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Rules versus Standards: What Are the Costs of Epistemic Norms in Drug Regulation?

Andreoletti, Mattia and Teira, David (2019) Rules versus Standards: What Are the Costs of Epistemic Norms in Drug Regulation? Science, Technology, & Human Values, 44 (6). pp. 1093-1115. ISSN 0162-2439

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Abstract

Over the last decade, philosophers of science have extensively criticized the epistemic superiority ofRandomized Controlled Trials (RCTs) for testing safety and effectiveness of new drugs, defending instead various forms of evidential pluralism. We argue that scientific methods in regulatory decision making cannot be assessed in epistemic terms only: there are costs involved. Drawing on the legal distinction between rules and standards, we show that drug regulation based on evidential pluralism has much higher costs than our current RCT-based system. We analyze these costs and advocate for evaluating any scheme for drug regulatory tests in terms of concrete empirical benchmarks, like the error rates of regulatory decisions.


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Item Type: Published Article or Volume
Creators:
CreatorsEmailORCID
Andreoletti, Mattia
Teira, David
Keywords: Clinical trials EBM+ regulation
Subjects: Specific Sciences > Medicine > Clinical Trials
General Issues > Experimentation
Specific Sciences > Medicine
General Issues > Science and Policy
Depositing User: Prof. David Teira
Date Deposited: 22 Sep 2020 19:04
Last Modified: 22 Sep 2020 19:04
Item ID: 18131
Journal or Publication Title: Science, Technology, & Human Values
Official URL: http://doi.org/10.1177/0162243919828070
DOI or Unique Handle: https://doi.org/10.1177/0162243919828070
Subjects: Specific Sciences > Medicine > Clinical Trials
General Issues > Experimentation
Specific Sciences > Medicine
General Issues > Science and Policy
Date: 2019
Page Range: pp. 1093-1115
Volume: 44
Number: 6
ISSN: 0162-2439
URI: https://philsci-archive-dev.library.pitt.edu/id/eprint/18131

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