Medical innovation: tracking transformations in the production, governance, clinical practice and access to medicines

Abstracts

Exploring Epistemic Divides in Citizen Involvement in Health Research

Jonas Stage, Roskilde University; with Mari Holen & Karen Christensen

Patient and public involvement (PPI) has become a central topic in health service research and policy in recent years. PPI has the potential to improve health services research by involving people with lived experiences of illness. While the value of PPI is recognized, little is known about health researchers' (e.g., doctors and nurses) receptiveness to it. To address this gap, we conducted a study based on interviews with health professionals as researchers in the Danish healthcare sector to investigate how nurses’ and doctors’ boundary work informs their statements about involvement. In particular, we explain how the credibility of PPI is challenged. Theoretically, we combine Lamont and Molnár’s theory (2002) of boundary work with Jane B's analysis of ‘epistemic positioning’ (Bacevic 2021). The study identified how health professionals engage in boundary work based on the hierarchy of evidence and professional struggles in various experiences and perceptions that contest beliefs about conducting research with citizens. Moreover, the division between nurses' and doctors' research roles is contested by new research policies valorizing involvement. These findings indicate that the potential value of involvement is shaped by the context of the healthcare sector it enters. This study highlights how involvement is contested by epistemic preferences, which can hinder its potential value. This study contributes to the current discussion about investigating "dark logic" working against involvement in the healthcare sector.

In a way, she’s our most important team member – Tracing reconfigurations of professional-patient encounters in cognitive neuroscience

Anja Kathrin Ruess, Technical University of Munich; with Franziska Schönweitz, Simon Jacob, Alena Buyx, Ruth Müller

Historically, medical sociology and medical ethics have studied the relationship between physician and patient as asymmetrical, characterized by power and knowledge differentials and often following paternalistic routines. More recently, scholars, particularly in the STS and neighboring fields, have witnessed reconfigurations of this dyadic framing at multiple levels, for instance in the contexts of increasingly individualized healthcare or information and AI technologies used in the medical field. Particularly the nowadays so frequently desired involvement of diverse actors in research and innovation processes prompts the question to what extent similar reconfigurations take place in medical research. In this paper, we interrogate emerging relationships between medical researchers and patients in cognitive neuroscience. Our analysis focuses on the case of an aphasia patient with multiple chronically implanted microelectrode arrays as well as the associated research team, which hopes to better understand both (disturbed) linguistic functions and the potential future use of brain-computer interfaces for rehabilitation purposes. Drawing on our ongoing ethnographic fieldwork and qualitative interview study, we trace novel relationships between the research team and the patient that create specific forms of intimacies, thus transcending what is commonly perceived as clinical space. Simultaneously, we delineate emerging dependencies, tensions, challenges, and potentials and discuss them in light of their potential relevance for future medical research. This paper is part of the Technical University of Munich’s Innovation Network for Neurotechnology in Mental Health (NEUROTECH), a four-year interdisciplinary research initiative (including an embedded ethics and social sciences team) dedicated to the study and treatment of mental dysfunction.

When the researcher and the user is that same person – A study of The National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway

Magnus Gulbrandsen, University of Oslo; with Knut Jørgen Vie

Medical researchers are often their own intended users. They can also inhabit multiple additional roles, such as clinicians, caregivers, lecturers, administrators, and leaders. Therefore, studying how they cope with their work is an interesting approach to understanding the benefits and perils of embedding researchers in the practice they study. The fusion of the innovator and the user in one and the same person can facilitate the uptake of innovations, but it can also lead to challenges in balancing the two roles. For the present paper, we will present a study where we interview medical researchers about how they turn their research into clinical practice. The focal point of the study is the Norwegian system for introducing innovations in the specialized healthcare services, called Nye Metoder. In addition to determining whether new methods should be prioritized and ensuring that all citizens have access to the same level of care, this system is tasked with ensuring transparency, including user groups in the process of adopting new treatments, and evaluating the ethical aspects of new methods. The system has a linear structure, where new pharmaceuticals, practices, equipment, or other changes are proposed, assessed, decided on, and implemented. Our approach is to use the database of the system to identify cases of researchers who have attempted to have their work adopted in the healthcare system and interview them about the process to get at how they balance their different roles, and whether they find that the system lives up to its intentions.

Whole Genome Sequencing for Diabetes Patients: What ‘Publics’ Benefit from Precision Medicine?

Laura Emdal Navne, The Danish Center for Social Science Research, VIVE; with Mette N. Svendsen and Sarah Wadmann

‘Precision medicine’ refers to health care strategies using genetic and other data to tailor prevention, diagnosis, and treatment to the individual. Among political actors, precision medicine is often envisioned to serve the common good of the public raising pressing questions about how ‘the public’ is delineated in practice – as this has important implications for whom benefits from the ‘goods’ of precision medicine. Drawing on ethnographic fieldwork in Danish clinical practice where diabetes patients are recruited for whole genome sequencing (WGS) as part of a research project, we ask who and what are enacted as the public and the good. We show how the research population – that stands in for the public of diabetes patients – is shaped by formal and informal criteria modelled over a combination of ethnic and sociodemographic criteria. While research protocols use inclusion criteria such as ‘Danish speaking’ to draw the lines around ‘the research public’, the clinicians recruiting patients set up their own demarcations for this public by excluding the vulnerable, the mentally unstable, and the elderly, and including the European English speaking patient. Moreover, where clinicians identify only genetic data with treatment implications as ‘the good’, many patients consider “knowing it all about their genome” as ‘the good’. Among researchers, WGS from patients contributes to basic science and in itself constitutes ‘the good’. With inspiration from science studies and the anthropology of bureaucracy, we show that only by attending to the situational enactments of the “who” of the public, and the “what” of the good may we address issues of fairness in access to precision medicine.

Access to orphan drugs in the US and Europe: sociotechnical regimes and the shaping of drug markets

Paul Martin, University of Sheffield; with Dr Jin Ding

The US Orphan Drug Act and similar legislation in other countries has been very successful in stimulating innovation in new medicines for rare diseases. Sings 2010 in the US alone some 600 new orphan medicinal products (OMPs) have been licensed by the FDA and half of all new US drugs approved in the last three years had orphan designation. A key feature of many of these products is their small market size and very high price. This paper presents data from a comprehensive quantitative survey of all US approved OMPs in the decade 2011-2020 and examines the pattern of their approval in the European Union. The main findings are that nearly 40% of these US OMPs are not available in the European market. Furthermore, of the 60% of those that are licensed in the EU, roughly half have been approved without orphan designation. This raises important policy questions about the lack of patient access to potentially valuable treatments in Europe. Several possible explanations will be examined, including regulatory divergence and the commercial decisions made by firms to not sell their drugs in Europe. The analysis will frame these in terms of the very different sociotechnical regimes for the assessment and reimbursement of pharmaceuticals in the US and EU. The forms of value embedded in market-based and more socialised healthcare systems powerfully shape knowledge production and the commercial diffusion of technology. The implications of these differences for the future of precision medicine and advanced therapies will be explored.

Peering into the ‘Dry Pipeline’ of antibiotics: Annual reports’ storytelling

Belma Skender, Institute of Health and Society; with Laura Daniela Martinenghi

Antibiotic resistance is a major global health concern as it undermines the effectiveness of antibiotics, which are vital for treating bacterial infections. One of the key strategies for addressing the issue is the development of new antibiotics. However, the number of new antibiotics on the market has declined substantially over the last few decades. The reasons behind the decline are complex, but the most discussed is a lack of investment by major pharmaceutical companies, which left the field during the 1990s and early 2000s. To understand events around antibiotics during this critical time period, the paper examines how these important drugs are described and presented in pharmaceutical company’s yearly reports by employing practice-oriented document analysis. The study focuses on German pharmaceutical company Bayer, being a pioneer in the field of antibiotics. An emphasis is drawn around efforts to textualize and visualize the company’s presentation, thus reasoning its decisions and future direction. This research aims to deepen our understanding of antibiotic field transformation and describe how antibiotics, being an important part of Bayer’s investments and activities, became a dispensable issue of the past. Even though the public health need for novel antibacterial has grown continuously.

Valuing pharmaceutical innovation: Temporal layers in the biography of a gene therapy

Anna Brueckner Johansen, VIVE / University of Copenhagen; with Sarah Wadmann and Susi Geiger

In this paper, we investigate how temporality matters for the valuing of objects. Our case is a novel gene therapy targeting a rare inherited eye disease, which in 2019 was rejected as treatment in Denmark due to ‘unreasonably high pricing’, causing uproar from the families affected by the disease. The gene therapy was eventually offered to Danish patients in 2020 as part of a pay-for-performance agreement, but while the pricing controversy was settled in the Danish case, it raised a more general issue about the relationship between morality and economy in dilemmas of valuation: what constitutes a ‘good’ price of a pharmaceutical product? And how may such dilemmas of valuation be shaped by the past and imagined futures of pharmaceutical innovations? Drawing on the notion of ‘temporal layering’, we argue that a combination of attention to the historical contingency of objects of exchange developed in the anthropology of value and the emerging insights in pragmatist valuation studies about the implications of future rhetoric for valuations and resource distributions in the present can foster constructive critique of developments in the life science industry and beyond. Bringing the two literatures into conversation, we show how attention to the historical contingency coupled with sociotechnical configurations of valuation as future projects can foster an analytical sensibility to temporality, which serves to trouble and question taken for granted claims about the ‘goodness’ of current developments in the life science industry.

The making of a Greek network of biobanks: continuities and disruptions in biomedical research supported by collections of biological material

Katerina Vlantoni, Department of History and Philosophy of Science, National and Kapodistrian University of Athens; with Giorgos Zoukas

Biobanks have emerged as a 'new' type of institution collecting and processing biological samples and associated data, which can be used in biomedical research, beyond the confined site of their production. They constitute a key infrastructure in biomedical research and are portrayed as crucial sites for human health promotion. Moreover, biobanks are sites of interaction between the public, patients, researchers, physicians, bioinformaticians, regulators, policymakers, and the industry. Our work in progress focuses on BBMRI-GR, an ongoing project to develop a 'Greek network of Biobanks'. Since there is no national biobank in Greece, the BBMRI-GR project attempts to interconnect the smaller collections of biological material and associate Greek biobanks with BBMRI-ERIC, the EU-supported infrastructure. We also explore how biobanks have been developed in Greece, specifically how different types of biorepositories/collections have positioned themselves in the shifting biomedical research landscape formed by diverse actors. Through a multi-method qualitative approach, involving the study of archives, documentary sources, news items, and interview data regarding different biobanks, we aim to explore the contingencies in the biobanking initiatives, showing the continuities in the operation of biobanking activities in research and clinical settings. At the same time, we question the effect of larger flagship projects, like those on Precision Medicine, as they presuppose biobanking infrastructure and invest in biobanks in a fragmented manner. Our hypothesis is that the rhetoric of expected public health benefits and economic growth does not match the policy efforts, where the support to biobanks is irregular, thus disrupting the biobanking efforts.

Infrastructuring precision medicine: making gene therapies for rare diseases workable in clinical practice

Sarah Wadmann, VIVE - The Danish Center for Social Science Research; with Anna Brueckner Johansen, Alfred Peter Born & Line Kessel

Precision medicine refers to ambitions of targeting diagnostics and treatment better to patient characteristics through genetic or molecular profiling. For long analyzed by social scientists as a future imaginary, precision medicine is now materializing in many healthcare systems through novel diagnostic regimes and treatment modalities such as gene therapies. As 'disruptive' technologies, in vivo gene therapies challenge existing ways of producing, delivering, administering, and evaluating the effectiveness of pharmaceuticals, raising questions about what it requires to make these therapies 'workable' in practice. Based on in-depth ethnographic studies of the introduction of two gene therapies for rare diseases in the Danish healthcare system, we investigate which spatial and temporal arrangements are necessary to ensure that the 'right' patients can be identified and undergo treatment at the 'right' time and at the 'right' place, and which challenges that can arise in this process. Drawing on the rich STS literature on infrastructuring and recent work in innovation studies on 'institutional readiness', we show how the introduction of novel gene therapies depends on the legacy of already established infrastructures (relating e.g. to patient registries, screening programs, and lab capacity) but also contributes to transform these.

Entanglement of Psychopharmacology, Molecular Neuroscience and the Production of Psychiatrized Bodies: From perspectives of discursive-materialist analysis

Yoonmee Han, York University

Anti-psychiatry Mad movements have called out psychiatric hegemony built on the molecular neurobiological explanation of mental distress that was explained as neuromodulatory imbalance in the brain (Rose, 2007; Burstow, 2015; Scull, 2015). This discursive practice has created new socio-economic relations, foregrounding aggressive pharmaceutical interventions on people experiencing mental distress while contributing to psychiatric consumerism enacted through the self-identification of 'pharmaceutical self' (Dumit, 2004; Rose, 2007). Given this context, my paper will scrutinize the ways in which neuroscientific practice is materialized, and the process through which material bodies with mental illnesses are produced along with the development of pharmacological drugs. I will interrogate how science informed and interconnected to the new concepts of mental illnesses emerged within post-war psychiatry and its embodied relationships with legal, clinical, and institutional configurations mutually produced in this process. While many scholars such as Foucault (1990) and Dumit (2003) focus on discursive practices that have shaped modern subjects in relation to psychiatric power, I will discuss how psychiatrized bodies, which are pathologized with diagnostic labels, became materialized and produced through the material workings of scientific and medical practices. I will use Barad’s (2007) onto-epistemological approach in order to critically read the epistemologies of psychiatry and neuroscience that produce biomolecular bodies. Drawing upon the literature of the history of psychopharmacology from the early twenty centuries onward (Shen, 1999; Healy, 2002; Healy, 2008), I will contextualize how the scientific and conceptual foundation of psychopharmacology has emerged, producing new bodies with mental illnesses.

Ethical implications of medical innovation: Clinicians’, patients’, and scientists’ understandings of ethical challenges with AI in prostate cancer diagnostics.

Maria Bårdsen Hesjedal, NTNU

Artificial intelligence (AI) is increasingly developed and used in healthcare with the promise of transforming current healthcare systems. AI is used to improve diagnostic processes and treatment of patients, and AI decision-making tools intended to help professionals make decisions in the diagnostic process are increasingly being developed in a variety of different medical fields. Despite the imagined benefits of this new technology, AI in healthcare is a contested topic, and scholars point to several ethical and social issues related to the development, implementation, and use of AI in the diagnostic process. In this paper, we investigate how three of the most relevant actor groups understand the ethical challenges with AI decision-making tools in the context of prostate cancer diagnostics. The three groups are: scientists developing an AI decision support tool for radiologists currently working with MRI scans of prostate cancer, clinicians working with prostate cancer, and prostate cancer patients. We ask: what kinds of ethical uncertainties arise, and how are they dealt with by scientists, clinicians, and patients? This is a qualitative study based on participant observation and interviews with the three above-mentioned groups. The analysis focuses on what each group identifies as key ethical challenges and how these differ between the groups. The paper’s main contributions are to demonstrate how ethical challenges with the use of AI in prostate cancer diagnostics are conceptualized, weighted, and negotiated among clinicians, patients, and scientists, and to give an empirical comparison of these actors not yet studied together in this context.

Algorithmic becoming in healthcare: putting collaboration and data-integration on recipe

Amalie Gjødsbøl, Iben University of Copenhagen; with Mette Nordahl Svendsen

Across medical specialties, clinicians hope that AI will help them diagnose and treat their patients more precisely and thus efficiently. Clinicians team up with bioinformaticians to collect and integrate huge amounts of data necessary to build predictive algorithms. Since 2019, we have followed ethnographically the research consortia PM Heart in which clinicians and researchers from Denmark, Norway, and the Icelandic genetic sequencing firm DeCODE have developed the HeartIHD algorithm. Through the integration of more than 500 features, the algorithm predicts the one-year, all-cause mortality risk for patients with ischemic heart disease. At the very moment, the algorithm is being integrated into the Electronic Health Record system operating in the Eastern part of Denmark. Since summer 2020, the algorithm has been expected to be ready for clinical use ‘in three weeks’. Drawing upon observations at meetings and interviews with central participants in PM Heart, we demonstrate that although much effort is being invested in the HeartIHD algorithm, this specific software and its predictions are not expected to change and thus improve clinical decision-making. Rather, the HeartIHD algorithm is practiced and experienced as an experiment, mainly considered valuable because of its ability to pave the way for an imagined, 2.0 upgraded edition of the algorithm. To build algorithms in healthcare, we argue, is not so much about increasing predictive power in the clinic as it is about finding a recipe—or an algorithm—for how to develop and consolidate research collaboration and academic networks in precision medicine across borders and disciplines.

Regulating Diagnosis – Molecular and economic sub-stratifications of lung cancer treatment

Amalie Hauge, VIVE - The Danish Center for Social Science Research

The sociology of diagnosis has shown that diagnosis not only serves to label the underlying cause of disease but also to provide access to services and resources. Elaborating on this double-affordance of diagnosis, this paper examines how precision medicine reconfigures diagnosis as a label and as a process in regulatory and clinical settings. Reporting from an ethnographic case study of the introduction of immunotherapy for lung cancer, the paper unfolds the uncertainties involved in dissecting diagnosis into layers and examines the efforts and negotiations it takes to enable these layers to work both as clinical entities and regulative entities with the purpose of delineating access to treatment. I suggest that the work of subdividing diseases into molecularly defined categories for the purpose of delineating treatment-eligible populations can be labeled ‘diagnostic sub-stratification’ and argue that it is pertinent to understand the political capacity of this strategy. Diagnostic sub-stratification involves a push of diagnosis from the clinic ‘up’ into the regulatory system and ‘out’ into the laboratories, obscuring who is accountable for the diagnostic categories employed to organize patients’ treatment trajectories.

The Body Electric in Pain: On the Re-Emergence of Electric Stimulation in Neurology

Mara Middleton, Alexandra, Lund University; with Benjamin Lipp

Electric stimulation is re-emerging as a frontline treatment for a number of neurological conditions. In the field of pain medicine specifically, electroceutical approaches are often heralded as a ‘riskless’ and ‘safer’ alternative to pharmaceutical treatments, which have come under scrutiny in light of the opioid addiction epidemic. This promissory discourse of bio-electronic medicine positions the body’s ‘natural’ electricity as a kind of universal control ‘language’ by which to treat and modulate a wide range of bodily functions and pathologies, including neuropathic pain. In this paper, we address how electroceutical therapies actively re-conceptualise the body (and brain) in pain, and in doing so, also re-map possibilities for treating it. Drawing on two case studies of chronic pain management in the US and phantom limb pain treatment in Sweden, we show that these therapies are underscored by an electric understanding of the pained body focusing on the peripheral nervous system, rendering the electrified body as a whole the site for neurological intervention. We argue that electricity is not only a medium of intervention but also a discursive device that does specific work, creating and sustaining frictions between different conceptualizations of the brain, body, and subject in pain. We argue that we have to account for the way neuro-technical interventions have ushered material and conceptual transformations in different domains of medicine, specifically neuroscience. Electrical approaches to pain, we show, divert and challenge assumptions rooted in early social studies of neuroscience, urging a revaluation of the “neuromolecular gaze”, the “brain”, and the “cerebral subject”.

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