Inside the ‘Black Box’ of Pharmaceuticalisation: NICE, the Permissive Principle and the Case of Anticoagulants

Sociological interest in pharmaceuticalisation continues to grow, especially regarding the expansion of pharmaceutical use in society. This article presents the first major empirical study focusing on the directionality of pharmaceuticalisation by taking cost-effectiveness assessment and regulation of anticoagulants in England by the National Institute of Health and Care Excellence (NICE) as a case study. During this century, anticoagulant therapy for the prevention of stroke and systemic embolism has changed direction profoundly away from warfarin towards newer and markedly more expensive direct oral anticoagulants. Drawing on established theoretical frameworks of pharmaceuticalisation, together with years of documentary research, interviews and observations of stakeholder meetings, it is demonstrated that this directional change cannot be adequately accounted for solely by reference to biomedicalism. Rather, such change must also be explained by key sociological factors, including the adoption of the permissive principle towards the newer drugs by the NICE regulatory system, pharmaceutical industry influence on governance processes, the 'coincidence' of expansion in diagnostic criteria for stroke risk with the introduction of the new direct oral anticoagulants, and the promotion of neoliberal patient choice and innovation by the regulatory state. Finally, the generalisability and policy implications of our findings for other therapeutic and institutional contexts are considered.