Abstract

While ethics and evidence‐based medicine are often viewed as separate domains of inquiry and practice, what we know influences what we can ethically justify doing, and what we see as our moral obligations shapes the way we interpret evidence. The boundaries between the moral and epistemic spheres become particularly blurred when the health of people is at stake and even more so when no “officially” recommended medical intervention is available to help a patient in need. The treatment of major hemorrhages using recombinant factor VIIa (rFVIIa), which was originally approved under orphan drug legislation to treat hemophilia, is a case in point.Following reports in the late 1990s that rFVIIa was success­fully used to stop bleeding in gunshot trauma, there was much excitement about its potential to help patients with uncontrolled bleeding in other clinical settings, leading to wide‐spread off‐label use of the drug. In recent years, new evidence has raised questions about the off‐label use of rFVIIa for severe bleeding. Nonetheless, while some clini­cians are now adamantly opposed to prescribing rFVIIa for massive bleed­ing, many remain determined to continue the practice. This raises the question: why do clinicians have such variable responses to the same body of evidence?We analyzed the debate around off‐label use of rFVIIa and character­ized its main conceptual features and tensions. We did not seek to provide a normative analysis as to whether the evidence supports the case for off‐label prescribing, nor did we try to provide a historical analysis of how attitudes and clinical practice have changed. Rather, we sought to make visible the moral and epistemic values underpinning stakeholders’ opinions and practices. On the basis of our analysis, which is described in this ar­ticle, we suggest that debates such as those surrounding rFVIIa will not be resolved simply by conducting more studies and that, therefore, there is also a need for conceptual and pro­cedural frameworks that more sys­tematically incorporate values into clinical policy‐making.