Approving Biogen's Alzheimer's Drug Is a Big Mistake
The FDA’s blessing of a controversial treatment on spotty evidence threatens to harm the agency's reputation, America's health budget and the quality of drug research.
The world badly needs an Alzheimer's drug. But letting one reach the market based on weak data isn't the answer.
Photographer: Matt York/AP via Getty Images
"Follow the science" has been a consistent refrain during the pandemic, and it's usually a core mandate of the Food and Drug Administration in evaluating medicines. But when it came to one of the agency's most consequential decisions — the approval Monday of Biogen Inc.'s controversial Alzheimer's drug aducanumab — science took a back seat.
Alzheimer's is a devastating illness with no treatments that do anything but ease symptoms. Biogen's drug is the first said to slow decline. If there was good evidence that it did so, it'd be a breakthrough, but the data is inconclusive at best. And while the FDA is and should be flexible when patients have no options, this decision does more than bend standards — it shatters them.