Studying women in clinical trials: Scientific and legal implications

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medications than do men; (2) most require some type of drug therapy during pregnancy; and (3) many drugs that have been withdrawn from the market had higher health risks for women.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.