FDA Chooses Science over Politics

FDA Chooses Science over Politics

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In the end, science, not politics, prevailed.

The Food and Drug Administration announced Thursday that it plans to withdraw its conditional approval of Genentech’s Avastin for treatment of metastatic breast cancer. The agency had been under intense pressure to grant permanent approval by the company, by some patient advocacy groups and conservatives on Capitol Hill who accused the agency of wanting to “ration” Avastin.

An outside advisory panel that carefully weighed the evidence last July concluded by a 12-1 vote that the drug’s risks, which include serious side effects like internal bleeding, hypertension and vascular perforations, did not outweigh its benefits. Still, Genentech, a unit of Roche, immediately announced yesterday that it would demand another hearing to present new data that might convince the FDA to rethink its decision.

Avastin’s fate has bitterly divided the politically active breast cancer advocacy community. Susan B. Komen for the Cure, the best-known group through its ubiquitous pink-ribbon campaigns, called on insurance companies to continue paying for Avastin while the company conducts new clinical trials that may prove that some women benefit.

But other leading groups like the National Breast Cancer Coalition applauded the decision “for responding to the scientific evidence in the face of significant political and public pressure. Women deserve access to treatments that evidence proves effective.”

Breast Cancer Action, a San Francisco-based advocacy group that often is at odds with the drug industry, highlighted the absence of any benefits from the drug. “The  FDA (should) not approve drugs unless they can be shown to 1) improve overall survival, and/or 2) improve quality of life, and/or 3) cost less than therapies already available. Unfortunately, Avastin fails on all counts,” its statement said.

The FDA clearly fears a backlash from Capitol Hill, where numerous incoming Congressmen ran on platforms attacking government control of health care. Janet Woodcock, the director of the Center for Drug Evaluation and Research at FDA, encouraged the company to conduct new clinical trials that might identify a subset of patients who would benefit from the drug.

But, she said, “none of the four trials (submitted to the agency) showed a survival benefit. It didn’t prolong the life of women with metastatic breast cancer, but it added many serious side effects. That’s sort of the bottom line.”

The original trial that led to the drug’s conditional approval in 2008 had lengthened the length of time before tumors began growing again by five months. At the time, FDA reviewers said that represented a clinical benefit all by itself.

The agency and the company were fairly confident that subsequent trials would confirm that women on the drug would live longer, too. European regulators even gave the drug their full blessing based on that limited evidence.

But when the final results of three larger trials were unveiled late last year, the-time-to-tumor progression had shrunk to a few months or less. More importantly, patients on Avastin did not live any longer than patients who received only chemotherapy.

“I understand these results are disappointing to patients,” said Richard Pazdur, director of the oncologic drugs division at FDA. “But these results are disappointing to the FDA as well. . . Given the number of serious and life threatening side effects, the FDA does not believe there is a favorable risk to benefit profile.”

The drug, which is designed to inhibit the development of blood vessels that feed solid tumors, will remain on the market because it is still approved for lung, kidney, and brain cancers. That means physicians can still prescribe it “off label” for metastatic breast cancer.

So the next front in the Avastin battle will now shift to insurers, including Medicare. Their decision makers will be confronted with the same political pressures – and the same scientific evidence.

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spent 25 years as a foreign correspondent, economics writer and investigative business reporter for the Chicago Tribune and other publications. He is the author of the 2004 book, The $800 Million Pill: The Truth Behind the Cost of New Drugs.