hate the notion -- but it becomes especially dicey when it affects Viagra.
Other states have debated spending on Viagra since the drug hit the market in April 1998, but the discussion has a twist in Florida. A computer program allows the state to determine not only how much of its Medicaid budget goes to the drug, but also which patients are receiving it. That's how the state determined that 14.6 percent of Medicaid spending on Viagra and other sexual potency drugs is going to HIV-positive men.
At this point, state officials, health experts and state lawmakers have not reached a consensus on the question Wells raised last year: Should the state deny Viagra to poor men infected with HIV?
"This is an issue that needs to be addressed when we move into this," said Gary Crayton, who heads the state's Medicaid program.
To some state lawmakers, the numbers alone suggest it is worth addressing.
"Fourteen percent? That's unbelievable," said Rep. Carlos Lacasa, a Miami Republican who is part of the negotiating team trying to find a legislative compromise on Bush's drug plan.
Lacasa said he would like to talk to AIDS activists, but his initial reaction was this: "We're sort of encouraging, it seems, potentially catastrophic behavior."
Not so, says Dr. Tom Coates, the director of the AIDS Research Institute at the University of California, San Francisco.
"The initial reaction is, "Why are we paying for a drug that increases sexual activity among people with a lethal disease that's transmitted by sexual behavior?' " Coates said. "But the evidence is pretty clear. Most HIV-infected people are, in fact, pretty responsible."
The institute recently conducted a national study of 6,000 gay men infected with HIV. Coates said 75 percent to 80 percent of the men surveyed said they always use a condom.
Men with HIV can experience a drop in testosterone levels, which can cause sexual impotency. Viagra is sometimes prescribed to address that problem.
For Carl Devine, an AIDS activist from St. Petersburg, it's a quality-of-life issue. As people live longer with the disease, he said, part of his job as a counselor is to teach them they can live a full life.
"Certainly having a sex life is part of doing that," he said.
Dr. Ira Wilson, an AIDS researcher at the New England Medical Center in Boston, said the state can't know how Viagra is going to be used.
"The link between paying for Viagra and spreading the disease rests on very shaky ground," Wilson said. "It assumes that people are not having sex with themselves; it assumes that they are not having safe sex or sex with an infected partner."
David Rothman, a professor of social medicine at the Columbia College of Physicians and Surgeons in New York, said the Viagra debate is difficult because of the stigma society places on the gay community.
Rothman recently was called in to consult on a case in which an HIV-positive woman wanted surgery that would allow her to become pregnant. Doctors were reluctant to do the surgery, in part because HIV can be passed on to a baby during pregnancy.
"I said, "Suppose she had Huntington's disease, which has a 50-50 chance of being passed on to the child. Would you do the operation?' The answer was a resounding "yes,' " Rothman recalled.
"With Viagra, are we really trying to protect the public health or are we really trying to say we don't want to support a particular kind of behavior?" Rothman said.
The state now spends $15-million a year trying to prevent the spread of HIV disease. The state's policy is to tell those with HIV that abstinence is the best, and only foolproof, method, said Tom Liberti, the chief of the Bureau of HIV-AIDS in the Florida Department of Health. Promoting condom use is the state's fall-back position.
Liberti said the department declined to address the matter last year because "our conclusion was there did not seem to be a public health consensus around the country about what to do."
Rep. Tom Feeney, a conservative Republican from Oviedo who is expected to become the next House Speaker, said the state's Viagra policy and its AIDS prevention policy certainly seem to conflict.
But, he added, "It's very difficult to devise a government policy that is discriminatory. I mean, I could also ask, "Should I provide Viagra to rapists? Or, should I provide Viagra for people with pedophilia in their past?' "
Instead, Feeney said Florida should join the ranks of other states that have bucked the federal law and refused to cover Viagra under any circumstances.
"If it means a legal battle, so be it," Feeney said. "I just think Viagra is a good example of the kind of thing I don't think the government should be funding."
Commission schedules public hearings
As part of its community planning process which will set priorities for Title I federal AIDS funds for the Philadelphia region in the year 2000, the Philadelphia EMA HIV Commission will hold a series of informational meetings seeking the input of people living with HIV/AIDS and other members of the community.
Six meetings are currently scheduled, four in Philadelphia and two in South Jersey. The schedule of the meetings is:
- Monday, May 3rd: Fairmount Health Center, 1412 Fairmount Avenue, 6-8pm
- Monday, May 10th: Fairmount Health Center, 1412 Fairmount Avenue, 6-8pm
- Tuesday, May 11th: Intercultural Family Services, 4225 Chestnut Street, 12-2pm
- Tuesday, May 11th: Cooper Hospital, 3 Cooper Plaza, Suite 400, 6-8pm
- Wednesday, May 12th: Cooper Hospital, 3 Cooper Plaza, Suite 400, 6-8pm
- Tuesday, May 18th: Intercultural Family Services, 4225 Chestnut Street, 12-2pm
To register to speak at a meeting, call the Commission at 1-888-624-0888. Free child care, food and transportation are available.
A settlement has been reached in a Chicago race discrimination lawsuit filed after a 9-year-old black boy who shared a white boy's snorkel at a suburban swimming pool was tested for HIV.
Lawyers for the American Civil Liberties Union announced the settlement but did not disclose the amount, which will go to the black child and his mother.
The federal lawsuit accused officials at Outreach Community Ministries, a Wheaton-based daycare provider, of pressuring the black boy's mother into having him tested for HIV and strep throat.
In addition to charges of discrimination, the lawsuit alleged that Outreach Ministry and clinic officials broke state law by releasing the negative test results to the white boy's mother.
In a statement, Outreach Ministries called the allegations inaccurate but said they settled the lawsuit "out of concern for people involved."
The case began in July 1996, when "Jimmy Doe" was enrolled in a summer day school at Outreach Community Center. During swimming activity, Jimmy shared the snorkel belonging to a white child he was playing with at the pool.
"In order to accommodate the racial prejudice of the white child's parent, and without any medical or public-health basis, Outreach coerced Ms. Doe into having Jimmy submit to an HIV test," said an ACLU press statement announcing the settlement. "Faced with the prospect of losing the daycare program she relied on, Jimmy's mother reluctantly agreed to the test demanded by Outreach. However, Ms. Doe consented to the test, against her better judgment, on the specific condition that the results, which turned out negative, be disclosed only to her. Nevertheless, the clinic revealed the test results to the white child's mother without Ms. Doe's consent."
In August 1998 the ACLU filed a suit on behalf of the Does, alleging racially-motivated discrimination in violation of federal laws, and improper disclosure of confidential medical information in violation of Illinois state law.
"Playing together at the pool with other kids should be a fun thing for kids to do, not a chance for discrimination," said Mary Doe, the mother. "The reason we asked ACLU to file the lawsuit was to make sure that nobody else's child has to go through what mine did."
Under the settlement agreement, the defendants do not admit liability. However, they agreed to provide copies of their current nondiscrimination and confidentiality policies for review by the ACLU. Further, the Does will receive an undisclosed monetary payment under the agreement.
"We're very happy with the settlement, which will let our family go on with our lives," said Ms. Doe.
"We are confident that the Community Center and the Clinic in this case will not act on stereotypes and fears about HIV again, or ignore patient privacy rights," said AIDS Project Director Roger Leishman, lead attorney on the case. "Most importantly, this has highlighted the ignorance and prejudice that continues to frustrate efforts to respond effectively to HIV."
Leishman also expressed satisfaction with the resolution of the case.
"Hopefully other organizations and health care providers will examine their own policies and practices, so that no one else has to suffer like the Does did." U.S. District Court Judge Ann Williams approved the settlement.
Janet Gillease, interim director of the AIDS Information Network, has announced that the organization will transfer its assets to Philadelphia FIGHT as of July 1st.
Philadelphia FIGHT, which also operates the Jonathan Lax Immune Disorders Treatment Center and Project TEACH, was started almost a decade ago as a community-based AIDS research initiative, and conducts many public and pharmaceutical company clinical trials in the area.
AIN, formerly the AIDS Library of Philadelphia, was begun in 1987 by its founder, Heshie Zinman, to provide a centralized resource of up-to-date AIDS-related information for people with HIV/AIDS and service organizations. The AIDS Library was the first such effort of its kind in the nation, and was established with an early grant from the then-fledgling Philadelphia AIDS Activities Coordinating Office.
Zinman ended an 11-year run as the agency's executive director in last year.
In addition to the Library, AIN also sponsors the gay men's health project, SafeGuards, and the Youth Health Empowerment Project, which conducts street outreach and education to help adolescents obtain health and social services. AIN has also sponsored the Critical Path AIDS Project and other treatment education activities.
AIN's contracts with the health department and other agencies are in the process of being transferred to FIGHT, according to Gillease, as are its 12 employees.
The "strategic alliance," as it is termed by Gillease, will bring FIGHT's annual budget to over $3.6 million, making it the second-largest AIDS service organization in the region. AIN's board approved the action in light of a growing deficit, and hopes that the transfer will result in lower administrative costs and improve fundraising efforts.
Chris Bartlett, coordinator of AIN's SafeGuards Project, told the Philadelphia Gay News that his project hopes to eventually separate from FIGHT and affiliate with another organization with a focus more directly on gay men's health.
WISDOM seeks risk reduction workers
WISDOM is a community based street outreach organization run by HIV positive women and women at high risk, located in the heart of Germantown. WISDOM services include street outreach, peer counseling, support groups, congregate meals and an emergency food cupboard.
WISDOM is currently recruiting HIV positive women to work as Risk Reduction/Outreach specialists. Women will be asked to work 4-6 hours per week. Street outreach involves giving information to women at risk out on the street. If you enjoy talking to other women, giving HIV related information and helping sisters take charge of their lives, this could be the job for you. Interested? Call Toni White at 215-991-6550.
Chester County AIDS Support Services is seeking two part-time staff. They are a Case Manager Assistant (Bilingual), who will work with the case manager in providing client services, particularly in Spanish-speaking communities. Computer literacy is preferred, and the minimum educational requirement is a high school diploma or GED, as well as a valid driver's license and a clean driving record; and a part-time Administrative Assistant, who will assist the executive director. Computer literacy required, fluency in Word Perfect suite of applications preferred. Typing at 50 wpm or greater with high degree of accuracy preferred. Familiarity with basic office machines and procedures necessary. Desktop publishing experience helpful. Minimum educational requirement HS diploma or GED.
If a suitable candidate is identified, CCASS says that the possibility exists to combine both positions to make one full-time position encompassing both jobs.
To apply, send resume with cover letter and salary requirements by April 30 to Executive Director, CCASS, 1854 E. Lincoln Hwy., Coatesville, PA 19320. No phone calls or faxes will be accepted. The deadline for applications is April 30th.
MANNA sponsors "Feeding Your Kids"
MANNA will sponsor another in its series of free breakfasts for people living with HIV, their caregivers, and AIDS service professionals on Friday, May 21, from8:30-10:00 a.m. at its offices at 12 S. 23rd Street, near Ranstead Street (enter on Ranstead).
This month's presentation will be made by Laura Kilbey, MS, RD, who is executive director of the WIC (Women, Infants, Children) program, and will discuss how to feed your child nourishing food, which foods keep kids healthy, easy-to-prepare foods, and feeding 'picky' eaters. The presentation includes a cooking demonstration and breakfast.
Advance registration is required before May 18th by calling 215-496-2662.
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