Prasanna Kumar Patra

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.

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.

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.

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.

Informed Consent and Benefit Sharing in Genetic Research and Biobanking in India

In this paper an attempt is made to understand common impediments in the application of two bioethical principles – informed consent and benefit sharing – in genetic and biobanking research in field situations in India. These evolving principles are discussed and addressed in contemporary national and international bioethical guidelines that reflect the nature of the population and technological systems that they deal with. Notably, the importance of these two principles is that they aim, on the one hand, to protect research participants from exploitation, harm and injustice and, on the other, to impose legal and ethical obligations upon those individuals and institutions conducting research and/or business enterprises. The major considerations that will be addressed by this paper are: firstly, whether there is a true, valid and ‘informed’ consent procedure that will be practicable, particularly in illiterate, resource-poor and marginalized social settings; and secondly, whether human genetic materials can be considered as resources or property and promoted for benefit sharing arrangements, as has been the case with respect to non-human genetic materials. The study draws on primary information collected in India during December 2006 and May 2007.

Following the banking cycle of umbilical cord blood in India: the disparity between pre-banking persuasion and post-banking utilization

To address critique of the rare uptake of umbilical cord blood (UCB) in private banks, hybrid-banking models would combine the advantages of “public UCB banking” and private UCB banking by responding to both market forces and public needs. We question both by following the cycle of UCB banking in India: the circulation and stagnation of UCB as waste, gift, biological insurance, enclaved good, source of saving lives and commodity through various practices of public, private and hybrid UCB banking. Making the journey from “recruitment,” “collection” and “banking” to “research” and “therapy” allowed us to identify concerns about the transparency of this cycle. Drawing on archival research and fieldwork interviews with different stakeholders in UCB banks in India, this article shows how private/hybrid cord blood banks are competing for their market share and its implication for the circulation of UCB: speculation, stagnation and opacity.

Informed consent in genetic research and biobanking in India: some common impediments

The principle of informed consent, codified in the Declaration of Helsinki, has been widely seen as fundamental to bio-medical and research ethics. The importance of informed consent is increasing in procedures regulating the acquisition, possession and use of personal information, including genetic and medical information. Informed consent, it is believed, ensures that patients and research subjects can decide autonomously whether to permit or refuse actions that affect them. In response to this assurance, there are numerous guidelines at local, national and international levels that recognise the importance of informed consent, especially in research related to healthcare in developing countries. However, complications arise in applying these guidelines to a particular situation, especially under conditions that are prevalent in developing societies, for instance in India. This article discusses common forms of impediments or hindrances encountered while exercising the principles of informed consent in the context of genetic and genomics related research among the tribal and rural caste communities in India. These hindrances include: illiteracy, poverty, paternalistic attitudes, socio-cultural barriers, ineffective regulatory mechanism and procedural inconsistency among others. The data used in this article is based on an ethnographic study conducted between December 2006 and May 2007 using social-science qualitative research techniques. We observe that three areas require attention: first, the ways in which informed public debate on bioethical issues can be held, and how the application of genetics and genomics in Indian society can be discussed; second, the readiness with which researchers, IRB members and the state appreciate and wish to map the genetic diversity in Indian society; and, third, the risks associated with the application of bioethical principles at a micro-level.

Bionetworking and Strategic Linking between India and Japan: How Clinical Stem Cell Intervention Continues despite New Regulatory Guidelines

Based on a case study of a clinical stem cell intervention (CSCI) center in Chennai, India, this article explores distinct entrepreneurial strategies for the promotion of unrecognized clinical stem cell applications in India. It shows that the center—an Indo-Japanese joint-venture—is able to promote the CSCI due to its central position in a network relationship, its possession of specialized skills and knowledge, and its ability to maneuver other actors in the network and to identify and utilize their latent value. We examine the developmental history of the making and remaking of regulation and the shift in the way clinical stem cell application providers function—from institutional embedment to strategic linking through collaborative networks. We ask why and how unauthorized clinical applications are sustained and promoted in India. We conclude that this is possible as a result of a number of factors: jurisdictional ambiguity, institutional inability, issues concerning the legal enforceability of the relevant guidelines, the complexity of the collaborative network structure that facilitates the circumvention of the regulation, and the nonfunctioning of apex-level committees.