Effectiveness of antidepressants: an evidence myth constructed from a thousand randomized trials?

Antidepressants, in particular newer agents, are among the most widely prescribed medications worldwide with annual sales of billions of dollars. The introduction of these agents in the market has passed through seemingly strict regulatory control. Over a thousand randomized trials have been conducted with antidepressants. Statistically significant benefits have been repeatedly demonstrated and the medical literature is flooded with several hundreds of "positive" trials (both pre-approval and post-approval). However, two recent meta-analyses question this picture. The first meta-analysis used data that were submitted to FDA for the approval of 12 antidepressant drugs. While only half of these trials had formally significant effectiveness, published reports almost ubiquitously claimed significant results. "Negative" trials were either left unpublished or were distorted to present "positive" results. The average benefit of these drugs based on the FDA data was of small magnitude, while the published literature suggested larger benefits. A second meta-analysis using also FDA-submitted data examined the relationship between treatment effect and baseline severity of depression. Drug-placebo differences increased with increasing baseline severity and the difference became large enough to be clinically important only in the very small minority of patient populations with severe major depression. In severe major depression, antidepressants did not become more effective, simply placebo lost effectiveness. These data suggest that antidepressants may be less effective than their wide marketing suggests. Short-term benefits are small and long-term balance of benefits and harms is understudied. I discuss how the use of many small randomized trials with clinically non-relevant outcomes, improper interpretation of statistical significance, manipulated study design, biased selection of study populations, short follow-up, and selective and distorted reporting of results has built and nourished a seemingly evidence-based myth on antidepressant effectiveness and how higher evidence standards, with very large long-term trials and careful prospective meta-analyses of individual-level data may reach closer to the truth and clinically useful evidence.     

The Integral Place of Religion in the Lives of Rural African–American Women Who Use Cocaine

To understand the culture of rural African–American women who use cocaine, ethnographic research was conducted in rural North Central Florida using in-depth interviews and participant observations with 30 respondents. Fourteen major themes emerged from the data; however, this paper focuses on one theme, that of religion. Nine sub-themes about religion and spirituality emerged. Religion was viewed as a personal relationship with God, which is not dependent on socializing with other church members, but was helpful in sustaining the respondents. While religiosity was a stable and consistent place in the respondents’ lives and some relied on their faith in God to replace their addiction, faith was not uniformly utilized by all respondents in this manner. Religiosity among African–American women who use cocaine cannot solely overcome the lack of drug treatment or treatment options and the stigma associated with drug use although it maybe a resiliency factor, which warrant promoting.Dr. Emma J. Brown, Ph.D., A.P.R.N., B.C., F.A.A.N., is an associate professor at the University of Central Florida in the School of Nursing. Dr. Brown’s primary area of research is STD/HIV prevention intervention among rural adolescents, women of color, and individuals who ab(use) illegal drugs. Dr. Brown’s secondary area of research is drug ab(use) prevention interventions among rural populations.