Thursday, July 29, 2010

Update on Avastin

Our voices have been heard. Please see our post from earlier this week, On Judah Folkman and Avastin.

Keep it up: never give in- never, ever give in.

July 29, 2010
Alicia Mundy
Wall Street Journal
Senator Slams FDA Advisory Committee’s Avastin Decision

An FDA advisory committee’s vote to revoke the approval of Roche-Genentech’s Avastin for treating breast cancer has drawn rough words from a Republican senator. David Vitter of Louisiana called the decision “essentially government rationing.”

The advisory panel last week voted 12-1 to remove the breast cancer indication from the drug’s label. If the FDA follows the advice of its committee — as it often does — the drug could still be marketed to treat colon, lung and other cancers. New studies presented to the panel showed more side effects among women being treated with Avastin and no overall survival benefit, though they did show women taking the drug had an extra month to 2.9 months of progression-free survival. Advisory panels do not discuss monetary costs of the drugs they consider.

“I shudder at the thought of a government panel assigning a value to a day of a person’s life,” Vitter said in a statement. “It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough.” In a letter to the FDA cancer division leader, Richard Pazdur, Vitter said the committee’s vote appeared to be based on cost effectiveness, not safety issues.
“I am not suggesting that Avastin is a perfect drug, but it has a proven record of effective treatment for some patients when used along with chemotherapy,” he wrote.

Vitter’s mother-in-law died of breast cancer. He has slammed the new U.S. Preventive Services Task Force mammogram guidelines that said yearly tests shouldn’t be automatic for most women under 50. In May he asked the HHS to take the recommendations off the agency’s website.

His Avastin statements, says an aide, were partly prompted by an online petition sponsored, according to the petition’s website, by “women with metastatic breast cancer.” The petition was created using a website called Care2, which offers “do-it-yourself tools for creating and promoting a petition” and says “it’s never been easier to support the causes you care about.” The petition overview says, in part, that “despite the study this drug is a miracle drug for some of (sic) metastatic breast cancer patients especially with a type of breast cancer called triple negative.”

The FDA’s spokeswoman said the agency “will respond to Sen. Vitter in a timely fashion.” A final decision on Avastin’s use in breast cancer is expected this fall.

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