Last Updated May 21, 2010 3:39 PM EDT
GSK didn't immediately respond to a request for comment. A staffer on GSK's trials hotline confirmed the study was ongoing, however. The drug carries a "black box" warning on its patient information sheet, warning doctors and consumers that the antidepressant is twice as likely to generate lethal thoughts than a placebo.
The trial criteria listed on ClinicalTrials.gov, however, provide an interesting lesson in how managers can carefully design drug trials designed to flatter their products -- something good companies don't do.
The primary aim of the study is not to find out why Paxil makes some children kill themselves. Rather, it's yet another efficacy study, which the drug doesn't need because it was approved years ago -- we already know the drug works.
Paxil is being tested against a placebo, so the results won't be very surprising -- even terrible drugs work better than sugar pills.
To what degree Paxil triggers suicide is only a secondary aim of the study. If the results suggest a lower suicide risk, expect GSK to play them up. If they're bad, expect the company to dismiss them in favor of the primary endpoint results.
About 130 children have been enrolled, according to ClinicalTrials.gov, which puts about 65 patients in each arm. That means the results won't be too statistically robust -- there only need to be two or three outlier results to skew the numbers by several percentage points.
The trial will wrap up in September.
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