There are so many painful emotions wrapped up in this FDA submission. It brings everything I’ve suffered from electroshock, psychiatry and an indifferent medical system and society.
This reality usually sits below the surface of my broken mind, then something pulls it to the surface and I grieve all my losses all over again. which I describe in a previous post.
This situation with the FDA is even more painful because it reminds me of how little I matter to the FDA, the psychiatric organization and how undervalued my voice is them.
It terrifies me that this reclassification travesty can happen and what will happen to psych patients if it goes through.
After submitting my response, I wanted to curl up under my blankets and cry–being reminded of my pain, and pain this “treatment” has caused my family members as well is damn near unbearable.
This reclassification has been eating away at my peace for the last three months–no more. I sat down and wrote out what I have control over and what I can do about this issue and I will fight it in every possible way I can, but I’m not going to let this psychiatry or the FDA take any more of my head space than necessary.
I’ve lost half of my life to the horrors of psychiatric drugs and electroshock; they don’t get any more of my peace.
I wouldn’t have known how to interpret the docket or surrounding issues, let alone how to respond had it not been for Lauren and other people like Mindfreedom international, actively fighting this reclassification and advocating for survivors. Knowing capable people are fighting this issue with us, I can hang onto a little more of my peace.
Thank you for your tireless work.
Below is my FDA response, which has been successfully submitted, but so far, not uploaded to the government public dockets.
Docket No. 2014-N–1210 for ‘‘Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment-Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses”
I do not support reclassification of the ECT shock device for any reason.
The terms in question
The terms treatment resistant depression and “requiring a rapid response” are arbitrary labels with no scientific basis (Caplan, 1995,). Using them as a measuring stick to determine if someone needs an electrically induced convulsion is misleading and irresponsible.
Treatment resistant depression (TRD) is a term based on how many psychiatric drugs the patient failed to respond to. There are variations on what constitutes TRD, either number or failed drugs tried and sometimes the inclusion of number of psychotherapy interventions.
As for psychiatric drugs, they are proven to be minimally effective (Kirsch, I. 2010). These drugs are known to cause mental and emotional symptoms they are supposed to treat and can also cause health problems that can present as depression.
Another issue is drug testing gender bias. Men are primarily used in drug trials however, women tend to diagnosed depressed more than men, and therefore are more likely to be given drugs already shown to be ineffective, that were tested on male physiology, open the possibility to greater failed responses and subsequent electroshock referrals.
Requiring a rapid response
Requiring rapid response is code for forced treatment. No one needs a forced electrically induced convulsion.
The terms treatment resistant depression and “requiring a rapid response” are arbitrary labels with no scientific basis. Using them as a measuring stick to determine if someone needs an electrically induced convulsion is misleading and irresponsible.
Additionally, many people who undergo shock, myself included, find out later they were misdiagnosed and their emotional distress was caused either by psychiatric drugs or other treatable causes and these very diagnostic labels the FDA is using to justify this reclassification may make this may delay understanding the underlying issue and receiving correct treatment, and leads to unnecessary injury.
The argument could be made that ECT is more cost effective, but that’s an erroneous one for several reasons. The fact that patients will have to resume taking medications and various therapies following ECT and the short lived effects of ECT themselves. The financial cost of those dependent on government welfare after being permanently disabled by ECT and unable to work. The rate of patients with actual treatable symptoms that were ignored because of unscientific labels such as treatment resistant depression when an in-depth assessment could undoubtedly save tens of thousands of dollars per patient by identifying real causes and appropriate treatments instead of using a catch-all term, throwing pills and electroshock at the problem and hoping for the best. In my case, I can only imagine the amount of insurance money could have been saved had taken the time to do a comprehensive look at my situation.
My experience with shock machines at class III
I was given shock treatments at age 17, without any legal hindrance for the arbitrary “treatment resistant depression,” for which I was labeled due to misdiagnosis and doctor negligence. No amount of electroshocks could have cured these underlying conditions creating my “treatment resistant depression.”
With shock machines at class III, my brain was permanently damaged in ways I wasn’t informed of.
I was only given the list of the risks once when I signed for consent. Any time after that I signed an abbreviated consent form.
My consent became void after my first treatment as I could no longer remember what risks were listed in the first consent form, nor was I capable of making informed, intelligent decisions after this time. I have no recollection of this information ever being presented to me again, even when I changed shock doctors.
With shock machines at class III, my life and future was destroyed by this procedure. Now I live out my days unable to work to support myself, get a college education, have meaningful social relationships and enjoy my life.
With shock machines at class III, I was denied any acknowledgement for my brain damage, and was only able to get help for requesting testing for an unrelated reason.
I was never offered before or after cognitive testing as I continued ECT.
Psychiatrists act as though shock is viewed as a last resort, and shock doctors are brave, heroic people who are willing to do anything to help ease their patients suffering. This is not what happened when I was referred to a shock doctor. He did not explore every avenue, did not critically look into my health’s role in my depression or consider the ramifications of these conditions or medical therapies effect of my mental state or consider if this heavily drugged, depressed 17-year-old was capable of making the decision to risk her life and mental capacity with his “remedy.”
No, I was there to be shocked. He simply followed the notes of my referring doctor without any real inquiry, and began shocking me.
When I relapsed after about a year and started maintenance ECT, I began to experience horrible fear and panic, in part from the procedure itself and also from the cold turkey off anti-seizure meds a few days prior to ECT, causing withdrawal symptoms I was never informed could make me feel this way. One particular session, I told my doctor, I was scared and wanted to skip this treatment. His response? Threaten to stop treating me. Thinking shock was my last hope, I complied, and never brought the issue up with any doctor again for fear of treatment denial of any kind.
During my last series of shock treatments, I felt strange. I told my doctor. He did not perform any tests. He did not suggest holding off on shock treatments until I recovered or questioning whether they should be stopped completely. Instead, he told me to come back for my next treatment. Dazed, I did. After that, it felt like my brain had been scrambled and I could barely function, think or feel.
I spent years trying to get recognition and help from my brain damage. I was stone walled with “ECT doesn’t do that.” This denial and isolation left me deeply suicidal for years. I could barely function, take care of myself, process information, or communicate clearly. Any expression of concern over my new impairments to my doctors were met with flat out denial that anything was wrong with me or shock treatment was the cause. It would be several years later when I would actually receive any cognitive testing. Not because my doctors finally decided to take me seriously, but because of an unrelated reason.
My testing showed severe deficits usually only associated with a head injury.
Continued blanket denial that ECT was to blame.
I later had more testing done that showed what looks like the early stages of dementia or Alzheimer’s for which I’m annually monitored in case it is progressive.
A career is out of the question; I am unable to go to college. I’ll be lucky to work a few hours a week.
I get mentally exhausted from doing the most basic tasks and often require help.
I’m socially ostracized because I can’t follow along in conversations or communicate effectively in real time and I get so confused and disoriented when talking, it’s often not worth the effort.
I become easily confused and disoriented.
With shock machines at class III, I was never told I could get dementia from ECT, lose emotional capacity to feel and connect with others, suffer cognitive problems I didn’t know were possible, or that no one would believe me if said I had problems, or that there were no rehabilitative services with for to address them. Nor was I told other people have experienced these problems from shock for as long as it’s been inflicted on humans—even in its modified form. I was never told of alternative explanations for ECT’s mechanism, or that treatment resistant depression is an arbitrary label based on lack of responsiveness to medications that have been proven little better than placebo and carry great risks.
All of this happened to me with shock machines at the highest risk classification, and continues to happen to countless, unsuspecting, desperate, hurting people who implicitly trust their doctors to recommend scientifically sound, safe medical treatments and to inform them the associated risks and the FDA to test and ensure appropriate protections and guidelines.
My mental and emotional devastation from shock is not an anomaly; I have met hundreds of shock survivors who are grappling with the same losses. The average shock survivor experiences drastic cognitive impairments that don’t clear up months or even years after they were shocked.
Most of us are unable to work and struggle with the basics of life management. Few are able to get anyone to take their brain damage claims seriously, and get appropriate testing or help.
Many additionally suffer other devastating ECT induced physical symptoms.
The lucky ones who are tested have proof of the cognitive devastation caused by electroshock.
Important memories are erased as though they never happened, along with skills, autonomy and dignity. We are shells of the people we once were.
We were not informed of these risks. We are permanently damaged and are actively being denied help. Many of us were misdiagnosed to begin with, and the “last great hope” of magical healing seizures, was completely unnecessary, a waste of insurance expenses and the life cost is incalculable.
And the FDA wants to reclassify shock machine for conditions like “treatment resistant depression” and “requires a rapid response” that are already the gold standard for shock treatment? All without conducting any safety testing?
The FDA’s risk mitigation plan is to put a label on a machine these patients will never see is an insult and beyond disturbing.
Can you imagine being told a procedure was “lifesaving, safe, that it wouldn’t cause permanent memory loss or cognitive impairments” and “definitely doesn’t cause learning problems,” that everything will come back after six months” only to find out it was all a lie?
That there has been clear, unequivocal evidence of brain damage available for decades as shown in animal studies, human autopsies of people who died FROM electroshock as well as carefully conducted cognitive tests that show clear, permanent cognitive impairments?
That psychiatry, an industry that purports to help hurting, desperate people went to great efforts to cover up or skew any scientific information that reflected poorly on its beloved electroshock? Cover-ups that kept me and countless others from knowing the truth before it was too late?
Misinformation that led to me not getting proper testing and rehabilitative services for over a decade? Lies that make people scoff and call me crazy when I say shock damaged me? Lies that continue to mislead more hurting people into thinking shocking their brains and bodies into grand mal seizures and brain damaged induced euphoria? Euphoria that will fade as the brain heals and will require more electrical assaults to maintain?
An organization that has actively sought to prevent data collection ECT’s use numbers as well as related deaths, and pre-market approval testing that would settle once and for all, safety concerns about ECT?
Or what about the Food and Drug Administration’s role in this? An agency created to protect American citizens from hazardous drugs and medical devices, never puts shock machines through testing, but allows it to continue to be used on unsuspecting people, who, are uninformed of the all the dangers and even at the highest risk classification is still damaging brains and destroying lives.
An agency that has heard countless testimonies and read letters of lives devastated, and suffering unimaginable, and still feels it appropriate to reduce the already minimally effective class III shock machine status to the same benign risk level as glasses and wheelchairs?
An agency that was advised to conduct animal studies in 2011, but never followed through (FDA Panel Recommends Testing of ECT Machines, Breggin 2011)?
An agency that has taken advantage of recent executive changes and declared, no hearings are needed because the committee already discussed shock machine reclassification, even though the committee pushing for shock machines as class II is not the same committee that ruled shock devices remain at high risk class III?
One can only imagine the scale of devastation this reclassification will unleash on our society, and the rest of the world as our country has global influence if this device is treated as safe as a walking cane.
Dear FDA committee members, history will remember you in one of two ways by how you rule on this issue.
You will either be known as the people who endangered countless more lives than ever by recklessly declaring shock machines as harmless as a pair of eyeglasses because of special interest influence, providing patients with nothing more for protection than a device label the patients will never see, or you will be remembered as the people who finally listened to voices of countless people disabled by the shock machine your organization regulates and maintains shock machines as class III and following your own rules to either put the device through rigorous PMA testing and ensuring patients are finally given truthful consent.
I hope you will choose patient safety and complete informed consent over special interest.
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