The FDA's insider review on aducanumab was all about politics, not science, and it threatens patients and the biopharma industry alike

The FDA deserves kudos for drawing a line in the sand over their review of Covid-19 vaccines. They’ve made it clear — after deep skepticism began to appear following the debacle over convalescent plasma — just what they will need to see before handing out an EUA, thus saving the agency’s rep for enforcing standards essential to maintaining public trust in drugs.

That same integrity, though, has gone missing from the FDA’s stance on Biogen’s Alzheimer’s drug aducanumab. Despite a statistical analysis that highlights the conflicting nature of the Biogen $BIIB data, a post hoc dumpster dive operation to find supportive data and a move to shine up small cohort results as backup proof of efficacy, the FDA division responsible for Alzheimer’s chose to endorse adu for use among millions of patients.