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?