FDA Wants Your Comments on ECT
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.
Grohol, J. (2009). FDA Wants Your Comments on ECT. Psych Central. Retrieved on June 29, 2016, from http://psychcentral.com/blog/archives/2009/12/11/fda-wants-your-comments-on-ect/