Last year an article ran in Bloomberg Business entitled, “Gilead’s Pill Can Stop HIV. So Why Does Almost Nobody Take It?” The article encouraged Gilead to do more promotion of the drug. It seems they took their advice, and made a whole lot of other people, including the FDA, mad in the process.
Truvada approved by FDA for treatment and prevention of AIDS
Gilead’s Truvada was first approved for treatment of HIV/AIDS patients in 2004. Then the FDA approved use of Truvada as pre-exposure prophylaxis (PrEP) to prevent HIV infection in non-infected individuals in 2012. Guidelines issued by the FDA for PrEP for individuals include 1) an initial baseline negative HIV test; 2) daily adherence to the Truvada medication; 3) ongoing periodic HIV testing to ensure the individual on PrEP remains HIV-negative; and 4) continued use of other prevention methods, such as condoms.
Now, perhaps in response to criticism that they weren’t doing enough to promote the drug, we have what seems to be the first direct-to-consumer drug advertising paid for by Gilead Sciences, Inc. for use of Truvada, and it apparently violates Food and Drug Administration (FDA) guidelines for PrEP by promoting off-label use of the drug by encouraging situational PrEP use for those who “… like to party.”
Controversial ad reported in Australia
November 8, 2015 news article on Australia’s ‘Gay News Network’ titled “New US PrEP Ads Target Men Who Like to Party,” said the ad appeared to promote situational—rather than daily—use of Truvada for PrEP for “… men who enjoy recreational sex and drug use but do not test regularly for HIV.”
The article also noted, “The campaign is supported by Gilead Sciences, manufacturer of Truvada.” The TV ad, titled “I Like to Party,” includes a slate at the end of the spot reading: “Supported by funding from Gilead Sciences.” The ad also credits Public Health Solutions, a New York City-based non-profit and Connected Health Solutions, a Brooklyn-based “organizational development consultancy” on the slate at the end of the ad.
You think Gilead would have known better. In April 2014 AIDS Healthcare Foundation (AHF) President Michael Weinstein offhandedly referred to PrEP as a “… party drug” to an Associated Press reporter. Since then, both he and AHF have been repeatedly and harshly criticized by the gay and AIDS communities for the observation. Instead of avoiding the controversy, it seems Gilead has jumped on the bandwagon, funding and promoting party use of Truvada in violation of FDA regulation.
Drug hasn’t been used by those who need it most
In the Bloomberg article a year ago they wondered why more people weren’t using Truvada, since taken daily, it can prevent infections 92 percent of the time, meaning it has the potential to drastically reduce new infections in sexually active gay men, among the U.S.’s highest-risk communities.
The article noted that while Truvada’s was already a financial success, thanks to its use in HIV patients, bringing Gilead $1.79 billion in 2014, of its 3.3 U.S. million prescriptions from January 2012 to March 2014, only 3,200 were for prevention. So there are thousands of people who could significantly lower their HIV risk, but aren’t.
According to the U.S. Centers for Disease Control and Prevention some 50,000 Americans are diagnosed with HIV each year, with the highest rates among young gay males. Yet in November of 2014, Gilead said that 42 percent of PrEP prescriptions written through March 2014 were for women, and only 7.4 percent were for men younger than 25.
So Gilead seems to be trying to promote its drug to the market that needs it most. But it doesn’t sound the like the FDA is going to be happy about it. Nor is Weinstein and the AHF, which has criticized and cautioned against the widespread deployment of PrEP as a community-wide public health strategy, such as the CDC’s recommendation that 1.2 million individuals go on PrEP. It does support its use on a case-by-case basis decided upon between a medical provider and his or her patient.
It will be interesting to see how this plays out.
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