<p>Epistemic policies are combinations of methodological and meta-methodological choices that determine both the objectives to be achieved and the pragmatic consequences generated in a regulatory science process. The epistemic policy advanced by Evidential Pluralism constitutes, among other things, an alternative for situations in which the procedure traditionally applied in the health sciences—based on a standard of proof centred on randomised controlled trials—cannot be implemented. Its application to certain types of drugs, such as anti-ageing medicines or those authorised under the FDA’s Accelerated Approval Program, helps overcome some obstacles by speeding up the authorisation process or promoting research. However, the literature has also pointed to a possible unintended pragmatic consequence: an increased susceptibility to external influences. To address this issue, we propose a modification of the pluralist epistemic policy based on the reassignment of the burden of proof: while drugs would initially continue to be regarded as unsafe and ineffective, regulatory agencies would be responsible for generating the information needed to overturn this consideration. The idea is that this proposal, aligned with other initiatives based on the transfer of responsibilities to the public sector, could reduce financial motives and conflicts of interest among scientists and owners that might influence the regulatory process, as well as promote an open-access data policy that would help identify external influences even after they have arisen.</p>

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Evidential Pluralism in the health sciences, external influences, and the reassignment of the burden of proof

  • Guillermo Marín Penella

摘要

Epistemic policies are combinations of methodological and meta-methodological choices that determine both the objectives to be achieved and the pragmatic consequences generated in a regulatory science process. The epistemic policy advanced by Evidential Pluralism constitutes, among other things, an alternative for situations in which the procedure traditionally applied in the health sciences—based on a standard of proof centred on randomised controlled trials—cannot be implemented. Its application to certain types of drugs, such as anti-ageing medicines or those authorised under the FDA’s Accelerated Approval Program, helps overcome some obstacles by speeding up the authorisation process or promoting research. However, the literature has also pointed to a possible unintended pragmatic consequence: an increased susceptibility to external influences. To address this issue, we propose a modification of the pluralist epistemic policy based on the reassignment of the burden of proof: while drugs would initially continue to be regarded as unsafe and ineffective, regulatory agencies would be responsible for generating the information needed to overturn this consideration. The idea is that this proposal, aligned with other initiatives based on the transfer of responsibilities to the public sector, could reduce financial motives and conflicts of interest among scientists and owners that might influence the regulatory process, as well as promote an open-access data policy that would help identify external influences even after they have arisen.