All I want for Christmas…
…is for you to comment to the FDA and ask that they do their job and test shock treatment (ECT) devices. It doesn’t matter how you feel about human rights, mental illness, recovery, psychiatry — any of it. All that matters is that the FDA has an obligation to test a medical device, especially one that is used involuntarily on our citizens, for safety and efficacy. It really is that simple. ECT is no gentle process. They are inducing grand mal siezures with electricity. Does that sound safe and effective to you? Please comment in the 16 days we have left.
From the Law Project for Psychiatric Rights:
The Food and Drug Administration is in charge of regulating medical devices just as it does drugs, including the machines used to give Electroshock. But it’s not doing its job. 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. But because of intense lobbying by the American Psychiatric Association — which claims the devices are safe but opposes an investigation — the FDA has disregarded its own law.
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 athttp://psychrights.org/Actions/FDA/090910FedRegisterFDAElectroshockReclassDkt.pdf
If you are not in a position to write something up, then please send in the below coupon:
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.
Also, The Opal Project has made it incredibly easy by allowing you to comment directly on their page which will then forward your comment to the FDA. It takes moments. It’s as easy as typing your name, address, email and opinion.