This is a second posting for those who did not see it the first time around. Please click here for an easy form to fill out to express your concern. Simply scroll to the bottom of the page after following that link
The Food and Drug Administration is in charge of regulating medical devices just as it does drugs, including the machines used to give shock treatment. 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. (For the full story of how shock survivors have fought for a scientific safety investigation of ECT for the past 25 years, see the new book Doctors of Deception: What They Don’t Want You to Know About Shock Treatment by Linda Andre.)
In April 2009—30 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 the device companies) as evidence that shock is safe.
The FDA is now supposed to require the ECT device to undergo the rigorous PreMarket Approval process (PMA) that is required of new devices, including clinical safety trials. But the FDA could have called for this investigation any time in the past 30 years and has steadfastly refused to do so. It has never wavered from its intention (as stated in 1990) to declare the shock machine safe, and downclassify it to the low-risk Class II, without scientific evidence of its safety. As a Class II device, the shock machine would never have to go through the PMA process. After all, if a PMA showed shock to be unsafe, the FDA would have to take shock machines off the market, and it knows that the American Psychiatric Association would never allow that.
The FDA has opened up a new docket for public comments on the device. If we don’t write in, they will almost certainly reclassify. Comments will be accepted up through January 8, 2010. Do you think shock is safe? Have you evidence you want FDA to consider, including your personal experience? Write a letter to the address below or send in the coupon. You can also make electronic comments at http://www.regulations.gov by entering “Notices” and then the docket number FDA-2009-N-0392.
To: Food and Drug Administration, Dockets Management Branch (HFA-305), 5630 Fishers Lane, Room 1061, Rockville, MD 20852
Re: Docket #FDA-2009-N-0392
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.
Write to the above address or click here and scroll down for an internet form.