Placebo Adherence and Its Association with Morbidity and Mortality in the Studies of Left Ventricular Dysfunction

A provocative finding from several double-blind clinical trials has been the association between greater adherence to placebo study medication and better health outcomes. We used data from the Studies of Left Ventricular Dysfunction (SOLVD) Treatment Trial (SOLVD-TT) and the SOLVD Prevention Trial (SOLVD-PT) to examine whether such associations could be validated and to examine several sources of bias and potential confounding. Survival analytic methods were used to estimate the association between placebo adherence and several health outcomes, employing a number of modeling techniques to test for the existence of alternative explanations for the association. Higher adherence was defined as having taken ≥75% of prescribed study medication. Higher placebo adherence was associated with improved overall survival in both SOLVD-TT and SOLVD-PT [hazard ratio (HR) = 0.52, 95% confidence interval (CI): 0.35 to 0.79 and HR = 0.52, 95%CI: 0.38 to 0.71, respectively]. Associations were similar for fatal or non-fatal cardiovascular or coronary heart disease events. Adjustment for both modifiable and non-modifiable cardiac risk factors (including age, gender, diabetes, blood pressure, smoking, weight, alcohol use, and levels of education) had minimal effect on the strength of the association. Little evidence of bias was found as an explanation for this relationship. In these two trials, better adherence to placebo was associated with markedly superior health outcomes, including total in-study mortality and incident cardiovascular events. No important confounders were identified. These data suggest there may exist strong but unrecognized determinants of health outcomes for which placebo adherence is a marker

Analysis of sex and gender-specific research reveals a common increase in publications and marked differences between disciplines

Oertelt-Prigione S, Parol R, Krohn S, Preißner R, Regitz-Zagrosek V. Analysis of sex and gender-specific research reveals a common increase in publications and marked differences between disciplines. BMC Medicine. 2010;8(1): 70.© 2010 Oertelt-Prigione et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited

The Food and Drug Administration Office of Women\u27s Health: Impact of science on regulatory policy

In 1994, the Food and Drug Administration Office of Women\u27s Health (FDA-OWH) was created to provide leadership and policy direction for the Agency regarding issues of women\u27s health. Within its first year, the FDA-OWH established a science program for women\u27s health research, promoting the development of sound policy and regulation. In a little over a decade, the program has provided approximately $14 million to fund more than 100 women\u27s health research studies covering a broad range of health topics affecting women across their lifespan. Some studies, such as those elucidating drug effects on QT prolongation in women and drug-dietary supplement interaction, have had significant influence on regulatory decisions. Other studies have provided sound scientific data on sex and gender differences supporting FDA guidelines to protect women\u27s health. This paper describes the science program at the FDA-OWH, providing examples of how funded research impacts regulatory policy. © Mary Ann Liebert, Inc