Drugs, risks, uncertainty and common good02/11
The aim of this conference is to encourage deeper reflection over possible changes that could be made to how the evaluation of medicines is organized and, more generally, to drug decision-making under conditions of uncertainty.
Medicines lie at the heart of the French health system. The pharmacological impacts that shape their efficacy are also behind the undesirable effects that they can cause. Choosing whether to make a drug available or not to prescribers, or directly to patients, therefore entails ensuring that it has a favourable benefit-risk ratio. However, evaluation of the latter can vary over time since the data available at the moment a medicine is put on the market is inevitably limited because of its generation by the experimental contexts of clinical trials. If these are ideal for measuring the intrinsic efficacy of a drug, they rarely replicate the actual conditions under which it is actually used. Medicines therefore need to be placed under constant surveillance in order to ensure that knowledge generated through experience of a drugs’ usage are consistent with the initial evaluations of their risk-benefit ratio. This surveillance and the decisions that stem from it are a delicate issue: because observation of actual usage and associated benefit/risk cannot attain the level of evidence obtained from experimental evaluation, a certain degree of uncertainty necessarily affects and complicates decision-making. This taking of decisions, despite often been done urgently, involves in different ways regulators, experts, carers, patients and, increasingly, public opinion and politicians. Given this context is heavily marked by the varying perspectives of these actors and that it has often been crystalized as the issue of conflicts of interests or at least their linkages, the aim of this conference is to encourage deeper reflection over possible changes that could be made to how the evaluation of medicines is organized and, more generally, to drug decision-making under conditions of uncertainty. In particular, it will seek to explore in full the mechanisms that can lead to pauses in decision-making, perhaps purposefully built into regulatory systems in order to attain the best possible care for patients and population health, as well as ensuring against the consumption of medicines that runs counter to this goal.
Within the framework of interdisciplinary research undertaken on the withdrawal of medicines, financed by the University of Bordeaux’s IdEx programme on Health Determinants and Societies (HEADS), Andy Smith, director of the Centre Emile Durkheim (made up of sociologists and political scientists), and Antoine Pariente, director of the Pharmacoepidemiology team within INSERM’s Bordeaux Population Health research centre, have brought together to discuss the issues raised above: Bernard Bégaud, Professor of Pharmacology, Joan-Ramon Laporte, director of the Catalan Institute of Pharmacology, Paul Benkimoun, editor of the health pages of Le Monde, Patrick Lefas, president of the Health section of the National Audit Office, Dominique Martin, Director General of the ANSM, Daniel Benamouzig, Director of research on Health Policies at the Laboratoire Interdisciplinaire d’Evaluation des Politiques Publiques and Virgine Tournay, a political scientist specialized in medicine-uncertainty relations.
Made up of researchers from the health and social scientists, journalists and actors from regulatory bodies and the senior civil service, these specialists will each set out their vision of the issues at stake. Discussions will be centred upon the relationship between medicine-related risks, communication over such risk, uncertainty and decision-making, as well as the question of conflicts of interest within the evaluative processes concerned.