In January the FDA had a meeting about whether electroconvulsive therapy (ECT) machines should be moved from the most dangerous category of medical devices (Class 3) to the less dangerous Class 2.
I saw people screaming about how wrong it was and writing petitions and wanting to go to the FDA meeting to voice their opinion. I mostly ignored this issue because, well, I didn’t care. I have so many important issues on my plate there just wasn’t room for one more.
That is until I can across an article in Psychiatric Times by Charles H. Kellner, MD. Kellner explains why the move from Class 3 to Class 2 is important and its possible effect on patients.
What if you didn’t have access to ECT anymore?
ECT Machines and Class 3
The classes for devices were created in 1976 so devices could be categorized by risk. Each class has its own requirements for what has to be done to attain approval in its class.
It was recognized ECT machines should be in the most dangerous class of devices, but they were grandfathered in. This means they did not have to conduct additional tests on the machines due to their current use and supporting body of literature.
Additionally, future ECT machines also didn’t have to have new safety and efficacy literature. Instead, ECT machine regulation “requires a showing of substantial equivalence to a legally marketed device,” which is usually reserved for “intermediate and low risk devices.”
In other words, they were grandfathered into Class 3 but never had to play by the Class 3 rules.
ECT Machines are Dangerous
At first glance it seemed to me like they should be in the most dangerous class of devices. What’s more dangerous than electrocuting your brain?
But the problem isn’t with the “danger” aspect; it’s with the regulatory aspect.
ECT Machines Should be Reclassified or Require Premarket Approval
In 2009, it was recommended the FDA reclassify grandfathered devices into Class 1 or 2, or require the standard class 3 requirements. This is when the FDA started considering moving the ECT machines into Class 2.
Here’s why.
Class 3 Requirements
In order for a medical device to be approved in Class 3 it must, “affirmatively demonstrate a reasonable assurance of safety and effectiveness.” And this means sham (placebo)-controlled clinical trials on the device before approval.
And as we discussed before, we cannot conduct sham-controlled clinical trials of ECT due to ethical issues.
The other option is a “paper” approval in which previous studies are used to certify a device.
Based on everything we know about ECT, can ECT gain Class 3 paper approval?
The FDA is uncertain, mostly because of political pressures. Mostly because of the stigma associated with the treatment. Mostly because of groups that haven’t put down their petitions long enough to understand the issues and read the actual, clinical information on ECT. (It’s freely available in a quaint 154-page document. Yes, I’ve snuggled with its pages.) Mostly because of people who fly by anecdotes and don’t medically know what they’re talking about.
Next time I’ll discuss the clinical evidence the FDA is reviewing around the safety and efficacy of ECT as determined by over 1000 clinical trials and what this decision means for patients.
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All medical trials with animals have shown brain damage.
Sackheim 2007 found brain damage in humans.Memory loss = brain damage.
People are forced to have ECT against their will. This is wrong. ECT should be banned – period.
The reason ECT is still around is because they make big bucks out of it and it shuts patients up by stunning their brains! Electrical lobotomy.
http://www.breggin.com
http://www.mindfreedom.org
http://www.electricshocktherapy.info
Hi Cheryl,
To the best of my knowledge there is no indication of brain damage in humans. Memory loss is _not_ brain damage.
It is _not_ the case that most people have ECT against their will. The vast majority of people undergo ECT under the strictest protocols of informed consent. Post-ECT 80% of patients say that ECT helped them.
ECT is not lucrative. Particularly here, in Canada, money has nothing to do with it.
ECT has a success rate of approximately 80% in the treatment of depression – often depression that responds to nothing else. This is not a minor thing.
I direct you to look at the FDA notes from January where they analyze over 1000 studies on ECT: http://1.usa.gov/mQyADg
(Page 24 lists the cognitive adverse events summary.)
- Natasha
Hi Cheryl and Natasha. I have a daughter who has struggles with psychosis since early childhood. She has been on clozaril since the age of 9, clozaril is reserved for the most treatment resistant cases. We have tried augmenting with many different classes of meds, the ketogenic diet, there is not a treatment that we have not tried. The past four years her psychosis became quite severe once again and we again tried all medications available. The voices and visual hallucinations do not leave her alone and all that she wants is to be rid of them. Her development has been delayed due to the severity of her hallucinations and its impact on development since she is not able to take in information like others due to her severe and chronic psychosis. We recently began Ect, she has had 20 treatments and we are seeing slow and steady improvement. She has had some of the clearest days that she has had in years. She has no memory loss or ill effects. It was not easy getting the ECT clinic to accept her since she is only 18 years old, so they are not out to make money, they are not out to perform barbaric procedures on people. I suppose that most people who resort to ECT are in a pretty desperate position and trying to regain some normalcy to their lives. I do not think that it is fair for anyone to judge until they have walked in the shoes of a severely mentally ill individual. As I have said my daughter has not had any ill effects from the ECT whatsover, the ECT is meant to help normalize her brain chemicals not to lobotomize her. I was very hesitant and scared since it sounded so drastic, but sometimes the brain needs to be reset and meds do not always work.