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Opinion: Stop blaming Biogen for putting profit at the expense of patients. Blame the systems that enabled it
18 days ago - By STAT
Two congressional committees recently released damning results of an 18-month investigation into the Food and Drug Administration's approval of Biogen's controversial Alzheimer's drug, Aduhelm. The systems that enabled Biogen's actions, however, went largely unscrutinized.
The report listed extensive and serious concerns about Aduhelm's rollout, including “atypical” interactions and collaboration between the FDA and Biogen; inappropriate use of the FDA's Accelerated Approval Program ; initially approving the product for anyone with Alzheimer's despite only testing it on patients in early...
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