From the margins to mainstream: How providers of autologous 'stem cell treatments' legitimise their practice in Australia.

This article examines how Australian providers of unproven autologous 'stem cell treatments' legitimise these products and their practices. We focus on the strategies employed by providers in their efforts to create and sustain a market for procedures that have yet to be proven safe and clinically efficacious. Drawing on the work of Thomas Gieryn and Pierre Bourdieu and the findings of research involving an analysis of direct-to-consumer online advertising of clinics that sell purported 'stem cell treatments' and interviews with clinicians who provide them, we examine the mechanisms by which medical legitimacy for these products is established and defended. We argue that Australian providers employ a number of strategies in order to create medical legitimacy for the use and sale of scientifically unproven therapies. A key strategy employed by providers of stem cell treatments is to use markers of social distinction, drawing strongly on the symbols of science, to confirm their legitimacy and differentiate their own practices from those of other providers, who are posited as operating outside the boundary of accepted practice and hence illegitimate. We argue there is a paradox at the heart of the autologous stem cell treatment market. Providers aim to create legitimacy for their work by emphasising the potential benefits of their 'treatments', their expertise and the professionalisation of their practices in an environment where regulators are yet to take a firm stance; they are also required to undertake the challenging task of managing patients' hopes and expectations that both enable and potentially jeopardise their operations and revenue. We conclude by suggesting that providers' creation of symbolic capital to establish medical legitimacy is a crucial means by which they seek to bring unproven 'stem cell treatments' from the margins of medicine into the mainstream and to portray themselves as medical pioneers rather than medical cowboys who exploit vulnerable patients.

Australian regulation of autologous human cell and tissue products: implications for commercial stem cell clinics.

In 2018, Australia's Therapeutic Goods Administration introduced regulatory reforms that set stricter criteria around the regulation of products derived from a patient's own cells and tissues, posing significant implications for clinics offering stem cell treatments. We review the regulatory framework and discuss its potential commercial implications, including the ambiguities that may arise from it in practice, as well as the likely impact it will have on product development and advertising practices in the future.

The direct-to-consumer market for stem cell-based interventions in Australia: exploring the experiences of patients.

The prevalence of businesses selling autologous stem cell-based interventions to patients in Australia has raised serious concerns about how weaknesses in regulation have enabled the emergence of an industry that engages in aggressive marketing of unproven treatments to patients. Little is known about how patients experience this marketing and their subsequent interactions with practitioners. This paper reports results from 15 semistructured interviews with patients and carers, and also draws upon discussion conducted with patients, carers and family members (22 participants) in a workshop setting. We explore how Australian patients and carers understand and experience these interventions, and how their presumptions about the ethics of medical practice, and the regulatory environment in Australia have conditioned their preparedness to undergo unproven treatments.

Navigating the cartographies of trust: how patients and carers establish the credibility of online treatment claims.

Digital media offer citizens novel ways of 'enacting' health and illness, and treatment and care. However, while digital media may so 'empower' citizens, those searching for credible information will be confronted with various, often-conflicting claims that may have 'disempowering' effects. This article uses Gieryn's concept of the 'cultural cartography' to explore the criteria that patients and carers employ in establishing the credibility of information on alleged treatments. Drawing on data from interviews with Australian patients and carers who have travelled or considered travelling abroad for unproven commercial stem cell treatments, the article examines how individuals assess rival sources of epistemic authority - science-based and non-science-based - as they search for credible information. As we argue, in a context where conventional treatment options are perceived to be limited or non-existent - which is likely to be the case with those suffering severe, life-limiting conditions - and the credibility of sources uncertain, matters of opinion and belief are prone to being interpreted as matters of fact, with potentially far-reaching implications for citizens' health. Revealing the mechanisms by which individuals ascribe credibility to health information, we conclude, has become crucial as digital media assume a growing role in health and healthcare and governments encourage citizens to become 'digitally literate'.

Citizens' use of digital media to connect with health care: Socio-ethical and regulatory implications.

Digital technologies promise to transform practices of health, medicine and health care and 'power' economies. In expectation of their presumed future benefits, governments in recent years have invested heavily in new technology initiatives and have sought to engender 'digital literacy' among citizens. This article introduces papers and expands on themes arising from a special issue that explores the socio-ethical and regulatory implications of citizens' use of digital media to connect with health care. We set the scene by examining the promissory discourse that attaches to digital technologies as applied to health care, and its role in shaping actions, and then consider the longer term prospects and implications of digitalisation for conceptions of citizenship and established categories and distinctions. As we argue, given the history of new technologies, the longer term implications of digitalisation are likely to differ significantly from those envisaged. Digital technologies promise radical positive disruption. Yet many uncertainties accompany their development and future applications and likely implications. Making reference to papers in the special issue and the wider literature, the article considers the prospects of digitalisation in medicine and health care in light of the colonisation of the Internet by powerful technology companies, the shift in capitalist economies from processes of production to technologies of prediction, evidence of inequalities in access to the Internet and related devices, and the growing number of data breaches involving personal health information. We draw attention to the failure of governments to engage citizens in substantive deliberations about digitalisation and its future potential implications and the ultimate democratic deficit that this represents. We ask, what does it mean to 'regulate' digital media in a context in which data are widely viewed as the 'new oil'? While we have no straightforward answers, we suggest that recent legislative efforts (e.g. General Data Protection Regulation in Europe) and growing calls for 'algorithmic accountability' have the potential to temper the more harmful aspects of digitalisation.

The politics of evidence in online illness narratives: An analysis of crowdfunding for purported stem cell treatments.

This article addresses the growing trend of crowdfunding for unproven stem cell-based treatments. Our analysis uses quantitative and qualitative data collected from two popular fundraising sites to examine how these sites are used to fund purported stem cell 'treatments' or 'therapies'. In addition to mapping the use and success of these online campaigns by people with different health conditions in different locations, we consider the breakthrough restitution story as a key narrative that campaign organisers use to solicit donations. We argue that crowdfunding is a rapidly growing digital space where 'truths' about experimental treatments are constituted and a politics of evidence is unfolding. These developments are to the potential financial benefit of crowdfunding platforms and businesses offering unproven stem cell-based interventions, and to the potential detriment of patients and their supporters.

The European General Data Protection Regulation: challenges and considerations for iPSC researchers and biobanks.

Increasingly, human induced pluripotent stem cells (iPSC) and their associated genetic and clinical information are being used in a wide range of applications, with large biobanks being established to support and increase their scientific use. The new European General Data Protection Regulations, which comes into effect in 2018, will have implications for biobanks that generate, store and allow research access to iPSC. This paper describes some of the challenges that iPSC biobanks face and suggests some points for the development of appropriate governance structures to address these new requirements. These suggestions also have implications for iPSC research in general.

The deadly business of an unregulated global stem cell industry.

In 2016, the Office of the State Coroner of New South Wales released its report into the death of an Australian woman, Sheila Drysdale, who had died from complications of an autologous stem cell procedure at a Sydney clinic. In this report, we argue that Mrs Drysdale's death was avoidable, and it was the result of a pernicious global problem of an industry exploiting regulatory systems to sell unproven and unjustified interventions with stem cells.

Between hope and evidence: how community advisors demarcate the boundary between legitimate and illegitimate stem cell treatments.

Stem cell science provides an exemplary study of the 'management of hope'. On the one hand, raising 'hopes' and expectations is a seen as a necessary aspect of securing investment in promising innovative research. On the other, such hyperbole risks raising hopes to a level that may lead people to undertake undue risks, which may ultimately undermine confidence in medical research. In this context, the 'management of hope' thus involves the negotiation of competing claims of truth about the value and safety of particular treatments and about the trustworthiness of providers. Using Gieryn's concept of boundary-work, this article examines the means by which this work of 'managing hope' is undertaken. Drawing on data collected as part of our study that investigated the perspectives of those who are consulted by patients and their carers about stem cell treatments, we explore how these community advisors ­ both scientists and clinicians with a stake in stem cell research and representatives from patient advocacy groups ­ demarcate the boundary between legitimate and illegitimate treatments. In particular, we examine how these actors rhetorically use 'evidence' to achieve this demarcation. We argue that analysing accounts of how advisors respond to patient enquiries about stem cell treatments offers a window for examining the workings of the politics of hope within contemporary bioscience and biomedicine. In conclusion, we emphasize the need to re-conceptualize the boundary between science and non-science so as to allow a better appreciation of the realities of health care in the age of medical travel.

A question of ethics: selling autologous stem cell therapies flaunts professional standards.

The idea that the body's own stem cells could act as a repair kit for many conditions, including cardiac repair, underpins regenerative medicine. While progress is being made, with hundreds of clinical trials underway to evaluate possible autologous cell-based therapies, some patients and physicians are not prepared to wait and are pursuing treatments without evidence that the proposed treatments are effective, or even safe. This article explores the inherent tension between patients, practitioners and the need to regulate the development and commercialization of new cellular therapies--even when the cells come from the patient.