Against Evidentiary Pluralism in Pharmaceutical Regulation

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Submission Summary
We examine arguments for and against the use of mechanistic evidence in assessing treatment efficacy and find that advocates of EBM+ and their critics have largely been talking past each other due to difference in focus. We explore aducanumab for the treatment of Alzheimer’s disease as a case which may (eventually) speak to the role of EBM+ in pharmaceutical regulation. The case suggests the debate may be more fruitful if philosophers confine debates to particular domains of medical science and weigh in prospectively instead of relying on historical cases where outcomes are known and which are susceptible to hindsight bias.
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PSA2022338
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