Baclofen is largely ineffective for alcohol use disorders, finds studyBMJ 2018; 360 doi: https://doi.org/10.1136/bmj.k930 (Published 26 February 2018) Cite this as: BMJ 2018;360:k930
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Mayor’s title, wild but wise, has not ended the baclofen saga. (1) Epidemiologists should help to understand how such a gross misconception has developed. Indeed, the Guardian subtitled it “the medical breakthrough of the century” despite no evidence for efficacy. (https://www.theguardian.com/society/2010/may/09/alcoholism-health-doctor...) The whole story began with the claim of a French cardiologist, from his personal case in 2008. However, the origin of the use of very high doses remains unknown: “for nothing (they) used high doses” (Ameinsen O, personal communication to AB, 1 Aug 2012) and is almost specific to France. Therefore baclofen is a double French exception.
While, evidence for ineffectiveness has been accumulating, (3) hope and hype have been continuing. This ineffectiveness has been publicly covered worldwide (https://www.theguardian.com/society/2016/sep/16/baclofen-controversial-p..., https://www.theguardian.com/society/2017/sep/21/pills-prescribed-for-alc...). In 2017 a pharmaco-epidemiological study in the real life setting showed an association between a two-fold increase in mortality and use of high doses (http://ansm.sante.fr/S-informer/Communiques-Communiques-Points-presse/Re...). This two-fold increase was also observed in a publicly funded trial sold to a drug company that is still unpublished. (3)
The news is that the French Drug agency (National Agency for the Safety of Medicines and Health Products, ANSM) just (24 April) released the verdict on the balance between safety and benefit of baclofen in alcohol use disorders from a special scientific committee of independent experts (http://ansm.sante.fr/S-informer/Actualite/Baclofene-dans-l-alcoolo-depen... ). Two major French trials had, said the committee, produced modest and patchy findings in favour of baclofen “the clinical relevance of [which] appears to be questionable”, while on the other side there was “a potentially increased risk of developing serious adverse events (including death) especially at high doses”. The benefit harm ratio “is negative”. This news, despite having been expected, deserves close scrutiny:
First, how could a drug company have rationally applied for marketing authorisation, even limited to France, as late as April 2017, considering the devastating evidence available for a long time? (3)
Second, why has the French Drug Agency not definitively rejected the application? Indeed, the process is continuing with public hearings (scheduled for July 2018) of different stakeholders including several associations with Key Opinion Leaders. (4)
Third, why did the Paris Public Hospital Authority highlight baclofen as safe and effective in 2017? (http://www.webcitation.org/6tiRJTHQz ) Several associations are also still lobbying against the Agency’s last year ruling which limits the use of high doses. This ruling has been challenged by a legal recourse before the Conseil d'Etat, the highest French Court.
Exception in healthcare never benefits patients. French people experienced it with benfluorex. Sadly, experience seems a gloomy lantern that does not even illuminate its bearer.
1 Mayor S. Baclofen is largely ineffective for alcohol use disorders, finds study. BMJ 2018;360:k930
2 Palpacuer C, Duprez R, Huneau A et al. Pharmacologically controlled drinking in the treatment of alcohol dependence or alcohol use disorders: a systematic review with direct and network meta-analyses on nalmefene, naltrexone, acamprosate, baclofen and topiramate. Addiction 2018;113:220-237.
3 Braillon A, Naudet F. Baclofen and the "first do not harm" motto: a new French paradox? Clin Toxicol (Phila) 2018;56:307-308.
4 Braillon A. Recommendations of French Alcohol Society and European Federation of Addiction Societies. CNS Neurosci Ther 2016;22:535-6.
Competing interests: No competing interests