We may be witnessing electroconvulsive therapy’s final days. This week, a U.S. Food and Drug Administration (FDA) panel will review whether there’s enough evidence to downgrade electroconvulsive therapy (ECT) devices into the Class II medical device category — that is, a medical device that carries only “medium risk.” Like a syringe.
That’s right, a device that can send electricity directly into your brain is being considered to be placed in the same medical device category as a syringe. And guess who doesn’t mind that reclassification? Why, the American Psychiatric Association, of course — they are right on board with this re-classification (PDF).
Currently ECT devices are classified as Class III devices — high risk. Yet they have never undergone the very basic safety and efficacy the FDA requires for all Class III medical devices and medications. Why not?
We’re told the devices were “grandfathered” into the Class III category because they’ve been around so long. That seems like an odd way to run an agency that’s supposed to be looking out for the public’s safety when it comes to medicine and medical devices.
In addition, the ECT devices that have been around so long are definitely not the ones in use today. Today’s ECT devices are reportedly much safer and even more effective — at least, that’s what the manufacturers claim! So given these are basically completely different devices, how could they have been “grandfathered” in?
The answer to that question is not entirely clear, although it may have something to do with taking the manufacturer’s word that the new “version” of a device is just an update, not a completely new machine. Yet, according to these same manufacturers — for instance, Dr. Conrad Swartz, one of the founders of an ECT manufacturer, Somatics — the devices are safer and better than ever:
Dr. Swartz […] said in an e-mail that any cognitive side effects from Somatics’ latest device “are distinctly less than they had been.”
The research base on ECT devices is much thinner than one would expect for a treatment that’s been available for over 70 years. Thinner — and full of the kind of bias that would make even today’s pharma-backed psychiatric researchers cringe. For instance, if you go back to some of the earliest research on the devices, you’ll regularly find researchers who had direct financial stakes in ECT device companies they were researching.
What this argument all comes down to is the usual — money. It has little to do with the actual safety and efficacy of the devices.
Professional associations like the American Psychiatric Association want to protect their members to be able to continue to “prescribe” such treatments because they are very lucrative to its members — according to the New York Times article, between $1,000 to $2,500 per session. As most patients get at least 8 to 12 ECT sessions, that’s between $8,000 and $30,000 — for just one patient.
But here’s the real kicker (for me, anyways) — the companies who’ve been raking in 70 years’ worth of profits from the sale of these machines suddenly claim they wouldn’t have the resources to do the basic safety and efficacy research the FDA would require if the devices remain classified as Class III medical devices:
“There is not nearly enough money in this industry to begin to pay for clinical trials that would be substantially larger than those already in the medical scientific literature,” Dr. Swartz wrote.
Well, then, perhaps if the device manufacturers can’t find a way to fund (or lobby the government to help fund) such studies, the devices are really not nearly as safe and as effective as they would have us believe. After all, if you really believed a treatment worked and was safe, why wouldn’t you pull everyone together and raise the money necessary?
It just seems kind of ridiculous for a company to claim that their very reason for being in business would suddenly become unaffordable if they were held to the same standards as any modern medical device manufacturer.
It is my opinion that ECT devices are neither particularly safe nor particularly effective (as I wrote 3 years ago here). Yes, of course they’ve worked for some people — every treatment works for some people. But they don’t seem to work for most people, and few doctors seem to give a very clear and complete picture of the device’s side effects. Especially when it comes to unrecoverable memory loss.
I’d love for ECT device manufacturers to prove me wrong. Go, do the basic 101 research that consumers should demand of any medical device that has the potential to turn their brain into the ultimate “living in the moment” organ. Show us all that the data support the use of these devices in a clinical setting.
Until then, the FDA should do its job and protect the public — not the professionals and the manufacturers — and demand the same minimal standard of safety and efficacy data that they demand of all modern medical devices and medications.
Read the full article: F.D.A. Is Studying the Risk of Electroshock Devices
71 comments
I guess I got off easy when 7 ECT treatments made me lose almost all memory from 2008. I do remember the abject terror of not knowing where I was, sometimes. I guess I ran off when I woke up and they had to restrain me and inject me with Haldol.
I can’t say anything good about medications, either. I gave up with med treatment 10 months ago and am doing quite a lot better, but still very depressed. 15 years of total hell, and it turns out that the worst of my suicidal thinking was some kind of agitation caused by a wide variety of medications. My husband is very relieved that the agitation is utterly gone.
Anyway, given the harm of memory loss, ECT should be last resort, and not classified as the same risk as a syringe.
I think ECTs are wrong and very dangerous, should be stopped and definately not lowered in class, what is wrong with people these days…Money is more important than ones life? What many don’t understand is how it hurts to have so much erased from your life (without my permission in my case, I was so heavily medicated in the hospital in Arizona), now, I just want to know what I can do to fix what has been taken from me. I went through treatments for 6 months. It has been nearly 2 years now, still don’t have my life. Just recently started doing some stuff again. Everyone who was around said I have been like a vegetable the past 2 years and my young children basically did not have a mother. I slept, took meds, ate, and went to appointments when needed. That was about it.. I now wonder what that has done to my kids now 8,13,15 years old. I don’t remember anything then and very few things before today, I can barely remember this morning still, and people are trying to say this is as safe as a syringe. I know that’s not true. I wish I could erase everything and speak for myself and say NO..
I would like to share real results from someone who is in treatment for depression with ECT. My first ECT was in August 2010. I received three treatments a week for the first month. Then slowing the treatments where tapper off to a maintenance level of one treatment a month. To date I have had 29 treatments. I take have the medicine since my treatments and have experience a less depressive life and can function better. I have experience very little memory loss. If I had to chose all over again I would elect to have the treatments.
i had 100 ects when i was 16 i was put in a straight jacket first night. all i was doing was getting into trouble i would have rather gone to jail then had all these ects
I just started ECT’s a little over a month ago. I can honestly say that if it wasn’t for ETC’s, I be dead. After almost 20yrs, my antidepresent stopped working and no medication could help me. Besides the occasional memory loss, I’ve had no negative symptons.
I have been having ect’s for the past 3 weeks and they have helped my depression. My memory could use a little help
ECTsaved my life. I had it done at Mayo Clinic. I had very little memory loss and experienced the first relief I have had from severe depression in years. I had five treatments…. Three unilateral and two bi-temporal. If it hadn’t worked I would be dead now. Thank God I was brave enough to put myself in the hands of caring professionals. My three children have a mother again. I have myself again.
I started ECT Jan. 6th, 2012 after a year of pills, inpatient and outpatient therapy failed completely. By the 5th session I was beginning to feel human again. My depression was reduced by about 70% and my anxiety was reduced by 50%. In short, ECT gave me my life back. I completed treatment #8 today and will post again after all sessions are completed.
I have just come through the first two treatments with ECT. The first one left me feeling happy and on top of the world. I was so excited. Two days later, I went for the second one, on Monday. Today is Thursday and I still have not bounced back. It left me feeling more depressed than I have ever felt in my life, so much so that my family does not leave me by myself. I feel lost, I feel as if I’m going to crawl out of my skin, and am so tearful…it’s a horrible feeling. I was supposed to go in for another one tomorrow, but I cancelled it. I cannot find, with all the online searching, anyone that has had this happen. It’s scary, so scary I just don’t know if I can do another one…I mean, sure it may make me feel better, or it could send me into a suicidal depression and there are no guarantees which way it will go. I’m beginning to think I just want out of this cycle, wanting to reclaim ME again, taper off all anti-anxiety and anti-depressant medications. I’ve always been a very independent person, now depending on family to keep me safe…all because of ECT. Is it worth it? I’m not so sure. I wish I had found THIS site BEFORE I went into the hospital! I would have given it more thought before jumping into it.
Despite all the controversy surrounding ECT, I can say it has changed my life. I have had >40 ECTs to treat my depression. I’ve tried MANY drugs, yet I’ve attempted suicide 5 times, and nearly succeeded. When my meds don’t appear to be doing the trick, ECT has returned me to a functional (and happier) state. Despite some mild memory loss, you bet I’d do it again.
I am one who stood before that panel and gave testimony to fact (not fiction) that Electroshock does brain damage, causes pain often unmanageable with pain medication, and destroys precious memories. I received 60 such treatments and I know first hand, although I was assured the memories would return shortly (medical record), the destruction is lifelong. The shocks ended for me in September 2000 and those memories have yet to return. I was lied to!
As the FDA panel was taking the vote, the air in the rood was HOT and HEAVY! I am so thankful they had enough sense to recommend the FDA gather more information, proof of safety and efficacy before deciding on reclassification. I would like to see Electroshock abolished. It should have remained in the hog pen along with Ugo Cerletti!
this dude doesn’t really know what he’s talking about. ect HAS been demonstrated to be safe, and 80% of patients are satisfied with the treatment despite the significant side effects associated. It’s only normally prescribed to patients who have failed to respond to several antidepressant medications,and who have little to hope for. Studies have found it to have the highest percentage of responders out of ANY antidepressant therapy. I’m not some kind of corporate drone, I’ve just read the research. Seriously people, stop being dumb.
I certainly hope ECT is in it’s last days of existence. My opinion is that it is a barbaric practice, and belongs back in the dark ages before progressive, comprehensive and compassionate treatment existed. In other words: History. History is something to be learned from. In this case, this is prime history of what NOT to use. Nor does it have a place.
i have never experienced ECT. I have, however, seen the results of it on people. Total strangers. I have wept because of the barbarism.
Would anyone lead their loved one into a chamber to be shocked by electricity? Do not human beings AVOID downed powerlines et al? i am sure the logic is coming through here. ECT never made sense.
Annie M.
Anne I totally agree with your view and was horrified to know that this practice is common in the 21st century. Medical research into mental health has not really progressed successfully over the years and logic should prevail. If patients are not getting better with medication and ECT then clearly it is not effective treatment. The industry is quick to treat a symptom but fail to recognize and address the cause, therefore patients relapse and some of the treatment actually causes more harm/issues.
I inadvertently found myself in a psychiatric ward after a manic episode due to sleep deprivation. I was researching psychology at the time,oddly enough. As I continued to push myself, my body produced natural adrenaline which allowed me to keep going. However I received a surge of adrenaline which created the episode.
The treating staff were quick to judge and categorize me as having a mental illness on my first and only episode with no other history. I have never been depressed or thought about suicide but was treated for this. Unbeknown to the doctors I bypassed the system whilst in hospital and didn’t take the medication. They said I was getting better. I had illegally recorded consults to protect myself and every time I challenged the staff they deemed it as part of my condition. When a family member compromised my position and told them I wasn’t taking my medication. They were about to inject me with resperidone. I had seen other patients suffer and even though I had no option to deny treatment. I provided some of my evidence and they refrained from giving me that drug. I was forced to take epilium for 8 weeks as a compromise to get out of hospital. I have since produced a biography of my experience, it can be found on http://www.lulu.com and it is called Crazy Normal, Normal Crazy! I have publicly named the hospital and all treating staff. I also included a transcript of one of the consults. I have also provided a good insight into the consistencies of mental health and have suggested other areas of research in order to help others. The book covers a great deal and is a light funny read about serious issues bit just with mental health but society as well.
Thank you for sharing your thoughts! The more people that challenge, the better for those that are suffering. I wish you well in your quest and find comfort that there are many voices trying to assist the vulnerable.
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