The FDA, Avastin, and Rationing

by Benjamin Domenech on 2:32 pm December 16, 2010

Ignoring the calls from breast cancer groups and from editorial boards like The Examiner’s, the Food and Drug Administration (FDA) announced today that they will not approve of the use of the drug Avastin in the treatment of breast cancer.

This story begain in the wake of a surprise ruling in June by the FDA’s Oncologic Drugs Advisory Committee (ODAC) that the drug’s benefit was not sufficiently significant. But in talking to leaders within this space today, there’s little question the FDA’s decision had less to do with clinical outcomes and a lot more to do with cost.

According to Sally Pipes, president of the Pacific Research Institute, the FDA’s decision is not one based on the best outcome for patients, but on the expense of Avastin, which can run as high as $90,000 per year for a single patient.

“The FDA claims its decision had nothing to do with Avastin’s cost and was based solely on the drug’s medical effectiveness,” Pipes told me today. “This isn’t believable. Every year about 40,000 American women die from breast cancer. Avastin is the last hope for many not to meet that fate. While the drug is costly, it often provides immense benefits to patients.”

Avastin works by cutting off blood flow to tumors, and has been used by thousands of women to treat late-stage breast cancer. Pipes points out clinical studies have shown improved survival rates for women who use the drug.

“By restricting blood flow to tumors, the medicine can decelerate cancer growth. In one clinical trial, 52 percent of women saw their tumors stop expanding or spreading. Some have gained years of extended life. Most major cancer groups think that’s enough. Susan G. Komen and the Ovarian Cancer National Alliance urged the FDA to maintain approval of the drug, arguing that treatment choices should be left to patients and doctors—not a government agency.”

I also contacted Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner of the FDA, who said the decision will be magnified as insurers take cues from the FDA.

“This decision will deny too many women the option to have their disease treated with a proven and effective therapy,” Pitts said. “Minus an FDA-approved indication, Avastin may still be prescribed by a physician—but it may very well not be reimbursed by a patient’s insurance. This is a bad day for the public health.”

According to Pipes, this may just be the beginning of rationing based on cost, thanks in part to President Obama’s health law.

“The Obama administration hasn’t been shy about expressing its affections for the practice,” Pipes told me. “None other than the head of the Centers for Medicare and Medicaid Services, Dr. Donald Berwick, has said that ‘it’s not a question of whether we will ration health care,’ but ‘whether we will ration with our eyes open.’ Government drug rationing isn’t going to stop at Avastin.”

If this is what we can expect as an inevitable consequence of Obamacare–something many observers warned of in advance of the legislation’s passage–we can expect Avastin to indeed be the first of many.

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