Observational studies have found associations between antidepressant drug prescription during pregnancy and autism and ADHD. But is the link actually related to genetic predisposition rather than to the antidepressant? This article explores that question.
An association between antidepressants during pregnancy and neurodevelopmental disorders has been found in many observational studies. But is anemia part of the culprit? Dr Andrade takes a closer look at a recent study relevant to this question.
Do benzodiazepines pose a risk when taken during pregnancy? A recent case-control study indicated nearly doubled odds of spontaneous abortion. Dr Andrade takes a closer look at this study and the impact that methodology might have on the conclusions.
Dr Andrade considers the findings of observational studies indicating a higher risk of hip fracture in older people who take antidepressants—and whether confounding by indication can fully explain the results.
Methylphenidate is related to sleep-related adverse events. This meta-analysis sought to quantify this impact of methylphenidate and determine the varieties of sleep problems associated with this drug.
Was the adverse event caused by the drug or by the condition itself? In this installment of his column, Dr Andrade points to the importance of controlling for confounding by indication in observational studies.
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.”