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Article  Aduhelm was a mess — and it could happen again

C C Offline

INTRO: Last week, Biogen announced it will cease both the study and sale of Aduhelm, its FDA-approved monoclonal antibody for the treatment of Alzheimer’s disease. Its decision, the company explained, is not a response to new data about the drug’s safety or efficacy, but instead “a reprioritization of resources.” Simply put, it wasn’t about science or medicine. It was about money.

In the eight years between the drug’s spectacular 2016 debut on the cover of Nature and its ignominious end, Biogen made multiple, really bad decisions. I don’t condone the company’s behavior, but I do understand it. In America, corporations develop drugs, and corporations are made up of ambitious, competitive people. Their measure of success is a simple language: profit.

What I cannot understand is the Food and Drug Administration. It twisted the practice of regulatory science so as to allow Biogen to walk itself into a mess. Two of the agency’s decisions in particular cause me to worry another Aduhelm-like decision could happen again, and, when it does, this mess will be huge... (MORE - details)

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