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FDA ECT deadline looms

Posted Dec 18 2009 9:25am
ECT2-RGB[1]I don’t claim to understand the way electroconvulsive therapy works or doesn’t work. Despite varying theories, its medical success and failure remains mysterious. “We don’t know how it works, but we know it works” is what ECT advocates will tell you. And indeed, I’ve seen evidence of people — especially those who are catatonic — having their lives positively transformed by the treatment.

I, however, was not one of those people. I would have done it under any circumstances, due to my desperation. But there was no informed consent involved. Certainly I didn’t understand the way ECT would lastingly affect my cognitive abilities and memory. If I had to do it all over again, knowing what I know now, I would run in the other direction — even into oncoming traffic. It was a huge mistake.

Turns out, the elements of recovery that changed my life were the right doctor, a job and blessingly effective medication. No electricity or seizures needed.

The most bizarre thing about ECT is that the machines are not regulated by the FDA. I know this sounds improbable, given their potential for damage and the controversy that persists. I guess it’s like the banks: Why regulate when you can profit?

And profit they have — the makers of the ECT machines and their accessories do quite well, and are surely distressed by this period of public comment. Here’s a little background from MedPage:

In 1976, the [FDA] began requiring that new medical devices undergo a rigorous premarket approval process in which manufacturers either had to prove they were safe and effective, or show that they weren’t high-risk and therefore didn’t need such stringent review.

In this context, high-risk means that the device’s failure to function properly could lead to serious or life-threatening complications.

But companies with high-risk products already on the market were allowed to keep selling them, with the understanding that eventually the agency would require them to submit the same type of data needed for newer products.

It took nearly 20 years for the agency to begin following through.

In the case of electroconvulsive therapy machines, for example, there are eight companies that market the devices, none of which were ever required to undergo premarket approval.

Rather, they all were cleared under the so-called 510(k) process, which automatically okays the devices if it is “substantially equivalent” to an already approved product, called a predicate device.

Since no ECT machine went through the premarket approval process, there is no predicate device. Hence, manufacturers of ECT machines must seek approval for them as if they were new to the market.

A few days ago, Dr. John Grohol reminded readers to get motivated:

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.”

So get on it, people. We only have till Jan. 8, which isn’t long. If you want more information before you comment, I recommend Linda Andre’s Doctors of Deception out from Rutgers Press. It breaks it all down for you. Or go to for more info.

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