We had previously posted about how an advisory committee to the FDA made the device "approvable" even though the the only relevant randomized controlled trial (RCT) found no significant improvement in patients in whom the device was implanted and turned on compared to patients in whom it was implanted but not turned on. The panel did hear some emotional testimonials on behalf of the device. Dissenters on the advisory committee at the time thought the decision was "nuts."
The Senate Committee found that Dr Daniel G Schultz, director of the FDA Center for Devices and Radiological Health, approved the device despite objections from staff scientists. The Times reported the devices' adverse effects include "voice alteration, increased cough, shortness of breath, neck pain and difficulty swallowing. The device has also been linked to rare reports of death, heart problems and vocal cord paralysis."
Emails from FDA internal reviewers of the device stated, "In my opinion, they do not have adequate data, and I don't understand how this can move forward," and "As an MD interested in science, it seems to me that such an approval would be akin to approving an experimental product."
The device is made by Cyberonics Inc. It's CEO, Robert P Cummins, said it is "the only safe and effective treatment opiton ever specifically developed, studied, F.D.A.-approved and fully informatively labeled for the treatment of chronic or recurrent treatment-resistant depression." It is not clear how he justified his statement that the device is "effective," given the results of the RCT.
Cyberonics, based in Houston, appears to have unique political connections. It includes among its directors former Congressman Tony Coehlo, who a Washington Times editorial recently charged was responsible for setting up the system that allowed the Abramoff scandal to occur.
The device reportedly costs $15,000.
It is not clear whose priorities were served by its approval, nor whether science was trumped by emotion, or something else in this case.
Post Title → Why Did the FDA Approve the Vagus Nerve Stimulator for Depression?
