This is one of many letters to the FDA Docket #82P-0316. Learn more about the FDA’s regulation of the ECT device.
Theresa G. Blumen shares her experience with electroconvulsive therapy (ECT) in a letter to the FDA, urging them to keep the electroshock therapy device at class III. Blumen underwent 32 ECT sessions in 1989 and experienced severe memory loss, cognitive problems, and a decline in her quality of life.
Dear Mr. Benson, I am writing you to use your influence to keep electroshock therapy in Class III regulation . . .
I was a patient at University Hospital, Denver, Colorado, from early January to March 22, 1989. I was given 12 treatments and allowed to come home.
A few days later, I was so desperate to get relief from anxiety and depression that I nearly died by a suicide attempt. I was asked to sign permission for further ECT. . .
I had 20 electroshock treatments and I regret very much my decision to have any of the treatments.
I had to retire from part-time work as a paraprofessional in a local high school and I doubt I will ever be able to work again.
I have forgotten how to weave, could not concentrate on anything, felt very little pleasure in life and still feel suicidal.
I often don’t remember people who speak to me, much of my past life is gone from my memory, I have cognitive thinking problems, fear being in any social situation, cannot spell, cannot remember factual information, and lead a rather hermit-like existence.
I believe I have permanent brain damage as a result of ECT and I do not think I will ever again be as intelligent a person as I was before the electroshock treatments. . .
Thank you,
Sincerely,
Theresa G. Blumen
This letter was accompanied by the following message about why it was selected:
James Benson was at the time the commissioner of the FDA. Blumen’s letter to him was one of over a thousand comments sent to the FDA in response to the American Psychiatric Association’s petition to reclassify the ECT device .’
The comments are filed under Docket #82P-0316 and like all dockets at the FDA, this is a public record which anyone can see on request.
I’ve chosen this letter from an ECT survivor because of its detail.
It gives not only the name of the hospital but the number of treatments, twenty (a fairly typical number no one would consider excessive) and the date (1989, a date putting it unquestionably well into the mythical modern or improved era of ECT by anyone’s calculations).
It is also quite detailed as to the effects of ECT on memory and cognition and the consequences for the writer’s social and economic life.
The opinions carefully stated at the end follow logically from the information in the preceding paragraphs.
The writer has done all she can do to make her case by reporting her observations. She does not have access to the technology to do a brain scan or neuropsychological testing.
She cannot ask the FDA to conduct a scan of her brain, because the agency has already said it will not do so.
If there were no other cases similar to Blumen’s in Docket #82P-0316, her letter could be dismissed as anecdotal, and her bad outcome could be attributed to chance.
The FDA could say hers was an isolated case, a random experience.
Her conclusions might be dismissed as nothing more than unsubstantiated opinion. Her experience would have no meaning. Least of all would it constitute scientific evidence.
If there were no similar reports.
As it happens, there are about two hundred. That’s approximately how many letter writers identified themselves publicly as ECT survivors.
Read more submissions to FDA Docket #82P-0316
