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FDA Bans 'Aversive' Shock Treatment

— Move comes 6 years after advisory panel urged end to controversial therapy

MedpageToday
A circle slash over an illustration of a person being electrocuted

WASHINGTON -- Devices that deliver electric shocks to individuals engaging in self-injuring or aggressive behaviors will soon be banned in the U.S., .

Only one clinic in the nation is believed to use this form of "aversive therapy," the (JRC) in Canton, Massachusetts, where the FDA said it believes some 45 to 50 people "are currently being exposed" to the treatment. The center was founded in 1971 and claims to provide "very effective education and treatment to both emotionally disturbed students with conduct, behavior, emotional, and/or psychiatric problems, as well as those with intellectual disabilities or on the autism spectrum."

However, the treatment has been controversial, to say the least. A movement to ban the therapy got a boost in 2012 when a Boston TV station aired a video that appeared to at JRC.

In 2014, the FDA convened an advisory committee meeting to consider whether to increase regulation on the devices used at the JRC or ban them entirely. No formal vote was taken, but the discussion indicated that most panel members wanted a full ban. Some said the treatment could be helpful in certain cases, but there was general agreement that the risks outweighed the benefits.

Why it took 6 years for the FDA to come to a final conclusion after that meeting wasn't clear. The agency proposed to ban the devices in early 2016, drawing some 1,500 comments, with an "overwhelming majority" supporting the ban. Nearly 4 years then elapsed before FDA issued the Wednesday with only "minor changes" from the 2016 draft.

Notably, the ban does not apply to electrical stimulation devices used for other "aversive" therapies, such as those approved for smoking cessation. Non-aversive electrical stimulators, such as for cranial electrotherapy, are also unaffected by the ban.

Only two other medical devices have been formally banned in the past 40 years: and .