2003P-0555 - Maintain the Electroconvulsive Therapy Device in Class III for All Indications
FDA Comment Number : EC19
Submitter : Dr. John Breeding Date & Time: 05/03/2004 05:05:42
Organization : World association of Electroshock Survivors
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
April 28, 2004

Food and Drug Administration
Dockets Management
Re: Docket #2003P-0555
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, MD 20852
USA
fdadockets@oc.fda.gov

TO WHOM IT MAY CONCERN:

I am writing to support the hundreds of previous petitions, including those from shock survivor-members of the Committee for Truth in Psychiatry in December 2003, urging you not to change the classification of electroshock ("ECT") machines from its current Class-III or hi- risk/unsafe category to the Class-II/safe category. I understand the FDA plans to move shock machines into Class-II. This would be a very serious error in judgement, besides being unscientific and irresponsible. Since the FDA has never
conducted its own inspections or tests on these machines to determine their medical safety, it has no scientific or rational basis to conclude that they are safe. If the FDA conducts such safety tests, I'm confident the findings would clearly and convincingly indicate the serious harm caused by these machines - brain damage, permanent memory loss, learning disability,even death. The content of this letter was mostly composed by a colleague fo mine, but I am in complete agreement with every word.

The fact that these machines are still in use - without the required
independent and scientific evaluation of their medical safety - is
inexcusable, irresponsible, unethical, and extremely dangerous. As major and tragic effects of electroshock, brain damage or electrically-induced closed head injury, and permanent memory loss have been scientifically documented for over fifty years - since the 1940s. In addition, well over four hundred deaths caused by or related to electroshock have been reported in the English-language medical literature since 1942 (see Frank, 1990 below).

The FDA and American Psychiatric Association should not continue to ignore or seriously minimize these and many other published scientific studies:
John Breeding, PhD "Electroshock and Informed Consent, Journal of Humanistic Psychology, Winter 2000, Vol. 40, No. 1, pp. 65-79).
Peter R Breggin, M.D. (1997). Brain-Disabling Treatments in Psychiatry: Drugs, Electroshock, and The Role of The FDA, Springer Publishing
Co., 119-156;
John Friedberg, M.D. (1977). "Shock treatment, brain damage, and memory loss: A neurological perspective." American Journal of Psychiatry, 134, 1010-1014;
Leonard Roy Frank (1990). "Electroshock: death, brain damage, memory loss,and brainwashing." Journal of Mind and Behavior,11, 489-512;
Douglas G. Cameron (1994). "ECT: Sham Statistics, the myth of convulsive therapy and the case for consumer misinformation." Journal of Mind and Behavior, Winter/Spring 15, 177-198.); Robert Morgan, Ph.D, ed (1991). Electroshock: The Case Against. Toronto: IPI Publishing.

It's also worth remembering this universally recognized warning in the
Hippocratic Oath which all physicians are required to swear: "FIRST DO NO HARM." Everytime a physician administers electroshock by pushing a button or pressing a lever on a shock machine releasing 175-200+ volts of electricity to the brain, he or she is violating this Oath. Again, I urge you to keep unsafe and harmful shock machines in your Class-III category until the memory-destroying and brain-disabling psychiatric procedure of electroshock is banned.

I would appreciate your reply.
Sincerely,

John Breeding, PhD
Advisory Board, World Association of Electroshock Survivors