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The National Institute for Health and Care Excellence (NICE) has given final draft guidance for the use of the drug nalmefene as a treatment for people with alcohol dependence.
Dr Niamh Fitzgerald, Lecturer in Alcohol Studies, Institute for Social Marketing (ISM), School of Health Sciences, University of Stirling, said:
“Nalmefene is the first drug to be licensed for reducing alcohol consumption in people with alcohol dependence, rather than to support complete abstinence from alcohol. Reducing consumption is likely to be beneficial in those individuals, and clinicians may feel that if patients cannot manage to cut down with counselling alone, nalmefene offers a helpful option. In my opinion however, there are reasons to be concerned about what the introduction of nalmefene will mean in practice.
“The published trials of nalmefene show efficacy in a very specific group of people, with a formal diagnosis of alcohol dependence, who drink at a high level. In these trials, which were funded by the pharmaceutical company, people received treatment in specialist settings (not from their family doctors) and the drug was shown to work only in conjunction with regular counselling (e.g. 15-30 minute sessions).
“While the licensing conditions and the NICE guidance reflect the trials, there is nothing to stop nalmefene being prescribed in other settings or for other patients, or with inadequate or no counselling. I believe that there is little/no evidence to suggest efficacy in such circumstances and that there is a need for independently-funded research to be conducted into the drug to further test the trial results. The risk of this kind of off-licence and possibly ineffective use is arguably higher if used by busy GPs, as the target group for the drug would take time to identify properly (given the complexity of understanding what constitutes ‘dependence’ and ‘high risk’ drinking), and the general discomfort on the part of many doctors with providing counselling for alcohol problems.
“The fact that alcohol problems are widespread in society is an important principle for effective policy options such as minimum unit pricing and restrictions on marketing of alcohol. It would be unfortunate if the availability of nalmefene led to a sense that the appropriate response to these widespread problems was for the NHS to medicate large numbers of people, rather than initiating these other more effective and less costly approaches to reduce consumption.”
Prof Matt Field, Professor of Addiction, University of Liverpool’s Department of Psychological Sciences, said:
Q: What is the difference between alcohol dependence and alcoholism? How frequently does dependence develop into alcoholism?
“There is no difference: the main clinical manuals (the WHO’s International Classification of Diseases, and the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders) refer to ‘alcohol dependence’ and ‘alcohol use disorder’, respectively. Both clinical manuals recognise that the disorders can vary in severity and you can see that in the case studies provided by Lundbeck – most of these people would warrant a diagnosis of alcohol use disorder but for some people it is mild and for others is it more serious.
Q: How does nalmefene work? How effective is it? What do we know about side-effects etc?
“The effectiveness of nalmefene is controversial. Although the published clinical trials show that it can help people to reduce drinking if they are unable to reduce their drinking by themselves, commentators in the BMJ have questioned the positive spin that Lundbeck put on their trial data. For example in one of the bigger trials, the reduction in drinking when given nalmefene was based on only a subgroup (one quarter of the patients) and there were lots of missing data (see http://www.bmj.com/content/348/bmj.g2017.full.pdf+html). In the ‘Nalmefene backgrounder’ document, Lundbeck acknowledge that it can reduce alcohol consumption ‘in certain patients’, but it is also important to note that, when data from all participants were considered in analyses, all participants reported a big reduction in drinking, even those who received placebo, and the additional benefit from nalmefene was small (see http://www.bmj.com/content/348/bmj.g1531)”
Q: How do any side-effects of nalmefene compare to harms from drinking? How damaging to an individual is being dependent on alcohol?
“In people who drink too much, any reduction in drinking is likely to lead to an improvement in health. Given that it is very difficult to help people to reduce their drinking, any treatment (be it a policy change, a talking therapy, or a drug, such as this one) should be welcomed.”
Q: Presumably this isn’t going to be forced on people, so would only be given to people who want to reduce their dependence? Or will there be certain people who are penalised if they don’t take the drug?
“All of the clinical trial data are from people who were motivated to reduce their drinking. It simply hasn’t been tested on people who are not interested in reducing their alcohol consumption and most clinicians believe that no treatment can be effective unless people are motivated to change. For this reason, motivational interviewing or enhancement therapy is often offered to people in the UK. The goal is to make people more motivated to reduce their drinking and therefore more likely to respond to other treatments, such as nalmefene or talking therapies such as CBT.”
Q: Is there any evidence that the drug should be used as a prophylactic to reduce alcohol dependence in the first place? Perhaps for people with certain genetic make-up or increased likelihood to become addicted?
“No, although given its hypothesised mechanism of action it could help people to arrest a ‘mild’ alcohol problem and stop it from getting worse. This would need to be studied though and again, it is likely that people would need to be motivated to reduce their drinking before taking the drug.”
Q: Will this drug be used for severe alcoholics? Are there different treatments for them and if so, why? Is it due to cost or side-effects or something else?
“The drug is not approved for people with physical withdrawal symptoms, one of the most prominent symptoms of ‘severe’ alcohol dependence. Other drugs such as acamprosate and disulfiram can be prescribed for people who are severely dependent. It is controversial whether alcoholics should ever be advised to ‘cut down’ rather than abstain altogether: Alcoholics Anonymous recommend abstinence, but some psychologists and psychiatrists may recommend that some of their patients try to cut down their drinking instead. At the moment there is no evidence that nalmefene can help people to completely abstain. However the other drugs mentioned, alongside social support and / or membership of an AA group, may be more effective for people who need to aim for complete abstinence.”
Q: Many people will consider themselves to fulfil these requirements but would not feel they are dependent or want to reduce their alcohol intake – is it likely that they are not recognising the harm they are doing to themselves, or is it a non-issue because only people who want to reduce dependence will take the drugs and the way that this decision is made is simply to say at what level it becomes cost effective?
“One of the biggest problems is that many people are drinking too much but they do not appreciate the harm that they are doing to themselves either because they do not understand government guidelines, or what is a unit of alcohol, or because they simply don’t believe that their drinking could be harming their health. The good news is that many people who drink too much can reduce their consumption if they decide that they want to and are given the social support to do so – and the results from the placebo groups in the clinical trials of nalmefene are consistent with this.”
Declared interests
Prof Matt Field: I have received funding from the Medical Research Council, Wellcome Trust, Economic and Social Research Council, and Alcohol Research UK. I have no other conflicts of interest.