Regulating biomedical lives

As a range of scholars have shown, economic value relates closely to how any new tool, technology or drug is apprehended by law, constituted through legal processes and regulated on the market.15 Questions of law and regulation, then, are central to innovation processes, both during development and after the finished products are released. Recent work at the interface of regulatory studies and STS has illustrated how particular modes of governance are part of the societal context that can be built into technologies, helping to shape their design and mode(s) of delivery.16–18 Sheila Jasanoff, for example, uses cross-cultural case study methods to demonstrate how political cultures affect the way societies assess evidence, evaluate risk and engage with publics around innovations in science and technology.19 Such perspectives could contribute considerably to understanding the differences regarding how policy issues around enhancements are framed, as well as what—and whose—values become embedded in the institutions governing their use.

Social histories of technologies are also often omitted from studies of ‘enhancements’, but can be key to understanding the interpretation of certain technologies. For example, the burgeoning science of optogenetics uses optics and gene modification techniques to control the activity of specific cells.ⁱⁱ In addition to the promise of modulating cell function in neurological disorders, scientists suggest they can alter addictions, depression and mood disorders and other behavioural and psychosocial conditions. Previous controversies over gene therapy and psychosurgery will surely colour how such emerging techniques will be viewed from both regulatory and ethical perspectives.20 ,21 Additionally, popular culture, including science fiction themes of mind control, have been known to affect legal frameworks in which such brain interventions would be viewed for therapeutic purposes, much less enhanced function. There has already been considerable scholarly interest in the interactions of law and neuroscience, particularly in light of questions of altered autonomy, identity, personal responsibility and liability with the use of brain stimulation techniques.22–24 Accordingly, it will be fruitful to examine how legal processes shape the production and deployment of tools and substances that are understood to enhance human bodies and cognition. This is in terms of how actual regulation directs innovation, and if and how imaginaries of future governance inform the development and marketing of objects framed as enhancements. Court cases where these figure would likewise be important to examine, in terms of how object ontologies (eg, purported nature of particular drugs and devices, and hence, the ‘appropriate’ uses to which they are put) and subjective properties (eg, authenticity, personhood, etc.) are co-produced. It is also important to attend to the ways that such innovations are situated within so-called knowledge-intensive societies, with their emphasis on performance, productivity, competition and connectivity. Markets are likely to help shape legal and regulatory environments as much as the technologies themselves.

Documenting how ‘enhancements’ are dealt with in clinical practice especially—including who is empowered to control access to them, and why—will be a key empirical task for those in the medical humanities and social sciences. Not enough is known about how physicians represent to patients (and themselves consider) the benefits, risks and harms of potentially enhancing products and treatments, nor how ‘legitimate’ use is configured.25 Further to reflecting on the philosophical or policy implications of how products might be classified as therapeutic or enhancing, scholars might ask: what comes to count in how health professionals (not solely medical practitioners) decide whether the use of one particular drug or technology counts as ‘therapy’ or as ‘enhancement’? For instance, do physicians consider the moral or legal implications of prescribing attention deficit-hyperactivity disorder (ADHD) drugs for off-label purposes, including enhancing cognition? To what extent are they aware of how patients may be using such prescribed drugs, including selling them to others?26 The literature on ethical decision-making in clinical practice will afford benefit to empirical analysis of such questions, which will in turn enrich scholarship around ethics-in-practice.27 ,28

Ethnographic and conversation analytic work might usefully examine the physician–patient dance involved in representing a subjective state as a legitimate target of optimisation, not least to cast further light on the cultural logics shaping discourses of legitimacy today.29 In cases where physicians may be reluctant to prescribe ‘enhancements’ to individuals who ask for them, where do individuals who wish to consume these then turn? Research exploring such issues may have much to offer sociolegal studies in terms of understanding how grey markets are formed and negotiated by a range of individuals. Further, interviews and other methodological strategies might be employed to examine how users construct the benefits, risks and harms of substances and tools used to enhance human bodies (in particular, where access is achieved beyond the clinic, such as via the internet). Users may employ these notions in ways that are quite distinct from those featuring within biomedical and bioethical discourses, and the regulatory regimes that are in part constituted through these (as we will show below—drawing on a range of work—for the case of cognitive enhancement).8 For example, comparative work between prescription and non-prescription ‘enhancements’ (such as the use of nicotine replacement patches as stimulants) regarding publics’ constructions of risk would be both timely and have import for scholarly interrogations of the production of risk, harm and safety in other (non-)medical domains. Since public engagement plays an important role in in shaping policy approaches to new and emerging technologies, consideration will be required of how this is leveraged as a regulatory device to either promote or curtail the use of supposed enhancements.30

Relatedly, more critical work might document the establishment of new professional networks (both formal and informal) of scientists and ethicists (such as the International Neuroethics Society), and the ways in which calls for regulation and ethical oversight can function as a means of rendering particular sociotechnical pathways legitimate.31 The legitimating function of bioethics has been analysed for ‘therapies’ rather than ‘enhancements’ (eg, using the case of pharmacogenetics), but any impact of (inter)national ethics bodies—if it exists—on the consumption of products that can be used to enhance bodily or cognitive function has not been formally examined.32 Further, we might also explore the degree to which the act of calling out issues of bioethical or regulatory concern can be employed as a vehicle for establishing organisational authority and legitimacy. In particular, under the Bush administration in the USA, the President's Council on Bioethics garnered considerable attention through bioethical agenda-setting and what some regard as overcautionary reports, including on enhancement.33 Both historical and ethnographic research could reveal how and to what extent ethical claims-making and organisational legitimacy relate to each other. Such scholarship could engage productively with feminist bioethics; this has cast a critical eye upon issues of authority and legitimacy, and renders problematic the universal subject that is often assumed by official ethics bodies. Rhetorical analyses of formal reports, documents and position papers deployed by such organisations will also illuminate embedded political rationalities (E Barr. The President's Council on Bioethics’ ‘Happy Souls’: discipline, citizenship and true selves, unpublished manuscript, 2014).

Diverse bodies

Above we noted some of the diverse kinds of empirical attention that could be paid to the development, production and marketing of technologies and pharmaceuticals characterised in various spheres as enhancements. Cutting across this must also be an analytic sensitivity to the ways through which the intertwined issues of gender, ethnicity, sexuality, sociodemographic status and other markers of identity are implicated in practices of innovation and consumption.34 How are particular ideas of gender, for instance, embedded within enhancements, and how are new drugs and technologies gendered within media and marketing portrayals (and, indeed, within academic writing)? How do they impact on experienced and ascribed gender? Viagra is perhaps the case per excellence here, and empirical, STS-inflected research on this has cast bright light on its gendered marketing and uptake—but also on sites of resistance, and communities of users (eg, women) who have appropriated this drug and re-inscribed its embedded scripts so as to situate it within new regimes of personal life.35 Likewise, painkillers have been used in Indonesia to enhance libido, and hormonal therapies have been documented as being repurposed by individuals self-identifying as men who seek to feminise their bodies.36 Research in this vein reveals the complex social lives of ‘enhancements’ that exceed anticipatory imaginaries of their uses and actions, and that also enrich medical humanities and social scientific understandings of the relationships between biomedicine and wider society.37

A concern with gender—as well as ethnicity and other somatic markers of identity—connects with themes of embodiment more generally. Debates in this area might stimulate a consideration of any changes to how bodies ‘dys-appear’ (ie, come to subjective attention through pain, disability or impairment), disappear and reappear in societal practices and discourses associated with the drugs and technologies that some deem to enhance human traits and states.38 What aspects of ‘normal’ bodies could come to be regarded as sites of intervention in contexts where diverse forms of customisation are possible? The use of human growth hormone to simultaneously ‘treat’ and ‘enhance’ height is one example where the differences between ‘therapy’ and ‘enhancement’ emerge as complex, contingent and readily reworkable. With a focus on the ‘treatment’ of short boys, such distinctions are also highly gendered.39 Further, the human brain seems often to only become salient in personal discourse through its dys-appearance due to injury or cognitive impairment—yet, in an era of proliferating enhancements, it may increasingly be viewed as a plastic organ operable upon through techniques of ‘objective self-fashioning’ via pharmaceuticals or electroceuticals.40–43

At the same time, ‘dys-appearing’ forms of (especially) neurological difference are increasingly subject to projects of de-stigmatisation (eg, in the case of autism).44 In this light, understandings of techniques that operate upon human difference (be those drugs, devices or psychological interventions) can shift from being conceptualised as part of a therapy-enhancement continuum to being questioned over whether they are unwanted (and perhaps even coercive) tools of normalisation. The use of enhancements therefore represents the opening up of a new set of cases for empirical examination both in terms of how ‘differences’ between humans come to be recognised as such, and of how much difference populations are prepared to accept. Historians, anthropologists, geographers and others are particularly well placed to parse out how the uses of enhancement technologies might recast what bodily properties are taken as valued in particular contexts, by who and to what ends, and how the practices and consequences of valuation interact with actual engagements with enhancing technologies.45 A reinvigoration of research around cosmetic surgery is one starting point for the interrogation of these questions, especially including non-Western spaces and places where empirical ethnographic research might render problematic any assumptions that emerge regarding such practices based on their contemporary uses in Europe and North America.46 In Brazil, for example, the experimental use of testosterone to enhance vigour and verve means that there is no ready place to position this along any kind of linear ‘therapy’/‘enhancement’ continuum.47 Rather, as Alex Edmonds puts it, ‘health and aesthetics become entangled’.48 Cross-cultural empirical research could further illustrate (and perhaps contribute to the destabilisation of) Anglo-American societal norms that assume what counts as ‘therapy’ and what comprises ‘enhancement’ (simultaneously decentring ‘the West’ within bioethical analyses in this area).

Constructing communities and contexts

Thinking about changing cross-cultural experiences and identities also directs our attention to the formation of new social groups orientated around apparent enhancements. Debates around the uses to which objects deemed enhancing might be put have helped to stimulate a range of neologisms (such as ‘bioconservative’ and ‘transhumanist’) that will be of interest to researchers keen to document, explore and understand how these become an idiom through which communities coalesce and expand. There are identity politics at play that are important to attend to: different communities can and could respond to discourses and practices centring on drugs and devices associated with human enhancement in diverse ways that speak to broader (and diverging) conceptions of humanity, sociality and public good.49 Disability studies scholars have begun to unpick some of the wider moral and political dimensions and implications of the imaginaries fuelling the speculation and advocacy of self-identifying ‘transhumanists’ (individuals who propose widespread adoption of a range of radical enhancements), for example. Their concerns regarding new forms of discrimination are suggestive of the need for empirical work with normative bite.50 Further, philosopher Trijsje-Marie Franssen has examined how the myth of Prometheus features within and configures debates around human enhancement and transhumanism (T-M Franssen. Prometheus through the ages: from ancient trickster to future human. University of Exeter: Unpublished doctoral thesis 2014. Available at: https://ore.exeter.ac.uk/repository/bitstream/handle/10871/15889/FranssenT.pdf?sequence=1). Scholarship of this kind provides insight into how images and imaginaries come to be instantiated within the identities of novel communities, and the discussions about medical technologies that these in turn propel.

A further point of departure for empirical work around the broad issue of ‘enhancement’ might be to interrogate how ethical debates and social practices (including but not limited to processes of innovation) mutually shape one another.51 The co-productionist tradition of STS—which foregrounds the dynamism between materiality and sociality—could provide rich conceptual resources for consideration of the reciprocal constitution of objects, moral discourse and social practices.52 Co-productionist studies of enhancement might also attend to how any routine use of enhancements could change their cultural contexts. How, for instance, does the promotion and use of particular technologies—such as drugs to enhance cognition—respond to issues of social concern (eg, educational attainment)? In turn: how, and to what extent, does the embedding of enhancements within societies recast the meanings of the terms by which societal issues are debated? Engagement with such a question necessarily entails an historical, rhetorical and ethnographic analysis of what ‘individual attainment’ is taken to be within specified cultures, and what cultural actors judge to be legitimate means of performing accomplishments. Accordingly, research that takes the practices of and politics around enhancement as a starting point could produce textured and nuanced scholarship that contributes to conceptual and empirical literatures far beyond the case study under primary examination.

Finally, a co-productionist perspective also enjoins us to engage with the emergence of the debate around ‘therapy’ and ‘enhancement’ itself. As indicated above, we argue that these concepts come to find meaning through particular configurations of social conventions, epistemic norms and biomedical tools. Intrinsically normative characterisations, their position in relation to each other is ambiguous and ever-changing, since the terrains of treatment and of enhancement have boundaries that shift according to mutations in the same sociotechnical practices that constitute them.6 ,10 The flexibility of these spaces underscores what we regard as a central problem for medical humanities and social science scholars: how, why and where do particular technologies come to count as ‘enhancing’? Since the categories of ‘therapy’ and ‘enhancement’ are emergent through social praxis, any definitional settlements are of course essentially contingent, yet historical, geographical and anthropological research tracing processes of stabilisation is both timely and important.