Friday afternoon, January 28, 2011: The FDA’s panel for electroconvulsive therapy (ECT) voted to place ECT machines in Category III for all but one indication. If the FDA accepts the panel’s recommendation, the agency will require testing for all uses except “catatonia” which was recommended for Category II, requiring less stringent testing.
Duff Wilson provided a service by presenting both sides of the controversy when he wrote his report “F.D.A. Is Studying the Risk of Electroshock Devices” in the January 24, 2011 New York Times. The FDA is proposing to move ECT from the high risk category to the medium risk category to avoid the necessity of any testing for safety or efficacy. As a result, ECT would be grandfathered into continued use without ever being tested. This would place ECT in the same category as syringes which no longer need proof of safety or efficacy. The FDA hearings will be held January 27-28, 2011, and I hope some of my more courageous colleagues will attend and testify against approving ECT without testing.
Psychiatric drug-induced Chronic Brain Impairment (CBI): Implications for longterm treatment with psychiatric medication. International Journal of Risk & Safety in Medicine, 23: 193-200. Peter R. Breggin, MD Abstract: Understanding the hazards associated with long-term exposure to psychiatric drugs is very important but rarely emphasized in the scientific literature and clinical […]