July 22nd, 2010

Lessons Learned from 2 Avandia Panels

In a perspective published online in the New England Journal of Medicine, Clifford Rosen, who was the chair of the 2007 FDA Advisory Panel that allowed rosiglitazone (Avandia) to remain on the market and also a member of the panel that met last week, writes about “lessons learned” from the extraordinary series of events involving this drug. Among the lessons:

  • “black box warnings sound impressive” but may not have a dramatic effect on usage,
  • “postmarketing studies [like RECORD] are fraught with hidden risks” and “require more careful designs and safeguards to protect data integrity and objectivity,”
  • “very little was said about the balance of risks and benefits… all committee hearings should be required to include a discussion of the risk-benefit balance,”
  • trials designed to gain approval for drugs must now “address hard outcomes rather than surrogate indexes.”

Rosen concludes that, in the wake of the meeting, “the FDA must consider only two choices: either stronger warnings plus the use of informed consent and a registry for compassionate use of rosiglitazone or removal of the drug from the market.”

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