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Open-label placebo works as well as double-blind placebo in irritable bowel syndrome

Open-label placebo works as well as double-blind placebo in irritable bowel syndrome
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Appealing the FDA s Denial of ECT s Harms

1914 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.”

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