The FDA Wants to Declare Electroshock Machines Safe Without a Safety Investigation

PsychRights

(The comment period ended 1/8/2010.)\ View Public Comments on the FDA website.

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 required to be subjected to thorough 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 and other advocates have fought for a scientific safety investigation of Electroshock for the past 25 years, see Linda Andre's new book, Doctors of Deception: What They Don't Want You to Know About Shock Treatment.)

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 companies making Electroshock machines) as evidence that shock is safe.

The FDA is now supposed to require Electroshock machines to undergo the rigorous Pre-Market Approval process (PMA) that is required of new devices, including clinical safety trials. 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 down-classify it to the low-risk Class II, without scientific evidence of its safety. As a Class II device, Electroshock machines would never be required to go through the Pre-Market Approval process. The amount of damage that electroshock has been allowed to inflict is an outrage. ]

The FDA has opened up a new docket for public comments on the ECT device. If we don't write in, they will almost certainly reclassify. Do you think shock is safe? Have you evidence you want FDA to consider, including your personal experience? We now finally have a chance to at least register our opposition. It is important for as many people as possible to write in. Comments will be accepted through January 2010.

If you have personal knowledge or expertise about Electroshock, writing about that can be good. Or you can pull information from various sources. Linda Andre's book, Doctors of Deception is a goldmine of information. Linda has compiled a two-page primer, "The FDA's Regulation of ECT (Shock Treatment): A Beginner (or Refresher) Course." In addition, Leonard Roy Frank's Electroshock Quotationary is another good source of material, and there is also a new web page of historical materials from Leonard. Also, PsychRights has a large collection of materials at http://psychrights.org/Research/Digest/Electroshock/electroshock.htm from which comments can be drawn.

If you are not in a position to write something up, then please copy and send in the below coupon. You can also make electronic comments at www.regulations.gov by entering “Notices” and then the docket number FDA-2009-N-0392. ]

PsychRights®
Law Project for Psychiatric Rights
406 G Street, Suite 206
Anchorage, Alaska 99501
Phone: (907) 274-7686) Fax: (907) 274-9493

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 Pre-Market Approval Applications for the device.

Name: _________________________

Address: _________________________

 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Signature: ________________________\

http://www.gpo.gov/fdsys/pkg/FR-2009-09-10/html/E9-21807.htm