Conjugated equine estrogens and medroxyprogesterone have been the most commonly prescribed postmenopausal hormone therapy in the U.S. for women with a uterus and, until 2001-2002, had been used each day by more than six million women. It had been thought that the use of these agents would prevent cardiovascular disease, osteoporosis, and cancer in postmenopausal [...]
Continue reading " Politics and Clinical Trials: THE WOMEN’S HEALTH INITIATIVE "
In 1981, the National Commission, in describing the principles of equitable selection of subjects, stated that women could take part in all research studies. This decision coincided with a publication by Kinney et al. showing that young women served as subjects in premarketing drug trials less frequently than young men. The authors discussed the moral, [...]
Continue reading " Politics and Clinical Trials: I980-I990s "
INTRODUCTION Prior to the third quarter of the 20thcentury, the Food and Drug Administration’s (FDA’s) guidelines for the inclusion of women in clinical studies for all types of illnesses were limited. The FDA barred women of childbearing age from all phase I trials (safety studies) and from all other studies until animal teratology and fetal [...]
