In 2011 the FDA held public hearings on the shock device that delivers electric shock treatment (electroconvulsive treatment, ECT). The panel voted in nearly all situations to keep the shock device a Class III Experimental Device.
Now, the FDA is proposing to down-classify the shock device to a Class II device with "special controls" that would put it in the same category as a pair of eyeglasses or a wheelchair specifically for people who are over 18, have a "major depressive episode" as part of "major depressive disorder" or "bipolar disorder" are deemed "treatment-resistant" or "require rapid response".
The FDA is proposing that since they held hearings in 2011 they do not need to hold hearings now. Not one of the members of the decision-making panel from 2011 is on the panel today.
Please get involved and tell the FDA not to down classify the shock device for any reason and to hold public hearings.
Psychiatry ought not be allowed to get away with this fraud! The FDA needs to be held responsible for the damage this will cause. Shock treatment will soar.
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