ECT Arguments: All Medical Procedures Have Risks

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strawman set in a green field. The sun and sky are a misty orange. Dark green trees off in the distance

“All medical procedures have risks,” is a common strawman tactic that stifles meaningful discussions of harms caused by electroconvulsive therapy (ECT).

Let’s look at a Twitter thread following the publication of Professor John Read’s response to yet another defence of ECT in the absence of robust efficacy and safety evidence.

“It’s a really serious treatment for really serious illness. And yes it can have side-effects, as do most medical interventions. But I cannot accept the argument that it ‘doesn’t work’ when I’ve literally seen it do so repeatedly.”

______

“And I would want it for myself, not too far from first line, if I were to ever find myself in a similarly desperate situation. We don’t vilify or seek to ban surgery for scars or complications, because we accept the life threatening nature of the conditions it seeks to treat.”


The Straw Man

From the website Effectiviology:

A strawman is a fallacious argument that distorts an opposing stance in order to make it easier to attack. Essentially, the person using the strawman pretends to attack their opponent’s stance, while in reality they are actually attacking a distorted version of that stance, which their opponent doesn’t necessarily support.

Strawman Arguments: What They Are and How to Counter Them

It’s a really serious treatment for really serious illness. And yes it can have side-effects, as do most medical interventions.

“We don’t vilify or seek to ban surgery for scars or complications, because we accept the life threatening nature of the conditions it seeks to treat.”

All Medical Procedures Have Risks

yes it [ECT] can have side effects, as do most medical interventions.“ is a variation of “all medical procedures have risks” that commonly appears in studies, news articles, and patient information resources:

“Like any therapy, ECT has risks.”

REGULATORY UPDATE TO THYMATRON® SYSTEM IV INSTRUCTION MANUAL

“Like any medical procedure, ECT has some risks.

Psychiatry.org – What is Electroconvulsive Therapy (ECT)?

“Like any procedure involving anaesthesia, ECT carries a small degree of risk.”

Electroconvulsive therapy (ECT) – Better Health Channel

This benign medical statement can turn into a strawman in ECT risk/benefit discussions.

It’s often used in a way that implies those raising concerns are childishly naïve about medical risks and surprised and outraged when they occur like someone who asked for an edgy haircut, hated the result, then blamed the stylist.

Injured ECT recipients who raise awareness are often portrayed as whiny and bitter, complaining about side effects we were supposedly warned of.

I should add there is no one single harmed group; motives and objectives vary among ECT activists yet we often get lumped together with the most fringe.

We’re frequently accused of being Scientologists, or trouble makers discouraging prospective patients from life-saving treatment while stigmatizing those benefiting from it, all for seeking recognition for our injuries.

In the Mad in America article, Fear and Loathing in the ECT Debate, Professor John Read breaks down tactics and provides examples in response to critical ECT research:

“Researchers and ECT recipients who question the efficacy and highlight the adverse effects of ECT are often publicly denigrated, by ECT advocates, as ‘anti-psychiatry ideologues’, ‘extremists’ ‘Scientologists’ and ‘nonmedical zealots’, who are spreading ‘garbage’ and ‘dangerous misinformation’.

Fear and Loathing in the ECT Debate – Mad In America

Below are a few psychiatrists’ responses to Electroconvulsive Therapy for Depression: A Review of the Quality of ECT versus Sham ECT Trials and Meta-Analyses:

“This reeks of Scientology”

“Clearly there is a scientologist who has infiltrated the Medscape editorial board.”

Only Know-nothing busybodies have the temerity to call for immediate suspension.

“I have complained about this and a series of such articles that seem to reflect the presence of a Scientologist in Medscape.

“This reminds me of the folks who were against the use of masks for the general public during the initial phases of the COVID epidemic.”

 “Most of the negative comments about ECT are from non-experts who have no familiarity with the procedure, and maintain a level of understanding equivalent to the falsehoods perpetuated by the media, such as ‘One Flew Over The Cuckoo’s Nest’.

comments from Experts Call for Immediate Suspension of ECT, Others Push Back (medscape.com)

More recent examples:

Responses to the BBC News article, Did we all believe a myth about depression? A peer shared how the now debunked chemical imbalance theory led her to have ECT treatments that caused permanent disability.

Activism for Survival

Those injured by ECT have no access to care from the medical system. We are treated as though we don’t exist. We advocate for ourselves by raising awareness and researching issues ignored by those with conflicting interests.

We do this so we can get the support we need to recover and future patients are protected through standardization and regulation of ECT.

Activism like this is common and necessary when harmed patients are abandoned by care providers and regulatory bodies like the Food and Drug Administration (FDA).

Examples of other patient-led campaigns:

These efforts can benefit society by helping medicine course-correct when doctors and regulatory systems fail patients. This activism is the only way to ensure recognition and treatment for those harmed and more refined care for future patients.

When the strawman Morphs into Victim Blaming

What psychiatrists say holds sway over society. Few question their claims or motives. This can lead to people implicitly parroting the doctor’s strawman argument rather than exploring complex issues themselves.

From the website, The Knowledge:

Authority bias is dangerous because it creates complacency among consumers about evaluating information critically, which makes them susceptible to misinformation or even worse yet, manipulation. 

The Expert is Always Right? Authority Bias

“All medical procedures have risks” actually encourages society to victim blame those reporting injuries. It sounds like this:

“you knew what you were getting into when you signed up for ECT. Stop complaining,” or “Stop ruining it for others.”

Examples

Are any other ECT lovers tired of hearing people who it didn’t work for advocate against it?

“I love ECT. It changed my life. Everything about it was completely worth the side effects, and I absolutely believe in dissolving stigma towards it. I can usually roll my eyes when normies talk shit about ECT because I know they don’t know anything, but when people who it didn’t work for talk shit I just feel like… You knew what you were getting into. You knew it might not work and it has large side effects, and you made the choice to take the risk. So don’t advocate for the treatment being taken away from everyone. The obvious exception is if you were coerced, forced, or manipulated into it- but in that case the real problem was psychiatric malpractice rather than ECT.”

Here’s one of many abusive comments I’ve received for sharing my experience:

You had me in your corner til you said fuck off. Quit your bitching and thank god your ALIVE. It was your decision. You live with it.

I was a minor when I began having ECT

Teen consent is an illusion; It’s not a real choice when your brain is undeveloped, marinating in mind-altering psychiatric drugs, while dependent on adults for survival.

Are People That Naive About Medical Treatment Risks

My fellow Americans, remember those early 90’s prescription drug ads on TV? Society was minding its own business, then out of nowhere our ears were violated with horrifying drug side effects thanks to direct-to-consumer advertising (DTCA).

If only we could forget!

They’d paint a story of some horrible ailment, introduce their product in glowing terms followed by an auctioneer-speed-read of truly horrifying, sometimes disgusting side effects.

Opdivo Commercial – New Hope – You almost want what they’re curing. – YouTube

Years of exposure to ads like these drills into you that drugs and medical procedures have risks. Not that it’s needed.

Consulting with your doctor before treatment will make you aware medications and procedures have risks.

Most people will take a prescription, over-the-counter medication, or undergo a medical procedure in their lifetime.

Medication examples:

an over-the-counter medication warning label
a prescription warning label
a supplement disclaimer

Procedure examples:

These patients are told what will be done, the risks, benefits, and alternatives. They will sign legally binding forms acknowledging and agreeing to them.

People expect risks.

ECT Compared to Other Procedures

We don’t vilify or seek to ban surgery for scars or complications

This type of statement assumes ECT has earned unquestioned equal status to other medical procedures and that it also must not be critiqued.

In the STAT news article, Don’t call electroconvulsive therapy ‘shock therapy,’ Dr. Charles Kellner and Kate Farber argue that ECT is a legitimate medical procedure like a heart disease surgery called angioplasty*:

Coronary artery stents are widely used to treat heart disease, even though they also increase the risk of blood clots and stroke. But reporters don’t give equal weight to arguments that stents are too dangerous to use and should be banned because a small percentage of patients have bad outcomes, including death.

Don’t call electroconvulsive therapy ‘shock therapy’

But has shock therapy earned the same legitimacy as procedures like heart stents?

Electroshock vs a Standard Surgery

Several years ago I had major orthopedic surgery. During my consultation, I was informed this was one of the most painful procedures a person can have. My surgeon told me about the benefits, scary risks, and the extensive rehabilitation commitment needed to recover from the assaults with scalpels, screws, and stitches.

Planning started months before surgery; a nurse taught me how to safely manage daily tasks with one arm. My family and I practiced all I would need help with like cooking, changing surgical stockings, buckling a seat belt, and so on.

Two weeks post-op I started physical therapy to bend and stretch my arm stiffened from immobilization followed by strength training.

I wasn’t alarmed by the side effects because I was informed of them, scars and all, beforehand. I got what I consented to.

I did have a few minor unanticipated problems post-op. The difference between them and ECT? My surgeon believed me, investigated, and treated them.

Exactly how one would expect legitimate medical procedures to go.

What Makes ECT Different

Let’s say people are shockingly naïve about ECT’s risks as implied. If anyone has overly optimistic views of the procedure it’s likely because of what they heard from doctors and the media.

What prospective patients are told about ECT

ECT providers (sometimes) acknowledge the possibility of serious adverse events before treatment. When they do, negatives are often downplayed with twice as many positives.

Since I was a teen who supposedly “chose to risk” my current disability, let’s start with articles focused on this age group. Here’s one published on WebMD a year before my first treatment:

Teens Given Electroshock Treatment Showed Few Bad Effects by Theresa Difno:

Electroconvulsive therapy (ECT), or “shock therapy,” did not cause long-term memory loss or brain damage in adolescents who underwent the procedure for severe depression, according to a new study…

WebMD interviewed the lead researcher, David Cohen

Cohen says fears about the use of ECT in youth “are not justified” and that some misunderstanding of the procedure comes from a lack of recognition of the severity of patients’ illnesses. When it is used appropriately, the benefits are enormous, Cohen says. “When ECT works it is unbelievable; it is like a miracle.”

An assistant professor at Harvard School of Medicine, Alec Bodkin, MD

The study indicates that most of the time, the most effective treatment for the most severe form of depression is safe and does not cause brain damage.

Later Bodkin states “You cannot parent someone out of the need for ECT.”

Teens Given Electroshock Treatment Showed Few Bad Effects (webmd.com), March 24, 2000

This article came out when the FDA moved to reclassify the shock device before the age restriction was lowered to 13:

“This amnesia is temporary,” says Dr. Huxsahl. “They may never have good recall of what happened while they were receiving ECT — that may never come back — but there’s no convincing evidence that it will interfere with their abilities to form new memories and be aware of their life experiences in the future.”

Electroconvulsive therapy for adolescents: Make sure it’s on the menu – Mayo Clinic, Nov. 17, 2017

Or how about this one:

A few side effects are associated with ECT use, the most common of which are transient: headaches, delirium lasting less than one hour post-procedure, hypomanic symptoms and memory loss. Cognitive effects associated with ECT are comparable to those in adults, and no data indicate long-term cognitive effects.

Dr. Austerman, ECT for Adolescents Doesn’t Deserve Its Bad Rap – Consult QD (clevelandclinic.org)

Let’s move on from adolescents to a veteran-focused video: Promoting ECT for Veterans with Depression:

And recently, BBC Woman’s Hour hosted a discussion between Dr. Trudi Seneviratne and psychologist Chris Harrop regarding the Independent article, Thousands of women with mental health issues in England given ‘dangerous’ electric shocks to brain:

Dr. Trudi’s response to Chris’s use of the term “brain damage” in relation to ECT:

“(sigh) this is going out to the general public. ECT does not cause brain damage. There is absolutely no evidence, let me finish forgive me, it does not cause epilepsy brain damage. There is absolutely no suggestion it causes brain damage. There are side effects that affect memory and cognitive deficits. I can talk more about that, but just being very clear it does not cause brain damage.

Her response to people not being warned of risks:

“That’s again simply not true. Bearing in mind, you know you mentioned the figure of only 2000-2500 people being used, and we use it far less, so we are talking about a very small number of people receiving it in the UK. The rest of the world is much better at using ECT, the States and Europe is much better, more people receive it, six times more people receive it. Which means that six times more people have a miraculous life-saving treatment for severe depression.”

Later in the interview, Dr. Seneviratne says:


…please stop using the words brain damage – we are talking – there is no evidence
about brain damage. Cognitive deficits and memory impairment yes. That ECTAS data
also showed that around 40% of people described having temporary, er, memory
problems. But we do know some people, a minority of people do have much more severe
long-term memory deficit and cognitive problems, but that’s a minority. And we also
showed that about 20% of people having ECT actually had quite severe cognitive
problems before having ECT.”

Woman’s Hour – Kate Bush, Lynn Fitch, Cost of living, Electroconvulsive therapy – BBC Sounds

See Chris’ Harrops response to Dr. Trudi’s talking points

My ECT consent experience

I was told a few scary side effects before starting ECT followed by twice as many positives. My memories of bad side effects became fuzzy during treatment. The abbreviated consent forms I signed after my consultation offered little reminders– not that I had the mental capacity to weigh risks after my first treatment. The medical staff was there to reassure me with claims like the above ECT endorsements while encouraging me to continue treatment.

Somatics, LLC

We’ve seen how many doctors and journalists present ECT’s risks and benefits. What do the electroshock device manufacturers say about the efficacy and safety of their products?

Following Riera v. Somatics, LLC, 2018 verdict, the device manufactured added a regulatory update for the Thymatron® System IV, the model my doctor used on me.

On page one of the current manual it mentions a study published the year I began ECT:

It is essential that doctors planning to use the Thymatron® System IV read and follow the warnings and recommendations of the Task Force Report of the American Psychiatric Association as set forth in “The Practice of Electroconvulsive Therapy” (APA, 2001), which states, in part, that “A small minority of patients treated with ECT later report devastating cognitive consequences. Patients may indicate that they have dense amnesia extending far back into the past for events of personal significance or that broad as of cognitive function are so impaired that the patients are no longer able to engage in former occupations…in some patient self-reports of profound ECT-induced deficits may reflect objective loss of function…In rare cases, ECT may result in a dense and persistent retrograde amnesia extending to years…

REGULATORY UPDATE TO THYMATRON® SYSTEM IV INSTRUCTION MANUAL, page 1

Here it mentions variables that can lead to drastically different outcomes including permanent brain damage:

Cognitive side effects are experienced in varying types and severity by ECT patients. Studies have shown that the methods used in ECT administration have a significant impact on the nature and magnitude of cognitive deficits. In general, the American Psychiatric Association recognizes that the following treatment parameters are each independently associated with more intense cognitive side effects:
• Bilateral electrode placement;
• Sine wave stimulation;
• High electrical dosage relative to seizure threshold;
• Closely spaced treatments;
• Larger numbers of treatments;
• Concomitant psychotropic medications;
• High dosage of barbiturate anesthetic agents.
ECT may result in anterograde or retrograde amnesia. Such post-treatment amnesia typically dissipates over time; however, incomplete recovery is possible. In rare cases, patients may experience permanent memory loss or permanent brain damage.

REGULATORY UPDATE TO THYMATRON® SYSTEM IV INSTRUCTION MANUAL page 4

This section of the Regulatory Update lists a litany of side effects many of us were never warned of:

REGULATORY UPDATE TO THYMATRON® SYSTEM IV INSTRUCTION MANUAL, page 7

Like any therapy, ECT has risks. Certain patients will experience adverse events in conjunction with electroconvulsive therapy. Patients should be made aware of these risks and confirm that they fully understand them prior to consenting to therapy.
The most common reported adverse effects of ECT are:

  • Headache Muscle soreness
  • Mild to moderate pain/discomfort, including jaw pain
  • Nausea
  • Disorientation immediately after seizure induction
  • Memory dysfunction (see further discussion below)

Regulatory update, page 3, Other serious adverse events have occurred, including:

  • Adverse reaction to anesthetic agents neuromuscular blocking agents
  • Adverse skin reactions (e.g., skin burns)
  • Cardiac complications, including
    • Arrhythmia
    • Ischemia/infarction (i.e., heart attack)
    • Acute hypertension
    • Hypotension
    • Stroke
  • Cognition and memory impairment
  • Brain damage
  • Dental/oral trauma
  • General motor dysfunction
  • Physical trauma
    • (i.e., if inadequate supportive drug treatment is provided to mitigate unconscious violent movements during convulsions)
  • Hypomanic or manic symptoms
    • (e.g., treatment-emergent mania, postictal delirium or excitement)
  • Neurological symptoms
    • (e.g., paresthesia, dyskinesias)
  • Seizures
    • Tardive seizures
    • Prolonged seizures
    • non-convulsive status epilepticus
  • Pulmonary Complications
    • (e.g., aspiration/inhalation of foreign material, pneumonia, hypoxia, respiratory
    • Obstruction such as laryngospasm
    • Pulmonary embolism
    • Prolonged apnea)
  • Visual disturbance
  • Auditory complications
  • Onset/exacerbation of psychiatric symptoms
    • Partial relief of depressive anergia enabling suicidal behavior
    • Homicidality
    • Substance abuse
    • Coma
    • Falls
  • Device malfunction (creating potential risks such as excessive dose administration)

You Knew the Risks

As you can see there are stark differences between what ECT promoters say compared to what Somatics, LLC, says in their update and the Thymatron manual. To say we knew what we were getting into based on the information we were given by our doctors is laughable.

Countless ECT recipients and their families are not fully informed of all risks. In many cases, they are told the opposite of what the true risks are. These unexpected, untreated injuries can devastate all aspects of a person’s life. Many of us never would have consented had we seen the Thymatron regulatory update. See Michelle Himes v. Somatics, LLC.

Blindsided

With my shoulder surgery, I had months to practice managing life with a disability. ECT recipients are blindsided with no way to prepare or cope with life after ECT treatment.

Life with Undiagnosed, Untreated Brain Damage

Secondary side-effects to undiagnosed, untreated ECT-induced brain damage can include loss of:

  • Education & employment
  • Capacity for self-care
  • Income
  • Memories & far-reaching consequences to one’s sense of self when they are lost
  • Relationships

Most of us didn’t know of ECT’s true risks let alone the secondary risks that accompany undiagnosed, untreated brain damage.

I’ve met hundreds of disabled ECT recipients and read thousands of personal accounts. Not one consented to follow disability-related issues:

In addition to losing personal autonomy, livelihood, and relationships, many suffer unusual health problems associated with electrical injury:

We Can’t Get Help for What We Weren’t Warned Of

For decades doctors and researchers have ignored injured recipients’ pleas for help.

Author Linda Andre described her experience seeking support for unresolved memory problems:

“My own doctor hung up the phone on me when I called, six weeks after shock, to say my memory hadn’t come back like promised.”

Linda Andre, Doctors of Deception, What They Don’t Want You to Know About Shock Treatment

A NIHM-funded ECT researcher deleted hundreds of injured ECT recipient’s emails seeking assessments he offered them:

Dr. Sackeim had claimed that he had never seen a case of permanent anterograde amnesia and publicly offered to evaluate former patients who had experienced it…at least 195 such patients contacted Dr. Sackeim, consistently reporting the same serious adverse effects…Dr. Sackeim later testified that he had thrown away all communications from these patients and did not conduct any evaluations.”

NIMH Funded ECT researcher deletes patient emails requesting cognitive evaluations after publicly offering them, Committee for Truth in Psychiatry, FDA-2009-N-0392-1243

When we ask For Help

Nowhere in the consent form does it say “you’re on your own with any disabling side effects you may experience,” but that’s what happens:

No one who experiences memory and cognitive problems after shock is offered follow-up. No one is told that there are tests that can diagnose these  problems, let alone what they are or how to get them. If former patients have the courage to tell the doctors who hurt them about their deficits, they’re simply told that any memory loss is only temporary. And when it doesn’t resolve, they’re on their own, months or years later, trying to figure out what happened to them and what to do about it.

Linda Andre, Doctors of Deception, What They Don’t Want You to Know About Shock Treatment

Medical gaslighting

For decades our serious adverse reports have been met with all manner of medical gaslighting:

I have noticed that some persons are troubled not at all by their memory loss, others an undue amount. Obsessional people tend to fall in the latter category. Sometimes the amount of emphasis placed on memory loss by the patient fits their needs at the moment. If it gets some attention, sympathy, or can be used as a rationalization it may be exploited. Often it is over-emphasized merely by virtue of having once existed. Shock becomes the scapegoat.

Psychiatrist Robert E. Peck, The Miracle of Shock Treatment, 1974

Complaints of persistent memory loss in otherwise well-functioning individuals after recovery from a psychiatric illness through ECT are best viewed as a conversion reaction or a somatoform disorder. The Camelford experience is a model for the complaints of ECT’s profound personal memory losses.

Max Fink, The Camelford Hysteria: A Lesson for ECT? (psychiatrictimes.com)

As noted in Memory and Cognitive Effects of ECT: informing and assessing patients, those injured by ECT are rarely referred for testing or rehab:

 When individuals who have had ECT report ongoing memory disability, it is necessary for a clinician trained in neuropsychological evaluation to tease out the roles played by attention, concentration, overall slowed mental processing and deficits of executive function such as inability to shift mental set. The ECT psychiatrist and treatment team may not be trained in neuropsychological evaluation, since outside of research settings it is not routinely performed on people who have had ECT. When it is, it is usually initiated by the patient, not the doctor. Because of this, the treating psychiatrist may fear personal liability and thus be unwilling to attribute deficits to ECT. 

Memory and cognitive effects of ECT: informing and assessing patients, Harold Robertson & Robin Pryor, download (psu.edu)

A recent article by UK ECT proponents also acknowledges the lack of proper testing, in reference to the 2003 paper, Patients’ perspectives on electroconvulsive therapy: a systematic review:

 The memory problems linked to ECT have been underestimated and understated, with little support provided. A review of patients’ views found that subjective memory complaints were common, and that the “neuropsychological tests to assess memory do not address the types of memory loss reported by patients”.

We need reasoned debate on ECT, not polarisation – New Statesman

The referenced paper was written 19 years ago! 19 years of people disabled by ECT have had to live without hope for testing, rehabilitation, or access to government disability pensions or social services, only obtained with diagnostic proof.

Rehab barriers

I’ve met hundreds of injured peers; only a handful of us have been tested. Fewer have accessed rehabilitation.

I was able to get cognitive testing and rehabilitation because I wanted to go back to school where I knew I’d need special accommodations. My desire to finish my education was the only reason I was able to get testing and rehab.

Medical care for our injuries is non-existent

I spent five years trying to get help for my injuries but was never taken seriously. I was told “ECT doesn’t cause brain damage,” and that “I sounded fine.

80+ years in use, still no rehabilitation for ECT recipients

In 2019 Maeve A. Mangaoang and Jim V. Lucey published Cognitive rehabilitation: assessment and treatment of persistent memory impairments following ECT, in Cambridge University Press said this about ECT recipients’ access to rehabilitation:

“At the time of writing, no attempts have been made to rehabilitate patients who experience persistent adverse cognitive effects, but clinicians should be aware of the potential beneficial role of cognitive rehabilitation in the treatment and management of these effects.”

cognitive-rehabilitation-assessment-and-treatment-of-persistent-memory-impairments-following-ect.pdf (cambridge.org)

Imagine if my orthopedic surgeon treated me like an ECT patient

Made miraculous claims about the procedure, tells me a few scary side effects, only to deny them when I report them post-op, refuse to give me recovery assessments, or physical therapy post-op? Then calls me an anti-vaxxer or Scientologist for raising awareness? A delusional person suffering from somatoform disorder? A malingering complainer?

Yet for some reason, it’s ok to treat those harmed by electroshock this way.

Not FDA Tested for Safety and Efficacy

“When used as intended this device provides short term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated, and long-term follow-up may be needed.”
Thymatron® System Instructions Manual, 2021

For decades the American Psychiatric Association (APA), device manufacturers, and practitioners have fought to keep the shock device from FDA premarket approval testing required for all medical devices. See The FDA’s Regulation of ECT (Shock Treatment): A Beginner (or Refresher) Course.

ECT device manufacturers claimed they didn’t have enough money for premarket approval testing (PMAs).

The 2011 New York Times article, F.D.A. Is Studying the Risk of Electroshock Devices, touches on this:

Supporters, including mainstream psychiatrists, say the treatment is much safer than it once was and could pass a rigorous F.D.A. review. But they assert that the device manufacturers cannot afford those tests.

F.D.A. Is Studying the Risk of Electroshock Devices – The New York Times (nytimes.com)

In the Devices & Diagnostics Letter published on Sept. 21, 2009, various parties weighed in on the proposed reclassification of the ECT device. 

Somatics co-owner, Conrad Swartz stated that ECT has already been proven safe and effective

“Having been on the market for more than 30 years, ECT “has been proven to be safe and effective.”

Robin Nicol, the co-owner of Mecta, stated  in response to the possibility of having to put the device through pre-market approval testing that would cost around 212k: 

“Paying the fee isn’t feasible for Mecta, Nicol said, and it could close the company. ”

Somatics LLC co-owner Conrad Swartz:

“the PMA process would be a challenge for Somatics.” 

The article continues:

“[Swartz] isn’t thrilled with the FDA’s request for public comment on ECT, saying that his company’s future may depend on people outside the medical industry. ” 

Swartz adds 

“This complicates things because the public doesn’t know any more about ECT than they do about surgery,” he said. ”

ECT proponent, Max Fink, echoes the sentiment that PMAs would put the industry out of business, saying this “would be bad news for patients with few options.”

Devices & Diagnostics Letter Sept. 21, 2009 | Vol. 36 No. 37

Are there really no grants, no financial support from institutions utilizing ECT to be found that would settle the PMA issue once and for all?

And why do shock machine manufacturers get a pass when they can’t “pay to play” with the “real medical devices?”

According to Linda Andre in her letter to the FDA 2016 reclassification dockets:

The manufacturers say they cannot afford safety tests – though the Janis test costs little. If manufacturers cannot afford to test their devices, they should not be selling them.

ECT Safety Reclassification: The Committee for Truth in Psychiatry to the FDA

Imagine the company that made the screws now holding my shoulder together fighting the FDA’s safety testing requirements (PMAs) saying they can’t afford to test their product Followed by “That’s ok, well let you keep in business anyways!” from the FDA.

Is this the best modern medicine can do for the vulnerable people they claim to care so much for?

PMAs

When FDA published its final proposed rule on the reclassification of the ECT device to class II for certain conditions. This change was contingent on the submission of PMA testing:

The U.S. Food and Drug Administration today published the final order, Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses, that requires the filing of a premarket approval (PMA) application for most uses of Electroconvulsive therapy (ECT) devices and reclassifies ECT devices for the treatment of catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder from Class III (higher risk) to Class II (moderate risk) with special controls. ECT devices are one of two device types remaining to be classified through the 515 Program Initiative…The final order requires ECT manufacturers to file a premarket approval (PMA) application for all uses that are not being reclassified to class II, such as schizoaffective disorder and bipolar manic states, because the FDA is unable to identify sufficient information to establish special controls to provide a reasonable assurance of safety and effectiveness of ECT devices for such indications.

FDA In Brief: FDA takes action to ensure regulation of electroconvulsive therapy devices better protects patients, reflects current understanding of safety and effectiveness

PMAs were due by March 27, 2019

The FDA has been silent regarding FOIA requests to access the PMAs results despite compelling patient safety concerns backed by over 100 citations and 200+ signatures:

Insufficient patient education

Some don’t consent to ECT at all

From a 2017 Vice article on forced ECT in New Zealand:

“The idea of having ECT forced on me scares the shit out of me, even having had it and knowing what it is like.” Caleb* a man in his 20s who had a positive experience with consensual ECT said the benefits from the treatments were life-changing—but consent was an essential part of the process.

Hundreds of Mental Health Patients Given Forced Electroconvulsive Therapy, Vice, 2017, Jessica McAllen

A disturbing account of forced ECT in California, one of the more regulated states:

…California supposedly has shock laws in place, but they did not stop my doctor from giving me 116 ECT treatments scheduled as repeat acute “index courses,” (three times a week, three times a week, twice a week, twice a week, once a week, rinse, repeat. Again and again and again. 116 times). No one stopped him.

No one investigated Kaiser or Sharp Mesa Vista like they would have if it had been a doctor overprescribing opioids. I literally escaped continued ECT by running away from the residential facility that dragged me against my consent to the outpatient clinic. I knew it wasn’t a matter of simply refusing to sign the consent forms at the clinic, because the last time I “signed the consent form” I lay in restraints on a gurney as they started the anesthetic IV.

Sarah Price Hancock, Whose Finger is Taking the Pulse of America’s Shock Treatment Controversy?

In a recent article from Bristol Live a doctor describes his experience with forced ECT:

“I had previously told the ECT consultant that under no circumstances would I agree to it,” Peter said. “But I was deemed to have no insight into my condition and no capacity to decide on its management. This was very insulting, after 25 years as a senior doctor. But my family and even my GP didn’t have the experience to argue with them.”

Bristol doctor describes how electroshock therapy ‘destroyed’ him – Bristol Live (bristolpost.co.uk)

Some die from forced ECT

And suicide after ECT

Abuses

Anytime someone says ECT is not like One Flew Over the Cuckoos Nest anymore I say that depends on your zip code and circumstances.

Max Fink, founder and former editor of the Journal of ECT recognizes abuses and the need for regulatory actions to protect patients:

“I edited the Journal of ECT for the first 10 years. I read many submissions. And when you read them, you realize that people have . . . mis­treated their patients. They don’t know it, but I know it from the way they write.” Fink says delivery protocol standards need to be developed where they don’t exist and enforced where they do. “Very few phy­sicians are trained properly (in ECT),” he says, adding that some institutions offer one-day training programs. He calls these pro­grams “spurious” and “unethical.” 

Max Fink, Shock, an investigation into the startling comeback of electroconvulsive therapy, page 27

We Know Medical Procedures Have Risks

We take issue with are side effects we weren’t warned about.

We take issue with being invalidated, ignored, and attacked when we report known medical side effects.

We have undiagnosed brain damage and are denied comprehensive testing and rehabilitation needed to survive life after ECT treatment.

We are gaslighted when we seek help for our injuries, many of which are listed by the device manufacturers and the FDA.

Our efforts to raise awareness are often misrepresented in public discussions, further hindering our access to care. See Ad Hominem: When People Use Personal Attacks in Arguments.

No one needs to be martyred to unnecessary risks

If you care about depressed people you should also care about the safety and efficacy of treatments they are given. Not blindly defend the status quo.

Final Thoughts

Medical progress

We don’t vilify or seek to ban surgery for scars or complications, because we accept the life threatening nature of the conditions it seeks to treat.”

Such unwavering devotion to a procedure is dangerous for patients.

Science can only progress when people are willing to question common wisdom and make necessary changes to ensure improved outcomes and protect future patients– not throw up their hands and say there is nothing left to try.

Many ECT recipients have been told there was no hope but ECT, only to find out they were misdiagnosed and fully treatable, just not by the psychiatric branch of medicine.

Doctors gave up on hope when they referred us for ECT. They stopped asking questions when they should have asked more.

Examples of ECT given based on misdiagnosis:

Angioplasty & ECT

The heart stents mentioned earlier by Dr. Kellner are analogous to the ECT debate; It turns out doctors and the media have questioned angioplasty risks & benefits. Research suggests they’re overused, and offer little benefit for the risks involved:

Critical discussions brought these facts to light. Patients will be safer as a result. Better options will be explored. This is how medicine improves.

Also, if everyone would stop calling us Scientologists that’d be great.


Learn how we can improve outcomes for all ECT patients by signing and sharing the audit ECT petition.

Anna

Anna is a childhood psychiatric drug and a teenage electroshock survivor. She founded Life After ECT to ensure people injured by electroconvulsive therapy have easy access to resources that can help them understand their injuries and find a path to recovery.