By Gary Schwitzer
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.