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6 ways the FDA’s approval of Aduhelm does more harm than good

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Bottom line. The FDA’s approval of Aduhelm raises more questions and creates more problems than a new drug approval should. It’s time for governmental, professional, and advocacy entities to step in where Biogen and the FDA have failed and explain to patients, caregivers, and clinicians how this drug is not the “new day” in the fight against Alzheimer’s disease and needs to be approached cautiously, if at all.

Sam Gandy is a neurologist; professor of neurology and of psychiatry at the Icahn School of Medicine at Mount Sinai where he holds the Mount Sinai Chair in Alzheimer’s Research; the founding and current director of the Mount Sinai Center for Cognitive Health and NFL Neurological Care; and associate director of the National Institute on Aging-Designated Mount Sinai Alzheimer’s Disease Research Center. He reports founding companies based on immunotherapeutic strategies for dementia; receiving personal or laboratory support from Wyeth, DiaGenic, Pfizer, Baxter, and Polyphenolics/Constellation Wines; and recently joined the scientific advisory board of Ritrova Therapeutics.
 
















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