2003P-0555 - Maintain the Electroconvulsive Therapy Device in Class III for All Indications
FDA Comment Number : EC18
Submitter : Ms. Katherine Kaplan Date & Time: 04/19/2004 03:04:46
Organization : Committee for Truth in Psychiatry
Individual Consumer
Category :
Issue Areas/Comments
GENERAL
GENERAL
I am dismayed and angered to find out that the FDA, with the American Pschiatric Association's blessing and encouragement, is reconsidering its stance on the safety and benefits related to ECT "therapy". This dangerous treatment not only should remain a Class III medical device, but should be banned from use altogether. There have YET to be ANY safety studies done by manufacturers on this particular treatment -- unlike other medical devices such as xray machines, for example. Reclassification, to be done SAFELY and with the consumer in mind at ALL times, should be based upon a COMPLETE AND UNBIASED REVIEW OF ALL LITERATURE AVAILABLE, along with testimonials from the people it is supposed to be "helping". Review of biased material, along with total disregard to the public, produces a statistically skewed result that only favors those who benefit financially! The FDA is a PUBLIC GOVERNMENT AGENCY. Therefore, it is accountable to the public, and not just private concerns. It has a DUTY to ensure public safety -- public hearings on this issue regarding the ECT device need to be held.
On a more personal note: I am an RN with a BSN. I've had a rather severe case of clinical depression for the past eleven years. I received a total of TWENTY-SEVEN ECT bilateral treatments back in the late 1990's. As a result of these treatments, I've experienced permanent long-term and short-term memory loss. I am unable to remember most of my children's childhood. These treatments have affected my ability to work safely as a clinician due to having difficulty remembering things that were just said to me -- especially in high stress situations. I'm back in school, and am trying to retrain to be a nurse paralegal. Studying has been very difficult, and I've had to come up with unique ways to try and remember information. I used to be able to remember EVERYTHING that I read or heard. Now, if I don't write it down, I may as well have never heard it in the first place. I am better at remembering general details, but specific details to remember continue to elude me. Due to the memory problems, my I.Q. test scores have decreased somewhat. I have, on numerous occasions, totally forgotten the names and faces of people who obviously know and talk to me as if we've met and spoken before. Needless to say, the ongoing effect of this does not improve my depression. At the time that I started the treatments, I was in the hospital and going through a severe depressive episode. My doctor gave me the choice of either receiving the ECT or entering the state hospital for an undetermined amount of time. I didn't want to do EITHER, but I consented only because I knew that my then-husband would not allow me to see the kids in the state hospital (he didn't allow them to see me at the private hospital, either, but at least it wasn't for long periods of time). I recently discussed this past situation with an attorney. It appears that due to the issue of consent under duress, unwanted contact, and fear of loss of freedom, that an intentional tort of assault and battery occurred related to the use of ECT. Medical treatment should NEVER be used as a threat or punishment to one's well-being, and yet...that was how I felt at the time.
Please, do the right action -- keep the classification of this antiquated and barbaric "treatment" as a Class III, and prevent others from being hurt by it.