Breast Cancer Awareness month, which wound down last month, appeared to get plenty of government support.
Health and Human Services Secretary Kathleen Sebelius held a teleconference in recognition of national mammography day. She and Thomas Frieden, director of the Centers for Disease Control, touted a new program to promote awareness. The Vice President’s wife, Dr. Jill Biden, spoke about the importance of early detection, and Barack Obama himself, in a Presidential proclamation, said that “we reaffirm our commitment to supporting breast cancer research.”
It’s a sad irony, then, that at the same moment our leaders say they’re working to fight breast cancer — which kills some 40,000 American women a year — the Food and Drug Administration is on the verge of revoking approval of an important treatment.
Once the FDA has authorized a medicine, it seldom withdraws its seal of approval. It approved Avastin to treat breast cancer in 2008. But in July, an FDA advisory panel recommended revoking that authorization.
The FDA won’t make a final decision until December, but only in rare cases does it reject the recommendations of its advisory panel. More than likely, breast cancer sufferers being treated with Avastin, which has been prescribed to some 17,500 patients, will find their lifeline cut off.
The panel concluded that Avastin, which will remain approved to treat other cancers, wasn’t showing enough promise against breast cancer. But we know that in the manufacturer’s crucial phase III trial, nearly 50 percent of patients receiving the medicine saw their tumors shrink — and that Avastin has added years of life for some patients.
Two major cancer-fighting organizations think that’s enough. Susan G. Komen for the Cure and the Ovarian Cancer National Alliance sent a letter to the FDA, urging the agency not to revoke approval. They argued that choosing a treatment should be left up to patients and doctors — not taken off the table by a government agency. Not only would revoking approval hurt current patients, the letter pointed out, it would also send a chilling message to the drug makers who develop new treatments.
So what’s really going on here?
If the FDA pulls its approval, doctors could still prescribe Avastin to breast cancer patients “off label.” But Avastin is expensive, running almost $90,000 a year, and we can expect private insurers and the government programs Medicare, and Medicaid, to stop paying for the drug.
Officially, the FDA advisory panel claims that price wasn’t a factor, and it’s not meant to be. But a member of the panel, Jean Grem, was quoted in the Wall Street Journal saying, “We aren’t supposed to talk about cost.”
The realities of this year’s health care bill make it hard not to think about price. Under Obama’s reforms, Medicare is cutting its budget, Medicaid is being expanded, and private insurers have much less leeway in deciding who and what to cover.
Being required to pay for pricey cancer drugs could put them all in dire straits. If the FDA withholds approval, it helps keep them afloat. This is just one example of government rationing that reform opponents feared would happen.
That it’s happening is no secret: The new head of the Centers for Medicare & Medicaid Services, Dr. Donald Berwick, has spoken in favor of rationing. He said “it’s not a question of whether we will ration health care,” but that “it is whether we will ration with our eyes open.”
Payments for cancer treatments, meanwhile, have already been shrinking, and under the CMS’ new proposed fee schedule, will fall even more. Since 2004, Medicare payments for chemotherapy have been cut by about 35%.
Our officials can’t have it both ways. It’s easy for HHS, the CDC, and the President to say that they’re going to fight cancer. But the fact is Obama’s health care reform bill is already doing just the reverse.
Adding 34 million more people to the insurance rolls, specifically 18 million to Medicaid and others who will receive subsidies from the federal government to purchase insurance in the state-run exchanges, while at the same time cutting budgets, will inevitably squeeze out more treatments. Avastin for breast cancer is just the first to go.