The FDA recently came close to taking away hope for thousands of terminally ill women. But at the last minute, the agency announced it was postponing until December whether to revoke approval of Avastin for advanced-stage breast cancer treatment.
Thisis a sign of things to come. New federal health laws give government dramatically more control over the health sector. The 2009 stimulus law created a federal “comparative effectiveness” research office. Similar agencies around the world have denied patients access to cutting-edge treatments in attempts to control costs. In Britain, the National Institute for Health and Clinical Excellence has denied advanced cancer drugs to at least 16,000 patients.
The new Independent Payment Advisory Board (IPAB), established in the health overhaul law, takes another step toward centralized decision making. IPAB is empowered to institute across-the-board reimbursement cuts for Medicare providers, and pressures are growing to grant the agency even greater power.
Avastin is the world’s top-selling cancer medicine. This biological drug slows the progression of cancer by cutting off the tumor’s blood supply, and has been approved to treat colon, breast, lung, brain, and kidney cancers. In the manufacturer’s final trial, patients with advanced breast cancer treated with the drug lived nearly twice as long as those not on it.
The FDA approved Avastin to treat breast cancer in 2008, but it now is revisiting that decision, claiming that the drug doesn’t extend life long enough overall. Some speculate that the real reason is price. Avastin is costly— about $88,000 annually, partly because it’s very expensive to make.
FDA officials say that without approval, Avastin could be prescribed “off-label.” But Medicare and private insurers generally don’t cover such treatments, so thousands of women would be denied access.
Some Avastin “super responders” can live for years after being diagnosed with terminal breast cancer. Scientists haven’t yet figured out the “biomarkers” of these “super responders,” but continuing research will help learn why—and how other patients can be helped. The FDA’s decision could deter research and development.
The FDA should make decisions based upon safety and effectiveness—not cost. We need a health sector where patients and doctors, not bureaucrats, decide if the benefit of a treatment is worth its cost.
Grace-Marie Turner
Alexandria, VA
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