In 2015, the U.S. Food and Drug Administration issued its “Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating,” recommending that the ECT device be rated Class II (less risk classification than its current Class III) for:
- Severe major depressive episode (MDE) associated with major depressive disorder (MDD) or
- bipolar disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which is a pre-amendments class III device, into class II (special controls) based on new information.[1]
Citizens Commission on Human Rights International, a mental health rights group, submitted a paper in opposition to any reclassification and, in fact, demands a complete ban on ECT.
Parts of CCHR’s submission to the FDA are reprinted here, the first exposing how psychiatrists dismiss patient adverse evidence against ECT as merely “anecdotal”:
In the more than 40 years that the ECT device manufacturers have had their shock devices on the market they have never conducted a clinical trial to support its safety and efficacy, from which they have profited. Add to this the psychiatric community’s negation of adverse electroshock feedback from patients to whom they have administered electro-shock. Who better to report what occurred, than the very person upon whom the treatment is being rendered?
Contrary to the psychiatric community’s position, the FDA is supposed to recognize “reports of significant human experience with a marketed device” as a form of valid scientific evidence.” (21 CFR Ch 1 860.7 (c)(2)[2]
The need to respect the patients’ perspective and not dismiss their experiences of harm as “anecdotal” was presented by psychiatrist, Dr. Colin Ross, in his submission to the FDA in 2011. He stated: “In general, the effectiveness of ECT is greatly exaggerated in the ECT literature and its toxicities and side effects are greatly minimized, discredited as ‘anecdotal, attributed to the depression rather than the treatment, or dismissed as ‘anti-psychiatry.’”[3]
In May 2006 Harold Robertson and Robin Pryor addressed the patients’ perspective in BJPsych. They said that ECT has come under scrutiny, “with the first systematic review of patients’ experiences and new national guidelines” in the UK. As part of a review of ECT undertaken by the UK’s Department of Health, the Service User Research Enterprise (SURE) published 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 in the UK.[4]
The authors report some of the conclusions to come out of the new work. In particular, at least one-third of patients experience permanent amnesia and newer methods of ECT have not resulted in an appreciable decrease in adverse effects.[5] [Emphasis added]
In contradiction to this, psychiatrists that appeared before [FDA’s] Neurological Devices Panel of the Medical Devices Advisory Committee hearings in January 2011 disputed patients’ experience as anecdotal: For example, Dr. Charles Kellner was a consultant for the two ECT device manufacturers, MECTA and SOMATICS, Inc. and wants the ECT device rated Class II.[6] Dr. Kellner (cited also in the MECTA submission to the FDA about five times) was also a member of the American Psychiatric Association (APA) ECT Task Force in 2001 and 2010.
Dr. Kellner claims that “almost all of the controversy about ECT is anecdotal opinion, unsupported by evidence.”[7] Yet, there is no science (clinical studies) to substantiate ECT as safe and effective.
Dr. Kellner provided his opinion against a patient who filed a lawsuit over ECT damage in 2003. He asserted that the patient, Ms. Peggy Salters’ suicidality justified the administration of ECT; however, the court found that this could not be substantiated by the medical records. As the result of an intensive course of outpatient ECT in 2000, she lost all memories of the past 30 years of her life, including all memories of her husband of three decades, now deceased, and the births of her three children.[8] In 2005, the court awarded Ms. Salters more than $635,000 for the long-term memory loss the ECT caused her.[9] By Dr. Kellner’s standards, this confirmed damage is “anecdotal.”
In March 2016, a coroner from Sunderland County in the UK heard how a hospital patient, Elsie Tindle, died after electroshock triggered an epileptic fit which caused irreparable brain damage. Home Office pathologist, Dr. Nigel Cooper, who performed the post mortem on Miss Tindle, concluded the formal cause of death as anoxic-ischemic brain damage, due to status epileptica, due to electroconvulsive therapy. The brain was completely starved of oxygen during the prolonged fit in 2015. After the third ECT session, Miss Tindle fell ill the following day. She died 25 days later, on April 4, 2015.[10]
FDA must put patient protection above the financial interests of companies that have failed to conduct clinical trials and provide a Pre-Market Application (PMA) for nearly 40 years. Because there are U.S. state laws that allow for electroshock to be administered to patients without their consent—as exemplified in the Elsie Tindle case above from the UK—even greater protections are needed.
Given that the APA is seeking to make the [ECT] device rated as Class II for an even wider range of mental disorders and for children, that its members discount the serious risks of ECT as “anecdotal” and consider clinical trials are “too expensive;” given that both Dr. Matthew Rudorfer, a psychiatrist and Chief of Nation Institute of Mental Health’s (NIMH) Somatic Treatments Program and the ECT device manufacturers claim the device makers cannot financially undertake a clinical trial, the FDA Proposal is disingenuous and misleading.
CCHR opposes the FDA’s Proposed Order. In lieu of removing the device from the market, it must remain as Class III so that FDA can ensure the health and safety of patients are protected and placed above the economic concerns of the ECT device manufacturers.
References:
[1] http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-1210-0001.
[2] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=860.7.
[3] Dr. Colin A. Ross, submission to the FDA, 10 Jan. 2011, http://www.electricshocktherapy.info/uploads/4/0/7/6/4076267/colin_a_ross_md_ect_psychiatrist.pdf.
[4] Harold Robertson, Robin Pryor, “Memory and cognitive effects of ECT: informing and assessing patients,” Advances in Psychiatric Treatment May 2006, 12 (3) 228-237; DOI: 10.1192/apt.12.3.228, http://apt.rcpsych.org/content/12/3/228.full.
[5] Ibid.
[6] Linda Andre, Doctors of Deception: What They Don’t Want You to Know about Shock Treatment, (Rutgers University Press, 2009) p. 101.
[7] Charles Kellner, M.D., “Electroconvulsive Therapy: The Second Most Controversial Medical Procedure,” Psychiatric Times, 8 Feb. 2011.
[8] Case 03CP4004797, Richland County, South Carolina, Filed October 03, 2003, Decided June 17, 2005, http://suemypsychiatrist.wordpress.com/category/ect/.
[9] Ibid.
[10] Petra Silfverskiold, “Electric shock therapy led to Sunderland patient having permanent fit,” Daily Mail (UK), 10 Mar. 2016, http://www.sunderlandecho.com/news/local/all-news/electric-shock-therapy-led-to-sunderland-patient-having-permanent-fit-1-7786233.