Making decisions about benefits and harms of medicinesBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7456.47 (Published 01 July 2004) Cite this as: BMJ 2004;329:47
- Trisha Greenhalgh, professor of primary health care1 (firstname.lastname@example.org),
- Olga Kostopoulou, Department of Health R&D/PPP national primary care postdoctoral fellow2,
- Clare Harries, lecturer3
- 1 Department of Primary Care and Population Sciences, University College London, London N19 5LW
- 2 Department of Primary Care and General Practice, University of Birmingham, Birmingham
- 3 Department of Psychology, University College London, London
- Correspondence to: T Greenhalgh
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?
Sources and selection criteria
This article was constructed through multidisciplinary dialogue between an academic general practitioner with a keen interest in evidence based and narrative based decision making, two cognitive psychologists specialising in risk perception, and an editor with a background in medical pharmacology. The authors drew on their own disciplinary perspective, expertise, and archives. The goal was not to produce an exhaustive overview of any of our areas of expertise but to use insights from one discipline (psychology) to illuminate findings from another (drug regulatory decisions).
Individual need versus population level policy
Suppose that, based on population estimates, a person's chance of benefiting from a drug is 75% and their chance of a fatal …