Experts Have Resigned from an FDA Committee over Alzheimer's Drug Approval

Re:Experts Have Resigned from an FDA Committee over Alzheime... by shkkmo on Wednesday September 22, 2021 @12:22PM (#28618255)

The facts here paint a pretty different picture. 10 of the 11 scientists on the panel voted "no" and the last member voted "uncertain". These no votes were precisely because the only "successful" study of the drug only showed plaque reduction and failed to show any direct improvement in Alzheimers outcomes.

To me that indicates that this isn't a controversy between scientists, but an example of corruption / regulatory capture. Biogen spent a bunch of money researching a drug based on an unproven theory. When their results were very poor, the FDA allowed them to switch to accelerated approval, then ignored their unanimous panel of experts to grant that approval. This allows Biogen to sell an extremely expensive drug and recoup some of their loses before the ongoing studies required under accelerated approval further undermine the drug's claims of effectiveness.

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Re:Experts Have Resigned from an FDA Committee over Alzheime... by jmartrican on Wednesday September 22, 2021 @02:15PM (#28619746)

Just finished reading a book where the Sackler family manipulated the FDA into allowing Oxycontin to be released. My regards for the FDA is pretty low right now. If the consumers of pharama can't trust the FDA, then this might end up hurting the big pharma, because the people will think twice before taking some meds.... i know do.

[ Parent | on HN ]