Despite a great deal of feminist work that has highlighted its social construction, menstruation seems a self-evidently “natural” bodily process. Yet, how menstruation is defined or what “counts” as menstruation is rarely questioned. Examining menstruation alongside technologies that alter it highlights these definitional questions. In this article, I examine menstrual suppression through an analysis of medical journal articles and FDA advisory committee transcripts, paired with websites used to market menstrual suppression to consumers. Across these contexts, new definitions of menstruation converged (...) on a distinction between bleeding that occurs when women are taking hormonal birth control and when they are not. The case of menstrual suppression birth control pills provides an opportunity to study the work of redefining a biological process understood as quintessentially natural and deeply significant for gendered embodiment, as well as a challenge to consider both the social and material construction of gendered bodies. (shrink)

The US Food and Drug Administration (FDA) is fraught with controversies over the role of values and politics in regulatory science, especially with drugs in the realm of reproductive health. Philosophers and science studies scholars have investigated the ways in which social context shapes medical knowledge through value judgments, and feminist scholars and activists have criticized sexism and injustice in reproductive medicine. Nonetheless, there has been no systematic study of values and gender norms in FDA drug regulation. I focus on (...) three questions about values in regulatory science. First, how have societal values and gender norms shaped the way that the FDA regulates drugs in the realm of reproductive health, specifically with drug labels? Second, what are the ethical, epistemic, and social consequences of these influences on regulation for women and other marginalized groups? Third, which societal values and gender norms ought to influence drug regulation about reproductive health, and how ought this happen? Integrating philosophical analysis with historical archival research and in-depth interviews, I conduct three case studies of drug labeling about reproductive health: (1) the “drug fact” about the mechanism of the morning-after pill; (2) the package inserts for patients about the health risks of oral contraceptives; and (3) the special physician labels made for prescribing drugs to pregnant women. I identify three challenges for the FDA and suggest ways to reduce the influence of sexist values and facilitate feminist alternatives. First, across these cases, I have found that there are many ways in which other concerns in reproductive medicine (such as zygotic life, fetal health, and population control) have devalued women’s health. Second, both knowledge and ignorance xvi about their reproductive health have contributed to women’s oppression, especially poor women and women of color. Finally, by avoiding the epistemic dimensions of ethics, powerful, mostly male parties in medicine (such as doctors, pharmaceutical companies, and religious institutions) have misused “informed consent,” “religious freedom,” and “paternalism” for unethical purposes. For improvement, I suggest extracting sexist values and gender norms from regulatory science that cause epistemic injustices, and I point to success stories for reforming sexism with feminism at the FDA. (shrink)

Philosophers of science and medicine now aspire to provide useful, socially relevant accounts of mechanism. Existing accounts have forged the path by attending to mechanisms in historical context, scientific practice, the special sciences, and policy. Yet, their primary focus has been on more proximate issues related to therapeutic effectiveness. To take the next step toward social relevance, we must investigate the challenges facing researchers, clinicians, and policy makers involving values and social context. Accordingly, we learn valuable lessons about the connections (...) between mechanistic processes and more fundamental reasons for medical interventions, particularly moral, ethical, religious, and political concerns about health, agency, and power. This paper uses debates over the controversial morning-after pill to gain insight into the deeper reasons for the production and use of mechanistic knowledge throughout biomedical research, clinical practice, and governmental regulation. To practice socially relevant philosophy of science, I argue that we need to account for mechanistic knowledge beyond immediate effectiveness, such as how it can also provide moral guidance, aid ethical categorization in the clinic, and function as a political instrument. Such insights have implications for medical epistemology, including the value-laden dimensions of mechanistic reasoning and the “epistemic friction” of values. Furthermore, there are broader impacts for teaching research ethics and understanding the role of science advisors as political advocates. (shrink)

With a focus on hormone treatments, this article contributes to recent problematizations of the ontology of bodies, illnesses and medication. Hormone treatment is conventionally understood to comprise preparations like pills, patches or injections, and following from this understanding, the materiality of risk is perceived as potential adverse effects of pharmaceuticals within individual bodies. By discussing Finnish trans persons’ experiences of hormone treatments, and drawing from material feminisms and trans/feminist studies, this article rethinks what ‘hormone treatments’ and their risks materially entail. (...) Stressing the importance of accounting for the relationality of risks, the article suggests that hormone treatment risks can be seen as Baradian ‘phenomena’ that materialize contextually within specific ‘treatment apparatuses’ and the power relations that saturate them. This process of materialization includes the gendering of risks and how the gender binary itself may at times constitute a risk. (shrink)

Though better recognized for its immediate endeavors in human embryo research, the Carnegie Department of Embryology also employed a breeding colony of rhesus macaques for the purposes of studying human reproduction. This essay follows the course of the first enterprise in maintaining a primate colony for laboratory research and the overlapping scientific, social, and political circumstances that tolerated and cultivated the colony’s continued operation from 1925 until 1971. Despite a new-found priority for reproductive sciences in the United States, by the (...) early 1920s an unfertilized human ovum had not yet been seen and even the timing of ovulation remained unresolved. Progress would require an organized research approach that could extend beyond the limitations of working with scant and inherently restrictive human subjects or with common lab mammals like mice. In response, the Department of Embryology, under the Carnegie Institution of Washington, instituted a novel methodology using a particular primate species as a surrogate in studying normal human reproductive physiology. Over more than 40 years the monkey colony followed an unpremeditated trajectory that would contribute fundamentally to discoveries in human reproduction, early embryo development, reliable birth control methods, and to the establishment of the rhesus macaque as a common model organism. (shrink)

This article uses the case of pregnancy testing in Britain to investigate the process whereby new and often controversial reproductive technologies are made visible and normalized in mainstream entertainment media. It shows how in the 1980s and 1990s the then nascent product placement industry was instrumental in embedding pregnancy testing in British cinema and television's dramatic productions. In this period, the pregnancy-test close-up became a conventional trope and the thin blue lines associated with Unilever's Clearblue rose to prominence in mainstream (...) consumer culture. This article investigates the aestheticization of pregnancy testing and shows how increasingly visible public concerns about ‘schoolgirl mums’, abortion and the biological clock, dramatized on the big and small screen, propelled the commercial rise of Clearblue. It argues that the Clearblue close-up ambiguously concealed as much as it revealed; abstraction, ambiguity and flexibility were its keys to success. (shrink)

Focusing on the controversial birth control pills Yaz and Yasmin, this article explores how debates about the safety of these drugs have materialized in risk evaluations and the management of technological risk. Drawing on in-depth interviews with stakeholders and content analysis of legal, medical, and regulatory documents, I highlight how professional contraceptive risk assessment is characterized by systemic uncertainty and doubt, resulting in increased responsibility for users themselves to manage the drugs’ potentially increased risks of venous thromboembolism. The analysis centers (...) on three key areas in the assessment process that denote disagreement: risk measurement in postmarket surveillance data, the distinctiveness of the drugs’ benefits when compared to other contraceptive technologies, and the weighing of the risks and benefits against each other. While professionals negotiate uncertainty both in epidemiological research and in clinical practice, users are constructed as agents who should manage risk individually. Such processes are underlined by a diffusion of responsibility in the systemic management of contraceptive risk. This article suggests, more broadly, that medical technologies can be conceptualized as artifacts that are instrumental in the dispersion of risks. (shrink)