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1- What exactly does the exclusion criterion "Patients in the opinion of the chief investigator (subinvestigator) judged as not eligible for the study" mean? What other criteria might this include not already listed. Could it possibly mean that children & adolescents will be pre-screened, by genetic testing to be sure that they are not deficient in the CYP450-2D6 enzyme that Paxil desperately needs to be safely cleared from a persons system. Will these kids not be included in the study?Â
2- Does the long list of exclusion criteria really represent the real world of kids that will be prescribed this drug in Japan, if it is approved. Will doctors use this same list of criteria when deciding to prescribe Paxil to their young Japanese patients?Â
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You have to ask yourselves if GlaxoSmithKline used the same criteria in other trials for Paxil other than trials for children. Whatever or whomever they excluded in all of the Paxil trials should be made abundantly clear to all.
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