Steve Nissen: The FDA Meeting On Avandia Will Be A ‘Whitewash’


Next month, the FDA will hold a two-day meeting to discuss the results of a clinical trial for the diabetes pill, three years after the agency greatly restricted use of the controversial drug. And , who co-authored a meta-analysis that several years ago found increased cardiovascular risks with the GlaxoSmithKline pill, believes the FDA has a hidden agenda for convening the session.

“The most likely explanation: the leadership of the division of the FDA responsible for drug regulation, the Center for Drug Evaluation and Research, is seeking to avoid accountability for its role in the Avandia tragedy,” he writes in an op-ed in Forbes. Nissen, by the way, is head of cardiology at the Cleveland Clinic.

The , which the agency had ordered, will reassess a clinical trial called RECORD that was, in part, the heated focus of a contentious 2010 FDA panel held to review the Avandia safety record. At the time, both the drugmaker and the FDA were under considerable pressure in the midst of growing public outcry over patient safety and the disclosure of clinical trial data.

In his essay, Nissen notes that Glaxo had secretly conducted an analysis in 2005 and 2006, and concluded its pill increased the risk of heart attacks and related events by about 30 percent. Initially, Glaxo withheld the data from the FDA, but did inform the agency of the findings. But in 2007, his meta-analysis was published, which “intensely embarrassed” the FDA.

“Since 2006, CDER has expended considerable taxpayer dollars trying to absolve itself of responsibility for this inexplicable error in judgment that cost many lives. In 2010, CDER and Glaxo saw an opportunity clear Avandia of any cardiovascular…Read more

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