Experimental stem cell therapy: Biohierarchies and bionetworking in Japan and India

Abstract

This article concerns new developments in autologous adult stem cell research in Japan and India through the notions of biohierarchy and bionetworking. It conceptualizes how human subject research in one country may be turned into experimental stem cell therapies in another through bionetworks. We analyse the processes that enable researchers in Japan to discard a therapy as being of reputational risk, while researchers in India employ it so that it becomes reputation enhancing. At the same time, scientists from both countries collaborate in and potentially benefit from the same bionetwork. Explaining how the recruitment of patients and scientists is organized through bionetworking, this article analyses how experimental research in India thrives using Japanese technologies. The concept of biohierarchy illustrates how inequalities in health and standards of living in India and in Japan underpin the methods by which researchers, medical professionals, managers and patients collaborate in bionetworks. The concept of 'boundary object' here captures the ways in which the meaning of experimental therapy is defined by subjective categories projected onto it by patients and scientists alike. The article is based on fieldwork conducted by both authors during 3 months between September and December 2008 at various locations in India and Japan. Data for this article were collected from a wide range of interviews with stem cell researchers, medical doctors, coordinators, managers and patients, primary and secondary sources gathered at these centres, and through web and archival research.

The large grey area between ‘bona fide’ and ‘rogue’ stem cell interventions — Ethical acceptability and the need to include local variability

“…While the wellbeing of the patient may be central to scientists' concerns, it is clear that there are many other factors that condition their ability to sustain their work successfully, be it in an academic department, a company or a clinic. Central to value realisation in the life sciences is the way in which exchanges are positioned in strategic networks shaped through socioeconomic, political-legal and cultural factors, or, 'bionetworking' (Sleeboom-Faulkner and Patra, 2011), also involving a myriad of nonscientific activities, including networking, lobbying, managing, trading, and collaborating to produce science. These activities encompass interactions with a wide variety of stakeholders and institutions, ranging from political agencies, corporate sponsors and subsidiary companies to patient groups, local hospitals, universities, and the media.…”

“…Some works on the clinical application of stem cells in LMICs have emphasised the importance of analysing regenerative medicine in the context of globalisation, global politics and global governance (Webster, 2013;Zhang, 2012;Bharadwaj, 2013;Chen and Gottweis, 2013;Sleeboom-Faulkner and Patra, 2011;. These and others (Salter et al, 2015) have especially focused on the central role of bioethics in the global hegemony of 'Western' stem cell science, whereby bioethics and stem cell governance have become a pawn in a global race.…”

Standardization as situation-specific achievement: Regulatory diversity and the production of value in intercontinental collaborations in stem cell medicine

“…A third body of work has been concerned with the provision of experimental for-profit interventions with stem cells, outside of the methodological format of the clinical trial. These studies have commented in particular on the situation in China (Song, 2011;Chen and Gottweis, 2013;Rosemann, 2013a) and India (Bharadwaj, 2013;Sleeboom-Faulkner and Patra, 2011).…”

“…The governments of the USA, the European Union and some other countries have now developed legal arrangements for the licensing of stem cell-based medicinal products (Halme and Kessler, 2006;Faulkner, 2012). In many other countries, however, including in population rich countries such as China and India e where unproven for-profit applications with stem cells constitute a huge market e the development of regulatory frameworks is evolving only gradually (Sleeboom-Faulkner and Patra, 2011;Rosemann, 2013a). In China, the experimental clinical use of stem cells remained completely unregulated until January 2012, with the result that highly dissimilar types of clinical research and experimental for-profit applications have surfaced since the early 2000s (Chen, 2009;Song, 2011;Rosemann, 2013a).…”

Badnam Science? The Spectre of the ‘Bad’ Name and the Politics of Stem Cell Science in India

“…15 Within academic debates-most notably, social science commentaries-the key concerns have centred around issues of governance vacuum, potential for harm, patient recruitment and patient exploitation, reputational risks, and therapeutic ambivalence (Patra and Sleeboom-Faulkner 2009;Salter 2008;Sleeboom-Faulkner & Patra 2011, Prasad 2015. The protagonists, mainly clinicians and scientists, are portrayed as breathing easily in a governance vacuum or as manipulating a range of uncertainties in pursuit of reputation enhancement (Salter 2008;Sleeboom-Faulkner & Patra 2008).…”