Nissen, Graham Lose Big Time, Media Rebuked in 22-1 Vote to Keep Avandia on Market

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  • 07/30/2007
The FDA Adcomm voted 22-1 to keep Avandia on the market, probably with some changes in the label to identify specific risks but no black box. Here's my take:

1. Steve Nissen is the Mike Nifong of health care. His analysis was shredded and dismissed as a cover-up of all the evidence.

2. David Graham came off as shrill and heartless.

3. The media was rebuked several times for contributing to hysteria and patient deaths. That means the NYT, USA Today and NEJM.

4. Glaxo and other companies had better do a better job of matching the right drug to the right patient. It's the right thing to do and the smart thing to do from a business perspective. And the old way of collecting data and avoiding answers and questions you would rather not know about is not going to work any more. People and doctors want and deserve better post market data sooner.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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