Leonard M. Fleck, PhD, and Irving E. Vega, PhD, presented at the March 24 Bioethics for Breakfast session, offering perspectives and insight on the topic “Aducanumab, Alzheimer’s: Having That Conversation.” Bioethics for Breakfast is generously sponsored by Hall, Render, Killian, Heath & Lyman. This session was the second of a two-part series on the theme “Paradoxes of Aging: Living Longer and Feeling Worse.” The presentation portion of the session was recorded and is available to watch on our website.
Aducanumab, a drug designed to treat Alzheimer’s disease, has been the focus of intense medical, scientific, social, and ethical controversy. The FDA Advisory Commission voted almost unanimously not to approve the drug. The research trials failed to show that aducanumab offered significant clinical benefit to patients in the early stages of Alzheimer’s, and notably the enrollment of Black and Latino patients was disproportionately low. It came as a surprise that the FDA itself ultimately gave its approval to the drug, which costs $28,000 per year and is administered monthly through infusion in a hospital setting.
Fleck provided background on Aducanumab and the clinical trials carried out by the developer, Biogen, that led them to seek FDA approval. He defined the different stages of Alzheimer’s disease, noting that over six million Americans currently have been diagnosed with some degree of Alzheimer’s. Fleck also outlined the FDA’s approval process, including their vote to grant emergency use authorization with the expectation of phase four clinical trials completed within nine years. He also pointed out that Aducanumab’s effects are limited to mild cognitive impairment and mild Alzheimer’s, with no benefit in more advanced stages. However, there have been no other Alzheimer’s disease drugs in the past twenty years with promise of significant benefit.
Bringing up concerns of social justice, Fleck discussed the cost Aducanumab within U.S. health spending, particularly within the Medicare program. It is estimated that 85% of the estimated 3.1 million Americans with a mild Alzheimer’s diagnosis are Medicare eligible, meaning the annual cost to Medicare would be in the hundreds of billions of dollars for the drug and its associated costs. Fleck asked attendees to consider whether this spending would be a just use of limited health care resources.
Vega offered attendees questions to consider: is there sufficient evidence about the safety of the drug? Is there sufficient evidence about the effectiveness of the drug? Does the treatment address health disparities in Alzheimer’s disease? He discussed the biology of Alzheimer’s disease, outlining its effect on the brain, and pointing out what is still unknown about the disease. After defining scientific rigor, Vega walked attendees through concerns about the Aducanumab clinical trials, such as participant age and the inadequate representation of Black, Hispanic, American Indian or Alaska Native, and Native Hawaiian or Pacific Islander populations.
Focusing on these disparities, Vega shared facts pertaining to Black Americans being twice as likely to have Alzheimer’s compared to non-Latino white Americans, and Latino Americans being 1.5 times as likely, compared to non-Latino white Americans. Disparities exist with increased likelihood of comorbidities like stroke, heart disease, obesity, and diabetes. Given these facts, Vega shared concern for observed adverse side effects of Aducanumab, particularly brain swelling, microbleeds, and slow brain bleeding.
Questions from attendees generation discussion about advocacy work, insurance companies, and direct and indirect costs of Alzheimer’s disease. Fleck and Vega noted the cost of care for an individual with Alzheimer’s, in a long term care facility, is typically in the $80,000-$100,000 range per year. Indirect costs include the lost wages of caregivers, and stress experienced by loved ones. Vega also importantly pointed out the context of the approval of Aducanumab: a global pandemic, COVID-19 vaccine development, and the subsequent spread of misinformation. Attendees also participated in polling questions with hypothetical situations, asking whether they agreed or disagreed with the scenarios. Responses were varied, highlighting the complexities of the topic.
- Faculty voice: Alzheimer’s, the FDA, and Aducanumab by Leonard Fleck, July 2021
About the speakers
Leonard M. Fleck, PhD, is a professor in the Center for Bioethics and Social Justice and the Department of Philosophy at Michigan State University. Fleck’s interests focus on medical ethics, health care policy, priority-setting and rationing, and reproductive decision-making. He explores the role of community dialogue (rational democratic deliberation) in addressing controversial issues of ethics and public policy related to emerging genetic technologies. More recently, he has been working on a book-length manuscript that addresses a number of ethical and policy issues related to precision medicine, primarily in a cancer treatment context.
Irving E. Vega, PhD, obtained his undergraduate degree in Biology from the University of Puerto Rico-Mayaguez Campus. He continued his research training in the Department of Cell Biology and Neuroscience at the Graduate School of New Brunswick, Rutgers University, earning his PhD. Vega completed a postdoctoral fellowship in the Neuroscience Department at Mayo Clinic Jacksonville, where he developed his research career focusing on the pathobiology of Alzheimer’s disease. Vega joined the faculty as an associate professor in the Department of Translational Neuroscience at the Michigan State University College of Human Medicine campus in Grand Rapids, MI in 2014. His research focuses on molecular and biochemical mechanisms that modulate the accumulation of pathological tau proteins in Alzheimer’s disease and related dementias. Vega is also working on ethnic disparities and the influence of ethnoracial factors on blood biomarkers in Alzheimer’s disease.