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Business More Important Than Health at the FDA

Another great example among a litany of reasons you can't trust officials at the FDA to make the right decisions about your health stems from a story I posted several months ago about a implanted device intended to "treat" depression.

At the time, there was much controversy swirling around the vagus nerve stimulator made by Cyberonics Inc. because some weren't sure it really worked. In fact, according to a report by the Senate Finance Committee, FDA scientists rejected Cyberonics' application unanimously and many times to sell the device as a treatment for depression.

However, the application kept climbing the ladder, thanks to help from Dr. Daniel Schultz, director of the agency's Center for Devices and Radiological Health, and was eventually approved.

What makes this decision more notable than others: Schultz approved the application despite unanimous opposition from FDA administrators and scientists. One sentence from an internal memo sums up why Dr. David Graham was right about the culture at the FDA and he isn't alone in his contempt for it: As an M.D. interested in science, it seems to me that such an approval would be akin to approving an experimental product.

Houston Chronicle February 18, 2006

Spartanburg Herald-Journal February 17, 2006

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