Food and Drug Administration
Dockets Management Branch (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 208252 Re: Docket #FDA 2009-N-0392
To Whom It May Concern:
The Center for the Human Rights of Users and Survivors of Psychiatry opposes the reclassification of the ECT device to Class Il in the absence of adequate scientific evidence of its safety, and request that the FDA call for PreMarket Approval Applications for the device.
Electroshock is among the treatments that come under heightened scrutiny as potential instances of torture and ill-treatment of persons with disabilitiesl when administered against the will of the person concerned. Unmodified electroshock (without anesthesia or muscle relaxants) may also constitute torture or illtreatment irrespective of whether consent was obtained. It is worth noting that harmful consequences cited in reference to unmodified electroshock apply to the unmodified form as well, especially cognitive defects and loss of memory.2
Electroshock is currently being performed in the United States without scientific evidence of its safety having been accepted or required by the government regulatory body. This leaves the treatment in an experimental category but the treatment protocols do not acknowledge its experimental nature. Especially when administered against a person’s will, on children who have no legal power to give or refuse consent, or without providing all relevant information including the lack of safety evidence, current practice with regard to electroshock violates the prohibition against nonconsensual medical experimentation contained in Article 7 of the International Covenant on Civil and Political Rights, to which the U.S. is a party.
1 Interim report of the UN Special Rapporteur on Torture and other cruel, inhuman and degrading treatment or punishment, U.N. Doc. A/63/175, July 28, 2008 [hereafter Interim Report on Torture], paragraphs 40, 41, 47 and 61. 2 Id., paragraph 61.
Center for the Human Rights of Users and Survivors of Psychiatry 44 Palmer Pond Rd.
Chestertown, NY 12817 USA
The Center for the Human Rights of Users and Survivors of Psychiatry is aware of many personal stories of individuals harmed by electroshock, with irreversible cognitive disabilities and loss of memory substantial enough to leave gaps in personal identity. These stories too are part of the evidence that needs to be taken into consideration in a full investigation of the device’s safety.
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