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

The prescription drug Avastin, produced by Genentech, has been pulled from the market by the Food and Drug Administration. But only for treatment of breast cancer. the drug will still be available for treatment of other medical problems. the FDA has essentially said the drug’s side effects, including death, outweigh any potential benefits. This story was reported in detail in the New York Times. Here are excerpts:

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.

Federal officials said on Friday that Medicare would still provide coverage for the drug’s use in breast cancer, though the government plans to “monitor the issue and evaluate coverage options.”

Medicare is obligated to pay for off-label use of cancer drugs that are listed in certain references, like the one published by the National Comprehensive Cancer Network, an organization of major cancer hospitals. In July a committee of breast cancer specialists from those centers reaffirmed that Avastin should remain listed as “an appropriate therapeutic option for metastatic breast cancer.” A third of the committee members had financial ties to Genentech, according to Dr. Hamburg’s memorandum.

Many breast cancer specialists say that Avastin does appear to work very well for some patients, and some advocates have said the drug should be left on the market for the sake of those patients. But Dr. Hamburg said there was no way to determine in advance who those patients were, so many women would use the drug. “The evidence does not justify broad exposure to the risks of this drug,” she wrote.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

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The title of this blog reflects my attitude toward those government agencies and insurance companies that routinely mistreat injured or disabled people. As a Dallas, Texas lawyer, I've spent more than 45 years trying to help those poor folk, and I have been frustrated daily by the actions of the people on the other side of their claims. (Sorry if I offended you...)

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