F.D.A. Considers Implant Device for Depression (NY Times, free reg. req’d)

The Food and Drug Administration may soon approve a medical device that would be the first new treatment option for severely depressed patients in a generation, despite the misgivings of many experts who say there is little evidence that it works.

The pacemaker-like device, called a vagus nerve stimulator, is surgically implanted in the upper chest, and its wires are threaded into the neck, where it stimulates a nerve leading to the brain. It has been approved since 1997 for the treatment of some epilepsy patients, and the drug agency has told the manufacturer that it is now “approvable” for severe depression that is resistant to other treatment.

But in the only rigorously controlled trial so far in depressed patients, the stimulator was no more effective than surgery in which it was implanted but not turned on.

While some patients show significantly improved moods after having the $15,000 device implanted, most do not, the study found. And once the device is implanted, it is hard to remove entirely; surgeons say the wire leads are usually left inside the neck.

Proponents say that many severely depressed patients do not respond to antidepressants or electroshock therapy and that those patients are desperate for any treatment to relieve their suffering.

Wow. I’m not sure what to say about this, as I find it fascinating that such treatments are approved for this kind of use. While fairly safe, they are not really all that effective. Makes you wonder what lengths folks will go to relieve their suffering…

Dr. John Grohol is the CEO and founder of Psych Central. He is an author, researcher and expert in mental health online, and has been writing about online behavior, mental health and psychology issues -- as well as the intersection of technology and human behavior -- since 1992. Dr. Grohol sits on the editorial board of the journal Cyberpsychology, Behavior and Social Networking and is a founding board member and treasurer of the Society for Participatory Medicine.

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    Last reviewed: By John M. Grohol, Psy.D. on 26 May 2005
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