Thursday, December 23, 2010

The Death Panel's First Murder

By Peter Ferrara
12.22.10

Last week, the Food and Drug Administration (FDA) revoked its regulatory approval of the drug Avastin to treat late stage, metastatic breast cancer. Each year, the practicing oncologists chosen by 17,500 American women to save them from their life-threatening, heavily progressed cancer prescribe Avastin to treat them.

The FDA explained that it was revoking approval of the drug for that use because it decided that the drug does not provide "a sufficient benefit in slowing disease progression to outweigh the significant risk to patients." Risk? The drug is prescribed for women who are otherwise going to die from cancer unless the drug saves them at least for a time. The far greater risk to these women is from the FDA, not the drug.

As The Wall Street Journal said last Friday in response to the FDA's explanation:

Ponder that [word] "sufficient." The agency is substituting its own judgment about clinical meaningfulness for those of practicing oncologists and terminally ill cancer patients.

That FDA judgment was determined last summer by an internal agency panel of 13 experts, only two of whom were breast cancer oncologists, and none of whom were breast cancer patients. the rest

The Susan G. Komen Foundation opposed the FDA's action. So did the Ovarian Cancer National Alliance, a cancer patients' advocacy organization. The U.S. National Comprehensive Cancer Network, an alliance of 21 top cancer centers that issues medical guidelines based clinical evidence, also supports the continued availability of Avastin for breast cancer. Even in Europe, where health care rationing is prevalent, the European Medicines Agency, which is the FDA for the European Union, ruled last week that Avastin would continue to be available for breast cancer treatment there.

To no avail. In America, the FDA has spoken.

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