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HELLO POP

Baclofen, a French Exception, Seriously Harms Alcohol Use Disorder Patients
Without Benefit To the Editor: Dr Andrade’s analysis of the Bacloville trial in
a recent Clinical and Practical Psychopharmacology column, in which he concluded
that “individualized treatment with high-dose baclofen (30-300 mg/d) 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 recall that the first pivotal trial 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 questionable, lacking robustness. Although he cited us,3 he overlooked
the evidence we provided indicating that the Bacloville article4 was published
without acknowledging major changes to the initial protocol, affecting the
primary outcome. Coincidentally (although as skeptics, we do not believe in
coincidence), the initial statistical team was changed when data were sold to
the French pharmaceutical company applying for the marketing authorization in
France. As Ronald H. Coase warned, “If you torture the data long enough, it will
confess.”

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