Not a lot of details have emerged yet about the FDA's decison to revoke approval for Avastin, aside from this brief notice at the Washington Post. Yesterday, the Examiner editorialized against this development:
On Friday, the Food and Drug Administration could doom thousands of breast cancer victims. The FDA will be considering the unprecedented step of revoking approval for Avastin, a drug that represents the last hope for women with late-stage breast cancer. About 17,500 women a year are treated with the drug, which cuts off blood flow to tumors. It does not cure cancer, but it does stop its growth and extend life. Unfortunately, medical miracles don't come cheap — treating a breast cancer patient with Avastin can cost $90,000 a year.In 2008, the FDA's Oncologic Drugs Advisory Committee put Avastin on a track to “accelerated approval” following a clinical study showing 52 percent of the women on the drug showed improvement in “progression-free survival.” On average, Avastin extended the life of patients by 5 1/2 months, but some survive for years. Subsequent clinical studies showed only 36 percent and 31 percent of women had improved survival rates, a far better outcome than the alternative — death. The FDA confirmed last year that Avastin would be approved pending “improvement in progression-free survival and evidence that survival is not impaired.”Doctors and patients were then stunned last summer when the ODAC ruled, by a vote of 12-1, that the drug did not produce clinically meaningful results. Why did the panel deny the obvious evidence of Avastin's effectiveness? One member of the FDA's panel, Jean Grem of the University of Nebraska, said, “We aren't supposed to talk about cost, but that's another issue.”
The drug's cost, not clinical effectiveness, appears to be the issue here. Welcome to the brave new world of health care rationing and death panels.