A 43-year patient advocate and shock survivor applauds mental health activist on her complaint filed with FDA to enforce patients being told the truth about ECT
Lauren Tenney, Ph.D., a psychiatric survivor and activist who has long-exposed the dangers of electroshock treatment, wrote a compelling article recently about her filing a regulatory misconduct complaint with the Food and Drug Administration (FDA) against The New York State Office of Mental Health (OMH). This alleged that OMH published false and misleading advertisements about electric shock services under the guise of educational materials.[1]
Ms. Tenney has worked with numerous patient advocacy groups and individuals opposed to the use of ECT, especially coercively, although Citizens Commission on Human Rights (CCHR) is not one of these. CCHR has no affiliations with Ms. Tenney or groups she works with. We are independent of each other. As President of CCHR International, which has been outspoken against ECT since 1969 and also as a shock survivor myself, our paths have not crossed, although we both testified at the FDA’s farcical Neurological Devices Panel examining the reclassification of electroshock (ECT) devices on January 27, 2011.[2]
Ms. Tenney was involuntarily committed at the unconscionable age of 15 and draws from her experiences, as I do mine, having been electroshocked ten times at around the age of 20. I “consented” to it, but was never informed of its real risks and gave it while incapacitated mentally and physically by powerful and addictive drugs prescribed me. Psychiatrists failed to give me a thorough and essential physical examination which would have discovered—as I later found out—that I had a serious underactive thyroid condition that manifests in “depression.” Having since documented thousands of psychiatric abuse cases over the past 43 years, I can say that such blatant misdiagnosis is common.
It is in this capacity that I applaud Ms. Tenney’s actions. Her description of ECT as “soul crushing” personally rings all too true.
Neither she nor I support the FDA’s Final Rule on ECT in December 2018 reducing the risk classification of the ECT device, but she raises an important issue—that even with what the FDA did publish—albeit, as she calls it, a “heinous ruling”—agencies, including OMH, and psychiatric facilities don’t abide by informed consent needs, even dictated by the FDA. As she stated: “Why shouldn’t the FDA hold the State of New York to the minimal standards the FDA rule on electric shock devices set, when OMH engages in omission of known risks, misbranding, and false labeling instead of transmission of accurate information concerning the myriad of risks that the electric shock treatment device causes the people who are subjected to its use?” [3]
Separately, in 2018-2019, CCHR downloaded scores of state mental health department and private and state psychiatric hospital “consent forms” for ECT. Analyzing their content, clearly OMH’s alleged misconduct concerning ECT information is not an exception to the rule. Rather, potential consumer fraud is being broadly committed on American patients and their families across the country.
Ms. Tenny points out that Section ix of the FDA ECT Final Rule “represents the warning labels that accompany the device as a class II device with special controls and warnings that must accompany the shock device, as advertised to the consumer of the product.” She adds, “OMH diminishes known risks for injury and withholds or obfuscates multiple known injury-causing risks associated with the practice of electric shock.” [4]
As she further details, people are legally subject to electric shock treatment, “without their full informed consent or choice, via compulsion, or over objection via a court ordered compliance, meaning a judge’s order that a person must comply with psychiatric orders to undergo electric shock treatment.”
Minimally, if the state is the purchaser of ECT devices from the manufacturer, “who has to be in compliance with the FDA December, 2018 rule,” the “FDA must hold State-operated psychiatric institutions, indeed all public and private institutions, and any settings of organized psychiatry, accountable in their labeling and advertising of electric shock services.” [5]
From both a personal and CCHR viewpoint, that accountability would not be necessary were the entire shock box simply put out of commission and banned. Until then, complaints such as Ms. Tenney’s and lawsuits proving the damage ECT causes are avenues that must pursued.
CCHR’s ongoing online petition supporting a ban on ECT can also be signed.
References:
[1] https://www.madinamerica.com/2020/05/ect-regulatory-misconduct-filed-fda/
[2] https://psychcentral.com/lib/lauren-tenney-on-ect/
[3] https://www.madinamerica.com/2020/05/ect-regulatory-misconduct-filed-fda/
[4] https://www.madinamerica.com/2020/05/ect-regulatory-misconduct-filed-fda/
[5] https://www.madinamerica.com/2020/05/ect-regulatory-misconduct-filed-fda/