ECT Safety Reclassification: The Committee for Truth in Psychiatry to the FDA

water trails from ferry with new york skyline in the distance. The sky is a blue pink with white cloud wisps in the sky

Committee for Truth in Psychiatry P.O. Box 1214

New York, NY 10003

Food and Drug Administration

Dockets Management Branch (HFA-305) 5630

Fishers Lane, Room 1061

Rockville, MD 20852

Re: Proposed Reclassification of the ECT Device —

Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses:

Draft Guidance for Industry, Clinicians and FDA Staff; Availability; Docket ID: FDA-2014-D- 1318 & FDA–2014–N–1210.

The Committee for Truth in Psychiatry (CTIP) was founded in 1984 with its mission to prod the FDA into researching ECT and telling patients the truth about shock treatment. To that end we filed a petition asking the FDA to adopt our proposed informed consent form and we monitored FDA’s grappling with the question of reclassification for the past forty years.

Now FDA intends to put the ECT device into the same category as an X-ray machine. But no one who ever had an X-ray ever got off the treatment table missing five, ten or twenty years of their lives. Never have they ever forgotten a spouse or a child, as has happened with ECT.

This issue before the FDA is the safety or lack thereof of the ECT device – safety for memory, and thus to the brain. It is fair to say that of the thousands of letters FDA has received on ECT, virtually no one has reported the temporary inconveniences like electrode burns and muscle soreness.

The letters are all about memory – ECT’s permanent effects – and they paint a convincing picture. Simply warning of “memory problems” is not sufficient to describe the severity and permanence of these problems, which is why we wanted to adopt our own consent form, which has been endorsed by over 1000 ex-patients.

Placing our trust in the FDA to listen to us, thousands of ex-patients have written letters that tell of the severity of the permanent amnesia and the impact of this memory loss on their lives. Teachers no longer teach, nurses no longer nurse, and professionals can no longer practice.

Patients must be prepared for this impact of ECT on the rest of their lives. All of us at the Committee for Truth in Psychiatry have in common a deep sense of feeling deceived, betrayed by doctors who have sworn to do no harm. And now, to have the memory loss reduced to a single phrase, “memory problems,” we feel betrayed again.

We feel betrayed especially because FDA wants to say that memory problems resolve in a short period of time. The return of memory is the big lie we were all subjected to. FDA cites to no study showing return of memory because there are none. Nor are there any studies to show the efficacy of ECT for more than a month or so.

Nor can any manipulation of the devices spare memory. As I discuss in my book Doctors of Deception, every time there has been a claim that modifications reduced or eliminated memory loss, that claim has been proven false.

A survey of the literature on memory loss that CTIP has compiled was included in the PsychRights and Committee for Truth in Psychiatry Submission to FDA opposing reclassification of electroshock machines (March 25, 2016).

And this article should also be before the FDA:

Robertson H, Pryor R. Memory and cognitive effects of ECT: informing and assessing patients. Advances in Psychiatric Treatment 12: 228-238. 2006.

Robertson and Pryor make a useful distinction between memory loss (amnesia) and memory disability (ongoing problems in memory function). They say that the test commonly used to assess memory loss, the Mini-Mental State Examination (MMSE), is too crude to detect memory problems caused by ECT.

Finally, as a practical matter, there is no way to distinguish ECT devices used for major depressive episode (MDE) and those used for schizoaffective and other diagnoses. There is no way to ensure that the devices are used for only one narrow use.

Thousands of patients and concerned citizens have written to the FDA over the years, always with the expectation that our words would not fall on deaf ears. The FDA is largely ignoring our voices and betraying the trust placed in it by the general public, in order to carry out the wishes of the ECT industry.

We are asking again that you adopt the statement of patient information we submitted in a previous petition. It warns that memory loss occurs in all instances of ECT.

After the ECT there is a period of about one month when the patient regains the outlines of his or her life, but after this, there is no recovery of lost memories. Some patients do not mind their memory changes and have little opportunity to notice them. At the other extreme are patients whose work or way of life is made impossible by them. In between are patients who gradually adjust to varying degrees of disability.

We would add that since our consent form was written, studies have shown that ECT commonly causes five to twenty years of amnesia. No X-ray machines can do this. No device which causes this should be in Class II. The Special Controls are just not sufficient to mitigate the routine damage caused by ECT.

If ECT is down-classified, basic research which is lacking will never be done. Manufacturers will not have to do tests like the Janis test, which has been recognized to be methodologically sound. We will never see a double-blind controlled investigation using the most modern imaging tools to assess the impact of ECT in before and after brain scans. The old question – “Does ECT cause brain damage?” will never be definitively assessed. This is not what ex-patients and concerned citizens want.

The manufacturers say they cannot afford safety tests – though the Janis test costs little. If manufacturers cannot afford to test their devices, they should not be selling them.

By reclassifying the devices, it is likely that ECT use will increase, causing a new generation of patients to be treated without care or concern for the impact of the treatment.

For all these reasons, we ask that the FDA listen to the voices of the ex-patients who know firsthand ECT’s deleterious effects. As one of us put it, “If a person, even when feeling horrible, knew how ECT results in a past and a present that can never be reconciled, he or she would know that ECT is unnatural and wrong.”

Linda Andre

Director, Committee for Truth in Psychiatry

March 26, 2016

View on Regulations.gov