hi dad
Baclofen, a French exception, seriously harms patients with alcohol disorders without benefit Editor: Dr. Andrade’s analysis of the Bacloville study in a recent column in Clinical and Practical Psychopharmacology, in which he concludes that “individualized treatment with high-dose baclofen (30 – 300 mg/day) may be a useful second-line approach in heavy drinkers’ and that ‘baclofen may be particularly useful in patients with liver disease’ deserves comment.1 First, Andrade failed to remember that the first major study of baclofen, ALPADIR (NCT01738282; 320 patients, as with Bacloville), was negative (see Braillon et al2). Second, Dr. Andrade should have warned readers that Bacloville’s results are most dubious and lack stability. Although he cited us3, he ignored the evidence we provided showing that the Bacloville paper4 was published without acknowledging major changes in the original protocol affecting the primary outcome. Coincidentally (although as skeptics, we don’t believe in coincidence), the original statistical team was changed when the data was sold to a French pharmaceutical company applying for marketing authorization in France. As Ronald H. Coase warned, “If you torture the data long enough, it will confess.”