Sumary of Explained: How an unproven Alzheimer’s drug got approved:
- The council, a group of 15 officials who review complex issues, concluded that another clinical trial was necessary before approving the drug.
- Allegations about the collaboration prompted the FDA to conduct an internal inquiry after a consumer advocacy group called for an inspector general’s investigation, according to documents reviewed by the Times.
- In written answers to questions, Biogen said, “Biogen stands 100% behind Aduhelm and the clinical data that supported its approval.
- Woodcock has publicly acknowledged “process problems,” but has not described what those problems were.
- 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.
- Two nearly identical late-stage clinical trials of aducanumab were shut down in 2019 because an independent monitoring committee concluded that the drug did not appear to be helping patients.
- But since the approval, some major medical centers have decided not to offer it, and the American Neurological Association’s executive committee told the doctors who are its members that “based on the clinical evidence, Aduhelm should not have been approved at this time.
- “This approval shouldn’t have happened,” said Dr. Vissia Viglietta, a former Biogen senior medical director, who helped design the two late-stage clinical trials of the drug.