Making decisions about benefits and harms of medicines

Abstract

Introduction Drug regulatory authorities, such as the Medicines and Healthcare Products Regulatory Agency in the United Kingdom and the Food and Drug Administration in the United States, award product licences by assessing the balance between benefit and harm. The decision to revoke a licence generally hangs on evidence of lack of efficacy or risk of serious adverse effects, taking account of the seriousness of the condition and the range of other treatments available. The authorities work at the level of the whole population. But individual patients may believe (rightly in some cases) that a particular regulatory decision is not in their own best interests, and vociferous campaigns sometimes result (box 1). Involvement of patients can be a powerful driver for improving services.5 But both lay people and professionals are susceptible to several biases when making health related decisions (box 2). What can be done to ensure that the care of individual patients is not compromised by regulatory decisions intended to protect the population as a whole, and to encourage objective and dispassionate decision making in the face of cognitive biases?