Glaxo 'Falls Short Of Open Data Disclosure:' Jureidini Explains

Over the past few months, a group of researchers has been haggling with GlaxoSmithKline over access to detailed data for an infamous 2001 study of its Paxil antidepressant called 329 that tested the pill for treating depression in adolescents. The researchers, who are led by Jon Jureidini, a clinical professor of psychiatry at the University of Adelaide in Australia, want a 1998 clinical study report that they hope to reanalyze and republish. The original results reported that Paxil was effective, but the trial actually missed its endpoints and figured in a ghostwriting controversy (here is the study). As a result, Glaxo signed a consent order with the New York State Attorney General to publicly disclose trial data and has since vowed to do so. But the drugmaker says that Jureidini, who also led an unsuccessful quest to have the study retracted (see this), must follow its new system for submitting proposals (back story and more here). We spoke with Jureidini about his efforts. This is an excerpt of our conversation… Pharmalot: Why did you make this request? Jureidni: I’ve been occupied with trying to get some truth about that study for a long time. And just because it had such an impact in child psychiatry in Australia at the time it came out. It was used to try to shift the approach to (treating) childhood depression and (Paxil) became first line (therapy). I looked at it the first time I read it and thought perhaps medication is the answer. But then, I reread it and spo...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs