ECT Survivors Take On the FDA

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In December, the FDA proposed down-classifying the device used in electroshock treatment (ECT), which would loosen regulations and potentially make ECT more widely available for use. In response, five individuals who were previously harmed by electroshock have filed a Citizens Petition with the FDA.

“I hope this is the beginning of the path to do away with shock [ECT]. Hopefully, it’ll go the way of lobotomies, another ‘miracle treatment’,” one ECT survivor, shocked as a teenager, said in a release.

 

More:

Full press release: http://www.prnewswire.com/news-releases/attorney-jonathan-emord-takes-on-the-fda-over-electroshock-ect-device-300318482.html

A copy of the Petition is available here, along with supporting Exhibits (Part 1, Part 2, and Part 3).

 

Note: This initiative may be associated with CCHR

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8 COMMENTS

  1. Hopefully lawyer Jonathan Emord will be successful in taking on the FDA regarding ECT. Just reading about the damages incurred by the five citizen petitioners is stomach churning. How is it that this lunatic bogus “treatment” has not be banned? When will the shock doctors admit to brain damaging their patients with ECT? Or do they just say the injured had “badly administered ECT”, with an outcome that is not the norm?
    We learn more each day about repetitive head injury in athletes resulting in CTE.
    ECT is repetitive head trauma. Could it cause CTE in its victims in addition to the immediate amnesia and cognitive dysfunction which its victims suffer?
    When does the FDA plan to reveal their latest decision about ECT classification?

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    • I’m trying to understand the layers of controversy. What significance is the classification of the device; whether it’s high risk level 3 or lower risk level 2. What would be the advantage to ECT defenders regarding clinical and business interests? I read that only 2 companies in the US make the machines and 1 of the companies is owned by psychiatrists. Would the reclassification of the device as level 2 allow the marketing of ECT as a “low risk” high benefit procedure? What would change? This dubious brain procedure is still available no matter. Would the designation change allow more brain zapping in less clinically restricted circumstances? Expansion of ECT “services” is not a good idea.

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      • I am having difficulty understanding the significance as well. If you look for example at the submission by Steve Seiner and colleagues at McLean Hospital
        https://www.regulations.gov/document?D=FDA-2014-D-1318-0188
        they say they give over 10,000 treatments a year. So being in level 3 obviously isn’t restricting its use at McLean Hospital, or indeed, other hospitals that use ECT.
        By the way, who is paying the lawyer for the citizen’s petition?

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        • Thanks for the link.. Seiner refers to his brain zapping at McLean as “neurotherapuetics” which has a nice sound to it. Anyway, they do have a brisk “therapeutic” business going at McLean and if they indeed do 10,000 a year ( that’s 192 weekly), that would be an impressive assembly line. The required support to do 3o to 50 a day M through F is logistically difficult to manage. Would 5 or more rooms be running simultaneously, all with a device in question and anesthesia personal and equipment. Then there is recovery. From what I’ve read, this classification change proposal is considered by the FDA every 10 years or so. 2011 was the last attempt. I also wondered if ECT was reimbursable through private insurance and medicare and if there was any perceived or real threat that those funds would dry up due to many factors. I heard the term “guild interests” thanks to Mr. Whitaker and others and admit to questioning the motives of one or more guilds. It appears that a reclassification (of a device) would have some positive ripple effect in validating the psychiatrist, the methodology, the underlying thin science, the equipment, and the incurred charges billed.
          The FDA supposedly weighs the opinions and comments sent to them by the public and concerned interests. I guess the lawyers who represent the complainants are just one aspect of the process.
          I have questions, like you.

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      • Hi, zoriolus. The significance is that if ECT devices are put into a lower risk category, then the device manufacturers probably will not need to do extensive testing through PMA. At least that’s my understanding. Here’s a quote from the 2011 FDA summary on ECT:

        “Electroconvulsive Therapy (ECT) devices induce seizure by applying electricity to the scalp and are used “for treating severe psychiatric disturbances (e.g., severe depression).” See 21 CFR 882.5940. These devices were legally marketed in the United States prior to the Medical Devices Amendments of 1976. Although classified into Class III, the highest risk-based classification for devices, FDA has not yet established a requirement for premarket approval (PMA) to affirmatively demonstrate a reasonable assurance of safety and effectiveness. ECT devices have instead been regulated through the premarket notification [510(k)] regulatory
        pathway, which requires a showing of substantial equivalence to a legally marketed device and is usually reserved for intermediate and low risk devices.” (page 5)

        Food and Drug Administration. (2011). FDA Executive Summary prepared for the January 27-28, 2011 meeting of the Neurological Devices Panel: Meeting to discuss the classification of electroconvulsive therapy devices (ECT). Retrieved from http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM240933.pdf

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  2. To loosen regulations and make ECT more widely available for use? Why don’t they dust off all the Medieval torture devices to see if they could be available for use and be new income streams for modern psychiatric practices? Is there a single thinking human in the FDA?

    And I assume ECT’s safety and efficacy is based on the type of solid, evidence-based research being written of here:

    http://www.madinamerica.com/2016/09/ioannidis-questions-strength-of-psychology-and-neuroscience-literature/

    Liz Sydney

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