FDA Avastin Hearing — live blogging

June 28, 2011
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The two-day hearing on Genentech’s appeal of the Food and Drug Administration’s decision to remove the breast cancer indication from Avastin’s label began with two hours of emotional testimony from breast cancer patients, their physicians and advocacy groups, most (but not all) of whom back continued approval of the drug. Anecdotal evidence isn’t science, and most of the women who testified self-identified themselves as super-responders who were different from most women with advanced metastatic breast cancer on the drug.

The two-day hearing on Genentech’s appeal of the Food and Drug Administration’s decision to remove the breast cancer indication from Avastin’s label began with two hours of emotional testimony from breast cancer patients, their physicians and advocacy groups, most (but not all) of whom back continued approval of the drug. Anecdotal evidence isn’t science, and most of the women who testified self-identified themselves as super-responders who were different from most women with advanced metastatic breast cancer on the drug. What can never be known is whether these particular women would have responded just as well in the absence of Avastin. What is known is that the aggregate data in the clinical trials that will be discussed later in the day does not show any increased survival benefit from use of the $8,000-a-month drug.

Listening to the poignant stories of individuals continuing to care for children, visit grandchildren, and climb mountains, a common thread emerged from their stories: please, they asked, don’t remove the indication from the label because then the insurance company won’t pay for it. That’s why the testimony of Bob Erwin, president of the Marti Nelson Cancer Foundation, struck me as the most relevant comment during the two-hour session. “Why,” he asked, “is a discussion between price and product performance off limits to the FDA?”

 

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