Breakthrough or Breakdown? Should the FDA Have Approved the New Alzheimer's Drug?
Should Patients Take It?
New Webinar, Monday, July 12
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 approval of the drug, Aduhelm (aducanumab), 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. Join Hastings president Mildred Solomon with Aaron S. Kesselheim and Jason Karlawish 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 in a Hastings Conversations webinar this Monday, July 12, 10 am EST. Learn more and register.
Hastings Center Welcomes First Sadler Scholars
The Hastings Center is pleased to welcome the inaugural Sadler Scholars, a select group of six doctoral students with research interests relevant to bioethics who are from racial and ethnic communities underrepresented in this field. “The Sadler Scholars represent the next generation of bioethics: a field that is more diverse, widely interdisciplinary, and prepared to engage directly with how social inequity shapes human health and well-being,” said Hastings Center research scholar Nancy Berlinger, who directs the visiting scholar program and designed this initiative. Stipends for Sadler Scholars are provided by The Blair and Georgia Sadler Fund for Socially Just Health Policy, which aims to cultivate a more diverse set of scholars committed to creating a more equitable world. Read more.
"Grave Omission" of Age Limit for Human Embryo Research
Writing in Nature, Hastings Center director of research Josephine Johnston and co-authors cite the “grave omission” of an age limit in the latest international guidelines on human embryo research. The guidelines from the International Society for Stem Cell Research lifted the longstanding limit on experiments on human embryos beyond 14 days of development, but didn’t propose an alternative. “At some point, the developing human embryo reaches a stage at which it should not be used for research,” they write. “There is disagreement about when that happens, but scientists need to acknowledge that it does, and reassure the public that they accept limits.” Read the Nature correspondence.
Upcoming Events
"Breakthrough or Breakdown? Should the FDA Have Approved the New Alzheimer's Drug?" Hastings Conversations webinar, with Hastings Center President Mildred Z. Solomon, Aaron S. Kesselheim, and Jason Karlawish. July 12, 10 am EST.
"Do Justice and Equity Concerns Bolster or Hinder the Case for the Use of Gene Drive Applications?" a panel with Hastings Center research scholar Carolyn Neuhaus organized by the Foundation for the NIH GeneConvene Global Collaborative and McMaster University's Institute on Ethics & Policy for Innovation. August 10, 10 AM EST.
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