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Abstract
Whether an individual has been dealt XX or XY chromosomes at conception has physiological and biological implications beyond reproductive differences, concludes an April 25 report released by the Institute of Medicine (IOM). The report, Exploring the Biological Contributions to Human Health: Does Sex Matter? confirms that a person's sex does matter in terms of susceptibility to a wide range of diseases, disorders, and conditions, and that it is time to focus on studying sex and gender differences at the cellular and molecular levels. The study is the first significant review of the status of sex and gender differences in biomedical research by an independent research organization.
While some health differences between men and women are obvious, others are subtler in nature. The report points out, for example, that females are more likely than males to recover language ability after suffering a left-hemisphere stroke because females rely on both sides of the brain while males rely mostly on the left brain for certain aspects of language. The report also documents that women and men suffer different side effects from medications such as antihistamines and antibiotics, that 80 percent of those diagnosed with osteoporosis are women, and that women are two to three times more likely to suffer depression than men.
The report is the result of a 16-month review that examined existing knowledge of molecular and cellular sex differences. The study identified current and potential barriers, including ethical and financial ones, to conducting valid and productive research on sex and gender differences and recommended strategies for overcoming such barriers. The report's authors also urged the scientific community to conduct sex-based research.
Mary-Lou Pardue, chair of the IOM Committee on Understanding the Biology of Sex and Gender Differences and Boris Magasanik, professor in the Department of Biology at the Massachusetts Institute of Technology, believe that the study can illuminate the area of molecular mechanisms in health problems. "The report emphasizes the importance of collecting and compiling comparative data on males and females in areas where we have not previously done studies in terms of biological differences. The impact on policy will be second down the line. As people start to look in new areas and find exciting problems, it will move the field in that direction."
The report urged additional research on sex differences. The report's authors concluded that "public, scientific, and policy communities will agree that the understanding of sex differences in health and illness merits serious scientific inquiry in all aspects of biomedical and health-related research. Until the question of sex is routinely asked and the results - positive or negative - are routinely reported, many opportunities to obtain a better understanding of the pathogenesis of disease and to advance human health will surely be missed."
"We're excited that the IOM has substantiated what we've been saying for 10 years," said Phyllis Greenberger, president and CEO of the Society for Women's Health Research (SWHR). "This report validates the need for research on sex differences. Now we must make sure that mechanisms are in place to translate an understanding of basic differences between the sexes into clinical practice to benefit both men and women." SWHR is the nation's only not-for-profit organization whose main priority is to improve women's health through research. The organization played a key role in initiating the study.
The report cites several barriers to progress in research on sex differences. With regard to terminology, both scientific literature and the popular press have inconsistently used the terms sex and gender. Another barrier is that research in this arena may "require more complex studies and additional resources" such as innovative designs, methods, and model systems. Useful information on the sex of origin of cell and tissue culture material, as well as consideration of hormonal variability is lacking in the literature. Studies and information on sex differences can be difficult to gather from published literature. Other barriers are the underutilization of opportunities for interdisciplinary and collaborative research and the lack of uniform application of federal regulations. Finally, there is the potential that identification of sex differences may lead to discrimination.
"The most overarching finding is that this field of sex-based research needs to go past the anecdotal or observational report toward hypothesis-driven research. For example, we know that the biological sex has an impact on gene expression. It starts in development in utero, but doesn't stop there," comments Sherry Marts, scientific director of SWHR.
To help the field of sex-based difference research progress, the report makes several recommendations, including promoting research on sex at the cellular level, mining cross-species information, and studying sex differences from "womb to tomb." It specifies the need to support and conduct additional research on sex differences, as well as make sex-specific data more readily available. Furthermore, sex of origin of biological materials used in research should be disclosed and hormonal variations should be identified. Longitudinal studies should be designed so that results can be analyzed by sex. The report also encourages and supports interdisciplinary research on sex differences and calls for reduction of the potential for discrimination based on identified sex differences.
The message of the report has resonated within the scientific community. Prior to publication of the report, SWHR, along with the National Institutes of Health's (NIH) Office of Research on Women's Health, convened a meeting with editors of 15 medical journals to discuss policies on reporting sex differences in the literature. Present were editors from leading publications such as the Journal of the American Medical Association, the Journal of the National Cancer Institute, and the New England Journal of Medicine. "Overall, most editors reached consensus that if the information about sex differences is not in the report, then it is important for peer reviewers and editors to ask," reports Marts. "There is a need to raise awareness that this kind of information is important and to make sure that the statistics analysis was done properly - in other words, ensure that the statistical power of the study is made clear." Following the release of the report at the American Psychiatric Association's annual conference in New Orleans, pharmaceutical companies and the U.S. Food and Drug Administration (FDA) were urged to conduct more sex analysis studies on drugs. An earlier General Accounting Office report found that a majority of drugs withdrawn by the FDA in the past four years had adverse effects on women.
Already SWHR is moving to implement the report's recommendations. Beginning in July and continuing into 2002, the society will convene a series of regional scientific conferences that put the IOM recommendations into practice. Topics of the conferences include areas of research in which sex differences are documented, changes in research policy that are needed, and what the NIH could be doing in terms of requests for research funding applications. The inaugural conference will be held in Washington, D.C., on July 16 and will feature leading experts including two panels moderated by the directors of the National Institute on Drug Abuse and the National Institute of Mental Health, as well as members of the IOM study committee. The meeting will examine three topic areas - neuroscience, the funding structures needed to foster interdisciplinary collaboration, and potential collaboration between the sciences and media to translate complex scientific concepts into understandable terms. The second meeting will be held in Boston in November 2001.
"The next step is to take up the challenge of the IOM report by examining what we know and looking at the recommendations and seeing how we are going to make this happen," states Marts. "By taking the meeting to Boston, for example, we will be reaching researchers from MIT, Harvard, Tufts, all of the top research schools in the Northeast to lay down the challenge to them."
The IOM study was sponsored by SWHR, NIH, the Centers for Disease Control and Prevention, the National Aeronautics and Space Administration, the National Science Foundation, the Department of Defense, the Environmental Protection Agency, as well as other private sector organizations.
Sanyin Siang works on a variety of issues at the intersection of science, ethics, and law at the Directorate for Science Policy Programs of the American Association for the Advancement of Science.
Julia Kuhl has done illustrations for the New Yorker and the New York Times, among others. She now lives in Heidelberg, Germany, with her neurobiologist husband and is working on a comic book - a Fulika atra (coot) version of Shakespeare's Hamlet.
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