Synthetic certainization in medical controversy: Evidence synthesis, NICE recommendations and the drug-device complex in stroke prevention

The National Institute for Health and Care Excellence (NICE) recommends rivaroxaban for stroke prevention in patients with non-valvular atrial fibrillation in England. While not a directive to practitioners, that advice is widely regarded as authoritative and intended to guide practice. Yet a medical device, INRatio2-PT for monitoring coagulation/blood-clotting and producing crucial data on rivaroxaban in its key clinical trial, was defective. Following discovery of the defective device, a medical controversy about the therapeutic value of rivaroxaban ensued. Drawing on social science theories of medical controversies, such as ‘chronic contestation’, ‘closure’, ‘corporate bias’, and ‘countervailing powers’, this article describes the unfolding of the INRatio2-PT/rivaroxaban controversy and seeks to explain it. We explore the role of key protagonists based on documentary and interview data. Our findings about the media partly support ‘countervailing powers’ theory, while those regarding industry and regulators support ‘corporate bias’ theory. We found little evidence of chronic contestation of medical knowledge-claims. Rather, we contend that a sociological process of closure through synthetic certainization of knowledge-claims that rivaroxaban is efficacious and cost-effective evolved via the combined political power and interests of the medical-industrial complex, capitalist industry, and the regulatory state. Synthetic certainization, together with a regulatory ideological commitment to innovation, curtailed contestation and discouraged the medical profession from facing troubling uncertainties.