FDA gives conditional approval for Avastin use by breast cancer patients.

I posted about this last week.  Tom Faranda’s Folly: The FDA and cancer drug testing The FDA went against past form and approved the drug –

Breast Cancer Reprieve – WSJ.com

Avastin shouldn’t have been controversial. But an FDA panel ruled that "progression-free survival" was not sufficient, because the agency’s usual acid test for anticancer agents is extending life overall. Such an analysis overlooks the real benefits to women in the months they have left. But as late as last week, it looked as though approval would be delayed or rejected outright.

The "accelerated approval" granted to Avastin is contingent on follow-up trials, and Avastin could be pulled from the market if future research fails to demonstrate that treatment prolongs life. In an interview with us on Monday, oncology drugs chief Richard Padzur said that the FDA was "not demanding" a survival advantage but would consider it a factor. In 2005, the lung cancer drug Iressa was approved and then withdrawn under similar conditions, and the danger is that history will repeat itself.

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The finality of life-and-death decisions makes the approval of such drugs fundamentally a moral issue. Avastin may have slid beneath the wire, but the FDA hasn’t changed its morally indefensible standard, and further drug approvals are still subject to the whims of a bureaucracy that puts statistical models above the choices of dying patients.