Tuesday, August 29, 2006

"Study" Says FDA Advisors Typically Recommend Approval, Medgadget.com Disapproves of AP's Choices in Science Coverage

Filed under: in the news...

So, without further adieu, we'll give you the flavor of the study they're talking about...

A new study finds that F-D-A advisers rarely say 'no' when deciding whether to recommend a drug or medical device for approval.

The study's author says that raises question about the independence of committees the Food and Drug Administration counts on for safety feedback. And author Diana Zucker -- of the National Research Center for Women and Families -- says the panels "seem more like a rubber stamp."

The report looked at the voting patterns of six randomly selected F-D-A drug advisory committees and five medical device advisory panels from 1998 through 2005. Medical advisory panels recommended approval 76 percent of the time and medical device panels 82 percent of the time.

What's so bad about this? First of all, it takes up the first 4 pages of results in a Google news search for medical device news. Second, it appears that the "study" in question was not published in any peer-reviewed literature, either medical or otherwise. That said, an attempt to find Diane Zucker, author of "the study" (which is all the AP feels the need to identify it by) at the National Research Center for Women and Families website yields no results. So, until someone can point us to the study in question, the title stands as true.

What we really suspect is that of course the FDA (without the silly AP dashes), is going to tend towards approval for medical devices. Devices are usually approved after a lengthy process involving round and round of discussion between an FDA liason and the device's manufacturer. In addition there's really no reason that the majority of devices shouldn't be recommended for approval. That's like saying the majority of high school students graduate, therefore high schools are mostly a rubber stamp institution.

We were hoping to see how the study in question came up with these numbers, but alas...it apparently doesn't exist. Press releases do not equal research...

More from one of the many AP outlets...

UPDATE: We've just determined that the author's name is actually Zuckerman, not "Zucker" as stated in the AP piece. We thought this would yield some results, but we're still 0 for 2 (PubMed, Google Scholar)

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