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/). This website is designed by the leader of the Audit ECT campaign.
I want the public to understand electroconvulsive therapy’s (ECT) safety testing, electrical dosing standards and limits to make informed treatment decisions. So 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. I was severely injured by ECT. Life after ECT is not easy because repetitive brain injury assessment, rehabilitation and other support is not available. I feel that all 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.
Click here to see the letter.
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