A Case Study of Long QT Regulation: A Regulatory Tennis Game Across the Atlantic

Abstract

This paper has been written in a context of vivid transatlantic discussions about regulation and precaution. The study is looking at a specific and topical issue of drug safety regulation, the so‐called QT interval. The QT interval is commonly described as a reflection of how long it takes to “recharge” heart cells after they have been stimulated to beat, and it has been argued that both natural and drug induced lengthening of this interval may lead to a increased risk of death. The paper is based on interviews with all the major regulatory bodies responsible for the regulation of QT prolongation. The research focused on a number of key questions, starting with the “story” behind present QT regulation. It describes the debates that emerged in the 1992s about the significance of QT variations, and the existing level of uncertainty, on whether long QT is something we should worry about or not. Looking at the QT regulation story, no doubt the regulator answered this question by “yes”. However, there are still some divergences about the magnitude of the risk between experts and non experts, between Europeans and Americans, between ‘insiders’ and ‘outsiders’, which the paper explores in its complexity. Finally, the paper is introducing a conceptual model to analyse these developments, the so‐called “regulatory tennis game” that shaped the present regulation. It is also stressing some of the intrinsic problems of the “expert driven bi‐partite model” for making evidence based decisions about risk.