How and why to use 'vulnerability': an interdisciplinary analysis of disease risk, indeterminacy and normality.

In recent years, 'vulnerability' has been getting more traction in theoretical, professional and popular spaces as an alternative or complement to the concept of risk. As a group of science and technology studies scholars with different disciplinary orientations yet a shared concern with biomedicine, self and society, we investigate how vulnerability has become a salient and even dominant idiom for discussing disease and disease risk. We argue that this is at least partly due to an inherent indeterminacy in what 'vulnerability' means and does, both within and across different discourses. Through a review of feminist and disability theory, and a discussion of how vulnerability and disease both get recruited into a binary conceptualisation of normal versus abnormal, we argue that vulnerability's indeterminacy is, in fact, its strength, and that it should be used differently than risk. Using COVID-19 management in the UK as an illustration of the current ambivalence and ambiguity in how vulnerability versus risk is applied, we suggest that instead of being codified or quantified, as it has started to be in some biomedical and public health applications, vulnerability and its remedies should be determined in conjunction with affected communities and in ways that are polyvalent, flexible and nuanced. The concept of vulnerability encapsulates an important precept: we must recognise inequality as undesirable while not attempting to 'solve' it in deterministic ways. Rather than becoming fixed into labels, unidirectional causalities or top-down universalising metrics, vulnerability could be used to insist on relational, context-specific understandings of disease and disease risk-in line with contemporary social justice movements that require non-hierarchical and non-universal approaches to problems and solutions.

Remaking critical care: Place, body work and the materialities of care in the COVID intensive care unit.

In this article, we take forward sociological ways of knowing care-in-practice, in particular work in critical care. To do so, we analyse the experiences of staff working in critical care during the first wave of the COVID-19 pandemic in the UK. This moment of exception throws into sharp relief the ways in which work and place were reconfigured during conditions of pandemic surge, and shows how critical care depends at all times on the co-constitution of place, practices and relations. Our analysis draws on sociological and anthropological work on the material culture of health care and its sensory instantiations. Pursuing this through a study of the experiences of 40 staff across four intensive care units (ICUs) in 2020, we provide an empirical and theoretical elaboration of how place, body work and care are mutually co-constitutive. We argue that the ICU does not exist independently of the constant embodied work of care and place-making which iteratively constitute critical care as a total system of relations.

Domesticating models: On the contingency of Covid-19 modelling in UK media and policy.

Our article traces the representation of pandemic modelling in UK print media from the emergence of Covid-19 to the early stages of implementing the first UK-wide lockdown in late March 2020. Covid modelling, it is widely assumed, has shaped policy decisions and public responses to the pandemic in unprecedented ways. We analyse how the UK print media has configured modelling as a significant evidence tool in the representation of the pandemic. Interrogating assumptions about infectious disease modelling, we ask why models became the trusted tool of choice for knowing and responding to the Covid pandemic in the UK. Our analysis has yielded four different periods in the evolution of intersecting policy and media frames. Initially, modellers, policymakers and media alike emphasized uncertainty about available data, and hence the speculative character of modelled projections, thus justifying a 'wait and see' approach to government intervention. With growing public pressure for government action, policy and media frames were adjusted to emphasize the importance of timing interventions for best effect, with modelling evidence mobilized to justify inaction. This gave way to a period of crisis, as the press increasingly questioned the reliability of the existing models and policies, leading modellers and policy makers to dramatically revise their projections. Finally, with the imposition of the first UK lockdown, policy and media frames were brought back into alignment with one another, in a process of domestication through which the language of modelling became a basic resource for the discussion of the epidemic. Our epistemological microhistory thus challenges general accounts of the impacts of pandemic modelling and instead emphasizes contingency and interpretative flexibility.

Framing utility: Regulatory reform and genetic tests in the USA, 1989-2000.

Before about 1990, insofar as diagnostic and other medical tests were subject to regulatory oversight, it was chiefly to ensure that they met appropriate standards of analytic and clinical validity. Over the course of the 1990s, however, regulatory reformers in the United States began to argue that genetic tests, specifically, should also be assessed to determine whether or not they actually benefit those undergoing testing-whether they possess "clinical utility", as they put it. The present paper asks why this shift in regulatory focus occurred specifically in relation to genetic tests, and why clinical utility became a key object of assessment. It answers these questions by situating concerns about genetic tests in the longer history of medical genetics. Looking back to the 1970s and medical geneticists' efforts to distance themselves from their earlier association with eugenics, it shows that they adopted a particular framing of the dangers of genetic testing which would inform their response to the proliferation of new genetic tests and the growth of commercial testing in the 1990s. In a series of policy committees convened over the course of that decade, medical geneticists called for regulatory measures to be implemented to ensure that genetic tests were only introduced into medical practice if they had been shown to be beneficial to those tested. The paper follows the deliberations of those committees to show in detail how geneticists worked within this framing to accommodate new technical capacities and regulatory opportunities. In the course of these deliberations, they adopted the idea of clinical utility to signify the need for evidence of benefit specifically to those tested. The paper concludes with some observations regarding how this framing of genetic tests relates to current understandings of "genetic exceptionalism" and to more recent articulations of clinical utility.

Critical care work during COVID-19: a qualitative study of staff experiences in the UK.

OBJECTIVE: To understand National Health Service (NHS) staff experiences of working in critical care during the first wave of the COVID-19 pandemic in the UK. DESIGN: Qualitative study using semistructured telephone interviews and rapid analysis, interpreted using Baehr's sociological lens of 'communities of fate'. PARTICIPANTS: Forty NHS staff working in critical care, including 21 nurses, 10 doctors and advanced critical care practitioners, 4 allied health professionals, 3 operating department practitioners and 2 ward clerks. Participants were interviewed between August and October 2020; we purposefully sought the experiences of trained and experienced critical care staff and those who were redeployed. SETTING: Four hospitals in the UK. RESULTS: COVID-19 presented staff with a situation of extreme stress, duress and social emergency, leading to a shared set of experiences which we have characterised as a community of fate. This involved not only fear and dread of working in critical care, but also a collective sense of duty and vocation. Caring for patients and families involved changes to usual ways of working, revolving around: reorganisation of space and personnel, personal protective equipment, lack of evidence for treating COVID-19, inability for families to be physically present, and the trauma of witnessing extreme patient acuity and death on a large scale. The stress and isolation of working in critical care during COVID-19 was mitigated by strong teamwork, camaraderie, pride and fulfilment. CONCLUSION: COVID-19 has changed working practices in critical care and profoundly affected staff physically, mentally and emotionally. Attention needs to be paid to the social and organisational conditions in which individuals work, addressing both practical resourcing and the interpersonal dynamics of critical care provision.

Half a Century of Wilson & Jungner: Reflections on the Governance of Population Screening.

Background: In their landmark report on the "Principles and Practice of Screening for Disease" (1968), Wilson and Jungner noted that the practice of screening is just as important for securing beneficial outcomes and avoiding harms as the formulation of principles. Many jurisdictions have since established various kinds of "screening governance organizations" to provide oversight of screening practice. Yet to date there has been relatively little reflection on the nature and organization of screening governance itself, or on how different governance arrangements affect the way screening is implemented and perceived and the balance of benefits and harms it delivers. Methods: An international expert policy workshop convened by Sturdy, Miller and Hogarth. Results: While effective governance is essential to promote beneficial screening practices and avoid attendant harms, screening governance organizations face enduring challenges. These challenges are social and ethical as much as technical. Evidence-based adjudication of the benefits and harms of population screening must take account of factors that inform the production and interpretation of evidence, including the divergent professional, financial and personal commitments of stakeholders. Similarly, when planning and overseeing organized screening programs, screening governance organizations must persuade or compel multiple stakeholders to work together to a common end. Screening governance organizations in different jurisdictions vary widely in how they are constituted, how they relate to other interested organizations and actors, and what powers and authority they wield. Yet we know little about how these differences affect the way screening is implemented, and with what consequences. Conclusions: Systematic research into how screening governance is organized in different jurisdictions would facilitate policy learning to address enduring challenges. Even without such research, informal exchange and sharing of experiences between screening governance organizations can deliver invaluable insights into the social as well as the technical aspects of governance.

Biomedicine, self and society: An agenda for collaboration and engagement.

The commitment of massive resources - financial, social, organisational, and human - drives developments in biomedicine. Fundamental transformations in the generation and application of knowledge are challenging our understandings and experiences of health, illness, and disease as well as the organisation of research and care. Coupled with the accelerated pace of change, it is pressing that we build authentic collaborations across and between the biomedical sciences, humanities and social sciences, and wider society. It is only in this way that we can ask and answer the penetrating questions that will shape improvements in human health now and in the decades ahead. We delineate the need for such commitments across five key areas of human and societal experience that impact on and are impacted by developments in biomedicine: disease; bodies; global movements and institutions; law; and, science-society engagements. Interactions between ideas, researchers, and communities across and within these domains can provide a way into creating the new knowledges, methods, and partnerships we believe are essential if the promises of biomedicine are to be realised.

Patient organization involvement and the challenge of securing access to treatments for rare diseases: report of a policy engagement workshop.

PLAIN ENGLISH SUMMARY: Patients with rare diseases often help to develop new treatments for their conditions. But once developed, those treatments are sometimes priced too high for many patients to access them. We became aware that this is a problem in the course of a social science research project that examines the place of rare diseases in health policy. We therefore organized a two-day workshop to try and understand why this problem occurs and what might be done about it. The people who participated in our workshop were: representatives of rare disease patient organizations, experts in matters of drug regulation and assessment of new health technologies, consultants involved with companies producing treatments for rare diseases, and social scientists researching related issues. The main conclusions to emerge from the discussions were as follows: Problems of access to treatments for rare diseases are not just due to high prices; procedures for regulating, assessing and delivering new treatments also need to be better organized. Patients and patient organizations have much to contribute to this process. However, their resources are often very limited. Consequently, more needs to be done to help them use those resources as effectively as possible. In particular, regulators and healthcare providers need to ensure that their procedures are clear and efficiently managed, so as not to waste patient organizations' time and money. Clearer guidance is needed on what patient organizations can do to provide evidence of the effectiveness of new drugs. Insights gained in tackling rare diseases might also be applicable to common disorders. Finally, the consequences of Brexit for UK policies on rare diseases urgently need to be assessed. ABSTRACT: Since the enactment of orphan drug legislation in the USA, Europe and several other countries, an increasing number of treatments for rare diseases have been developed and many of them been approved for marketing. However, such treatments tend to be priced very high, and access to effective treatments remains a major challenge for patients with rare diseases - despite active involvement of patients and their support organizations in various stages of basic and applied research and commercial development. In order to allow patients to benefit from treatments proved effective for their diseases, we need to better understand why this challenge persists, and what steps might be taken to address it. To that end, we organized a policy-engagement workshop, bringing together individuals and organizations with direct experience of trying to secure access to a treatment for a rare disease along with individuals with relevant expertise in regulatory and commissioning processes for new medicines. With additional input from social scientists who offered different perspectives on the value of patient involvement, the workshop aimed to initiate a dialogue among the participants about how to address the challenge in a sustainable manner. Discussions at the workshop stressed that active involvement of patients is as valuable in the regulatory and commissioning processes as in the research and development of new medicines. However, it also highlighted certain risks and costs associated with such involvement. These include the costs of adjusting to abrupt changes in regulatory and commissioning processes, and the risk of being perceived as too close to commercial interests. To optimize use of scarce resources and ensure continuing active involvement, such risks and costs need to be better managed. Participants also noted that, owing to advances in genomic technologies, common diseases are also becoming divided into rare sub-categories, which are equally eligible for orphan drug designation. Consequently, involvement of wider patient communities beyond rare disease communities will be critical for continuing discussions about patients' involvement in regulatory and commissioning processes, and to consider how patients and their support organizations can best work with other stakeholders - including companies, regulators and policymakers - to ensure access to effective medicines.

Personalised Medicine and the Economy of Biotechnological Promise.

Rather than seek to distinguish hype from legitimate promise, it may be more helpful to think about personalised medicine as embodying a promissory economy which serves both to mobilize resources for research and - partly at least - to determine the ends to which that research is directed. Personalised medicine is a development of the larger promissory economy of medical biotechnology. As such, it systematically conflates public benefit with the pursuit of commercial and especially pharmaceutical interests. Consequently, research and development in personalised medicine tends to favour the production of expensive new treatments over unprofitable forms of prevention or more effective use of older therapies. A rebalancing of research priorities is needed to favour the pursuit of public benefit, even when it does not deliver private profits. This will in turn require sustained reflection, self-criticism and often self-denial on the part of public research funders and the scientists they support.

Biotechnology and the transformation of vaccine innovation: The case of the hepatitis B vaccines 1968-2000.

The approval, from 1986, of a series of recombinant hepatitis B vaccines was a landmark both in the growth of biotechnology and in the development of the vaccine innovation system. In this paper, we show how the early development of the hepatitis B vaccines was shaped by a political and economic context that newly favoured commercialisation of academic research, including the appropriation and management of intellectual property; we elucidate the contingent interests and motivations that led new biotechnology companies and established pharmaceutical businesses to invest in developing recombinant vaccines specifically against hepatitis B; and we show how these and other factors combined to make those vaccines an unexpected commercial success. Broadening the scope of our analysis to include not just North America and Europe but also low- and middle-income countries, we show how the development of the hepatitis B vaccines facilitated the emergence of a two-tier innovation system structured by tensions between the demands for commercial profitability on the one hand, and the expectation of public health benefit for low- and middle-income countries on the other.

Implementing recovery: an analysis of the key technologies in Scotland.

BACKGROUND: Over the past ten years the promotion of recovery has become a stated aim of mental health policies within a number of English speaking countries, including Scotland. Implementation of a recovery approach involves a significant reorientation of mental health services and practices, which often poses significant challenges for reformers. This article examines how four key technologies of recovery have assisted in the move towards the creation of a recovery-oriented mental health system in Scotland. METHODS: Drawing on documentary analysis and a series of interviews we examine the construction and implementation of four key recovery 'technologies' as they have been put to use in Scotland: recovery narratives, the Scottish Recovery Indicator (SRI), Wellness Recovery Action Planning (WRAP) and peer support. RESULTS: Our findings illuminate how each of these technologies works to instantiate, exemplify and disseminate a 'recovery orientation' at different sites within the mental health system in order to bring about a 'recovery oriented' mental health system. They also enable us to identify some of the factors that facilitate or hinder the effectiveness of those technologies in bringing about a change in how mental health services are delivered in Scotland. These finding provide a basis for some general reflections on the utility of 'recovery technologies' to implement a shift towards recovery in mental health services in Scotland and elsewhere. CONCLUSIONS: Our analysis of this process within the Scottish context will be valuable for policy makers and service coordinators wishing to implement recovery values within their own national mental health systems.

Scientific method for medical practitioners: the case method of teaching pathology in early twentieth-century Edinburgh.

The appointment of James Lorrain Smith as first full-time professor of pathology at the University of Edinburgh in 1912 led to a series of reforms in pathology teaching there. Most significant was the inception of what Lorrain Smith called the "case method of teaching pathology," which used the investigation of clinical cases as the basis for a series of exercises in clinico-pathological correlation. This paper examines the social and cognitive organization of the case method of teaching, and shows how such exercises were expected to inform the students' future medical training and practice. In so doing, it also throws light on the relationship between medical science and clinical practice that obtained in Edinburgh at that time.

Biomedicine in Edinburgh, 1887-1920.

This paper examines the scientific work of the Laboratory of the Royal College of Physicians of Edinburgh from its foundation in 1887 to 1920. It looks in particular at the pivotal role of clinical cases in the work of the Laboratory, using the concept of 'triangulation' to analyse how cases served both as objects of scientific knowledge and as sites for articulating and aligning the concerns of medical practitioners and career scientists. It goes on to propose a general model for thinking about the role of cases in scientific knowledge production, based on a rereading of Kuhn as seen through the lens of the sociology of scientific knowledge. It concludes with some general reflections on how this analysis of the work of the Laboratory helps us to rethink the relations between basic and applied medical science in the period before the emergence of modern biomedicine.