Alcohol‐dependence: The Current French Craze for Baclofen

Over the last 3 years, the word 'baclofen' has appeared on the cover of numerous non-specialized French journals, which sing the praises of its potentially miraculous effects on alcohol dependence. Baclofen is a gamma-amino-butyric-acid-B (GABA-B) receptor agonist, approved for many years for spasticity. Some recent works reported promising effects of low-dose baclofen (30 mg/day) for alcohol dependence [1], but these data remained largely confined to the medical community. A few years ago a French cardiologist suffering from alcohol dependence, Olivier Ameisen, tested baclofen on himself, at doses reaching a maximum of 270 mg/day, and published an atypical 'autocase' report in which he maintained that high-dose baclofen (HDB) had suppressed his dependence [2]. Ameisen also wrote a best-selling book describing the story of his addiction, and of his use of HDB. This book attracted media attention and popularized baclofen among the French general public. An overwhelming number of patients now beg their physicians to be treated with HDB, and sales of baclofen increased by 20% between 2008 and 2010 (see Fig. 1). Moreover, an association of physicians prescribing HDB and patients proclaiming that they were cured of their alcohol dependence through this treatment are now lobbying for official approval to extend HDB to alcohol dependence. Evolution of baclofen's sales in France (source: AFSSAPS, published with their kind permission) Thus far, the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), the French health authority, has refused to officially recommend baclofen for alcohol-dependence. In a recent online publication [3], the AFSSAPS called for caution in the use of HDB, noting that no scientific data were currently available concerning the efficacy and the tolerance of this medication in alcohol-dependent patients, and officially encouraged the realization of well-conducted trials. In practice, AFSSAPS faces a dilemma. If they refuse to approve the use of HDB for alcohol dependence because of insufficient scientific data, as has been their position thus far, they are immediately accused by pro-baclofen associations of depriving alcohol-dependent patients of a potentially miraculous treatment; but if they approve it prematurely under the pressure of the same associations, and if serious adverse events are reported secondarily, they will be accused of laxity. Currently, the issue of baclofen in France seems to have taken quite an emotional turn. Perhaps this current craze will end soon. Some clinical trials should start in the near future [4], and it is hoped that they will provide definitive answers on the efficacy and tolerance of HDB in alcohol dependence. However, until such results are available patients will continue to clamour for the treatment the media is talking about, and many general practitioners (GPs) and addiction specialists already face the same dilemma as the AFSSAPS: refuse to prescribe HDB because of the lack of scientific data or prescribe off-label. A decline in the prescription could lead to a self-medication trend by patients who can easily buy baclofen on the internet, but it also seems risky for isolated GPs and specialists to provide regular and numerous HDB prescriptions. As long as this very specific situation lasts, our personal perspective is that the least negative solution is to entrust off-label HDB prescription to specialized medical teams that can provide a sufficient supervisory system, based on the same rules required for clinical trials [5]. Protocols for HDB prescriptions should be validated by a collegial expert group of practitioners, and patient follow-up should be monitored strictly to identify immediately any adverse events during treatment. Such a supervised prescription system fits into a logic of harm reduction. Because it would be illusory to prevent patients from obtaining baclofen by their own means, it seems preferable to deliver HDB under close observation by teams with good scientific knowledge and regular use of the product. The authors would like to thank AFSSAPS for kindly permitting the publication of data related to baclofen's sales. B.R. and O.C. were investigators in a clinical trial on Nalmefene in 2010, organized by Lundeck. B.R. has participated as an unpaid speaker for the Institut de Recherche Scientifique sur les Boissons (IREB), which receives funding from the alcohol industry.