Avastin & FDA Were Both On Trial: Dan Explains

Avastin & FDA Were Both On Trial: Dan Explains

June 30th, 2011 // 1:43 pm @

After months of controversy, an FDA advisory panel yesterday voted unanimously to uphold an earlier agency decision to yank the breast cancer indication for Avastin, a widely used sold by Roche and its Genentech unit (see this). The run-up to the two-day meeting was highly contentious as the drugmaker accused the FDA panel of bias, there were behind-the-scenes debates over potential conflicts of interest among expert speakers, and patients and their families organized protests – online and in person. Clearly, more was at stake than the fate of a best-selling med, which remains available for treating other cancers.

The hearing was also a referendum of sorts on the veracity of the FDA accelerated approval program and, by extension, the agency itself. Daniel Carpenter, the Allie S. Freed professor of government at Harvard University and author of “Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA,” comments:

Q: This was an extraordinary meeting. What was at stake here for the FDA?
Carpenter: There were several distinctive features to this meeting. First, it comes at an incredibly polarized time in our national politics, where every conceivable issue is getting mapped onto the left-right battles in Washington. With the debate over health care reform, the scientific debate over Avastin has been imbued with the ideological overtones of a debate over rationing and the role of regulation in American society.

Second, the shift in clinical evidence on Avastin – initially, there was a promising set of results in E2100 (a clinical trial) and then a progressively weaker set of results in CONCORD (another clinical trial), including poor safety signals – put the FDA in a more difficult position than it has ever been with an accelerated approval. More than any case before it, Avastin for breast cancer combines a variable evidence base with a disease of almost unparalleled cultural and social proportions, with a large-scale market drug. It was one of the few blockbusters to emerge from the biotech industry.

Third, the company and some patient advocates were much more aggressive in contesting the FDA’s recommendation. You could see this in Genentech’s brief, which advanced some pretty radical arguments about the kind of values that should apply in these situations. You could also see the hostility of some of the patient advocates, such as when one witness told the committee members that they would be individually responsible for their votes and for the fates of the women affected.

This meeting exposed a deep division in the advocacy community for breast cancer patients. There were individual patients and their family members who spoke up for keeping the drug’s indication. Yet the major breast cancer organizations came out in favor of removing the indication. It isn’t the first time that patient representatives have split, but it’s perhaps the most vocal one.


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