Dr. Toby Watson, Psy.D.

This document has been written to help educate the reader about Electro-convulsive shock therapy (ECT).  I have special research interest and expertise in this field of study, and I have provided written testimony to the United State Federal Drug Administration (FDA) on this specific topic, whereby, the FDA upheld and supported the request to keep the stringent class III classification rating upon the ECT devices.  I have also submitted research to the Australian government when requesting information regarding ECT effectiveness and safety; whereby, that government banned shock therapy upon children and young teens.  

As Clinical Director of an outpatient mental health center in the United States, as a former Federal Social Security Mental Health Disability Examiner, the past Chief Supervising Psychologist for the State of Wisconsin-USA, Department of Corrections-KMCI, and as the past International Executive Director for the International Society for Ethical Psychology and Psychiatry (ISEPP, formerly ICSPP), have been able to witness first hand the long term damaging effects of ECT.  This is not to state I have not spoken with people who have reported great benefits to using such intervention; however, as a scientist and researcher, I am outlining what is often not known by most doctors, practitioners and patients regarding the peer reviewed evidence and research about the actual overall effects of using such intervention.

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Summary:

People need to be fully informed of the serious risks of undergoing ECT, an outdated and harmful procedure whereby the safety and effectiveness has not been shown.  The decision to use this intervention is often not fully realized until it is too late, and the risks are often under-reported or minimized by far too many.  People suffering are especially vulnerable, as are the elderly and children.  There are no studies to date showing any long term effects for these developing brains, and ECT should never be used without full informed consent and with all other interventions being fully exhausted. 

​Summary on ECT


An ECT device is often used upon an individual in order to stop severe psychiatric disturbances (e.g., severe depression, psychosis) by inducing in the individual a major motor seizure by applying a brief intense electrical current to the patient's head.  This is called Electroconvulsive Therapy, often simply called ECT, and also known as Shock Therapy (ST).  It is a psychiatric intervention used in the hopes to provide emotional relief in cases of severe depression and other disorders often called “mental illness” (e.g., catatonia and mania episodes).  However, people who have undergone such procedures have reported to this examiner that the intervention was used to silence their complaints and unhappiness with lack of effectiveness of treatments.  In the administration of ECT, electrodes are sometimes placed on one side of the head, known as unilateral ECT, or, on both sides of the head, known as bilateral ECT.  After a patient has been given muscle relaxing drugs, as well as anesthesia, a jolt of electricity is sent into the patient’s brain inducing a grand mal seizure which usually lasts between forty to sixty seconds.  Due to the use of anesthesia and muscle relaxant drugs, the patient does not seem to move about on the table and appears to others as not in distress or pain (i.e., the violent convulsions which regularly occurred in the 1940’s through the 1960’s or onward).  An average course of ECT ranges from between six to twelve shocks over a period of two to four weeks, but many cases involve upwards of 40-50 shock “treatments”.  


History of Devices


The Medical Device Amendments of 1976 (“Amendments”), enacted on May 28, 1976, established three classes of medical devices: Class I (General Controls; considered safest), Class II (Performance Standards; more risky), and Class III (Premarket Approval; highest risk). Whether a device is Class I, II, or III depends upon its intended use, indications for use, and risk to the user.  In 1979, the FDA categorized the ECT device as a Class III high risk device, meaning that its benefits have not been shown to outweigh its risks, and that it presents a “potential unreasonable risk of injury or illness.” It ruled that brain damage and memory loss were risks of the procedure. About thirty years later, on January 28, 2011, the FDA appointed panel recommended and upheld that ECT devices should continue to be classified as “high risk” devices (i.e., Class III as the highest risk classification), as there has not been enough evidence to indicate the procedure is safe and effective.  Psychiatrists on the panel were “all in favor” of loosening the restrictions, despite a stream of continued evidence in the research demonstrating significant harmful effects and despite noting that the reason ECT “works” is ultimately unknown. 

Then in December of 2018, the FDA reclassified ECT as a Class II device only for certain cleared indications (depression and catatonia).   The list of “cleared indications” prior to the reclassification was depression (unipolar and bipolar), schizophrenia, bipolar manic (and mixed) states, schizoaffective disorder, schizophreniform disorder, and catatonia. In order to become Class II or Class I, the device manufacturers would need, and were told for decades to perform, “premarket approval” (i.e. clinical controlled trials showing it is safe and effective) for any and all indications. Supporters of ECT claimed controlled trials could never be performed due to the financial and ethical requirement that one could not withhold the much needed ECT treatment for these seriously ill patients. However, this equates to stating that no drug should ever be given a clinical trial for safety and effectiveness because it would be too costly and it would be wrong to withhold a valuable untested drug from an ill patient.  “It was crucial that some (at least one) of the previously “cleared indications” be moved to Class II, in order not to interrupt the availability of ECT devices for the US market.” In order to be cleared, “special control” requirements must be met (a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients aged 13 years and older who have treatment resistance or who require a rapid response due to the severity of their psychiatric or medical condition).  Despite no new data on safety and effectiveness, this reclassification for some disorders constitutes approximately 60-70% of the patients being given ECT in the USA.  The remaining 30-40% however can still obtain ECT, as the FDA does not regulate clinical practice, and thus, the roughly 1,000 (of 49,000 psychiatrists) performing ECT in the USA are free to continue performing shock treatment (i.e. similar to prescribing any medication off label).


Amnesia and Memory Dysfunction


There are seventy years of reports of permanent extensive amnesia and memory dysfunction in a large percentage or majority of patients.  Reviewing the evidence to date, in 1985 the NIMH Consensus Conference on ECT found that the average loss was eight months of life and that the majority of ECT patients had chronic memory impairment three years after “treatment”.  Then in 2003, the first-ever systematic review of all the evidence to that date found at least 33% of ECT patients experienced permanent memory loss.  An even more recent prospective study found that at least 45% of patients experienced permanent amnesia, and 40% reported loss of intelligence.


One of the most concise analyses of memory loss and cognitive damage caused by ECT, and historically ignored by the FDA, was published in 2006 in the Advances in Psychiatric Treatment, as reported by the United Kingdom’s (UK’s) Royal College of Psychiatrists. In January 2002, as part of a review of ECT undertaken by the UK’s Department of Health, the Service User Research Enterprise (SURE) undertook the first-ever systematic review of patients’ views on ECT. The review encompassed several large-scale surveys by or of people who had received ECT.  They concluded: 


At least one-third of patients experience permanent amnesia, 

“Memory” is too simple a term to encompass the range of ECT’s permanent adverse effects, and there has been almost no work done on improving terminology, 

A comprehensive battery of neuropsychological tests revealed impairment on a range of measures, even with controlling for symptom severity and medication (Freeman et al, 1980), 

One SURE group found that 65% of people who had received ECT reported impaired organizational skills (ECT Anonymous, 1999), 

Another SURE group found that one-third had difficulty concentrating, and 15% reported loss of reasoning ability (Pedler, 2001), 

Forty percent (40%) of people asked if they had experienced a loss of intelligence “soon after the treatment” answered affirmatively (Philpot et al, 2004). 


The research on permanent amnesia can be summarized as follows: researchers have mostly avoided conducting any long term (six months or longer) studies, but whenever they have looked for permanent memory deficits, they have found them. There have been only two long term (i.e., six month) studies of amnesia done in the past 33 years, and both, despite serious methodological problems, show that permanent extensive amnesia is common.  One found “provocative evidence for autobiographical memory loss lasting at least six months” and the other study, the largest study of memory ever done, concluded “adverse effects can persist for an extended period.”  In December 2013, researchers investigated how ECT impacts reconsolidation of memory and concluded that just one shock treatment “impairs reconsolidation of episodic memories in humans.”


In January 2007, researcher Sackeim, a strong supporter of ECT, reported on how ECT techniques still used today produced cognitive deficits immediately after ECT and six months post ECT.   Sackeim stated, ECT produces “pronounced slowing of reaction time” and significant “persistent retrograde amnesia”.  The study is the very first study conducted six months or longer post treatment for memory loss, and demonstrates: 


“Shortly following the ECT, most patients manifest deficits in retaining newly learned information (anterograde amnesia) and recalling events that occurred in the weeks or months preceding the ECT course (retrograde amnesia)”.

“Empirical information about ECT’s long-term effects derives mainly from small sample studies conducted in research settings, with follow-up intervals frequently limited to 2 months or less. By excluding individuals with significant medical and psychiatric comorbidities, use of optimized forms of ECT, and limited statistical power, these studies could not adequately assess the severity and persistence of long-term deficits.”

Sackeim’s study was “the first large-scale, prospective long-term study of cognitive outcomes following ECT.”

A substantial percentage of the patients will have “marked and persistent retrograde amnesia” even after 6 months, and memory loss and inability to learn new matters will be directly related to the number of ECT treatments received. 

Numerous controlled studies have shown that individuals who are depressed, but have not had ECT: 

do not suffer amnesia (Janis, 1950), 

rarely mistake depression effects and ECT effects (FDA, 1982; Donahue, 2000), 

state ECT’s effects are different and worse than depression and that the negative effects occur only after ECT,

 have negative reactions post treatment even in the absence of depression and drugs.  


ECT Effectiveness


In seven decades there have been only two methodologically sound, randomized controlled clinical trials investigating whether ECT is more effective than drugs, and neither of these studies compared shock to drugs currently in use today.  Interestingly, it has never been compared to other forms of true treatment, such as psychotherapy, exercise, and nutritional changes.


In 1992, and again in 2006, researchers systematically reviewed the literature on real versus sham ECT (i.e., giving someone the anesthetic but no electricity/shocking of the brain), and concluded the studies (i.e. last one in 1985) show no advantage for real ECT.  All 11 such studies failed to meet today’s methodological standards. Only two studies described their randomisation process and tested their blinding, none were double-blind, only four reported any ratings by patients, none assessed the patients quality of life, all were small sample sizes (8-77 subjects), four of the eleven only found ECT significantly superior to sham ECT, five found no difference from sham ECT, and two found the psychiatrist reported a difference and the patients did not.  The two higher quality studies did not find any difference from sham ECT and ECT, and when pooled together, there was a very small effect in favor of Sham ECT.


 Even the most recent American Psychiatric Association Task Force report, though it asserts ECT’s efficacy, did not cite a single study showing real ECT having a superior outcome (a difference in a depression score) when compared to a sham ECT for treating depression. The cost-benefit of ECT is therefore, in general, negative, as ECT includes a host of injuries of the most dire magnitude: death, cardiovascular complications, and, most often, memory loss and cognitive impairment.


In 1985, the NIMH found there was no evidence for any benefit of ECT lasting more than four weeks, and there are no studies since 1985 showing any longer benefit other than Huuhka, Viikki, and Tammentie’s study published in the Journal of ECT in April 2012.  Huuhka et al. acknowledged the relapse rate of short term c/mECT for depressed patients is 40-60% even with antidepressant medication continuing, and for patients with more severe pathology (e.g., schizophrenia, bipolar), patients were even more likely to relapse within 8-12 months. 


In 2001, researchers at Columbia University reported that with a combination of ECT and psychiatric drug intervention, approximately 61% (14 people) of depressed patients had successfully responded to the interventions over a six month period, however, they also noted that with ECT alone, the rate dropped to only 16% (25 people). This might be seen as important if it were not for the fact that there were a total of 316 people originally enrolled in the study and there were so many drop outs and disenrollments, that about half of the people never saw any significant improvement with ECT, even in the very short term.  They also reported the majority who relapsed within one and six months later were suffering long term adverse effects, and that overall only 10% were in remission. The authors concluded without continual therapy “almost universal relapse should be expected” and that without continuing to “treat” them, “virtually all remitted patients relapse within 6 months of stopping ECT.” 


The idea that ECT continues to be effective is inaccurate, and it is not uncommon for initial high success rates to be reported, only to be recanted and clarified later in the study. The FDA requires that all ECT devices have a notice next to them that states “The long term safety and effectiveness of ECT has not been demonstrated.”


It is noteworthy to acknowledge that when researchers assessed who was reporting the results of positive outcomes, there was a difference based on who was reporting.  Some reports indicate that at least 55% of patients who had ECT would not recommend it, nor want it again, and this seems to hold true by most reports, however, when patients are allowed to help design and conduct ECT surveys, only 1/3 of the respondents indicate it was helpful, compared to 3/4 of the doctors saying it was beneficial to their patients.  Given it is the patient's perception of depression or ill feelings, one must certainly question who was reporting on future studies of “success” and which reporting system would really be warranted.


In 2004, another study claimed 70-90% efficacy, which was called “wildly inflated”, as the actual positive rate ranged from 30 to 46% when reviewed and the positive outcomes were noted as only measured a few days immediately after ECT was administered.


In 2010, researchers John Read and Richard Bentall set out to conduct a large literature review and meta-analysis review of over 100 studies on the efficacy of ECT when compared to sham-placebo ECT.  They concluded:


Controlled studies show minimal support for the effectiveness of ECT for depression or “schizophrenia”, however, only:

a) During treatment,

b) For some patients,

c) On some measures,

d) And only by psychiatrists’ reports, not patient reports/raters.

AND,

There was no evidence of any benefits beyond the short treatment period (“a few days”),

f)  There are no placebo-controlled studies showing ECT prevents suicide, 

g)  There is persistent evidence of permanent brain dysfunction, primarily evidenced in 

the form of retrograde and anterograde amnesia, and evidence of significant increased risk of death by ECT.


Read and Bentall concluded by stating:


“Given the strong evidence of persistent and for some, permanent brain dysfunction, primarily evidenced in the form of retrograde and anterograde amnesia, and the evidence of a slight but significant increased risk of death, the cost-benefit analysis for ECT is so poor that its use cannot be scientifically justified.”  


As with the Ross study, the Read and Bentall study was selectively eliminated from the FDA’s literature review for the 2010 Executive Summary Advisory Panel, which was to make a recommendation regarding ECT safety and effectiveness.  Repeatedly, the FDA has not adequately evaluated the research on ECT.


The Manufacturer Somatics, Inc. 's 2010 submission to the FDA conceded that absent continuing treatments, “evaluations performed weeks or months after completion of the acute ECT treatment course usually fail to show a significant advantage of ECT” (Exhibit 6, p. 15). They concede it is necessary to continue other forms of psychiatric treatment for patients after the ECT, or to continue “maintenance” ECT if any improvement is to be expected. (Id.) In short, even the manufacturer admits that once the patient “comes around” from the overwhelming shock to the brain, and begins to recover some sensibility, the “effectiveness” of ECT is absent.  As of today, the device makers have never submitted any clinical evidence to the FDA to prove that the device is safe or effective.






Suicide


Despite claims repeatedly made that ECT is safe and effective for severe depression and helps with suicide, research shows that ECT has no protective effect against suicide either in the short or long term, and thus, such claims certainly are debatable within the literature.


In one of the very few studies looking at ECT and suicide, researchers in 1985 found that ECT patients committed suicide more frequently than those who had not received ECT, even when level of depression was taken into account.

 

The meta-analysis by the UK ECT Review Group (2003) states “Although ECT is sometimes thought to be lifesaving treatment, there is no direct evidence that ECT prevents suicide.”  


In 2004, the Minstiry of Health for new Zealand also found no “...randomised evidence that ECT prevents suicide.”


As noted in the 2010 Read and Bentall meta-analysis literature review of over 100 studies on the efficacy of ECT when compared to sham-placebo ECT, they concluded: “there are no placebo-controlled studies showing ECT prevents suicide.”  However, two studies within the literature review showed that ECT treated patients were five times and three times more likely to kill themselves than patients who had not been given ECT. 


A 2019 literature review found that none of the five meta-analyses of ECT versus placebo for depression reported a single study showing that ECT is more effective than sham ECT at preventing suicide. There was only one in 1978 that assessed suicidal intent, and that study found no difference.


Since 2019, six large scale studies (all without placebo groups) have compared suicide and patients who did, and did not, have ECT.  

A Canadian study found less than .2 of 1% in favor that ECT may reduce suicide, thus becoming the first ever study to support the prior claims. The rate was unrelated to the number of ECTs received.  

A second study found a very small but statistically significant difference in suicides, if over 12 months, between ECT group (1.1%) and non-ECT group (1.6%); however, only if depressed patient was also psychotic, and under 45 years old, and only undetermined intent was also included into the suicide intent group. 

A third study of U.S. veterans found that those who had ECT were 16 times (1600% increase) more likely to try to kill themselves in the year after ECT than a matched group of veterans, and after controlling for demographic, clinical and service use characteristics, ECT patients were 1.3 times more likely to kill themselves (nonsignificant difference).

In 2022, another U.S. veteran study found “no evidence that ECT course decreased the risk of death by suicide”, after 30 days and at one year. 

A fifth study also found an increased risk of suicide after one year by patients who underwent ECT, compared to equally depressed non-ECT patients.

Lastly, the sixth study conducted with U.S. veteran homeless patients showed that ECT treated patients made significantly more suicide attempts (30 days, 90 days, 1 year) than matched non ECT treated patients.


Thus, after 85 years of ECT supporters claiming ECT prevents suicide in depressed people, we find no difference between patients undergoing ECT and those who did not. However, we do find several studies showing ECT associated with an increase in suicide and attempted suicide, and find in general only one study in favor of ECT; however, the difference was 0.2 of 1% (Kaster et al, 2021, 2022).



Neurogenesis


Some researchers have suggested that ECT can cause neurogenesis, or new neural connections as a result of ECT, claiming it is these new neural connections that make ECT “effective.”   The studies purporting to show brain cell proliferation due to ECT may in fact be showing evidence of brain cell damage.  Richard Nowakowski, a neuroscientist at the Robert Wood Johnson School of Medicine in Piscataway, NJ, and a researcher who pioneered the use of the cellular techniques used in these type of experiments, stated “It’s not clear in these studies whether they’re seeing proliferation or something else…[if]… anyone who tells you they know…[what these new networks mean]...they don’t know.” He and other neuroscientists indicated the brain’s nerve networks are laid down over years, and the brain develops and responds to the outside world. The chances that an instantaneous, shock-induced fiber would make exactly the right connections to enhance function is extremely remote and nearly impossible. Moreover, the kind of neural sprouting or mossy fiber proliferation observed in shocked animals also turns up in the brains of people who have epilepsy, a neurological disease in which the body suffers periodic, unexplained seizures. “In this area, there’s a debate over whether the epilepsy causes the fibers, or the fibers cause the epilepsy,” said Nowakowski.


Dr. Peter Sterling, a ECT neuroscientist and professor at the University of Pennsylvania, testified before the New York State Assembly on July 18, 2001 regarding the effects of ECT on the brain, which was also provided to the FDA in Docket No. FDA-2010-N-0585, but again ignored by the FDA in its executive summary, during which he stated ECT unquestionably damages the brain, and there are a variety of mechanisms that lead to this damage: 


“…electroshock delivered to the skull is basically similar to what you would get out of an electrical wall outlet, except…[it] steps up the voltage…when this is done two or three times a week for weeks, it’s just completely obvious that this is going to eventually cause some kind of brain damage…[further] ECT causes…grand mal epileptic seizures…and this causes an acute rise in blood pressure, well into the hypertensive range…and it frequently causes small…hemorrhages in the brain…[whereby] the nerve cells die, and they are not replaced (despite reports of neurogenesis)…[further] ECT ruptures the blood brain barrier. This barrier normally protects the brain from potentially damaging substances in the blood…breaching this barrier exposes nerve cells in the brain to chemical insults that can kill them…[and ECT] also leads…to swelling of the brain…swelling leads to local arrest of blood supply to loss of oxygen…and to death of neurons…[and] ECT…causes neurons to release large quantities of…glutamate. Glutamate excites further neuronal activity…and this becomes a vicious cycle…Neurons literally kill themselves from overactivity…the key manifestation of this brain damage is retrograde memory loss.”   


Brain Damage


Prior to modern brain imaging technology, dozens of human and animal autopsy studies documented brain damage from ECT.  One ECT device manufacturer (Somatics) includes “permanent brain damage” in its lists of risks.  In the modern era, brain scan studies of psychiatric patients show treatment with ECT and cerebral atrophy. The very few studies investigating the ECT brain structure damage link have had serious methodological flaws resulting in inconclusive results (i.e., they did not use normal controls and allowed patients who had previously had shock to be considered as “before shock” or non-shock subjects).


The apparent reason for this memory loss and cognitive impairment is the effect of as much as 450 volts of electricity being forced randomly through the brain, with electrodes being placed at two parts of the head and allowing the electricity to flow through the brain where it may, without control, overwhelming delicate brain circuitry and function. 


There are many studies noting the brain damage caused by ECT.  A study in Archives of General Psychiatry documented that cerebral atrophy (brain shrinkage) was significantly more common in those patients who had ever received electroshock therapy, and that atrophy was significantly more common in ECT recipients than other mental patients in general.  An MRI scan study demonstrated a strong correlation between the numbers of previous ECT treatments and loss of brain tissue, and that those who have ECT were twice as likely to have measurable loss of brain tissue in the front area of the brain and a tripling of brain tissue loss in the back of the brain, even when age, alcohol use, gender, family history of mental illness, age at the time of psychiatric diagnosis, and severity of mental illness were considered.  In addition to the FDA Executive Summary ignoring such information, it also ignored a particularly graphic study of brain damage caused by ECT devices, noting intracranial bleeding.  


ECT manufacturers state the electricity causing the damage to the brain is in fact the “therapeutic agent,” but they concede the resulting convulsions do not cause the appropriate purported therapeutic result, and, in turn, they recommend practitioners give patients substantially more electricity than is necessary to produce a convulsion – called a “supra-threshold or multiples of electricity above convulsion threshold.”  They noted using “2.5 times the initial seizure threshold” amount of electricity (MECTA Manual, p. 33), all the way to six TIMES the amount of electricity needed to cause a seizure.   The conclusion to be drawn from the manufacturer’s recommendations regarding the amount of electricity necessary to produce the desired effect, is that: 


The manufacturers know seizures are not the basis for the alleged benefit from ECT, 

The manufacturers recommend unilateral ECT, but assert that to get the same efficacy, practitioners need to double the electricity, 

Doubling the electricity translates to up to six times the amount of electricity needed to cause a grand mal seizure (which elsewhere in medicine is recommended to be assiduously avoided).  


Research Effect


There seems to be a growing concern and consensus around the world regarding ECT. In February 2013, in the United Nations Special Report on Torture, Mr. Juan Mendez recommended, and the United Nations approved an:


“absolute ban on forced and non-consensual medical interventions against persons with disabilities, including non-consensual administration of psychosurgery, electroshock and mind-alternating drugs such as neuroleptics, [and] the use of restraint and solitary confinement, for both long and short-term application.”  


Following the United Nations call for a ban upon forced ECT and noting it was “torture”, and on behalf of the International Society for Ethical Psychology and Psychiatry (ISEPP), I provided a written summary of the above research on November 5, 2013 to the Australian Minister of Mental Health-Disability Services and Child Protection division, supporting the Mental Health Bill 2013 which banned ECT being performed on children under the age of eleven, and provided more safeguards for older children (i.e., forcing shock doctors to present before a mental health tribunal before trying to administer such intervention).  


Despite the FDA’s inability to enforce requests upon the ECT device makers, and their inability to adequately alert legislation and the public to the harm done by ECT, the World Health Organization stated, and recommended: 


“There are no indications for the use of ECT on minors, and hence this should be prohibited through legislation.”


FDA


The FDA’s 2010 Executive Summary prepared for an Advisory Committee an exhibit for them to review, acknowledging the FDA located more than 1,200 studies relating to ECT.  However, the FDA rejected more than 94% of all studies relating to ECT because the studies allegedly were unreliable.  Thus, the committee included for serious evaluation only 68 studies published in the past 70 years, and excluded 1,163 other studies and gave them no consideration.  Many of the excluded studies concluded that ECT lacked efficacy and unquestionably created severe and permanent injury, including the death of some patients. The FDA did not conclude that there was no scientific merit in the 1,163 studies excluded, only that the studies failed to satisfy arbitrarily selected exclusion criteria by the committee members, thereby deeming them as being “unreliable”.  The FDA only considered an extreme subset of the ECT evidence, allowing for a skewed data assessment, biasing itself in favor of ECT, and abusing the agency’s obligation to protect the public. 


The FDA also excluded from substantive consideration the extensive comments and research submissions, as made by myself, in the 2011 Advisory Committee hearing, seemingly because thousands of comments explaining actual harm caused to patients, was merely “anecdotal.” The FDA excluded direct evidence of injury caused by ECT, despite at other times relying upon the Adverse Reporting System for making decisions regarding safety. In the end of that 2011 hearing, a small number of unauthenticated and even anonymous reports were considered, and about 2,400 adverse comments were excluded from consideration by the FDA – including 103 reports of deaths, 529 reports of memory impairments, 413 reports of cognitive impairments, and 298 reports of brain damage. Moreover, the former commissioner of the FDA has conceded that only “about 1% of serious adverse events are reported to FDA.”    

 

ECT and the Elderly


ECT is much more frequently used on the elderly, as two articles highlighted on one of the manufacturer’s (MECTA) websites concedes.  It promotes an article entitled, “ECT in Geriatric Neuropsychiatric Practice”. The article notes: For years after its introduction in 1938, ECT was used primarily in younger adults because of concerns about its safety in older patients. Kramer (1985) reviewed patterns of ECT use in California from 1977 to 1983 and found that the probability of receiving ECT increased with age of the patient.  Patients ages 65 years and older were given ECT at a rate of 3.86/10,000 population, compared with 0.85/10,000 in those aged 25 to 44 years.  In an analysis of the data of ECT use in California from 1984 to 1994, Kramer (1999) found similar patterns. 


Thompson et al. (1994) analyzed data from the National Institute of Mental Health Sample Survey Program for 1980 to 1986, which included representative samples of psychiatric inpatients in the United States. They found that approximately one third of ECT recipients were aged 65 years and older, a figure far out of proportion to the representation of that age group in the sample (8.2%). 


Rosenbach et al. (1997) studied a sample (~4,000 people) of Medicare Part B claims from 1987 to 1992 and found an ECT rate of 5.1/10,000 population.  In an analysis of inpatient data from the 1993 Healthcare Cost and Utilization Project of the Agency for Healthcare Policy and Research, Olfson et al. (1998) found increasing age was one of several patient variables associated with higher ECT use; persons aged 65 years and older were seven times more likely to receive ECT than were persons aged 18 to 34 years. It would appear that Medicare aged patients are among those at highest risk of injury from ECT, presumably because of their uniform health insurance coverage and because of a lessened age-related ability to withstand their physician’s suggestions for treatment.  


Researcher Fink concluded in “Electroshock - Restoring the Mind”, the ECT device is “riskier” and “inadequate for effective treatment” in the elderly population. In a study conducted at Brown University with 65 elderly patients hospitalized and treated for depression, the 37 patients who had received ECT has survival rates of 73.0% at one year, 54.1% at two years, and 51.4% at three years, whereby and in contrast, the depressed patients who did not receive ECT had survival rates of 96.4%, 90.5%, and 75.0% at one, two, and three years, respectively. In a large retrospective study of 3,288 patients receiving ECT in Monroe County, NY, recipients were found to have a substantially increased death rate from all causes, when compared to those not undergoing ECT. Another study reported the death rate was doubled in depressed patients who received ECT in a seven-year follow up study of 188 patients. 


Despite the higher usage with the elderly, children are also subjected to ECT. The Autism Key, an online information and support network, states that ECT is being recommended and used on autistic children who self-harm and warns about more “widespread autism applications”, noting a lack of evidence that electroshock is safe for children. There is now a prohibition of pediatric ECT in some US states and a recent ban under the Western Australian Mental Health Act and by the Australian Capital Territory, something I personally submitted written testimony towards and assisted in creating. In response to that work, in October 2014, the Western Australia Mental Health Act banned the use of ECT on those younger than 14 and posed a $15,000 fine and two years imprisonment on anyone performing the procedure on this age group. Even an adolescent aged between 14 and 18 who is a voluntary patient cannot have the treatment without informed consent and approval by a mental health tribunal.


The World Health Organization’s Resource Book on Mental Health, Human Rights and Legislation 2005 also states, “...if ECT is used, it should only be administered after obtaining informed consent.” Further, “there are no indications for the use of ECT on minors, and hence this should be prohibited through legislation.”


Reporting on ECT


Texas is one of only two states that require practitioners of ECT to provide information to the state regarding “reportable events” arising out of ECT, which include memory loss and death. In 2008 alone, five patients died soon after receipt of ECT, out of the several hundred that received the treatment.  In 2006, there were 3 additional deaths reported in Texas following treatment.  In the first three years of mandated reporting in the early 1990s, 21 patients were reported as having died soon after receiving ECT.  From June 1993 through August 1994, eight deaths were reported among less than 1,700 ECT patients.  Reports from Texas for state fiscal year 2014 are even worse, in that a significant number of the deaths immediately following ECT were suicides. In the 2014 ECT Annual Report, six deaths were reported shortly after ECT administration, “which was double the average number for the prior five years.”  Thus, the modification of the electrical delivery to “brief-pulse” wave lengths, which some have reported as being safer, has actually resulted in no benefit and a statistically significant indication that the newer forms of electrical delivery are more, rather than less, harmful.  


Using the given number of ECT reports as an approximate figure for numbers of patients who died, the six deaths in 2014, when calculated by the standard of deaths per 100,000 persons, equate to an astonishing death rate of 243 deaths per 100,000 persons receiving ECT. Suicide deaths immediately following ECT (four of the six deaths reported in Texas 2014), reveals a suicide rate of 162 per 100,000 persons. The overall Texas suicide rate according to the American Foundation for Suicide Prevention was 12.18 per 100,000. Thus, the suicide rate for Texas patients shortly following ECT was 13 times greater than the state suicide rate for the year. As noted above, the Texas reporting system captures the annual number of reports (the overall number of ECT treatments) rather than the total number of patients treated. Hence, the suicide rate post ECT is likely to be much higher than what is here presented.  


Proponents of ECT calculate a mortality rate based upon the number of sessions rather than the number of patients who received the treatment. Some calculations in ECT proponents’ publications will reference number of suicides or deaths by the total number of treatments delivered. Such a methodology is comparable to calculating the suicide rate for persons taking antidepressants by the number of pills (doses), or deaths of heroin addicts by the number of heroin fixes divided by number of deaths. Since a single patient may take hundreds or even thousands of doses over time, mortality rates would be reduced exponentially. Thus, like the hypothetical antidepressant users above, calculating mortality rate based on dose or treatment instead of number of people treated with ECT minimizes death as a rare event. For example, a recent paper published in the July 2016 Journal of ECT, by Somatics and MECTA consultant Richard Weiner et al., calculated mortality rates based on Texas data on deaths versus number of treatments rather than deaths versus number of people. And even with that minimization of data, they were still able to find that the “death rate increased significantly with increasing patient age (P = 0.001).”  Moreover, it is clear from the FDA’s Executive Summary for the 2011 FDA Advisory Committee Hearings that the FDA improperly accepted such skewed data as accurate.  


Informed Consent


In November of 2023, through the Freedom of Information Act, Read et al conducted an ECT provider audit throughout England, assessing the accuracy of ECT therapy information leaflets. 71% of the providers required to provide such information did in fact provide their ECT leaflets. Leaflets were scored on a 40 item accuracy scale, ranging from 4-20 points (20 being most accurate).  The average accuracy score was only 12.8.  


Most noteworthy failures of information consent were the following: 

0 leaflets indicated ECT memory impairment is more common for women and elderly. 

0 of 36 leaflets disclosed the amount of electricity being applied to the brain. 

1 of 36 indicated the right to discuss the ECT option for 24 hours prior to procedure. 

6 of 36 noted that sham ECT/placebo works for some patients.

6 of 36 only indicated there is no long term evidence on benefits. 

6 of 36 mentioned the risk of increased cardiovascular problems following ECT. 

11 of 36 wrongly indicated ECT is “most effective” compared to other treatments. 

11 of 36 falsely claimed ECT is mostly/all voluntary. 

12 of 36 only noted ECT should be used after other treatment failures. 

15 of 36 wrongfully blamed memory loss on depression rather than ECT.

22 of 36 only mentioned patient consent rights.

22 of 36 falsely claimed that ECT saves lives by preventing suicide. 

26 of 36 indicated some people have memory loss/brain damage/cognitive dysfunction.

0 of 36 indicated there may be psychosocial causes for the disorder (loss, abuse, poverty).

Summary 

In summary, the researchers concluded that most of the treatment centers refused to provide their leaflets about ECT, and even after a second attempt to obtain the leaflet with the administration, most still did not provide the patient information leaflet (i.e. despite being mandated by law to provide them). Of those ECT providers who did, only three amended their leaflets after being notified of the false misleading and missing information for patient informed consent. The researchers noted their “disturbed findings” and noted how “no one is monitoring or regulating”, as it applies to providing accurate informed consent for ECT. 


ECT has not been shown to be safe or effective, and serious harm does result.  It likely should be completely banned, but if any such device and intervention is going to continue to be used, it absolutely cannot and should not be used upon the most vulnerable populations, namely children and the elderly.  There has never been any clinical trial showing the effect upon the developing brain.  

Dr. Toby Watson, Psy.D.

Dr. Toby Watson, PsyD

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