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CEI Slams FDA Vote on Avastin

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CEI Slams FDA Vote on Avastin

Agency Wrong to Revoke Approval for Breast Cancer Drug

Washington, D.C., June 29, 2011 --- An FDA advisory committee voted today to revoke the approval for breast cancer treatment from the drug Avastin. The agency had previously given Avastin an accelerated approval for use by women fighting late-stage breast cancer. But after studies suggested that the expensive drug benefitted only a small number of patients, the FDA’s Oncology Drugs Advisory Committee made a value judgment that those benefits did not outweigh the drug’s side effects.

Policy analysts at the Competitive Enterprise Institute condemned the advisory committee’s decision to take away one of the few available treatment options for women diagnosed with late-stage, or metastatic breast cancer. Senior Fellow Gregory Conko argued that cancer patients should have the right to decide whether the potential benefits of Avastin are worth the costs.

“Avastin doesn’t work for most breast cancer patients, but it works tremendously well for a small percentage of them,” Conko said. “And while clinical studies show that Avastin doesn’t lengthen survival time for the average breast cancer patient, they do show that it slows tumor growth in patients, doubling progression-free survival even for the average patient.”

Some 40,000 American women die every year from metastatic breast cancer, and a staggering 90% of those diagnosed will not survive the disease. “It’s unfortunate that the FDA may take away a dying patient’s right to make her own choice as to whether the benefits outweigh the risks,” Conko said. FDA Commissioner Margaret Hamburg is expected to make a final decision within the next few weeks.

“Individual patients respond differently to treatments,” said Conko. “The FDA is wrong to make a sweeping decision for all breast cancer patients. They’re effectively keeping a potentially-beneficial drug from terminally-ill patients.”

See also from Gregory Conko:

Op-ed in The Wall Street Journal: "There's No 'Average' Cancer Patient." (June 20, 2011)

Interview on CNBC's Closing Bell: "FDA: Protecting or Overstepping?" (June 28, 2011)