FDA adviser who resigned over Alzheimer's drug says 'no good evidence' it works

One of the FDA advisory panel members who resigned after the agency granted Biogen’s Alzheimer’s drug Accelerated Approval has said "the drug showed no good evidence that it worked."

The agency’s decision, which was met with mixed reviews and marked the first approval of an Alzheimer’s drug in nearly two decades, came after the Peripheral and Central Nervous System Drugs Advisory Committee said in November that it was not reasonable to consider clinical benefit of the drug based on one successful study. "The drug showed no good evidence that it worked because it had important side effects and then the FDA is totally switching gears over the last six months and approving this drug on the basis of a theory relating to the surrogate marker of amyloid plaques that we as an advisory committee back in November were told to not consider," Kesselheim told CBS.