Risk Labeling for Electroshock: Consumer Fraud Passed Off as “Informed Consent”

In the third part of a series of public awareness articles posted on TruthAboutECT.org, Jan Eastgate, the president of mental health industry watchdog, Citizens Commission on Human Rights International continues to explore the cover-up of the dangers of psychiatric electroshock treatment, or electroconvulsive therapy (ECT), which constitutes consumer fraud.

To camouflage the false idea that electroshock treatment (ECT)—up to 460 volts of electricity through the brain, damaging it—is a legitimate medical therapy, the U.S. Food and Drug Administration (FDA) and electroshock enthusiasts claim that patient labeling (consent information) and “special” and “general controls” can “mitigate the identified risks of ECT.”[1]

The misleading information that patients and their families are given about the mind-altering procedure—and the fact that brain damage has been struck from ECT’s roster of adverse effects—should constitute consumer fraud.

Biomedical engineer Ken Castleman, Ph.D., puts ECT into perspective: “Stun gun (taser) devices are used by law enforcement to subdue suspects and by citizens for self-defense. They incapacitate a person by inducing massive muscle contractions. A stun gun can develop up to 50,000 volts in order to penetrate clothing, initiate a spark, and make contact with the body. But the amount of current that it actually forces through the victim’s body is only about 0.002 amps….Cattle prods also deliver about 0.002 amps, and an electric fence can turn a cow around with only about 0.012 amps…. Slaughterhouses use a one-second electric shock to the head to ‘stun’ animals (knock them unconscious) before slaughter…. The recommended current for stunning sheep is one amp, and for 200 pound pigs it is 1.25 amps.” Electroshock uses 1 amp or 500 times the amp used in a stun gun or more than the shock used to incapacitate pigs before killing them.[2]

Dr. Colin Ross, a psychiatrist with a published review of sham ECT studies[3], stated in his submission to that FDA in 2011: “In general, the effectiveness of ECT is greatly exaggerated in the ECT literature and its toxicities and side effects are greatly minimized, discredited as ‘anecdotal,’ attributed to the depression rather than the treatment, or dismissed as ‘anti-psychiatry.’”[4] But “claims in textbooks and review articles that ECT is effective are not consistent with the published data,” Ross found from his review.[5]

Yet, the most the FDA has conceded to is a warning that “The long-term safety and effectiveness of ECT treatment has not been demonstrated.” [6]

Despite this, in December 2018, the FDA reduced the risk classification of the ECT device without clinical trials showing proof of safety and efficacy for treatment of four “mental disorders.”

FDA recommended that “certain information be provided in the patient labeling” and by telling patients, this mitigates the risk of damage. This includes a prominent statement: “Warning: ECT device use may be associated with: disorientation, confusion, and memory problems,” although later FDA claims these “go away within a few days to a few months after the last treatment with ECT.” It omits the fact that memory loss can be permanent.

It also omits brain damage, despite the FDA being put on notice of several lawsuits that prove otherwise. FDA was aware of the 2005 Santa Barbara Superior Court Judge Denise de Bellefeuille ruling that a psychiatrist and a psychiatric hospital, Santa Barbara Cottage Hospital, deceived its patients by failing to tell them that ECT causes irreversible memory loss, and prohibited the hospital from giving shock treatments.

The patient who brought the suit, Atze Akkerman, a professional musician, underwent a series of electroshock “treatments” and, consequently, could no longer remember his wife of 20 years, his children, or how to play music.[7]

The court ordered that the hospital “immediately cease providing ECT to patients and advise its attending physicians that the hospital has lost the right to perform such treatment.” The court also ruled the treating psychiatrist Joseph Johnson had violated the California consumer fraud statutes.  Johnson (who had performed shock treatment for over 20 years), admitted that neither he nor anyone else understood how shock treatment worked, and that the consent form Johnson provided to patients was “decidedly misleading in a critical regard,” concerning the permanency of memory loss.[8]

Other electroshock adverse effects FDA recognizes include manic symptoms (including euphoria and/or irritability, impulsivity, racing thoughts, distractibility, grandiosity, increased activity, talkativeness, and decreased need for sleep), or a worsening of the psychiatric symptoms they are being treated for. The physical risks of ECT may include the following (in order of frequency of occurrence) pain/somatic discomfort (including headache, muscle soreness, and nausea); skin burns; physical trauma (including fractures, contusions, injury from falls, dental and oral injury); prolonged or delayed onset seizures; pulmonary complications (hypoxemia [abnormally low level of oxygen in the blood], hypoventilation, aspiration, upper-airway obstruction); cardiovascular complications (cardiac arrhythmias, heart attack, high or low blood pressure, and stroke); and death.[9]

But in omitting “brain damage,” psychiatrists are given license to assault patients, sanctioned by the State.

Informed consent cannot and should not mitigate the damage inflicted. Patients cannot willfully consent to be the victim of assault. Where doctors are administering electroshock with full knowledge that it can cause brain damage and permanent memory loss, this should be subject to felony assault charges. Serious bodily injury includes loss or impairment of a bodily function or organ or mental faculty.[10] Major traumas such as brain damage are “obvious types of great bodily injury,” according to one California law group’s website.[11]

Los Angeles attorney, David Karen, who has litigated ECT, said, “Upon review of hundreds of the ‘informed’ consent forms received from those suffering permanent cognitive impairment after receiving ECT, the overwhelming majority of consent forms do not provide the patient with any form of disclosure that ‘brain damage is a risk that can potentially occur from ECT, whether performed properly or not.’ Nor do consent forms describe the ongoing debate within the medical field about ECT’s safety and effectiveness.”[12]

Further missing from any “patient labeling” or “consent” proposal is that psychiatrists haven’t a clue how ECT supposedly “works.” Imagine a heart surgeon telling you he didn’t know how the heart works while explaining that there are dozens of theories about why a coronary bypass operation should be performed and how it should be done—it’s a ‘pot luck’ choice. There may be some minimal risks, the surgeon says, such as pain, wound infection, fever, memory loss but this often improves in 6-12 months, and are probably reactions to anesthesia. But the surgeon completely omits the fact that the operation could cause stroke, heart attack, or death. Psychiatrists have been getting away with minimizing the risks of ECT for decades and the FDA’s Final Rule on ECT is complicit in this.

ECT device manufacturer executive, psychiatrist Richard Abrams, thought criticism of ECT could be reduced by advising psychiatrists to avoid giving ECT to those patients “who frequently express anger and resentment over alleged misdiagnosis or mistreatment by previous physicians, no matter how highly they praise your skills in comparison. Such patients rarely respond favorably to ECT.”[13]

A consent form for ECT offered by the Johns Hopkins Hospital in Baltimore, Maryland, adds weight to why ECT should be banned. It tells consumers that no guarantees can be “made concerning the outcome [of ECT], as the practice of medicine and psychiatry is not an exact science.”[14]

As ECT is so damaging, with no studies scientifically proving how it “works,” no guarantees for its safety and nor is it a cure, “informed consent” is not only based on a fraud but simply doesn’t exist today.

Tens of thousands of people have signed CCHR’s online petition to ban electroshock. More are encouraged to sign this and also to report any incident of ECT damage to CCHR.

References:

[1] “Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended  Uses,” A Rule by the Food and Drug Administration on 12/26/2018, https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of, Response (8)

[2] Expert Report on Electroconvulsive Therapy by Kenneth R. Castleman, PhD, 9 Sept. 2018.

[3] Colin A. Ross, “The sham ECT literature: implications for consent to ECT,” Ethical Hum Psychol Psychiatry, 2006 Spring;8(1):17-28, https://www.ncbi.nlm.nih.gov/pubmed/16856307.

[4] Dr. Colin A. Ross, submission to the FDA, 10 Jan. 2011, http://www.electricshocktherapy.info/uploads/4/0/7/6/4076267/colin_a_ross_md_ect_psychiatrist.pdf.

[5] https://www.ncbi.nlm.nih.gov/pubmed/16856307.

[6] Op. cit., “Neurological Devices; Reclassification of Electroconvulsive Therapy Devices….”

[7] Case No. 1069713, Atze Akkerman and Elizabeth Akkerman vs. Joseph Johnson, Santa Barbara Cottage Hospital, et al., Superior Court of the State of California for the County of Santa Barbara, Statements of Decision on Submitted Issues, Filed, 5 Jan. 2005.

[8] Ibid.

[9] Op. cit., “Neurological Devices; Reclassification of Electroconvulsive Therapy Devices….”

[10]  “Serious Bodily Injury Law and Legal Definition,” USLegal.com, https://definitions.uslegal.com/s/serious-bodily-injury/.

[11] https://www.shouselaw.com/gbi.html.

[12] David Karen, “ECT Litigation Update: Are Patients Being Warned of Brain Damage Risk?” 13 June 2019, https://www.madinamerica.com/2019/06/ect-litigation-patients-not-warned-brain-damage-risk/.

[13] Richard Abrams, M.D., Electroconvulsive Therapy, Fourth Edition, (Oxford University Press, 2002), p. 236.

[14] https://www.hopkinsmedicine.org/psychiatry/specialty_areas/brain_stimulation/docs/ECT%20consent_Feb2017.pdf.

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