Food and Drug Administration
Dockets Management Branch (HFA-305),
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket #FDA-2009-N-0392
The Mental Health Empowerment Project, Inc. (MHEP) is a not for profit agency organized in 1988 to develop & strengthen self help & mutual support activities throughout the United States.
For Twenty years, MHEP has placed high value on promoting community partnerships and helping people find personal satisfaction through mental health recovery and active citizenship.
As people who have been given a psychiatric diagnosis, the staff of MHEP is in a unique position to mentor others to give back to each other and become active members of their communities.
MHEP receives funding from the federal, state and local governments in exchange for delivering services to people who have been given a psychiatric diagnosis.
These services relate to developing grassroots advocacy networks through community organizing, offering education through workshops and conferences and engaging in advocacy related efforts as directed by our constituency.
The use of electroshock is a consistent concern of MHEP, particularly when it is forced, court-ordered, or delivered without informed consent of its many risks, on children and adults.
Subsequently, the reclassification of the ECT device to Class II by the FDA without a safety investigation has become one of the issues we have worked to help bring public attention to as we want to do all we can to see this not happen.
Please consider this letter as not only the position of this agency, but the position of thousands of individuals who have told their stories over the course of our tenure as a grassroots, community based organization.
As the agency in charge of regulating ECT devices, you have allowed these machines to be used on millions of patients over the past generation without requiring any evidence whatsoever that shock treatment is safe or effective!
This is so even though shock machines are Class III—high risk—devices, which, by law, are supposed to be investigated by clinical trials as thoroughly as new drugs and devices just coming onto the market.
Many advocates speculate that this is because of the intensive lobbying efforts of groups like the American Psychiatric Association. Still, the massive resources of the A.P.A. and other such groups does not stop the tens of thousands of survivors who have experienced ECT first hand from fighting for a scientific safety investigation of this “treatment”.
MHEP urges the FDA to not reclassify electroshock machines without a full investigation into its safety.
Further, we believe that stricter guidelines should be imposed on its use, especially when the controversial procedure is done under force, coercion, or without full informed consent.
View submission on Regulations.gov
