ECT Device Reclassification – International Center for the Study of Psychiatry and Psychology to the FDA

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International Center for the Study of Psychiatry and Psychology
2808 Kohler Memorial Drive, Suite 1
Sheboygan, WI 53081
920-457-9192 Tele/Fax
www.icspp.org

Demember 4, 2009

Re: OPPOSE Docket #FDA 2009-N-0392: Electroconvulsive Therapy Safety and Effectiveness, and request PreMarket Approval Applications for the devices.

To whom it may concern:

The International Center for the Study of Psychology and Psychiatry (ICSPP) is an international network of over 250 varied psychiatrists, psychologists, neurologists, pediatricians, social workers, educators and professors, researchers and lawyers, consumers of mental health services and concerned family members, as well as advocates at large.

The considerable scientific evidence available suggests the efficacy of electroconvulsive therapy (ECT) is very questionable, at best, causes brain damage to all, and causes very serious brain damage to many (see attached letter detailing research available on these devices).

Other submissions to the FDA may give praise for such devices and report safety; however, no specific research is provided.

For these reasons, we urge the FDA to maintain the Class III scheduling of the ECT device until and unless clinical trials are conducted as part of the Premarket Approval application process, which validly demonstrates such reclassification is warranted. Please review the attached summary of ECT research.

Kindest regards,

Dr. Toby Watson, Psy.D.
ICSPP International Executive Director

Clinical and Doctoral Training Director
Assocaited Psychologial Health Services
Licensed Clinical Psychologist

Attachment

December 1, 2009

Food and Drug Administration

Dockets Management Branch (HFA-305)

5630 Fishers Lane, Room 1061

Rockville MD 20852

Re: Docket #FDA 2009-N-0392: Electroconvulsive Therapy Safety and Effectiveness

    The International Center for the Study of Psychology and Psychiatry (ICSPP) is an organization of over 250 psychiatrists, psychologists, neurologists, pediatricians, social workers, educators and professors, researchers and lawyers, consumers of mental health services and concerned family members, and advocates at large that are concerned about how mental health theories, research and devices affect public policy and individuals at large. 

The considerable scientific evidence available suggests the efficacy of electroconvulsive therapy (ECT) is very questionable, at best, it causes brain damage to all, and very serious brain damage to many.

For these reasons, we urge the FDA to maintain the Class III scheduling of the ECT device until and unless clinical trials are conducted as part of the Premarket Approval application process, which validly demonstrates such reclassification is warranted.

There is ample evidence and controversy regarding the lack of safety regarding these devices.

        In 1979, the FDA categorized the ECT device as a Class III, high risk device, meaning that it’s benefits have not been shown to outweigh its risks, and that it presents a “potential unreasonable risk of injury or illness.”

It ruled that brain damage and memory loss were risks of the procedure. Thirty years later, no evidence has accumulated to disprove these findings, but rather there has been a stream of continued evidence in the research demonstrating significant harmful effects. 

Here we briefly summarize the evidence on ECT’s lack of safety and efficacy.

On safety to the brain: 

      Prior to modern brain imaging technology, dozens of human and animal autopsy studies documented brain damage from ECT.[i]

In the modern era, brain scan studies of psychiatric patients show a correlation between treatment with ECT and cerebral atrophy.[ii]

The very few studies which set out to investigate the question of ECT’s effects on brain structure are both seriously methodologically flawed and inconclusive (i.e. they did not use normal controls, and allowed patients who had previously had shock to be considered as “before shock” or non shock subjects.)[iii]

On safety to memory:

      There are seventy years of reports of permanent extensive amnesia and memory dysfunction in a large percentage or majority of patients.[iv]

Reviewing the evidence to date, in 1985 the NIMH Consensus Conference on ECT found that the average loss was eight months of life and that the majority of ECT patients had chronic memory impairment three years after shock.[v]

More recently, the first-ever systematic review of all the evidence to that date (2003) found that at least one-third of ECT patients experienced permanent memory loss.[vi]

An even more recent prospective study found that at least 45% of patients experienced permanent amnesia, and 40% reported loss of intelligence.[vii]

      The research on permanent amnesia 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.

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.[viii]

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, and (usage) characterizes routine use of ECT in community settings.”

On efficacy:

      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.[ix]

       In 1992 and again in 2006 researchers systematically reviewed the literature on real vs. sham ECT and concluded the studies show no advantage for real ECT.[x] Even the most recent American Psychiatric Association Task Force report, though it asserts ECT’s efficacy, did not cite a single study showing real ECT having a superior outcome to a sham ECT, when treating depression.

       In 1985, the NIMH found there was no evidence for any benefit of ECT lasting more than four weeks, and there are no studies since 1985 showing any longer benefit.  

A large recent study 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.[xi]

An even more recent study found claims of 70-90% efficacy to be wildly inflated, with the actual rates from 30 to 46%; however, these positive outcomes were measured only in the few days immediately after ECT.[xii]

      Despite claims repeatedly made by ECT practitioners, including in the current docket, research shows that ECT has no protective effect against suicide either in the short or long term. [xiii]

A very 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.[xiv]

        If the FDA must consider the overwhelming evidence that does supports the continued need for ECT devices to be categorized as a Class III, device.

Clinical trials on the device are long overdue and in need for professionals and practitioners to make informed decisions. 

The FDA’s original determination of ECT’s risk was and is accurate.  

The International Center for the Study of Psychiatry and Psychology is calling upon the FDA to keep the Class III schedule until PMAs are performed on the devices.  In truth, we would suggest an impartial review of the evidence requires the withdrawal of ECT machines from the market.

Respectfully,

Dr. Toby Watson, PsyD, ICSPP International Executive Director, Psychologist

Martha Sarasua, MD, PhD,  Psychiatrist

Daniel Doorman, MD, Psychiatrist

Howard Glasser, MA, Researcher-Psychotherapist

John Breeding, PhD  Researcher- Psychologist

Linda Andre, Researcher- Author

Lloyd Ross, PhD, Psychologist

Dominick Riccio, PhD, Psychologist

Charles L. Ruby, PhD, Psychologist

View on FDA Docket


[i] L. Andre, Doctors of Deception: What They Don’t Want You to Know About Shock Treatment (Rutgers University Press, 2009), 44-48.

[ii] D. R. Weinberger, E. F. Torrey et al, “Lateral Ventricular Enlargement in Chronic Schizophrenia,” Archives of General Psychiatry 36 (1979), 735-739. S. P. Calloway, J. R. Dolan et al, “ECT and Cerebral Atrophy,” Acta Psychiatrica Scandinavica 64 (1981), 442-445. P. J. Shah, M. F. Glabus et al, “Chronic, Treatment-Resistant Depression and Right Fronto-Striatal Atrophy,” British Journal of Psychiatry 1980 (2002), 434-440.

[iii] C.E. Coffey, R. D. Weiner et al, “”Effects of ECT on Brain Structure: A Pilot Prospective Magnetic Resonance Imaging Study,” American Journal of Psychiatry 145(6), (1988), 701-706. C. E. Coffey, R. D. Weiner et al, “Brain Anatomic Effects of Electroconvulsive Therapy: A Prospective Magnetic Resonance Imaging Study,” Archives of General Psychiatry 48 (1991), 1013-1021.

[iv] The literature on permanent memory loss from the 1940s through 2009 is summarized in L. Andre, op. cit.

‘[v] “Consensus Conference: Electroconvulsive Therapy,” Journal of the American Medical Association 254 (15), (1985, October 18), 2103-2108.

[vi] D. Rose, P. Fleischmann et al, “Patients’ Perspectives on Electroconvulsive Therapy: Systematic Review,” British Medical Journal 326 (7403),  (2003, June 21), 1363-1367.

[vii]  M. Philpot, C. Collins et al, “Eliciting Users’ Views of ECT in Two Mental Health Trusts with a User Designed Questionnaire,” Journal of Mental Health 13(4), (2004, August), 403-413.

[viii] R. Weiner et al, “Effects of Stimulus Parameters on Cognitive Side Effects,” Annals of the NY Academy of Sciences 462 (1986), 315-325; H. Sackeim, J. Prudic et al,“The Cognitive Effects of Electroconvulsive Therapy in Community Settings,” Neuropsychopharmacology 32 (2007), 244-254.

[ix] A. Rivkin, “Shock Therapy: A History of Electroconvulsive Treatment in Mental Illness” (book review), New England Journal of Medicine 358(2), (2008, January 10), 204-205.

[x] G. Shepard, S. Ahmed, “A Critical Review of the Controlled Real vs. Sham ECT Studies in Depressive Illness,” paper presented at the First European Symposium on ECT, Graz, Austria, March 1992. C. Ross, “The Sham ECT Literature: Implications for Consent to ECT,” Ethical Human Psychology and Psychiatry 8(1), (2006), 17-28.

[xi]H. Sackeim, R. Haskett et al, “Continuation Pharmacotherapy in the Prevention of Relapse Following Electroconvulsive Therapy,” Journal of the American Medical Association 285(10), (2001, March 14), 1299-1307.

[xii] J. Prudic, M. Olfson et al, “Effectiveness of Electroconvulsive Therapy in Community Settings,” Biological Psychiatry 55 (2004), 301-312.

[xiii] V. Milstein, J. G. Small et al, “Does Electroconvulsive Therapy Prevent Suicide?” Convulsive Therapy 2(1), 1986, 3-6.

[xiv] T. Munk-Olsen, P. Videbech et al, “All-Cause Mortality Among Recipients of Electroconvulsive Therapy,” British Journal of Psychiatry 190 (2007), 435-439.

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