Margaret Sleeboom-Faulkner

Marketing of unproven stem cell–based interventions: A call to action

Commercial promotion of unsupported therapeutic uses of stem cells is a global problem that should be addressed by coordinated approaches at the national and international levels. Commercial promotion of unsupported therapeutic uses of stem cells is a global problem that has proven resistant to regulatory efforts. Here, we suggest a coordinated approach at the national and international levels focused on engagement, harmonization, and enforcement to reduce the risks associated with direct-to-consumer marketing of unproven stem cell treatments.

Bionetworking: experimental stem cell therapy and patient recruitment in India

Over the last three to four years, an increasing number of private and public sector tertiary level hospitals and research centres in India have been using stem cell therapy, especially adult stem cell therapy, in the guise of experimental therapy for a variety of medical conditions. The promotion and growth of this experimental field across local and national borders traverses regulatory, ethical, social and financial boundaries. In this complex context, the article examines how healthcare centres in India negotiate bio-medical and health care circumstances in promoting a therapy that raises questionable medical, technical and ethical issues. The process of promoting experimental stem cell therapy is explained here by employing the concept of bionetworking and illustrated by two case studies of hospital groups. The case studies show how through bionetworking a centre creates and maintains novel networks of mutual exchanges with other collaborative bodies situated in local, national and global relations of inequality. Drawing on a three-month period of fieldwork and interviews in various locations in India, this article shows that: (1) Questionable stem cell therapy is promoted through bionetworks that resonate across local, national and global constellations; (2) Regulatory gaps facilitate the growth of such therapeutic practices; (3) The experimental stem cell therapies augment the healthcare divide in Indian society; (4) The weakening Indian state facilitates commercialisation of health, indirectly supporting the ‘bionetworking’ practices of therapy providers.

Tensions between Medical Professionals and Patients in Mainland China

In China, state investment into public hospitals has radically decreased since the early 1980s and has brought on the dismantling of the healthcare system in most parts of the country, especially in rural areas. As a result of this overhaul, the majority of public hospitals have needed to compete in the so-called socialist market economy. The market economy stimulated public hospitals to modernize, take on highly qualified medical professionals, and dispense new therapies and drugs. At same time, liberalization has clearly affected the attitude and behavior of both medical professionals and the general public. The public has many concerns about the healthcare system for various reasons: there are long hospital waiting lists, patients experience difficulties in obtaining an appointment to see a qualified doctor, and, over the past decades, there has been an increase in out-of-pocket healthcare expenditure. These and other changes in post-reform China have radically reshaped the doctor–patient interaction, which is increasingly eroded by tension and violence.

Experimental Stem Cell Therapy: Biohierarchies and Bionetworking in Japan and India

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.

Debates on human embryonic stem cell research in Japan: minority voices and their political amplifiers

Abstract Compared to debates in the West, the debate on human embryonic stem cell research (hESR) in Japan is said to be hardly existent. According to established views, the country has no cultural canons that forbid hESR, so a debate on the status of the embryo is hardly relevant to Japanese culture. The existing debate is considered crucial to science policy-makers, though monopolized by the voices of only a few social groups. Three such minority voices are: the Anti-Eugenic Network, a feminist-cum-handicapped movement; the Japanese Association for Spinal Cord Injuries; and a few radical Buddhist sects. These three groups clearly support or oppose hESR. Nevertheless the public debate is carried mainly by political interest groups that amplify and mis-quote the minority voices. These interest groups capitalize on the hopes placed on hESR in promoting financial and political support, at the same time as they aim to cure disease. The past experiences of the three social groups with Japanese politics on health are linked to promises, risk perception and doubts about the future of hESR.

The Bioethical Vacuum: national policies on human embryonic stem cell research in India and China

Developing countries have sought to profit from the bioethical vacuum that has come about when President Bush in 2001 called for a moratorium on federal funding of human embryo stem cell research (hESR). Seizing the opportunity, both China and India started to invest proportionally many available resources in advanced technology and hESR, in the hope to achieve economic success. We argue that for the following reasons this field is hazardous especially for large developing countries: a.Capital resources are relatively important to poorer countries; b.Lucrative applications are not guaranteed: losses are harder to compensate in countries with little surplus; c.The benefits of possible profits may not go to the needy; d.It may be harder for China and India to advance in these advanced fields because of their institutional history in the field of science and technology; e.Even if applications are successful, there is a chance of developing countries becoming so-called techno-coolies: supplying standard advanced technologies, using human resources that are rare elsewhere in the world; f.A rush to grab the emerging opportunity obtained as a result of the bioethical vacuum may lead to overlooking appropriate monitoring and regulatory measures, hampering the formation of long term international collaborations and public trust. Secondly, we discuss government policies on the institutional aspects of hESR that have made China relatively attractive to foreign investors compared to India. In the concluding part, we discuss various dimensions of bioethics with regards to hESR, and how governing bodies mobilise cultural resources as economic capital.

New regulation for clinical stem cell research in China: expected impact and challenges for implementation

On August 22, 2015 the Chinese National Health and Family Planning Commission (NHFPC, the former Ministry of Health, MOH) have issued the long awaited “draft” regulation on clinical research and applications that involve human stem cells [1] [2] [3]. In China, regulation usually starts out as a draft (草案) or trial regulation (试行). A draft regulation should be regarded as valid as formal regulation, but it is flexible enough to leave space for change. The document announces the central elements of a regulatory foundation for the clinical translation of stem cell-based medicinal products and procedures. What does China’s future regulation for clinical stem cell trials look like? What challenges can be expected with regard to its implementation? And what impacts will the regulation have for domestic researchers, clinics and corporations in China and at an international level?

Genetic testing, governance, and the family in the People's Republic of China

In western countries the rise of genetic testing has been accompanied by ethical arrangements like autonomy and informed consent that help to dissociate genetics from eugenic policies. However, critics have argued that this trend to increase individual choice should be considered as a neoliberal governance strategy to promote bio-citizenship. These western concepts are often used to discuss genetic testing in the Peoples Republic of China as well. Chinas population policy has a reputation for condoning eugenic practices and for ruthless one-child and family planning policies, but there have been many reforms recently, which, together with the revival and development of traditional religions and beliefs, have complicated the discussion about the meaning of the Chinese family. In this context, the introduction of genetic testing in China has been linked to state eugenics as well as post-reform neo-liberalist governance. Based on fieldwork and various archival and literature studies it explores genetic testing in five different Chinese contexts. The analysis makes clear that, although population planning in China proceeds from the idea that the planning of family health leads to a healthier population, traditional beliefs, individual initiative, group pressure, commercial organisations and state policies make for an amalgam of genetic testing practices that cannot be understood in terms of eugenics or liberal governance.

Recruiter-patients as ambiguous symbols of health: bionetworking and stem cell therapy in India

Healthcare service providing centers in India offer contentious stem cell-based therapies to patients for an array of medical conditions. Among strategies these centers adopt to recruit new patients from local, regional and global spheres, the most prominent is the use of “recruiter-patients.” Recruiter-patients are a group of patients who either have already received or are in the process of receiving the therapy and, importantly, are used by service providers as mediums or tools to attract desperate yet novice therapy seeking patients to the ambit of the stem cell therapy enterprise. This article is based on a multi-sited ethnographic study at stem cell-based therapy providing centers in different parts of India between July 2008 and June 2009. Using the concepts of “bionetworking” and “ambiguous symbols,” this article explores how recruiter-patients are used by service providers as tools for the recruitment of new patients and why they are effective.

Governance of stem cell research: public participation and decision-making in China, Japan, South Korea and Taiwan.

This article compares and explores forms of ‘public’ participation in the development of bioethical governance of human embryonic stem cell research (hESR) in four Asian societies, and in doing so it contributes to the wider discussions on expertise and public inclusion. The article aims to add nuance to the concept of ‘public consultation’ by focusing on the contested meanings and relationships through which public roles and public debates are defined. The analysis seeks to go beyond a straightforward comparison by interpreting public discussions of hESR as being influenced by both local conditions and interconnected global science institutions. An adequate understanding of the public participation in debates on science requires the analysis of (a) particular reasons for scientific issues to require public discussion; (b) pressures of transnational forces; (c) variability of publics relevant to bioethical regulation; and, (d) the effects of institutionalization of bioethics. This study uses data from fieldwork conducted between 2006 and 2010 in four Asian countries. Most of the interviews were conducted in the local languages and concerned various kinds of public participation in bioethics activities, as well as the views of stem cell scientists on the need to involve the public in discussions on the acceptability of their research.