Friday, September 18, 2015
This is seriously ugly
And, it concerns my employer. A study published in 2001 reported that the anti-depressant paroxetine was safe and effective for treating depression in adolescents. Long story short, it isn't either one. The trial failed to show any significant benefit over placebo, and it failed to report on the very troubling association of paroxetine with increased suicidality and self-harm.
Although many critics recognized that the trial did not seem to support the conclusions, two million off-label prescriptions for the drug were written for children and adolescents in 2002 alone. In 2012, GlaxoSmithKline, the study's sponsor and the drug's manufacturer, paid a $3 billion fine for several criminal violations regarding off-label marketing, the most important of which pertained to paroxetine.
The occasion for this post is that the BMJ has published a re-analysis of the data establishing with precision and rigor that the original report was fraudulent. But, the journal has not retracted it, despite many calls to do so over the years, and the principal author's university has taken no action whatsoever and has stonewalled all inquiries. That happens to be Brown University.
There is a "circle the wagons" mentality in academia, unfortunately, which does a disservice to the public and to the mission of the university, obviously; but also to our students, and to our investigators who work with integrity. I'm disappointed to find it here.