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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.
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