Saheli Datta

Hegemony in the marketplace of biomedical innovation: Consumer demand and stem cell science

The global political economy of stem cell therapies is characterised by an established biomedical hegemony of expertise, governance and values in collision with an increasingly informed health consumer demand able to define and pursue its own interest. How does the hegemony then deal with the challenge from the consumer market and what does this tell us about its modus operandi? In developing a theoretical framework to answer these questions, the paper begins with an analysis of the nature of the hegemony of biomedical innovation in general, its close relationship with the research funding market, the current political modes of consumer incorporation, and the ideological role performed by bioethics as legitimating agency. Secondly, taking the case of stem cell innovation, it explores the hegemonic challenge posed by consumer demand working through the global practice based market of medical innovation, the response of the national and international institutions of science and their reassertion of the values of the orthodox model, and the supporting contribution of bioethics. Finally, the paper addresses the tensions within the hegemonic model of stem cell innovation between the key roles and values of scientist and clinician, the exacerbation of these tensions by the increasingly visible demands of health consumers, and the emergence of political compromise.

Bioinformatics and the Politics of Innovation in the Life Sciences: Science and the State in the United Kingdom, China, and India

The governments of China, India, and the United Kingdom are unanimous in their belief that bioinformatics should supply the link between basic life sciences research and its translation into health benefits for the population and the economy. Yet at the same time, as ambitious states vying for position in the future global bioeconomy they differ considerably in the strategies adopted in pursuit of this goal. At the heart of these differences lies the interaction between epistemic change within the scientific community itself and the apparatus of the state. Drawing on desk-based research and thirty-two interviews with scientists and policy makers in the three countries, this article analyzes the politics that shape this interaction. From this analysis emerges an understanding of the variable capacities of different kinds of states and political systems to work with science in harnessing the potential of new epistemic territories in global life sciences innovation.

Governing new global health-care markets: the case of stem cell treatments

ABSTRACT Stem cell innovation has enabled the growth of a global market of treatments for a wide range of diseases but most of this market operates outside the domain of orthodox forms of innovation governance. Much of the analysis of this issue has adopted a supply side perspective informed by the values of the orthodox scientific model of biomedical innovation, arguing that national and transnational regulation has failed to impose appropriate standards on the ‘illicit’ supply of stem cell treatments. In contrast, this paper shows how and why the analysis of global stem cell innovation governance must incorporate the market and health consumer demand into the conceptual framework. Central to the argument is the role of innovation models in mediating the relationship between demand and supply in the global market of new stem cell treatments. Different models of scientific and medical innovation mediate that relationship in different ways and, in jurisdictions where health consumer demand is frustrated, may result in parallel political demands for change in stem cell innovation governance. Such demands are likely to be resisted by the dominant scientific model, producing a further response from health consumers and a continuing dynamic in the political economy of stem cell treatments.

Making Choices: Health Consumers, Regulation and the Global Stem Cell Therapy Market

Existing modes of regulation in stem cell therapy innovation offer little recognition of the role of health consumer choice in the governance of this emerging global market. Instead, there is a strong and familiar emphasis on the roles of scientists, clinicians and bioethicists in determining what regulation should be provided, when and by whom. For the most part, it is assumed that health consumers (patients) should be protected from themselves through regulation that renders consumer choice redundant because the apparatus of the state or professions has ensured on their behalf that available treatments are safe and efficacious. Their best interests are served, it is maintained, by their continuing faith in their regulatory guardians. This article argues that such an approach to regulation is outmoded and inefficient because it fails to address the governance needs of motivated, mobile consumers in the global stem cell therapy market. Such consumers require a balance between information that facilitates their ability to make rational choices and the confidence that provider regulation is fit for their purpose. The orthodox approach to governance works so long as the authority of science, medicine and, to a lesser extent, bioethics is able to control the operation of the health care market by convincing consumers that their choices of treatments should be what science, medicine and bioethics say they should be. The logic of this interpretation of the market is that consumer demand for stem cell therapies should adjust to the available supply generated by the orthodox scientific model of stem cell innovation charac-terised by the sequence of basic research, clinical experimentation, product development, clinical trials, product approval and clinical application, regardless of the timescale involved. In the case of stem cell therapies, this approach to market governance has clearly failed. The rapid and continuing expansion of a global market of innovative treatments measured in terms of hundreds of clinics treating thousands of patients has occurred independently of the very small stem cell therapy market supplied by the outputs of the orthodox model [1]. Alternative, practice-based models of stem cell innovation have emerged that respond to consumer demand much more readily than the orthodox model. This poses demand-side governance challenges which need to be recognised and addressed. To an extent, recognition of the governance challenge is hampered by the analysis of the latter market offered by proponents of the orthodox model. Essentially a normative approach, this analysis suggests that innovative …

Emerging dynamics of evidence and trust in online user-to-user engagement: the case of ‘unproven’ stem cell therapies

Abstract This article explores the ways in which patients and their families (hereafter referred as ‘users’) share and evaluate disease-specific evidence via online communities. The aim is to understand what this user engagement in healthcare and knowledge production reveals about society’s shifting perceptions of trust in the institutions of ‘evidence-based medicine’ (EBM) such as regulators, bioethicists and scientists and the implications for EBM. To do this, I use the case of experimental stem cell therapies (eSCTs). ESCTs are commonly labelled in academic literature as ‘unproven’, a label that frames their lack of conclusive clinical evidence as unsafe, inefficacious and thus unethical when clinically used. Despite this framing, users engage with other users to share and evaluate all available evidence for themselves, including on-going clinical trial and experiential evidence to build trust for and undertake eSCTs. Increasingly, this user engagement with evidence takes place in online communities that range from user-created and user-run Facebook pages to user-to-user discussion forums on healthcare provider sites or blogs with little if any provider-input in conversations. In this paper, I draw on a sample of these user conversations to show the complex and unpredictable ways in which what counts as evidence and how trust is built for it are shifting. In so doing, I reflect on the shifting relations between the institutions of EBM and society for greater control over evidence that lies at the heart of the evidentiary basis of public health policies.

An endogenous explanation of growth: direct-to-consumer stem cell therapies in PR China, India and the USA

The recent expansion of direct-to-consumer stem cell therapies (DSCTs) across nations where medical malpractice laws are the strongest globally challenges the causal assumption that low regulatory standards in developing countries bolster DSCTs. Drawing on firm-level data of existing biopharmaceuticals, approved stem cell therapies (SCTs) and DSCT clinics across the USA, PR China and India, this paper provides an innovation studies perspective of the ways in which the paradigmatic shift in fundamental knowledge production - from in vitro to in vivo stem cells - is transforming SCT discovery and delivery. It argues that the endogenous and inherent disruptive attributes of SCTs, rather than exogenous conditions like regulations, provide a substantive explanation for the recent expansion of DSCTs and urges regulatory adaptation to endogenous imperatives for effective governance of SCTs.