Diabetes pill controversy puts spotlight on seldom-seen federal scientists

By Matthew Perrone, AP
Wednesday, July 14, 2010

Avandia debate spotlights key FDA decision makers

The Food and Drug Administration typically goes to great lengths to keep its decision-making process out of the public eye. As an agency that handles confidential data from drug companies, FDA staffers are typically barred from speaking out about their work.

But as the agency considers whether to withdraw the troubled diabetes drug Avandia, the public is getting a rare look at some of the personalities within the FDA.

Avandia was once a blockbuster drug for GlaxoSmithKline, but it has been under a cloud since a 2007 analysis first suggested it may increase heart attack risk. This week the FDA is considering the latest data on the drug’s safety at a two-day public meeting. Below are some of the key figures in the FDA’s review.

THOMAS MARCINIAK, DRUG REVIEWER: Until last week, Marciniak was one among hundreds of nondescript FDA scientists tasked with reviewing drugs. However, Marciniak has emerged as a key figure in the Avandia debate after writing a blistering review of a key trial which GlaxoSmithKline says proves its drug is safe.

In an unusually candid presentation Tuesday, Marciniak described the FDA as being divided into three camps on Avandia.

The first faction, he said, are those staffers who initially approved the drug and “understandably don’t want to be seen as reversing themselves.” The second camp involves staffers who have long thought the drug is dangerous and should be withdrawn. Marciniak places himself in a third camp as a “tie breaker” because he only recently began working on Avandia.

Marciniak told a panel of outside experts that Glaxo’s trial was poorly designed and provides no evidence of Avandia’s safety. The panel is scheduled to vote late Wednesday on the fate of Avandia.

As one of the few fresh voices in the Avandia debate, Marciniak’s opinion could be key as panelists consider the drug.

DAVID GRAHAM, DRUG REVIEWER: If the FDA has anything resembling a celebrity, it would be David Graham. The drug reviewer first came to national prominence during the scandal over Vioxx, a blockbuster pain killer that was pulled from the market after showing links to death and heart attack. Graham was the first to blow the whistle on Vioxx’s risks and argued that lives could have been saved if the FDA had acted sooner.

Known for his rhetorical flair and safety-first approach to drugs, Graham is leading the charge within the FDA to withdraw Avandia. In a recently published analysis of Medicare patient data, Graham estimated Avandia could have caused roughly 100,000 heart problems, including some fatal.

Graham told panelists Tuesday that the risks of Avandia are real enough “to put you in a hospital or a cemetery.”

JANET WOODCOCK, DRUG CENTER DIRECTOR: A 24-year veteran of the FDA, Woodcock has been involved with the Avandia saga since the drug’s approval in 1999. While Woodcock has made few public comments at the meeting, the FDA confirmed she made the decision to keep Avandia on the market in 2007. Instead, the agency added a warning label to the drug about potential heart risks.

As the director of FDA’s Center for Drug Evaluation and Research, Woodcock is ultimately accountable for the safety of all drugs approved for commercial use.

JOSHUA SHARFSTEIN, PRINCIPAL DEPUTY COMMISSIONER: Although he did not attend the two-day meeting on Avandia, FDA deputy Joshua Sharfstein may have the final word. Though Woodcock made the decision on Avandia’s fate three years ago, many FDA observers believe the controversy surrounding the drug will force a decision by a higher-level official.

In a press conference with reporters last week, Sharfstein gave little indication of what role he would play in the Avandia decision.

“The FDA is going to make a decision on behalf of the public,” he said.

Sharfstein came to the FDA after serving as Baltimore’s health commissioner, where he took on drug companies over the risks in children’s cough and cold drugs. President Obama appointed Sharfstein last year to help restore the FDA’s image as a watchdog of public health.

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