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. They simply point to the opinions of shock doctors (including those who have financial interests in companies making Electroshock machines) as evidence that shock is safe.
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), but I don't like to use this euphemistic term for running electricity through people's brains. The FDA could have called for this investigation any time in the past 30 years but has previously failed to do so. There is great risk the FDA will downclassify it to the low-risk Class II, without scientific evidence of its safety. As a Class II device, Electroshock machines would never have to go through the PMA process. The amount of damage that electroshock has been allowed to inflict is an outrage. We now finally have a chance to at least register our opposition because the FDA has opened up a new docket for public comment on electroshock machines. It is important for as many people as possible to write in with their opposition. Comments will be accepted up to January 8, 2010.
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 and Linda Andre's book, Doctors of Deception is a gold mine of information. In addition Leonard Roy Frank published the free, downloadable Electroshock Quotationary, in June 2006, which is a good source of material, and there is also a brand new web page of historical materials from Leonard at http://psychiatrized.org/LeonardRoyFrank/FromTheFilesOfLeonardRoyFrank.htm Also, PsychRights has quite a large collection of materials at http://psychrights.org/Research/Digest/Electroshock/electroshock.htm from which comments can be drawn.
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 www.regulations.gov and either type in electroconvulsive therapy as a keyword, or the number of the federal register notice: 2009-N-0392
The Federal Register Notice can be found on PsychRights' website at http://psychrights.org/Actions/FDA/090910FedRegisterFDAElectroshockReclassDkt.pdf
The following are the comments of three organizations:
If you are not in a position to write something up, then please send in the below coupon or the on at http://psychrights.org/Actions/FDA/FDAShockDktFlyer.pdf.
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.
Last modified December 28, 2009