The Accelerated Shortcut: Inside the FDA's Alzheimer's Gamble
Internal documents reveal how regulators overruled their own statisticians to approve a failed Alzheimer's drug, exposing how the 'accelerated approval' pathway has become a controversial industry standard.
Listen in the Fylom app.
Internal FDA memos regarding the June 2021 approval of aducanumab.
Statistical review from the FDA Office of Biostatistics (Sylvia Collins).
House Oversight Committee report on the FDA-Biogen 'collaborative workstream'.
Summary of the Food and Drug Omnibus Reform Act (FDORA) of 2022.
Medicare's National Coverage Determination (NCD) for amyloid-targeting monoclonal antibodies.
- 01Intro1 min
- 02The Resurrection of Aduhelm2 min
- 03The Surrogate Endpoint Gamble3 min
- 04A Pathway Transformed2 min
- 05The Fallout and Reform2 min
- 06Outro1 min
Fylom generates episodes like this on any topic you're curious about.
Fylom episodes are researched, written, and voiced by AI. Automated checks help catch inaccuracies, but episodes aren't reviewed by a human and AI can still get things wrong. Treat them as a starting point, not a source of record — more in our accuracy disclaimer.