PHARMACEUTICAL DECISION-MAKING - PHARMACOEPIDEMIOLOGY OR PHARMACOECONOMICS - WHOS IN THE DRIVERS SEAT

Although it is well known that clinical trial findings and actual clin ical experience can differ substantially in pharmaceutical decisionmak ing, it is our working hypothesis that this divergence is critically i mportant in the area of psychopharmacology. We support this contention with a discussion of recent findings from post-marketing pharmacoepid emiologic and pharmacoeconomic investigations of clozapine. The pharma coeconomic evaluations purport to show cost savings of clozapine versu s standard neuroleptic therapy but these conclusions are flawed, in la rge part because the epidemiologic investigations on which they are ba sed are inadequate. To correct this situation, long-term, randomized f ield trials (usual practice settings) are needed to compare costs and outcomes of clozapine versus standard therapy. The design of these stu dies should incorporate multidimensional outcomes, including social fu nction, employment, and rehospitalization, as well as measures of symp toms and self-reported quality of life. Pharmacoeconomic evaluations t hat adopt the designs of typical clinical trials with limited outcome measures, such as symptoms or self-reported quality of life measures, will not be sufficient to determine cost-effectiveness for psychopharm acologic therapies of severe mental disorders.