FDA Again Pursues Ban on Behavioral Electroshock Device

LOS ANGELES - Amzeal -- The U.S. Food and Drug Administration (FDA) is pushing again to ban the use of electrical stimulation devices (ESD) for behavior modification, determining that they present an "unreasonable and substantial risk of illness or injury."[1] Organizations such as the Citizens Commission on Human Rights International and the United Nations Committee Against Torture have long called for the device and its electroshock practice to be outlawed. The device is solely used on students at a behavioral facility in Canton, Massachusetts.

The FDA previously banned the ESD, but the U.S. Court of Appeals for the District of Columbia Circuit claimed the FDA did not have the authority to ban the practice. In 2023, Congress passed a bill defining the FDA's ability to do this.[2]

A disturbing video of a student, Andre McCollins, being shocked and restrained for seven hours after he refused to take his coat off when instructed to, further ignited the campaign for a ban. He was shocked 31 times while he cried out, "Please stop, please stop." When it was over, McCollins had burn wounds on his arms and legs, reported the disability rights group, ADAPT.[3]

A decade later, UN Special Rapporteur on Torture, Manfred Nowak, said the aversion therapy using this device was torture and sent an urgent appeal to the U.S. government asking it to investigate.[4] Speaking about electroshock treatment in general, Mr. Nowak told CCHR in an interview, "Against-your-will electroshock therapy is in my opinion absolutely prohibited."[5]

In 2012, another Special Rapporteur, Juan Mendez, called for the torturous practice to end, stating: "The passage of electricity through anybody's body is clearly associated with pain and suffering." Mendez, a human rights lawyer during the Argentina "Dirty War" knew only too well how brutal the practice is, himself a victim of police electroshock torture in 1975.[6]

CCHR says that, astonishingly, the FDA originally classified the device, called a Graduated Electronic Decelerator (GED), as an Aversive Conditioning Device because researchers considered that the pain or discomfort it inflicted was an indicator of "effectiveness."[7]

Jan Eastgate, President of CCHR International, said, similar analogies have been used to justify the use of electroconvulsive therapy (ECT) on 100,000 Americans each year, including 5-year-olds.

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The GED uses 9 volts, while an ECT device uses 50 times that—up to 460 volts—but "with ECT, the electrical assault on the body," Eastgate said, "is masked by an anesthetic and muscle relaxant."

A GED-4 emits 45.5 milliamps of electricity—more than 15 times as powerful as stun belts used on incarcerated adults that deliver shocks of 3 to 4 milliamps. Modern electroshock delivers a pulse of current to the brain that is 7.5 times stronger than electrical fences used to deter wild bears.[8]

The GED was developed by a psychologist and founder of the MA facility, who came up with the idea of a punishment regime for children when he read a novel called Walden Two, written by behavioral psychologist B. F. Skinner. The book described a fictitious utopian community in which positive behavior is encouraged and negative behavior is thwarted. The Guardian reported that in 2007, staff "received a call from a senior manager instructing them to administer shocks to two badly behaved students aged 16 and 19. Over the following three hours, one of the boys was given 77 shocks, the other 29. It was later revealed that the phone call had been made not by a manager but by a prankster." The psychologist and head of the facility was forced and "sentenced to five years' probation. Despite his departure, the electric shocks have continued."[9]

Eastgate said that the "use of electroshock for any form of mental health or behavioral therapy, is not only harmful but also a draconian practice—an admission of abject failure that in order to help individuals pain and force must be resorted to."

Since 1976, when the FDA began to regulate medical devices and grandfathered in the ECT device under the Medical Device Amendment Act, CCHR has called for a ban of all electroshock devices. It has successfully obtained legislation banning its use on minors in several U.S. states and Western Australia but continues to demand it be prohibited for all ages.

In 2018, the manufacturer of one electroshock device admitted that ECT can cause brain damage.[10] The FDA has resisted all consumer, family and industry concerns about ECT, allowing the electroshock devices to remain on the market without clinical trials proving their safety and efficacy.

In November 2023, Massachusetts introduced an "An Act regarding the use of aversive therapy," which bans any facility from administering "any procedure which causes obvious signs of physical pain, including, but not limited to, hitting, pinching, and electric shock for the purposes of changing the behavior of the person."[11]

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CCHR wrote to all MA state legislators supporting the bill, reiterating that the FDA had determined that the shock device presented "substantial risks of both physical and psychological injury." They say this also applies to all electroshock treatment devices.

"You're not allowed to use electric shock on prisoners or prisoners of war or convicted terrorists," said Nancy Weiss, a retired professor who has helped organize opposition to the GED practice since 1993. Weiss said a ban on the use of painful electroshocks will be fought by those using the device because "this is how they make their money."[12] The behavioral therapy has a lucrative annual price tag of $200,000 per student.[13]

The U.S. Centers for Medicare and Medicaid (CMS) just offered a higher incentive for psychiatrists to electroshock their patients, increasing the charge per treatment from $385.58 to $660.30.[14] It is already a more than $3 billion-a-year industry.

The FDA has called for public comments on the proposed GED ban until May 28 before issuing a final ruling.[15]

About CCHR: CCHR was founded in 1969 by the Church of Scientology and the late Dr. Thomas Szasz, Professor of Psychiatry. It has helped achieve many laws that protect patients from abuse in the mental health system.

Sources:

[1] www.thesunchronicle.com/news/local_news/fda-moves-again-to-ban-controversial-shock-therapy-devices-used-by-rotenberg-center/article_5b3792d4-3dd0-5745-a92b-332edf69b33f.html

[2] www.bostonglobe.com/2023/01/30/opinion/will-shock-treatment-finally-be-banned/

[3] adapt.org/andre-mccollins-a-judge-rotenberg-torture-center-survivors-story/

[4] abcnews.go.com/Nightline/shock-therapy-massachussetts-school/story?id=11047334

[5] www.prnewswire.com/news-releases/cchr-supports-uns-and-rights-groups-demand-for-urgent-fda-ban-on-skin-electric-shock-devices-300770689.html

[6] www.cchrint.org/2012/06/21/electroshocktorturekid/;

[7] www.federalregister.gov/documents/2020/03/06/2020-04328/banned-devices-electrical-stimulation-devices-for-self-injurious-or-aggressive-behavior; http://www.accessdata.fda.gov/

[8] abcnews.go.com/Nightline/shock-therapy-massachussetts-school/story?id=11047334.; www.huffpost.com/entry/abuse-is-not-the-answer-shut-down-the-judge-rotenberg_b_585be5dde4b068764965bab3.

[9] www.theguardian.com/us-news/2018/nov/16/judge-rotenberg-center-massachusetts-electric-shocks

[10] www.cchrint.org/2023/06/23/consumers-unaware-that-brain-damaging-electroshock-devices-are-not-fda-approved/

[11] malegislature.gov/Bills/193/H180

[12] www.cchrint.org/2023/10/13/ma-bill-ban-electroshock-aversion-therapy-needed-nationwide/ citing www.wcvb.com/article/5-investigates-judge-rotenberg-center-shock-therapy/42526127; autisticadvocacy.org/stoptheshock/; www.nbcnews.com/health/health-care/decades-long-fight-over-electric-shock-treatment-led-fda-ban-n1265546

[13] www.prnewswire.com/news-releases/cchr-supports-uns-and-rights-groups-demand-for-urgent-fda-ban-on-skin-electric-shock-devices-300770689.html citing abcnews.go.com/Nightline/shock-therapy-massachussetts-school/story?id=11047334

[14] bhbusiness.com/2024/03/28/cms-proposed-2-7-rate-hike-for-inpatient-psychiatric-facilities-in-2025/

[15] www.federalregister.gov/documents/2024/03/26/2024-06037/banned-devices-proposal-to-ban-electrical-stimulation-devices-for-self-injurious-or-aggressive