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

Nature Reviews Neurology volume 17, pages 523–524 (2021)Cite this article

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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.

In science, as in the law, process matters — it is not mere ceremony. Process allows scientists, clinicians and patients to trust the results of research and regulatory science decisions. This process requires the rigorous conduct of research, public and open presentation and peer review of results, and meetings of experts to review evidence and arrive at consensus. On 7 June this year, the FDA apparently disregarded this scientific process when it granted accelerated approval to Biogen’s amyloid-β (Aβ)-lowering drug aducanumab (Aduhelm) for the treatment of Alzheimer disease (AD)1. This approval relied upon regulations that permit changes in a surrogate end point to stand in for evidence of clinical efficacy, turning the AD world upside down and threatening the credibility of the FDA2.

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References

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Authors and Affiliations

  1. Departments of Medicine, Medical Ethics and Health Policy, and Neurology, Perelman School of Medicine, The University of Pennsylvania, Philadelphia, PA, USA

    Jason Karlawish

  2. Departments of Psychiatry & Human Behavior and Neurobiology & Behavior, Institute for Memory Impairments and Neurological Disorders, The University of California Irvine, Irvine, CA, USA

    Joshua D. Grill

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  1. Jason Karlawish
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  2. Joshua D. Grill
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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). https://doi.org/10.1038/s41582-021-00540-6

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