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The Aducanumab shitstorm

Congratulations to  Al Sandrock , from Biogen, for never giving up on science and for being a  risk-taker extraordinaire .   Photo by Markus Winkler on Unsplash The FDA’s controversial approval of aducanumab for the treatment of Alzheimer’s disease on Monday has caused a shitstorm. The main reason is that in November the FDA’s independent advisory committee voted against recommending approval; they said the data failed to demonstrate persuasively that aducanumab slowed cognitive decline. In a NY Times article Dr Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California and one of the aducanumab site investigators said “This should not be approved, because substantial evidence of effectiveness hasn’t been shown and there’s very little potential that this will address the needs of patients.” What the FDA has done is use the so-called Accelerated Approval Pathway , which allows them to approve a drug for a serious or life-threatening