FDA ‘Scolds’ Gilead Sciences Over Comments Likening Viread to a ‘Miracle Drug’
The FDA has "scolded" biotech firm Gilead Sciences for making "several false and misleading claims" to physicians about its new antiretroviral drug Viread, the San Francisco Chronicle reports. Viread, which was approved by the FDA in October, is designed to attack drug-resistant strains of HIV. Viread has been shown to boost immune response and lower viral levels in the bloodstream, and AIDS advocates and doctors are pleased with the drug's performance in patients who are resistant to other antiretrovirals. But in a March 14 letter to Gilead, the FDA criticized the company over statements made by Gilead representatives to physicians attending a scientific conference in December. The FDA said that Gilead representatives told doctors that Viread has "no toxicities" and is a "miracle drug." Norbert Bischofberger, a research director at Gilead, said that the "miracle drug" comment was "way out of bounds," adding, "Those were stupid statements." Viread comes with a warning label stating that it can cause numerous side effects, including nausea, diarrhea and vomiting. Tom Dietz, a financial analyst with Pacific Growth Equities, said that Gilead's statements constituted a "minor infraction." But Dr. Sidney Wolfe, head of Public Citizen's Health Research Group, said that the FDA "has so greatly scaled back efforts to police drug company claims that he was surprised the agency even bothered to chastise Gilead" (Abate, San Francisco Chronicle, 3/26).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.