Appealing the FDA’s Denial of ECT’s Harms

To leave the year with a bang, and to kick off 2021 as the year prioritizing patient safety and informed consent, I authored an open letter to the FDA appealing their denial of Freedom of Information Act (FOIA) request number 2020-7319.

The letter requested all electroconvulsive therapy (ECT) safety studies, pre-market approval (PMA) applications, and electric current limits (product development protocols or PDP) submitted by March 27, 2019.

Knowing my own ECT outcomes, and having researched similar outcomes for a decade, I feel ECT presents an “imminent threat to the life or physical safety” of gravely disabled individuals, warranting expedited release of data. The FDA denied it, however, writing that I had not “demonstrated a compelling need.”

What an invitation! I dug into my ECT research database, drafting a letter with nearly 100 citations. Then, figuring a singular clarion call did not demonstrate a public’s desire to have more information, I invited others to co-sign my letter. By midnight of my deadline, 14 professional and paraprofessional organizations, 168 Americans, and 49 international citizens from countries whose medical device regulations rely in part on FDA decisions had signed on. Signatories included up to eight words describing their real-world data and real-world evidence regarding ECT’s post-market safety and adverse events.

I submitted the letter December 28, 2020. The perfect way to close 82 years of ECT use.

What’s the weirdest thing you’re looking forward to in 2021? Me? I’m testing and retesting a few hypotheses. My hypotheses are:

1. The US FDA has no recorded safety studies (PMA) or electrical dosing protocols (PDP) for ECT use.
2. ECT use is growing exponentially across America.
3. American psychiatric facilities are marketing ECT directly to consumers using false information.
4. Some psychiatric facilities providing ECT are exploiting vulnerable patients desperate for quick symptom relief by offering ECT with increasing frequency and cashing in on private insurance, Medicaid, and Medicare’s easy reimbursement policies which pay even without proper documentation.
5. ECT clinics are capitalizing on ECT use because there are zero systemic accountability measures in place to prevent it.

ECT use without safety testing or universally regulated electrical dosing protocols

I arrived at my first hypothesis after discovering the FDA convened way back in 2011 to discuss the reclassification of ECT devices. The Washington Post reported that the chairman of the Neurological Devices Panel, Thomas G. Brott, a neurologist, said “he was amazed that ‘essentially no research had been done on ECT’s effects using functional MRI imaging, repeated brain wave (EEG) studies, or autopsy examinations of patients. I tried to look and saw very little. I concluded that the evidence is not there to decide either way.’” Consequently, the panel determined that ECT devices needed to undergo the same rigorous testing as new medical devices.

Even though the 2011 FDA device panel recommended PMA and PDP, requiring ECT device manufacturers meet the criteria for new medical devices by developing protocols which elicit the least amount of injury, the 2018 FDA device panel decided safety testing and safety limits were not necessary, and chose to reclassify the devices without receiving PMA or PDP. Instead they extended the deadline for PMA and PDP to March 26, 2019.

According to their own rules, the FDA must complete several tasks to reclassify medical devices. However, the final ruling of reclassification for ECT devices occurred without completing Task B, a public advisory committee (or panel) meeting to solicit input from panelists. The FDA also omitted Task C, issuing a proposed classification order so that the public could comment on the proposed order and reclassification.

Instead, the closed meeting occurred the day before the federal shut-down, without public input. The FDA neurological device panel reclassified ECT devices, approving them for use on children 13 and older with an intended use “for treating catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.”

December 26, 2020 marked the two-year anniversary of the FDA’s Center for Devices and Radiological Health (CDRH) reclassification of the ECT devices. That reclassification has opened a pandora’s box of unstudied longitudinal neurological fallout in America’s vulnerable youth.

ECT use growing exponentially across America

I developed my second hypothesis because I began meeting an increasing number of people seeking help for problems they developed during or after ECT. To my surprise, more men were seeking ECT recovery help (historically, women receive 70% of ECT treatments in America).

In states like California, the only thing necessary to qualify for ECT is to not have satisfactory improvement after trialing two antidepressants. Psychiatry is now advocating ECT use as a first line of treatment in “emergency situations.”

To test my second hypothesis, I conducted an audit of the Substance Abuse and Mental Health Services Administration’s (SAMHSA) 2020 National Directory of Mental Health Treatment Facilities, comparing it with the 2018 directory. I discovered that since the FDA’s 2018 decision to reclassify ECT devices, there’s been a 34% increase in the number of American hospitals providing unregulated ECT. New clinics providing unregulated ECT include pediatric psychiatric facilities. (I use the word “unregulated” because though a few states loosely monitor ECT on a passive basis, with the exception of Texas, ECT use has never been routinely audited. Ever.) I eagerly await a SAMSA’s 2021 facility directory to re-confirm my hypothesis.

American psychiatric facilities are marketing ECT directly to consumers

Since the ‘70s, Americans have heard psychiatry’s insistence that ECT is safe and effective, despite irrefutable evidence to the contrary. Long before device reclassification, psychiatrists working as paid medical device reps at hospitals and other research facilities began marketing ECT directly to consumers through mainstream media, Facebook Q&A sessions, and other efforts, even though “A Class III device that fails to meet PMA requirements is considered to be adulterated under Section 501(f) of the act and cannot be marketed.”

My third hypothesis revolves around the evolving inaccuracy of information used in marketing ECT directly to consumers. It appears marketing ECT as “safe and effective” is no longer sufficient. Having repeated that false mantra in the first or second paragraph of nearly every article written about ECT without FDA intervention in previous marketing efforts, some ECT providers are emboldened to make outlandish claims.

As a result, psychiatrists receiving honorariums from device manufacturers create patient information documents and facilitate public discussions laced with false ECT information. Bad information includes statements that ECT involves “small electric currents,” “a controlled seizure,” and “triggering mature neurons to sprout new axons and behave like young neurons.”

Psychiatry’s claim that 800-900 milliamperes (mA) current is “small” highlights how little they understand electricity’s physics. Depending on device settings, the Thymatron machine will give brief pulses of 900 mA for up to eight seconds. Even a partial understanding of how the body responds to 900 mA current provides a window of understanding into unfounded promises which have no place in evidence-based medicine. But studying neuropathology of repeatedly exposing the human brain to high field-strength electricity is not required to qualify for advising patients about ECT.

Consequently hospitals, psychiatrists, doctors, nurses, and counselors echo promises likely without realizing they’re spreading misinformation. Just like the average American, some medical providers assume ECT information written by psychiatrists receiving reimbursements for providing it is true and accurate. After all, accuracy is normally regulated by the FDA and medical boards.

Psychiatry is capitalizing on providing bad information to patients desperate for quick symptom relief

Unregulated information on ECT allows psychiatry to make public claims of safety and efficacy. For example, my fourth hypothesis springs from Dr. Konoy Mandal, a psychiatrist who recently opened a new ECT clinic at the University of Colorado’s Refractory Depression Clinic in Longmont. According to Mandal, “One has to remember ECT was initially developed when electricity was not able to be managed as it is now. […] Now, we can mimic the way neurons communicate between themselves and know where to aim, thanks to PET and Functional MRI scans. And today’s ECT also has 1% of the side-effects of ECT even 10 years ago.”

The idea that ECT’s electrical output can be managed, controlled, or “aimed” better than ten years ago and that ECT devices can mimic how neurons communicate with each other is preposterous. We are still talking about medical devices which use up to 900 mA electrical charge for up to eight seconds on a human brain made of 72% water with no internal rubber bumpers or wires.

I’ve researched ECT for more than a decade. There are no neuropathology studies published in the last ten years supporting Dr. Mandal’s claims. His referencing the evolving ability to use modern brain scanning techniques to somehow guide psychiatrists in aiming the current is so ludicrous that not a single hospital wastes time or resources to routinely give ECT recipients a PET or fMRI scan for the purpose of aiming ECT current.

Considering California’s hospital financial transparency reports, ECT’s average reimbursement rate is $3,400 per treatment. When analyzing outrageous claims which cannot be supported by research, one can only conclude they were made for institutional-promotional purposes. Is it any wonder Dr. Konoy Mandal contacted his local media outlet, making wild claims of safety and efficacy to market a treatment with no regulatory limits?

Unfounded ECT claims are worse than claims made by nutritional supplement companies because the FDA doesn’t regulate or fine for erroneous ECT information, leaving patients and their family members vulnerable to emotionally driven, hope-filled promises of success and safety.

When discussing ECT with desperate patients and their equally desperate loved ones, psychiatry focuses attention on treatment benefits. Any concerns regarding risks are addressed by focusing on the controversy of stigmatizing media portrayals rather than discussing the real controversy: ECT was never safety tested using modern clinical parameters on humans and has zero regulated electrical dosing protocols.

Doctors do not admit that ECT is more an art than evidence-based medicine. All psychiatrists giving ECT feel they are Picassos. Patient outcomes lead me to wonder if perhaps some of these artistic psychiatrists are more akin to Florence Foster Jenkins, myopically glamorizing the immediate benefits of ECT while completely ignoring long-term consequences on the quality of life after ECT.

Instead, hospitals and doctors choose not to assess ECT’s severe effects in every patient, eagerly proceeding with business as usual. ECT is an unregulated multi-billion-dollar industry. They bank on the fact that the public will continue believing the only thing controversial about ECT is its historically accurate portrayal in “One Flew Over the Cuckoo’s Nest.” Psychiatry knows they can reassure people that ECT’s safer now that it’s given under general anesthesia with medication to paralyze the body and prevent broken bones. An escalating number of psychiatric treatment facilities follow this lead.

Hospitals marketing directly to consumers and the resulting revenue explains why I eagerly anticipate SAMHSA’s publication of their 2021 facility directory. How many new facilities are brushing off their old ECT machines or purchasing new ones to take advantage of this easy funding source? We’ll soon find out!

Where is the proof that ECT is safe?

After approving the reclassification without receiving PMA and PDP, the 2018 FDA device panel required all ECT device manufactures to submit PMA and PDP on or before March 26, 2019. Fascinated that the FDA would establish a solid deadline for this data, I found myself genuinely curious about the safety testing and electrical dosing recommendations. I wanted to learn more about the neuropathology studies submitted by the FDA’s “deadline” (I put the word deadline in quotes because ECT continues even if device manufacturers do not submit the required information).

I checked to see if the records I wanted were digitally available in the FDA’s Reading Room. A void of information convinced me to submit a request to FDA Director Carlos Pena for the expedited release of PMA and PDP submitted to the FDA between December 26, 2018 and March 27, 2019, per the Freedom of Information Act (FOIA). In part, my letter (dated October 9, 2020) stated:

I request that FOIA fees for electroconvulsive therapy’s PMA and PDP submitted by March 27, 2019 be waived because the disclosure of requested information is in the public interest. It will significantly enhance patient, caregiver, and public understanding of ECT’s safety and efficacy which will in turn help patients, medical providers and the general public understand the operations and activities of the FDA.

I request expedited processing pursuant to the FOIA and 21 C.F.R. 20.44 because recently Irving Kirsch, Associate Director of the Program in Placebo Studies and lecturer in medicine at the Harvard Medical School and Beth Israel Deaconess Medical Center co-authored “Electroconvulsive Therapy for Depression: A Review of the Quality of ECT versus Sham ECT Trials and Meta-Analyses” which concluded:

“The quality of most [Sham] ECT–ECT studies is so poor that the meta-analyses were wrong to conclude anything about efficacy, either during or beyond the treatment period. There is no evidence that ECT is effective for its target demographic—older women, or its target diagnostic group—severely depressed people, or for suicidal people, people who have unsuccessfully tried other treatments first, involuntary patients, or children and adolescents. Given the high risk of permanent memory loss and the small mortality risk, this longstanding failure to determine whether or not ECT works means that its use should be immediately suspended until a series of well designed, randomized, placebo-controlled studies have investigated whether there really are any significant benefits against which the proven significant risks can be weighed.”

Given Dr. Kirsch’s vast experience in placebo trial construction and assessment, he and his coauthors concluded that continued ECT use is an imminent danger to human life and morbidity warranting immediate suspension. There is a demonstrated urgency to inform the public. This urgent need to inform the public will enhance informed consent for people with severe mental illness considering ECT, caregivers, medical and rehabilitation providers. Since nations around the world look to the FDA to establish safety measures, disclosing PMA and PDP will impact informed consent for more than two million people receiving ECT internationally each year—an estimate under-oath by Dr. Harold Sackeim. One in five people receiving treatment for mental illness and their family members constitute a substantial number of Americans potentially interested in ECT’s PMA and PDP data.

I received their initial reply on October 14, 2020. It stated, in part:

Due to an increase in the number of incoming requests, we may be unable to comply with the twenty-working-day time limit in this case, as well as the ten additional days provided by the FOIA. The actual processing time will depend on the complexity of your request and whether sensitive records, voluminous records, extensive search, and/or consultation with other HHS components or other executive branch agencies are involved. Please note that requests for medical device approval records (e.g. 510K, PMA, DEN) may take up to 18 to 24 months to process.

At the time, I was not concerned by the automated response. These are unprecedented times. I figured the response was likely sent to everyone who submits a FOIA as a placeholder until the FDA can read the request in its entirety. My original letter explained why I felt my FOIA request deserved expedited action based on the devices’ involving “an imminent threat to the life or physical safety of an individual,” or in the case of a request made by “a person primarily engaged in disseminating information, urgency to inform the public concerning actual or alleged Federal Government activity.”

I waited, patiently. Eager to share the information with other individuals who prioritize patient safety.

Imagine my surprise when I received their email on October 21, 2020, which stated, in part:

You have not demonstrated a compelling need that involves an imminent threat to the life or physical safety of an individual. Neither have you demonstrated that there exists an urgency to inform the public concerning actual or alleged Federal Government activity. Therefore, I am denying your request for expedited processing. The responding agency office will process your request in the order in which it was received.

People deserve to understand ECT’s risks

I took the FDA’s response as an invitation to provide nearly 100 citations demonstrating the urgency to inform the public and wrote an open letter to appeal their decision. I am but a small voice in this effort to raise awareness about the long-term consequences of ECT. For that reason, I invited signatories who share my desire for access to safety testing and dosing protocols to add their voices.

Fourteen American and international organizations formally signed my open letter to the FDA: Connecticut Legal Rights Project; Law Project for Psychiatric Rights; Disability Rights—Vermont; National Association for Rights Protection and Advocacy; MindFreedom, International; Mental Patients Liberation Alliance; MadFreedom, Inc., Legal Guidance; Global Wellness Warriors; Ruh Global Impact; Hopeworx, Inc.; Progressive Voices; Consumers Health Freedom Coalition and OCSC.

Two hundred twenty-five individuals also signed. Each individual was given the opportunity to submit up to eight words describing their experience with ECT either as a recipient, caregiver/friend of ECT recipients, or professional who works with ECT recipients. Read the independent submissions yourself. It is astounding to count the number of people with real-world experience living life after ECT (or witnessing it first-hand) who describe ECT as torture, barbaric, or inhumane treatment with horrific unforeseen consequences. Many call out the lack of informed consent.

Information the FOIA request provides will help the American public understand ECT’s real controversy. Perhaps Americans will use the information to demand US hospitals prioritize patient safety concerns by conducting a formal nationwide inquiry and independent review of ECT use, like what’s happening in the United Kingdom. In the UK, 40 professionals, paraprofessionals, ECT survivors, and caregivers signed a different letter calling for a formal inquiry into ECT use and related patient safety concerns. The United Kingdom’s mental health advocacy organizations Mind (the UK’s largest mental health charity), The Royal College of Nursing, The Council for Evidence-Based Psychiatry, The Association of Clinical Psychologists, The National Counselling Society, Headway (the brain injury association), and Psychologists for Social Change support the formal inquiry.

At this time, more than 12,300 people have signed my international petition to standardize, regulate, audit ECT and provide comprehensive brain injury assessment/rehabilitation. As people begin realizing the magnitude of ECT use and its resulting injury, more will demand comprehensive brain injury assessment and rehabilitation as indicated for every ECT recipient.

Hope for the future

Increasing awareness of ECT’s critical issues gives me hope that all ECT recipients will break through current barriers and access necessary rehabilitative supports. Is it odd I ring in the new year with an open FOIA request letter to the FDA with more than 200 signatures? Yes. Is it even more odd I eagerly await SAMHSA’s national facility directory release? Yes. But if I can get my hands on the data, I believe it will be a monumental step towards America’s prioritizing patient safety. That will improve quality of life for all ECT recipients for the first time in 83 years of ECT use. Hopefully, the FDA will expedite this process.