Monday, December 17, 2007

The Politics of Cancer Drugs

Last week, the Oncologic Drugs Advisory Committee (ODAC) of the Food and Drug Administration (FDA) voted 5-4 to recommend against approving the drug Avastin for first-line use in advanced breast cancer. In clinical trials to date, Avastin has not been shown to extend overall survival or to improve quality of life for women with metastatic breast cancer.

Sounds reasonable, doesn't it. Good decision making, based on good science.

However, the FDA is not bound to heed the advice of ODAC, and Avastin’s manufacturer, Genentech, will be lobbying hard to persuade FDA to grant approval in spite of the ruling.

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