AIDS Healthcare Foundation lobbies against fed PrEP approval

In Advocacy by AHF

By: SAM SPOKONY, Gay City News

New York – August 11, 2011

While medical professionals and advocacy groups have begun to promote the research and development of pre-exposure prophylaxis (PrEP) as a method of HIV prevention for gay men, the AIDS Healthcare Foundation (AHF) has created a stir with its nationwide media campaign bent on stopping federal approval of PrEP. The campaign’s primary target is the drug Truvada — manufactured by Gilead Sciences (a California-based company that creates antiretroviral drugs used for treatment of HIV-positive patients).

“As a gay man, I believe this would be a catastrophe for HIV prevention,” said AHF President Michael Weinstein in an August 3 phone interview. “The drug companies are not our friends, and I just don’t think that they, the government or the academics involved in PrEP studies can claim to understand the gay community better than any gay man does.”

The campaign, which can be seen at the website, has been most notable in full-page advertisements in prominent gay publications such as Gay City News, Frontiers, Washington Blade and South Florida Gay News (among others). The ads also cite the support — in the form of protest letters to the Food and Drug Administration (FDA) and Gilead CEO John C. Martin — of 618 doctors and advocates calling for a halt to any implementation of PrEP.

Weinstein and other members of the campaign often invoke the 44 percent efficacy results of last year’s iPrEx study (which enrolled 2,499 participants to test Truvada’s ability to prevent seroconversion in at-risk, HIV-negative gay men), as well as low adherence rates and thoughts that no clinical PrEP research will translate into real world success for sexually active gay men.

“If this pill were approved by the FDA,” Weinstein added, “why would those men bother to keep wearing condoms?”

Some HIV researchers do not agree with the campaign, including Dr. Roy Gulick (the principal investigator for an upcoming PrEP study that will include the drugs Truvada and maraviroc) — who believes the organization misunderstands the nature of scientific research and, referring to the AHF, has stated that “the FDA is capable or judging the pros and cons of a drug without their help.”

Cara Miller, a spokeswoman for Gilead, declined to comment specifically on any correspondence between the drug maker and the FDA.

“Over the past several months, we have talked to community members around the country — including Michael Weinstein — about the many complex issues around PrEP,” Miller wrote in an August 1 email. “Overall, the community has been very supportive of our plans.”

Weinstein stated that he has attended a Gilead-sponsored PrEP forum in Los Angeles, and found there to be “no real debate” on the issue. He went on to say that the “forums are carefully scripted and invitation only, and I don’t think that really qualifies as objective.”

The biggest cause of that one-sided argument, Weinstein believes, is the “conflict of interest” that he says is created when Gilead provides heavy funding to the gay advocacy groups it needs to present Truvada in a positive light. Referring to a Gay Men’s Health Crisis (GMHC) PrEP forum covered by Chelsea Now in a previous article (which did not include any Gilead staff but featured a researcher from the iPrEx study), he accused the drug maker of “showering communities with money, [including] organizations like GMHC.”

Dr. Marjorie J. Hill, CEO of GMHC, wrote in an August 4 email to Chelsea Now that Gilead had recently given a $30,000 grant to GMHC to fund “a social marketing campaign designed to inform HIV-negative men who have sex with men on ways to remain HIV-negative.” While Hill denied in the message that the organization identifies any Gilead products in its marketing campaign, a new, GMHC-sponsored PrEP palm card — currently being distributed on Fire Island — refers to Truvada by name when mentioning the iPrEx study.

Erica Jefferson, a spokeswoman for the FDA, stated in an August 9 phone interview that her organization could not comment directly on any drugs (such as Truvada) that have not yet been approved, nor on the AHF campaign. Though she would not confirm or deny any actions taken by Gilead, Jefferson added that a company that has put a drug through a Phase III clinical trial (which Gilead has with Truvada) can apply for FDA approval of the drug — a process that, unless given priority, takes ten months before a decision is reached. All HIV prevention drugs are handled in the Division of Antiretrovirals, within the Office of Antimicrobial Products.

“That division has not received funding from Gilead in any way,” Jefferson said. “And, by law, it never will.”

Condoms-in-porn L.A. ballot initiative petition effort underway