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The approval of Aduhelm risks eroding public trust in Alzheimer research and the FDA

The FDA has granted accelerated approval to aducanumab (Aduhelm) for the treatment of Alzheimer disease with an overly broad label. The decision disregarded key aspects of scientific process and risks eroding public trust in research, regulatory science and the FDA.

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The authors contributed equally to all aspects of the article.

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Correspondence to Jason Karlawish.

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Competing interests

J.K. is a site investigator for studies sponsored by Biogen, Eisai and Eli Lilly. J.D.G. receives research support from Biogen, Eisai, Eli Lilly and Genentech; and consulting fees from Cogniciti, Flint Rehab and SiteRx.

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Karlawish, J., Grill, J.D. The approval of Aduhelm risks eroding public trust in Alzheimer research and the FDA. Nat Rev Neurol 17, 523–524 (2021).

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