In episode 483, James and Mike invite Tina to the podcast to talk about the aducanumab (Aduhelm) FDA approval story. We look at all the latest evidence, we talk about how people analyzed the data, whether or not the findings were clinically important, the side effects and finally the cost. And no matter how we looked at it we were still puzzled it got FDA approval. What do you think?
1) Effect of reductions in amyloid levels on cognitive change in randomized trials: instrumental variable meta-analysis.
2) Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE trials as reported by Biogen, December 2019
3) Institute for Clinical and Economic Review