LOS ANGELES--(BUSINESS WIRE)--In what looks to be the first direct-to-consumer drug advertising paid for by Gilead Sciences, Inc. for use of its AIDS treatment, Truvada, as pre-exposure prophylaxis (PrEP) to prevent HIV infection in non-infected individuals, Gilead has paid for an ad that 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.”
A November 8, 2015 news article on Australia’s ‘Gay News Network’ titled “New US PrEP Ads Target Men Who Like to Party,” appears 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.
Gilead’s Truvada was first approved for treatment of HIV/AIDS patients in August 2004. The FDA formally approved use of Truvada as PrEP on July 16, 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.
It now appears AHF President Michael Weinstein made a prophetic comment to an Associated Press reporter in April 2014 when he offhandedly referred to PrEP as a “… party drug.” Since then, both he and AHF have been repeatedly and harshly criticized by the gay and AIDS communities for the observation, while Gilead itself now funds and promotes party use of Truvada as PrEP in violation of the law and FDA regulation.
“When I referred to PrEP as a party drug two years ago, it created a nationwide scandal. Now Gilead—in what looks to be its first official paid advertising for Truvada as PrEP—explicitly promotes PrEP as a party drug for situational use in direct violation of FDA regulations. This is illegal and we will seek to hold them accountable for their irresponsible and illegal advertising,” said Michael Weinstein, President of AIDS Healthcare Foundation, 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, but supports its use on a case-by-case basis decided upon between a medical provider and his or her patient.
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 500,000 individuals in 36 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare.