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Quote of the Day

"I was obsessed"

— Hilary Duff on the two childhood celebrities she loved and eventually met. We had the same fascination, but all we got was a Tiger Beat poster.

US Food and Drug Administration (FDA) Commissioner Martin Makary speaks during an announcement event with US President Donald Trump
Health

Trump's FDA Is Backpedaling

What's going on: For months, President Donald Trump’s administration touted leucovorin — a synthetic form of vitamin B9 long used to help ease the side effects of chemotherapy — as a treatment for autism symptoms. At the same time, the Food and Drug Administration (FDA) weighed whether to expand the drug’s use. FDA Commissioner Marty Makary even said it could help “hundreds of thousands” of children. Yesterday, the agency did broaden leucovorin’s approved uses — just not the way Trump wanted. Instead of giving it the OK for autism symptoms, the FDA said doctors can prescribe the drug for cerebral folate deficiency, a rare neurological condition that affects fewer than one in 1 million people.

Why the FDA did what it did: Regulators spent months reviewing studies to determine whether the evidence supported leucovorin as an autism treatment. It didn’t. A handful of small studies from the US and abroad suggested the drug may improve speech and behavior in some people. But the data lacked the scale and rigor the FDA requires. One study, which suggested favorable results for the use of leucovorin, was even retracted earlier this year. The administration’s push still had an impact. After Trump touted the drug at a September news conference, off-label prescriptions for children jumped 71%, according to a recent study. Some parents struggle to find it. Now, many say the Trump administration’s mixed signals about the drug have only added to the confusion.

Related: Could Mushrooms Help the Smoker in Your Life Quit? (NPR)

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