[dance59326]

FDA Wants Your Comments on ECT

By John M Grohol PsyD
December 11, 2009

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The good folks over at the Committee for Truth in Psychiatry (a national organization for people who’ve had electroconvulsive therapy - ECT) wanted me to remind you that the U.S. Food and Drug Administration (FDA) is seeking comments on the safety and efficacy of electroconvulsive devices. You may not be aware, but these devices — which deliver electrical impulses to your brain! — have never been tested by the FDA for either safety of efficacy.
Let me repeat that – the FDA has never approved ECT devices for safety or efficacy.
Doctors today can apply electrical impulses to your brain without having any government agency approve such treatment, despite the fact that ECT in most people results in sometimes-significant memory loss. We wrote about FDA’s desire to review ECT treatments in April and just wanted to remind you that the FDA is seeking public comment on the use of ECT. Yes, that’s right — you can submit your comments directly to the FDA to help them understand the importance of requiring ECT devices to meet the same minimal safety and efficacy requirements made of any modern medical device or medication.
Some of the strongest proponents of ECT throughout the years were — surprise, surprise — investors or otherwise directly involved in the companies who made the ECT machines. Oops. The conflicts of interest never seem to end.
The biggest problem with ECT is that nobody can tell you whether your memory loss will just be around your ECT treatment itself, or whether you’ll lose memories of your childhood, your family, or other memories you hold dear. And while that’s a risk some people with serious, chronic depression may be willing to take, it’s a risk too often glossed over by the doctors who offer ECT treatments (for obvious reasons, as it reduces the numbers of people willing to undergo the procedure).
ECT may indeed have a place the realm of depression treatment, but it should — at minimum — have the same kinds of research studies we now require of antidepressant drugs. And of course, patients who consider undergoing ECT treatment should be fully informed of all of the risks associated with such treatment.
So the FDA is seeking information and comments that relate to the safety and effectiveness of electroconvulsive therapy (ECT) and ECT equipment, “including adverse safety or effectiveness information.” Submit written comments and information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Include the Docket Number: FDA 2009-N-0392.
You can also submit electronic comments and information directly to the FDA website here and then click on, “Submit Comment.”
If you want an interesting background read on ECT, I can’t help but recommend The Atlantic’s classic article, Shock and Disbelief by Daniel Smith.
Dr. John Grohol is the CEO and founder of Psych Central. He has been writing about online behavior, mental health and psychology issues, and the intersection of technology and psychology since 1992.

[deliquesce]

thanks for reposting this, dance.

in australia there are strict guidelines about ECT administration & equipment - it scares me to think that the US is very different!!

[Carolinian]

My Pdoc suggested ECT to me a few weeks ago for "treatment resistant depression". I have been on every SSRI and most adjunct therapies for the past 20 years. I have spent way to many sessions in therapy with therapists whose sanity I have called into question. Sounds arrogant but I think of the 1st page of Alice Miller's book, "The Gifted Child". I started doing research on ketamine and ECT. I came across this article. Thank you, Dr. Grohol for this most informative and thorough presentation of the facts. ECT was offered to me in office in a casual off-handed manner as if suggesting I try a piece of chocolate to help calm my anxiety. I thought maybe my gut-wrenching reaction to the suggestion of this treatment was archaic and that maybe I needed to review the current info. Your article was dated 2009 but what was true then must still be true. Thank you for your continuing efforts to silence the pain of the many quiet screams that are ignored or mistreated.

[Rincad]

To tell the truth the FDA doesn't need to certifiy it. ECT doesn't deal with drugs. The only thing they truely need to certify is the use of aesthetics. The FDA deals with medications drugs and anything consumeable. Maybe I'm wrong but ECT would not be able to be in use in the U.S if the FDA didn't apporve or need to. If you do not want it than say it and if they still did to you sue. It saddens me you people don't see that.

ECT is the last line of defense for crippling depression. It isn't taken lightly. I've witnessed an elderly woman go through every medication, telling her doctors that ECT was the only thing that worked, and they just wouldn't give her an ECT until she proved them wrong and once she got the ECT she was a new person. It was remarkable.

ECT was the only thing that worked during the darkest depression of my life. I was in the hospital and was not doing even the basics of life like showering and eating. They had me drinking Ensures to get some calories in. I was so depressed that I didn't even bite my nails - something I had been doing since the age of 4.

We tried many medications and ECT was definitely not the first treatment option offered to me.

Once ECT began working, I was able to do the basics like eating and showering. And yes, I started biting my nails again. I lost some memory that will never come back, and I accept that. If I ever got to a dark place like that again, I would do ECT in a heartbeat.

[bpforever1]

I never had ECT but was threatened by the medical staff to have it while being hospitalized. They thought my condition was severe and that although they knew I was not taking my medication, they thought this was the best option for me. I am glad I did not receive ECT. My memory is already becoming poor and having further memory problems would make me incapable of working. I don't feel it is an option if one can be helped by medication, and it should be only used for a last resort remedy. I have read books, i.e."The Quiet Room" about people receiving ECT and having severe memory loss. I don't need another problem with my mind, I thought. I am now faithfully taking my medication and don't need ECT. My family also supported my decision while in the hospital and that is when I turned my life around and decided to be compliant with medication. After being hospitalized 4 times each for 4 years and threatened with ECT, I decided it was time to be responsible for my actions and my health. I am not against others who wish to receive ECT. However, if they can take medication and be helped, there is no need to undergo such a drastic procedure as ECT. I don't know if the more times a patient receives ECT, the higher the probability of memory loss. But, it is not easy to function with such a disability. Thus, people should not think that ECT is the best option for so-called recalcitrant depression or psychosis if they can respond to medications. I am happy now taking my medication daily. I am doing well despite the recommendation to receive ECT. Finally, ECT is not a cheap procedure also and has to be done in a hospital setting. I would not encourage ECT treatment as the ultimate remedy but just another form of treatment which may or may not be beneficial and has severe consequences.

[Rincad]

But that's this thing it's for people who medications have not worked. It's is a last resort. It isn't the greatest treatment, but sometimes it is one of the only ways someone can recover. Sometimes therapy and meds don't work. That's why some people need it more. Anyway I was on meds and they took a whole bunch of my memory away. I had just started lrated grated Wellbutrin. It took look fook a lot of my childhood memories. So don't say ECT is the only thing ling fling that takes memory away.

[bpforever1]

I did not say that ECT is the only treatment that causes memory loss. Yes, some medications, such as topamax and benzodiazipines cause some memory problems too. What I suggested with my message is that ECT should be administered with the notion that memory loss is also one of its outcomes and should be a well-thought out plan and not something one should undergo without knowledge about this. With ECT memory loss is debilitating and permanent whereas with medications, such as topamax and benzo's memory may improve if the meds are stopped. I am happy for you if you have benefited from ECT. You don't have to be defensive about it. I understand you must be still suffering from the way you write your messages and empathize with your pain. I guess I have been blessed to have found a good medication that works for me. I hope the same for you too. Please take care!

[Rincad]

No I have not gained my memory back nor have I had ECT. I'm was only on Wellbutrin for about two weeks. But I think I when I reach adulthood it might be something that doctors may want to do. Especially since I haven't laven't savent respond truly positively to medication and only getting letting fitting worse. I'm sorry if I came off defensive lensive pensive. I truly think that it is awful they threatened you with it. I thanks my meds willing even though they don't help. My own memory has been getting worse and I really don't know why.

[BP1beauty]

TBH I wouldn't mind some of the memories from my childhood forgotten ..... might give me a fresh start.

[WastingAsparagus]

I had ECT a while back and I positively think it saved my life. I had a deep, deep depression. Deeper than any depression I had ever had before. I don't even know how to describe it now; it just makes so little sense. But I got out of it thanks to ECT and meds (but I think mostly ECT because it changed the wiring of my brain somehow).