The PCAST report: impact and implications for the pharmaceutical industry.

The President's Council of Advisors on Science and Technology (PCAST) report sets out an ambitious goal: to double the output of innovative, new medicines with increased efficacy and safety within the next 10-15 years. If attainable, this could change the face of medicine and bring great benefit to society. Clear leadership, commitment to action, and unprecedented collaboration will be essential if the goal of the report is to be realized.

Fluoxetine vs. tricyclic antidepressants in women with major depressive disorder.

Major depressive disorder and dysthymia are twice as prevalent in women as in men, and the lifetime risk of a woman's developing a major depressive disorder is about 20%. Yet depression is often unrecognized or misdiagnosed in women, and only about one quarter of women who meet criteria for major depressive disorder receive appropriate therapy. Until recently, women were generally excluded from clinical drug trials because of concerns of inadvertent pregnancy and risk of teratogenicity. Thus, information on safety and efficacy in those most likely to require antidepressant therapy is lacking. Studies have shown that the antidepressant fluoxetine, a selective serotonin reuptake inhibitor (SSRI) has a more tolerable side effect profile than do tricyclic amine (TCA) antidepressants, but few data have been reported on the efficacy and tolerability of fluoxetine or other SSRIs in female patients. In this study, a retrospective analysis of 11 randomized, double-blind, well-controlled trials was done to compare data from 427 female patients on fluoxetine and 423 female patients on TCAs. Both fluoxetine and TCAs significantly reduced the HAMD17 total mean score from baseline to end point, week 5 (fluoxetine, 24.35 to 14.37; TCAs, 24.57 to 14.43; p < 0.001). Both treatment groups were associated with significant reductions in the HAMD17 anxiety/somatization and insomnia subfactor scores. Abnormal vision, constipation, dizziness, dry mouth, and somnolence occurred more frequently (p < 0.05) in the TCA group. Insomnia and nausea were the only adverse events more common (p < 0.05) in the fluoxetine group. This study demonstrates that fluoxetine is an effective and tolerable agent for the treatment of major depressive disorder in women.

Gender differences in psychotropic medications.

During the past decade pharmacological research has greatly enhanced the understanding of several variables affecting the prescription of psychotropic medication. One variable of increasingly recognized importance is the gender of the patient. Significant gender differences have been described for psychiatric disease prevalence, symptom presentation, treatment-seeking behavior, and receipt of psychotropic medication. Despite these findings little has been investigated in the potential gender differences in efficacy, dosage, and side effects influenced by pharmacokinetic or pharmacodynamic properties of psychotropic medications. This leaves an important gap in information of potential clinical importance. This relatively young field of study has a number of variables to consider including the impact of psychosocial issues, environmental components, and genetic and hormonal influences. We will review literature on the impact of gender on psychotropic medications and make recommendations for further research.