On Friday, the Food and Drug Administration could doom thousands of breast cancer victims. The FDA will be considering the unprecedented step of retroactively 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 5½ months, but some survive for years. Subsequent clinical studies showed only 36 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 this past 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.” If the FDA follows through on the ODAC’s finding and revokes Avastin’s approval, both the government and private insurers will quickly cease paying for its use on breast cancer sufferers.
The Obama administration wants to ration health care in order to help pay for universal coverage and other Obamacare goodies. Donald Berwick, President Barack Obama’s controversial nominee to head the Centers for Medicare and Medicaid Services, has explicitly endorsed rationing. The CMS is now considering whether to refuse Medicare payments for Provenge — another expensive but effective late-stage prostate cancer treatment.
Government bean counters were never supposed to determine what your treatment options are, and patient advocacy groups are justifiably outraged. If Avastin and other expensive wonder drugs are denied approval because of costs, proponents of government-run health care will have to no choice but to admit “death panels” have gone from rhetoric to reality.