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1Northeast Program Evaluation Center (182),VA Connecticut Health Care System, 950 Campbell Ave. West Haven, CT 06516, and at the Child Study Center, Yale Medical School, New Haven, CT, United States. Robert.Rosenheck@Yale.Edu
Abstract:
The rapid growth in sales of psychotropic medications during the late 1980s and 1990s, eventually reaching $20 billion/year, reflected the increased use of seritonin reuptake inhibitors for depression and atypical antipsychotics for schizophrenia. Recently, however, some of the therapeutic claims for these medications have been challenged, and under-appreciated risks have turned out to be significant liabilities. Drug manufacturers increasingly dominate clinical trials research and evidence suggests that study designs and data presentations have been slanted to show products in a favorable light while unfavorable data were suppressed. At the same time, during the 1990s, potentially independent voices did not effectively or consistently present countervailing views. The extensive financial ties between the pharmaceutical industry and academic researchers, professional associations, and consumer groups may also have discouraged expression of critical views. Additionally, the narrow legal mandate of the FDA to evaluate the safety and efficacy of new drugs only in comparison to placebo (rather than in comparison to other treatments) probably limited its contribution. In the absence of reliable, impartial research on the risk and benefits of psychotropic medications, both before and after they are brought to market, pharmacy benefits management cannot achieve its goal of maximizing health care benefits per dollar spent. Further institutional support is needed for independent research, either conducted or funded by the federal government.
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