Monday, 15 September 2014

Shock treatment sparks FDA concern

Massachusetts Center is only place in entire country that uses skin shocks as aversive conditioning for aggressive disabled patients

BOSTON
 Self-injury is one of the most difficult behaviours associated with autism and other developmental or intellectual disabilities, and a private facility outside Boston that takes on some of the hardest-to-treat cases is embroiled in a major debate: Should it use electrical skin shocks to try to keep patients in control?

The US Food and Drug Administration (FDA) is considering whether to ban devices used by the Judge Rotenberg Educational Center in Canton, Massachusetts, the only place in the country known to use skin shocks as aversive conditioning for aggressive patients.

It's a rare move by the FDA, following years of complaints from disability rights' groups and even a UN report that the shocks are tantamount to torture.

"We really wanted to take a much more focused and rigorous look at it," FDA Commissioner Margaret Hamburg said. "There's a lot of concern about the downside of this approach and the risk to the patients."

Rotenberg must get a court's approval to begin administering skin shocks to a student. The centre uses a graduated electronic decelerator (GED), attached to arms or legs. If the student starts head-banging, throwing furniture or attacking someone, then a worker can press a button to activate the electrode, delivering a two-second shock to the skin.

Some patients compared the shocks to a hard pinch or bee sting, but some said it was like being stung by a thousand bees.

At an FDA advisory committee hearing this year, most neurology and ethics experts concluded the device poses an unreasonable and substantial risk, while acknowledging that other therapies don't work for everyone.

Rotenberg's executive director, Glenda Crookes, calls the shocks a last resort coupled with positive behaviour programmes, such as rewarding students with time at JRC's Internet cafe or arcade games. The two-second shock is quick but painful enough to jar the patient out of the harmful episode. Of the 235 patients, 55 are being treated with skin shocks. Most are in their 30s; five are between age 17 and 21.

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