Following up on our previous post, the FDA panel reviewing the classification of devices used in electroshock therapy (also known as electroconvulsive therapy, or ECT) recommended that the devices remain in Class III and undergo the strict premarket approval testing that is required by that designation.
After a two-day meeting to review the treatment, which, according to the above-linked account in The Washington Post, was filled with the kind of emotional testimony one would expect of such a historically controversial topic, the expert panel decided that the devices need to undergo clinical testing. As the story notes, FDA is not bound by the panel's recommendations, but tends to follow the advice of expert panels.
Dr. Peter Breggin, a psychiatrist who has come out strongly against ECT, expressed approval of the panel's recommendation in a blog entry on the Huffington Post, though he was not without concern regarding a possible loophole. According to Breggin, the recommendation allows for ECT devices to treated as if they are in Class II when used to treat catatonia. Breggin believes that if that aspect of the recommendation is implemented by FDA, "we will see more and more people diagnosed with this disorder." As he writes, "It's a very obscure disorder, but it will become a widespread disorder in order to justify shock treatment."
It will be interesting to see how FDA decides to ultimately classify these devices, and how that will impact psychiatric treatment in this country.
-- Thomas Blair