Global Diversification in Medicine Regulation: Insights from Regenerative Stem Cell Medicine

ABSTRACT

Medicine regulation worldwide has undergone a process of regulatory diversification. The evidence-based medicine (EBM) paradigm, centered on multi-phase randomized controlled trials, is increasingly contested and replaced by new models of clinical validation. To explain these changes, STS research has cited just a few factors, e.g. growing pressure form health consumers; the role of pharmaceutical companies to lobby for fast, affordable drug development; the influence of neoliberal ideas and libertarian advocacy of deregulation; and the agency of national governments to enable domestic innovation opportunities in the context of global competition and inequalities. Those factors individually cannot account for the increasing variation in medicine regulation at both national and global levels. Instead it is helpful to integrate elements of existing explanations into a framework with four pairs of conflicting regulatory choices, which play a central role in the formation of medicine regulation. We use this framework to compare regulatory changes in the USA, European Union, China, India, Argentina, and Japan. Across these jurisdictions, the case studies illustrate four dynamics of diversification. Key regulatory concepts such as evidence, risk, safety, efficacy, responsibility and accountability acquire different meanings, reshaping medicine innovation in far-reaching and often contradictory ways. The boundaries between medical research and healthcare provision, commerce and humanitarian service, as well as state control and medical self-regulation are re-defined.     

Sexual Assault in Intimate Relationships: Introduction to Special Issue

ABSTRACT

The 13 articles in this special issue draw from the experience of women and men in Australia, Canada, Denmark, India, Micronesia, Sierra Leone, Tanzania, Vietnam, and the US to shed light on the complex problem of accounting for Intimate Partner Sexual Violence (IPSV) in a globalizing world. As a collection, the articles draw from qualitative methodologies in social science and humanities privileging local narratives drawn through interviews, focus groups, participant observation and historical surveys. This special issue presents articles from multiple disciplinary vantage points that seek to bring to the fore insight drawn from the close reading of sexual violence in varied global cultural contexts. The collection of articles challenges the idea that there is a universal way to understand and measure IPSV. Together the articles demonstrate key elements of the disconnect between local understandings and the assumed universality of concepts that undergird most sexual violence research. Congruent with our previous work, the challenge of the work in the cross-cultural perspective taken by this special issue lies in the acknowledgement that the ways we account for and define sexual violence in intimate (dating, cohabiting and marital) relationships is culturally-situated and must be contextualized as such. This cross-cultural perspective values the conceptual insight that can be drawn from cultural difference and pushes against a homogenization of notions of sexual violence in studies within global societies as well as those that work to compare them.