Depression Devices Await Results of FDA Review Two medical devices aimed at treating depression are up for review this week by the Food and Drug Administration: Transcranial magnetic stimulation and vagus nerve stimulation.
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Depression Devices Await Results of FDA Review

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Depression Devices Await Results of FDA Review

Depression Devices Await Results of FDA Review

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JOANNE SILBERNER: Psychiatrists are divided about these two therapies. Paul Holtzheimer of Emory University has done some research paid for by a TMS manufacturer, and he took part in a government-funded evaluation of a TMS system. In that study, 68 patients sat under the electromagnet. Everyone thought they were getting the treatment, but only half did. For some, the magnetic field was aimed away from the head.

PAUL HOLTZHEIMER: And we showed a 30 percent difference versus a 6 percent difference in the sham group. And that was, we felt, clinically significant. And when we talked to the patients, for those patients that got better, that was a very meaningful change. And that change was in a group of patients that we didn't otherwise expect to get better with just another medication.

SILBERNER: Holtzheimer has also had patients who opted for the other approach being considered by the FDA: vagus nerve stimulation.

HOLTZHEIMER: The small wire attached to the vagus nerve - which is a nerve that comes out of the brainstem - and that electrode around the nerve, delivers stimulation to that nerve, which actually feeds back into the brain. So it's a form of brain stimulation from a remote location from the vagus nerve.

SILBERNER: Washington, D.C. psychiatrist Wayne Blackmon is among a group of psychiatrist who think it should never have been approved.

WAYNE BLACKMON: Although there is some promise that appears to be held out by some studies, the studies backing the use of VNS for severe depression really are inadequate, and it really is not ready for primetime.

SILBERNER: Blackmon doesn't agree with psychiatrists who say that given the real risk of suicide among these patients, the FDA approval was justified.

BLACKMON: VNS is an invasive procedure. So you expose people to risks without any clear-cut benefit beyond placebo.

SILBERNER: Joanne Silberner, NPR News, Washington.

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