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.

If you would like to read the open letter, please click here.