Paxil and Pimping

A preliminary ruling has indicated that GlaxoSmithKline should pay out $63.8 million to make amends for making misleading claims about its antidepressant Paxil (Seroxat) in kids. Of course, the company admits no wrongdoing.

I wonder if the authors who stamped their names on the the main ghostwritten "scientific" publication for Paxil in kids should also be shelling out some cash. After all, it was the paper (chock full of HUGE misinterpretations of the study data) with their names on it that was doubtlessly used as part of the Paxil in kids marketing campaign. Were these "independent" academics innocent parties who were misled by the corporate meanies at GSK? Or, conversely, were these academics an integral part of the marketing team and should they also be held accountable for making false claims? Like these claims made in the infamous GSK study 329 (from an earlier post)...

Article: Paroxetine is generally well-tolerated and effective for major depression in adolescents (p. 762).

Data on effectiveness: On the primary outcome variables (Hamilton Rating Scale for Depression [HAM-D] mean change and HAM-D final score < 8 and/or improved by 50% or more), paroxetine was not statistically superior to placebo. On four of eight measures, paroxetine was superior to placebo. Note, however, that its superiority was always by a small to moderate (at best) margin. On the whole, the most accurate take is that paroxetine was either no better or slightly better than a placebo.

Data on safety: Emotional lability occurred in 6 of 93 participants on paroxetine compared to 1 of 87 on placebo. Hostility occurred in 7 of 93 patients on paroxetine compared to 0 of 87 on placebo. In fact, on paroxetine, 7 patients were hospitalized due to adverse events, including 2 from emotional lability, 2 due to aggression, 2 with worsening depression, and 1 with manic-like symptoms. This compares to 1 patient who had lability in the placebo group, but apparently not to the point that it required hospitalization. A total of 10 people had serious psychiatric adverse events on paroxetine compared to one on placebo.

What exactly were emotional lability and hostility? To quote James McCafferty, a GSK employee who helped work on Study 329, “the term emotional lability was catch all term for ‘suicidal ideation and gestures’. The hostility term captures behavioral problems, most related to parental and school confrontations.” According to Dr. David Healy, who certainly has much inside knowledge of raw data and company documents (background here), hostility counted for “homicidal acts, homicidal ideation and aggressive events.”

Suicidality is now lability and overt aggression is now hostility. Sounds much nicer that way.

What counts as safe and effective on Planet Paxil passes as ineffective and dangerous to us Earthlings. So while I'm glad to see that it appears GSK will be shelling out some dough to compensate its , consumers, the systemic problems of ghosted science and outright lying are not addressed. What is $64 million to GSK? Roughly a drop in the bucket. And the "key opinion leaders" who pimped Paxil escape unscathed.

Please read the fine post at Health Care Renewal about how academics might be brought to think twice before becoming drug pimps. I also think that giving out sarcastic awards to academics who participate in ghosted science is a good idea, so here goes...

Awards? I'd like to nominate Dr. Karen Wagner for a Golden Goblet, or perhaps a Krusty the Klown award for her pimping of Paxil as well as her stalwart work on the "SSRIs are great for kids" report authored on behalf of the American College of Neuropsychopharmacology. Her reports of clinical trials that overstated the efficacy and hid serious side effects of Zoloft also merit special mention. Overstating the efficacy of citalopram in kids was also nice work. While she was co-authoring the report saying that SSRIs are great for kids, she was also busy conducting trials of SSRIs for kids. Sound like a conflict of interest? Worry not, because she was also sitting on the conflict of interest committee at her own university!

Please feel free to add your nominations.

Oh, and as for the latest version of SSRIs are great for kids report (in JAMA). I'll hopefully get on that sometime in the near future. Suffice to say that it is highly misleading for now.