Gilead Ups Stealth Marketing Campaign for PrEP, Skirting FDA Oversight

In News by AHF

Gilead awards PrEP “education and awareness” grants to 66 groups, many serving populations that top PrEP research studies have shown had issues with drug adherence, behavior that can greatly decrease its efficacy for HIV prevention. Many of these organizations also are in a position to prescribe PrEP.

Gilead, which has said it is not advertising its AIDS treatment, Truvada, for use as pre-exposure prophylaxis (PrEP), manages an end run around the FDA—and its own claim of not marketing PrEP—by instead directly funding AIDS groups with over $13 million. AHF says company can no longer say it is not marketing PrEP.

WASHINGTON (August 24, 2015) AIDS Healthcare Foundation (AHF) is speaking out about the underhanded influence of Gilead money in pushing the use of its AIDS treatment, Truvada, for pre-exposure prophylaxis (PrEP) for HIV prevention. Gilead Sciences’, which on more than one occasion has said that it, “…does not view PrEP as a commercial opportunity and is not conducting marketing activities around Truvada as PrEP, is  directly funding HIV/AIDS and community groups nationwide with ‘Gilead PrEP Grants.’ AHF believes the community grants and other such funding awarded by Gilead—which some groups have used to run advertising of their own promoting PrEP use—constitute a stealth marketing campaign that allows Gilead to bypass FDA oversight of its marketing statements.

On August 14th, Gilead announced an additional 66 ‘Gilead PrEP Grants’ to  community groups, many serving target populations and groups that several leading PrEP research studies have shown had issues with adherence to the daily drug regimen. Drug adherence—or lack there of—can significantly decrease overall efficacy of Truvada when used for pre-exposure prophylaxis or PrEP. Adherence is also one of the primary reasons that advocates from AHF are opposed to community-wide deployment of PrEP as a public health intervention/prevention strategy, such as when the CDC recommended last year that 500,000 high-risk individuals go on PrEP.

“It’s time to pull back the curtain on the influence of Gilead money: the company’s ongoing  funding community groups with ‘PrEP Grants’ really constitute a form of stealth marketing and should be recognized as such,” said Tom Myers, General Counsel and Chief of Public Affairs for AHF. “Instead of  mounting its own direct-to-consumer advertising for Truvada as PrEP and instead spreading its considerable cash far and wide among community groups, Gilead bypasses rigorous FDA oversight of its own advertising copy while at the same time dodges potential issues of liability and responsibility. The funded groups, which are being paid to promote Truvada as PrEP, have no virtually no restrictions on what they can communicate to people when espousing PrEP.  Many of these groups can also write and fill prescriptions for PrEP, creating a potential conflict of interest that would benefit Gilead financially.  It really is a stealth drug marketing campaign for PrEP worthy of a business school case study, if not a government investigation.”

Despite the fact that in May 2014, the CDC recommended that 500,000 men-who-have-sex-with-men and other high-risk individuals go on PrEP in the U.S., uptake of PrEP appears to be slow overall: As few as 20,000 prescriptions for Truvada for a PrEP indication are thought to have been written since the FDA first approved such a use on July 16, 2012.

“We believe there can be a use for PrEP in certain circumstances, but that PrEP should be prescribed on a case-by-case basis by medical providers working in conjunction with their patients, not deployed as a community-wide public health intervention strategy bankrolled by “education and awareness” grants, as Gilead is apparently seeking to do by funding these community organizations,” added Myers.

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