Pharmaceutical giant Glaxo Smith Klyne (GSK) has begun a new test study of its controversial antidepressant Paxil using a group of 7-year-old Japanese children as the subjects.
GSK officials confirmed that the test has begun but have not commented on the study. The aim seems to be an attempt at casting doubt on the well-established risk of increased suicidal thoughts when young people take the potent medication.
Part of the controversy surrounding the study concerns its confusing criteria. Officially, the listed information says that this study is an efficacy test — in short, to determine whether Paxil works against a placebo as a control group. However, Paxil already is an approved drug. It has been demonstrated to help people with their depression. This is no longer an issue, so testing it again seems rather odd, unless you consider the company may be looking for some additional good press.
Notably, the study does not include a test against other antidepressant medications as a measure of suicide risk among the selected age group. Given that the drug already has been verified to work, why not test it against other drugs for the most famous problem associated with it? The only allowance the study makes for determining suicide risk is as a secondary aim. In other words, such info is “nice to know,” but hardly the goal.
Further, the trial group doesn’t seem to be large enough to allow for a truly representative sample. There are only about 130 children listed as participants. With approximately half in the test group and the other half in the control group, this means even small instances of unusual results can change the percentages dramatically. So in short, the study is pursuing something already known, with a sample group nowhere near large enough to provide telling results. Given the very real cases continually levied against GSK, one wonders what the point could be.
