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FDA Panel Recommends Testing of Electroshock Devices
Date:1/31/2011

SATURDAY, Jan. 29 (HealthDay News) -- An advisory panel to the U.S. Food and Drug Administration decided on Friday that electroconvulsive (also known as "electroshock") devices should be subject to the same tough testing as other medical devices entering the market.

The much-awaited decision is the latest chapter in the decades-old controversy surrounding the psychiatric treatment, which some patients see as doing great harm, even as others hail it as a valuable treatment.

The FDA doesn't have to follow its advisory committees' recommendations but usually does.

The panel's decision was endorsed by those worried about the potential harms of electroconvulsive therapy (ECT).

"It was the best possible outcome we could have gotten," Austin, Texas-based clinical psychologist John Breeding told the Washington Post. Breeding, a longtime opponent of the procedure, testified before the panel at a two-day meeting that began Thursday in Gaithersburg, Md.

The panel heard testimony from both ECT patients and FDA researchers who pored over hundreds of studies into the therapy. According to the Post, the FDA staffers said that current research suggests ECT does outperform placebo or "sham" ECT and after a month it may also outperform antidepressants.

But on the other hand, the FDA review of data also found that the treatment was tied to "impairment in orientation, memory and global cognitive function immediately after ECT and up to six months," the Post reported, although many aspects of memory do seem to return to normal after another six months.

Supporters of electroshock had lobbied for the devices to be downgraded to a medium-risk classification, which would put the devices in the same category as syringes and allow them to be sold without new testing.

The advisory panel did not support such a move, and their recommendation might push the FDA to require manufacturers to demonstrat
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