The New York Times revealed a report by the Senate Finance Committee, chaired by Sen. Charles Grassley (R-Iowa), on the US Food and Drug Administration's (FDAs) approval of a vagus nerve stimulation device to treat chronic depression.
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.
First of all, the FDA did NOT approve the VNS device. They actually denied its application for approval but "Dr." Daniel Schultz of the CDRH over-ruled them. There was absolutely no evidence that this thing worked but he said that the reason he over-ruled them was that there was really no other options available. You know, I could have thrown a couple of wires together and maybe slapped a battery or two on it if I knew it was that easy. But what they do not tell you about this device is that you can develop a serious psycosis after the implantation. Too bad my sister didn't know that because she now sits in an institution because of a psycosis SHE developed after getting this piece of crap implanted for seizure control. And to make it worse not only did it not control her seizures but they are now GRAND-MAL seizures lasting to almost 20 minutes each. Way to go, Schultz. If he is so sure this thing works then maybe he ought to hook himself up to one. Any idiot who approves a device because he doesn't see a better alternative could definetly use a little brain stimulation.
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