Thirty years ago, the health of women was at serious risk.
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 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. Join us.
Timeline: A History of SWHR and Women’s Health
View the PDF version of this timeline.
FDA Guidance Excludes ‘Women of Childbearing Potential’ From Research
In the 1960s and 1970s, birth defects caused by the drugs Thalidomide and DES led to increased concern about the safety of drugs and drug trials during pregnancy. At-home pregnancy tests did not exist at this time so the public’s concern expanded to include all women capable of becoming pregnant. The Food and Drug Administration (FDA) in 1977 published guidelines advising the exclusion of “any premenopausal woman capable of becoming pregnant” from participating in Phase I and II clinical research.
Federal Task Force Reports Excluding Women From Research Harms Their Health
A report from the U.S. Public Health Service Task Force concluded that the exclusion of women from clinical research was detrimental to their health and recommended expanding research to include diseases or conditions that solely or disproportionately affect women of all ages.
NIH Encourages Inclusion of Women in Clinical Research
In response to the U.S. Public Health Task Force’s report on women’s health, the National Institutes of Health (NIH) Guide for Grants and Contracts (vol. 15, no. 22) included a notice that encouraged — but did not require — researchers to include women in their clinical studies.
Dr. Florence Haseltine Organizes Meeting on Women’s Health at ACOG
Florence Haseltine, PhD, MD, organized a meeting at the American College of Obstetricians and Gynecologists (ACOG) to discuss the state of research on women’s health. This meeting set the stage for the the Society for Women’s Health Research (originally called the Society for the Advancement of Women’s Health Research).
SWHR Founded by Dr. Florence Haseltine
The Society for Women’s Health Research (SWHR) was officially founded by Dr. Florence Haseltine, along with other physicians, medical researchers, and health advocates, to change the culture of medical research and advocate for the inclusion of women in clinical research at a time when they were being actively and intentionally excluded.
GAO Report Reveals NIH Not Including Women in Research
SWHR and the Congressional Caucus for Women’s Issues requested that the Government Accountability Office (GAO) examine whether NIH was following its 1986 guideline that encouraged the inclusion of women in clinical research. The resulting GAO report, “Problems in Implementing Policy on Women in Study Populations,” revealed the guideline was not being followed as NIH did not make information regarding the inclusion of women readily available, and when it did, the guideline was only applied to extramural research.
NIH Strengthens Policy on the Inclusion of Women in Research
Just one month after a GAO report that showed NIH was failing to comply with its policy on including women in clinical research, NIH published an updated policy in the NIH Guide to Grants and Contracts (vol. 19, no. 31) that required “a clear rationale” for the exclusion of women and minorities in grant applications for clinical research.
NIH Establishes the Office of Research on Women’s Health
In addition to strengthening its policy of inclusion, NIH also established the Office of Research on Women’s Health (ORWH). The mission of this office is to “strengthen and enhance the prevention, diagnosis, and treatment of illnesses in women and to enhance research related to diseases and conditions that affect women.”
HHS Creates Office of Women’s Health
The Office of Women’s Health within the Department of Health and Human Services (HHS) was created to serve as the focal point for women’s health across all HHS offices and agencies. Later that year, OWH published the Action Plan for Women’s Health, which identified widely disparate health needs of women that required more attention and scrutiny.
Dr. Bernadine Healy Becomes NIH’s First Female Director
NIH took another step forward for women when President George H.W. Bush appointed Bernadine Healy, MD, as NIH Director. Healy, a cardiologist, went on to establish NIH’s $625 million Women’s Health Initiative. This 15-year study enrolled more than 160,000 women to make strides in preventing heart disease, breast and colorectal cancer, and osteoporosis.
SWHR Holds First Scientific Advisory Meeting: ‘Towards a Women’s Health Research Agenda’
SWHR kicked off a decade of annual Scientific Advisory Meetings (SAMs) with an event in Washington, D.C., to establish priorities for women’s health research. The top priorities identified were: (1) cardiovascular disease, (2) cancer, (3) violence against women, and (4) depression/ substance abuse. The first SAM also shed light on the need to increase the number of women in STEM leadership positions.
Journal of Women’s Health Launches
SWHR helped establish the Journal of Women’s Health, whose founding editors were SWHR Founder Dr. Florence Haseltine and former SWHR Board member Dr. Anne Colston Wentz. The first issue featured a foreword about SWHR and a short commentary by then-NIH Director Dr. Bernadine Healy.
GAO Report Reveals Women Are Underrepresented in Drug Trials
SWHR asked the GAO to review the inclusion of women in clinical trials used by FDA to evaluate drugs for market approval. The resulting report, “Women’s Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drug Testing,” concluded that women were underrepresented in drug trials and that even when women were included, the data were not analyzed to determine whether their responses to drugs differed from those of men.
SWHR Holds Meeting Series on Women in Medicine
From October 1992 to February 1993, SWHR held a series of roundtables that collectively served as its second Scientific Advisory Meeting. These meetings focused on the need for more women in academic medicine or health science careers, and SWHR produced a series of recommendations meant to advance the prevalence of women in these fields.
SWHR Opens Official Headquarters and Hires Professional Staff
SWHR opened its official headquarters in Washington, D.C., and hired a professional staff, including its first executive director.
SWHR Hosts Two-Day Workshop on Menopause
SWHR held a workshop on menopause’s potential influence on neurological, cardiovascular, social, and psychological changes, as well as its effect on bone, endometrial and breast cancer. SWHR published a report on the meeting, “Women’s Health Research and Menopause: A Dialogue Among Public Policy, Community, and Health Leaders.”
NIH Revitalization Act Mandates Inclusion of Women and Minorities in Research
In a historic moment for women’s health research, President Bill Clinton signed into law the NIH Revitalization Act, which was written with input from SWHR. The law mandated that women and minorities be included in all NIH-funded clinical research and that Phase III clinical trials be analyzed for sex differences. Although the NIH Office of Research on Women’s Health was already established, the law also permanently secured that office and gave it the authority to monitor the inclusion of women in the NIH’s clinical research.
SWHR Focuses on Environmental Health
SWHR’s third Scientific Advisory Meeting discussed environmental health and its relation to women’s health. SWHR hosted a series of roundtables across the country (Seattle, Baton Rouge, Denver) to dive deeper into this topic and produced a report focused on environmental health concerns most important to women.
FDA Rescinds Guideline Banning Women of Childbearing Potential From Research
In response to GAO’s October 1992 report on the inclusion of women in drug testing, FDA rescinded its 1977 guideline that banned all women capable of becoming pregnant from Phase I and Phase II clinical research. FDA released new guidance, “Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs,” encouraging the participation of women in Phase I and II studies and requiring their inclusion in Phase III efficacy studies. The new guidelines also required that FDA analyze drug data for sex, racial, and ethnic differences.
FDA Establishes Office of Women’s Health
A congressional mandate created the FDA Office of Women’s Health (OWH), whose mission is to “protect and advance the health of women through policy, science and outreach; and to advocate for the participation of women in clinical trials and for sex, gender and subpopulation analyses.” The office’s first director, Dr. Ruth Merkatz, noted the efforts of SWHR staff were “extremely important and lasting, especially to be able to influence members of Congress about the importance of establishing the Office of Women’s Health at the FDA.”
SWHR Promotes Healthy Behavior in Young Women
SWHR’s fourth Scientific Advisory Meeting targeted the unmet health needs of young women ages 18-24. A series of focus groups on college campuses found considerable misinformation about women’s health circulating in this age group, so the SAM produced an educational program, “Get Real: Straight Talk About Women’s Health,” in collaboration with the U.S. Public Health Service’s Office on Women’s Health. This program included a video that addressed topics of interest to college-age women, including nutrition, exercise, eating disorders, alcohol/substance abuse, violence, contraception, STDs, and smoking.
SWHR Hosts First Sex Differences Meeting
SWHR held its fifth annual Scientific Advisory Meeting (and first-ever sex differences meeting) on sex differences in neurobiology, language ability after stroke, autoimmunity, and osteoporosis. After the meeting, SWHR published several articles about sex differences in the August issue of the Journal of Women’s Health.
Hillary Clinton Speaks at SWHR Awards Dinner
Then-First Lady Hillary Rodham Clinton spoke at SWHR’s annual awards dinner, saying: “We have a very long way to go before we can say with any confidence that women’s health has taken its rightful place in the American health care system.” She also thanked the organization “on behalf of literally millions and millions of American women who will never hear of the Society for the Advancement of Women’s Health Research.”
SWHR Holds Meeting on Genetics and Women’s Health
SWHR held its sixth Scientific Advisory Meeting on the role of sex-based research in human genetics. The meeting focused on the idea that a better understanding of differences in genetics and inheritance between males and females would facilitate improved diagnostics, preventative strategies, and therapies for women and men.
SWHR Publishes Book on Women’s Health Research and Policy
With the goal of making women’s health a priority for U.S. researchers and policymakers, SWHR published “Women’s Health Research: A Medical and Policy Primer.” SWHR Founder Dr. Florence Haseltine served as editor for the book, which outlined research and policy agendas aimed at improving women’s health research at an institutional level. Recommendations included improving medical school education and changing the ways women’s health research is funded.
SWHR Examines Health Care Outcomes for Women
SWHR’s seventh Scientific Advisory Meeting explored research on health care delivery outcomes. The meeting stressed the importance of understanding when differences in health outcomes between women and men are sex-based (due to biological differences between males and females) and when they are service-based (meaning they differ because women and men receive a different standard of care).
SWHR Looks at Discoveries in Gender-Based Biology
SWHR’s eighth Scientific Advisory Meeting examined sex neurology, psychiatry, immunology, and pharmacology. Based on the meeting’s findings SWHR published the article “The Sexual Revolution in Science: What Gender-Based Research Is Telling Us” in March 1999 in the Journal of Investigative Medicine.
SWHR Establishes National Women’s Health Research Coalition
SWHR brought together a broad spectrum of health researchers, health care providers, and policymakers to promote a women’s health agenda by creating the National Women’s Health Research Coalition. The WHRC’s mission was to encourage coordination and funding of women’s health research. The coalition included more than 600 advocates from academic, medical, and scientific institutions, as well as health-related associations. They advocated for SWHR’s legislative priorities during an annual Capitol Hill Day.
SWHR Conference Addresses Barriers to Participation in Clinical Research
SWHR convened a thought leader conference, “Covering Routine Patient Care Costs of Clinical Research,” to discuss the importance of clinical trials and the reduction of barriers to voluntary participation in research. The objective was to identify areas of agreement among federal agencies, industry, and private interest groups about financial coverage of routine patient costs of clinical trials, and to discuss potential coverage models.
SWHR Explores Role of Estrogen in Heart Disease
SWHR Hosts First Women’s Health Legislative Strategy Conference
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 Holds First Sex and Gene Expression (SAGE) Conference
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.
GAO Reports NIH Research Includes Women, But Doesn’t Analyze Data by Sex
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.”
SWHR Hosts Scientific Meeting on Women’s Nutrition
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 Studies Drug Addiction and Pain
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.”
GAO Concludes FDA Failed to Analyze Sex Differences in Drug Development
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 Hosts Second Women’s Health Legislative Strategy Conference
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.
Institute of Medicine Report Concludes That Sex Matters From ‘Womb to Tomb’
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.”
GAO Report Finds FDA Not Sufficiently Analyzing 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 participants’ sex affected the drugs’ safety or efficacy.
SWHR Kicks Off Event Series on IOM Report Findings
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 Meeting Addresses Sex Differences in Immunology and Autoimmunity
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 Kicks Off Interdisciplinary Network on Sex, Gender, Drugs, and the Brain
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 Scientific Meeting on How ‘Sex Begins in the Womb’
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 Hosts Third Legislative Conference on Women’s Health
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.
SWHR Raises Awareness of Sex Differences in Heart Health
In 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 Tackles Sex Differences in Environmental Exposures
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 Kicks Off Interdisciplinary Network on Metabolism
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.
SWHR Conference Explores Future of Sex and Gene Expression Research
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 Report Reveals Only 3% of NIH-Funded Research Analyzes Sex Differences
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 actually appeared to be doing the least amount of work in sex differences research.
SWHR Establishes the Organization for the Study of Sex Differences (OSSD)
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.
RAISE Project Recognizes Women in STEM
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 Publishes Book to Educate Women Patients on Sex Differences
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 Explores Sex Differences in Lung Cancer
SWHR convened thought leaders to discuss sex differences as they relate to lung cancer development and treatment. Attendees discussed recent data on epidemiological aspects of lung cancer in women, lung tumor biology and emerging trends in research. A summary of the meeting was published in the Journal of Investigative Medicine in 2007.
SWHR and WomenHeart Release First Edition of Women’s Heart Health Report
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 Medtronic Establish Prize for Female Scientists
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 Hosts Sex Differences Workshop with FDA Office of Women’s Health
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 Kicks Off Interdisciplinary Network on Musculoskeletal Health
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 Roundtable Addresses Hormonal Transitions and Mood Disorders
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.
SWHR Brain Network Members Publish Book on Sex Differences in Neurology
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.
Congress Passes Genetic Information Non-Discrimination Act
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 Convenes Expert Workshop to Address PTSD in Women
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 Kicks off Interdisciplinary Network on Cardiovascular Disease
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.
SWHR Launches Interdisciplinary Network on Exercise and Breast Cancer
In collaboration with the Susan G. Komen Foundation, SWHR established the Breast Cancer Network, which ran from 2011 to 2013, to examine how exercise impacts breast cancer risk and recurrence. The Network resulted in a study published in 2019 the journal Clinical Cancer Research that provides some of the first evidence in humans that exercise could directly fight breast cancer.
SWHR Launches Biology of Sex Differences Journal
SWHR and the Organization for the Study of Sex Differences (OSSD) founded the peer-reviewed, open-access academic journal Biology of Sex Differences, the official journal of OSSD. Published by BioMed Central and SWHR, Biology of Sex Differences aims to improve understanding of sex differences and foster development of therapeutic and diagnostic tools that are specific for sex differences.
Patient Protection and Affordable Care Act Becomes Law
President Barack Obama signed into law the Patient Protection and Affordable Care Act. This bill included the Women’s Health Office Act (WHOA), for which SWHR had long advocated. The WHOA was originally introduced in 1994 and subsequently re-introduced in every Congress from 1994 to 2009. Finally, 15 years later, SWHR’s signature piece of legislation passed, securing the offices of women’s health in the NIH, FDA, and many other federal agencies as well.
SWHR and WomenHeart Release Updated Report on Women’s Heart Health
SWHR’s Cardiovascular Disease Network partnered with WomenHeart to update the “10Q Report: Advancing Women’s Heart Health through Improved Research, Diagnosis and Treatment,” which addressed many of the questions that still existed about heart disease and women.
SWHR Conference Explores Conditions Affecting Female Veterans
This scientific conference highlighted sex differences in conditions that affect female veterans of military combat. The resulting report published in the Journal of Women’s Health focuses on posttraumatic stress disorder (PTSD) and depression, urogenital health, musculoskeletal health, and traumatic brain injury. This meeting is an example of SWHR’s participation in the “Fatigues to Fabulous” national campaign to honor and support women veterans in America.
SWHR and FDA Partner on Women and Minorities in Clinical Trials
SWHR and the FDA Office of Women’s Health collaborated on a two-day conference, “Dialogues on Diversifying Clinical Trials,” and resulting white paper about successful strategies for the recruitment, retention, and subsequent analysis of women and minorities in clinical research.
SWHR Roundtable Reviews State of Sex Differences Research in Alzheimer’s
SWHR hosted a roundtable of experts from academia, medicine, industry, and government to discuss the current state of sex and gender differences research in Alzheimer’s disease and identify gaps in need of further study. A summary of the meeting was published in the Journal of Women’s Health. This meeting laid the groundwork for SWHR’s follow-up roundtable in 2015 and the establishment of its Interdisciplinary Network on Alzheimer’s in 2016.
Congress Passes Law Requiring FDA to Report on Sex, Race, and Ethnicity
Less than a year after SWHR and the FDA Office of Women’s Health collaborated for a conference and report about the inclusion of women and minorities in clinical research, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA), which requires FDA to provide special reports and accounts of clinical trials by sex, race, and ethnicity.
SWHR Roundtable Discusses Autoimmune Diseases
SWHR hosted a roundtable meeting to discuss autoimmune diseases, including differences between men and women and environmental factors that may have led to a rise of autoimmune diseases in the years prior to the meeting.
SWHR Gathers Experts on Menopausal Hormone Therapy
SWHR hosted a roundtable meeting of researchers to analyze evidence on the effects of menopausal hormone therapy, as well as discuss next steps for research. Participants identified gaps in menopause research and published a peer-reviewed article in the Journal of Women’s Health based on discussions at the roundtable.
FDA Issues Report on Demographic Subgroup Data
As required by the 2012 FDASIA law, FDA issued a report, “Collection, Analysis and Availability of Demographic Subgroup Data for FDA – Approved Medical Products.” The report examined tools for submission of demographic information, subset analysis, and demographic subgroup participation in clinical trials submitted to the agency. The report mentioned the 2011 joint public workshop hosted by SWHR and the FDA Office of Women’s Health.
SWHR Event Explores Sex Differences in Sleep
SWHR’s roundtable meeting explored the role that sex and gender play in sleep, as well as the state of women’s sleep health research. It aimed to identify basic and clinical research about specific challenges facing women with sleep-related problems. The roundtable resulted in a peer-reviewed paper in the Journal of Women’s Health and served as the launching pad for SWHR’s Interdisciplinary Network on Sleep.
SWHR Launches Interdisciplinary Network on Sleep
SWHR’s Sleep Network, which ran from 2014 to 2018, featured a diverse group of researchers and health care providers working to bring attention to sleep health issues in women in order to improve diagnosis, treatment, and management of sleep disorders. The network produced a “Women & Sleep Guide,” as well as a handout for patients and clinicians on “Women and Sleep Apnea.”
‘60 Minutes’ Reports on Sex Differences
Lesley Stahl of CBS News’ “60 Minutes” reported a story titled “Sex Matters: Drugs Can Affect Sexes Differently” that revealed pharmaceutical companies have almost exclusively tested new drugs on men despite marketing and selling them to women. SWHR provided historical background information, as well as expert contacts, to help CBS develop this story. The report shocked Americans and inspired renewed congressional interest in sex differences.
SWHR Survey Finds Less Than Half of U.S. Women Get Mammograms
SWHR conducted a survey on breast cancer screening and what women want out of it. The survey found that cost and lack of insurance were the biggest barriers women faced in having mammograms. A majority of women were unaware that the Affordable Care Act required Medicare and commercial insurers to cover mammography screenings at no cost to the patient.
SWHR Hosts Roundtable on Women’s Urologic Health
SWHR convened experts from diverse backgrounds for a meeting on women’s urologic health. The experts reviewed urologic conditions prevalent during key stages of a woman’s life, identified research gaps, and addressed psychosocial and physical challenges to women with urologic conditions. The roundtable resulted in a peer-reviewed report in the Journal of Women’s Health and led to the formation of SWHR’s Interdisciplinary Network on Urological Health in Women.
FDA Launches Drug Trials Snapshots
The FDA’s Drug Trials Snapshots website provides consumers with valuable information about who participated in clinical trials supporting FDA approval of new drugs. Ensuring transparent clinical trial data has positive implications for women’s health because it allows the public to hold organizations accountable for the appropriate inclusion of women in clinical research.
SWHR Establishes Interdisciplinary Network on Urological Health in Women
SWHR’s Urology Network ran from 2015 to 2019 with a goal of raising awareness of the impact of bladder health on women’s well-being across the lifespan. The Network conducted a survey of school nurses revealing that many schools do not have bathroom policies and do not educate students on bladder health. It also published a peer-reviewed paper in Biology of Sex Differences about sex differences in the lower urinary tract.
SWHR Report Identifies 10 Relevant Health Topics for Women with Diabetes
SWHR released “Women & Diabetes: 10 Relevant Health Topics for Women with Diabetes” in collaboration with DiabetesSisters to address women’s unique health concerns associated with diabetes over the lifespan, especially during periods of hormonal fluctuation (puberty, pregnancy and menopause).
SWHR Celebrates 25th Anniversary
More than 600 guests attended SWHR’s 25th Anniversary Gala at the Ritz-Carlton in Washington, D.C. to celebrate its achievements for women’s health research. Dr. Francis S. Collins, Director of the National Institutes of Health, received the Pioneering Biomedical Research Award for his development of the NIH policy on inclusion of sex as a biological variable, which would be implemented in 2016. Rep. Lois Capps (D-CA), Rep. Rosa DeLauro (D-CT) and Rep. Nita Lowey (D-NY) were presented with Women’s Health Research Legacy Awards. Finally, former Secretary of State Hillary Rodham Clinton was recognized for making women’s health a national priority with the Dr. Estelle Ramey Award for Women’s Health Leadership.
SWHR Hosts Second Roundtable on Alzheimer’s Disease
SWHR’s second roundtable meeting to discuss sex and gender differences in Alzheimer’s disease covered new advancements in research since the 2011 meeting, as well as explored gender-specific issues in caregiving. The two roundtables led to the creation of SWHR’s Interdisciplinary Network on Alzheimer’s Disease.
GAO Issues Report on Women’s Participation in NIH Research
A GAO report concluded that NIH needed to implement better oversight to ensure continued progress on including women in health research. The report examined women’s enrollment in NIH-funded clinical research and NIH’s efforts to monitor this enrollment. The report also reviewed NIH’s efforts to ensure that clinical trials were designed and conducted to analyze potential sex differences.
SWHR Launches Interdisciplinary Network on Alzheimer’s Disease
SWHR’s Alzheimer’s Disease Network aims to understand and leverage the scientific basis of the roles of sex and gender in Alzheimer’s to inform prevention and treatment and provide guidance for research, clinical trials, and policy. The group’s major accomplishments include publication of a peer-reviewed paper in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, which garnered significant media attention, including commentaries in STAT and Scientific American.
NIH Implements Policy on Sex as a Biological Variable in Research
NIH began implementing its new policy (announced in 2014) on sex as a biological variable in research. This policy requires grant applicants to account for sex as a biological variable in their research designs, analyses, and reporting in vertebrate animal and human studies. SWHR strongly supported the policy in a white paper titled “New Policies Signal Changing Attitudes on Sex Differences Research: An SWHR Perspective,” which reflected on and analyzed the new policy and made recommendations on the policy’s implementation.
SWHR Holds Workshop to Produce Feedback for FDA on Clinical Trial Design
SWHR held a two-day workshop “Achieving Meaningful Subgroup Data in Clinical Trial Design and Development: Scientific Approaches and Considerations” to develop information to share with FDA in response to its 2014 Action Plan to Enhance the Collection and Availability of Subgroup Data. The workshop focused on understanding the drivers of variability in drug response among different patient populations, improving drug development and approval processes, and refining communication to patients and health care providers about medication response variability.
SWHR Cohosts Conference on Sex Differences at University of Colorado
In partnership with the University of Colorado’s Center for Women’s Health Research, SWHR hosted the National Conference on Women’s Health Research on sex differences in metabolism. Experts gathered to discuss their latest findings in cardiometabolic risk across the lifespan as well as recognize critical next steps to take in order to advance the field of sex differences research.
SWHR Roundtable Examines Sex and Gender Differences in Migraine
SWHR hosted a roundtable discussion and public panel (the first of its kind at SWHR) on sex and gender differences in migraine. The meeting aimed to establish next steps to address the gaps in migraine knowledge and resulted in publication of a peer-reviewed paper in the Journal of Women’s Health. This meeting led to the formation of SWHR’s Interdisciplinary Network on Migraine.
SWHR Creates Interdisciplinary Network on Migraine
SWHR’s Migraine Network provides thought leadership about migraine in the U.S. health care system, with a focus on the disease’s disproportionate burden on women. The Network’s major accomplishment to date is its Migraine Patient Toolkit, which provides easy-to-understand information about migraine diagnosis and treatment, as well as tips on interacting with health care providers and health insurance companies.
SWHR Roundtable Identifies Gaps in Endometriosis Research and Care
SWHR brought together patients, clinicians, researchers, and other stakeholders for a roundtable discussion and public panel on unmet needs and knowledge gaps in endometriosis. The roundtable set the stage for a congressional briefing in June with three endometriosis experts identifying policy needs to improve diagnosis, treatment, and access to care for women with endometriosis. Roundtable members also published a peer-reviewed paper in AJOG that analyzes research gaps in endometriosis and unmet needs for women with the disease. These events gave rise to SWHR’s Interdisciplinary Network on Endometriosis and Fibroids.
SWHR Establishes Interdisciplinary Network on Endometriosis and Fibroids
SWHR’s Network on Endometriosis and Fibroids provides thought leadership on how to address the gaps in research, diagnosis, treatment, and care for endometriosis, uterine fibroids, and related conditions. The Network is working on projects to raise awareness about stigma around these conditions and to help patients achieve optimal outcomes in their care.