Ethics and Evidence in Medical Debates: The Case of Recombinant Activated Factor VII

Abstract

It is broadly acknowledged that even the most “evidence-based” clinical practice is highly value laden. These values are particular evident in debates about the use of recombinant activated factor VII (rFVIIa)--a drug that is approved only for use in patients with rare clotting abnormalities, but is often used “off-label” to treat major hemorrhage. The debate about whether rFVIIa should be used more broadly for the management of life-threatening bleeding is polarised in spite of stakeholders having access to the same evidence. To understand the disagreement, we conducted a qualitative analysis of the published commentaries surrounding the ‘off-label’ use of rFVIIa. We found that conflicting epistemic and moral values influenced how evidence was interpreted, and contributed to the intransigence of the debate. We conclude that debates about individual therapeutic agents have a moral and political dimension involving competing “prudences” and that new ‘post-normal’ decision-making paradigms are required to resolve such disputes. Key Words: factor VII; Novoseven; off label; evidence; ethics; post-normal