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.