Biogovernance Beyond the State: The Shaping of Stem Cell Therapy by Patient Organizations in India

ABSTRACT

Public engagement through government-sponsored “public consultations” in biomedical innovation, specifically stem cell research and therapy, has been relatively limited in India. However, patient groups are drawing upon collaborations with medical practitioners to gain leverage in promoting biomedical research and the conditions under which patients can access experimental treatments. Based on qualitative fieldwork conducted between 2012 and 2015, I examine the ways in which two patient groups engaged with debates around how experimental stem cell therapy should be regulated, given the current lack of legally binding research guidelines. Such processes of engagement can be seen as an alternative form of biomedical governance which responds to the priorities and exigencies of Indian patients, contrasting with the current measures taken by the Indian state which, instead, are primarily directed at the global scientific and corporate world.

KEYWORDS:

• Activism
• biomedicine
• governance
• patient organizations
• stem cells

Acknowledgments

I thank the many respondents who took part in the research, in particular the members of the two patient organizations on which I focus. Earlier drafts were presented at the 2014 University of Sussex Centre for Bionetworking Biannual meeting, the Science and Democracy Network Meeting held at Harvard University, L’École Normale Supérieure de Lyon, the Indian Institute for Technology in Hyderabad and the French Institute of Pondicherry, and I am grateful for the comments and feedback which proved very useful in refining the final article.

Thank you also to the anonymous reviewers for their careful reading of the text and thoughtful feedback as well as Stuart Blume, Jyotsna Gupta and my colleagues in the Centre for Bionetworking, University of Sussex. Due to ethical concerns, supporting data cannot be made openly available.

Funding

The research for this article was funded by the Economic and Social Research Council (ES/I018107/1) and the European Research Council (283219).

Notes

1. A study conducted by the Stem Cell Network of the Health Law Institute in the University of Alberta around direct-to-consumer marketing of experimental stem cell therapy by clinics in different countries found that the average price for treatment came to CAN $21,500, excluding travel and accommodation for patients and their caretakers (Lau et al. 2008:594). My interviews with patients who had researched or undergone stem cell therapy suggest that more established stem cell therapy providers in India can charge similarly high fees, depending on the condition being treated and the financial capacity of the family and her family. While stem cell treatment for terminal conditions such as muscular dystrophy and spinal cord injury could cost around Rs 8 lakhs (US $12,000), cosmetic procedures (e.g., using adipose stem cells for breast augmentation) would cost around Rs 2 lakhs (US $3000).

2. This is often referred to as ‘direct citizen action’ (Khanna et al., 2013).

3. In this, I use the term ‘biogovernance’ to refer to the regulation of the life sciences and biomedical sector, whether by the state or non-state actors. Within the specific context of stem cell sector, regulatory activities include ensuring that scientific, ethical, and safety standards are adhered to by practitioners and that treatment is administered in a transparent and accountable way.

4. Media sources included English language national newspapers such as The Hindu, Times of India, Hindustan Times and Indian Express. In addition, regional papers for areas with large biotech sectors and/or policy relevance such as Mumbai, Bangalore and Delhi were included. I also included press releases for new industry reports on the stem cell sector and official policy documents (search terms included “stem cell therapy,” “stem cell research,” “India,” “Mumbai,” “Bangalore,” “Chennai,” “regulation,” “Indian Council for Medical Research (ICMR),” “Department of Biotechnology”). Lastly, the specific websites for commercial stem cell providers and biotech companies, research institutes conducting stem cell research, patient organizations, and patient list serves (in particular for conditions in which stem cell therapy is in demand, such as muscular dystrophy and spinal cord injury) were included in the documentation review.

5. For example, the All India Institute for Medical Sciences (AIIMS) in New Delhi, the National Centre for Cell Science in Pune, Indian Institute of Science and the Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR) in Bangalore and the National Institute for Research in Reproductive Health (NIRRH), Mumbai.

6. These were subsequently published in 2007 as the National Guidelines on Stem Cell Research and Therapy.

7. As Tiwari and Raman (2014: 421) note, both the ICMR and the DBT are funding agencies rather than regulatory bodies and do not technically have a legislative remit over medical research. A spokesperson for the Drugs Controller General of India (DCGI), which does have a mandate to regulate clinical trials, stated that they, however, did not have the necessary expertise in stem cell proposals.

8. See ICMR website: http://www.icmr.nic.in/icmrnews/NAC.htm

9. As Patra and Sleeboom-Faulkner (2009) have documented, in some cases, individuals posing as patients will approach potential clients considering stem cell therapy in order to recruit them for treatment in a specific clinic.

10. Interview with Dr P, a gynecologist in a “boutique maternity hospital” in Bangalore (November 19, 2012) and A, a marketing representative for a large umbilical cord banking company with branches across India (October 9, 2012).

11. The term “parent organization” here is used to refer to a patient organization which is comprised predominantly of parents of children living with muscular dystrophy, rather than the patients themselves, who because of the early onset of the condition, are children or youth.

12. More recently, the organization decided to temporarily suspend the collaboration after Dr Manish decided to terminate the research on muscular dystrophy in order to concentrate exclusively on using stem cells for skin grafting purposes. Senthil has in the interim applied for permission from the Indian Council for Medical Research to continue the clinical research and plans to continue working with the stem cell scientist who had previously worked with Dr Manish. At the time of the writing, the organization had finally concluded an exhaustive search for an affordable and reliable company from which to source stem cells and had set up a partnership with a local hospital to administer treatment once official permission is granted.

13. Excerpt from “Stem cell therapy: The cautionary paradigm,” written by Naresh.

Additional information

Funding

The research for this article was funded by the Economic and Social Research Council (ES/I018107/1) and the European Research Council (283219).

Notes on contributors

Carolyn Heitmeyer

Carolyn Heitmeyer is a research associate in the Department of Anthropology at the University of Sussex. She has conducted extensive research around health citizenship in India with a specific focus on patient and health activism, new medical technologies, stem cell research and therapy, and reproductive and maternal health.