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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. . .
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