The Center for Devices, Bethesda, Maryland, May 4, 1992

_____ Present, FDA: _____
Phillip White, Director of Office of Standards and Regulations
Midge Brier, Secretary to Mr. White
London Haflin(?), Office of Science and Technology
Gordon Johnson, MD, Head of Office of Health Affairs
Lynne Reamer, Assoc. Dir., Office of Device Evaluation
Elizabeth Jacobson, Deputy Director, Center for Devices and Radiological Health

_____ Present, Support Coalition International: _____
Sally Clay, PEOPLe, Ulster County, NY
Larry Plumlee, MD, National Capital Area Advocates, Washington, DC
Dennis Nester, Phoenix, Arizona
Linda Andre, Committee on Truth in Psychiatry, New York, NY
Louisa Jackson, PEOPLe, Dutchess County, NY
George Ebert, The Alliance, Syracuse, New York
Mary Ann Ebert The Alliance, Syracuse, New York

SALLY-First I should say that we represent a nationwide, even an international, network of people who are psychiatrically labeled. One of our main concerns is the issue of ECT. We want to talk about is what we know from our experience can happen with ECT, and why we believe it is a very dangerous procedure.

LARRY-A task force by the American Psychiatric Association published a report recently that made the claim that about one person in 200 who has had repeated shock therapy has longterm brain damage. People who have had these treatments have the impression that the frequency of longterm brain damage is much higher than 1 in 200, and when they asked the head of public affairs of the APA what was the scientific basis for this figure, no one could produce any reference. Yet those hospitals who use informed consent usually say that this risk of longterm memory loss is about 1 in 200. They cite the APA report. Yet the APA says that this report is not an official APA sanctioned document. "It was put together by a group of advocates and practitioners of ECT who are experts in this area, and it is their best opinion of what is the situation. But we, the APA, do not stand behind the information or endorse it. We merely published the task force report."

FDA-Was a guy named Weiner the head of that task force report?

LARRY-Wasn't it Max Fink? So basically we have a situation here where information is being cited by the medical community, but data is not provided to substantiate it. The anecdotal impressions of these people who received it, and networked among others who had it, is that the problems are much more frequent, and informed consent is not complete. People were very upset when they heard that the FDA had been petitioned by the American Psychiatric Association to reclassify this device from Class III to Class II. We have a situation where the advocates of electroshock therapy, people who make their living by it, have prepared a report by their trade association, the APA, and it disagrees with the anecdotal opinions of these people, and it seems as if some scientific resolution of this dispute is needed, rather than reliance on the authority of this task force of the American Psychiatric Association.

FDA-Thank you, Larry, that was very well said.

SALLY-That is basically our position, that if a proper scientific study were made, it would be found that the damage is far greater that (it seems) so far.

DENNIS-The only way I found out that I had memory loss was that I saw a magazine saying that Robert Kennedy was assassinated, and I was dumbfounded. This was two years after the shock ...inaudible... Unless you have such a signpost you might not realize you have the memory loss....inaudible...

FDA-I think it's well known that memory loss is common, and the question is, is it permanent or not?

SALLY-In my case, I completely lost two years of memory from the treatment that I had in 1969, and those two years included the years when my daughter was two and three years old, which are even more precious than they would normally be, because I lost custody of her. I forgot everything during that period, including a wonderful cross country trip that I know was wonderful from what people told me about it, but I can't remember a thing about it. And I should say, also, that the shock treatment did not help me at all in removing the depression and despair that I felt, which is why I did consent to it.

FDA-It is my impression that most of the proponents, even the staunchest advocates of ECT, separate short term impairments versus longterm impairment.-short term cognitive dysfunction versus long term. Is that your general sense?

LARRY-Now that we have imaging techniques for the brain that are very sensitive, that are very non-invasive, it seems to me that a well-controlled, longterm follow-up study might lend information on this.

FDA-Maybe it would be helpful if we talked a little bit about what the responsibility of FDA is and how we go about getting data and information in which to make judgments, because I think it is not always clear to people how we do that. Unlike NIH or EPA or those agencies, we do not have money to do big studies. We are not a funding organization, so we do not have a grants program where we can go out and fund them.

LARRY-I remember that when Lithium was approved, there was an effort on the part of some psychiatrists to get Lithium through. It had no advocate in industry who was willing to make the safety and efficacy studies, and ultimately some pressures from Congress led the NIH to fund the studies independently of FDA, but in order to meet FDA requirements for safety and efficacy, and lithium was summarily approved by the FDA. So it might be in this situation also that a research agency could contract monies if the FDA were very clear that the APA and the advocates of the devices had not provided adequate basis for making regulatory judgment.

FDA-I think that that is always a possibility. We are dependent on the research that comes in from other sources, whether that be from NIH...inaudible...ECT was on the market before our law came to be, so it was a pre-amendment device. It was placed in Class III by our panel, and that means that we need data to show safety and effectiveness before we approve it. Since it was a pre-amendment device, through, it is allowed to stay on the market legally until we call for that data.

SALLY-Can I ask how this worked with the silicon devices, the breast implants? How did it reach the point where you determined that there was a danger?

FDA-Reports back in from the user, for one thing. That is another part of the system. When a device is on the market, it is incumbent upon the user or the physician or the manufacturer to report any malfunctions.

SALLY-Well, as I understand it, you have received hundreds of letters (regarding ECT). Linda can give you the figures. I know I sent a letter. Here is the letter that I sent in 1987, and this is just one of many hundreds of letters that were sent by users of ECT (gives letter to Philip White).

FDA (Mr. White)-We received a number of letters on the reclassification issue. Did you get a response from us?

SALLY-No, I don't believe I did.

FDA (Mr. White)-...inaudible...I'll make sure that it's part of our record.

FDA-I think that, as with any technology, the problem with ECT has to do with the benefit/risk analysis--what is the benefit to the patient versus the risk. And that is always problematic, because, again, in the absence of clinical trials. And for an individual patient who has experienced some adverse effects, it doesn't matter how good the benefit/risk equation was, for that patient it was a disaster. And I think right now I would say that ECT is on the slow track to reclassification, because we have not closed reclassification under the condition that there be a standard developed by the APA, which has not happened. I honestly don't know where the development of that statement is, but we have no intention of proceeding forward until we get such a statement and are satisfied with it.

LINDA-The study that was cited...inaudible...on the risk of suicide showed that ECT had no effect on the suicide rate. There has never been any study that showed that ECT prevents suicide or has any effect on the suicide rate. And in fact I went through the Federal Register, and checked on many of the studies that were used in the so-called "literature review"...inaudible..., and many of the studies sometimes have nothing to do with the point they are supposed to be making. In many studies that have to do with memory loss and brain damage, and the longterm effects of ECT, were not at all included in this literature. We found the literature used to be very selective and (with a) very biased point of view based on reclassification. The manufacturers have admitted that they have never done studies on some of these devices for 20 years. How is it possible to take a selective review of old literature which does not even support the points that it is supposed to support, and then say that it justifies reclassification-especially when there are 32 volumes of letters in the dockets room regarding this device, more than half of ex-patients stating adverse and very tragic results-dozens of letters from congresspeople and letters from every 50 states, from Protection and Advocacy agencies. Don't these carry any weight, especially when in the case of the reclassification of breast implants, there were very few letters from ex-patients with adverse effects? There were very many ex-patients with positive benefits from this device, and here we have the ECT device, with literally hundreds of letters, and each letter representing hundred more cases of adverse, longterm, tragic, brain-damage effects, and only a handful of letters supporting positive experiences. ...inaudible...How can you justify this? How can you compare this with the breast implants device, where a very well-publicized investigation took place on the basis of much less evidence of adverse effects?

FDA-Well, it is not a question of justifying it. I think it is important for us to have a dialogue and to hear the things that you have to say. It is not that the letters are not important to us--they are very important to us. But it's a very tough area, it really is. It is difficult when people say, "Look, we don't have many modalities that are effective at all in treating some of these conditions, and this is one thing, we need it...inaudible... You get cogent arguments on the other side, too. None of that takes away from or negates the pain that people feel that have suffered adverse effects from this technology, and that is one of the reasons that we're sitting here today is because we feel very much for you, and we want to see what we can do to come to the best resolution of this. I think even looking at the data, the data does not really give you ... inaudible...but I would like to hear from some of our folks who have looked at this science. I don't think the science presents a particular...inaudible...

LARRY-I come away from the data with very much the same impression. ...inaudible...If this were a drug seeking approval... I gather you would say that the safety and efficacy data would be nowhere near what would be necessary for approval.

FDA-I am not familiar with the drug regulations and procedures...inaudible...I'm simply saying that I don't find the data reported to be particularly...inaudible... It is really kind of an unknown, we hear polar positions...inaudible...

LINDA-It is interesting that just based on this literature, we find that the literature is very equivocal, even studies that talk about longterm effects...inaudible...So even with these studies that were left out of the APA's very selective literature review, you still find that this literature is very equivocal.

FDA-I'd like to ask a question. Traditionally, as I understand it, ECT has been used for drug-resistant, or so-called pharmico-resistant, patients as a sort of last-chance therapy. Is that still the case?

LINDA-Not any more; that is not any longer the party line. That part of the APA which is on the APA task force to use electroshock...inaudible...

FDA-In the traditional view, in patients where drugs or pharmacological agents have no effect, and there is no ECT...inaudible...?

LINDA-Well, let's point out that ECT ...inaudible...In the studies that have been done on efficacy show that the beneficial effect of ECT, if any, lasts for a very short time, only for a week ...inaudible... So four weeks at most, if anything, a tradeoff for an indeterminable permanent memory loss, of up to 40 years and permanent cognitive dysfunction.

LARRY-FDA does not permit the marketing of snake oil for those illnesses for which medicine does not have safe and effective treatments, so why would something, in which possibly 55 per cent of people receive longterm memory loss, be acceptable, simply because there is no other treatment available? It seems that one would want proof of safety and efficacy before allowing a device to be used which inherently so dangerous.

SALLY-I would also like to state my view, and the view of a lot of us here, that we are dealing with an industry here, the mental health industry, that, in fact and in itself, is responsible for creating more "mentally ill" people than for curing them. And I think if you look at those of us here who have achieved a degree of recovery and wholeness of mind, most of us would tell you that we have done it in spite of the mental health system, not because of it.

LINDA-Again I think we need to look at the longterm social cost of ECT-the four weeks of benefit, after which there is commonly what they call "relapse"...inaudible...But what about the longterm social cost of people who have had ECT and formerly were productive and working, and after ECT (such as myself and a great number of other people)...inaudible.... What does that cost our society to take somebody who was a productive person, who maybe experiences some temporary distress, and create a permanent disability?. ...inaudible...Consider the cost of disability payments ...inaudible...You know, most people who have ECT end up on SSI and disability.

FDA-I hear you. I think that statements like that, though, are a little incendiary, because before you can say that most people who have had it end up on Social Security roles, you need to know how many of them would have ended up there anyway. I mean, that's kind of inflammatory.

SALLY-We would like to see all these things studied scientifically.

FDA-That gets to my next question, which is what would you, if you had three wishes, what would you like to see the agency do? What is it that you would like of us?

LINDA-First of all, we would like to see you do your job, which is to call for a safety investigation under Class III, ...inaudible...and we would like you to make it a very high priority, given the controversy now going back twelve years, with much public interest on this issue. The 32 volumes of letters in the dockets would justify making it a very high priority.

LARRY-Well-controlled, double blind clinical trials.

FDA-How do we do double blind clinical trials? How is that possible?

FDA-Are you talking about the FDA doing the studies, or ...inaudible...doing the studies?

FDA-We had a discussion before you came in, but I think...We don't have the resources to fund clinical trials, so we are dependent either on the profession funding such a study or the manufacturers or another agency.

LINDA-We have a problem in that many people who have done such research as does exist are themselves paid by the shock machine companies...inaudible...and I think that raises an ethical question: Can this research be done fairly by persons who have a financial interest? That would be a big concern of ours, that whatever research be done be very carefully and ethically by people who have no financial interest in this treatment.

LARRY-Since the approved device can be used for things other than that for which it is approved, as is true of a drug, it seems to me we would want to have some input into the follow-up. Certainly no psychologists now have tests for memory, for learning ability, for mood. We would want to look at things such as employability.

LINDA-...inaudible...It does not have to be an expensive kind of test...inaudible...For organic brain injury, from my own experience and the experience of other people, after a year post ECT, recovery is as stable as it is ever going to be. So I would say wait at least one year afterwards to allow the person to recover as much as is possible, maybe three years...inaudible...

LARRY-I haven't heard any mention yet of the impression that I have that of the amount of ECT being used, but my impression is that the amount of electroshock therapy being used by psychiatrists is greatly increased. It was something that had faded out in the 60's, and now it is increasingly used. During this very time, the psychiatrists at APA are attending a course on learning these techniques. Then new people will be qualified to do it. So its importance from a regulatory priority is probably dependent on whether it is in frequent use, or whether it is very uncommonly used, it is important that someone address this question of how rapidly is the use increasing.

FDA-I'd like to make a couple of quick points. I think there are two separate issues here--it's hard to keep them separate. One is that we have published a proposal to reclassify ECT devices from Class III to Class II for one specific indication-that is severe depression. I gather that you oppose that--but to the extent that there is a reference to it in literature, there is data-whether it is anecdotal or whether it is published in studies-that we may not know about or have not identified- please get that into the record, so it will be included. Mr. White just indicated that we have not closed that record. Anything along that line, if we could get it in writing and formally submitted, we can guarantee you it will be considered.

SALLY-I was concerned that you said that one of the reasons for approving the use for depression was that you were told by physicians. . .

FDA-Could I just correct that? We haven't approved anything. What we did was, we proposed reclassifying from Class III to Class II. We have not finalized that yet, and, as I said, that's really on a very slow track, because one of the conditions was that we wanted to see a standard for its use. And that has not materialized. So right now the status is Class III, and it has not changed.

SALLY-What concerns me about the thought process involved here is the weight given to the psychiatrists who claim that this is their only effective treatment, or something to that effect. I would hope that you people might keep in mind that we are the users here, and in my view and in most of our view, this industry is very questionable--the whole mental health system. And I think it is a little different from looking at treatments in other areas like diabetes, which these things are so often compared to, because it is not the same thing. And I hope you will keep that in mind and continue to listen to people who are the recipients of this treatment.

FDA-We will. But one point I made is the Class II proposal of reclassification. The other is that, I gather, as Ms. Andre indicated, that this group is opposed to the use of these devices for any purposes--that it really has no place in clinical medicine and clinical practice.

LINDA-There may be individuals who have. ...inaudible... But the position of the organization of people who have had ECT is that there should be informed consent, and that people need to be told accurately of the risks, and then if they wish to have it they can have it.

LINDA-One thing we would like to see is the FDA...inaudible...In 1982 it said they were considering an informed consent statement. Because, as you may know, there is no standard informed consent statement. Any hospital can make up their own, each of the different manufacturers has its own version, the APA has another version, different doctors in the APA have their own version. We think there should be a standard for an informed consent statement...inaudible...

LARRY-Even if it is just your own staff saying, "Indeed the scientific evidence is very weak, that it is either ineffective or harmful." This is an astounding thing, that such a device is permitted, yet stronger regulatory action has been taken in much less toxic...inaudible...

LARRY-You see, we're not even dealing with a disease. Maybe we're dealing with people who are sad about their lives and need to talk it over with someone and figure out that they need to make changes in their lives. And yet psychiatry is decreasingly interested in listening to people and increasingly interested in wanting the imprimatur of scientific medicine, by using devices and drugs to obviate this time-consuming process which actually peer counseling is beginning to replace. And perhaps a lot of people need to be in touch with their sadness to explore what are they sad about and how can they change their lives. And yet that opportunity is scarcely considered by many psychiatrists, particularly the advocates of these biological...inaudible...

SALLY-Psychiatrists base their judgments and their diagnoses on behavior, not on the basis of what is going on inside a person-what we feel like, or whether we are trying to make a spiritual transformation, or whether we are grieving for a lost husband or something like that. It is simply on the way we behave. And their judgment of success is very often-especially with ECT-whether we become compliant. And that it is true, because that is one of the first effects of ECT-apathy and compliance.

FDA-We control the device itself through our restrictions on the manufacturers that sell the devices. We don't impact on those devices that are already out there, that have been sold legally in the past. I just want to make sure you understood that.

SALLY-But still, the findings of your agency do carry a lot of weight.

FDA-And I want you to know we really did hear you. I think it's important that we can't maybe control mental health care in this country, obviously, but we are responsible for this particular device, and we are responsible for getting the word out on what we know and don't know about that device. You really came through loud and clear. And I guess I want you to know that we take that responsibility very seriously, we will do the very best we can to get out solid data on what is known and what is not known. People really do need to make an informed choice. I don't know how to do that-that's a different question. But at least we can get the information out there.

LARRY-We really appreciate this meeting. It is clear to me that the agency has brought forth people who have responsibilities in this area, and people who have useful information. It's very nice of you.

***** Sharewrite 1994 Sally Clay * sallyclay@aol.com ***** Permission is granted for personal or electronic distribution of this document as long as it is unchanged in any way and this notice is included. For permission to reprint it for general publication, contact me at 310 Elm St., Northampton, MA 01060, or by email.