Column: How the FDA's lousy judgment and a greedy drug company combined to hit Medicare members hard

The FDA’s approval of an Alzheimer’s drug of dubious value will throw U.S. healthcare spending into crisis.

The author of those words, neurologist David Knopman of the Mayo Clinic, resigned after the FDA’s approval. Two other members also resigned, including Aaron Kesselheim of Harvard Medical School, who called the FDA’s action “probably the worst drug approval decision in recent U.S. history” in his resignation letter.

Biogen executives were shameless about the potential profits they expect to be reaped from the full price. “We believe Aduhelm represents a significant long-term growth driver with modest revenue in 2021 ramping to a multibillion-dollar U.S. sales opportunity over the next several years,” Chief Financial OfficerThe company’s stock soared by about 45%, to a peak of $414.71, in the days after the FDA approval, though it has since fallen back to earth.

It gets worse. Because the clinical trials revealed that about 30% of patients receiving a high dose of Aduhelm experienced brain swelling, patients will have to undergo regular MRI tests to watch out for this dangerous side effect. They’ll have to pay their 20% share of those, too.

good luck

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Источник: Reuters - 🏆 2. / 97 Прочитайте больше »