Forced to obtain electroshock statistics through FOIA, CCHR finds states electroshocking those 0–5 and up to age 12. UN defines any ECT without consent as an act of torture—yet this increasingly occurs throughout the U.S.
Statistics on electroshock treatment (ECT) usage in the U.S. for 2019 reveals at least four of 27 states reporting ECT use under Medicaid, to children five years of age or younger. The Citizens Commission on Human Rights International, a mental health industry watchdog, condemns the practice of electroconvulsive therapy, which sends up to 460 volts of electricity through the brain to treat mental issues, saying that its use, especially in youngsters, is simply cruel and brutal. As children are too young to consent, non-consensual ECT constitutes torture, according to United Nations bodies such as its Committee Against Torture. In 2013, it recommended “an absolute ban on all forced and non-consensual” use of electroshock. The World Health Organization made similar recommendations in June 2021.[1]
The four states that report still giving electroshock in the 0-5 age bracket in 2019 (Georgia, Massachusetts, Mississippi and Utah) should immediately prohibit this, CCHR says.
A promising outcome in the wake of CCHR’s nationwide campaign against electroshocking children, is there was a 60% decline in states (from 10 to 4) shocking the 0-5 age group since approximately 2016. The six states are Florida, Pennsylvania, Washington state, Illinois, Indiana and Kentucky, the latter not reporting any in 2018.
Since 2015, CCHR has kept legislators in every state apprised of the risks of ECT, with studies, statistics on usage and experts’ opinions against ECT, supporting a ban on the treatment’s use.
In order to obtain accurate statistics on ECT use, CCHR needed to file Freedom of Information Act (FOIA) requests state-by-state. Some states do not even collect the information, despite the potential for the practice to cause severe memory loss, cognitive damage, heart attacks, brain damage and death. The FDA estimates that 100,000 Americans receive ECT each year, although this appears to be based on estimated statistics from 1995.
In response to the FOIA requests, 27 states responded on ECT usage under Medicaid between 2015 and 2020. Of these, 15 (56%) had increases in the number of people receiving ECT, while, commendably, 12 states (44%) reported decreases.
Six of the 27 states also show ECT given to those aged 6-12 years old, with Florida having the highest usage reported as fewer than 30 for each of the years 2017-2020. Massachusetts followed, reporting fewer than 11 in 2020. Kentucky, Indiana and Rhode Island reported one each for the years, 2017, 18 and 19 respectively.
In 2018, the Food and Drug Administration (FDA) cleared the marketing of ECT devices to teens aged 13 and older for specific “disorder,” despite there being no clinical trials to support safety and efficacy for, any use of ECT devices. There’s no clearance for the ECT device to be marketed for use in those younger than 13.
CCHR helped obtain the first ban on ECT for minors in California in 1976. Three more U.S. states followed, and West Australia also banned it for those 14 and younger, with criminal penalties if administered. A Texas ban exists for up to age 16.
Seventeen states report ECT for the 13-17 age group, although about four reported no ECT use in this age group since 2019 (Idaho, Iowa, Kentucky and Nebraska), while Georgia and Vermont have none reported since 2018, and Kansas not since 2016. This is a positive response to the national and international calls to eliminate coercive psychiatric treatments such as ECT.
In Texas, one of the states where ECT is banned on minors up to age 15, the number of 16–17-year-olds receiving it decreased by nearly half—from seventeen in 2017 to nine in 2020. But these are nine too many.
CCHR says those states with a general decline in ECT use are going in the right direction of eliminating the practice entirely. These include Mississippi with a 23% decrease, New Hampshire (20%) and Indiana (20%).
However, the most appalling finding is the states registering massive increases in the use of ECT: Michigan (415%), Oklahoma (413%), South Dakota (320%), and Rhode Island (151%).
Texas tops the states with the highest number of patients of all age group shocked in 2020 at 2,645, although the statistics can’t be compared to other states as they include all hospitals delivering ECT, and not limited to Medicaid beneficiaries.
ECT remains so controversial that on January 5th this year, some 50 experts, including 12 psychiatrists, ECT recipients and relatives thereof in the UK signed a letter to the country’s National Institute for Health and Excellence (NICE), calling for radical changes to the country’s ECT guidelines. The letter contains notes that while the practice is still in use, cognitive testing should be done after every treatment to monitor adverse effects and that NICE informs patients that they have the right to be compensated for the memory loss and brain damage ECT causes.
Electroshock remains a contentious issue because there are no clinical trials that have proven the safety and efficacy of its devices. This is because FDA grandfathered the device in in 1976 as it had been in use since 1938, when an Italian psychiatrist discovered it calmed pigs before they were slaughtered.[2]
FDA Failure to Approve ECT Devices: No Clinical Trials
Few are aware that the ECT device is “cleared” only for marketing and use in the U.S. There is a big distinction between a medical device (and drug) that’s been FDA cleared and approved.
- FDA “cleared” means the manufacturer can demonstrate that their product is “substantially equivalent to another (similar) legally marketed device” that already has FDA clearance or approval.[3] In the case of the ECT device it was the fact that the device had already been in use for several decades, although without clinical trials and proof of safety. It avoided the usual FDA approval process.
- “FDA approved” means that manufacturers must submit a premarket approval (PMA) application and the results of clinical tests (trials) proving the “benefits of the product outweigh the known risks for the intended use.” Even then, just because a device is FDA cleared or even approved does not always mean it is safe.[4]
- As one report on the safety issue explained: far from being free from harm, safety represents “a value judgment of the acceptability of risk.” The FDA gauges “safety” by what constitutes a level of “acceptability” within the industry.[5] Risk is, therefore, an arbitrary opinion: “a measure of the probability and severity of harm to human health.” Essentially, if the risks of using a product are “acceptable” to the patient, physician, society, or other decisionmakers, it may be arbitrarily considered “safe.” Efficacy is looked at in terms of a benefit; safety in terms of risk.[6]
- In other words, safety, efficacy and risk are agreed upon arbitrary opinion. Psychiatrists opine that forcing electroshock on an individual to damage the brain is therapeutic and as such harm is redefined as benefit.
- After 84 years, psychiatrists still admit they don’t know how ECT “works,” yet they administer it, well aware that it cannot cure—but it can cause serious damage.
- FDA defers to a U.S. Federal Code about safety and efficacy, which does not actually define what these mean. A representative of the agency admitted to The People’s Pharmacy that “our Food and Drugs Act of 1906 founding fathers were specifically unspecific describing ‘safe and effective’ as it applies to drugs.”[7] (Medical devices did not fall under the FDA’s jurisdiction until 1976.)
- Even when the FDA approves a product, it never actually guarantees that it is safe or effective. The ClassAction.org website, which provides consumers with information about the dangers of products which have been negligently put on the market, says that often “companies will prey on consumer beliefs that ‘FDA approved’ means the federal agency has reviewed clinical studies regarding the product in question and decided that it is safe and effective.” In fact, “many times ‘FDA approved’ labels should be red flags for consumers, because products that the FDA does evaluate (e.g., food, drugs, etc.) typically have implied Manufacturers who explicitly use ‘FDA approved’ labels may be doing so just to deceive you about the quality of their products.”[8]
- In relation to the ECT devices, they are on the market with no clinical trial support—a different “standard” for approved medical drugs. Regarding another medical treatment, in January of 2022, the British Medical Journal reported that a majority of trials that underpin regulatory approval are sponsored by the manufacturer; most are unpublished, those that are published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lack access to the raw data, and academics who request access to the data for independent analysis are denied.[9]
- In a separate but “mental health” example, Study 329 was a study involving the antidepressant Paxil that was published in 2001 by over a dozen well-credentialed academics and failed to disclose the drug could induce suicidal ideation in children and teens. The controversial case has been debated ever since, finding:
- Prominent U.S. psychiatrists put their name to the study, lending credence to its misleading conclusions.
- Not made public was that the study was ghostwritten by a PR company hired by the manufacturer (SmithKline Beecham, aka GlaxoSmithKline or GSK.) The study’s reported findings were contrary to the actual underlying raw data, which was manipulated to make Paxil appear safe and effective for youngsters, covering up potential suicidality from this age group taking the drug.[10]
- The lead author of the study, Dr. Martin Keller, Professor Emeritus, Department of Psychiatry and Human Behavior at Brown University, admitted in a deposition that he did not look at the raw data, but only at summaries provided to him by GSK. GSK was sued for “concealing negative information” concerning Paxil.[11]
- Most scientists, and even the reviewers who review papers for publication, generally see the data already packaged in the way that the authors present it—not the raw data.[12] Even the FDA’s website concedes that it does not look at the raw data: “FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers.”[13]
- Jon Jureidini, professor and research leader of critical and ethical mental health at the University of Adelaide, charged that the authors of the original paper “deliberately misrepresented the outcomes of the study” and adverse events were not reported in the proper way, with suicide attempts severe enough to require hospitalization mislabeled as “emotional liability.” Jureidini and his team were able to make these discoveries because they eventually got access to the raw data generated from the trial, something that is not routine when clinical trials are published.[14]
The consequences in relation to studies such as “329” is that consumers and families are not warned of potential serious adverse effects and, in the case of Paxil and other antidepressants, if the person becomes suicidal, it can be erroneously attributed to the mental state of the individual, obfuscating that it is a drug-induced condition. The person can be falsely diagnosed as “treatment” or “antidepressant-resistant,” and thereby be referred for ECT.
Clinical trials rely upon the honesty (or dishonesty) of the manufacturer as they tend to focus on the “benefits” and downplay the risks for the sake of profit, which becomes biased information.
There are several phases to clinical trials:
Phase 1) Study Participants: 20 to 100 healthy volunteers or people with the disease/condition, with trial lasting several months to determine “safety and dosage.”
Phase 2) Up to several hundred people with the disease/condition, lasting several months to two years to determine “efficacy and side effects.”
Phase 3): 300 to 3,000 volunteers who have the disease or condition, for 1-4 years for efficacy and monitoring of adverse reactions.
Phase 4) Several thousand volunteers who have the disease/condition for further safety and efficacy. This process continues until the developer decides to end clinical trials or files a marketing application. Before filing a marketing application, a developer must have adequate data from two large, controlled clinical trials.[15] A controlled trial has two groups to compare outcome, one group is given the product while another has, for example, a placebo or no active treatment is given.[16]
Now, take this a giant step further, making it worse when it comes to ECT device manufacturers, as they have never been required, nor have they ever conducted clinical trials attempting to prove safety and efficacy. They don’t even conduct research—they rely on already published studies conducted often by psychiatrists.
MECTA Corp, the manufacturer of two ECT devices could not provide evidence of how ECT works other than its machines are designed to cause a grand mal seizure. Beyond that, the mechanism is entirely theoretical.[17] The president of MECTA said that the company “does not do research…. We are not responsible for individual patients….”[18] No effort is made to acquire adverse information caused by its devices.[19]
Consider the long list adverse effects of ECT to fully understand how egregious it is that ECT devices are allowed on the market without clinical trials: Brain damage, manic or worsening of “psychiatric” symptoms, skin burns, physical trauma (including fractures, contusions, injury from falls, dental and oral injury), prolonged or delayed onset of seizures, pulmonary and cardiovascular complications (including heart attack and stroke), permanent memory loss—and death.[20]
In May of 2018, the UN Human Rights Council’s report on “Consultation on Human Rights and Mental Health,” said enforced ECT (or any other psychiatric practice) can “amount to torture and ill-treatment” and laws allowing this should be repealed.[21]
On June 10th, 2021, the World Health Organization released a damning guideline which said that people who are subjected to forced electroshock report feelings of dehumanization, disempowerment and being disrespected.[22]
Ignoring UN concerns about ECT, in 2015, ECT devices, which are historically cleared (not approved) and with no specific age indicated, the FDA issued a Proposed Order for ECT device classification (to lower its risk classification from Class III requiring an application with clinical trials to Class II, with no clinical trials to support this). FDA recommended that the indications for use be limited to use in patients 18 years old and older. However, in 2018, without any clinical trials or raw data proving safety and efficacy, and without public debate, FDA reduced the age to 13.[23]
The FDA lacks a valid scientific basis to conclude that ECT devices are safe and effective as they have no clinical trials and the raw that to support them to make such a determination. It claims to have reviewed psychiatrists’ studies—not the device manufacturers—comparing ECT with either placebo (sham) or antidepressant therapy. But such clinical studies, as laid out above, are biased in favor of ECT and a CCHR review of some of those the FDA relied on revealed questionable outcomes.
The public remains at risk.
Electroshock is like administering medical blunt force trauma. It should be banned. As Craig Newnes, a UK clinical psychologist and author of A Critical A-Z of Electroshock, and interviewed in CCHR’s documentary, Therapy or Torture: The Truth about Electroshock, says, “The biggest mystery of all is why on Earth people think that putting bolts of electricity through people’s heads is a good idea.”[24]
Sign the petition here to support total ban on all ECT.
References:
[1] Jan Eastgate, “World Health Organization New Guidelines Are Vital To End Coercive Psychiatric Practices & Abuse,” CCHR International, https://www.cchrint.org/2021/06/11/world-health-organization-new-guidelines-are-vital-to-end-coercive-psychiatric-practices-abuse/, citing: “Guidance on Community Mental Health Services: Promoting Person-Centered and Rights-Based Approaches,” World Health Organization, 10 June 2021, https://www.who.int/publications/i/item/9789240025707 (to download report)
[2] “Documented Facts & Statistics About Modern Electroshock (ECT),” CCHR International, https://www.cchrint.org/electroshock/, citing: “Origins of ECT,” Convulsive Therapy, Vol. 4, No. 1, 1988, p. 7, http://www.academia.edu/10921818/The_Origins_of_Electroconvulsive_Therapy_ECT
[3] Sarah Mitroff, “FDA approved vs. FDA cleared: Why you need to know the difference,” CNET, 5 Aug. 2020, https://www.cnet.com/health/fda-approved-vs-fda-cleared-whats-the-difference/
[4] Ibid.
[5] Assessing the Efficacy and Safety of Medical Technologies, Office of Technology Assessment, Congress of the United States, September 1978, https://www.princeton.edu/~ota/disk3/1978/7805/780504.PDF, p. 17
[6] Ibid., pp. 17, 18
[7] Joe Graedon, “Is the FDA’s Definition of Safe a Lie?” The People’s Pharmacy, 1 July 2019, https://www.peoplespharmacy.com/articles/is-the-fdas-definition-of-safe-a-lie
[8] Melissa Anthony, “What Does ‘FDA Approved’ Mean?” ClassAction.org, 28 Oct. 2014, https://www.classaction.org/blog/what-does-fda-approved-mean
[9] Editorial, “Covid-19 vaccines and treatments: we must have raw data, now,” British Medical Journal, 19 Jan 2022, https://www.bmj.com/content/376/bmj.o102
[10] Baum Hedlund Aristei & Goldman PC, “Misleading Paxil Study Exposed in New BMJ Study,” 18 Sept. 2021, https://www.baumhedlundlaw.com/blog/2015/september/misleading-paxil-study-exposed-in-new-bmj-study/
[11] Ibid.; Gardiner Harris, “Spitzer Sues a Drug Maker, Saying It Hid Negative Data,” The New York Times, 3 June 2004, https://www.nytimes.com/2004/06/03/business/spitzer-sues-a-drug-maker-saying-it-hid-negative-data.html
[12] Alice Park, “Paxil Is Not Safe or Effective For Teens, Finds New Analysis of Major Study,” TIME, 16 Sept. 2015, https://time.com/4037075/antidepressant-depression-teens/
[13] FDA website, “Is It Really ‘FDA Approved?’” https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved
[14] Op. cit., TIME, 16 Sept. 2015
[15] https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
[16] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6434767/
[17] Jan Eastgate, “Electroshock: The Redefinition of Assault and Battery as “Therapy” and Torture as Treatment,” TruthAboutECT.org, 5 Sept. 2018, https://truthaboutect.org/electroshock-the-redefinition-of-assault-and-battery/, citing: Deposition from Robin Nichol in civil case of Atze Akkerman vs MECTA, 18 Nov. 2004
[18] Ibid., Deposition from Robin Nichol in civil case of Atze Akkerman vs MECTA
[19] Rick Moxon, LLB, lawsuit and comment submitted to Docket 2009-M-0392, deposition testimony of Mecta president, Robin Nichol
[20] “Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses,” U.S. Food and Drug Administration, Final Rule, 83 FR 66103, 26 Dec. 2018, https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of; http://www.thymatron.com/catalog_cautions.asp
[21] “Mental health and human rights Report of the United Nations High Commissioner for Human Rights, Human Rights Council Thirty-ninth session, 1-28 Sept. 2018, https://www.ohchr.org/Documents/Issues/MentalHealth/A_HRC_39_36_EN.pdf
[22] Op. cit., World Health Organization, 10 June 2021, p. 8
[23] Op. cit., U.S. Food and Drug Administration, Final Rule, 83 FR 66103, 26 Dec. 2018
[24] Therapy or Torture: The Truth About Electroshock, CCHR documentary, 2018, https://www.cchr.org/ban-ect/watch/therapy-or-torture-the-truth-about-electroshock.html