WASHINGTON — An FDA panel took a major step Wednesday toward ending use of the best-selling drug Avastin for treating advanced breast cancer in the United States, despite appeals from angry patients and the company making the drug.
A crucial six-member FDA advisory committee unanimously concluded that the drug was harming women more than it was helping them. FDA Commissioner Margaret Hamburg must make a final decision, but agency commissioners usually follow panel recommendations.
The fate of Avastin has been closely watched by patients, oncologists, women's health advocates, health care policymakers, politicians and the pharmaceutical industry. The case has triggered strong reactions from advocates of easier access to new treatments and from critics fearing health care rationing. It is also being seen as one of the most visible medical examples of scientific evidence winning out over public outcry. Ultimately, clinical trials failed to support the drug's early promise for breast cancer treatment.
"I think we all wanted Avastin to succeed, but the reality is that these studies did not bear out that hope," said Natalie Compagni Portis, who represented patients on the panel.
If the FDA revokes Avastin's approval for treatment of breast cancer, the drug would remain available for other cancers, enabling doctors to prescribe it "off-label" for breast cancer patients. But the decision would probably prompt insurers to stop paying for the drug, which costs about $88,000 a year, for breast cancer treatment. Breast cancer patients also would lose eligibility for a program sponsored by the drug maker, Genentech, that caps the annual cost at about $57,000 for women making less than $100,000 a year.
"A terrible tragedy has occurred," said Frank Burroughs of the Abigail Alliance for Better Access to Developmental Drugs, which is among the groups that has been pressing the FDA to maintain Avastin's approval on the grounds that it benefits some patients.
The decision was praised by others, including leading breast cancer groups and experts who said it is important for the agency to base its decisions on scientific evidence, not emotional appeals, when lives are at stake and controlling health care costs is so crucial to the nation's economy.
The FDA is not supposed to acknowledge cost in drug approvals, and officials have stressed that the price was irrelevant. But the fight about Avastin has become entangled in the politically sensitive struggle over medical spending and effectiveness.