July 29, 2010
WSJ: Senator Slams FDA Advisory Committee's Avastin Decision
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.)
Comments (2)
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
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.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like