Ethics in Medicine

Approval for Avastin for Breast Cancer Revoked by FDA

Kristen Sparrow • November 21, 2011

I’ve been putting off posting about this latest article about Avastin for breast cancer. I find the way that these very loaded controversies are settled very depressing. In the case of Avastin, it looks like in the best case scenario it extends life for 5-6 months at a cost of $88,000 per year. Recent studies show that the life span extension is more like 1-2 months. It also comes with many nasty and dangerous side effects. To lobby against the FDA ruling, Genentech and Roche mount a defense including the impassioned pleas of patients themselves. I get queasy even writing about this. Medicine needs to have studies to evaluate treatments, not anecdotes from desperate patients. It brings up the horrors of cancer and how we want to do anything in reason to help fight it. But we have to balance the evidence with the emotion and it’s so incredibly difficult. If patients have been harmed, and their lives shortened, those voices should be out there also or should they? Should we really be deciding drug efficacy issues in the court of public opinion? We have always needed to studies to weed out anecdotal results. It is a sad day when questions in medicine are decided much as in politics, that those with the money have an outsized voice. Science is getting sidelined because money speaks loudest. But those heart breaking voices of cancer patients are so compelling, we all get that…
November 18, 2011

F.D.A. Revokes Approval of Avastin for Use as Breast Cancer Drug

The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancer, ruling on an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials. The commissioner, Dr. Margaret A. Hamburg, said that clinical trials had shown that the drug was not helping breast cancer
patients to live longer or to meaningfully control their tumors, but did expose them to potentially serious side effects like severe high blood pressure and hemorrhaging.

“Sometimes, despite the hopes of investigators, patients, industry and even the F.D.A. itself, the results of rigorous testing can be disappointing,” Dr. Hamburg told reporters Friday. “This is the case with Avastin when used for the treatment of metastatic breast cancer.

Avastin will remain on the market as a treatment for other types of cancers, so doctors can use it off-label for breast cancer. But insurers might no longer pay for the drug, which would put it out of reach of many women because it costs about 88,000 a year…

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