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pregnancy; and (3) many drugs that have been withdrawn from the market had higher health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 …