Zoom Talk (Work in Progress): Jürgen Landes (MCMP)
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Drug (Dis-)Approval in the Real World
The Evidence Based Medicine approach to causal medical inference is paradigmatic among medical methodologists. Three competing approaches originating in the philosophy of medicine seek to mount a challenge to this paradigm. In order to see how successful these challenges are, we need to assess the performance of all approaches in real world medical inference, which is based on studies produced by a multi-billion dollar industry. One important real world problem all approaches can be applied to is the assessment of drugs for drug (dis-)approval by a drug regulation agency. We first present criteria for judging how well an approach addresses this problem and then apply these criteria to the approaches.
We conclude that while all approaches hold promise, they are at least as susceptible to manipulation as the current drug (dis-)approval decision procedures. Furthermore, in order to properly assess the philosophy of science approaches which only exist on paper, they need to be implemented in the real world. Finally, we call for the development of benchmarks and/or criteria that facilitate a resolution of the challenges and a continuation of the development of alternative approaches.