Shai Mulinari

Based on a case study in pulmonary medicine, this article demonstrates how a biological concept of race with roots in slavery persists in Swedish medicine, despite the established view that Sweden abandoned race after the Second World War in favour of a sociocultural concept of ethnicity, and despite widespread international criticism of algorithms that adjust for race. Through analyses of interviews, clinical guidelines, software manuals, research papers, clinical trials and international standards, we highlight how lung function measurements are based on assumptions of biologically grounded group differences in lung capacity, which influence the assessment of individuals’ health. We also demonstrate how social and biological explanatory models become intertwined in ways that blur the boundary between race and ethnicity. We argue for the need for developing analytical tools in social science that can capture the flexible and contradictory expressions of the concept of race, while challenging the assumption that biological racial thinking exists only within far-right environments. We demonstrate how the use of outdated and biologising categorisations risks reproducing unequal healthcare and contributing to misdiagnosis, and we warn of the biopolitical consequences it may have in an increasingly racist social climate.

Business responds to demands for responsibility and accountability in a range of ways – including by outright resisting, negotiating, evading, or partially complying. This chapter explores these responses in the field of pharmaceutical industry self-regulation. It analyzes how corporations respond to complaints filed with the Prescription Medicines Code of Practice Authority (PMCPA), a self-regulatory body of the Association of the British Pharmaceutical Industry (ABPI). The chapter traces discursive patterns in the initial responses by corporations, as well as in their subsequent appeals, with particular attention to more serious cases of misconduct (so-called Clause 2 breaches). Through quantitative and qualitative analysis, and an actor-focused perspective, the chapter shows that, while corporations “play the game” by contesting, conceding, and reframing allegations of wrongdoing in different ways, these responses nevertheless align with the preservation of the self-regulatory system itself. Exploring this through a Bourdieusian lens, which frames corporations as actors struggling to maintain legitimacy and power in a regulatory field, we argue that the corporations deploy a particular kind of symbolic capital (regulatory competence) to protect their position in a field in which they ultimately set the rules of regulation and benefit from their continued legitimacy.

Background: General practices have been a long-standing focus of pharmaceutical promotion, but their financial relationships with pharmaceutical companies remain understudied. Aim: To examine pharmaceutical company payments to general practices in England from 2015–2022, focusing on changing patterns of payments and what this reveals about companies’ marketing. Design & setting: Descriptive analysis of pharmaceutical company payments made to practices using data from industry’s Disclosure UK database, covering 4430 recipient practices and 54 companies over an 8-year period. Method: Annual Disclosure UK data from 2015–2022 were merged, identifying practices using a novel algorithm-based methodology, and categorising payments by type (for example, donations and grants, event sponsorship). Trends were analysed by company and payment type. The Gini coefficient measured payment concentration, and the persistence of relationships was assessed over time. Results: Pharmaceutical payments to general practices rose from £2.5 million in 2015 to £7.5 million in 2022. While 54 companies made payments, just one company, Chiesi — marketing commonly prescribed respiratory inhalers — accounted for more than 50% of the payment value from 2017 onwards. More than 40% of practices received payments from only one company, and 74% of company-practice relationships lasted just 1 study year. A few companies dominated, with a Gini coefficient of 0.86, driven by Chiesi’s payments. Conclusion: The growing scale and concentration of payments and the dominance of one company raises concerns about bias in general practice. Future research should investigate the impact of payments on clinical decision making, but to do so, payment disclosures need enhanced transparency, particularly through including product-specific payment details.

Drug company funding can create conflicts of interest that compromise the integrity of patient organizations, a problem studied primarily in Western Europe and North America. To address this research gap, we conducted a case study in Poland, a Central European country. Between 2012 and 2020, 33 companies reported payments worth €13 729 644 to 273 patient organizations in Poland. The funding was highly concentrated, with the top ten recipients amassing 46.2 percent of the total amount. Cancer patient organizations were the primary recipients, receiving 37.5 percent. The funding focused on patient organizations’ educational activities, constituting 40.4 percent of the total. For the ten companies reporting payments consistently from 2012 to 2020, we detected an increase in both the value of individual payments and the overall value of the funding. Additionally, some patient organizations formed exclusive, or nearly exclusive, ties with single companies. Overall, our study reveals important similarities between Poland and Western countries in the reported distribution of drug company payments to patient organizations. It also highlights priority areas for further research, including the evolution and structure of the financial connections.

The field of biological psychiatry faces a growing influx of digital biomarkers spanning self-report, social, behavioral, cognitive, and physiological indicators of various mental health conditions. However, the definition of “digital biomarker,” particularly the “bio-” component, remains unclear. This article reviews the terminology of digital biomarkers in psychiatry and argues for the reservation of the term exclusively for measures of biological parameters with a plausible pathway connecting to the disease or condition of interest to enhance terminological clarity and consistency with conventional definitions of biomarker, short for biological marker. While the distinction between biological and non-biological parameters may blur at the edges, the Research Domain Criteria (RDoC) developed by the US National Institute of Mental Health offers a valuable heuristic. The RDoC distinguishes between biological (genes, molecules, cells, neural circuits, physiology) and non-biological (broadly understood behavior and self-report) units of analysis. Aligning digital biomarker definitions in psychiatry with the RDoC framework would mark a significant shift from the current broad usage, where almost any digitally measured characteristic, when used as an indicator, qualifies as a digital biomarker.

Regulatory authorities must balance ensuring evidence of efficacy and safety of new drugs. Various regulatory pathways, such as the accelerated approval program in the United States (US), allow authorities to quickly approve drugs for severely ill patients by granting market authorization based on surrogate end points and pending confirmatory trials. In this cross‐sectional study, we considered 23 indications of cancer drugs that received accelerated approval by the US Food and Drug Administration (FDA) but were subsequently withdrawn as of April 2023. Our investigation extended to assessing the regulatory status of these accelerated approvals in the European Union (EU) and Japan, examining relevant regulatory documents and identifying factors contributing to the withdrawal in the United States. Comparing regions, we found that for 52% (12/23) and 30% (7/23) of withdrawn accelerated approvals in the United States, sponsors had also sought marketing authorization from the European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), respectively. As of the April 30, 2023 study cutoff date, 83% (10/12) of drug–indication pairs remained approved by the EMA, while the PMDA retained 100% (7/7). For these indications, the time from FDA withdrawal until the study cutoff date ranged from 0.23 years to 11.45 years for EMA approvals (median: 1.28 years) and 1.10 years to 11.45 years for PMDA approvals (median: 3.22 years). These findings highlight substantial regulatory discrepancies concerning cancer drugs with unconfirmed benefits. Addressing these discrepancies may involve requiring pharmaceutical companies to confirm clinical benefits using more robust end points and fostering international harmonization in regulators' assessment.