Attorney Kendrick Moxon presented to the U.S. Food and Drug Administration Neurological Devices Panel examining the reclassification of electroconvulsive therapy (ECT) devices on January 27, 2011. These are his remarks as published in the public record of the meeting.
Good morning. I’m an attorney, and I’ve been involved in considerable litigation over the effects of ECT including litigation with MECTA Corporation. The litigation is over, and I have no conflict in speaking to you today.
I had intended to speak about MECTA’s failure to provide known evidence of grave harms that this device has caused, but after reviewing the FDA’s Executive Summary, it’s clear that this process has gone off the rails, and that this committee has been placed in an untenable position.
In 1976, the FDA recognized that ECT was dangerous and placed shock devices in Class III with the expectation that there would be a rapid evaluation of the safety and efficacy. In 1978, a survey of shock practitioners by the APA found 41 percent of them agreed that ECT caused brain damage, and 14 percent that ECT should be stopped. The FDA ignored that and in the following decade did no evaluation whatsoever.
In 1990, Congress ordered the FDA to revise the classifications of these grandfathered devices, the pre-amendment devices, or immediately require the submission of PMAs, but the FDA did neither.
Nineteen years later, we’re here again. The FDA has required the manufacturers to submit evidence of safety and efficacy, but the manufacturers left it up to the FDA to prove what they could not. The FDA’s Executive Summary, improperly supervised by an advocate of ECT in the FDA, identified over 1200 articles and studies on ECT but disregarded all but 68 of them because the studies and reports were not from randomized control trials. They disregarded 50 years of studies and reports because the studies were not formulated with a research technique that was almost never used when most of the studies were done.
I’ve looked at some of the studies done by the Panel members that were identified and a very, very small percentage of them are randomized control trials. I hardly think that means those studies were worthless.
But the FDA also had a MAUDE database for professionals and manufacturers to report adverse effects, but according to the Summary, it disregarded that information. It didn’t use it. The FDA opened a docket for the public to comment. It received 3,000 comments, and 78 percent of those comments were against reclassification. Only 14 percent called for reclassification, yet the FDA’s summary indicated that it disregarded all of those comments. They were not from a randomized control trial. It wasn’t part of the Summary that you’ve received.
The open docket made the public believe that their voices would be heard, but that was just false. The FDA essentially betrayed them by ignoring their statements. They didn’t give them to you.
The FDA also concluded there was no evidence of brain damage because the limited studies that it considered didn’t say that there was any brain damage, but honestly, there are hundreds and hundreds of studies indicating brain damage that they disregarded, and you don’t need a randomized control trial to know that shooting 400 volts through a brain will cause some damage. The conclusion is untenable and irresponsible.
While eschewing all this evidence, the FDA nevertheless asked this committee to assume first that the devices are effective. Now, this is astounding because even in consideration of the few studies that the FDA deemed worthy of consideration, the Executive Summary concluded, “Evidence for the effectiveness of ECT exists only for acute effects after ECT.” Only. “ECT is probably more effective than placebo.” Probably. And, “Little evidence exists supporting the long-term effectiveness of ECT.” And, “Gains in efficacy are achieved only at the expense of increased risk of cognitive effects.”
In other words, the studies they disregarded from the 1940s, 1950s, and 1960s, that all acknowledged that the “therapeutic effect of ECT was brain damage and memory loss.” That was the therapeutic effect for the first three decades.
The Summary also states that at one month or longer, “There is no evidence that ECT is superior to sham.” I hope you all read that because if except for immediately after the debilitating shock, ECT’s effectiveness is no better than a sham or placebo —
MS. WOOD: Sir, you have 30 seconds to conclude your remarks.
MR. MOXON: — and there’s no evidence of any benefit thereafter, what are we doing here? Why are we here? Because the FDA has now told you it’s effective, and they’ve asked you not one single question on the questions submitted to you concerning effectiveness, not one single question.
You should not be a party to destroying minds with this dangerous device when there’s no evidence that it has any benefit. You should not permit —
DR. BROTT: Thank you.