Electroconvulsive Therapy is Still Used Today Without Proof of Safety and/or Efficacy
From the early days of electroconvulsive therapy to the present day, psychiatric experts have documented brain damage and memory loss correlated with ECT. A vocal “ECT survivor community” has been voicing their objection to the continued use of shock treatment for decades.
Between 2009 and 2011, the FDA opened a public docket seeking reports of adverse events related to ECT. Thousands of adverse event complaints were submitted, hundreds of which alleged serious brain injury. Following a 2011 FDA hearing, the FDA provided “An Executive Summary” containing information on the available safety and effectiveness data for ECT in treating various forms of severe psychiatric illness. According to the FDA, memory loss, including autobiographical memory loss (memory loss of personal events and self-identity), was one of the “most concerning” adverse events associated with ECT.
As for the efficacy of ECT, researchers conducted an analysis of all ECT studies meeting the criteria for the highest and most conclusive level of evidence in medicine: randomized, prospective, double-blind placebo-controlled trials of ECT (conducted by others, not by ECT manufacturers). These studies compared real ECT with “sham” ECT. According to the researchers, the studies “provide definitive evidence that real ECT is no more effective than sham ECT.”
In a meta-analysis of pre-existing ECT studies conducted by Irving Kirsch of Harvard University and John Read and Laura McGrath of the University of East London, the authors concluded:
“Given the high risk of permanent memory loss and the small mortality risk, this longstanding failure to determine whether or not ECT works means that its use should be immediately suspended until a series of well designed, randomized, placebo-controlled studies have investigated whether there really are any significant benefits against which the proven significant risk can be weighed.”
Listen to the PODCAST: John and Irving Kirsch – ECT, Does the Evidence From Clinical Trials Justify its Continued Use?
Dose optimization of ECT remains controversially “unreconciled despite decades of research.”
“After more than 80 years of use, ECT proponents haven’t come up with standardized protocols based on safety studies. Nor can they. Between more than 12 dosing variables involved plus the individual patient’s anatomic differences, it literally creates infinite dosing variables with potentially catastrophic risk. Due to the number of variables involved in its administration, ECT is basically the equivalent of medically sanctioned Russian Roulette.” – Sarah Price Hancock, Life After ECT
“Due to the number of variables involved in its administration, ECT is basically the equivalent of medically sanctioned Russian Roulette.”
Is ECT Approved by the FDA?
No. ECT devices were “grandfathered” in before a new law would have required their approval. They remain on the market unapproved because of a troubling and dangerous loophole.
Before Congress enacted the comprehensive Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act, medical devices could be marketed and sold without prior approval from the U.S. FDA. The Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device Amendments of 1976, established a framework for regulating medical devices by placing them into one of three risk-based categories before they are allowed to enter the U.S. market:
Class I Medical Devices: Present no unreasonable risk of illness or injury and are subject to regulation through “general controls.” This includes such devices as tongue depressors and bandages.
Class II Medical Devices: Present potentially more harmful risks and are subject to general controls. FDA has authority to require Class II devices comply with other “special controls” or performance standards.
Class III Medical Devices: Present “a potential unreasonable risk of illness or injury.”
New medical devices, including those not in commercial distribution before 1976, are classified automatically as Class III without any FDA rulemaking process. Before a Class III device may be introduced into the market, a manufacturer must obtain “premarket approval,” which requires the device manufacturer to submit information to FDA that provides reasonable assurance that the device is safe and effective for its intended use.
Premarket approval is the most detailed type of device marketing application and review the FDA requires. A premarket approval application must include sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). It also requires clinical testing.
However, a loophole known as the “grandfathering” provision permits Class III devices that were on the market before the 1976 Medical Device Amendment’s enactment to remain on the market until FDA initiates and completes rulemaking requiring device manufacturers to submit a premarket approval application.
In addition, Congress created another loophole which permits new manufacturers to distribute similar devices by showing through a premarket notification process that their new devices are “substantially equivalent” to grandfathered devices. A device is “substantially equivalent” to a grandfathered device only if, among other things, the device has the same “intended use” as the predicate device.
According to the ECT lawsuits, it is this grandfathering loophole that has allowed ECT manufacturers like Somatics and MECTA to keep their dangerous machines on the market. Because ECT machines were on the market prior to the 1976 enactment of the Medical Device Amendments, ECT companies obtained grandfathering clearance for ECT devices without submitting a premarket approval application and without having to submit any clinical trials concerning the safety and efficacy of ECT devices.
For decades, the FDA’s position on ECT machines has been clear: “The long-term safety and effectiveness of ECT treatment has not been demonstrated."
In issuing its clearance to Somatics, the FDA on multiple occasions, informed Somatics that:
This letter does not in any way denote official FDA approval of your device or its labeling. Any representation that creates an impression of official approval of this device because of compliance with the premarket notification is misleading and constitutes misbranding. (emphasis added)
Resources (ECT Court Documents – Legal Briefs, Internal Documents, and Depositions)
ECT Expert Reports
Expert Report of Dr. Janet Arrowsmith
- Former Deputy Director U.S. Food and Drug Administration’s AIDS Coordination Staff
- Board Certified in Internal Medicine
- Elected Fellow of the American College of Physicians
- Elected Fellow of the American College of Epidemiology
According to Dr. Arrowsmith’s report, despite roughly 80 years of use worldwide, “there are no blinded, appropriately powered, adequate, and well-controlled studies published in the medical literature or submitted by ECT device manufacturers supporting the efficacy or safety of electroconvulsive therapy in psychiatric patients.”
Expert Report of Dr. Kenneth Castleman
- Biomedical Electrical Engineer
- Senior Scientist U.S. National Aeronautics and Space Administration’s Jet Propulsion Laboratory (retired)
- Served on the Faculty at Caltech
- Adjunct Professor at the University of Texas
- Research Fellow at the University of Southern California and the University of California, Los Angeles
According to Dr. Castleman’s report, “ECT has the potential to injure or kill brain cells by at least two different electrical mechanisms, heating and electroporation. The scientific literature has demonstrated brain damage in earlier times, and recent studies using high magnet-strength MRI show ECT-induced changes in the sizes of certain brain structures. Little is known about whether damage on a cellular level is continuing to occur with modern ECT devices and practice. Further, studies to evaluate the risk of electroporation by ECT have not been reported. Despite its widespread use, ECT exposes patients to risks of brain damage that have not been thoroughly evaluated. The opinion of ‘authorities in the field’ is being substituted for scientific fact.”
Expert Report of Dr. Bennet Omalu
- Clinical Pathologist, Anatomic Pathologist, Forensic Pathologist, Neuropathologist, and Epidemiologist
- President and Medical Director of Bennet Omalu Pathology and a Clinical Professor at the Department of Medical Pathology and Laboratory Medicine at the University of California, Davis.
- Received the “Distinguished Service Award” from the American Medical Association, the AMA’s most prestigious award.
- Life and work featured in the Hollywood film “Concussion,” where actor Will Smith portrayed Dr. Omalu’s work as the first person to discover chronic traumatic encephalopathy (CTE) in football players.
According to Dr. Omalu’s report, “[t]he amounts of electrical energy introduced to the human brain by ECT machines can be nothing but harmful and dangerous. These mounts of energy are exponentially outside the tolerable homeostatic ranges and thresholds of the human brain and nervous system and will no doubt, and are in fact expected to cause cellular physiologic, biochemical, and anatomic injuries to the human brain. Since the human brain is post-mitotic and cannot completely regenerate itself following such injuries, and since such ECT-induced electrical injuries occur repeatedly over time, the patient who receives ECT therapy will manifest permanent and cumulative brain injury, which can be progressive over time and result in chronic encephalopathies and brain degeneration. Such brain degeneration can manifest with multi-domain neurological impairments including cognitive impairment, mood disorders and neuro-psychiatric impairment, behavioral impairment, motor disorders and other somatic symptoms and signs.”
Expert Report of Dr. John Read
- Professor of Clinical Psychology at the University of East London, England
- Clinical Psychologist and manager of mental health services, in the United States, England, and New Zealand, predominantly with patients at the extreme end of the spectrum of psychiatric disturbance.
- Has over 200 research publications (Google Scholar 4.12.2021), which have been cited over 17,000 times, published over 50 book chapters, edited or authored five books, and given over 60 invited plenary/keynote addresses at psychiatric conferences in 17 countries.
- Published four reviews of the research literature on the efficacy, safety, and mechanisms of action of electroconvulsive therapy.
According to Dr. Read’s report, there is “little evidence that ECT is more effective than placebo in the short-term, and none at all in the long-term. ECT does not prevent suicide. ECT causes persistent/permanent memory loss and brain damage in a substantial proportion of recipients, somewhere in the range of 12% to 55%. This damage takes the form of both anterograde and retrograde amnesia. The number of electroshocks received is predictive of the degree of damage done by ECT.
Litigation Can Help Make the World a Better Place
Attorneys from the national law firm of Wisner Baum have always fought to ensure that consumers are fully and honestly informed about risks associated with pharmaceutical products and medical devices. Our attorneys will continue to work tirelessly to ensure those rights are defended and victims of injustice are compensated for their injuries.