FDA Approved — And Ineffective

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From The Lever (free subscription required): “Federal regulators have authorized hundreds of drugs without evidence they work, and many are dangerous.

Nieraj Jain was puzzled by the patient sitting quietly in front of him. The woman, in her 60s, was losing her eyesight; that much was clear. Her vision was blurred, and she was having increasing difficulty seeing at night and in bright sunlight. Less obvious was the cause. A retinal specialist and surgeon at Emory University in Georgia, Jain pored over specialized scans of her eye and saw odd patches of pigment on her retina — patches that didn’t fit with any known diagnosis.

A fleeting memory pulled him up short; hadn’t he seen another patient a few months before with a similar finding? Combing through patient records, Jain dug up five more patients at Emory with the same puzzling retinal changes. All were going blind — and all happened to be taking Elmiron, a drug for a bladder condition called interstitial cystitis. In 2018, Jain and his colleagues published their findings about this new cause of blindness, dubbing it “pigmentary maculopathy.”

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