The AIDS Healthcare Foundation accused Gilead of inadvertently creating a "black market" for its Truvada HIV drug by running a marketing campaign aimed at persuading the FDA to approve the blockbuster for prophylactic use.
Florida's Agency for Healthcare Administration told the AIDS Healthcare Foundation (AHF) that a spike in demand for Truvada for prophylactic use is behind a recent state policy change requiring pharmacy claims for antiretrovirals to confirm HIV/AIDS or Hepatitis B diagnosis.
"The fact that a black market has cropped up in response to Gilead's campaign to obtain FDA approval for Truvada shows what a dangerous game Gilead is playing," said AHF president Michael Weinstein in a statement. "The increased demand that has been created by Gilead's reckless push to have Truvada approved prematurely for this new use is only a preview of what is to come. If the company succeeds, Gilead will have free reign to market Truvada to HIV-negative individuals. This will open up a demand for the drug that will inevitably create an even bigger black market, ultimately resulting in increased infections, viral resistance and a huge step backwards in efforts to fight the pandemic."
The watchdog group-slash-service provider has opposed Gilead's efforts to obtain marketing approval for Truvada as pre-exposure prophylaxis, based on its iPrex study of HIV-negative but high-risk men who have sex with men (MSMs) that found the once-daily pill could cut the risk of HIV infection by 44% in that demographic. Critics point to subsequent studies that show the drug to be less effective, due mainly to poor adherence, and 618 doctors or advocates recently signed letters to FDA and Gilead expressing concerns that prophylactic use of the drug could lead to more risky behavior by some users. AHF has even set up a website to fight the indication, at www.nomagicpills.org.
The drug generated $2.6 billion in revenue last year, with at least one analyst suggesting, as AHF noted, that an indication for prophylactic use could add another billion in sales.