Should a new Alzheimer’s drug have been approved by the FDA? Elizabeth Tracey reports
Podcast: Download (Duration: 1:04 — 1.5MB)
Aduhelm is the proprietary name for aducanumab, a just approved medication for treatment of Alzheimer’s disease. Caleb Alexander, an internal medicine expert at Johns Hopkins, sat on the FDA review board for this medicine and explains why he voted no regarding its approval.
Alexander: We have a product with very unclear safety and effectiveness for a disease that’s common and often devastating, that affects millions of Americans and their loved ones, and a product that also may cost tens of thousands of dollars a year. The FDA’s decision has been a very contentious one, the product’s safety and effectiveness is so muddled most scientists didn’t expect that it would be approved. :28
Alexander says so far, three of the experts on the review panel have resigned over this decision on the part of the FDA and there is much controversy among clinicians who treat people with Alzheimer’s disease. At Johns Hopkins, I’m Elizabeth Tracey.