November 22, 2011
IT HAS NOTHING TO DO WITH SCIENCE:
Why Doesn't No Mean No? (JOE NOCERA, 11/21/11, NY Times)After Genentech appealed, Dr. Margaret Hamburg, the F.D.A. commissioner, affirmed the decision on Friday in a ruling that would seem, on its face, unassailable. She essentially said that F.D.A. decisions had to be driven by science, and the science wasn't there to support Genentech's desire to market Avastin as a breast cancer drug.
Yet there was an immediate outcry. Some breast cancer patients, convinced that the drug was helping them stay alive, condemned the ruling. That's certainly understandable. Less understandable was the reaction from conservatives, who cast the F.D.A. decision as an example of the nanny state making decisions that more properly belonged to doctors and their patients. The Wall Street Journal editorial page called Dr. Hamburg's decision a "blunt assertion of regulatory power" and described Avastin as "potentially life-saving," which it most certainly is not.
The strangest reaction, though, has come from the nation's health insurers and the administrators of Medicare. Despite the clear evidence of Avastin's lack of efficacy in treating breast cancer, they have mostly agreed to continue paying whenever doctors prescribe it "off label" for breast cancer patients. Avastin, by the way, costs nearly $90,000 a year.
The reason they are doing so is obvious: the science notwithstanding, no company wants to be cast as so heartless that it would deprive a seriously ill cancer patient of a drug that might offer hope, however slim.
It's magical-thinking.
Posted by oj at November 22, 2011 4:10 PM
Tweet