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CSS Colloquium - Jacob Stegenga: Hollow Hunt for Harms

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Mandag 12. maj 2014,  kl. 10:15 - 12:00



Hollow Hunt for Harms

Jacob Stegenga

Harms of medical interventions are systematically underestimated in clinical research. Numerous factors—conceptual, methodological, and social—contribute to this underestimation. I articulate the depth of such underestimation by describing these factors. The ways harms are operationalized in clinical research contributes to their underestimation. Phase 1 ‘first in human’ trials are rarely published, but such trials provide the foundation for assessing the harm profile of medical interventions. One way to think about the problem of underestimating harms is in terms of the ‘power’ of a clinical trial—the ability of a trial to detect a difference of a certain effect size between the experimental group and the control group. Power is normally thought to be pertinent to detecting benefits of medical interventions. It is important, though, to distinguish between the ability of a trial to detect benefits and the ability of a trial to detect harms. I refer to the former as power­B and the latter as powerH. I identify several factors which maximize powerB by sacrificing powerH. The decision to maximize powerB at the expense of powerH influences the content of the evidence available for causal hypotheses in medicine, and yet is itself directly influenced by social values. Post-market surveillance of harms further contributes to underestimating the harm profile of medical interventions. Finally, at every stage of biomedical research the hunt for harms is shrouded in secrecy, which further contributes to the underestimation of the harm profiles of medical interventions.