(by Andrew Gelman)
New York Times columnist Joe Nocera tells the story of Avastin, a cancer drug produced by Genentech that Medicare pays for in breast cancer treatment even though the Food and Drug Administration says it doesn’t work. Nocera writes:
For breast cancer patients, Avastin neither suppresses tumor growth to any significant degree nor extends life. Although a 2007 study showed Avastin adding 5.5 months to progression-free survival, subsequent studies have failed to replicate that result.
As a result of that first, optimistic study, the Food and Drug Administration gave the drug “accelerated approval,” meaning it could be marketed as a breast cancer therapy while further studies were conducted. Those follow-up studies are what caused a panel of F.D.A. experts to then withdraw that approval . . . After weighing the evidence, the F.D.A. panel voted 6 to 0 against Avastin.
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.
And here’s the punch line. After describing the political pressure coming from cancer support groups and political hacks such as Sarah Palin and the Wall Street Journal editorial board, Nocera continues:
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. . . .
Medicare . . . is, by statute, guided in such decisions not by the F.D.A. but by various compendia of drug use put together by such groups as the National Comprehensive Cancer Network. The network’s 32-member breast cancer panel is made up almost entirely of breast cancer specialists, nine of whom have financial ties to Genentech. The last time the panel voted on Avastin, it voted unanimously in favor of continuing to recommend it as a breast cancer therapy.
Here is an enormously expensive drug that largely doesn’t work, has serious side effects and can no longer be marketed as a breast cancer therapy. Yet insurers, including Medicare, will continue to cover it.
If we’re not willing to say no to a drug like Avastin, then what drug will we say no to?
Based on Nocera’s description, this does seem pretty scandalous. Perhaps not quite on the scale of a financial and public health disaster such as the pouring of antibiotics into animal feed in our subsidized farms, but still a bit disturbing.
And I know people who work at Genentech, which makes it seem that much worse.
On the other hand, I don’t know anything about this case. I’m curious what experts on medical decision making would say. Is Nocera right on this one? Should we as statisticians be raising our voices and making a fuss about Medicare’s apparent disregard of the principles of evidence-based medicine?