Paxil, Lies, and the Lying Researchers Who Tell Them

I'd thought it wasn't possible for the infamous Paxil Study 329 to be even more infamous, but I was clearly wrong. A new paper, based upon court documents, is out and, while you need to understand stats more than usual to understand what's going on, it's clear that GlaxoSmithKline and the study's authors were up to some deceptive crap. Not that that wasn't clear before.

For newbies, Study 329 was published in the Journal of the American Academy of Child and Adolescent Psychiatry in 2001. It claimed that Paxil was good for treating depression in kids and that patients didn't suffer many adverse effects from taking the drug. The study, however, was one of the most corrupt I have ever seen in all of psychiatry--and that's saying something--and contained all sorts of jury-rigged data, hidden data and, yes, it was ghost written as well. That means many of the big name psych docs such as Martin Keller whose names were on the study didn't have much of an idea of the supporting data. The paper has been thoroughly discredited at this point, but has never been retracted by the journal.

Healthy Skepticism has been questioning this study for years and has a resource page here.

CL Psych gets all the credit for getting this new analysis of 329 online the other day and for explaining what's really going on here. (I also need to credit him for the fabulous headline I stole for this post!)

"Let's break this thing down for a minute. The authors planned to look eight different ways for Paxil to beat placebo. They went zero for eight. So, rather than declaring defeat, the authors then went digging to find some way in which Paxil was better than a placebo. Devising various cutoff scores on various measures on which victory could be declared, as well as examining individual items from various measures rather than entire rating scales, the authors were able to grasp and pull out a couple of small victories. In the published version of the paper, there is no hint that such data dredging occurred. Change the endpoints until you find one that works out, then declare victory."

Fiddy has his take on this new paper, as does John Grohol at Psych Central. Matthew Holford writes about the study as well and wonders aloud if there wasn't some actual fraud involved, as opposed to usual chicanery. I wonder the same thing.

The whole sordid saga of this study isn't really worth repeating, but for those of you who are new to these issues you need to understand that the reason this study has generated so much heat over the years was because it involved children. I think as a culture we expect the pharma companies to lie like crazy when it comes to studies of how "well" their drugs work in adults, but when one of them would clearly manipulate a study involving children so shamelessly...well, that just hits the outrage button so much harder.

Besides, this study and the initial paper in 2001 establish just how ugly the world of academic publishing has become and just how badly it needs to be reformed. Why this hasn't happened yet is far beyond me.