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NPR Addresses Upcoming Final Decision On Avastin’s Fate

On the NPR Shots blog, Scott Hensley addresses, “Avastin For Breast Cancer: Hope Versus False Hope.” Excerpt:

Any day now FDA Commissioner Margaret Hamburg is expected to make a final decision on Avastin’s fate. Women who said Avastin helped their breast cancer were out in force at a June hearing of an appeal of FDA’s proposal. At this point, it would be a big surprise if the agency let the approval, granted on an accelerated basis back in 2008, stand.

Now, one of the cancer specialists on the expert panel, which voted unanimously against the Avastin appeal, invokes a hypothetical conversation with a breast cancer patient to explain why.

In a letter published in the latest New England Journal of Medicine, Dr. Mikkael Sekeres, who heads the leukemia service at the Cleveland Clinic, asks what sort of chat he would have with a woman, if he was the doctor leaning toward Avastin for breast cancer.

The bottom line:

“Well, I can offer you a drug that will not make you live longer, won’t make you feel better, and may have life-threatening side effects, but it will keep your cancer from worsening by an average of 1 to 2 months.”

Hensley also addresses the limitations of progression-free survival as an endpoint.

Should this progression-free survival “in the absence of an overall survival advantage or any improvement in quality of life” sway a patient? In the end, Sekeres saw it as a Pyrrhic victory for the drug and decided it wasn’t enough to keep the approval for the drug intact.

His letter concludes:

“We did not make this decision because we do not care about women with breast cancer or because we want to deny them therapy for a terrible disease but because we do not want people to be hurt by a drug that does not work that well. We do not want to provide false hope.”

In another example of political rhetoric on medical evidence (earlier this week we cited Newt Gingrich’s recent example), we reported back in July, 2010 that:

Senator David Vitter of Louisiana says that an FDA advisory committee’s vote to revoke the approval of Roche-Genentech’s Avastin for treating breast cancer is “essentially government rationing.”

Be ready for a firestorm of more of this if and when the FDA rules as expected.

Meantime, more background on the mounting questions about progression-free survival as an endpoint is provided in a New England Journal of Medicine perspective piece.

*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*


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