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.
Electroconvulsive Therapy (ECT) Introduction:
An ECT device is often used upon an individual in order to stop severe psychiatric disturbances (e.g., severe 3 depression) by inducing in the individual a major motor seizure by applying a brief intense electrical current to the patient's head. This is called Electro-Convulsive 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 in treatments. In the administration of ECT, electrodes are sometimes placed on one side of the head, known as unilateral ECT, or more commonly 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 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-four weeks, but may cases I have heard 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), Class II (Performance Standards), and Class III (Premarket Approval). 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 it’s 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 continue should be classified as “high risk” devices (i.e. Class III is 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. Nevertheless, articles and newspaper commentaries continue to be positioned throughout the United States making false claims of ECT effectiveness and safety. This false is idea that ECT is safe and effective is commonly acknowledged by the psychiatric community, noting that the reason ECT ‘works’ is ultimately unknown.
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 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:
1) At least one-third of patients experience permanent amnesia,
2) ...‘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,
3) 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),
4) one SURE group found that 65% of people who had had ECT reported impaired organizational skills (ECT Anonymous, 1999),
5) Another SURE group found that one-third had difficulty concentrating, and 15% reported loss of reasoning ability (Pedler, 2001),
6) 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 (e.g. 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: just one shock treatment “impairs reconsolidation of episodic memories in humans.”
In January, 2007, researcher Sackeim, a strong supporter of ECT, reported on how current ECT techniques still used produced cognitive deficits immediately and after 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 of 6 month or greater post treatment for memory loss, and demonstrates:
1) “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)”,
2) “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.”,
3) Sackeim’s study was was “the first large-scale, prospective long-term study of cognitive outcomes following ECT.”,
4) 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.
5) Numerous controlled studies have shown that individuals who are depressed, but have not had ECT: A) do not suffer amnesia (Janis, 1950), B) rarely mistake depression effects and ECT effects (FDA, 1982; Donahue, 2000), C) state ECT’s effects are different and worse than depression and that the negative effects only only after ECT, D) have negative reactions post treatment even in the absence of depression and drugs.
In seven decades there here 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 vs. sham ECT (i.e. pretending they gave someone ECT when in fact they did not), and concluded the studies show no advantage for real 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, 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 successful 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 dis-enrollments, 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 later in the study to be recanted and clarified.
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, 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 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.
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.
Researchers John Read and Richard Bentall in 2010 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 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.
There was no evidence of any benefits beyond the short treatment period (“a few days”).
There are no placebo-controlled studies showing ECT prevents suicide.
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 patent “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.
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 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 Robert Wood Johnson School of Medicine in Piscataway, N.J., 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, 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 over activity… the key manifestation of this brain damage is retrograde memory loss.”
Prior to modern brain imaging technology, dozens of human and animal autopsy studies documented brain damage from ECT. 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 of the FDA Executive Summary ignoring such information, it also ignored a particularly graphic study of brain damage caused by ECT devices, noting inter-cranial 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 6 TIMES the amount of electricity needed to cause a seizure. The conclusion to be drawn from the manufacturers’ recommendations regarding the amount of electricity necessary to produce the desired effect, is that:
1) The manufacturers know seizures are not the basis for the alleged benefit from ECT,
2) The manufacturers recommend unilateral ECT, but assert that to get the same
efficacy, practitioners need to double the electricity,
3) Doubling the electricity translates to up to 6 times the amount of electricity needed to
cause a grand mal seizure (which elsewhere in medicine is recommended to be assiduously avoided).
There seems to be a growing concern and consensus around the world regarding ECT. In February 2013, the United Nations Special Report on “Torture”, Mr. Juan Mendez recommended, and the United Nations approved:
"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”, I on behalf of the International Society for Ethical Psychology and Psychiatry (ISEPP) provided a written summary of the above research on 11-5-13 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 11, 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 by ECT, the World Health Organisation stated and is recommending:
“There are no indications for the use of ECT on minors, and hence this should be prohibited through legislation.”
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, 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 “about 1 % of serious adverse events are reported to FDA...”
ECT and Elderly
ECT is much more frequently used on the elderly, as two articles highlighted on one of the manufacturer's (MECTA’s) website 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 ages 25–44 years. In an analysis of the data on 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 and 1986, which included representative samples of psychiatric inpatients in the United States. They found that approximately one third of ECT recipients were ages 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 Health Care 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 ages 65 years and older were seven times more likely to receive ECT than were persons ages 18–34 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 conceded 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 had 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 1, 2 and 3 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 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. Yet, there is now prohibition of pediatric ECT in some U.S. states and a recent ban under the Western Australian Mental Health Act and by the Australian Capital Territory, something I personally submitted written testimony upon and assisted in creating. In response to that work, in October 2014, the Western Australian Mental Health Act banned the use of ECT on those younger than 14 and poses a $15,000 fine and 2 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 includes 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 in Texas reported following treatment. In the first three years of mandated reporting in the early 1990’s, 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, 6 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, actually has resulted in no benefit and a statistically significant indication that the newer forms of electrical delivery is more, rather than less, harmful.
Using the given number of ECT reports as an approximate figure for numbers of patients who died, the 6 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 (4 of 6 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, since 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 proponent’s 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, calculates mortality rates based on Texas data on deaths vs. number of treatments rather than deaths vs. number of people. And even with that minimization of data, they were still able to find that “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.
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.
Dr. Toby Watson, Psy.D.
2808 Kohler Memorial Drive, Suite 1, Sheboygan, WI 53044
.Mental Health: A Report of the Surgeon General, United States Department of Health and Human Services (1999), at p. 258-261.
 Mental Health: A Report of the Surgeon General, United States Department of Health and Human Services (1999), at p. 258-261.
 American Psychiatric Assocationhttp://www.ect.org/resources/apa.html
 See 44 Fed. Reg. 51776 (Sep. 4, 1979); 21 C.F.R. § 882.5940.
 http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM240933.pdf
 Rudorfer, MV, Henry, ME, Sackeim, HA (2003). "Electroconvulsive therapy". In A Tasman, J Kay, JA Lieberman (eds) Psychiatry, Second Edition. Chichester: John Wiley & Sons Ltd, 1865–1901.
 Andre, L. (2009) Doctors of deception: what they don’t want you to know about shock treatment., Rutgers University Press.
 “Consensus Conference: Electroconvulsive Therapy,” Journal of the American Medical Association 254 (15), (1985, October 18), 2103-2108.
 D. Rose, P. Fleischmann et al, “Patients’ Perspectives on Electroconvulsive Therapy: Systematic Review,” British Medical Journal 326 (7403), (2003, June 21), 1363-1367
 M. Philpot, C. Collins et al, “Eliciting Users’ Views of ECT in Two Mental Health Trusts with a User Designed Questionnaire,” Journal of Mental Health 13(4), (2004, August), 403-413.
 Robertson, H., Pryor, R. (2006) Memory and cognitive effects of ECT: informing and assessing patients, Advances in Psychiatric Treatment Vol. 12, pages 228–238. http://apt.rcpsych.org/cgi/reprint/12/3/228.pdf
 R. Weiner et al, “Effects of Stimulus Parameters on Cognitive Side Effects,” Annals of the NY Academy of Sciences 462 (1986), 315-325; H. Sackeim, J. Prudic et al, “The Cognitive Effects of Electroconvulsive Therapy in Community Settings,” Neuropsychopharmacology 32 (2007), 244-254.
 M. Kroes, I. Tendolkar, et al, “An electroconvulsive therapy procedure impairs reconsolidation of episodic memories in humans,” Nature Neuroscience, Dec. 22, 2013.
 Harold A. Sackeim, et al., “The Cognitive Effects of Electroconvulsive Therapy in Community Settings, Neuropsychopharamacology (2007) 32: 244-254.
 A. Rivkin, “Shock Therapy: A History of Electroconvulsive Treatment in Mental Illness” (book review), New England Journal of Medicine 358(2), (2008, January 10), 204-205
 G. Shepard, S. Ahmed, “A Critical Review of the Controlled Real vs. Sham ECT Studies in Depressive Illness,” paper presented at the First European Symposium on ECT, Graz, Austria, March 1992. C. Ross, “The Sham ECT Literature: Implications for Consent to ECT,” Ethical Human Psychology and Psychiatry 8(1), (2006), 17-28.
 H. Huuhka, M. Viikki, T. Tammentie et al, “One-Year Follow Up After Discontinuing Maintenance Electroconvulsive Therapy,” Journal of ECT (April 24, 2012).
 H. Sackeim, R. Haskett et al, “Continuation Pharmacotherapy in the Prevention of Relapse Following Electroconvulsive Therapy,” Journal of the American Medical Association 285(10), (2001, March 14), 1299-1307.
 Squire, L, Slater, P, “Electroconvulsive therapy and complaints of memory dysfunction: a prospective three-year follow up study”, In Brit. J. Psychiatry, 142 (1983), 1-8.
 Shock Therapy and the Brain' Los Angeles Times, November 11, 2003, online Dec. 23, 2015: http://articles.latimes.com/2003/nov/17/health/he-ect17/3
 J. Prudic, M. Olfson et al, “Effectiveness of Electroconvulsive Therapy in Community Settings,” Biological Psychiatry 55 (2004), 301-312
 V. Milstein, J. G. Small et al, “Does Electroconvulsive Therapy Prevent Suicide?” Convulsive Therapy 2(1), 1986, 3-6.
 T. Munk-Olsen, P. Videbech et al, “All-Cause Mortality Among Recipients of Electroconvulsive Therapy,” British Journal of Psychiatry 190 (2007), 435-439.
 J. Read and R. Bentall, “The Effectiveness of electroconvulsive therapy: A literature review”, In Epidemiological e Psischiatria Sociale, 19, 4 (2010), 333-347.
 “FDA: Electroshock has risks but is useful to combat severe depression,” The Washington Post, July 18, 2016, washingtonpost.com/national/health-science/fda-electroshock-has-risks-but-is-useful- to-combat-severe-depression/2016/07/18/4a109cbc-2f4e-11e6-9de3-6e6e7a14000c_story.html?postshare=7721468884912250&tid=ss_tw.
 Inta, D., Lima-Ojeda, J. et al. Electroconvulsive Therapy Induces Neurogenesis in Frontal Rat Brain Areas. In PLOS one. July 26, 2013. DOI: 10. 1271/journal.pone.0069869. Online Nov. 23, 2015. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0069869
 Madsen, T., Treschow, A., et al. Increased neurogenesis in a model of electroconvulsive therapy. Biol Psychiatry. 2000 Jun 15;47(12):1043-9.
 Carey, B. Shock therapy and the brain: new studies on the treatment for depression emphasize uncertainty about its effects. The Los Angeles Times, November 17, 2003. Online Nov. 23, 2015. http://articles.latimes.com/2003/nov/17/health/he-ect17/2
 Report to the New York Assembly reviewing the safety of ECT, 2001. http://www.survivorlink.org/electroshock/nyassemblyreport/AR-safety.html
 “FDA: Electroshock has risks but is useful to combat severe depression,” The Washington Post, July 18, 2016, washingtonpost.com/national/health-science/fda-electroshock-has-risks-but-is-useful-to- combat-severe-depression/2016/07/18/4a109cbc-2f4e-11e6-9de3-6e6e7a14000c_story.html?postshare=7721468884912250&tid=ss_tw.
 Weinberger, et al. (1979) Structural abnormalities in the cerebral cortex of chronic schizophrenic patients. Archives of General Psychiatry, 36:935-939.
 Callaway, et al., (1981) ECT and cerebral atrophy: a CT study. Acta Psych Scand, 64:442-445.
 Andreasen, et al., (1990) MRI of the Brain in Schizophrenia. Arch Gen Psych, 47:35-41.
 Dolan, R.J.; et al., (1986) The cerebral appearance in depressed subjects. Psychol Med, 16:775-779.
 Kulkarni and Melkundi (2012) Subdural Hematoma: An Adverse Event of Electroconvulsive Therapy – Case Report and Literature Review. Case Reports in Psychiatry. While other articles are merely referenced, the instant article, containing graphic scans, is attached hereto as Exhibit 4.
 (See Exhibit 5, MECTA Submission to FDA, p. 6, 10, 23; Exhibit 6, Somatics, Inc. Submission to FDA, p. 9, 10, 16, 17.
 Weinberger, et al. (1979) Structural abnormalities in the cerebral cortex of chronic schizophrenic patients. Archives of General Psychiatry, 36:935-939.
 Statement by Mr. Juan E Méndez, SPECIAL RAPPORTEUR ON TORTURE AND OTHER CRUEL, INHUMAN OR DEGRADING TREATMENT OR PUNISHMENT, 22nd session of the Human Rights Council Agenda Item 3, March 4, 2013, Geneva.
 WHO Resource Book on Mental Health, Human Rights and Legislation, World Health Organisation, 2005, p.64.
 See Executive summary, p. 12. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM240933.pdf
 Kessler, D.A. (June 2, 1993) Introducing MEDWatch. A New Approach to Reporting Medication and Device Adverse Effects and Product Problems by David A. Kessler, M.D., for the Working Group. JAMA, Vol. 269, No. 21 pages 2765-2768. www.fda.gov/downloads/Safety/MedWatch/UCM201419.pdf
 Coffey CE, Cummings JL (eds): The American Psychiatric Publishing Textbook of Geriatric Neuropsychiatry, Third Edition. 2011 American Psychiatric Association. http://www.mectacorp.com/clinician.html
 Fink, Max. (1999) Electroshock – Restoring the Mind. New York, NY: Oxford University Press. page 108 “The devices now sold in the United States are inadequate for effective treatment of some patients.14 ” Citation #14 “For some elderly patients, psychiatrists must now use cumbersome and riskier techniques, such as the administration of caffeine or theophylline (Nobler and Sackeim, 1993) or double stimulation (Swartz and Mehta, 1986; Andrade, 1991)...”
 Kroessler, D. and Fogel, B., (1993) Electroconvulsive Therapy for Major Depression in the Oldest Old. Am J Geriatr Psych;1:1: pages 30-37.
 Babigian, H., et al., (1984) Epidemiologic Considerations in ECT. Arch Gen Psych;4:246-253.
 O'Leary, D. and Lee, A. (1996) Seven Year Prognosis in Depression - Mortality and Readmission Rates in the Nottingham ECT Cohort. British J of Psychiatry. 169: 423-429.
 Cheryl van Daalen-Smith, et al., “The Utmost Discretion: How Presumed Prudence Leaves Children Susceptible to Electroshock,” CHILDREN and SOClETY, Vol. 28, 205-217 (2014) , http://www.breggin.com/ECT/vanDaalen-Smith&Breggin2014_ECTchildren.pdf
 Australian Capital Territory Mental Health Bill 2015,
 “Electroshock therapy on under-14s banned in WA after law passes Parliament,” ABC News, 17 Oct. 2014, http://www.abc.net.au/news/2014-10-17/mental-health-bill-passes-wa-parliament/5822874
 Benedetto Saraceno, MD, “WHO RESOURCE BOOK ON MENTAL HEALTH, HUMAN RIGHTS AND LEGISLATION WHO 2005,” p. 64.
 Texas Department of State Health Services. Electroconvulsive Therapy (ECT) Reports. Report of ECT and Other Therapies (page 2). http://www.dshs.texas.gov/mhsa/bhmd/ect/
 Kessler, D.A. (June 2, 1993) Introducing MEDWatch. A New Approach to Reporting Medication and Device Adverse Effects and Product Problems by David A. Kessler, M.D., for the Working Group. JAMA, Vol. 269, No. 21 pages 2765-2768. See http://www.fda.gov/downloads/Safety/MedWatch/UCM201419.pdf
 Texas Department of State Health Services. Electroconvulsive Therapy (ECT) Reports. FY08 Annual ECT Facility Summary. http://www.dshs.texas.gov/mhsa/bhmd/ect/
 Texas Department of State Health Services. Electroconvulsive Therapy (ECT) Reports. FY 2006 ECT Data
 Don Gilbert, Commissioner, Texas Department of Mental Health and Mental Retardation, 1996.
 Gary Null, citing Peter R. Breggin M.D., (1998) “Electroshock: scientific, ethical, and political issues,” International Journal of Risk & Safety in Medicine 11 5-40 IOS Press. http://www.garynull.com/documents/ECT/SideEffects2.htm
 Texas Department of State Health Services. Electroconvulsive Therapy (ECT) Reports. FY 2014 ECT Annual Report, page 1. http://www.dshs.texas.gov/mhsa/bhmd/ect/
 American Foundation for Suicide Prevention. State Fact Sheets. Suicide: Texas 2016 Facts & Figures. https://afsp.org/about-suicide/state-fact-sheets/#Texas
 Texas Department of State Health Services. Electroconvulsive Therapy (ECT) Reports. FY 2014 All Facilities Summary. http://www.dshs.texas.gov/mhsa/bhmd/ect/ “Number of patients, reported quarterly, to have received ECT: 2466*” “*This number may reflect patients who have received ECT in more than one quarter this year.”
 Dennis NM, Dennis PA, Shafer A, Weiner RD, Husain MM. (July 16, 2016) Electroconvulsive Therapy and All-Cause Mortality in Texas, 1998-2013. J ECT. DOI: 10.1097/YCT.0000000000000340 http://www.ncbi.nlm.nih.gov/pubmed/27428480
 FDA Executive Summary. Prepared for the January 27-28, 2011 meeting of the Neurological Devices Panel Meeting to Discuss the Classification of Electroconvulsive Therapy Devices (ECT). FDA, 515(i) Executive Summary, beginning on page 35.
Electro-Convulsive "Therapy" - ECT - Shock Treatment