- The Washington Times - Wednesday, December 29, 2010


Breast-cancer patients are charging the Food and Drug Administration (FDA) with moving toward Obamacare-style rationing of useful treatments. Congressional overseers should monitor how the FDA handles an appeal of its ruling to disapprove the drug Avastin in the fight against breast cancer. The sick need every weapon in the struggle against this killer disease.

Avastin is acknowledged as a helpful treatment against colorectal cancer and also is approved for use against some lung, kidney and other cancers. It works by stopping the formation of the blood vessels that feed tumors. With early trials showing Avastin shrank tumors in nearly 50 percent of breast-cancer patients while adding years to the lives of at least some, the FDA originally gave “conditional approval” for its widespread use against breast cancer. Yet, after further tests showed fewer benefits and more potential side effects, the FDA on Dec. 16 voted to withdraw that approval. Doctors still could legally prescribe Avastin for breast cancer, but Medicare and most insurance companies wouldn’t pay for it.

Leading breast-cancer organizations are unhappy with the decision, and nearly 10,000 people have signed a petition against FDA disapproval that calls it a “death sentence” for certain patients. After the ruling, Elizabeth Thompson, president of Susan B. Komen for the Cure, said, “We want to be sure … that their insurers will continue to pay for [Avastin]” for women who are finding the drug helpful. She said she hopes the manufacturer, Genentech/Roche, will “continu[e] making the drug available … and conside an expanded access program.”

Some government critics, such as Sally C. Pipes of the Pacific Research Institute, a conservative think tank, accuse the FDA of illegally taking cost, rather than effectiveness, into account. This would be a step toward rationing of care. They cite a member of the key FDA advisory committee who said, “We aren’t supposed to talk about cost, but that’s another issue.”

Even in Europe, where health care rationing is common, regulators who looked at the same test results didn’t block Avastin. Instead, on the same day as the FDA decision, the European Medicines Agency gave full approval for Avastin’s use under certain circumstances as long as it’s in conjunction with paclitaxel, a chemotherapy drug that produced superior trial results in combination with Avastin.

Genentech/Roche is appealing the FDA’s decision, and the agency is required to consider the appeal. For the vast majority of Americans unqualified to make heads or tails of the science, two common-sensical middle-ground options readily suggest themselves. First, the FDA should not withdraw approval for any breast-cancer patients currently on an Avastin regimen. Second, what’s accepted by European cheapskates with socialist medicine should be available in the still-superior system in the United States, with a caveat. Because of the moderately positive results when used with paclitaxel, Avastin could be approved for use with that chemotherapy with a requirement that patients be told the treatment is still considered experimental and that side-effect warnings be highlighted.

Congress, meanwhile, without overtly politicizing the issue, can demand the records of the FDA’s deliberations. This is needed to ensure that the decision is indeed based on science rather than on cost rationing. If a drug can be a lifeline, it shouldn’t be redlined.

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