Oversight of psychiatric facilities during COVID-19 is being reduced, putting patients at risk of treatment death, watchdog warns. CCHR says electroshock and other psychiatric treatments cause damage and tighter but safer controls need to be restored.

By Jan Eastgate
President, CCHR International
The Mental Health Industry Watchdog
April 27, 2020

A patient of Stepping Stones for Living, a for-profit group home in Hermantown, Minnesota died earlier this year after undergoing electroshock treatment (ECT). A Department of Human Services’ Office of the Inspector General’s report noted the group home had failed to inform the patient’s guardian that the person “had been having seizures,” which was not something the person had previously experienced. ECT, the passage of up to 460 volts of electricity sent through the brain, causes a grand mal seizure and prolonged seizures. The guardian had expressed concerns to the State that the ECT treatments “were doing more harm than good for the (person).”[1] The death shows the need to increase, not reduce oversight of mental health services.

According to the Food and Drug Administration (FDA), prolonged seizures are a risk of ECT, as well as physical trauma and death.[2] A coroner in one patient inquest said that that the seizure from ECT caused irreparable brain damage, leading to a death.[3]

HHS instigated a maltreatment investigation into the death, finding two staff members had failed to check on the person who was dead for hours. On February 21, 2020, the person was electroshocked at a specialized clinic and was told to expect to be groggy and sleepy. According to the Duluth News Tribune, following this, “the person went to bed and never left it, and was declared dead almost 24 hours later.”

The OIG found: “The (person) was largely unresponsive during most, if not every, check, and even when (staff) was shaking the (person’s) shoulder.” Further, “during the almost 24 hours that the (person) remained in his/her bed…never got up to use the bathroom, never spoke a word, never opened his/her eyes, and missed all of his/her meals and scheduled medications.” One staffer went their entire shift on the day of the person’s death without checking on the person, and documentation for safety checks was not filled out.

The person’s diagnoses included schizophrenia and schizoaffective disorder,[4] yet in the FDA’s Final Rule on ECT in December 2018, FDA said: “There were insufficient clinical data to support effectiveness for treating schizophrenia” and “schizoaffective disorder,” which implies the person was administered ECT off-label.[5]

The facility was given a “correction order” but complying with this was waived due to the coronavirus pandemic. While this is understandable, it means oversight of potential abuse in behavioral or psychiatric facilities generally may be virtually non-existent, putting patients at risk, not from COVID-19, but, potentially from psychiatric treatment administered to them. The Centers for Medicare & Medicaid Services, which sets and enforces essential quality and safety standards for the nation’s healthcare system, has suspended non-emergency inspections across the country, allowing inspectors to turn their focus on threats like infectious diseases and abuse.[6]

The OIG report does not cite a cause of death involving ECT nor does it determine “whether more thorough checks of the (person) would have prevented the (person’s) death.”[7]

FDA does not monitor or regulate the use of ECT. And it also says that it cannot “completely eliminate risks” of ECT, only mitigate them.[8] In a 2011 FDA Expert advisory committee hearing into ECT, an FDA official told the panel that “mitigation does not mean elimination of the risk.”[9]

• Texas is the only state that reports a death within 14 days of ECT being administered. Based on the deaths recorded for 2013, 2015 and 2016, there was a 0.069% average death when applied to 100,000 Americans reported to undergo ECT every year, represents about 69 deaths every year.[10]

• A 2017 Scandinavian review of 15 studies with data from 32 countries reported 16 cases of ECT-related death yielding an ECT-related mortality rate of 2.1 per 100,000 treatments.[11]

• In 2016, a coroner in a death inquest in the UK said that that the seizure from ECT caused irreparable brain damage in an elderly woman. Her brain was completely starved of oxygen during the prolonged fit that the ECT she underwent produced.[12] According to a review of ECT studies published in Epidemiologia e Psichiatria Sociale in 2010, there’s an estimated death rate of 1 in 1,000 that for the general (non-elderly) patient population.[13] In another inquest, in Australia, a coroner determined that involuntary ECT did not prevent but may have led to a patient’s suicide.[14]

CCHR, a non-profit watchdog, has remained open, with staff working remotely, to ensure patients in psychiatric facilities not being monitored, can report abuses.

People can also help by signing the online petition to ban ECT.

Risks also include brain damage. In October of 2018, in Riera v. Somatics, LLC, 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.[15] Somatics settled the case, avoiding a trial and posted a warning on its website for the potential of ECT to cause “permanent brain damage.”[16]

CCHR is responsible for more than 180 laws that now protect patients from damaging practices. DONATE to support its work here: https://www.cchrint.org/cchrint-donate/

References:

[1] “Duluth group home avoids penalty for resident’s death,” Duluth News Tribune, 22 Apr. 2020, https://www.duluthnewstribune.com/newsmd/health-news/5921381-Duluth-group-home-avoids-penalty-for-residents-death

[2] Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses Draft Guidance for Industry, Clinicians and Food and Drug Administration Staff,” p. 18, 29 Dec. 2015, https://www.fdanews.com/ext/resources/files/2016/01/01-16-FDA-ECT.pdf?1451949526, pp. 13-14

[3] “Woman died after NHS electric shock therapy was given without consent or second opinion,”, A coroner has expressed concern after the death of Elsie Tindle, who was mentally ill and given the treatment as a ‘last resort’,” Daily Mirror, 11 Mar. 2016, https://www.mirror.co.uk/news/uk-news/woman-died-after-nhs-electric-7540901

[4] “Duluth group home avoids penalty for resident’s death,” Duluth News Tribune, 22 Apr. 2020, https://www.duluthnewstribune.com/newsmd/health-news/5921381-Duluth-group-home-avoids-penalty-for-residents-death

[5] https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of

[6] https://www.cms.gov/files/document/qso-20-12-allpdf.pdf-1

[7] “Duluth group home avoids penalty for resident’s death,” Duluth News Tribune, 22 Apr. 2020, https://www.duluthnewstribune.com/newsmd/health-news/5921381-Duluth-group-home-avoids-penalty-for-residents-death

[8] Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses Draft Guidance for Industry, Clinicians and Food and Drug Administration Staff,” p. 18, 29 Dec. 2015, https://www.fdanews.com/ext/resources/files/2016/01/01-16-FDA-ECT.pdf?1451949526

[9] FDA Hearing on ECT, “CENTER FOR DEVICES AND RADIOLOGICAL HEALTH MEDICAL DEVICES ADVISORY COMMITTEE, NEUROLOGICAL DEVICES PANEL,” 28 Jan. 2011, p. 454.

[10] https://ps.psychiatryonline.org/doi/pdfplus/10.1176/appi.ps.52.8.1095; Texas Department of State Health Services. Electroconvulsive Therapy (ECT) Reports, 2013, 2015 and 2016, http://www.dshs.texas.gov/mhsa/bhmd/ect/

[11] “The mortality rate of electroconvulsive therapy: a systematic review and pooled analysis,” Acta Psychiatr Scand. 2017 May;135(5):388-397. doi: 10.1111/acps.12721. Epub 2017 Mar 23, https://www.ncbi.nlm.nih.gov/pubmed/28332236

[12] “Woman died after NHS electric shock therapy was given without consent or second opinion” Daily Mirror, 11 Mar. 2016, https://www.mirror.co.uk/news/uk-news/woman-died-after-nhs-electric-7540901

[13] John Read and Richard Bentall, “The effectiveness of electroconvulsive therapy: A literature review,” Epidemiologia e Psichiatria Sociale, 2010, https://www.ncbi.nlm.nih.gov/pubmed/21322506

[14] Niall McLaren, M.D., “No Psychiatrist Needs to Use ECT,” 27 June 2017, https://www.theage.com.au/national/victoria/grandfather-forced-to-undergo-ect-before-preventable-death-20180418-p4zacy.html

[15] http://www.dk4law.com/blog/dk-law-group-news/ect-shock-treatment-litigation-case-update-june-2019/

[16] http://www.thymatron.com/catalog_cautions.asp