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