Making a 'sex-difference fact': Ambien dosing at the interface of policy, regulation, women's health, and biology.

The U.S. Food and Drug Administration's (FDA) 2013 decision to lower recommended Ambien dosing for women has been widely cited as a hallmark example of the importance of sex differences in biomedicine. Using regulatory documents, scientific publications, and media coverage, this article analyzes the making of this highly influential and mobile 'sex-difference fact'. As we show, the FDA's decision was a contingent outcome of the drug approval process. Attending to how a contested sex-difference fact came to anchor elite women's health advocacy, this article excavates the role of regulatory processes, advocacy groups, and the media in producing perceptions of scientific agreement while foreclosing ongoing debate, ultimately enabling the stabilization of a binary, biological sex-difference fact and the distancing of this fact from its conditions of construction.

The future of sperm: a biovariability framework for understanding global sperm count trends.

The past 50 years have seen heated debate in the reproductive sciences about global trends in human sperm count. In 2017, Levine and colleagues published the largest and most methodologically rigorous meta-regression analysis to date and reported that average total sperm concentration among men from 'Western' countries has decreased by 59.3% since 1973, with no sign of halting. These results reverberated in the scientific community and in public discussions about men and masculinity in the modern world, in part because of scientists' public-facing claims about the societal implications of the decline of male fertility. We find that existing research follows a set of implicit and explicit assumptions about how to measure and interpret sperm counts, which collectively form what we term the Sperm Count Decline hypothesis (SCD). Using the study by Levine and colleagues, we identify weaknesses and inconsistencies in the SCD, and propose an alternative framework to guide research on sperm count trends: the Sperm Count Biovariability hypothesis (SCB). SCB asserts that sperm count varies within a wide range, much of which can be considered non-pathological and species-typical. Knowledge about the relationship between individual and population sperm count and life-historical and ecological factors is critical to interpreting trends in average sperm counts and their relationships to health and fertility.