Aaron S. Kesselheim, MD, JD, MPH
Professor of Medicine, Harvard Medical School and Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital in Boston
Jason Karlawish, MD
Professor of Medicine, University of Pennsylvania’s Perelman School of Medicine
Co-director of Penn’s Memory Center
Abstract: The Food and Drug Administration’s accelerated approval of a new Alzheimer’s drug has created a firestorm of praise and outrage. Dissenters include the FDA’s own advisory committee members, who unanimously recommended against approval of the drug, Aduhelm, because it showed no convincing evidence of efficacy. Three committee members resigned in protest after the approval. Numerous scientists, clinicians, bioethicists, and policymakers have serious concerns about the drug’s efficacy, its side effects, and possible negative social, scientific, and financial consequences of its approval. The Alzheimer’s Association hailed the drug’s approval as “a new era in Alzheimer’s treatment and research.” Biogen, the drug’s maker, has set an annual price tag of about $56,000, representing an annual cost to Medicare of anywhere between $29 and $100 billion dollars.
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