CCHR Condemns FDA's Approval of Electricity-Zapping for 'ADHD' Kids
Mental health watchdog group says electrical "treatment" creates harm
LOS ANGELES, May 1, 2019 /PRNewswire/ -- The Food and Drug Administration (FDA) has approved a device to zap a low-level electrical pulse through the forehead of 7-12 year olds as treatment for Attention Deficit Hyperactivity Disorder (ADHD).[1] But the mental health watchdog, Citizens Commission on Human Rights International (CCHR), says with concern that some psychiatrists have now turned to the FDA to approve a device that "electro-shocks children into docility."
The Monarch eTNS System device costs around $1,000, according to CNN. A patch placed on the forehead uses a 9-volt lithium battery stimulation that creates a "tingling sensation" on the skin between the eyebrows.[2] Jan Eastgate, president of CCHR International says, "With no FDA regulation of psychiatry,[3] this latest practice of zapping a lack of focus could send a wrong message to children. There are psychiatrists that would have them believe that electricity pulsing through their brain while they sleep may help control impulsive behavior." And pediatric neurologist, Dr. Fred Baughman advises parents that there is no proof that "ADHD" behavior has a medical or neurobiological cause.[4]
Recently, the FDA also cleared the usage of electroshock treatment—up to 460 volts of electricity through the brain—for adolescents aged 13 and above with "bipolar" disorder.[5] Yet according to the FD&C Act, the "FDA does not regulate the practice of medicine."[6] As such, "How psychiatrists administer electroshock is a free-for-all license for potentially committing 'mental euthanasia' on anyone they please, including children," Eastgate adds. She called on people to sign CCHR's petition to ban ECT.
Freedom of Information requests CCHR filed in seven U.S. states reveal that psychiatrists are electroshocking kids aged five and younger.[7]
It is common for psychiatrists to say they don't know how ECT "works." In a petition to the FDA Commissioner in 2016, Constitutional attorney, Jonathon Emord noted, "How ECT 'works' and even if it works is highly disputed."[8]
Nor are there clinical studies proving safety and efficacy of ECT devices, Emord says.[9] Likewise, the exact mechanism of the Monarch eTNS System and its long term effects is unknown.[10]
As Forbes pointed out: "There are nearly a dozen neurostimulation devices on the market that claim to improve cognitive function by allowing you to zap your brain with a small electrical current. But just because you can now do this at home doesn't mean it's a good idea. ECT uses electrical current in the range of 600-1000 milliamps.... But you're welcome to zap your brain with a much lighter touch of roughly 1-2 milliamps from the comfort of your couch for anywhere between $99 and $800 dollars. That is, if you don't mind leaving the state of your brain up to chance."[11]
The marketing hype fed parents for this new device is likely to go something like this, Eastgate says: The "zapping" ADHD device is a "noninvasive treatment" and less risky than cocaine-like amphetamines or stimulants currently prescribed to treat "ADHD." This avoids drug side effects like anorexia, poor growth and cardiovascular problems.[12]
Jessica Baron, writing in Forbes noted, "While it's true that the [neurostimulation] electrodes don't penetrate your head, they must produce enough current to reach the brain in order to have any effect at all. Calling these products 'noninvasive' is merely a marketing technique and a misleading one if you ask me."[13]
Researchers do not understand the effects of long-term use of brain stimulation, but say that no brain region exists in isolation. Modulating one brain area may impact on other areas.[14]
Nick J. Davis Ph.D. from the Department of Psychology, Swansea University in the UK, explains that because the brain continues to develop until the age of 20, stimulation in children and adolescents would have a stronger impact.[15]
Davis said there is evidence that enhancing one aspect of cognition may be detrimental to other cognitive faculties. "There is also the worrying possibility that electrical stimulation of the skull may induce or inhibit bone growth, an issue of particular importance in children whose cranial bones are not yet fused. This latter possibility has not been explored in human volunteers in brain stimulation experiments," Davis wrote in 2014.[16]
Davis pleaded for "calm and caution" when opting for stimulation device use in children because serious effects of transcranial stimulation include seizure, mood changes or induction of hyper- or hypo-mania.
It's a "calm and caution" the FDA ignores, Eastgate alleges. The studies of the current ADHD device have been small—about 60 children, using the device or a placebo each night for four weeks only. [17] However, Carlos Peña, Ph.D., Director, Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health, said: "This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients."[18]
Dr. Peña also said that the FDA's Final Order on the ECT device classification provides information on its "safe and effective use" of ECT devices.[19]
Yet he was part of an FDA hearing in 2014 investigating the practice of aversive conditioning electrical devices to modify undesirable behavior.[20] In that case, the FDA recommended the device be banned, saying it subjected residents at the Judge Rotenberg Center in Massachusetts to "an unreasonable and substantial risk to public health."[21] For almost three decades the Center has been zapping its special-needs residents with a custom-designed electric shock machine that delivers charges of up to 41 milliamps—10 times the amperage used in most stun guns—to their legs, arms, hands, feet, fingers or torsos via electrodes on the skin.[22] In 2013, Juan Mendez, the UN's former special rapporteur on torture, concluded that the rights of students "subjected to electric shocks and physical means of restraints have been violated under the UN convention against torture."[23]
CCHR says ongoing dangerous decisions by the FDA warrant a Congressional investigation into children and others potentially being put at substantial health and mental risk.
CCHR is a nonprofit mental health watchdog group dedicated to eliminating abuses committed under the guise of mental health. CCHR works to ensure patient and consumer protections are enacted and upheld as there is rampant abuse in the field of mental health. In this role, CCHR has helped to enact more than 180 laws protecting individuals from abusive or coercive mental health practices since it was formed 50 years ago. As a nonprofit, CCHR relies on memberships and donations to carry out its mission and actions to curb psychotropic drug use in foster care. Click here to support the cause.
Contact: Amber Rauscher, [email protected] or (323) 467-4242
[1] "FDA approves breakthrough medical device to treat ADHD in children," CBS News, 24 Apr. 2019, https://www.cbsnews.com/news/fda-approves-breakthrough-adhd-medical-device-to-treat-children/; "First medical device approved to treat children with ADHD," Philly Voice, 24 Apr. 2019, https://www.phillyvoice.com/first-medical-device-treat-adhd-no-drugs.
[2] https://www.reddit.com/r/tDCS/comments/1kpqpx/trigeminal_nerve_stimulation_tns_shows_promising/.
[3] https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of, Section B, Response 9, "Comments on Reclassifying ECT Based on Safety and Effectiveness."
[4] Dr. Fred Baughman, Jr., "ADHD is Neither a Disease or a Disorder," BMJ, 2008;337:a1239, https://www.bmj.com/rapid-response/2011/11/02/adhd-neither-disease-or-disorder.
[5] https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of, Section B, Response 9, "FDA does not regulate the practice of medicine."
[6] https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of, Section B, Response 9, "Comments on Reclassifying ECT Based on Safety and Effectiveness."
[7] State records CCHR obtained through public records requests from Indiana, Iowa, Kentucky, Maryland, Oregon, Pennsylvania and Utah; https://healthimpactnews.com/2017/psychiatric-association-wants-fda-to-expand-electroshock-used-on-children-and-elderly/.
[8] http://emord.com/blawg/wp-content/uploads/2016/08/1-ECT-Citizen-Petition.pdf, page 30.
[9] Jonathon Emord, "To date, no human clinical trials have been required for a new ECT device to receive marketing clearance from the FDA under section510(k) of the FDCA" and "FDA declined to require manufacturers ever to provide PMA information demonstrating either safety or efficacy of these devices," http://emord.com/blawg/wp-content/uploads/2016/08/1-ECT-Citizen-Petition.pdf, page 4-5.
[10] Op. cit., Philly Voice.
[11] Jessica Baron, "At-Home Brain Stimulation - What Could Possibly Go Wrong?," Forbes, 16 Nov. 2018, https://webcache.googleusercontent.com/search?q=cache:ELNiLuAmUq0J:https://www.forbes.com/sites/jessicabaron/2018/11/16/at-home-brain-stimulation/+&cd=1&hl=en&ct=clnk&gl=us.
[12] Op. cit., CBS News.
[13] Op. cit., Jessica Baron.
[14] Nick J. Davis, "Transcranial stimulation of the developing brain: a plea for extreme caution," Frontiers in Human Neuroscience, 5 Aug. 2014, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4122183/.
[15] Melissa Hogenboom, "Warning over electrical brain stimulation," BBC News, 24 Aug. 2014, https://www.bbc.com/news/health-27343047.
[16] Op. cit., Nick J. Davis.
[17] https://www.inverse.com/article/55140-monarch-etns-fda-approved.
[18] https://www.formularywatch.com/fda-approval/fda-clears-first-non-drug-option-treat-adhd-children.
[19] https://www.fda.gov/news-events/fda-brief/fda-brief-fda-takes-action-ensure-regulation-electroconvulsive-therapy-devices-better-protects, citing: "The reclassified uses for ECT devices into Class II are limited to the treatment of catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients age 13 years."
[22] "'It's torture': critics step up bid to stop US school using electric shocks on children," The Guardian, 16 Nov. 2018, https://www.theguardian.com/us-news/2018/nov/16/judge-rotenberg-center-massachusetts-electric-shocks.
[23] Ibid.
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CCHR Condemns FDA's Approval of Electricity-Zapping for "ADHD" Kids
Mental health watchdog group says electrical "treatment" creates harm
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Sign CCHR's Petition to Ban ECT
Find out more about the dangers of electroshock
SOURCE Citizens Commission on Human Rights
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