This is a reminder that comments are due to the FDA on the safety of electroshock machines by January 8, 2009.
The FDA Wants to Declare Electroshock Machines Safe without a Safety Investigation. TELL THEM NO!
It has 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.
In April 2009---20 years after it first ruled the devices high-risk and named brain damage and memory loss as risks of the treatment---the FDA belatedly announced it would call on the manufacturers of the devices to provide evidence of safety and efficacy. The deadline for submissions has passed, but the manufacturers have not conducted any clinical trials, claiming they cannot afford them.
The FDA is now supposed to require Electroshock machines to undergo the rigorous PreMarket Approval process (PMA) that is required of new devices, including clinical safety trials. These machines, technically known as "devices," are referred to as Electro Convulsive Therapy (ECT).
If you have personal knowledge or expertise about Electroshock, writing about that can be good. Or you can pull information from various sources. For more information a Briefing Sheet is available, http://psychrights.org/Actions/FDA/FD...
If you are not in a position to write something up, then please print out the section below, fill it out and send it in to the FDA:
To: Food and Drug Administration,
Dockets Management Branch (HFA-305),
5630 Fishers Lane, Room 1061,
Rockville, MD 20852
Re: Electroconvulsive Therapy Device (882.5940), Docket #FDA-2009-N0392
The undersigned opposes the reclassification of the ECT device to Class II by the FDA in the absence of adequate scientific evidence of its safety, and asks the agency to call for PreMarket Approval Applications for the device.
Name: _____________________________
Address: __________________________________________________________
__________________________________________________________
Signature:_____________________________
The FDA Wants to Declare Electroshock Machines Safe without a Safety Investigation. TELL THEM NO!
It has 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.
In April 2009---20 years after it first ruled the devices high-risk and named brain damage and memory loss as risks of the treatment---the FDA belatedly announced it would call on the manufacturers of the devices to provide evidence of safety and efficacy. The deadline for submissions has passed, but the manufacturers have not conducted any clinical trials, claiming they cannot afford them.
The FDA is now supposed to require Electroshock machines to undergo the rigorous PreMarket Approval process (PMA) that is required of new devices, including clinical safety trials. These machines, technically known as "devices," are referred to as Electro Convulsive Therapy (ECT).
If you have personal knowledge or expertise about Electroshock, writing about that can be good. Or you can pull information from various sources. For more information a Briefing Sheet is available, http://psychrights.org/Actions/FDA/FD...
You can make comments in writing to Food and Drug Administration, Dockets Management Branch (HFA-305), 5630 Fishers Lane, Room 1061, Rockville, MD 20852
You can also submit comments by going to http://www.regulations.gov/, and scroll down to complete the form regarding electroconvulsive therapy, or the number of the federal register notice: 2009-N-0392
If you are not in a position to write something up, then please print out the section below, fill it out and send it in to the FDA:
To: Food and Drug Administration,
Dockets Management Branch (HFA-305),
5630 Fishers Lane, Room 1061,
Rockville, MD 20852
Re: Electroconvulsive Therapy Device (882.5940), Docket #FDA-2009-N0392
The undersigned opposes the reclassification of the ECT device to Class II by the FDA in the absence of adequate scientific evidence of its safety, and asks the agency to call for PreMarket Approval Applications for the device.
Name: _____________________________
Address: __________________________________________________________
__________________________________________________________
Signature:_____________________________
SEE: Jim Gottstein's Psyche Rights; Wikipedia's Electroconvulsive Therapy and Terry Messman's Mad in America for more detail.
This post first appeared on Short Notes: Will Brady's Ruminations, please read the originial post: here
