HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Tuesday, July 31, 2007

Avandia Update

Yesterday an advisory committee of the FDA recommended that Avandia remain on the market with new warnings.  The New York Times reports today

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.

Dr. David Graham, a drug safety officer at the federal agency, called for withdrawing the drug and estimated that its toxic effects on the heart had caused up to 205,000 heart attacks and strokes, some fatal, from 1999 to 2006. For every month that Avandia is sold, Dr. Graham said, 1,600 to 2,200 patients will suffer more of those problems.

Dr. Robert Meyer, director of the F.D.A. office that approved the initial Avandia application, immediately disagreed.  “I think it’s important that the committee understand there’s a fundamental disagreement” within the agency, Dr. Meyer said.  Other diabetes drugs also have risks, he added, and doctors and patients need a variety of options.

After the votes, Rebecca Killion of Bowie, Md., a patient representative on the advisory panel, said, “My feeling here is that we’re being asked to take a very draconian action based on studies that are very inadequate for us to make that kind of decision.”

The panel did say the agency should require strict warnings on Avandia labels. . . .

The division in the agency reflects a fierce debate among diabetes experts since The New England Journal of Medicine published a study in May suggesting that Avandia, made by GlaxoSmithKline, increased the risks of heart attacks.  In a cascade of reports since then, agency officials have said that GlaxoSmithKline told the agency about this risk nearly two years ago but that because of internal disagreements, it never warned patients.  In Europe, regulators required that the drug label reflect some concerns about the risks.

The lack of action here helped persuade some lawmakers to support a measure giving the agency more money and power to police drug safety. That bill has passed both houses of Congress and is expected to go to President Bush in days.

For more information, listen here to the National Public Radio stories and also here for a discussion about the FDA and how it functions when reviewing drugs post-approval.

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