New article: GenderSci Lab Examines the Tensions Between “Sex as a Biological Variable” Mandates and Precision Medicine Initiatives
By Marina DiMarco, Helen Zhao, and Marion Boulicault
Today, the GenderSci Lab has a new commentary out in Cell Reports Medicine, “Why ‘Sex as a Biological Variable’ Conflicts with Precision Medicine Initiatives” (the article is open access). This piece, coauthored by the Lab’s philosophers of science, argues that mandates to make male-female sex comparisons in all areas of biomedical research conflict with precision medicine’s goal of individualized and targeted treatments.
Advocates have claimed that funding mandates like the NIH Sex As a Biological Variable policy, which requires the inclusion of male and female materials and disaggregation of results by binary sex in all federally funded preclinical research, promote women’s health and further the clinical aims of precision medicine.
Photo by JOSHUA COLEMAN on Unsplash
We argue, however, that the single-minded focus on sex differences built into these mandates obscures clinically relevant within-sex differences, null findings of sex similarity, and social and environmental causes of gendered patterns of health and behavior, and fails to do justice to the plurality and context-specificity of sex-related variables. Much of the research that adheres to these mandates also fails to specify how it operationalizes ‘sex.’
As several analysts have pointed out, a crude binary approach to the study of sex lacks statistical rigor. In aggregate, these oversights and elisions not only produce a “literature of contradiction” but also run the risk of overshadowing empirical findings that align with the stated mission of precision medicine, namely the development of targeted medical interventions and care.
As we argue in the article, “A one-size-fits-all approach to sex [comes] at the expense of the rigor and precision at which precision medicine aims.”
Our commentary advocates a “sex contextualist” approach to biomedical research, which encourages researchers to tailor their operationalization of “sex” to a specific biological context and research question. A sex contextualist approach recognizes that sex may not always be relevant and challenges researchers to take responsibility for their decisions about whether and how to operationalize and analyze sex-related variables in preclinical and clinical research.
Read the full article here.
To learn more about sex contextualism, you can read our blog Q&A on sex contextualism and check out our teaching module and research tip sheet for scientists.
Key takeaways:
Policies that require analyzing sex as a biological variable through the disaggregation of all findings into “male” and “female” comparisons conflict with the research agenda of precision medicine.
Binary approaches to the study of sex are anything but precise and are often inaccurate, misleading, and exclusionary.
“Sex contextualist” approaches to studying sex-related variables in preclinical and clinical research better align with the mission of precision medicine.
Recommended Citation
DiMarco, M., Zhao, H., and Boulicault, M. ”New article: GenderSci Lab Examines the Tensions Between ‘Sex as a Biological Variable’ Mandates and Precision Medicine Initiatives.” GenderSci Blog. 19 April 2022. genderscilab.org/blog/precision-medicine-commentary
Statement of Intellectual Labor
Marina DiMarco and Helen Zhao contributed to the drafting and editing processes. Marion Boulicault contributed to the conceptualization and editing processes.