investigating and exposing crimes in mental health 
ECT & The FDA
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January 4, 2010
U.S. Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852
SUBJECT: Electroconvulsive Therapy Device (882.5940), Docket #FDA-2009-N0392
Our organization is aware that the FDA is considering the reclassification of the device used to administer electroconvulsive therapy from its current category as a Class III medical device to Class II. The agency plans to take this action based at least in part on information submitted by ECT device manufacturers.
We strongly oppose this decision. There is ample valid scientific evidence extant in the medical literature that electroconvulsive therapy can cause irreversible brain damage and long term, permanent impaired cognitive function and accidental death. See Research Summaries and Citations attached hereto.
Since the procedure for which the ECT device is intended has thus been proven unsafe, the device itself cannot be considered a Class II low-risk device.
Per this valid scientific evidence, the device, when operated as directed by the manufacturers, presents a “potential, unreasonable risk of illness or injury†which, per 21 CFR Part 814, makes it a Class III device. It is therefore not possible for the device to have a “performance standard†of instructions and protocol that assures that precautions can be taken to protect a patient, as is required for a Class II device.
The American Psychiatric Association has put forth an argument that the safety of the device itself must be separated from the safety of ECT, giving as an example X-ray machines that can administer potentially harmful doses of radiation if used incorrectly. This is a flawed comparison since the ECTdevice, unlike an X-ray machine, is harmful when used as directed by its manufacturer.
As with any medical device, the burden of proof must be on ECT device manufacturers to prove that their devices are safe and effective. Had the manufacturers submitted to the FDA “any information known or otherwise available to them†as was required by the FDA in its April 9, 2009 notice (Federal Register Vol.74, No. 67, p.16214-16217), it should have been clear that there is no valid scientific evidence that the device is safe.
Our organization requests that the FDA calls for pre-market approval applications of these devices, which includes proof of safety and efficacy as a result of valid scientific evidence per 21 CFR Part 860.7(c)(2) of Part 860. We also request that the FDA prohibits their marketing and use until such pre-market approval has been given.
Sincerely,
Hakan Johanson
Citizens Commission for Human Rights of Florida
1217 North Fort Harrison Avenue, Clearwater, FL 33755
ATTACHMENT:
RESEARCH SUMMARIES AND CITATIONS
There is strong valid scientific evidence in medical literature, from the 1940s to the present, that
electroconvulsive therapy—and therefore by extension the ECT device—causes structural brain
damage, cognitive damage and accidental death.
NATIONAL COUNCIL ON DISABILITY
In the year 2000, the National Council on Disability, the federal agency that is responsible for
making disability policy recommendations to the president and Congress, after reviewing such
scientific evidence, made a policy recommendation that ECT should be eliminated as an
"unproven and inherently inhumane procedure".
STRUCTURAL BRAIN DAMAGE FROM ECT
• ECT can form scar tissue (gliosis) around nerve cells damaged by the electricity. This is
otherwise seen in Alzheimer's disease and multiple sclerosis;
• ECT can cause brain hemorrhages, large and small;
• ECT can kill nerve cells;
• ECT can cause nerve cells to disappear;
• ECT can cause what psychiatry refers to as "Large Areas of Devastation" in the brain;
• ECT can cause brain tissue to shrink (atrophy);
• ECT can cause brain swelling (edema);
• ECT can cause the formation of "shadow" brain cells—where genetic material and other
cellular components have just disappeared, leaving only the shell of the cell.
REFERENCES
1. D. R. Weinberger, E. F. Torrey, et al. “Lateral Cerebral Ventricular Enlargement in Chronic Schizophrenia,†Archives of General Psychiatry 36 (1979):735-739.
2. S. P. Calloway, R. J. Dolan, et al. “ECT and Cerebral Atrophy: A Computed Tomographic Study,†Acta Psychiatrica Scandinavica 64 (1981):442-445.
3. R. J. Dolan, S. P. Calloway, et al.,â€The Cerebral Cortical Appearance in Depressed Subjects,†Psychological Medicine 16(4) (1986, November):775-779.
4. B. J. Alpers, “The Brain Changes Associated with Electrical Shock Treatment: A Critical Review,†Journal-Lancet 66 (1946):363-369.
5. S. E. Barrera, N. D. C. Lewis, et. al., “Brain Changes Associated with Electrically Induced Seizures,†Transactions of the American Neurological Association 68 (1942 June):31-35.
6. A. Ferraro, L. Roizen, M. Helfand, “Morphologic Changes in the Brain of Monkeys Following Electrically Induced Convulsions,†Journal of Neuropathology and Experimental Neurology 5 (1946):285-308.
7. A. Ferraro, L. Roizen, “Cerebran Morphologic Changes in Monkeys Subjected to Large Numbers of Electrically Induced Convulsions,†American Journal of Psychiatry 106 (1949):278-284.
8. H. Hartelius, “Celebral Changes Following Electrically Induced Convulsions,†Acta Psychiatrica Neurologica Scandinavica 77 (Supp.) (1952):1-128.
9. J. Quandt, H. Sommer, “Zur Frage der Hirngewebsschadigungen nach electrischer Krampfbehandlungâ€, Zeitschrift für Neurologies und Psychiarie 34 (1966):513.
10.M. M. Aleksandrovaskaya, R. I. Krugilov, “Influence of Electroshock on Memory Function and Glial-Neuronal Relationship in the Rat Brain,†Proceedings of the Academy of Science (USSR) 197 (1971):1216-1218.
11.E. J. Colon, S. L. H. Notermans, “A Long-Term Study of the Effects of Electro-Convulsions on the Structure of the Cerebral Cortex,†Acta Neuropathologica 32 (1975):21-25.
12.B. J. Alpers, J. Hughes, “The Brain Changes in Electrically Induced Convulsions in the Human,†Journal of Neuropathological and Experimental Neurology I (1942):172-177.
13.L. Madow, “Brain Changes in Electroconvulsive Therapy,†American Journal of Psychiatry 113 (1956):337-347.
COGNITIVE DAMAGE FROM ECT
• ECT can cause long term or permanent sudden amnesia;
• ECT can cause inattention and an inability to concentrate;
• ECT can cause a patient to become dazed and stupefied;
• ECT can cause a difficulty carrying out manual tasks for which a patient has been trained;
• ECT can cause a reduction in intellectual abilities—known in psychiatry as the “taming effectâ€;
• ECT can cause a drop in IQ, as measured by tests.
REFERENCES
14.C. P. L. Freeman, D. Weeks, R. E. Kendell, “ECT III: Patients Who Complain,†British Journal of Psychiatry 137 (1980):17-25.
15.H. A. Sackeim, J. Prudic, et al., “The Cognitive Effects of Electroconvulsive Therapy in Community Settings,†Neuropsychopharmacology 32 (2007):244-254.
16.11. J. L. McGaugh, T. A. Williams, “Neurophysiological and Behavioral Effects of Convulsive Phenomena,†in Max Fink et al., eds., Psychiobiology of Convulsive Therapy (New York: Wiley, 1974), 85-97
17.R. R. Grinker, N. A. Levy, H. M. Serota, “Disturbances in Brain Function Following Convulsive Therapy,†Archives of Neurology and Psychiatry 80 (1958):380-384.
18.A. Meyerson, “Borderline Cases Treated with Electric Shock,†American Journal of Psychiatry 100 (1943):355
19.M. Fink, “Effect of Anticholinergic Agent, Diethazine, on EEG and Behavior: Significance for Theory of Convulsive Therapy,†Archives of Neurology and Psychiatry 80 (1958):380-384.
20.S. E. Barrera, N. D. C Lewis, et al., “Brain Changes Associated with Electrically Induced Seizures,†Transactions of the American Neurological Association 68 (1942 June):31-35.
21.L. Salzman, “An Evaluation of Shock Therapy,†American Journal of Psychiatry 103 (1947):676.
22.C. Stone, “Losses and Gains in Cognitive Functions as Related to Electro-Convulsive Shocks,†Journal of Abnormal Psychology 42 (1947):206-214.
FATALITY RATE FROM ECT
The fatality rate of the modern modified ECT can be as high as 1 in 200 for people over sixty
years of age. This rate is higher than the rate for the unmodified ECT administered in the 1940s
and early 1950s when the electrical current required to trigger a convulsion was lower (the use of
anesthesia in modern ECT raises the brain seizure threshold, requiring more electricity to
override the body’s defense mechanisms).
REFERENCES:
22. J. C. Barker, J. A. Baker, “Deaths Assiciated with Electroplexy,†Journal of Mental Science 105 (1959):339-348
23.J. R. Novello, ed, A Practical Handbook of Psychiatry (Springfield, Ill: Charles C. Thomas, 1974)
24.20. L. Kalinowsky, “The Danger of Various Types of Medication during Electric Convulsive Therapy,†American Journal of Psychiatry 112 (1956):745-746.
25.D. Impastato, “Prevention of Fatalities in Electroshock Therapy,â€Diseases of the Nervous System 18 (Sec. 2) (1957):34-75.
26.W. Riese, “Report of Two New Cases of Sudden Death after Electric Shock Treatment with Histopathological Findings in the Central Nervous System,†Journal of Neuropathology and Experimental Neurology 7 (1948): 98-100
PSYCHIATRY’S OWN ADMISSION OF ECT DAMAGE
• ECT works to “knock out the brain and reduce the higher activities, to impair memory [so
that] the pathological state is forgottenâ€.
• “Disturbance of memory is … an integral part of the recovery process…people have…more
intelligence than they can handle and a reduction in intelligence is an important factor in the
curative process.â€
• “There must be … organic changes in the brain, and the cure is related to these organic
changesâ€.
• “A socially adaptable individual with a little brain pathology is preferable to a psychotic
patient with no demonstrable brain changes.â€
REFERENCES
27.A. Myerson, in “Discussion of Franklin G. Ebaugh et. al., Fatalities Following Electric Convulsive Therapy: A Report of 2 Cases with Autopsy Findings,†Transactions of the American Neurological Association 68 (1942):39.
28.B. L. Pacella, “Squelae and Complications of Convulsive Shock Therapy,†Bulletin of the New York Academy of Medicine 20 (1944):575-585.
29.A. Myerson, “Borderline Cases Treated With Electric Shock,†American Journal of Psychiatry 100 (1943):355.