Debate over the use of Nalmefene (Selincro) has opened up following NICE draft guidance which says it should be available as an option for some dependent drinkers. Nalmefene is the first drug available intended to help eligible problem drinkers cut down, whereas existing NICE approved medications are licensed for use to support abstinence.
Below we explore some key considerations for the alcohol field in the wake of the recent attention and forthcoming full NICE guidance on Nalmefene.
Understanding 'alcohol dependency' in a treatment context
Some of the debate stems from poor journalism or misunderstanding around the use of the drug and in particular, alcohol dependency itself. Whilst many people perceive alcohol dependency only in terms of 'alcoholism', recognising a spectrum of dependence ranging from mild to severe is favoured by most addiction experts.
Most people with alcohol problems though, including mild or even moderate dependency, are usually a long way from common ideas of the 'alcoholic'. This causes challenges such as barriers to early recognition of 'alcohol problems' or acceptability of interventions and support. The concept of a 'pill to help reduce drinking' therefore seems controversial given a common belief that 'all "alcoholics" need to go for abstinence'.
However, alcohol services reflecting NICE treatment guidance will support those with alcohol dependency to aim for reduced drinking if they chose to do so. Evidence of some dependent drinkers returning to non-dependent drinking does exist, albeit less severely dependent drinkers seem more likely to achieve this (and multiple factors will be influential).
What this means for Nalmefene?
Nalmefene is therefore aimed at 'mildly dependent' drinkers, whilst those with severe dependence (i.e physically dependent) and those with other complicating factors are not eligible. One further complication is the measures used in the research trials to define eligible drinkers. The studies identify those qualifying as having a sufficient 'Drinking Risk Level' (DRL) when having a significant score on the Severity of Alcohol Dependence Questionnaire (SADQ) and drinking more than:
- 5 units in a drinking day if female
- 7.5 units in a drinking day if male
In addition to fulfilling a criteria for dependence, drinkers in the trials were advised to cut down and had not reduced two weeks later to be eligible (but many did). Yet some media headlines inferred anyone drinking 'two glasses' of wine was being lined up for the treatment - see this example from the Telegraph. However most media reports also highlighted some of the concerns or considerations voiced by addiction or public health specialists. In particular, concerns over an expectation that it is the pill alone that 'works', when there is only evidence to support its use alongside psychosocial support. One of a number of issues previously explored here in this guest post.
Dr Niamh Fitzgerald, Lecturer in Alcohol Studies at the University of Stirling, has also highlighted other areas for consideration. In this Science Media Centre article, she cautions over 'what the introduction of Nalmefene will mean in practice'. The studies informing the NICE approval were conducted with people recruited through specialist services, not those visiting their GP. There is therefore a gap in evidence for its use in Primary Care settings where efforts to implement simpler psychosocial approaches such as IBA have been mixed at best.
Other public health roles highlighted the role of environmental factors in addressing alcohol misuse. Policies such as minimum pricing, or tighter controls on availability or advertising which don't require NHS spending on medications and would reach a broader group of harmful drinkers. Other questions such as the nature of pharma funded trials and the various policy implications have been raised in relation to Nalmefene.
Whilst a consensus may be that Nalmefene could be a 'helpful option' for certain problem drinkers, there may be significant efforts needed to ensure it is used only as intended - for instance only alongside psychosocial support, for properly eligible drinkers and in tested settings. Calls to further study its use and effects therefore seem well warranted.
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