Women in Clin Trials - Gender Med 2007

Women in Clin Trials - Gender Med 2007 - GENDER...

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GENDER MEDIClNE/VoL. 4, No. 1, 2007 Law, Ethics, and Gender Studying Women in Clinical Trials: Scientific and Legal Implications Steven M. Weisman, PhD; and David Schwartz, PhD Innovative Science Solutions, LLC, Morristown, New Jersey ABSTRACT 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 medica- tions than do men; (2) most require some type of drug therapy during pregnancy; and (3) many drugs that have been withdrawn from the market had higher health risks for women.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 un- favorable 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 kid- ney stone development. Although the health risks were minimal, physicians feared any possible liti- gation involved with the use of HRT and were concerned with any possible adverse effects from cal- cium supplementation, and therefore altered their prescribing practices. Women, fearing any long-term health risks, also began seeking alternative treatments. However, the safety of these alter- native 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. Over the past SO years, women's health issues have driven much of the US Food and Drug Administration's (FDA) regulatory policy. 1 Injuries to women and their infants that were associated with the use of thalidomide and diethylstilbestrol, for example, prompted an increase in the FDA's authority. Today, women's health issues continue to have a tremendous impact on pharmaceutical regulation, and have contributed to the rise in litigation involving oral contraception, fertility, HRT, pregnancy, and breast implants. 2 Women-specific clinical studies have emerged only recently, how- ever, and are spawning their own controversies. Historically, the exclusion of women from clinical trials was justified by a range of concerns. First, inclusion of women posed potential threats to an unborn fetus, and women traditionally were not Accepted for publication January 31, 2007. Gend Med. 2007;4:3-7. 1550-8579/$32.00 Copyright © 2007 ExcerptaMedica, Inc. 3
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GENDER MEDICINE trusted to avoid pregnancy during the course of a trial. 3 Furthermore, trials with women were considered to be more expensive than trials with men, because women's trials were compli- cated by considerations of their estrous cycles, use of oral contraceptives, and use of HRT, thereby adding potentially problematic vari- ables and necessitating larger sample sizes. 4
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