Saturday, May 21, 2005

Implant Device for Depression

The New York Times published an article today called "FDA Considers Implant Device for Depression" (reg required). Here's a clip:

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.
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This prompted me to write the following Letter to the Editor:

Dear Editor,

In Benedict Carey's article "FDA Considers Implant Device for Depression", Dr. Harold Sackeim said of those who are severely depressed,"These people have no other options, so we need to consider anything that shows potential to help".

Those words sound frighteningly similar to the phrase "anything that holds out hope should be tried". Last time psychiatry fell into that thinking 50,000 Americans, one of them my own grandmother, were lobotomized. The effects were devastating for the patients and their families who were left to deal with the aftermath. Psychiatry simply moved on to the next vogue, and profitable, "treatment".

Sincerely,

Christine Johnson

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