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

doi:10.1038/s41582-021-00540-6

Review

. 2021 Sep;17(9):523-524.

doi: 10.1038/s41582-021-00540-6.

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

Jason Karlawish¹, Joshua D Grill²

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

PMID: 34267383
DOI: 10.1038/s41582-021-00540-6

Review

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

Jason Karlawish et al. Nat Rev Neurol. 2021 Sep.

. 2021 Sep;17(9):523-524.

doi: 10.1038/s41582-021-00540-6.

Authors

Jason Karlawish¹, Joshua D Grill²

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

PMID: 34267383
DOI: 10.1038/s41582-021-00540-6

No abstract available

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References

1. Cavazzoni, P. FDA’s Decision to Approve New Treatment for Alzheimer’s Disease. FDA https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-... (2021).
1. McGinley, L. Two members of an FDA advisory committee quit after approval of controversial Alzheimer’s drug. Washington Post https://www.washingtonpost.com/health/2021/06/09/alzheimers-drug-controv... (2021).
1. Food and Drug Administration. Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) meeting. Virtual meeting. Friday, November 6, 2020. FDA https://www.fda.gov/media/145691/download (2020).
1. Food and Drug Administration. Aducanumab for the treatment of Alzheimer’s disease: clinical overview of efficacy. FDA https://www.fda.gov/media/143504/download (2020).
1. CNBC. First on CNBC: CNBC transcript: Biogen CEO Michel Vounatsos speaks with CNBC’s “Power Lunch” today. CNBC https://www.cnbc.com/2021/06/07/first-on-cnbc-cnbc-transcript-biogen-ceo... (2021).

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[1] Cavazzoni, P. FDA’s Decision to Approve New Treatment for Alzheimer’s Disease. FDA https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-... (2021).

[2] Cavazzoni, P. FDA’s Decision to Approve New Treatment for Alzheimer’s Disease. FDA https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-... (2021).

[3] McGinley, L. Two members of an FDA advisory committee quit after approval of controversial Alzheimer’s drug. Washington Post https://www.washingtonpost.com/health/2021/06/09/alzheimers-drug-controv... (2021).

[4] McGinley, L. Two members of an FDA advisory committee quit after approval of controversial Alzheimer’s drug. Washington Post https://www.washingtonpost.com/health/2021/06/09/alzheimers-drug-controv... (2021).

[5] Food and Drug Administration. Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) meeting. Virtual meeting. Friday, November 6, 2020. FDA https://www.fda.gov/media/145691/download (2020).

[6] Food and Drug Administration. Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) meeting. Virtual meeting. Friday, November 6, 2020. FDA https://www.fda.gov/media/145691/download (2020).

[7] Food and Drug Administration. Aducanumab for the treatment of Alzheimer’s disease: clinical overview of efficacy. FDA https://www.fda.gov/media/143504/download (2020).

[8] Food and Drug Administration. Aducanumab for the treatment of Alzheimer’s disease: clinical overview of efficacy. FDA https://www.fda.gov/media/143504/download (2020).

[9] CNBC. First on CNBC: CNBC transcript: Biogen CEO Michel Vounatsos speaks with CNBC’s “Power Lunch” today. CNBC https://www.cnbc.com/2021/06/07/first-on-cnbc-cnbc-transcript-biogen-ceo... (2021).

[10] CNBC. First on CNBC: CNBC transcript: Biogen CEO Michel Vounatsos speaks with CNBC’s “Power Lunch” today. CNBC https://www.cnbc.com/2021/06/07/first-on-cnbc-cnbc-transcript-biogen-ceo... (2021).

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

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

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