Grandfathering ECT Machines

I only had one grandfather as I grew up (the other was dead before I was born — a good thing, I was told), and he wasn’t much good to me. Mainly, he ignored me. I would see commercials on TV about warm, loving grandfathers and I would think, What the hell went wrong? That didn’t look at all familiar.

But the kind of grandfather I speak of now is different. It’s about ECT machines — the little zappity zappers they use to jolt you with electricity to make you convulse so that you can have relief from your symptoms for, at best, a few weeks, but be left with side effects that can last years. And this isn’t just my opinion on it; the industry itself concedes that benefits are not long-term, but negative effects can be.

The best, most comprehensive book on this matter is by Linda Andre, long-time advocate and thorn in the side of ECT manufacturers and practitioners. It should be noted that for years she was dismissed as something of a kook, but she never stopped working to have the practice reassessed. This year she had a book, Doctors of Deception: What They Don’t Want You to Know About Shock Treatment, published by Rutgers University Press, and I’m still working my way through it. I’m not aware of any other book that treats the subject so thoroughly, or indeed at all.

I’ve “known” Linda Andre for years. We’ve corresponded on and off, as I’ve written about my own experience with ECT and also subjected the industry to scrutiny. At some point I felt I was repeating myself and that it was hopeless, but Andre never gave up. Yesterday she sent me the following email:

Now: I won’t take no for an answer on this one. Have you read that the FDA is waking up and calling on the manufacturers of shock machines (and other medical devices) to submit evidence of safety and efficacy for their products? I just forwarded you one of the news items. It has been in the New York Times and the Wall Street Journal.

The manufacturers are supposed to submit something by the end of the summer. Of course they won’t, and the FDA will just go ahead and reclassify the device as it’s always wanted to. Unless we can prevent it by public outcry!

Basically this is validating the story I just broke in the book about how the devices have never been tested, though of course the book adds the story of how patients and doctors battled over this for decades.

She’s right, of course. The machines have not been regulated because they’ve been grandfathered out of regulation, which is patently insane. This means they’ve never been approved for safety, so a machine can be as trashed and iffy as an old radio in a garage, and no one would be the wiser.

From Medpage.com:

WASHINGTON, April 9 — The FDA is finally closing a loophole that has allowed high-risk medical devices to remain on the market in the absence of clinical test data.

The agency decreed Wednesday that it would require safety and efficacy data from manufacturers of certain medical devices who, thanks to a quirk in previous regulations, never had to prove their safety or efficacy.

The devices fall into 25 categories and include automated external defibrillators, female condoms, and electroconvulsive therapy machines. Their manufacturers have until this August to submit data on these devices.

They may be required to go through the agency’s full premarket approval process as if they were entirely new products.

In 1976, the agency 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.

…

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.

Keep your eyes peeled for more.

liz | 10:28 AM | electroshock (ECT)