Newswise — FREDERICKSBURG, VA, June 16, 2011 -- 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.
Dr. Tucker treats cancer patients at his practice, and writes frequently about cancer topics. He has no ties to, nor receives compensation from, the F.D.A. or any drug manufacturers.
For more information about the Avastin debate visit these online resources:
“Drugs and Profits,” May 25, 2011, New York Timeshttp://www.nytimes.com/2011/05/25/opinion/25tucker.html
“Judging a Cancer Drug: Avastin’s Story” (Letters to the Editor)June 1, 2011, New York Timeshttp://www.nytimes.com/2011/06/02/opinion/l02avastin.html?scp=1&sq=avastin&st=Search
Documents Regarding the F.D.A. Bevacizumab (Avastin) Decisionhttp://fredericksburgoncology.com/wp/2011/05/documents-regarding-the-fda-bevacizumab-avastin-decision/
F.D.A. Hearing on Proposal to Withdraw Approval for the Breast Cancer Indication for Bevacizumab (Avastin)June 28-29, 2011 http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm255874.htm
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