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May 23, 2012 | www.gaycitynews.com
HEALTH
FDA Committee Urges Pre-Exposure HIV Drug GMHC lauds recommendation of Truvada; critic likens it to Tuskegee experiment BY DUNCAN OSBORNE
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n advisory committee of the US Food and Drug Administration (FDA) recommended that the regulatory agency approve the use of Truvada, an anti-HIV drug, for HIV-negative people in certain risk groups to prevent them from becoming infected with the AIDS virus. On May 10, the 22-member Antiviral Drugs Advisory Committee voted 19 to three to approve the use of Truvada for gay and bisexual men. The drug was recommended for any HIVnegative person who has a partner who is positive in a 19 to two vote, with one abstention. The committee was less enthusiastic about recommending that Truvada be used for others who may acquire HIV through sex. Twelve members supported that, eight opposed it, and two abstained. While pre-exposure prophylaxis (PrEP), as this use of Truvada is called, has support from leading
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AIDS groups, including the Gay Men’s Health Crisis (GMHC) and Project Inform in San Francisco, it remains controversial as it proposes to give a powerful drug with serious side effects to otherwise healthy people. “This new drug indication is the baseline, or building block, for a new type of biomedical HIV prevention,” said Marjorie Hill, GMHC’s chief executive officer, said in a May 11 statement. “While we do not have all the necessary information about how the public will respond and potentially utilize this medication for prevention, our constituents, clients, family, and loved ones deserve complete support to advance HIV prevention.” AIDS groups see PrEP as a welcome addition to their limited arsenal of HIV prevention tools and hope it will reduce new HIV infections among gay and bisexual men, which have remained stubbornly high and unchanging for years. Truvada, marketed by the pharmaceutical company Gilead
CATHCART, from p.3
Cathcart said, “is a winner” at the appellate level. If that’s true, the Supreme Court would have no choice but to take the case, since the federal government could not recognize same-sex marriages in some federal appellate circuits but not others. The issues raised in the DOMA litigation, he explained, are also “an easier conceptual challenge and lift. We’re not asking the court to tell any state what to do.” Instead, the goal is to change the way the federal government treats gay and lesbian couples who marry in states where it is legal. He likened the DOMA issue to what Lambda came up against in its sodomy litigation. When the Georgia sodomy law went before the high court, more than half the states still had such statutes. By 2003, only 13 did. “Thirteen states is easier,” he said. “They were no longer being asked to tell a majority of states what to do. In 2003, they were only asked to bring a small minority along in a clean-up operation.” Despite the marriage referendum loss in North Carolina several days before, Cathcart was upbeat about the prospects for success in Novem-
Sciences, is a combination of two anti-HIV drugs, emtricitabine and tenofovir. Tenofovir is known to cause damage to kidneys and can lead to a loss of bone density, which creates the risk of fractures. Other Truvada side effects can include weight loss, nausea, vomiting, and dizziness. The rationale for PrEP is based on three large studies. A study of 2,499 uninfected gay and bisexual men and transgender women in six nations found that the risk of becoming infected was cut by 42 percent among participants. A study of uninfected heterosexual men and women and another of sero-discordant couples, where one partner is positive, found the infection risk was cut by 62 percent to 75 percent. The committee was apparently not convinced that this better data, compared to that for gay men and transgender women, warranted a more general application of PrEP. “Basically it’s a Tuskegee experiment for gay men,” said
ber, when Washington State, Maryland, Maine, and Minnesota may also be voting on marriage equality in one fashion or another. “If we win a couple of those and also get marriage back on line in California,” he said, “it makes it feel more inevitable than it did before.” Conceding that a loss of three or four contests in November would be “a terrible thing,” he noted, “We have shown we can win in the courts and in the legislatures in far worse times.” Pointing to the overwhelming rejection of repeal efforts earlier this year by the Republican-dominated New Hampshire Legislature, Cathcart said, “I can’t be more surprised by North Carolina than I was by New Hampshire.” Cathcart was effusive in his praise for President Barack Obama’s comments two days earlier endorsing marriage equality. “It didn’t feel like, ‘Oh, I got forced into it,’” he said. “It felt like the best part of the last campaign. It sounded like he finished evolving. He did it beautifully.” Asked if he was troubled by the president’s statement that marriage will “continue to be worked out at the local level,” Cathcart said, “No, he was recognizing the state of play. In
Michael Weinstein, president of the AIDS Healthcare Foundation, who opposes PrEP. For four decades beginning in 1932, the US Public Health Service let some 400 African-American men with syphilis in Tuskegee, Alabama, go untreated to observe the disease course in them. “I think it’s going to be catastrophic for HIV prevention efforts in this country and particularly among gay men,” Weinstein said. “I think that it’s the easy way out; it’s telling people that there is a magic pill.” Some PrEP opponents have raised concerns that the Truvada regimen could erode adherence to condom use, the most effective prevention measure. “I don’t question the efficacy of PrEP on an individual basis, but I’m not confident it will work on a population basis,” Sean Strub, a longtime AIDS activist and the founder of POZ magazine, wrote in an email. “I am concerned that the focus on PrEP will harm behavioral-based prevention efforts.” A major issue for PrEP is
2012, marriage jurisprudence is state by state. Federalizing the issue too soon is unlikely to be good.” Despite a lengthy discussion of marriage equality, Cathcart made a point of emphasizing that the issue of nondiscrimination on the job is probably what concerns LGBT Americans more than any other. Lambda’s hotline got about 7,000 calls in 2011, and “employment is the largest single thing people call us about, year in and year out.” The group’s offices in Atlanta and Dallas cover 20 states, none of which offers any nondiscrimination protections above the local level. He praised Equality Florida’s success in pushing for municipal and county ordinances, but said that “local laws are never as strong as state laws.” Noting Census findings that show impr essive numbers of same-sex couples raising children in regions such as the South, Cathcart said that offering them legal protections could have “a snowballing effect... If you don’t feel safe in your job or in your housing or regarding custody of your children, it’s effectively a gag order. It is not safe to be politically active.” Pointing to a recent decision from the 11th Circuit Court of Appeals in the case of a transgender woman fired
whether those taking the drug will be able to follow the regimen given the side effects. After the study of gay men and transgender women ended, the FDA measured the “plasma and intracellular emtricitabine and tenofovir concentrations” and found that “less than half of the subjects” taking the drug had “measurable drug levels,” the FDA wrote in a guidance. An analysis of those who became infected during the study produced an estimate that only 10 percent of participants had “intracellular drug concentrations consistent with daily dosing” requirements of PrEP. Such “poor adherence,” as the FDA called it, could render PrEP ineffective. “The public health benefit of Truvada for a PrEP indication can only be achieved with access to Truvada and strict adherence with the recommended dosage regimen,” the FDA wrote. “These are the two key factors to achieve efficacy for Truvada for a PrEP indication.”
by the Georgia General Assembly as well as a ruling last month by the federal Equal Employment Opportunity Commission regarding a transgender woman denied a job by the Bureau of Alcohol, Tobacco, Firearms and Explosives, Cathcart said, “We are amazingly closer than we were just a year ago to having gender seen as sex for discrimination purposes.” However, future progress, in the courts and federal agencies, he warned, is dependent on the election outcome in November –– not only for president but for control of Congress as well. “We desperately need to pass ENDA, and we need it to be trans-inclusive,” he said of the long stalled effort to enact the federal Employment NonDiscrimination Act. Still, Cathcart does not see a strong push on marriage equality as inconsistent with any other goal Lambda has. “I sort of believe in a rising tide theory on marriage gains,” he said. “We litigated Iowa because we thought we could win and because we thought it was critical to have a heartland victory.” In other words, married gay and lesbian couples in the Midwestern farm belt are well positioned to change hearts and minds that have too infrequently been engaged.