About 100,000 Coloradans have been forced to evacuate their homes due to wildfires since 2020. The growing number of evacuees each year can carry a burden.
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To leave the year with a bang, and to kick off 2021 as the year prioritizing patient safety and informed consent, I authored an open letter to the FDA appealing their denial of Freedom of Information Act (FOIA) request number 2020-7319.
The letter requested all electroconvulsive therapy (ECT) safety studies, pre-market approval (PMA) applications, and electric current limits (product development protocols or PDP) submitted by March 27, 2019.
Knowing my own ECT outcomes, and having researched similar outcomes for a decade, I feel ECT presents an “imminent threat to the life or physical safety” of gravely disabled individuals, warranting expedited release of data. The FDA denied it, however, writing that I had not “demonstrated a compelling need.”