How an Unproven Alzheimer’s Drug Got Approved

Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.

Two months before the Food and Drug Administration’s deadline to decide whether to approve Biogen’s controversial Alzheimer’s drug aducanumab, a council of senior agency officials resoundingly agreed that there wasn’t enough evidence it worked. The council, a group of 15 officials who review complex issues, concluded that another clinical trial was necessary before approving the drug. Otherwise, one council member noted, approval could “result in millions of patients taking aducanumab without any indication of actually receiving any benefit, or worse, cause harm,” according to minutes of the meeting, obtained by The New York Times. “It is critical that the decision be made from a place of certainty,” the minutes said.