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Marion Boulicault (MIT), "Feminist Philosophers of Science Analyze the Tensions Between 'Sex as a Biological Variable' Mandates and Precision Medicine Initiatives"
"Why 'sex as a biological variable' conflicts with precision medicine initiatives" - Cell Reports Medicine, 2022
Scientific research on sex is hot. In the last decade, the National Institutes of Health (NIH) and the European Commission have mandated that researchers collect and report data on “sex as a biological variable” (SABV) in their research. With the goal of promoting women’s health, the core requirement of the NIH policy, affecting over $30 billion of funding each year, is that researchers report data disaggregated by sex—meaning male and female. Strong binary sex essentialist statements characterize the supporting literature for SABV mandates: “Sex makes us male or female. Each cell is either male or female depending on whether you are a man or a woman”.
At the same time, the last decade has seen extraordinary attention and investment towards developing “precision medicine”: a vision of medicine where large multidimensional genomic, environmental, and lifestyle datasets are used to tailor medical treatments to each individual. As the US Food and Drug Administration explains: “The goal of precision medicine is to target the right treatments to the right patients at the right time”.
Women’s health advocates have claimed that SABV policies align with and further the aims of precision medicine. Requirements that researchers collect and disaggregate data by sex will allow for the tailoring medical treatments to members of each sex, which is one step along the road to tailoring treatments to each individual. Given the extraordinary investment in precision medicine as the future of healthcare, claims that link SABV to precision medicine could have significant influence on the continued success of SABV policies.
In an April 2022 paper out in the journal Cell Reports Medicine, a group of feminist philosophers of science based at the Harvard GenderSci Lab–an interdisciplinary feminist research group–argue that SABV mandates do not in fact align with precision medicine’s goal of individualized and targeted treatments. The single-minded focus of SABV policies on sex differences 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.’ And, 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 paper: “A one-size-fits-all approach to sex [comes] at the expense of the rigor and precision at which precision medicine aims.”
Our paper advocates instead for 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. By offering our critique and advocating for the adoption of sex contextualism, our paper aims to model how philosophers of science, working alongside scholars from other disciplines, can play a role in critical policy-relevant debates about the future of medicine, and of science and technology more broadly.
You can learn more about the work of the Harvard GenderSci Lab here. And to learn more about sex contextualism, you can read our blog Q&A and check out our teaching module and research tip sheet for scientists. Finally, for further discussion of this article, check out the GenderSci Lab’s twitter thread, and the twitter thread of the Cell Reports Medicine editor Isdabel Goldman.
Acknowledgements: This blog post is adapted from an earlier blog post co-authored by Marina DiMarco, Helen Zhao and Marion Boulicault.
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