Watchdog says electroshock must be banned, but until this occurs, hospitals are being notified that omitting patient information of how electroshock treatment causes brain-damage and memory loss may constitute consumer fraud.
CCHR is responding to consumers reporting severe and permanent memory loss from undergoing electroconvulsive therapy (ECT). CCHR is writing to the more than 400 psychiatric facilities in the U.S. delivering ECT alerting them to the recognized risks that patients must be informed of to protect them and to avoid consumer fraud action being taken against the hospital and psychiatrists administering ECT. As part of a worldwide movement that wants electroshock permanently banned, until this occurs, every known risk of the damaging practice must be disclosed along with all safer, non-physically invasive alternatives that are available.
Each year, the controversial treatment, which uses electricity to induce a grand mal seizure to treat depression, is administered to at least 100,000 Americans, representing a $3-$5 billion a year industry. Astonishingly, as CCHR established through state Freedom of Information Act requests, this includes children aged five or younger receiving it, although ECT is not approved for this age group or children in general.
The Food and Drug Administration (FDA) which issued a Final Rule regarding electroshock devices in December 2018, requires patient labeling to include warnings regarding risks of ECT, and alternative treatments. A prominent notice must state at least the following, “Warning: ECT device use may be associated with: disorientation, confusion, and memory problems.”[1] A further warning states, “Long-term safety and effectiveness of ECT treatment has not been demonstrated.”[2]
However, CCHR’s review of hospital websites offering ECT and electroshock informed consent forms, shows grossly inadequate information, which is misleading to patients. At a time when mental health is so prevalent in the news, better information must be disclosed until the brain-damaging procedure is banned. The FDA’s Final Rule is being challenged to that end.
All ECT devices should be taken off the market! These include Mecta Corp’s SpECTrum series and ∑igma™ devices and Somatics LLC’s Thymatron®.
This call is strengthened by a World Health Organization guideline on community mental health released in June which cited the UN Convention on the Rights of Persons with Disabilities (CRPD) that says patients must not be put at risk of “torture or cruel, inhuman or degrading treatment or punishment,” which includes electroshock given without informed consent. “Coercive practices such as forced admission and treatment” and “the administering of antipsychotic medication, electroconvulsive therapy (ECT) and psychosurgery without informed consent,” should be forbidden, the report says. “Many stakeholders are now calling for…alternatives in mental health and related services.”[3]
Patient testimony that CCHR provided to the FDA’s Public Docket discussing ECT in 2015 included: “After ECT I could no longer play my guitar. I could not remember chord sequences/patterns, words or songs that I had performed hundreds of times before ECT. The ability to play or learn new music has never returned.” And “Before ECT, I studied math up through calculus. After ECT, I can just barely make change in a store. ECT gives a person a different brain from the one a person had.”[4]
CCHR’s current letter to electroshock-delivery hospitals provides the additional FDA data that was not generally found in the materials it found hospitals used or promoted. For example, FDA says patients should be told “Memory loss includes short-term (anterograde) and long-term (autobiographical) memory loss following treatment…some patients have reported a permanent loss of memories of personal life events (i.e., autobiographical memory).”[5]
According to the FDA, the physical risks may also include the following (in order of frequency of occurrence): pain/somatic discomfort (including headache, muscle soreness, and nausea); skin burns; physical trauma (including fractures, contusions, injury from falls, dental and oral injury); prolonged or delayed onset seizures; pulmonary complications; cardiovascular complications and death.[6]
Additionally, “Patients, or their legally authorized representative, may withdraw consent and request that ECT treatment be stopped at any time.”[7]
How electroshock “works” is unknown; there are multiple theories, but none are proven.
Another contentious issue is the brain damage that many patients report. The American Psychiatric Association recommended brain damage be omitted from consent forms. However, an ECT device manufacturer admits that “patients may experience permanent memory loss or permanent brain damage.”[8]
In Riera v. Somatics, LLC (the manufacturer of an ECT device), the United States District Court for the Central District of California ruled that there was sufficient evidence for a reasonable jury to find that the prominent manufacturer of ECT devices, Somatics, LLC, caused brain injury in the plaintiffs by failing to warn their treating physicians of the risk of brain injury associated with ECT, and also through a failure to investigate and report to the FDA complaints of brain damage and death resulting from ECT.”[9]
Patients and their families may also not be aware that hospitals are required to provide cognitive status monitoring prior to beginning ECT and during the course of treatment via formal neuropsychological assessment for evaluating specific cognitive functions (e.g., orientation, attention, memory, executive function).[10] Such testing could indicate cognitive or brain damage.
The above is a recommended minimum warning, factoring in the many other harmful results also identified in an FDA Executive Summary for a Panel investigating the appropriate classification for the device in 2011. Among those harmful and deadly effects reported to the FDA are the following:
memory dysfunction, general cognitive complaints, brain damage, death (including reports of reduced life span), onset/exacerbation of psychiatric symptoms, general motor dysfunction, seizures (including prolonged seizures, physical trauma, skin burns, neurological symptoms (e.g., paresthesias,[i] dyskinesias[ii]), respiratory complications/prolonged apnea, sleep disturbance, visual changes, hypertension, hypotension, suicidality, homicidality, substance abuse, coma.
While there are no manufacturer clinical trials to prove ECT is safe and effective, the FDA has approved the ECT device for use in treatment of catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients aged 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.[11]
There are some serious flaws and/or arbitrariness in the studies the FDA relied upon to issue its Final Rule, with the agency apparently bent only on using those studies that would support its decision to not only keep the shock device on the market but also to reduce its risk classification to make it even more widely available. Autistic children are subjected to electroshock, even though autism is not an approved indication for its use. As the FDA does not regulate medicine, once a medical device such as for ECT is approved, psychiatrists can decide to subject anyone with a “mental health diagnosis” to it.
The bottom line is that electroshock should be banned and because, arguably, its use constitutes assault and battery—certainly from a patient’s perspective. It does not belong in any mental health system.
CCHR’s letter warns hospital directors that while psychiatrists assert 460 volts of electricity sent through the body is safe and effective, with fewer risks since those observed in ECT being given to Jack Nicholson’s character in the 1970s film One Flew Over the Cuckoo’s Nest, this is false. No ECT device manufacturer in the U.S. has produced clinical trials that prove safety and effectiveness.
Until ECT is banned, CCHR intends to investigate and monitor precisely what information is provided to potential ECT patients and their families by electroshock-hospitals, so that such information may be available to regulatory entities and legal counsel for the those harmed by this practice.
Actions to take
- ECT is a brutal practice and people should sign CCHR’s online petition supporting a ban.
- Patients damaged by ECT or their families should report all ECT adverse effects and damage experienced to the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database. MAUDE reports already include incidents of stroke, brain damage and death.
- Before filing the MAUDE report, establish from the facility that delivered the electroshock what the ECT device model and its manufacturer were to include in the report. Include, if you have a copy, any inadequacy in the informed consent document, indicating a failure to inform of all risks, which could be grounds for consumer fraud action.
- Obtain all medical records pertaining to the ECT treatment that can be provided to attorneys to seek compensation for damage incurred.
[i] This is a persistent “pins and needles” feeling or “crawling” of the skin
[ii] Involuntary and uncontrollable movement of part of the body.
References:
[1]“Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses,” U.S. Food and Drug Administration, Final Rule, 83 FR 66103, 26 Dec. 2018, https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of, § 882.5940, Electroconvulsive therapy device, (ix), (F)
[2] Ibid., § 882.5940, Electroconvulsive therapy device, (ix), (G) and (Response 23))
[3] “Guidance on Community Mental Health Services: Promoting Person-Centered and Rights-Based Approaches,” World Health Organization, 10 June 2021, https://www.who.int/publications/i/item/9789240025707 (to download report)
[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., § 882.5940, Electroconvulsive therapy device, (ix), (H) (1)
[6] Ibid., § 882.5940, Electroconvulsive therapy device, (ix), (H) (3)
[7] Ibid., § 882.5940, Electroconvulsive therapy device, (ix), (G) and (Response 23))
[8] http://www.thymatron.com/catalog_cautions.asp
[9] David Karen, “ECT Litigation Update: Are Patients Being Warned of Brain Damage Risk?” MAD, 13 June 2019, https://www.madinamerica.com/2019/06/ect-litigation-patients-not-warned-brain-damage-risk/
[10] Ibid., (Response 26) and § 882.5940, Electroconvulsive therapy device, (ix), (B) (7)
[11] Ibid., § 882.5940, Electroconvulsive therapy device, (b) classification