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Issue #183: June 28, 1998
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 Reuters, Southern Medical Journal, Wall Street Journal .Supreme Court rules HIV is a protected disability
NNRTIs added to state AIDS drug program
Activist: AIDS in 90s means change for gay men
Pina gets probation, stiff fine
Supreme Court rules HIV is a protected disability
The Supreme Court has ruled that HIV positive individuals are entitled to anti-discrimination protections afforded by the 1990 Americans With Disabilities Act (ADA) even if they suffer no physical symptoms."HIV infection, even in the so-called asymptomatic phase, is an impairment which substantially limits the major life activity of reproduction," wrote Justice Anthony Kennedy in the 5-4 ruling. The disabilities act, known by its acronym, ADA, outlaws discrimination in employment and "public accommodations" against those with conditions that limit major life activities. Protecting those with HIV and AIDS was a key goal of those who drafted the law, and was specifically mentioned in the report that accompanied the bill.
The case decided by the court, Bragdon v. Abbott, grew out of a dispute between Maine dentist Randon Bragdon and an HIV positive patient, Sidney Abbott. Bragdon refused to fill Abbott's infected tooth in his office, insisting that her HIV status required a hospital procedure. Abbott sued, arguing that she was protected under the ADA because her HIV disease substantially limited her ability to reproduce.
Mark Robinson, executive director of Gay Men's Health Crisis in New York City, said in a statement, "The Court has chosen to recognize the rights of all people with HIV and to furnish safeguards from the discrimination they've faced or feared for nearly two decades."
Today's ruling "...sends a clear signal to healthcare providers that discrimination against people living with HIV is scientifically unjustified and forbidden under the law," Tony Varona, Chief Counsel of the Human Rights Campaign commented in a press release. "By making clear that objective medical standards and not the individual judgment of health care providers determine the applicability of the ADA, the Supreme Court has ensured that all individuals Congress intended to be protected by the ADA are indeed protected from discrimination."
AIDSVAX trial begins at FIGHT
Philadelphia FIGHT began inoculating the first volunteers in the North American trial of AIDSVAX, the first-ever Phase III trial of a vaccine against HIV-1, this week at its center city Philadelphia clinic.The trial, which eventually will include 5,000 volunteers at high risk for HIV infection, is sponsored by VaxGen, Inc., the developer of AIDSVAX.
According to Jane Shull, Executive Director of Philadelphia FIGHT, "We were honored to be chosen as the first site to enroll patients in this trial. Each day, 16,000 people worldwide are infected with HIV, 3,000 of them children. While our commitment to researching effective treatments and a cure for HIV remains unchanged, vaccines offer the best hope of ending the AIDS epidemic, worldwide and here in Philadelphia."
Volunteers are eligible for this study if they are HIV negative men who have sex with men, or women at risk through heterosexual sex. Injection drug users are not eligible. There is a separate study for injection drug users which will enroll in Thailand.
The trial will last up to four years. Volunteers will receive three primary inoculations, followed by booster shots every six months. This is a placebo controlled trial, in which neither volunteers nor study personnel will know who is receiving vaccine and who is receiving placebo. The ratio of vaccine to placebo will be 2:1, with two volunteers receiving vaccine for every one receiving placebo.
AIDSVAX is a gp120 bivalent vaccine, engineered to be effective against the predominant strains of HIV in the United States. The current formulation of AIDSVAX are the successor vaccines to a monovalent vaccine developed during 14 years of research at Genentech, Inc., the parent company of VaxGen. The monovalent vaccine was tested in more than 1,200 human volunteers and was shown to be safe and to induce antibodies against HIV in 99.5% of vaccinated individuals, while producing no side effects.
"We are excited and, at the same time, humbled by the distinction of being the first to reach this point in what is one of the most vital public health battles facing the world today," Dr. Donald P. Francis, VaxGen president commented.
However, not all AIDS experts are excited. In fact, some think that the AIDSVAX, which has continued in development using $27.5 million in funds from private investors, is unlikely to protect against HIV.
"I personally believe people should be able to try what they want to try, but it's a very, very long shot to expect anything," Dr. David Baltimore commented in The Wall Street Journal
In addition, Dr. Baltimore, who is currently the head of the NIH-sponsored AIDS Vaccine Research Committee, believes this trial could "seriously dent the reservoir" of potential volunteers for HIV vaccines that hold more promise.
As would be expected in a major medical issue like this, there has been a tremendous amount of opinion in this debate, Dr. Robert C. Nowinski, VaxGen's co-founder, told Reuters Health. However, Dr. Nowinski believes the current FDA decision to approve the phase III trial of AIDSVAX has effectively ended this debate.
"At this point we know that the vaccine induces antibody in 100% of people that we inoculate," he continued. The issue in the 3-year phase III trial is to find out to what extent it prevents HIV infection, he said, and this can only be done in a real-life situation.
"It's no surprise to me that competing researchers are throwing cold water on the VaxGen trial," said David Fair, who is among those who've signed up for the trial. "This is the same industry that poisoned and killed thousands of PWAs with high doses of AZT, just do they could prove what we already knew: it didn't work by itself. In the real world, whatever we learn from this trial will advance the effort to find a cure. If it's not perfect, or only protects some people and not others, it will be worth every penny." Fair said that he thinks the strong opposition to VaxGen's efforts are based more on the "petty rivalries of the AIDS research community, which are no more relevant here than they are in the rest of AIDS politics. It's ironic that there is a group of researchers who are so strongly against learning more about how a vaccine can work. My hope is to put them out of business by doing something, anything, to move us closer to a cure."
NNRTIs added to state AIDS drug program
Pennsylvania's Special Pharmaceutical Benefits Program (SPBP) will add Viramune and Rescriptor beginning July 1, state Public Welfare Secretary Feather O. Houstoun has announced.The two new non-nucleoside reverse transcriptase inhibitors (NNRTIs) are among 13 exclusive drugs used in the treatment of HIV/AIDS. NNRTIs typically are prescribed for individuals who cannot tolerate or are failing other drug treatments.
ACT UP and other AIDS advocates have pressured the state to add the two NNRTIs to the protocol for the program for many months, once they were approved by the U.S. Food and Drug Administration. After several Christmas time protests last winter, the state promised it would add the drugs by this summer.
The SPBP, established in 1987, now provides more than 60 HIV/AIDS drug treatments free of charge to eligible individuals who cannot afford the high cost of medications.
Pennsylvania's program is funded through a combination of state and federal Ryan White Emergency Care Act funds.
"Adding these two drug treatments to our program keeps Pennsylvania in line with the current federal treatment guidelines," Houstoun said. "Without this program, many individuals might not have access to these life-sustaining medical treatments."
Current federal guidelines recommend combinations of drugs that are proving clinically effective in helping to prolong and sustain the quality of life for individuals with HIV/AIDS.
To be eligible for the program, an individual must have a medical need for the drug and live in Pennsylvania -- but not in an institution. There is an income ceiling of $30,000 for individuals and families, with an allowance of $2,480 for additional applicable family members.
Applications are available from county assistance offices, AIDS service agencies, hospital social service departments, state health centers, hemophilia and renal-dialysis centers, mental health centers, and some physicians and pharmacies.
For more information, people may call the department's toll-free hotline at 800-922-9384, or write to the Department of Public Welfare, Special Pharmaceutical Benefits Program, P.O. Box 8021, Harrisburg, PA 17105.
NY passes HIV reporting bill
New York doctors must report the names of people living with HIV and AIDS and notify their sexual partners under legislation approved by the New York State Assembly.The legislature passed the sweeping notification measure 112-34 after two hours of heated debate that pitted civil liberties concerns against public health needs.
Under the legislation, health care workers must try to get infected patients to identify any former sexual partners who may be at risk and then notify them. Currently, doctors have the option of telling partners about the virus in some cases, but health workers say they fear lawsuits if they do so.
The state Senate had already passed the bill, which advocates say is among the most far-reaching in the nation.
Critics say requiring such reporting will deter some people from seeking testing and treatment. Public health officials argue the notification program could help stem the spread of HIV.
Pennsylvania public health officials are currently considering implementing a similar policy sometime later this year. The Allegheny County council, which includes the Pittsburgh area, has also recently passed legislation which will require name reporting of HIV+ people, although that bill has still not been enacted into law.
Black gays also at risk of KS
Among HIV-positive blacks, homosexual or bisexual activity is the primary risk factor for developing Kaposi's sarcoma (KS), according to researchers at Howard University.The risk of KS is known to be six times greater among HIV-positive homosexual men compared with other risk groups. However, "there have been few reports of AIDS-associated KS among the black population," Dr. Fitzroy W. Dawkins and colleagues in the Washington, DC area said. In addition, some research has indicated that white homosexuals with AIDS are more likely to develop KS than black homosexuals with AIDS.
This prompted Dr. Dawkin's group to conduct a retrospective study of all HIV-positive patients with KS seem from February 1985 to June 1995 at an urban university-based hospital. Their findings appear in the June issue of the Southern Medical Journal.
Of the 73 patients identified, 90% were black and 92% were male. Sixty-six percent of the subjects were homosexual or bisexual men and 14% of these also used injection drugs. In addition, of the 6 female HIV-positive KS patients, 4 reported heterosexual anal sex as an HIV risk factor.
Dr. Dawkin's group noted that "the median survival was 2.2 years...from the time of HIV-1 diagnosis." In addition, significantly shorter survival correlated with CD4 counts of less than 200 cells per microliter. Homosexual or bisexual men who also used injection drugs had a significantly shorter survival compared with their counterparts who did not use injection drugs.
Overall, they found that the median survival of black patients with KS "...closely approximates the survival among majority groups with KS."
The researchers conclude that homosexual or bisexual activity is the predominant risk factor for KS in this primarily black HIV-positive population. "Continued surveillance of this patient population and further virologic and immunologic characterization of KS cases is warranted and may yield important clues into the etiology of this enigmatic malignancy."
Activist: AIDS means change for gay men
Reprinted from NY Blade
"AIDS as we have known it," says Eric Rofes, "is over."Rofes, author of Dry Bones Breathe: Gay Men Creating Post-AIDS Identities and Cultures, does not mean that the epidemic has ended. His point is that the disease now affects gay men's lives far differently than during the peak plague years of the mid-1980s to the early 1990s.
"We have 17 years of experience with AIDS that allows us to integrate it into our everyday lives and divest it of much of its symbolic power," he explains in the book. "New understandings of AIDS need to be accepted and acted on."
Rofes says he knows that Dry Bones Breathe will prove controversial. Many people -- activists, service providers, health educators -- have relied on a crisis model of AIDS to organize demonstrations, raise money, and teach prevention. But whatever the challenges of shifting to a new way of thinking, says Rofes, those people must make the change if they want to "speak to the realities of gay men's lives."
In his book, Rofes argues that most gay men no longer find AIDS to be an all-consuming catastrophe. Most gay men, he says, have begun to concentrate on other aspects of their lives.
But despite this fact, the "formal structures" of the gay community remain locked in what Rofes calls "the AIDS-as-crisis mentality." He claims that AIDS service organizations and activists, HIV prevention campaigns, queer cultural events, and gay men's literature "all continue to operate out of assumptions and understandings rooted in the AIDS event of the 1980s."
Rofes says that this failure to change with the times has serious consequences.
"Our leadership exploits AIDS as a continuing emergency, while the reality of most gay men's lives is that it's not so," he says. "The political fallout is distrust in community leadership, disaffection from community structures, and a kind of powerful resentment."
Rofes argues that in the name of empowering gay men, prevention campaigns all too often have resorted to "manipulation, policing,,subtle guilt-tripping, and outright shaming." He calls for a "radical re-thinking of HIV prevention."
"We shouldn't organize gay communities around HIV prevention, but around gay men's health," he says, "and work with gay men of all backgrounds on the full spectrum of their health needs: prostate cancer, aging, substance abuse, and gay men's sexual health, broadly defined.
"All these issues have to be integrated," says Rofes. "That's what post-AIDS prevention is all about."
Rofes has a long history of activism around AIDS and gay sexual politics. Born in Long Island, Rofes relocated to Boston in the 1970s, where he was a member of the Gay Community News collective and founded the Boston Lesbian and Gay Political Alliance. Rofes then turned his energies to AIDS, eventually becoming director of San Francisco's Shanti Project, an experience he described in his previous book, Reviving the Tribe.
Pina gets probation, stiff fine
Stephen Pina, the disgraced executive director of One Day At A Time, was sentenced to five years probation and told to repay $20,000 in a plea bargain related to charges that he had defrauded the state Medicaid program while director of the agency, according to press reports.Pina, a highly controversial figure in the city's AIDS community for his aggressive advocacy on behalf of African American neighborhoods affected by AIDS, plead guilty several months ago to charges that he had submitted false paperwork to a Medicaid transportation program for services which had never been deliver.
A federal judge in Philadelphia ordered Pina to make payments of $500 per month until the $20,000 is repaid. The total amount of Medicaid funding misdirected by Pina was over $150,000, according to government attorneys.
The payments are added to an existing arrangement arising from another case, which requires Pina and other ODAAT staffers to repay over $150,000 in federal income taxes to the U.S. Internal Revenue Service.
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