So, the F.D.A. is considering approving this "vagus-nerve stimulator" which actually gets implanted surgically into your upper chest and twiddles nerves in your neck, kind of like a pacemaker for your brain. The evidence for the effectiveness of such a treatment is shoddy at best (no more effective than if the stimulator is implanted but not turned on).
"I've never seen anything quite like this," said Dr. Peter Lurie, deputy director of health research at Public Citizen, a nonprofit group that is a frequent critic of the F.D.A. and the drug and medical-device industries. "What we could be setting ourselves up for is an epidemic of implantation of a device with no proven effectiveness."
My question is: what contitutes a "drug"?
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