STAT+: Pharmalittle: We’re reading about Sarepta conceding to the FDA, the U.S. transplant system, and more
Good morning everyone, it’s Jason Mast, filling in for Ed again. Here’s a fun fact about drugs, pulled from Anne Harrington’s “The Mind Fixers,” a fascinating history of psychiatry I’ve recently picked up: After Albert Hoffman synthesized LSD, Sandoz promoted it as a “psychosis mimicking” drug. Company scientists, along with some psychiatrists, believed the delusions of a good (or bad) trip effectively simulated the experience of having schizophrenia. Clinicians, at least one psychiatrist proposed, might take it themselves to better empathize with their patients. But mostly it was used on volunteers — from mental hospitals, VA hospitals, universities, prisons — to model and understand the disease. (Some of this work, yes, received CIA funding.)
The term psychedelic, meaning “mind manifesting,” only emerged in 1956, thanks to author Aldous Huxley. In 1953, he had a mystical experience while taking mescaline and became convinced these drugs had to be rebranded. “It will give that elixir a bad name if it continues to be associated, in the public mind, with schizophrenia symptoms,” he wrote. “People will think they are going mad, when in fact they are beginning, when they take it, to go sane.” And so the ‘60s were born. Anyway! Here’s some news. …
Sarepta Therapeutics agreed to halt all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, STAT reports. Sarepta had initially rebuffed a request from the U.S. Food and Drug Administration to suspend shipments, following three deaths from the treatment and a related product. It’s not clear when or how the company will be able to get the drug back on the market, particularly in young children, in whom the therapy has seemed safer.
The federal government is launching a reform effort for the U.S. organ transplant system, Reuters tells us. The announcement follows a Health and Human Services probe into 351 cases in which organ donation was authorized but not completed, which found 73 patients had shown neurological signs incompatible with organ donation and at least 28 patients may not have been deceased at the time organ procurement was initiated. It also follows New York Times investigations into attempted organ retrieval from donors who showed signs of life, using a procedure called donation after circulatory death, in which donors are not brain dead.
Jason Mast
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