FDA Waives Off Obvious Conflict of Interest on Avandia Panel

The chairman of the Food and Drug Administration advisory panel that voted last month to allow Avandia (rosiglitazone) to stay on the market with stricter heart risk warnings did not receive a conflict-of-interest waiver despite having recently earned a $2,000 speaking fee from the drug’s manufacturer, GlaxoSmithKline.

Clifford Rosen, an endocrinologist and professor of nutrition at the University of Maine, told the agency about that relationship as well as his clinical trial work for Glaxo competitors Eli Lilly, Merck and Novartis. He also revealed it on the New England Journal of Medicine website last week at the tail end of his essay entitled “The Rosiglitazone Story – Lessons from an FDA Advisory Committee Meeting.”

“I listed it all on the FDA sheet, and they never saw it,” Rosen told Integrity in Science Watch, a newsletter published by the Center for Science in the Public Interest. “They told me, ‘I’m sorry. We missed it.’”

An FDA spokeswoman claimed that “Dr. Rosen did not have any interests relevant to the meeting topic that rose to the level that would require a waiver.”