Subject: Relabeling ECT as a Low Risk Device Without Appropriate Research
CIRCARE is concerned the Food and Drug Administration is going to quietly relabel Electroshock Treatment from a CLASS III
High Risk medical device, to one which is CLASS II and
Low Risk, without the testing normally required for such a medical device. The use of Electroconvulsive treatment has been on the resurgence for some years, with estimates of tens of thousands of Americans receiving the treatment yearly.
Medical devices are required to have clinical safety testing, but in 1976 ECT was
grandfathered in, without any such testing. In 1997, the FDA ordered the three manufacturers of ECT machines to provide such evidence, but it was ignored by the manufacturers. (See Federal Register Notice Vol. 60 No. 156, August 14, 1995.)
According to an advocacy group, the Committee for Truth in Psychiatry, the FDA has convened a select internal committee, whose membership is unpublished, to make the decision on reclassification without a call for more evidence, or any inclusion of advocates or ex-patients who may have benefited or been harmed by ECT . Apparently, the FDA will make their decision based on a literature review rather than the required testing.
We ask the FDA:
Enough evidence is in to suggest that ECT is a high risk treatment and warrants more study. ECT uses up to .9 amps through the brain which carries significant risk. Changes in treatment modalities have not made ECT risk free. Repeated deaths and adverse effects have been reported in recent years, including many cases of permanent, extensive memory loss. Documentation of memory loss, for example, can be found from the January, 2002, SURE report in England – the equivalent of our NIMH (see ect.org ). This report found high rates of permanent memory loss – at least 28% and over 80% in some studies. As for efficacy, studies have also cast doubt, as many patients show relapse within four weeks or six weeks. (See the NIMH Consensus Conference on ECT report, JAMA, October 18, 1985). In a just published study, success rates in community settings are low, varying from 30% to 50% – rates which might be expected from placebo (Biological Psychiatry, February, 2003 1:55(3):301-312).
In sum, CIRCARE believes that new evidence is necessary in order to reduce the safety classification of ECT, and hearings on the issue should be conducted in a transparent way. We should not expose children and fragile adults to potentially high risk treatments, without sufficient research and accurate informed consent.
The FDA may be reached for public comment on this issue by a petition found on their web site at www.fda.gov, by clicking on dockets and choosing the menu
submit electronic comments, and choosing 2003P-0555.
Michael A. Susko MS, CIRCARE President
Adil Shamoo Ph.D., CIRCARE Co-Founder
Updated / Corrected Information
2004-09-28: The CIRCARE InfoMail of 2004-02-25 reported inaccurate information. FDA had no plans to re-classify this device. Read FDA's letter in response to the citizen's petition (Docket No. 2003P-0555):
Kahan L. Letter to L. Andre re: Docket No. 2003P-0555. 2004-09-03. Available from http://www.fda.gov/ohrms/dockets/dailys/04/sep04/091504/03p-0555-let00002-vol2.pdf
Link: To create an HTML link to this InfoMail cut and paste the following:
<a href="http://www.circare.org/im/im25Feb2004.htm">Relabeling ECT as a Low Risk Device Without Appropriate Research</a>. CIRCARE InfoMail (2004-02-25)
Last Updated: 2006-04-25
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