Wim van den Brink and colleagues reply to Des Spence and Alain BraillonBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g2605 (Published 07 April 2014) Cite this as: BMJ 2014;348:g2605
- Wim van den Brink, professor of psychiatry and addiction1,
- Karl Mann, professor of psychiatry and addiction2,
- Antoni Gual, director3,
- Henri-Jean Aubin, professor of psychiatry and addiction medicine4
- 1Academic Medical Centre, University of Amsterdam, Meibergdreef 5, 1105 AZ Amsterdam, Netherlands
- 2University of Heidelberg, Heidelberg, Germany
- 3Addictions Unit Clinic, Hospital of Barcelona, Barcelona, Spain
- 4Université Paris-Sud, Paris, France
Two opinions about nalmefene, a new drug for treating alcohol dependence, were recently published in the BMJ: Des Spence refers to nalmefene as bad medicine and Alain Braillon accuses the European Medicines Agency (EMA) of having performed a junk evaluation of it.1 2 We challenge their arguments.
Spence incorrectly mentions that nalmefene was added to “extensive counselling,” whereas patients in the study in fact received only short sessions (10-15 minutes) of support to enhance compliance and motivation from their doctors, which is very close to standard clinical management. He then talks about the “dark art of subgroup analysis” but fails to mention that the results from the total group analyses were all very similar to those of the subgroup analyses.3 4 5 Indeed, the subgroup analysis was clearly marked as secondary analyses performed to …
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