Washington D.C. [USA], Sept. 9 : A new article says that the decision to show green-light to the drug nalmefene for curbing excess drinking among the alcohol-dependents, should be overturned.
Rather, the manufacturers have been compelled to provide solid evidence of its effectiveness. Nalmefene, which interferes with the reward mechanisms in the brain, triggered by alcohol consumption, has been available as a daily tablet for use in the United Kingdom since 2013 for those who don't require an immediate detox.
It was approved for use in the NHS in England by the National Institute for Health and Care Excellence (NICE) in 2014, since when expenditure on the drug in primary care has quintupled to about 15,000 pounds a month in England.
But when dtb reviewed the evidence on which that decision was based, the editors expressed doubts about its approval.
"We concluded that we could not recommend its use 'based on the limitations of the evidence, the relatively modest reductions in drinking compared with placebo, lack of evidence on health-related outcomes and concerns over the generalisability of the data'," they wrote at the time.
Since then three groups of researchers have highlighted several issues relating to the licensing and approval of nalmefene.
These include that none of the studies specifically targeted the people for whom the drug was licensed, and that the licensing criteria were based on an ad hoc analysis of subsidiary data.
Furthermore, none of the trials compared nalmefene with any other drug, and the outcomes were not fully specified before the trials started.
There was "no direct evidence" to show that it reduced harmful drinking, improved quality of life, or curbed other aspects of harmful behaviour associated with heavy drinking.
Additionally, it was unclear whether the trial data were relevant to UK clinical practice in primary care, the editors pointed out.
Last but not least, the level of counselling provided in the trials was less than that recommended by NICE, suggesting that the true costs of prescribing the drug are likely to be flawed, they suggest.
"Given such widespread concerns, we would urge agencies that appraise medicines on behalf of the NHS to revisit their decision," write the editors, adding, "The company should be required to produce more robust evidence to demonstrate that nalmefene results in clinically meaningful harm reduction." "At a time when the NHS is removing some basic items from prescription, it seems incongruous that it continues to fund nalmefene despite having no real understanding of its actual impact on patient outcomes," they conclude.
This article has been published in Drug and Therapeutics Bulletin..