Only so much to say about this story.
It’s about Senator David Vitter of Louisana.
He 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.” The WSJ reports:
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.
This is the same Senator who, as the WSJ reminds us, “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.”
Summary:
Scientists find no overall survival benefit and considerable side effects. Senator says the drug has proven track record of effective treatment and calls rejection “sickening…rationing.”
Questions:
Who knows better?
Whose advice to trust?
(There, I’ve blogged about it without injecting my own opinion. Just the facts and some pertinent questions. Talk amongst yourselves. I’m verklempt.)
Opinions on other issues in news, journals, PR, advertising, marketing
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
Comments (2)
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Krista
July 29, 2010 at 4:00 pmWell put, Gary! I’ve been waiting for you to weigh in on the recent FDA advisory news coverage. Regardless of who knows better, we won’t know until September how the FDA will decide on Avastin’s indication and marketing regulations. It’s often reported that the agency doesn’t have to take its advisory board’s vote into consideration, but often, they agree.
I’m sure there is a larger groundswell of voices from the breast cancer community that is also reaching out to the agency about this issue. Cancer approvals are very touchy and their support communities are large and vocal. The FDA knows that, so this decision will not be an easy one to make.
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