Nalmefene has been approved in Europe for the treatment of alcohol dependence and subsequently recommended by the UK National Institute for Health and Care Excellence (NICE). This study examines critically the evidence base underpinning both decisions and the issues arising. Published studies of nalmefene were identified through a systematic search, with documents from the European Medicines Agency, the NICE appraisal and public clinical trial registries also examined to identify methodological issues.
- brief intervention
- trial regulation
- vested interests
Fitzgerald, N., Angus, K., Elders, A., de Andrade, M., Raistrick, D., McCambridge, J., & Heather, N. (2016). Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers. Addiction, 111(8), 1477–1487. https://doi.org/10.1111/add.13438