A Strong Dose of Hubris

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.

The fact that the FDA may cut off patient access to a popular and effective medicine is a sign of things to come. New federal health laws give government dramatically more control over the health sector. When public officials control medical decisions, treatment inevitably becomes centralized and patients wind up with fewer choices and compromised care.

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.

The new Independent Payment Advisory Board (IPAB), established in the United States 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.

Avastin has improved the quality and length of life for thousands of breast cancer patients. In the manufacturer's critical 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 is revisiting that decision, claiming the drug doesn't extend life long enough overall.

Many observers have speculated that the real reason for the FDA's backtracking is price. Avastin is costly - about $88,000 annually, partly because it's very expensive to make.

FDA officials have pointed out that without approval, Avastin could still be prescribed "off-label." But such treatments generally aren't covered by Medicare and private insurers, meaning thousands of women who could benefit from Avastin would be denied access.

The FDA's decision on Avastin could deter future research and development.

Most patients benefit from Avastin. Some benefit greatly. These "super responders" can live for years after being diagnosed with terminal breast cancer. Scientists haven't yet figured out the "biomarkers" that indicate if a patient will be a super responder, but continuing research will help us learn why - and how other patients can be helped.

The FDA has the authority to make decisions based upon safety and effectiveness - not cost. We need a health sector where patients and doctors, not government bureaucrats, decide if the benefit of a treatment is worth its cost, but that is not the path we're on.

Unless the trajectory of current law is reversed, average citizens will find themselves with fewer treatment options as bureaucrats gain more and more control over our medical decisions.