The FDA’s approval of Alzheimer’s drug Aduhelm last month brought feelings of relief to many Americans watching their loved ones struggling with the disease.
But the decision-making process was marred by controversy: Ten of the eleven experts on the FDA advisory committee had voted against the approval, saying there was not enough evidence of its efficacy — of particular concern given its high cost and potential side effects — and, on Friday, the acting FDA commissioner wrote to the Inspector General for the Department of Health and Human Services, calling for an independent investigation into her own agency’s decision making.
Jim Braude was joined by Dr. Aaron Kesselheim, a professor at Harvard Medical School who resigned from the advisory committee in protest after the drug’s approval, to learn more on Greater Boston.
“The FDA is one of our most important public health agencies, and I like to think that they make the right decision most of the time, but unfortunately, when there are decisions like this that are really problematic ... I think it kind of does erode this trust that people have — the trust that we need for people to take vaccines that have been coming through the FDA, or other drugs,” Kesselheim said.
WATCH: Former FDA advisory committee member Aaron Kesselheim on new Alzhimer’s drug Aduhelm
