Ethics in Medicine

How Aduhelm Got FDA Approval

Kristen Sparrow • September 12, 2021


“This incident has shaken F.D.A. integrity quite significantly,” said Wayne Pines, a former F.D.A. senior official who has written histories about the agency. “The F.D.A. is obligated to be sure that all stones are turned over, that every avenue is pursued to make sure that this was a decision that was made on the basis of scientific judgment and not on the basis of anything else.”

While some Alzheimer’s experts did support the drug’s approval given the dearth of treatment choices for patients, many say it was a mistake to approve a medication with such unclear evidence of benefit and that trials showed can cause brain swelling or brain bleeding.

Insurance companies are balking at paying for this drug, so it may not be as damaging as I was afraid of.