Controversy over F.D.A.-Avastin decision to reignite June 28-29 with new round of hearings

Controversy over the F.D.A.'s proposal to withdraw approval of Avastin (bevacizumab) for breast cancer treatment will reignite June 28-29 with a new round of hearings. One oncologist who will be monitoring the hearings is Dr. Frederick C. Tucker Jr. of Fredericksburg Oncology in Virginia, whose recent New York Times op ed defended the F.D.A.'s position on scientific grounds.

Dr. Tucker's op ed, "Drugs and Profits," contends that the drug's maker, Genentech, has been unable to show that patients taking the medication live longer or with an improved quality of life.

"It was this lack of demonstrated clinical benefit, combined with the potentially severe side effects of the drug, that led the F.D.A. last year to reject the use of Avastin with Taxol or with the other chemotherapies for breast cancer," Dr. Tucker wrote.

He argues that Genentech, in appealing the F.D.A. decision, has merely changed its interpretation of its data.

"Perhaps more troubling is the resort to anecdote in the brief to the F.D.A. and in the news media. Oncologists recounted their successes, and patients who were doing well on Avastin argued for its continued approval," Dr. Tucker wrote. "But anecdote is not science. Such testimonials may represent the human voices behind the statistics, but the sad fact is that there are too many patients who have been treated with Avastin but are not here to tell their stories."

His op ed concludes that Genetech's efforts would be better spent developing more effective breast cancer treatments.