The Alzheimer’s Treatment Controversy
Implications of Accelerated Drug Approvals

Summary

The Alzheimer’s Treatment Controversy: Implications of Accelerated Drug Approvals

Live Online Q&A with Aaron Kesselheim, Professor of Medicine, Harvard Medical School, and Director, Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women’s Hospital

Presented jointly with Reuters

Tuesday, July 20, 2021

The recent controversy surrounding the FDA approval of a new Alzheimer’s treatment has prompted questions about the standards that should be used to evaluate investigational drugs. The drug, aducanumab (brand name, Aduhelm), received FDA approval despite an independent advisory committee nearly unanimously rejecting the drug; the group described a lack of convincing evidence that the drug slowed progression of cognitive dysfunction in patients with Alzheimer’s and presented important safety concerns. Dr. Aaron Kesselheim, who served on the panel that advised against the drug, discussed the situation from his perspective during this live online Q&A with Reuters’ Julie Steenhuysen. Included was a discussion of possible reforms to the FDA’s accelerated approval pathway, a program intended to facilitate faster drug approvals based on indirect measures of benefits.

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Presented jointly with Reuters

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