“If psychiatry continues to define failure as a patient flaw, not a treatment flaw, more lives will be harmed. Legislators must intervene and demand the FDA process that has overseen the clearance and approval of ECT and brain stimulation devices to be overhauled.”

Exposing Dangerous Neurological Interventions Being Pushed on Veterans, Children, and the Vulnerable

By Jan Eastgate
President CCHR International
April 11, 2025

• Psychiatry is redefining treatment failure as “treatment resistance”—shifting blame onto patients rather than acknowledging the failure of psychiatric drugs and other treatments and using this label to justify increasingly invasive brain interventions.

• A growing $51 billion global brain device industry is exploiting vulnerable populations—veterans, children, and vulnerable, desperate over treatment failures—with FDA-cleared devices like ECT, DBS, VNS, and TMS, often approved without rigorous proof of safety or efficacy.

• Psychiatrist Admits it’s Mind-Control: Psychiatrists admit the precise physiological mechanisms of these devices in treating “mental disorders” are not known. A professor of psychiatry admits: “This really is a kind of mind control.”

• Legislative action is urgently needed to prohibit the use of unproven brain devices based on flawed diagnoses, ban electroshock and its use as a predicate device, and demand patient-centered, non-invasive alternatives that uphold human dignity and accountability.

When psychiatric drugs and therapy don’t work, psychiatry rarely blames the treatment—it blames the patient. ‘Treatment-resistant’ is the label stamped on anyone who doesn’t respond to standard psychiatric interventions. It’s not a diagnosis—it’s a deflection. And it’s being used to justify aggressive, invasive brain procedures like Electroconvulsive Therapy (ECT), Deep Brain Stimulation (DBS), Vagus Nerve Stimulation (VNS), and Transcranial Magnetic Stimulation (TMS).

These devices were Food and Drug Administration (FDA) “cleared” or given “Humanitarian Device Exemptions” (HDEs) without requiring rigorous proof of safety or effectiveness for treating certain mental disorders. Many are approved based on ECT as the predicate device—an intervention long associated with brain damage, memory loss, and even death.[1]

Even leading psychiatrists admit: “The precise physiological mechanisms of DBS are not yet fully understood.”[2] Or put bluntly by Dr. Steven Rasmussen, professor of psychiatry, at Alpert Medical School, “This really is a kind of mind control.”[3]

Rather than acknowledging failure, psychiatry moves the goalposts: it’s not that the treatment didn’t work—it’s that the patient is the problem. This dangerous logic leads to irreversible procedures administered to children, veterans, and vulnerable adults in the name of hope.

The truth? These treatments aren’t based on solid science. They’re based on profit—and patients are paying the price.

The Device Industry’s Psychiatric Gold Rush

“Treatment-resistant” is a smokescreen—one that fuels a growing neurostimulation industry projected to reach $51 billion globally by 2030.[4] Statistics are bandied about to justify it:

• 48% of patients with depression are labeled “treatment-resistant.”[5]

• 30% of schizophrenia patients are said not to respond to at least two antipsychotics.[6]

• Up to 60% of psychiatric patients may be deemed “treatment-resistant.”[7]

• 25% of patients develop tolerance to stimulants within weeks, leading to dependence.[8]

This isn’t rare. It’s systemic failure—rebranded to justify more aggressive interventions.

Electroshock, Repackaged

ECT delivers up to 460 volts to the brain, triggering a grand mal seizure.[9] Today’s version is no safer—voltage is higher than in the past when broken bones were common due to convulsions.[10]

• FDA Device Clearance: It was grandfathered into the market in 1976, with no required clinical trials.[11] In 2018, the FDA lowered the risk class for some uses and permitted its use on children as young as 13, despite 2,400 public submissions objecting to this.

• Global Warnings: The World Health Organization (WHO) and the United Nations (UN) warn that ECT on minors and non-consenting individuals constitutes torture.[12] Yet, ECT is given involuntarily to patients and children in the U.S.

• Risks: Neurologists equate ECT’s effects to traumatic brain injury, with victims suffering permanent cognitive impairment.[13] Courts have ruled manufacturers failed to warn patients about brain damage.[14] But ECT continues—with the FDA even removing “brain damage” from its official risk list.[15] Patients who received ECT may be 44 times more likely to die by suicide than the general population.[16] 1 in 15 ECT patients face life-threatening heart problems.[17]

• Costs: ECT is a $3–5.4 billion industry.[18] Medicaid spent $9 million in 2023 on ECT patients in 27 states.[19] Veteran Affairs (VA) and/or the Department of Defense (DoD programs) have electroshocked veterans and military families, including children under age five.[20]

Attorney Jonathan W. Emord, in challenging the FDA’s refusal to ban ECT, stated: “After rejecting lobotomies in light of their horrific consequences, the FDA still clings to shock treatment, despite an equally long and tragic history.” It refused to demand proof of ECT safety and efficacy, “bending instead to industry by allowing marketing of the devices without pre-market approval.” He added, “All patients who receive ECT suffer memory loss and cognitive impairment with many, if not most, experiencing severe memory loss, forgetting much of their lives before treatment (including who their children are, their spouse, and learned skills such as how to play the piano).”[21]

A 2020 peer-reviewed study concluded ECT has “no place in evidence-based medicine.”[22]

Electronic Psychiatry—Dangerously Experimental

Deep Brain Stimulation (DBS)

• Procedure: Surgeons implant electrodes deep in the brain, connected to a chest device that emits electrical pulses.[23]

• FDA: In 2009, Medtronic received an HDE (Humanitarian Device Exemption) for OCD despite lacking safety and efficacy proof.[24] A 2025 device for depression received “Breakthrough” status, although similar past trials were shut down for poor results.[25]

• Risks: Stroke, hemorrhage, apathy, hallucinations, sexual dysfunction [could not find this].[26] Suicidal tendencies and attempts.[27]

• Costs: It has been estimated to be up to $100,000 for the surgery (including the implanted device, hospital fees and anesthesia).[28]

Patients Jim and Rich had DBS implants in a failed trial. Both experienced severe cognitive disruption and emotional damage. Jim, a former attorney, who had already endured 26 rounds of electroshock that left him with significant memory loss—including of his own wedding—applied for disabilities after he wanted the device out. Rich spiraled into self-harm and apathy before having it removed.[29]

Vagus Nerve Stimulation (VNS)

• Procedure: Electrodes are wrapped around the vagus nerve near the heart and lungs to deliver electrical pulses to the brain.[30]

• FDA: Originally developed by Cyberonics, it was approved in 2005 for “treatment-resistant depression,” despite the criticism of weak scientific backing.[31]

• Risks: Hoarseness, nerve damage, infection, breathing problems.[32] The FDA’s database has received 10,000+ reports of device malfunctions, injuries, or deaths.[33]

• Costs: Approximately $30,000+.[34] By 2006, over 550 Americans treated for depression at a total cost nearing $14 million.[35]

Transcranial Magnetic Stimulation (TMS)

• Procedure: A coil delivers magnetic pulses to the brain over 30+ sessions in six weeks.[36]

• FDA: Cleared in 2008 for depression unresponsive to one antidepressant. In 2024, approved for adolescents as young as 15. The NeuroStar device is made by Neuronetics.

• Risks: “Brain fog,” mood alterations, emotional instability and seizures.[37] One patient reported TMS “destroyed my life”—yet was told there were “no major side effects’: “This treatment should not be on the market. It gave me false hope. Please investigate.”[38]

• Costs: Average cost for a single TMS is from $100 to $300. Could cost upwards of $15,000.[39]

There are more of these devices such as Repetitive Transcranial Magnetic Stimulation (rTMS), approved for treatment-resistant depression; Intermittent theta-burst stimulation (iTBS) that are bursts (30 pulses), repeated every 10 seconds, daily stimulation (600 pulses) for six weeks; and Continuous Theta-Burst Stimulation (cTBS): 20-40 second train of uninterrupted bursts (about 300 to 600 pulses.[40]

No Medical Proof = No Medical Justification

Despite the use of cutting-edge technology, no psychiatric disorder has been proven to be caused by a brain defect. There are no blood tests. No biomarkers. No neuroimaging.[41]

“There is no chemical imbalance to begin with…. When treating mental illness with drugs, we create a chemical imbalance.” – Professor David Healy, psychiatrist [42]

“Unlike our definitions of ischemic heart disease, lymphoma, or AIDS, the DSM diagnoses are based on a consensus about clusters of clinical symptoms, not any objective laboratory measure.” – Dr. Thomas Insel, psychiatrist, former director, National Institute for Mental Health [43]

“There are no objective tests in psychiatry—no X-ray, laboratory, or exam that says definitively that someone does or does not have a mental disorder.” – Professor. Allen Frances, former chair of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) Task Force [44]

DSM diagnoses are not grounded in biology but professional “consensus.” As researchers Professors Herb Kutchins and Stuart Kirk put it: “Agreements do not establish truth.”[45]

It’s the Treatments That Are Resistant—There is No Accountability

This is an abusive system stacked against patients: Imagine a mechanic who, after failing to fix your car with multiple wrong parts, for which you’ve paid tens of thousands of dollars, blames the car for being ‘repair-resistant.’ In any other field, such a diagnosis would be absurd. Yet in psychiatry, it is normalized. The implication is not that the treatments were flawed or ineffective, but that the patient is somehow uniquely defective for not responding.

The industry uses ‘treatment resistance’ to push patients into increasingly aggressive, expensive, and irreversible interventions. But what’s really resistant is the system—resistant to transparency, science, and admitting when something doesn’t work.

Legislative Action Needed

1. Prohibit the use of “treatment-resistant” as justification for brain intervention and stimulation devices for treatment of mental disorders in the absence of objective, biological testing confirming such disorders.
2. Ban the use of all ECT and its use as a predicate device for other brain stimulation devices.
3. Support humane, non-invasive, non-drug solutions, non- brain stimulation that respect patient dignity and avoid neurological harm.

If psychiatry continues to define failure as a patient flaw, not a treatment flaw, more lives will be harmed. Legislators must intervene and demand the FDA process that has overseen the clearance and approval of ECT and brain stimulation devices to be overhauled.

References:

[1] U.S. Food and Drug Administration, Final Rule on Electroconvulsive Therapy Devices, Federal Register, Vol. 83, No. 246, Dec. 26, 2018, https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of; World Health Organization, OHCHR, “Guidance on Mental Health, Human Rights and Legislation,” 9 Oct. 2023, p. 58, https://www.ohchr.org/sites/default/files/documents/publications/WHO-OHCHR-Mental-health-human-rights-and-legislation_web.pdf

[2] Lavanya P. Sharma, et. al, “Deep brain stimulation – A primer for psychiatrists,” Asian Journal of Psychiatry, Vol. 104, Feb. 2025, https://www.sciencedirect.com/science/article/abs/pii/S1876201824004477

[3] Lauren Slater, “Who Holds the Clicker?” Mother Jones, Nov. 2005, https://motherjones.com/politics/2005/11/who-holds-clicker

[4] https://www.globenewswire.com/news-release/2022/12/21/2577595/0/en/Neurostimulation-Devices-Market-Forecast-Showing-51-Billion-Opportunity-Current-Perspectives-and-Industry-Outlook.html

[5] “Nearly half of depression diagnoses could be considered treatment-resistant,” University of Birmingham,20 Mar. 2025, https://www.birmingham.ac.uk/news/2025/nearly-half-of-depression-diagnoses-could-be-considered-treatment-resistant

[6] https://pmc.ncbi.nlm.nih.gov/articles/PMC6478792/

[7] “Treatment resistance in psychiatry: state of the art and new directions,” Mol Psychiatry, July 2021, https://pmc.ncbi.nlm.nih.gov/articles/PMC8960394/#fn-group1

[8] https://pmc.ncbi.nlm.nih.gov/articles/PMC9332474/

[9] https://www.cchrint.org/electroshock/ citing https://archive.org/details/hiddenside_psychiatry/mode/2up

[10] https://www.cchrint.org/electroshock/; Douglas G. Cameron, “ECT: Sham Statistics, the Myth of Convulsive Therapy, and the Case for Consumer Misinformation,” The Journal of Mind and Behavior, Vol 15, No 1 and 2, Winter and Spring 1994, pp 177-198, http://www.ectresources.org/ECTscience/Cameron__DG___1994_critique_of_ECT.pdf.

[11] https://www.cchrint.org/electroshock/

[12] World Health Organization, OHCHR, “Guidance on Mental Health, Human Rights and Legislation,” 9 Oct. 2023, pp. 15, 58 and 59, https://www.ohchr.org/sites/default/files/documents/publications/WHO-OHCHR-Mental-health-human-rights-and-legislation_web.pdf; https://www.cchrint.org/2023/09/18/who-guideline-condemns-coercive-psychiatric-practices/ citing: “Mental health and human rights: Promotion and protection of all human rights, civil, political, economic, social and cultural rights, including the right to development,” Annual report of the United Nations High Commissioner for Human Rights and reports of the Office of the High Commissioner and the Secretary-General, Human Rights Council, 10-28 Sept. 2018, https://documents-dds-ny.un.org/doc/UNDOC/GEN/G18/232/93/PDF/G1823293.pdf?OpenElement ‘ https://www.cchrint.org/electroshock/

[13] “Electroconvulsive Shock Therapy Lawsuit – What You Should Know About ECT,” https://www.wisnerbaum.com/defective-medical-device-injuries/ect/

[14] “Wisner Baum Prevails in Landmark Win for Patient Autonomy in CA Supreme Court Ruling,” June 20, 2024, https://www.wisnerbaum.com/blog/2024/june/wisner-baum-prevails-in-landmark-win-for-patient/

[15] “Electroconvulsive Shock Therapy Lawsuit – What You Should Know About ECT,” https://www.wisnerbaum.com/defective-medical-device-injuries/ect/; U.S. Food and Drug Administration, Final Rule on Electroconvulsive Therapy Devices, Federal Register, Vol. 83, No. 246 Dec. 26, 2018, https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of

[16] https://www.cchrint.org/2024/11/08/veterans-day-cchr-calls-for-safeguards/, Peter Simons, “ECT Does Not Seem to Prevent Suicide,” Mad In America, 17 Feb. 2023, https://www.madinamerica.com/2023/02/ect-does-not-seem-to-prevent-suicide/

[17] John Read, Ph.D., “Major Adverse Cardiac Events and Mortality Associated with Electroconvulsive Therapy: Correcting and Updating a 2019 Meta-analysis,” School of Psychology, University of East London, London, UK, Ethical Human Psychology and Psychiatry, Oct. 2024, https://repository.uel.ac.uk/item/8xyx0

[18] https://www.cchrint.org/2018/08/17/constitutional-attorney-supports-mental-health-watchdogs-call-for-electroshock-ban-2/

[19] https://www.cchrint.org/2024/08/23/the-collapse-of-electroshock/ Based on Freedom of Information Requests to 27 states

[20] https://www.cchrint.org/2018/10/12/veterans-get-damaging-mental-health-deal/; Tricare Encounter Data (TED) Non-Institutional (Outpatient) for Purchased Care claims, Data Extract as of 10/21/2016, Data received from CCHR International Freedom of Information Request, 2016.

[21] Jonathon Emord, “FDA unjustified in downgrading shock therapy brain injury risks,” The Washington Times, 12 Oct. 2016,
https://www.washingtontimes.com/news/2016/oct/12/fda-unjustified-in-downgrading-shock-therapy-brain/

[22] “ECT depression therapy should be suspended, study suggests,” BBC News 2 June 2020, https://www.bbc.com/news/uk-52900074

[23] http://my.clevelandclinic.org/neurological_restoration/dbs_ocd_depression.aspx; http://www.neurostartms.com/TranscranialMagneticStimulation/index.aspx

[24] “Brain Stimulation Device For Treatment Of Obsessive-Compulsive Disorder Approved In Europe,” Science 2.0, 16 July 2009, http://www.science20.com/news_articles/brain_stimulation_device_treatment_obsessivecompulsive_disorder_approved_europe; in children http://www.ayushveda.com/healthcare/depression-in-children.htm; “The Decline of Deep Brain Stimulation for Obsessive–Compulsive Disorder Following FDA Humanitarian Device Exemption Approval,” Frontiers, 11 Mar. 2021,
https://www.frontiersin.org/journals/surgery/articles/10.3389/fsurg.2021.642503/full

[25] https://news.unchealthcare.org/2025/03/fda-grants-breakthrough-device-designation-for-non-invasive-brain-stimulation-device-to-treat-major-depressive-disorder/; Peter Simons, “Transcranial Direct Current Stimulation (tDCS)Fails to Treat Depression,” Mad in America, 16 July 2023, https://www.madinamerica.com/2023/07/transcranial-direct-current-stimulation-tdcs-fails-to-treat-depression/?utm

[26] “Brain Stimulation Therapies,” NIMH, http://www.nimh.nih.gov/health/topics/brain-stimulation-therapies/brain-stimulation-therapies.shtml, accessed 21 Feb. 2011; https://pubmed.ncbi.nlm.nih.gov/32358462/; http://www.winmentalhealth.com/psychosurgery_lobotomy_cingulotomy.php; http://www.ucsfbenioffchildrens.org/treatments/deep_brain_stimulation/; http://www.tardivedyskinesia.com/treatment/deep-brain-stimulation.php

[27] Dr. Ananya Mandal, MD, “Deep Brain Stimulation Side Effects,” News Medical Life Sciences, 22 July 2023, https://www.news-medical.net/health/Deep-Brain-Stimulation-Side-Effects.aspx

[28] https://www.healthyplace.com/other-info/mental-illness-overview/what-is-deep-brain-stimulation-benefits-cost-risks

[29] Danielle Egan, “Adverse Effects: The Perils of Deep Brain Stimulation for Depression,” Mad in America, 24 Sept. 2015,
https://www.madinamerica.com/2015/09/adverse-effects-perils-deep-brain-stimulation-depression/

[30] https://my.clevelandclinic.org/health/treatments/17598-vagus-nerve-stimulation

[31] “Brain Stimulation Therapies,” NIMH, http://www.nimh.nih.gov/health/topics/brain-stimulation-therapies/brain-stimulation-therapies.shtml, accessed 21 Feb. 2011.

[32] Philip R Brauer, Eric D Lamarre, et al., “Laryngology Outcomes Following Implantable Vagus Nerve Stimulation,” JAMA Otolaryngol Head Neck Surg, 2022 Nov 23;149(1):49–53. doi: 10.1001/jamaoto.2022.3699, https://pmc.ncbi.nlm.nih.gov/articles/PMC9685541/

[33] https://www.hg.org/legal-articles/patients-with-complications-from-cyberonics-vns-therapy-systems-may-qualify-to-file-a-lawsuit-49467

[34] Natasha Tracy, “Vagus Nerve Stimulation (VNS) for Treating Depression,” Healthy Place, 11 Jan. 2022.
https://aws.healthyplace.com/depression/depression-treatment/vagus-nerve-stimulation-vns-for-treating-depression

[35] Sandra G. Boodman, “Now There’s a Device to Treat Depression. If Only There Were Solid Evidence That It Works,” Washington Post, 21 Mar. 2006, http://www.washingtonpost.com/wp-dyn/content/article/2006/03/20/AR2006032001181.html

[36] “Transcranial magnetic stimulation,” MayoClinic.com, http://www.mayoclinic.com/health/transcranial-magnetic-stimulation/MY00185; https://pmc.ncbi.nlm.nih.gov/articles/PMC5612370/

[37] https://neurolaunch.com/tms-therapy-long-term-side-effects/

[38] FDA MAUDE report, Neurostar TMS, 07/14/2021 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=15283600&pc=OBP

[39] https://tmstherapynearme.com/resources/how-much-does-tms-therapy-cost/

[40] “Brain Stimulation Therapies,” NIMH, http://www.nimh.nih.gov/health/topics/brain-stimulation-therapies/brain-stimulation-therapies.shtml, accessed 21 Feb. 2011; https://www.tmshealthandwellness.com/what-is-theta-burst-stimulation-therapy-tbs/; https://www.tmshealthandwellness.com/what-is-theta-burst-stimulation-therapy-tbs/; https://www.sciencedaily.com/releases/2020/08/200817104247.htm

[41] https://davidhealy.org/psychiatry-gone-astray/

[42] https://www.cchrint.org/2015/10/15/nimh-diagnosis/ citing https://psychrights.org/2013/130429NIMHTransformingDiagnosis.htm

[43] https://www.cchrint.org/psychiatric-disorders/psychiatristsphysicians-on-lack-of-any-medicalscientific-tests/; Allen Frances, “Normality Is an Endangered Species: Psychiatric Fads and Overdiagnosis,” Psychiatric Times, 6 July 2010, https://www.psychiatrictimes.com/view/normality-endangered-species-psychiatric-fads-and-overdiagnosis

[44] https://www.cchrint.org/psychiatric-disorders/psychiatristsphysicians-on-lack-of-any-medicalscientific-tests/l Dorothy Rowe, “Mental health diagnoses mask the real problems,” The Guardian, 29 Jul. 2010, https://www.theguardian.com/commentisfree/2010/jul/29/mental-health-diagnostic-manual