In this piece from Scientific American, R. Douglas Fields argues that the new US National Institutes of Health policy, which is intended to drive research in sex differences, is a major step in the wrong direction. The new policy requires NIH-funded projects to use equal numbers of male and female animals and cells in their studies. Fields is correct that additional targeted funding would strengthen the initiative, but even without targeted funding the policy still has value.
The importance of sex differences varies according to the condition in question. But we often don’t know how and to what degree sex matters because differences are not routinely investigated. Many clinical guidelines and Cochrane reviews note that evidence regarding sex difference is missing. Meta-analysis can often not be conducting because journals continue to publish studies that don’t provide sex-specific reporting of results. For example, clinical guidelines on the use of antiarrhythmics continue to be based on research that significantly under-represents women relative to the proportion of women prescribed these drugs. It is too late at the point of guideline development to demand further information about sex difference because the research simply isn’t there. Investigation, analysis and reporting of sex differences needs to be systematically built into research further up-stream. Certainty this requires more money and time, and diverts resources from other avenues of research. But whether this requires “a duplication of time and effort that is rarely practical or scientifically warranted”, as Fields argues, depends on the value one places on having evidence based medicine that equally serves male and female patients. When data is systematically collected and reported, patterns can be detected, often years after the original research. However it can be prohibitively expensive to replicated studies because sex differences are subsequently thought relevant.
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PJW Note: Much more can be found on this issue in IJFAB‘s special issue, “Research Ethics: Women, Sex, and Gender in Biomedical Research,” guest edited by Angela Ballantyne, Belinda Bennett, Isabel Karpin, and Wendy Rogers. (Content is behind a paywall if you or your institution does not subscribe.)
