FDA Panelist Defending Avandia was on its Manufacturer's Payroll
It was recently reported by the Wall Street Journal that one of the members of the government advisory panel who voted to back Avandia last week was on GlaxoSmithKline’s payroll. More specifically, endocrinologist David Capuzzi is a paid speaker for the drug manufacturer.
Avandia, a diabetes drug, has carried the Federal Food and Drug Administration’s (“FDA’s”) strongest warning, a black box warning, regarding its risk for heart problems since 2007. Last week, a FDA advisory panel met to consider further restrictions on the drug in the wake of new information indicating it to be more harmful than previously thought. During the meeting of 33 panel members, 12 voted Avandia should be withdrawn; 10 voted its sales should be restricted and warning labels enhanced; 7 voted solely for enhanced warning labels; and 3 voted to keep Avandia on the market with no changes to its warnings. Because of the lack of unity, it is difficult to predict what the FDA will do with regard to the drug.
According to the Wall Street Journal, Dr. Capuzzi was one of the three panel members who voted to keep Avandia on the market with no changes to its warnings, and defended the drug during the two-day panel meeting. Dr. Capuzzi has received almost $15,000 in speaking fees from GlaxoSmithKline, but has denied previously speaking about Avandia. The controversy surrounding Dr. Capuzzi and Avandia highlights a problem in the FDA’s regulations: the disclosure form for outside experts who advise the FDA on risky drugs only requires them to list fees from speaking or writing for a drug company for the previous 12 months or that are under negotiation. This is typically too short a period of time to catch most conflicts in the pharmaceuticals business. In Dr. Capuzzi’s case, the FDA’s current requirement would not have captured the majority of GlaxoSmithKline’s payments to him.