FDA Orders Gilead for Second Time to Stop Downplaying Risks, Inflating Benefits of Antiretroviral Drug Viread
August 8, 2003
The FDA for the second time in little more than a year has ordered Gilead Sciences to stop downplaying the risks and inflating the benefits of its antiretroviral drug Viread, the Los Angeles Times reports (Douglass, Los Angeles Times, 8/8). Thomas Abrams, director of the FDA's division of drug marketing, advertising and communications, wrote in a July 29 letter to Gilead that the company's representatives at an early April AIDS conference failed to disclose the risks of acid accumulation and severe liver enlargement associated with Viread and claimed that the drug could be used in a broader range of patients than the group of patients for whom it is approved (Beasley, Reuters, 8/7). Representatives at the conference exhibit said that Viread is more potent, has fewer side effects and is safer than similar antiretroviral drugs, claims which Abrams says there are no "data from head-to-head clinical trials to substantiate." Abrams said that the representatives' actions are "particularly troubling" because the company had been issued a similar warning in March 2002 (Los Angeles Times, 8/8). The FDA in a March 14, 2002, letter criticized the company over statements made by its representatives to physicians attending a scientific conference in December 2001. The FDA said that Gilead representatives told doctors that Viread has "no toxicities" and is a "miracle drug" (Kaiser Daily HIV/AIDS Report, 3/27/2002). The company is required to respond to the FDA in writing by Aug. 12 with details of its plans to identify and correct violations and to retrain its sales force. Failure to respond could result in regulatory action, including seizure and injunction, according to the letter. Gilead spokesperson Amy Flood said that the company believes the violations were an "isolated incident," adding that Gilead takes the FDA's concerns "very seriously." Flood said that the company will be "working to respond to the FDA" (Reuters, 8/7).
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