Posts tagged ‘Shock treatment’

FDA May Require Testing of Electroconvulsive “Therapy” Devices

You may remember a couple of posts I made last year at this time about the importance of speaking up when the FDA opened itself up to comments on the issue of reclassifying the as yet untested ECT (shock treatment) machines from a class III to a class II. The situation was simple — in all the years the machines have been in use, the industry has never had to prove that they are either safe or effective. For decades people have been having their frontal lobes assaulted by electricity in varying amounts from just plain dangerous to thoroughly destructive on machines with no standard of testing to ensure that they’re working as designed, much less designed to address any established clinical use at all. This is not only frightening but a terrible insult to the rights and safety of the approximately 100,000 people who face ECT each year in the US (by choice or force) and only serves those profiting from the shock industry. In essence, the hundreds of thousands of people who have undergone this so-called treatment are the experiment — the living test.

Well, the good news is that it seems that the FDA’s protection of the shock industry may be coming to an end…

Peter Breggin, MD for the Huffington Post:

Friday afternoon, January 28, 2011: The FDA’s panel for electroconvulsive therapy (ECT) voted to place ECT machines in Category III for all but one indication. If the FDA accepts the panel’s recommendation, the agency will require testing for all uses except “catatonia” which was recommended for Category II, requiring less stringent testing.

A tiebreaker by the chair was needed to propose putting ECT machines into Category III for depression. Given acute trauma caused by the treatment and the evidence for long-term memory and cognitive problems, it reflects poorly on the panel that the vote was so close.

Indeed. Despite the polarized response to the matter from proponents and opponents of giving ECT a pass, each side claiming history has proven their point, the fact of the matter is that the FDA is supposed to be ensuring our expectation of some level of safety. If an industry is unwilling or unable (or in this case both) to prove its product safe and effective given the established (and frankly, lax) channels, then that product has no business being passed off as a reasonable course of action in our nation’s hospitals. This shouldn’t have come off as a vote on ECT’s supposed merits but on its decades-long exemption from the system — and that shouldn’t be a close vote at all.

It’s a little early to cry victory as it remains to be seen whether the FDA will follow the panel’s recommendation, what result that will actually have and how much the overlapping psychiatric and shock industries will play off of the catatonia exemption.

If the diagnosis of catatonia is given this loophole, we will see more and more people diagnosed with this disorder…It’s similar to what happened to children: massively increasing the diagnosis of bipolar disorder to justify giving them adult mood stabilizers and antipsychotic drugs.

Unfortunately, the FDA is already waffling about whether or not it will in fact require the usual testing for Category III devices. In response to questions at the hearing, the agency staff said it was not certain whether a Category III designation for ECT would require the same rigorous testing routinely carried out for safety and efficacy. No one on the panel seemed to think the treatment should be phased out until safety and efficacy were proven.

Psychiatric reform moves ahead a step at a time, falters, and hopefully moves ahead again. The classification of ECT into Category III for most conditions, which at this point is only a recommendation, is a step forward and a somewhat positive sign to those of us who have called for this for decades. We hope the FDA will uphold its obligation to the public to thoroughly test such a dangerous device for safety and efficacy.

Since the psychiatric and shock industries have essentially shaken off the burden of responsibility for the safety of the consumer (certainly at the industry level the term is more fitting than patient) and the FDA is apparently questioning its convictions about the protection of the public, the burden rests on the people. As neither of those entities are wholeheartedly committed to moving forward of their own accord to ensure the safety and the efficacy of products on the market and ECT cannot prove itself under any honest scrutiny, the burden then falls on the people to pressure them toward forward momentum and to keep the scrutiny honest…but then, has there ever been a time when that wasn’t the case?

January 31, 2011 at 11:01 am 6 comments

The Deadline for Comments to the FDA on ECT is Tomorrow.

I can’t stress enough the importance of taking an active role in this instance. The FDA has been in a position to regulate ECT (shock treatment) for decades by way of clinical trials determining its safety and efficacy and has chosen not to. Proponents proclaim its safety and efficacy but oppose its testing. Why? If ECT is as safe and effective as those proponents claim, the device would fly through the testing without a hitch. If not, however, the FDA is our only safeguard from a procedure that many of its recipients have found ineffective at best and debilitating at worst.

Proponents of ECT claim it is fear mongering based on old and outdated methods that opponents use to bolster their argument but little has changed in ECT over the years, other than adding drugs into the mix. The same damaging and unpredictable shock is administered to the brain, intentionally causing a seizure. Ask anyone who has seizures and chances are they will not praise them for their safety and depression reducing qualities. Muscle relaxants are used to minimize muscle contractions and anesthesia is offered, making the procedure more appealing and easier to market but certainly not safer given the increased potential for toxic or allergic effects and harmful drug interactions.

Proponents of ECT claim it is an often life saving last resort that has proven its safety and efficacy through publice use. I’ll simply say two things to that. First,that the same was said about lobotomy and second, that using the public over time to determine the benefits of a procedure is using the public as guinea pigs in a poorly regulated experiment.

When ECT proponents weigh in on the topic, they often frame it in terms of taking ECT out of their arsenal. You know something is wrong when testing something to assure it is safe and useful to the public is tantamount to banning it. The move the FDA is considering is not to ban it but to test it. If those two things are one and the same in the eyes of the shock industry, then it’s no wonder they would rather have us take their word on it.

Please speak up. A brief comment, even a single sentence is all it takes. I’ve commented and it is incredibly easy. If you can post on your friends facebook wall or comment on their myspace photo, you can comment to the FDA.

Simply go to regulations.gov. Copy and paste this docket number into the search bar on the right: 2009-N-0392. A list of comments will come up. You can view the comments of others and add your own.

More info: Jon Breeding PhD on Electroshock

January 7, 2010 at 11:40 am 2 comments

Memory is Sacred

This painting is not yet for sale as it will be part of an upcoming show. More soon.

The FDA could very well be on the way to approving electroconvulsive therapy (shock treatment) without the benefit of clinical trials to determine safety and efficacy. This is great for the psych and shock industries but a terrible step in the wrong direction for you and me. ECT is currently legal and administered to approximately 100,000 people in the US and 1 million globally. It is often happening with poorly informed consent and also by force. The ECT industry depends on its untested approval because it simply can’t pass the test. It has never proven to be predictable, safe or effective. Typically the only long term effects are the adverse effects, while the perceived “benefits” are temporary, requiring “maintenance treatments”.

Regardless of whether you stand aside me or in opposition to me in terms of the rights of people diagnosed as mentally ill, the FDA has a job to do and failure in this instance sets a precedent we can’t afford. If ECT gets reclassified it will be as a favor to a large and prosperous industry and  not in the interest of health of any kind. You don’t have to join a group, a team or a movement to be able to say you spoke up when it was necessary.

The FDA is open to comments on the issue but only for a limited time and, as it stands, proponents are speaking over opponents ten to one. I, for one, am tired of seeing victory go to the people who speak the loudest instead of those who are actually right. Here are two links that provide information on the matter. Both MindFreedom International and Jim Gottstein of PsychRights have laid out the facts and made it extremely easy to comment to the FDA.

December 4, 2009 at 9:24 am 1 comment


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