Clash between data and emotion in FDA decision on Avastin for metastatic breast cancer

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Dr. Len Lichtenfeld of the American Cancer Society, who drew raves on Twitter today for tweeting from the FDA meeting about whether Avastin should be allowed for the treatment of metastatic breast cancer, also blogged about his day’s experience.

“As one might expect, the experience ran the gamut from deeply felt emotions to cold hard statistics.

Clearly, we are in a place where emotion meets science and the FDA’s decision will prove to be a difficult one. Ultimately, we hope the FDA will make the best decision possible based on the science–flawed that it might be–and in consideration of the public interest and our deep felt concern for the welfare and treatment options for women with metastatic breast cancer.”

Read his entire post, and you can check his tweets at @DrLen.

ADDENDUM on June 29:

An FDA advisory committee voted unanimously today that the approval of Avastin as a treatment for breast cancer should be revoked, despite a two-day appeal hearing by Genentech, the drug’s manufacturer.

In four 6-0 votes, the committee said recent studies have not shown that the drug is safe and effective. It unanimously rejected a compromise proposal made by Genentech that the approval be retained while the company conducts another clinical trial to confirm that the drug works.

Details here.


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