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3 Yale J. Health Pol'y L. & Ethics 253 (2002-2003)
Sex & (and) Gender: The Politics, Policy, and Practice of Medical Research

handle is hein.journals/yjhple3 and id is 259 raw text is: Sex & Gender: The Politics, Policy, and Practice of
Medical Research
Sarah K Keitt, M.P.H.*
While women generally live longer than men,' they often do not live
healthier.! Historically, women have suffered from a lack of medical
information specific to their needs and problems.3 This information gap is
the  result of policies and     practices  that excluded    women    from
participating as research subjects in most clinical trials until the late 1980s.
Women were initially excluded from participating in clinical trials due to
neglect and, after the Thalidomide tragedy of the 1960s, misguided efforts
at protection. It was not until the mid-1980s that the medical research
community began to recognize that the information gap created by these
policies had a detrimental effect on women's health and began to take
action to fill this gap.
This Article explores issues surrounding women's participation in
clinical trials. Part I outlines the cultural and regulatory norms that for
many years resulted in the exclusion of women from clinical trials. It
includes a discussion of protectionist regulations, landmark legislation,
and the backlash against the women's health movement. Part II provides
* Sarah K. Keitt is a program manager with the Society for Women's Health Research. She
would like to acknowledge and thank Dr. Florence P. Haseltine for her substantial
contributions to this Article. Dr. Haseltine is currently the Director of the Center for
Population Research at the National Institute of Child Health and Human Development
and is the founder of the Society for Women's Health Research.
1. Robert N. Anderson, United States Life Tables, 1997, NAT'LVITAL STAT. REP., Dec. 13,
1999, at 1, 3.
2. BERNADINE HEALY, A NEW PRESCRIPTION FOR WOMEN'S HEALTH 16 (1995); Terie T.
Wetle & RichardJ. Havlik, Foreword to THE WAOMEN'S HEALTH AND AGING STUDY: HEALTH AND
SOCIAL CHARACTERISTICS OF OLDER WOMEN WITH DIsABIrITy, at xii (Jack M. Guralnik et al.
eds., 1995).
3. U.S. Pub. Health Serv., Report ofthe Public Health Service Task Force on Women's Health
Issues, 100 PuB. HEALTH REP. 73 (1985).
4. See also Edward N. Brandt, Jr., Some Thoughts About Women's Health and Its Evolution, 1
J. GENDER-SPECIFIC MED. 48, 48-49 (1988) (discussing the establishment of a U.S.
Department of Health and Human Services Talk Force to analyze and assess the
information gap).

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