A drug prescribed to treat alcohol dependence could be ineffective
Posted on 15 June 2016
A drug prescribed to treat alcohol dependence could be ineffective after a study found that the evidence-base was weak. Nalmefene was approved in Europe in February 2013 and was heavily marketed following approval by National Institute for Health and Care Excellence. However, a study published in the journal 'Addiction' claims that there were several problems with the way that the clinical trials were conducted and raised concerns about the behaviour of the drug company, and the dilemmas posed for clinicians.
Professor Jim McCambridge, the Department of Health Sciences’ Chair in Addictive Behaviours and Public Health, joined researchers at the University of Stirling and other institutions to analyse the studies of Nalmefene that formed the basis for the licensing decision. They found that any possible effect on patients was small – a reduction of about one drink per day on average, if they exist. Side-effects were also more common in patients taking Nalmefene. Nalmefene is more expensive than similar drugs and that no comparison with these alternatives has been made.
Niamh Fitzgerald, lead author of the study, said: “We found problems with the registration, design, analysis and reporting of these clinical trials, which did not prevent the drug being licensed or recommended for use.”
Matt Field, professor of psychology at the University of Liverpool, said that errors like this were “all too common in trials of novel medications for psychiatric disorders.”
For more information visit http://www.stir.ac.uk/news/2016/06/weak-evidence-for-prescribed-drug/ or listen to an interview on BBC Radio Scotland on 6 June at http://www.bbc.co.uk/programmes/b07cyl1k#play (1 hr 14 in).
Notes to editors:
- The article “Weak evidence on Nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers” is published in Addiction journal. http://onlinelibrary.wiley.com/doi/10.1111/add.13438/abstract
- Research was led by the University of Stirling, with co-authors from Glasgow Caledonian University, University of Edinburgh, Leeds Addiction Unit, Northumbria University and University of York.
- Researchers identified published studies of Nalmefene 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.