Addressing Women's Health

• Published date: 01 June 2018
• Author: Arnauld Nicogossian,Edward Septimus,Otmar Kloiber,Bonnie Stabile
• DOI: http://doi.org/10.1002/wmh3.269
• Date: 01 June 2018

Editorial

Addressing Women’s Health

Arnauld Nicogossian, Bonnie Stabile , Otmar Kloiber, and Edward Septimus

Disparities in women’s health and health care increasingly fuel concerns,

prompt studies, and advance international policies. The World Medical Associa-

tion has consistently highlighted the need to address inequities in women’s health

care, and the World Health Organization continues to include improvements to

women and children’s health prominently among its goals (World Health

Organization, 2009; World Medical Association, 2002, 2008).

Until recently, women’s health suffered from a void in knowledge to

appropriately inform practice and medical policies (Institute of Medicine, 2010),

despite the fact that women represent the largest segment of the world

population. Until the post-World War II era, male subjects were exclusively used

in animal or human biomedical experiments and drug trials. The results of these

studies were extrapolated to female, elderly, and child patients. For example,

common medications used in men were administered to children, but in smaller

doses, and aspirin was administered to women to prevent heart attacks.

In 1990, the National Institutes of Health (NIH) required the inclusion of

female subjects in clinical trials and biomedical research. Unfortunately, inade-

quate knowledge and neglect persists in many world medical communities, even

after the mandatory inclusion of women in clinical trials. The U.S. Government

Accountability Off‌ice f‌inds that the Federal Drug Administration

does not now have appropriate management systems to monitor how

many women are in clinical trials, to be assured that NDAs and IND

annual reports are in compliance with pertinent regulations for present-

ing outcome data by sex and tabulating the number of women included

in ongoing trials, or to conf‌irm that its medical off‌icers have adequately

addressed sex-related issues in their reviews. While FDA has taken some

promising initial steps to address these def‌iciencies, it is important that

the agency f‌inalize the pilot programs it has underway and give sustained

World Medical & Health Policy, Vol. 10, No. 2, 2018

126

doi: 10.1002/wmh3.269

#2018 Policy Studies Organization