FDA Panel Backs Implant To Counter Depression
Using a technique known as vagus nerve stimulation, the device uses electrodes implanted in the neck to activate brain regions that are believed to regulate mood....
The verdict by the advisory panel came after FDA scientists and some panel members argued the data presented by the manufacturer to show the device works were not convincing.
The agency is not required to follow the guidance of its advisory committee but usually does.
The device has been used in the United States since 1997 to control epileptic seizures. The manufacturer, Cyberonics Inc. of Houston, hopes to expand its market...
even creepier: the reuters article doesn't mention that Cyberonics Inc. is out of Houston. It does, however, say this:
Analysts say the chronic depression market could be as much as 10 times larger than the one for epilepsy.The article also goes on to describe what one FDA member called "annoying side effects:"
In one group of 342 patients studied, 68 percent suffered voice problems while another 29 percent reported coughing. Other reactions included breathing difficulties and heart problems, studies showed.not that pills are any better
FDA staff also told the panel the number of suicides or attempted suicides were "enough to make us concerned." In the same 324 patients, 3.5 percent tried to kill themselves.