Open Letter of Appeal to FDA about Electroconvulsive Therapy (ECT)

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During ECT, a large electric charge (800-900 milliamperes) is pulsed through the brain for up to eight seconds (depending on device settings). It causes the “Flat-lining” of brain activity.

When brain activity resumes, it resumes in periodic flashes of coma (delta) waves. Those flashes gradually become more frequent and then the recipient awakes from a coma. (Kirstein, L., & Ottosson, J.-O. (1960).

Experimental studies of electroencephalographic changes following electroconvulsive therapy: the role of the electrical stimulation and of the seizure studied by variation of stimulus modification by lidocaine of seizure discharge. Acta Psychiatrica Scandinavica. Supplementum, 35(145), 49–67. Retrieved from https://pubmed.ncbi.nlm.nih.gov/14409401/).

I was severely injured by ECT so I have a deep personal interest in ensuring the public understands the true risks of this procedure to make informed treatment decisions.

Poorly understood risk factors patients should be aware of:

  • electroconvulsive therapy’s (ECT) safety testing
  • electrical dosing standards and limits

Reaching out to the FDA

To do this I submitted a Freedom of Information Act request to the FDA for all of ECT’s Premarket Approval (PMA or safety testing) applications and Product Development Protocols (PDP or ECT’s electrical dosing rules).

The FDA established a deadline for manufacturers to submit this information by March 26, 2019. I gave device manufacturers an extra day, requesting information submitted by March 27, 2019.

I requested this information from the US FDA because I feel it is the only way to prioritize patient safety.

Life after ECT is not easy because repetitive brain injury assessment, rehabilitation and other support is not available.

I feel that all electroshock patients and their family members deserve to understand:

  • ECT is not standardized
  • Every doctor who administers ECT does so using more than seven variables and including unique settings on one of several unstandardized medical devices
  • ECT is a more an art than an evidence-based medical treatment
  • Research confirms that ECT Risks outweigh perceived benefits
  • There is no after care to identify, manage or support people who live with the severe effects of ECT

The FDA denied my expedited request saying that I did not demonstrate compelling need.

I responded by writing an open letter of appeal which included 97 citations.

It is co-signed by 14 professional and paraprofessional organizations, 168 Americans, and 49 international citizens whose countries base their guidelines in part on the FDA’s decisions.

Signatories included up to eight words to describe their perspective on “Real-World Data” and “Real-World Evidence” regarding electroconvulsive therapy’s (ECT) post-market safety, adverse events and regulatory decisions. (read here)

You can find more information about the Audit ECT Campaign and the international patient safety petition from the following links

Sarah P. Hancock

Sarah Price Hancock, MS, CRC, lived for nearly two decades misdiagnosed with severe mental illness. She was given 116 bilateral ECT treatments and now lives with delayed electrical injury. Sarah holds a Master’s in Rehabilitation Counseling and taught for four years in San Diego State University’s Rehabilitation Counseling program. She also hosts The Emotional Self-Reliance Podcast and guest lectures on psychiatric recovery.

This Post Has One Comment

  1. Luc De Bry, Ph.d.

    A number of my friends, as well as my own son, have been prescribed or forced to ECT.

    In all the appeals, to FDA, to Courts, and so on, it seems to me that the five most important facts are missing:

    Fact # 1 : Electroshocks are excruciatingly painful ! – For instance ask Dorothy Dundas who has been electroshocked in the 1960s, before that anaesthesia was introduced into the ECT procedure. Her friend lying next to her died from ECT.

    Fact # 2 : Pain is mother Nature’s way to inform us that something, ECT in this case, is not good for you and that it is even dangerous !

    Fact # 3 : psychiatrists abuse anaesthesia to hide the pain alerting on the danger, hence misinforming the patients, who then give back a misinformed consent.

    Fact # 4 : the apparent relief of depression after ECT is a false positive. Instead of being due to ECT, it is due to the combination of attention that the patient got in order to give his misinformed consent, and to the euphoria- and sedation-like effects caused by the anaesthetics and the muscle relaxants.

    Fact # 5 : the only reason why ECT is still prescribed and abused is because a series of ten ECTs brings some US$ 35,000 to the psychiatrist and the hospital. Some 100,000 Americans are submitted to ECT per year. That makes a 3.5 billion dollars business thank to the constant flow of misinformed consents…

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