F.D.A. Is Studying the Risk of Electroshock Devices

I threw this together really quickly, just so that it might be covered. Forgive any possible grammatical errors or typos.

New York Time’s covering the Electroshock FDS hearings here: F.D.A. Is Studying the Risk of Electroshock Devices. Go to the NYT to read that.

I have some info on ECT that I’ve collected below, most of which has already been on this blog:

(First posted here)

This is the body of an email I got from Vince Boehm, written by Vince, regarding the FDA hearings for Electroshock devices. (used for electro-convulsive “therapy” or ECT) Wanted to pass on the information for anyone who might be able to testify.

Background: Electroshock devices have been on the market since 1937, but have never undergone the approval process for safety and efficacy required by the FDA for devices of this type. These devices were “grandfathered” into the system when the U.S. Food and Drug Administration assumed jurisdiction in this area in 1976.

There will be an FDA hearing on the proposed reclassification of devices indicated for use in electroconvulsive therapy. The Food and Drug Administration has classified the devices used to administer ECT as Class III medical devices. Class III is the highest-risk class of medical devices. A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I (tongue depressors, etc) or Class II (treadmills, ultrasound, etc) devices.

The industry-proposed reclassification of these devices to the lower Class II has been on the FDA docket for many years. Two years ago, the agency sent letters to the manufacturers demanding that these devices to undergo clinical trials for safety and efficacy. The industry has not responded.

A Class III device needs premarket approval. Class II devices do not!

Proof of safety or efficacy will never happen if these machines get reclassified to Class II.

This will be “Put Up or Shut Up Time” for the shock industry if these devices remain in Class III.

I plan to go to this hearing. I am certain that many members of this list will testify in the Public Comment portion of this hearing as well. Please let me know if you will attend and testify. If you cannot go, you can submit a written statement.

Public safety and public responsibility demands that these devices get a full review by its regulatory agency.

Vince

Liz Spikol shares her experience of electroshock in a youtube video I posted a while back.

A fact I personally take interest in is that 2/3’s of ECT users are women. 70 percent of forced ECT is also done on women. Psychiatric abuses are a feminist issue that most feminists don’t want to attend to. An article I wrote a while back on this issue here.

Another large population is the elderly. As the article quotes: A pet or a conversation is a better healer. The truth is many elderly are very lonely.

John Breeding says, also in the NYT article, “It’s a very strong treatment for despair and hopelessness,” he said. “It’s a temporary blunting of your feelings, so you feel better for a while, then you feel worse, and now you’ve got the memory loss and brain damage.”

More critical perspectives on ECT here in regards to the book Doctors of Deception written by a survivor of ECT