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Avastin’s removal from market: Not a “Death Panel”


It’s good to see that someone else is disproving this rumor about the FDA’s decision to remove Avastin (bevacizumab) from the market.  I’ve seen fellow Tea Partiers of mine going to the “Death Panel” excuse as an explanation, and I’ve had to explain. Avastin doesn’t have a good risk/benefit profile, and this has nothing to do with limiting expenses.


Let’s just say this really clearly, again and again. The Food and Drug Administration’s decision to withdraw approval for Avastin in breast cancer is not an example of a “death panel.” It’s not an example of making health care decisions on the basis of cost, even though Avastin can cost $80,000 a year. It is an example of something far more common: a big-selling drug that is failing to live up to its initial promise.

Avastin, which is effective in colon cancer and some other types of cancer, was approved by the FDA only over the objections of an FDA advisory panel. Some of the same people who are calling this a “Death Panel” are the ones who decry examples when the FDA overrules a positive panel vote, as happened with Orexigen’s obesity drug yesterday or Dendreon’s prostate cancer treatment a couple years ago. In cases of rejection, of course, the FDA can always change its mind based on more data — as it did with Dendreon’s Provenge.

In the case of Avastin in breast cancer, the FDA granted only a provisional approval. Further studies were supposed to provide further evidence that the drug made patients feel better or live longer. They didn’t. If Avastin remains on the market, FDA panels are going to be more risk-averse about new drugs.

And you don’t have to take our word on this. Take a look at the scathing editorial that ran in the current issue of the Journal of the American Medical Association, written by Daniel F. Hayes of the University of Michigan. He uses the generic name of the drug, bevacizumab.

In the same editorial, Hayes proposes that Avastin might work better used for longer in the right patients. But his editorial drives home the difficult choices that must be made with this drug. Invoking the “death panels” trope trivializes these choices.

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