Dr. Peter Breggin’s response to the FDA’s proposal.
On December 29, 2015, the FDA proposed reclassifying ECT, essentially approving of its routine clinical use. The FDA describes its recommendation as follows:
… To support reclassification of Electroconvulsive Therapy (ECT) Devices into class II (special controls) for severe major depressive episode (MDE) associated with Major Depressive Disorder (MDD) or Bipolar Disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.
The FDA is also proposing specific warnings that should go along with the ECT devices. The strongest of the warnings — “Warning: ECT device use may be associated with: disorientation, confusion, and memory problems” — is grossly inadequate and misleading.
In response to the FDA’s request for responses, I submitted the following statement…