WOMEN’S HEALTH In Focus AT NIH

FE AT U R E S TO RYThe first Acting Director of ORWH,Ruth L. Kirschstein, M.D., speaks at anNIH event in the early 1990s.Medical Research Prior to theEstablishment of ORWH. Historically,some biomedical research practicesand persistent social inequities resultedin a scientifically inaccurate premise.Many studies functioned under the tacitassumption that aside from their sexualand reproductive organs, men andwomen are, in essence, physiologicallyidentical. Most clinical trials excludedwomen as subjects, ostensibly toprotect women of childbearing ageand their babies and to avoid what wasperceived as the confounding factor ofwomen’s fluctuating hormone levels.2However, some observers commentedthat—because many clinical trials tacitlytreated men as the medical norm andexcluded postmenopausal women,racial and ethnic minorities, children,and the elderly—systemic and culturalbiases might also have contributed tothe exclusion of women.Since the late 1960s, in the wakeof multiple national civil libertiesmovements, women’s and minorityadvocacy groups have drawnattention to the inequities inherent inbiomedical research and the healthcare system. In so doing, they beganwhat became known as the women’shealth movement. In the early 1970s, forinstance, the Boston Women’s HealthBook Collective—cofounded by activist,writer, and editor Judy Norsigian—published literature on women’s health,most notably the enormously influentialOur Bodies, Ourselves, which addressedwomen’s reproductive health andsexuality.3 This organization, now knownas Our Bodies Ourselves, continues toadvocate for women’s health today.In 1984, health care activist ByllyeAvery established the National BlackWomen’s Health Project, now the BlackWomen’s Health Imperative, to addressthe reproductive and general healthof African-American women within asystem that tended to marginalizethem. These and other efforts bymembers of the women’s healthmovement attracted the attention oflawmakers, health officials, and otherinfluential stakeholders.The Federal Response to the Women’sHealth Movement. In the years leadingup to the establishment of ORWH,several Federal officials took action toaddress women’s health concerns. In1983, then-Assistant Secretary of HealthEdward Brandt, Jr., M.D., establishedthe Public Health Service (PHS) TaskForce on Women’s Health Issues1 andappointed Ruth L. Kirschstein, M.D.,as its chair. Dr. Kirschstein, the firstwoman to serve as the Director of anNIH Institute (the National Institute ofGeneral Medical Sciences, or NIGMS),was already a respected figure in thebiomedical research and health policycommunities. (Dr. Kirschstein would laterserve as the Deputy Director of NIH,twice as the Acting Director of NIH, andas the first Acting Director of ORWH.)Under Dr. Kirschstein’s leadership, thePHS Task Force on Women’s HealthIssues advocated greater inclusion ofwomen in NIH-funded clinical research.The task force also recommended thatbiomedical and biobehavioral researchbe expanded to ensure emphasis onconditions and diseases unique to—ormore prevalent in—women of all agegroups1 and established evidence-basedclinical standards for determining healthproblems, conditions, and diseases thataffect women.4Meanwhile, the Congressional Caucus forWomen’s Issues responded to calls fromscientific and advocacy organizationsto improve women’s health andassociated research efforts and joinedthe PHS Task Force in calling for greaterinclusion of women in federally fundedclinical research. Four members ofthe U.S. Congress—Barbara Mikulski,Connie Morella, Olympia Snowe, andPat Schroeder—pushed for increasinginclusion of women as research subjects.In 1986, in response to (1) encouragementfrom the Congressional Caucus forWomen’s Issues, (2) the recommendationsof the PHS Task Force on Women’s HealthIssues, and (3) concerns raised by healthadvocates in the women’s healthmovement, NIH enacted the Inclusion ofWomen and Minorities in Clinical Researchpolicy, which urged researchers applyingfor NIH funding for studies involvinghuman subjects to include womenand minorities.In 1989, the Congressional Caucusfor Women’s Issues and the U.S.House of Representatives Energy andCommerce Subcommittee on Health andEnvironment introduced the Women’sHealth Equity Act, which called for theGeneral Accounting Office (now theGovernment Accountability Office, orGAO) to investigate NIH’s policy andpractices regarding the inclusion ofwomen as research subjects in NIHsponsored studies.1 In a 1990 report,GAO described its examination of about50 NIH grant applications, most ofwhich proposed studies on conditionsthat affect both men and women.5Approximately 20% of the proposalsprovided no information on the sexof the study population, and over athird indicated that both sexes wouldbe included but did not specify inwhat proportions.5 Some applicationsproposed all-male studies withoutproviding a rationale.5 The findings in theGAO report led the Congressional Caucusfor Women’s Issues and other legislatorsto take action.The Establishment of ORWH. InSeptember 1990, Senator Mikulski andRepresentatives Morella, Schroeder, andSnowe requested a meeting with NIHleadership and held a news conferenceW O M E N ’ S H E A LT H I N F O C U S AT N I H V O L . 3, N O. 1, 2020 4

FE AT U R E S TO RYon the NIH campus to express concernsabout the lack of inclusion of women inclinical research. Acting under the aegisof U.S. Department of Health and HumanServices (HHS) Secretary Louis WadeSullivan, M.D., then-Acting NIH DirectorWilliam F. Raub, Ph.D., used the occasionto give assurance that efforts would bemade to include more women in clinicalstudies and announced the establishmentof ORWH.6 The new office would striveto increase women’s participation inNIH-funded clinical research; enhanceNIH’s efforts to improve the prevention,diagnosis, and treatment of illness inwomen; and enhance research related todiseases, disorders, and conditions thataffect women.1Dr. Raub appointed Dr. Kirschstein toserve as the new office’s Acting Director,and she insisted that research remaincentral to the mission of ORWH andthat the new office should also focuson increasing the number of women inbiomedical careers.6 At the time, womenin biomedical research and healthcare faced numerous barriers to careersuccess, including unequal pay, lack ofopportunities for promotion, sexualand gender harassment, and unfriendlyfamily leave policies. Despite considerableprogress, some of these exclusionaryworkplace barriers persist to this day.Over the next year, Dr. Kirschsteinorganized, staffed, and set the prioritiesof the new office, with strong supportfrom the newly appointed Directorof NIH, Bernadine Healy, M.D., thefirst—and, to date, only—womanto hold the position. Dr. Healy was astrong advocate for women’s healthresearch and the architect of NIH’sWomen’s Health Initiative (WHI), a 15year research program addressing thehealth of postmenopausal women.1,7Drs. Kirschstein and Healy organized the“Hunt Valley Conference” for scientists,clinicians, and other stakeholdersto share their ideas for ORWH overseveral days of meetings and workinggroup sessions. A formal report of theconference’s proceedings, often referredto as the “Hunt Valley Report,” set NIH’sfirst women’s health research agenda.8The Hunt Valley Report summarized thetopics discussed at the conference andarticulated some of the goals that wouldbecome central to ORWH’s mission, suchas ensuring the inclusion of women inclinical research, addressing gaps inscientific knowledge about women’shealth across the lifespan, and increasingthe number of scientific investigationsdesigned to reveal sex and genderdifferences in health outcomes.8Dr. Kirschstein also recruited keypersonnel to the ORWH staff, includingJudith H. LaRosa, Ph.D., who served asORWH’s first Deputy Director for severalyears; Wendy Wertheimer, a legislativeand health policy specialist and latera Senior Advisor in the Office of AIDSResearch (OAR); and Vivian Pinn, M.D.,a pathologist from Howard University,who, in 1991, became the first full-timeDirector of ORWH, a position she wouldhold until she retired in 2011. Additionalindividuals who made substantialcontributions to the establishment of theoffice and/or were general supportersof women’s health research around thattime include U.S. Representatives LouiseSlaughter and Henry Waxman; formerU.S. Congressional staffers Cindy Hall,Ruth Katz, J.D., M.P.H., and Susan F. Wood,Ph.D.; and health advocates Cynthia A.Pearson and Diana Zuckerman, Ph.D.*Dr. Pinn’s Tenure: Setting Prioritiesand Initiating Changes in Women’sHealth Research. Prior to taking thehelm of ORWH, Dr. Pinn had brokenmany barriers over a successful andtrailblazing career. In 1967, she earned hermedical degree as the only woman andonly person of color in her class at theUniversity of Virginia School of Medicine.She received her postgraduate trainingas a Research Fellow in pathology at theMassachusetts General Hospital, with afocus on immunopathology. She was aTeaching Fellow at Harvard Universityand, later, an Assistant Professor ofFormer Ambassador and U.S.Representative Connie Morella, oneof the Congresswomen who helpedestablish ORWH, speaks about theformation of the office at a2010 NIH event.Pathology and Assistant Dean of StudentAffairs at Tufts University. In 1982, Dr.Pinn became a Professor and the Chairof the Pathology Department at HowardUniversity Hospital—only the thirdwoman and the first African-Americanwoman to lead a pathology departmentin the United States.ORWH accomplished much duringDr. Pinn’s early tenure. ORWH initiatedthe Re-Entry into Biomedical ResearchCareers program, which assistsresearchers with high potential tore-enter active research careers after aqualifying interruption, such aschildbirth7, and the ResearchEnhancement Award Program (REAP),which supported universities that trainedresearch scientists but that had not yetreceived major NIH support.7 ORWH alsocosponsored the Women’s ReproductiveHealth Research (WRHR) CareerDevelopment Program, an initiativecreated by the Eunice Kennedy ShriverNational Institute of Child Health andHuman Development (NICHD) topromote the physician-scientistworkforce with a focus on women’sreproductive health. In 1993, the U.S.Congress statutorily established ORWHas a provision of the NIH RevitalizationAct.1 This legislation also mandated thatORWH establish the CoordinatingCommittee on Research on Women’sHealth (CCRWH), a group of NIH Directorsor their senior-level designees that* Early advocates, including government officials, who had a role in the origins of ORWH remained supportive through the years, and in different rolesin their careers.W O M E N ’ S H E A LT H I N F O C U S AT N I H V O L . 3, N O. 1, 2020 5

FE AT U R E S TO RYmakes recommendations to advance NIHgoals regarding women’s healthresearch, and the Advisory Committeeon Research on Women’s Health(ACRWH), a group of non-Federal expertswho make similar recommendationsfrom an external perspective.7In 1999, ORWH launched the BuildingInterdisciplinary Research Careers inWomen’s Health (BIRCWH) program, amentorship program aimed at careerdevelopment within fields relatedto the health of women.9 Since itsestablishment, BIRCWH has connectedjunior and senior faculty with sharedresearch interests in women’s healthand sex differences. In 2002, the Officeof Women’s Health (OWH) of the U.S.Food and Drug Administration (FDA)and ORWH started the SpecializedCenters of Research (SCOR) on Sex andGender Factors Affecting Women’sHealth program (now known as SCORE),supporting research centers thatintegrate sex and gender factors anddifferences into their interdisciplinarystudies of major medical conditions.9Under Dr. Pinn’s direction, ORWHpublished or supported the publicationof several seminal texts on women’shealth and research. Women and HealthResearch, an ORWH-supported reportfrom the Institute of Medicine (IOM),describes the facts behind perceptionsof women as subjects in biomedicalresearch as well as principles for ethicalconduct of research on women.10Women’s Health in the Medical SchoolCurriculum details results from surveys ofmedical schools and provides a rationalefor the development of a women’shealth curriculum.11 The Women of ColorHealth Data Book provides clinicians andresearchers comprehensive informationon the unique health features ofwomen of color.12 Beyond Bias andBarriers: Fulfilling the Potential of Womenin Academic Science and Engineering,an ORWH-supported publication ofthe National Academies of Sciences,Engineering, and Medicine (NASEM),made recommendations for supportingwomen working in scientific andacademic fields.13In response to the NASEM report,NIH established the Working Groupon Women in Biomedical Careers in2007. Since its inception, the workinggroup has sponsored workshops onmentoring and sustaining career success,changed NIH grant and conferenceapplications to accommodate workingwomen, improved family leave policies,and established the Women of ColorResearch Network, a social networkingplatform for women of color andtheir supporters in the biomedicalworkforce. In 2008, the working group,in concert with ORWH and numerousparticipating ICs, developed a Requestfor Applications (RFA) titled “Researchon Causal Factors and Interventions thatPromote and Support the Careers of

published literature on women’s health, most notably the enormously influential . Our Bodies, Ourselves, which addressed women’s reproductive health and sexuality. 3. This organization, now known as Our Bodies Ourselves, continues to advocate for women’s health today. In 1984, health care activist Byllye Avery established the National Black