Somehow I missed the Wall Street Journal’s November 19 broadside against the Food and Drug Administration on the occasion of the agency’s decision to remove approval for use of Avastin as a breast cancer treatment. In The Avastin Denial, the Journal comes down hard on the FDA and its head, Dr. Margaret Hamburg, going so far as to claim that:
“The FDA’s real goal was to send a warning to the rest of the drug industry about who is in charge of drug development.”
FDA has handled this exactly right. Avastin was approved for breast cancer in 2008 under an accelerated review process designed to allow potentially life-saving treatments on the market on a provisional basis before all the evidence is in. In this case follow-up studies failed to demonstrate efficacy but did show plenty of harsh side effects, including hemorrhage and severe high blood pressure. FDA review panels voted overwhelmingly to remove the breast cancer indication, and after five months of further analysis and deliberation FDA decided to follow that recommendation.
Also as I pointed out the drug remains on the market for other conditions –giving doctors the right to prescribe it for whatever they want– while Medicare and many insurers will continue to pay for Avastin for breast cancer.
Luckily the Journal is still confident enough to print dissenting letters, including one from the president of the National Breast Cancer Coalition, who presumably has more insight on the topic than the Journal editorial staff. She writes:
Breast cancer advocates had high hopes that Avastin would save lives. Unfortunately, the evidence before the FDA was clear that Avastin does not increase survival and that it sometimes has severe side effects that are far from manageable, and even lead to death. The FDA’s mandate is to apply scientific evidence to promote and protect the health of the public, not simply to get drugs on the market regardless of their effectiveness or harm. The FDA made the right decision on Avastin.
December 1, 2011