July 31, 2007

Yesterday, after a contentious FDA advisory panel meeting that underlined divisions within the agency over the safety of Avandia, the panel voted overwhelmingly to keep Avandia on the market, albeit with an increased warning about a potential heart attack risk:

Panel members said that studies concerning Avandia were too murky to merit drastic regulatory action and that other diabetes medicines might have similar risks.

The votes — 20 to 3 on the heart attack risk and 22 to 1 on the marketing — were cast after an extraordinary meeting in which officials from the Food and Drug Administration, which brought the committee together, openly disagreed with one another on the course to take.

So what is the "take away" message here? How about that we need more "me too" drugs. Although critics attack the idea that drugs with similar efficacy mechanisms may have different safety and efficacy profiles (think Vioxx v. Celebrex), several recent safety disputes facing the agency - for SSRIs, COX-2 inhibitors, and now Avandia, have all underscored how risks and benefits within drug classes can vary.

We are also learning that the translation of safety signals from clinical trials to "real world" use can be incredibly complex, and that the FDA is only beginning to learn how to interpret masses of data streaming in from multiple sources.

For instance, at the Avandia hearing, the Times reports that "executives from Tricare, a managed care company that serves active and retired military personnel, and WellPoint, a huge health insurer, said they had found no evidence in their records that patients given Avandia had suffered more heart attacks."

The data is murky, and the FDA should invest significantly in additional post market safety sureillance tools to help physicians and patients navigate these kinds of tricky questions. But, at the same time, the agency should continue to rapidly approve new medicines to ensure that patients have many effective therapeutic options to choose from.

Posted by Paul Howard at July 31, 2007 04:50 PM

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