ICSPP Endorses the FDA Advisory Panel's Decision Regarding ECT Devices

Feb. 11, 2011 - PRLog -- On January 27 and 28, 2011 members of a Food and Drug Administration (FDA) Advisory Panel heard patients, doctors and mental health professionals present evidence that Electro-Convulsive Treatment (ECT), popularly known as electroshock, is too harmful and not effective enough for the FDA to downgrade ECT devices from Class III to Class II.  Class III devices are required to prove their safety and effectiveness through clinical trials during a pre-market approval process, a standard that is not required of Class II devices.  

In 1979, the FDA categorized the ECT  (electroshock) devices as Class III, high risk devices, meaning their benefits were not shown to outweigh their risks, and that they presented a “potential unreasonable risk of injury or illness.”  The FDA ruled brain damage and memory loss were the main risks of the procedure.  However, in spite of those concerns and the steady stream of continuing evidence of harmful effects, ECT is experiencing a resurgence of use by psychiatrists.

The testimony of January 27 and 28 was convincing enough that a majority of the Panel voted to keep ECT devices as Class III devices.  

The International Center for the Study of Psychology and Psychiatry, Inc. (ICSPP), a non profit professional group of hundreds of psychiatrists, psychologists, pediatricians and other mental health professionals and consumers today urges the FDA to maintain the Class III classification of Electro Convulsive Treatment (ECT) devices.   Dr. Joseph Tarantolo, a board certified psychiatrist practicing for 34 years and Chairperson of ICSPP, highlighted the deepening disparity between the negative safety research and the resurgence in use of such devices. Dr. Tarantolo stated there have always been psychiatrists opposed to using such dangerous and harmful means to "help" people who are diagnosed with mental disorders.  

http://www.youtube.com/watch?v=Y5LIVAaYNrQ



Researcher and Author, Linda Andre, in her recent book on ECT, stated that prior to modern brain imaging technology, dozens of human and animal autopsy studies documented brain damage from ECT. Drs. P. J. Shah, M. F. Glabus and others in 1980, found that patients with chronic, treatment-resistant depression, when given ECT, demonstrated right fronto-striatal brain shrinkage. Dr.s. P. Calloway, J. R. Dolan with their colleagues a year later also found that ECT caused cerebral atrophy.

Dr. Toby Tyler Watson, International Executive Director of ICSPP and researcher, highlighted "the current research being investigated by the FDA is somewhat problematic since there are very few studies which set out to investigate the question of ECT’s effects on brain structure, and the few that have are seriously methodologically flawed and inconclusive, as they did not use normal controls and allowed patients who had previously had shock to be considered as “before shock” or non shock subjects.” Dr. Watson futher elaborated that examples of such flawed research are the C.E. Coffey studies of 1988 and 1991.

The Journal of the American Medical Association in October. 1985 summarized Ms. Andre by stating the literature on permanent memory loss from the 1940s through 2009 is extensive and (such loss) occurs in "the majority of patients."  In 1985 the National Institute of Mental Health (NIMH) Consensus Conference on ECT found that the average loss was eight months of life and the majority of ECT patients had chronic memory impairment three years after shock.

Dr. Dan Dorman, a Beverly Hills Psychiatrist and member of ICSPP, highlighted that Dr. D. Rose and his colleagues did the first ever systematic review in 2003 of all the evidence to that date, and found that at least one-third of ECT patients experienced permanent memory loss.  Dr. Doorman went on to state that an even more recent prospective study in 2004 by Dr. Philpot and his colleagues found that at least 45% of patients experienced permanent amnesia, and 40% reported loss of intelligence.

Psychiatrist Dr. Martha Sarasua, MD, PhD, stated in a letter to the FDA that the research on ECT can be summarized as follows: "researchers have mostly avoided conducting any long term, six months or longer, studies, but whenever they have looked for permanent memory deficits, they have found them. Citing the research of Dr. H. Sackeim from the 2007 Neuropsychopharmacology article she said there have been only two long term (e.g. six month) studies of amnesia done in the past 33 years, and both, despite serious methodological problems, show that permanent extensive amnesia is common. One found “provocative evidence for autobiographical memory loss lasting at least six months” and the other, the largest study of memory ever done, concluded “adverse effects can persist for an extended period.”

In a more recent review by Dr. A. Rivkin, “Shock Therapy: A History of Electroconvulsive Treatment in Mental Illness”, Dr. Rivkin notes in seven decades there here have been only two methodologically sound randomized controlled clinical trials investigating whether ECT is more effective than drugs, and neither of these studies compared shock to drugs currently in use today.

Dr. G. Shepard from Graz, Austria, in 1992, and Dr. C. Ross in 2006, both systematically reviewed the literature on real ECT vs. doing a sham ECT procedure, and concluded the studies show no advantage for real ECT by comparison. Despite the most recent American Psychiatric Association Task Force report stating ECT was "effective", it failed to cite any depression study in which real ECT was superior to a sham ECT procedure.

So the question is raised: Is there any benefit to ECT? In 1985, the NIMH found there was no evidence for any benefit of ECT lasting more than four weeks, and Dr. Watson indicated there are no studies since 1985 showing any long term benefit.  Drs. H. Sackeim and R. Haskett in March of 2001 indicated approximately one half of patients had no significant improvement to ECT, even in the very short term, and the majority who relapsed within one and six months later were suffering long term adverse effects, while overall only 10% were in remission.  Researchers  J. Prudic and M. Olfson set out to study the effectiveness of ECT in community settings in 2004.  They found claims of 70-90% efficacy to be wildly inflated, with the actual rates from 30 to 46%. Drs. Prudic and Olfson noted these positive outcomes were measured only in the few days immediately after ECT.

Dr. Watson stated that, despite the claims of Somatics and Mecta, ECT machine manufacturers, research shows that ECT has no protective effect against suicide either in the short or long term and a recent study found that ECT patients committed suicide more frequently than those who had not received ECT, even when level of depression was taken into account."

Dr. Watson, indicated the FDA's original determination was correct and it should consider the overwhelming evidence that ECT is harmful and of limited effectiveness.  He said the devices should continue to be categorized as Class III and that clinical trials on them are long overdue. The International Center for the Study of Psychiatry and Psychology called upon the FDA to classify ECT devices as Class III until adequate pre-market approval research is performed.

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The International Center for the Study of Psychiatry and Psychology is a nonprofit organization acting as a vast network of professionals and individuals concerned with the impact of mental health theories and practices.