Irma Goertzen and Suzanne Stone “True science investigates and brings to human perception such truths and such knowledge as the people of a given time and society consider most important.” —Leo Tolstoy The Society for Women’s Health Research (SWHR), established in 1990, has changed the way research is conducted in the United States. Because of the SWHR’s efforts, women are included in medical research and scientists are investigating the different ways health and disease affect men and women as well as the reasons why. The SWHR attributes its advocacy success to four factors: demonstrating evidence-based policy needs (each of the SWHR’s campaigns to effect change has begun with documentation of the problem sought to be corrected), including multipronged education efforts, involving a mix of health care providers and policymakers, and extending lobbying beyond legislators and regulators. The SWHR’s advocacy includes education of federal legislators and their staff members; scientists employed by the federal government, in academia, and in industry; and the public. The SWHR remains, 20 years after its founding, the only organization dedicated to exploring differences in research as it relates to men and women. It was the idea of Florence Haseltine, PhD, MD. When she first started working at the National Institutes of Health (NIH) in 1985, Haseltine was advised her role was “to champion the field of obstetrics and gynecology,” which at that time was underrepresented in research. Near that time, Congresswoman Patricia Schroeder said, “There are three gynecologists and 39 veterinarians at NIH,” highlighting the lack of focus on women’s health in the research community (Haseltine, 2006). In 1989, Dr. Haseltine gathered individuals from medical and scientific organizations to meet in Washington, D.C. Those gathered agreed on the need for more women’s health research at NIH, but they also agreed that women’s health generally lacked sufficient research focus. From this discussion, the Society for Women’s Health Research was born (Box 43-1). To validate its belief that the health of American women was at risk due to biases in biomedical research, the all-volunteer members of SWHR’s first Board of Directors worked with the Congressional Caucus for Women’s Issues and its Executive Director Leslie Primer and Congressman Henry Waxman (D-CA). They requested the Government Accountability Office (GAO) (then called the General Accounting Office) to study NIH’s policies and practices concerning the inclusion of women and minorities in clinical trials. The GAO report was released at an NIH reauthorization hearing in June 1990. It concluded that the NIH policy (NIH, 1986) announced in October 1986 to encourage the inclusion of women in clinical trials had not been well communicated or understood within NIH or the research community, was applied inconsistently across institutes, and only was applied to extramural research. The GAO report concluded that there was “… no readily accessible source of data on the demographics of NIH study populations” (U.S. GAO, 1990). So at that time it was impossible to determine if NIH was enforcing its own recommendations. Haseltine found this to be a “tipping point” that spurred significant advocacy efforts that would result in major policy changes over many years. Throughout the advocacy work, the SWHR leaders sought evidence to support their initiatives. They used an Institute of Medicine (IOM) report that demonstrated federal funding for research in obstetrics and gynecology to be inadequate as the tool to garner additional evidence in the form of the GAO audit. The SWHR’s first policy efforts were addressed almost exclusively at lobbying members of Congress to change policies and regulations at federal agencies that affected women’s equity in health research. Shortly after release of the 1990 GAO audit, the NIH published guidelines that required women be included in clinical research and established the Office of Research in Women’s Health. Because these guidelines were not fully implemented, the SWHR advocated for passage of the 1993 NIH Revitalization Act, which codified these requirements and also required that Phase III clinical trial results be analyzed by sex. This act permanently established the NIH’s Office of Research on Women’s Health. Next came important changes at the U.S. Food and Drug Administration (FDA). Following the successful tactic of securing information via a GAO review, the SWHR asked members of Congress to request that the GAO examine the inclusion of women in the clinical trials used by the FDA in evaluating drugs for marketing approval. The resulting 1993 report found that while women were sometimes included in drug trials, they were significantly underrepresented (U.S. GAO, 1993). Even when women were included, data were not analyzed to determine if women’s responses to drugs differed from those of men. The report found an insufficient number of women were included in preapproval clinical trials of drugs and charged the FDA with improving women’s representation. It concluded by recommending that the FDA ensure that drug companies consistently include “sufficient numbers of women in drug testing to identify gender-related differences in drug response and that such sex differences are explored and studied” (U.S. GAO, 1993). Later in 1993, the FDA reversed its 1977 guidelines and published a new Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs that encouraged the inclusion of women in Phase I and II (safety and dosing) studies and required their inclusion in efficacy studies. The guideline also requires analysis of data on sex differences, as well as race and ethnicity. At the SWHR’s urging, the GAO was asked to review the NIH’s practices again. In 2000, the GAO issued a follow-up report concluding that “NIH has made less progress in implementing the requirement that certain clinical trials be designed and carried out to permit valid analysis by sex, which could reveal whether interventions affect women and men differently.” Another GAO report sought by SWHR concluded “The FDA has not effectively overseen the presentation and analysis of data related to sex differences in drug development” (U.S. GAO, 2001). To have success with government entities, it was important that the SWHR’s voice represent a broad spectrum of health care researchers, providers, and policymakers. In 1999, the SWHR established the Women’s Health Research Coalition. It now comprises more than 600 advocates from a broad range of academic, health care, and scientific institutions. The SWHR reaches out to health care providers including nurses and researchers in many fields when invited to provide testimony at government hearings and to present briefings. These briefings inform policymakers about contemporary women’s health issues, the need for increased research funding for women’s health, and the need to study biological sex differences affecting the prevention, diagnosis, and treatment of disease. As a non-profit entity, the SWHR functions under the governance of a board of directors. Within 5 years of being hired, the SWHR chief executive officer Phyllis Greenberger formed a team of administrative, fund-raising, government relations, and scientific staff, whose efforts gradually replaced much of the work that had been accomplished by the all-volunteer board. Board members still were called on to represent the SWHR, particularly in scientific venues, and to network to advance advocacy efforts. Second, the findings from studies that included women in clinical trials corroborated the SWHR’s belief that, in matters of health and disease, men and women are different. Now, scientists needed to be convinced of this so they would design studies to explain these differences. The SWHR response to this challenge was multipronged. It sought and received independent, unbiased validation of research on sex differences, hosted interdisciplinary conferences on sex differences in biology, and successfully sought funding for novel interdisciplinary sex differences research. Greenberger led a 6-year campaign to secure funding for the formation of an IOM “Committee on Understanding the Biology of Sex and Gender Differences.” The strength of long-term relationships that she had forged through the years was instrumental in securing the necessary funding from private and public sources for this initiative. The SWHR submitted a proposal to the IOM to validate the concept of sex differences. In 2001, the IOM published a landmark report generated by this committee, Exploring the Biological Contributions to Human Health: Does Sex Matter? This IOM report pointed out that every cell has a sex, sex begins in the womb, and sex affects behavior and perception. The IOM report concluded the following: There is now sufficient knowledge of the biological basis of sex differences to validate the scientific study of sex differences and to allow the generation of hypotheses with regard to health. . . Naturally occurring variations in sex differentiation can provide unique opportunities to obtain a better understanding of basic differences and similarities between and within the sexes. (Institute of Medicine, 2001, p. 3)
The Society for Women’s Health Research
Using Evidence-Based Policy to Improve Health
Founding of the Society for Women’s Health Research
The Birth of An Advocacy Organization
Congressional Advocacy
Continuing Sex and Gender Inequities Found
The Importance of Integrated Professional Action
Expanding the Understanding of Sex and Gender Differences in Health and Disease
Does Sex Matter? Absolutely
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