Should the FDA Have Approved the New Alzheimer’s Drug?

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 in November 2020 unanimously recommended against approving the drug, Aduhelm, because it showed no convincing evidence of efficacy, leading three committee members to resign 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 it 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, depending on the number of patients who take it, with additional patient expenses for copays and imaging to screen for side effects.

Watch Hastings Center president Mildred Solomon as she gets to the bottom of the FDA’s decision and its consequences for patients and families, the health care system, and the integrity of regulatory oversight.