Bioethics Forum Essay
Would I Give Aducanumab to My Mother?
Aducanumab has just been approved by the Food and Drug Administration to slow the progress of Alzheimer’s disease. It is likely that many people who are candidates for the drug will no longer be competent to make their own health care decisions, and will be relying heavily on others to make the decision with them or for them. As a layperson, how would I evaluate the risks and benefits of this drug, were I acting as a health care proxy for someone with Alzheimer’s disease?
A number of years ago, when my mother was in the middle of her 10-year decline into dementia, her physician wanted to give her Aricept (donepezil) and was very unhappy when I turned it down. At first it had seemed to me that anything was worth a try. There was evidence that some people experienced small, temporary benefits in cognitive function and activities of daily living. On the other hand, my mother had problems swallowing pills and hated to take any medication. Her caregiver was reluctant to coax my mother to take yet one more pill. Side effects included nausea, vomiting, weight loss, dizziness, diarrhea, drowsiness, weakness, trouble sleeping, shakiness, and muscle cramps. My mother already weighed about 90 pounds soaking wet, so even minor weight loss was a worry. Dizziness meant higher risk of falls. Intestinal distress, for someone who was already upset about the loss of dignity associated with bathroom issues, seemed like a really bad idea. All of this might have made sense for someone willing to take on the risks and downsides for the sake of the possible benefit—but my mother could hardly be called willing, as she no longer understood cause and effect.
My mother is long gone, but I thought of my decision on Aricept when the FDA announced its approval of aducanumab. How would I decide whether to have this drug prescribed for a family member? I am pretty sure I would say no. And that is assuming that there was a choice: at over $50,000 a year, it is not clear who will be able to pay for it. I would ask myself: does the drug work? What are the risks? What are the side effects? And how would taking the drug affect the overall quality of life of someone with Alzheimer’s?
First, it is not at all clear that the drug works, in terms of affecting cognition and slowing decline. As Jason Karlawish explains in an incisive piece in STAT, crucial scientific steps were missed, and the current data are inconclusive and contradictory.
Side effects include possible brain swelling and bleeds (which appear to be severe in about 6% of patients), headache, falls, diarrhea, and what Biogen describes as “confusion/delirium/altered mental status/disorientation.” Wait a minute! I thought the reason to take this drug was that one already had altered mental status and confusion.
Before someone is even considered eligible for aducanumab, they must take a PET scan to ascertain that they have elevated levels of amyloid and then an MRI to make sure they don’t already have brain swelling. MRIs have to be repeated regularly while people are on the drug. I know perfectly competent adults who are freaked out by MRI’s. How do you explain this to someone with dementia? Or do you sedate them, thus adding to the risk? Furthermore, the drug itself is not a pill, but a monthly infusion.
Put that all together, and it just doesn’t add up. How would my mother’s life change for the better? There is little evidence of the drug’s efficacy. Meanwhile, her peaceful life in her rural home with her dedicated caregiver would now be punctuated by trips to the hospital for MRI’s, and monthly struggles to start infusions in her 90-year-old body, with its tiny veins and paper-thin skin. Aducanumab is apparently best suited to people in the early stages of Alzheimer’s, but even in the earliest stage my mother refused to accept that she had a problem. I cannot imagine successfully explaining that we were taking these measures in the faint hope of combatting a problem she insisted she didn’t have. And in the absence of an explanation she could understand, surely the frequent hospital trips would feel to her like unpleasant, even scary, invasions.
Like most people with a family member with dementia, I would have crawled on my knees over broken glass to get access to something that helped, even if that help was merely to slow down the inevitable. Sadly, aducanumab is not that help. I just hope that all the family decision-makers out there can resist the pressures of guilt, hope, desperation, and the need to do something, that they will take a deep breath and decide what is best for their loved one.
Dena S. Davis, JD, PhD, a Hastings Center Fellow, is the endowed presidential chair in health and a professor of bioethics and religion studies at Lehigh University. Her blog is Bioethics and Other Stuff.