Lack of applicable safety data has effected an ease in federal restriction on the inclusion of women in clinical trials, particularly because: (1) they consume more prescription and over-the-counter medications than do
men; (2) most require some type of
drug therapy during pregnancy; and (3) many drugs that have been withdrawn from the market had higher health risks for women. The desire for more women-specific data prompted the Women's Health Initiative (WHI) studies, which reported an unfavorable risk-benefit relationship for
hormone replacement therapy (HRT), as well as no significant reduction in disease or fracture risk with
calcium and
vitamin D supplementation but possible
kidney stone development. Although the health risks were minimal, physicians feared any possible litigation involved with the use of HRT and were concerned with any possible adverse effects from
calcium supplementation, and therefore altered their prescribing practices. Women, fearing any long-term health risks, also began seeking alternative treatments. However, the safety of these
alternative therapies may be questionable, because they often are not subjected to extensive scrutiny and do not require federal approval. Alternative
prescription drug treatments may have long-term adverse consequences that will only become evident with years of use. It is important to recognize that over-generalization and extrapolation of data may deny appropriate treatment to certain subgroups of women who may benefit.