LOS ANGELES - ColoradoDesk -- Amid increasing worries about the potential for addiction with stimulant drugs used to treat Attention Deficit Hyperactivity Disorder (ADHD), the Food and Drug Administration (FDA) has approved the Monarch eTNS System, an electrical stimulation device. This move has been criticized by the mental health industry watchdog Citizens Commission on Human Rights International, which argues that the device will only exacerbate concerns about interfering with children's brain development. A recent Gold Report underscores the controversy, noting that the FDA's approval was based on a limited four-week study involving just 31 children while acknowledging that "...the long-term effects of using" the device are unknown.[1]

"Years ago, the FDA demanded multiple trial results before approving drugs and devices. In recent years, the results of just two trials have generally been enough to satisfy federal regulators." However, with this latest device, "the FDA was happy with just one trial, even though only 31 children were exposed" to it, says The Gold Report.

According to CCHR, when invasive mental health treatment involves children, greater, not fewer clinical trials are needed—and more to the point, it says, it should never be considered in the first place. For electroconvulsive therapy (shock treatment or ECT), there are no clinical trials proving safety and efficacy. The external trigeminal nerve stimulation (eTNS) is not ECT but it is based on the same unproven theory that a non-physical "disorder" can be corrected by an electrical assault on the brain, CCHR adds.

About the size of a cell phone, the eTNS connects to a disposable patch placed on a child's forehead at bedtime. Once turned on, the device sends low stimulating pulses to the trigeminal nerve—the body's thickest nerve—through the patch overnight. The nerve's branches are located close to the skin's surface, just above the eyebrows. It's approved for children ages 7-12. The most common side effects to date are drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue.[2]

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However, CCHR says there's no long-term studies that determine the effects of sending continuous electrical pulses through a child's brain every night.

The industry behind ADHD thrives on the fact that an ADHD diagnosis is based solely on behavioral assessments, with no medical tests to confirm it as a biological condition requiring treatment. No brain scan can determine the existence of ADHD.[3] The psychiatric drugs prescribed to treat it are linked to psychosis, addiction, cardiac arrest and suicide and rake in $20 billion a year in U.S. sales alone.[4]

The eTNS adds to this lucrative market. The pulse emitter alone costs $1,000 and a month's supply of patches costs $100. According to another report, the broader field of wearable technology is forecast to become a huge $291 billion industry by 2030, with healthcare identified as a key market for wearable devices.[5]

The FDA trial summary said that some trial volunteers were invited to continue treatment for an entire year. However, most of them dropped out way before the year was up. In fact, only 18 children were still in the trial at 3 months. By 6 months, 10 had dropped out. At 9 months, there were just 6 children left. At 12 months, only 3 children were left using eTNS. The Gold Report rightly questions: "If eTNS was so effective (not to mention safe), why did 15 out of 18 children stop using it?"

For three children, some of the results had to be omitted "due to excessive movement artifact." "In plain language, what this means is that the kids moved around too much in their sleep, which affected the accuracy of the readings," according to the Gold Report article. There were likely serious adverse events, which were not listed, other than the researchers decided that the device was not responsible for them.[6]

Experts remain highly critical of the ongoing biological model of "mental disorder" that is relied upon. Australian psychiatrist, Niall McLaren, writes, "Psychiatry's headlong rush to be 'more biological than thou' is partly because they have no theory of mind and don't know where to start…."[7] Psychiatrists say "'Mental disorder is brain disorder,' but that is an ideological claim, not a scientific statement."[8]

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Pediatric neurologist, the late Dr. Fred Baughman, author of The ADHD Fraud: How Psychiatry Makes Patients Out of Normal Children said making children "believe they have something wrong with their brains that makes it impossible for them to control themselves without a pill"[9]—or in this case electricity—does them a great disservice. Labeling children's "unwanted" behavior as a brain disease or mental disorder is based on "pure speculation with never a shred of scientific evidence to back it up."[10] Parents, he said, are deceived and misled.

CCHR is unwavering in its stance that all forms of electrical "treatment" for behavioral or learning disabilities must be outlawed, particularly when it comes to vulnerable children. The approval of the latest electrical stimulation device, despite its lack of long-term safety data, is seen as a dangerous precedent that prioritizes profit over the well-being of young patients. CCHR argues that the mental health industry's reliance on invasive interventions like electrical stimulation is not only scientifically unfounded but also ethically indefensible.

CCHR, established in 1969 by the Church of Scientology and renowned psychiatrist Dr. Thomas Szasz, remains committed to exposing and challenging the psychiatric industry's profit-driven practices. Their call to action is clear: children's minds and futures should not be subjected to experimental and invasive treatments in the name of mental health.

Sources:

[1] Y. Rabinovitz, "From Ritalin to brain implants: How the FDA is fast-tracking the devices of the future," The Gold Report, 2 Aug 2024, www.thegoldreport.com/news/from-ritalin-to-brain-implants-how-the-fda-is-fast-tracking-the-devices-of-the-future

[2] neurosigma.com/

[3] www.cchrint.org/2023/04/05/millions-adhd-drugs-without-knowing-side-effects/

[4] www.cchrint.org/2022/10/07/cchr-warns-children-labeled-adhd/

[5] www.thegoldreport.com/news/from-ritalin-to-brain-implants-how-the-fda-is-fast-tracking-the-devices-of-the-future

[6] www.thegoldreport.com/news/from-ritalin-to-brain-implants-how-the-fda-is-fast-tracking-the-devices-of-the-future

[7] "Is There Room for a Human Spirit?" Niall McLaren on Critical Psychiatry, 30 July 2024

[8] "Last Mention of ADHD for the year," Niall McLaren on Critical Psychiatry, 21 Nov. 2023

[9] Fred A. Baughman, Jr., MD, "Treatment of Attention-Deficit Hyperactivity Disorder," Journal of the American Medical Association, Vol. 269, No. 18, 12 May 1993, p. 2369

[10] www.cchrint.org/2022/10/28/cchr-launches-investigation-into-educational-decline/