Women were intentionally excluded from participating in most medical research, setting a dangerous precedent that overlooked fundamental biological differences between women and men.
In 1990, the Society for Women’s Health Research (SWHR) was founded by Dr. Florence Haseltine to confront this injustice and change the culture of medical research. Thanks to SWHR and other advocacy groups, women are now routinely included in medical research and make up a larger portion of the scientific workforce, and scientists are studying how biological sex differences affect the prevention, diagnosis, and treatment of disease.
Since its founding, SWHR has fought to bring attention to research gaps and unmet needs in women’s health and to advance its mission to eliminate imbalances in care for women through science, policy, and education.
SWHR is making women’s health mainstream.
Building on its regular briefings on Capitol Hill, SWHR expanded its policy efforts by bringing together members of the Congressional Caucus on Women’s Issues for a series of annual legislative strategy conferences. Attendees discussed advancements in women’s health and developed a women’s health action plan for the caucus.
SWHR began a new annual program called Sex and Gene Expression (SAGE) conferences, which ran through 2006. The initial conference covered molecular and cellular mechanisms that underlie sex differences, and ultimately resulted in publication of the article “Sex, Genes and Women’s Health” in Nature Genetics.
SWHR requested another audit of NIH and the subsequent GAO report, “Women’s Health: NIH Has Increased its Efforts to Include Women in Research,” stated that while women were included in clinical research appropriate to their proportionate population representation, the resulting data was almost never analyzed for sex differences. Specifically, the report states, “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.”
Nationally recognized leaders in the field of nutrition research gathered in Washington, D.C., to discuss the latest findings that significantly affect women throughout their lifespan. The conference, “Nutrition Research: The Unique Needs of Women,” focused on the themes of early intervention and prevention as strategies for dealing with such increasing problems as eating disorders, obesity, and osteoporosis.
SWHR concluded its decade-long Scientific Advisory Meeting program with an event on drug addiction and pain in women. The meeting stressed that while drug abuse is typically thought of as a male-dominated disease, it may be equally as prevalent in women but not as easily recognized because of the lack of sex differences research in this area. This meeting led to two publications in the Journal of Women’s Health in 2001: “Women and Tobacco Use” and “Women, Men, and Pain.”
Another SWHR-backed GAO audit of FDA records revealed that 8 out of the last 10 drugs withdrawn from the market caused adverse effects more often in women than in men. Four of the drugs were more often prescribed to women than men, explaining the higher number of negative outcomes in women. However, the other four appeared to present a true sex difference in the incidence of adverse effects. The GAO report concluded: “The FDA has not effectively overseen the presentation and analysis of data related to sex differences in drug development.”
SWHR’s second annual Sex and Gene Expression Conference discussed sex differences during fetal development and later in life, as well as mitochondrial diseases and X-chromosome contributions to sex differences in mammals.
This Capitol Hill event, in collaboration with the Congressional Caucus on Women’s Issues, provided an opportunity for members of Congress, their staff, and executive agency leaders, to discuss their health policy priorities and craft a women’s health action plan. Attendees also visited an academic women’s health center to get an overview of its activities.
As a result of SWHR’s advocacy efforts, the Institute of Medicine published the landmark report “Exploring the Biological Contributions to Human Health: Does Sex Matter?” The report came to the groundbreaking conclusion that sex DOES matter from “womb to tomb” and that “every cell has a sex.” It stated: “There is now sufficient knowledge of the biological basis of sex differences to validate the scientific study of sex differences.”
The GAO conducted another FDA audit and subsequently released the report “Women Sufficiently Represented in New Drug Testing, but FDA Oversight Needs Improvement.” The report found that although women were now included in drug testing, sex differences were not being taken into account. The report suggested that FDA was not sufficiently monitoring research data to analyze or determine how a participant’s sex affected the drugs’ safety or efficacy.
In response to the IOM report, SWHR convened a series of five scientific meetings focused on sex differences research. This first workshop addressed strategies for conducting subgroup analyses to detect sex differences. Participants concluded that understanding sex differences will enable medical researchers to design health care interventions for both men and women more effectively and that researchers can plan for and conduct sex analysis without compromising the quality of the study or making the study prohibitively expensive. The meeting resulted in the following publications: “What Women Want: Taking Sex Differences Seriously in Clinical Trials” in Clinical Researcher and “Understanding the biology of sex and gender differences” in Medscape General Medicine.
SWHR discussed sex differences in immunology and autoimmunity for the second meeting in its IOM report series. The meeting resulted in the booklet “Autoimmune Diseases in Women” (a joint project of SWHR and the National Women’s Health Resource Center) as well as an article “Molecular and clinical evidence of the role of estrogen in lupus” in Trends in Immunology in May 2002.
SWHR established the first of its Interdisciplinary Science Networks — formerly called Interdisciplinary Studies in Sex Differences (ISIS) Networks — to identify knowledge gaps in women’s health and sex differences research and recommend steps to address them. The Brain Network ran from 2002 to 2007 and aimed to develop collaborations for research on sex differences in nervous system function and to translate the results of this research into new and improved therapies.
SWHR held the third meeting in its IOM report series at the Stanford University School of Medicine to discuss the origins of sex differences. Topics explored included imprinting and x-inactivation, the intrauterine environment, congenital diseases, and sex and the developing brain. Four publications resulted: a) “Early Encounters, Lifetime Effects: Hormones in the Intrauterine Environment,” b) “Sex, Genes and Hormones,” c) “Sex, Cells and Signals in the Developing Brain,” and d) “Strategies and Methods for Research on Sex Differences in Brain and Behavior.”
SWHR hosted the third Public Policy Conference on Women’s Health (originally the Women’s Health Legislative Strategy Conference) with a focus on health issues gaining political momentum in Congress. The conference included a breakfast briefing with members of Congress, a congressional committee health staff briefing, and a visit to NIH.
At SWHR’s third Sex and Gene Expression Conference, speakers discussed sex differences in development, sex and gene expression in the immune system, steroid hormones, apoptosis, cancer, and more.
n partnership with the University of Wisconsin Medical School, SWHR hosted a meeting on sex differences in cardiovascular disease as a part of its series around the 2001 IOM report. Although heart disease is the leading cause of death in women, that fact remained largely unknown to the public and even to some in the medical community. The meeting resulted in publication of the article “Sex, Hormones and the Cardiovascular System” in Trends in Endocrinology & Metabolism.
SWHR’s final event in its series on the 2001 IOM report took place at the National Institute of Environmental Health Sciences to discuss recent advances in environmental health research that explain sex differences in response to environmental exposures. The meeting resulted in the report “Understanding Sex Differences in Environmental Health: A Thought Leaders’ Roundtable” in Environmental Health Perspectives.
SWHR’s Interdisciplinary Network on Metabolism ran from 2003 to 2009 and advanced the understanding of sex-dependent differences in energy homeostasis and metabolic disorders. SWHR funded three projects investigating sex differences in this topic, and Network members published multiple peer-reviewed articles and presented at two meetings on metabolism.
At SWHR’s fourth annual Sex and Gene Expression Conference, speakers discussed the future of sex and gene expression research, sex differences in aging, and emerging technologies like somatic cell nuclear transfer.
SWHR’s fifth annual Sex and Gene Expression Conference featured speakers on topics including sexual dimorphism in the brain, environmental effects on development, and sex chromosome dosage effects.
At SWHR’s sixth and final Sex and Gene Expression Conference, speakers presented on sex differences in mental health; molecular, genetic and behavioral basis of drug addiction; chromosome disorders, epigenetics and disease; and sex differences in metabolism and energy homeostasis. Additionally, a workshop helped attendees brainstorm the future of sex and gene expression research.
SWHR released a report, “National Institutes of Health: Intramural and Extramural Support for Research on Sex Differences,” analyzing NIH’s focus on sex differences in research and found that only 3% of all grants given by NIH take sex differences into consideration. It also noted that the institutes with the largest budgets appeared to be doing the least amount of work in sex differences research.
SWHR established the Organization for the Study of Sex Differences (OSSD) to continue scientific collaboration on sex and gender research, with researchers from SWHR’s Brain Network as some of the founding members. OSSD is a scientific society with a mission of “enhancing knowledge of sex and gender differences by facilitation, communication, and collaboration among scientists and clinicians of diverse backgrounds.” OSSD was funded and supported by SWHR until 2012, when it became an independent organization.
Directed by SWHR Founder Dr. Florence Haseltine, the RAISE Project tracked awards given by scientific societies and professional organizations to recognize the achievements of women and to demonstrate the underrepresentation of women receiving prestigious awards.
SWHR wrote and published the book “The Savvy Woman Patient: How and Why Sex Differences Affect Your Health.” The book is designed to be a woman’s guide to her own health — from young adulthood to menopause and beyond. It covers topics like sex-based biology, nutrition, exercise, aging, addiction, cancer, cardiovascular disease and more.
SWHR wrote and published the book “The Savvy Woman Patient: How and Why Sex Differences Affect Your Health.” The book is designed to be a woman’s guide to her own health — from young adulthood to menopause and beyond. It covers topics like sex-based biology, nutrition, exercise, aging, addiction, cancer, cardiovascular disease and more.
SWHR and WomenHeart published “The 10 Q Report: Advancing Women’s Heart Health Through Improved Research, Diagnosis and Treatment,” which identified the top 10 unanswered research questions related to the diagnosis and treatment of heart disease in women. The groups released an updated report in 2011.
SWHR and the Medtronic Foundation established a prize (given from 2006-2013) of $75,000 to recognize a woman scientist or engineer for her significant contributions to women’s health. Winners: Marisa Bartolomei (2006), Elizabeth Petri Henske (2007), Karyn Frick (2008), Kimberly Kenton (2009), Sabra Klein (2010), Denniz Zolnou (2011), Tracy Bale (2012, pictured), and Mia K. Markey (2013).
SWHR and the FDA Office of Women’s Health collaborated to hold a workshop on the FDA Critical Path Initiative, which called for the use of modern research and analysis methods and tools to speed the development of new medical products. The event highlighted the importance of recognizing biological differences between men and women in the context of improving or accelerating development of drugs, devices and biologics. A report from the meeting was published in May 2007.
SWHR’s Musculoskeletal Health Network focused its efforts on osteoarthritis (OA) of the knee joint because women are more likely than men to experience this condition. The group produced multiple peer-reviewed publications and symposia, and researchers in SWHR-funded pilot projects investigated genetic, physiological, biochemical, and biomechanical sex differences in knee OA.
SWHR and the National Institute for Mental Health held a roundtable meeting about the effects of pregnancy and postpartum hormonal transitions on mood disorders in women. The thought leaders in attendance at the meeting published a report.
Edited by SWHR Brain Network member Jill B. Becker, PhD, the groundbreaking book “Sex Differences in the Brain: From Genes to Behavior” provides a comprehensive overview of the differences between male and female neurobiology, as well as outlines areas that need further exploration. The book serves as an educational resource for clinicians, scientists, and students.
The Genetic Information Non-Discrimination Act prohibits discrimination on the basis of genetic information in health insurance and employment. SWHR advocated for the bill because of concerns about the impact of genetic discrimination on the participation of women in clinical trials.
SWHR hosted a workshop in Washington, D.C., to discuss the state of research, knowledge gaps, and science related to post-traumatic stress disorder in women. The experts in attendance discussed the current state of this topic and then developed a plan for improving diagnosis and treatment of PTSD in female veterans. SWHR published a summary report after the meeting.
SWHR’s Cardiovascular Disease Network, which ran from 2009 to 2014, spurred groundbreaking research on sex and gender differences in heart disease and propelled knowledge in this field forward. The Network promoted research that defines sex and gender differences in pathophysiology, health care delivery, and treatment effectiveness to reduce cardiovascular disease burden. The Network members produced dozens of peer-reviewed publications, abstracts, and meeting presentations.