Monday, May 23, 2005

F.D.A. Considers Implant Device for Depression

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.
"These people have no other options, so we need to consider anything that shows potential to help," said Dr. Harold A. Sackeim, chief of biological psychiatry at the New York State Psychiatric Institute, who consults for Cyberonics Inc., the Houston company that makes the stimulator.
But Dr. Michael Thase, a psychiatrist at the University of Pittsburgh who consults for the company, said there was "simply not a good enough basis in evidence" for approval. While the device is promising, Dr. Thase said, "the shaky state of the evidence means we have to be very cautious with this and prepare for the possibility that the hoped-for benefit isn't there."


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